Yves here. Reader IM Doc, an internal medicine practitioner of 30 years, trained and worked in one of the top teaching hospitals in the US for most of his career before moving to a rural hospital in an affluent pocket of Flyover. He has been giving commentary from the front lines of the pandemic. Along with current and former colleagues, he is troubled by the PR-flier-level information presented to the public about the Pfizer and Moderna vaccines, at least prior to the release of an article in the New England Journal of Medicine on the Pfizer vaccine: Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. However, he did not find the study to be reassuring. He has taken the trouble of writing up his reservations after discussing the article with his group of nine physicians that meets regularly to sanity check concerns and discuss the impact that articles will have on their practices.
By IM Doc, a internal medicine doctor working in a rural hospital in the heartlands
Right off the bat – I am as weary and concerned about this pandemic as anyone. What my little rural area has been through in the past three weeks or so has been nothing short of harrowing. This virus has the ability to render patients about as sick as I have ever seen in my life, while leaving more than half the population with minimal if any symptoms. The patients who are sick are often very sick. And instead of slow and steady improvement like we normally experience, most of these patients are assigned to a long and hard slog. Multiple complications arise. This leads to very diminished throughput in the hospital. The patients literally stack up and we have nowhere to put the new ones coming in who themselves will be there for days or weeks. On top of that are the constant donning and doffing of PPE and intense emotional experiences for the staff, who are themselves becoming patients or in this small town have grandma or Aunt Gertrude as a patient.
To put it bluntly, I want this pandemic over. And now. But I do not want an equal or even worse problem added onto the tragedy. And that is my greatest fear right now. And medical history has demonstrated conclusively over and over again: brash, poorly-thought-out, emotion-laden decisions regarding interventions in a time of crisis can exponentially increase the scale of pain and lead to even worse disasters.
I am not an anti-vaxxer. I have given tens of thousands of safe and tested vaccines over my lifetime. I am very familiar with side effects and safety problems associated with all of them. That is why I can administer them with confidence. I am also an optimist, so all of the cautions I discuss below are the result of experience and the information made public about the Pfizer vaccine, not a temperamental predisposition to see the glass as half empty.
I know this piece is long, but I wanted to completely dissect the landmark New England Journal of Medicine (from now on NEJM) publication of the first Pfizer vaccine paper. I am replicating the method of my mentor in Internal Medicine, a tall figure in 20th Century medicine. He was an internationally recognized authority and his name is on one of the foundational textbooks in his specialty. He was a master and he taught me very well, including the fundamentals of scientific inquiry and philosophy, telltale signs of sloppy or dishonest work, the order in which you should dissect someone’s work, and the statistics involved.
When I have a new medical student doing rotations with me, I give them a collection of reading. At the very top is Drug Companies & Doctors: A Story of Corruption from the New York Review of Books in 2009 by Marcia Angell, MD. She was the editor-in-chief of the NEJM, the very journal that published this Pfizer vaccine paper.
Dr. Angell’s article is the Cliffs Notes version of much longer discussions she had about corruption, corporatism, managerialism, profiteering, greed, and deception in in the medical profession. Patient care and patient concerns and indeed patient lives in her mind have been absolutely overcome by all of these other things. It is a landmark paper, and should be read by anyone who is going to interact with the medical community, because alas, this is the way it is now. I view this paper the exact same way I view Eisenhower’s speech about the military industrial complex. What she said is exactly true, and has only become orders of magnitude worse since 2009.
And now the paper.
Unfortunately, this study from Pfizer in the latest NEJM, and indeed this whole vaccine rollout, are case studies in the pathology Agnell described. There are more red flags in this paper and related events than present on any May Day in downtown Beijing. Yet all anyone hears from our media, our medical elites, and our politicians are loud hosannas and complete unquestioning acceptance of this new technique. And lately, ridicule and spite for anyone who dares to raise questions.
I have learned over thirty years as a primary care provider that Big Pharma deserves nothing from me but complete and total skepticism and the assumption that anything they put forth is pure deception until proven otherwise. Why so harsh? Well, to put it bluntly, Big Pharma has covered my psyche with 30 years of scars:
• As a very young doctor, I treated an extraordinary middle-aged woman who had contracted polio as a toddler from a poorly tested polio vaccine rolled out in an “emergency.” Tens of thousands of American kids shared her fate1
• The eight patients I took care of until they died from congestive heart failure that had been induced by a diabetes drug called Actos. The drug company knew full well heart failure was a risk during their trials. When it became obvious after the rollout, they did everything they could to obfuscate. Actos now carries a black box warning about increased risk of heart failure
• The three women who I took care of who had been made widows as their husbands died of completely unexpected heart attacks while on Vioxx. I have no proof the Vioxx did this. But when Vioxx was finally removed from the market, the mortality rate in the US fell that year by a measurable amount, inconsistent with recent trends and forecasts. Merck knew from their trials that Vioxx had a significant risk of cardiovascular events and stroke, and did absolutely nothing to relay that danger in any way. Worse, they did everything they could to muddle information and evade responsibility once the truth started to come out
• The dozens upon dozens of twenty and thirty-something patients who have been rendered emotional and spiritual zombies by the SSRIs, antipsychotics and amphetamines they have been taking since childhood. Their brain never learned what emotions were, much less how to process them and we are left with empty husks where people never developed. The SSRIs and antipsychotics were NEVER approved for anyone under 18. EVER. While there are some validated uses for stimulants in children, they are obviously overprescribed, as confirmed by long-standing media reports of their routine use as a study/performance aid. It is all about the lucre.
• The hundreds and hundreds of 40-60 year olds who have been hollowed out from the legal prescribing of opioids. All the while the docs were resisting this assault, the drug companies and the paid-off academics and medical elites were changing the rules to make physicians who did not treat any pain at all with opiates into evil Satan-worshippers. And they paid for media appearances to drive across the point: OPIATES ARE GOOD. WE HAVE MADE THEM SO YOU CANNOT GET ADDICTED. And here we are now with entire states taking more opioids than in the waning days of the Chinese Empire, and we all know how that story ended. All this misery so a family of billionaires can laugh its way to the bank.
I carry all these people and more with me daily. I would not be doing a service to their memory if I allowed myself to be duped into writing another blind prescription that was going to add yet another scar.
I will dissect the important parts of this paper exactly as my mentor described above taught me. He performed years of seminal research. He was a nationally-known expert in his field.
In medicine, especially in top-tier journals like NEJM, landmark papers are always accompanied by an editorial. These editorials are written by a national expert who almost always has “peer-reviewed” the source material as well. This is how the reader knows that an expert in the field has looked over the source material and that it supports the conclusions in the paper. My mentor did this all the time. The binders all over his office were the actual underlying data that he scrutinized to confirm the findings. There is no way on earth to print and publish the voluminous source material. Editorial review was one sure way all to assure that someone independent, with appropriate experience, confirmed the findings. This was onerous work, but he and thousands of others did it because this is the very essence of science. He was scrupulous in his editorials about findings, problems, and conclusions. It was after all his reputation as well.
My first lesson from him: READ THE EDITORIAL FIRST. It gets the problems in your head before you read the statistics and methods, etc. in the actual paper. It gives you the context of the study in history. It often includes a vigorous discussion of why the study is important.
Admittedly, over the past generation, as the corporatism and dollar-counting has taken over my profession and its ethics, this function of editorial authoring has become at times increasingly bizarre and too-obviously predisposed to conclude with glad tidings of joy, especially if pharmaceuticals are involved.
So I read the editorial first. You can find it on the NEJM webpage, in the top right corner.
And, amazingly, it is basically a recitation of the same whiz-bang Pfizer puffery that we have all been reading for the past few weeks. There really is not much new. Furthermore, it is filled with words like “triumph” and “dramatic success”. Those accolades have yet to be earned. This vaccine has not yet even been released. Surely, “triumph” is a bit premature. Those words would NEVER have been used by my mentor or similar researchers in his generation. They would have been focused on the good, the bad and the ugly. A generation ago, editorial reviewers saw their job as informing the reader and making certain the clinicians that were reading knew of any limitations or problems.
In quite frankly unprecedented fashion, two different events that were carefully reported occurred almost simultaneously with the release of both the paper and the editorial. Both of these events contradict and contravene data and conclusions reported in both the paper and the editorial and I believe they deserve immediate attention. They both belie the assertions of the editorial writers that [emphasis mine] “the (safety) pattern appears to be similar to that of other viral vaccines and does not arouse specific concern”.
First, a critical issue for any clinician is “exclusion criteria”. This refers in general to groups of subjects that were not allowed into the trial prima facie. Common examples would include over 70, patients on chemotherapy and other immunosuppressed patients, children, diabetics, etc.. This issue is important because I do not want to give my patient this vaccine (available apparently next week) to any patient that is in an excluded group. Those patients really ought to wait until more information is available – FOR THEIR OWN SAFETY. And not to mention, exclusion criteria exist because the subjects in them are usually considered more vulnerable to mayhem than average subjects. From my reading of this paper, and the accompanying editorial, one would assume there were no exclusion criteria. They certainly are never mentioned.
I reiterate, the paper is silent on this question of exclusion criteria, as is the editorial. Had my mentor seen something like “exclusion criteria” in the source material, and realized that it was not in the final paper, he would have absolutely included a notice in his editorial. This would have been after calling the principal investigator and directly questioning why there was no mention in the original paper. Patient safety should be foremost on everyone’s mind at all times in clinical research and its presentation to practitioners.
And now we know there were exclusion criteria, not because of anything Pfizer, the investigators, or the NEJM did but because of stunning news out of the UK. UPDATE: I will address this at greater length, but an alert reader did find the study protocol, which were not referenced in any way that any of the nine members in my review group could find, nor were they mentioned in the text of paper or editorial, as one would expect for a medication intended for the public at large. I apologize for the oversight, but this information was not easy to find from the article, not mentioned or linked to from the text of the article, the text of the editorial, in the “Figures/Media,” or in a supplemental document.
In the UK on day 1 of the rollout, two nurses with severe allergies experienced anaphylaxis, a life-threatening reaction to this vaccine. Only after world-wide coverage did Pfizer admit that there was an exclusion criterion for severe allergies in their study.
Ummm, Pfizer, since we are now getting ready to give this to possibly millions of people in the next few weeks – ARE THERE ANY OTHER EXCLUSION CRITERIA? Should I, as a physician, specifically not be giving this to patients with conditions that you have excluded?
Furthermore, NEJM, since you published this trial, have you bothered to at least put a correction on this trial on your website that it should NOT be given to people with severe allergies? I certainly see nothing like this.
Should someone from the NEJM or the FDA be all over Pfizer to ascertain the existence of other exclusion groups so we do not accidentally harm or kill someone over the next two weeks?
Unfortunately, Americans, you have your answer from the FDA about severe allergic reactions right from a press conference in which Dr. Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research is quoted as saying:
Even people who’ve had a severe allergic reaction to food or to something in the environment in the past should be OK to get the shot….1.6% of the population has had a severe allergic reaction to a food or something in the environment. We would really not like to have that many people not be able to receive the vaccine.
Are you serious? Dr. Marks, have you ever seen an anaphylactic reaction? I live in a very rural area. Many patients live 30 minutes or more from the hospital. What if one of them had an anaphylactic reaction to this vaccine hours after administration, had no epi-pen and had to travel a half hour to get to the nearest hospital? There is a very high likelihood that a good outcome would not occur. Sometimes, as a physician, I simply cannot believe what I am hearing out of the mouths of our so-called medical leaders.
To the writers of the editorial accompanying this research:
Did you actually look at the source material? The existence of at least one exclusion criterion for severe allergic reactions had to be in there somewhere. If you did look at the source material, are there others that the physicians of America need to know about? If they were not in the source material, after the events in the UK, has anyone bothered to follow up with Pfizer about this omission?
Does anyone at NEJM or Pfizer or FDA plan to fully inform the physicians of America? Does ANYONE at NEJM or Pfizer or FDA care about patient safety?
Now for the second story that got my attention this week, an article from JAMA Internal Medicine, a subsidiary of JAMA, The Journal of the American Medical Association.
JAMA, like NEJM, is one of America’s landmark medical journals. I will assure you that JAMA is not the National Enquirer. This piece was written by a nursing researcher. It is very likely she is well-versed in all aspects of American medical research.
In her story, she details her recruitment and her experience in the Pfizer COVID trial, the same one we are dissecting here. She describes in detail her experience with the vaccine and the fact that she is concerned that many patients are likely going to feel very sick after the injection. She wrote up her own reactions, and included a very troubling one. About 15 hours after her second injection, she developed a fever of 104.9. She explained that she called her reaction to the Research Nurse promptly the next morning. The recounted the response of the Research Nurse to her information as “A lot of people have reactions after the second injection. Keep monitoring your symptoms and call us if anything changes.”
Thankfully, it appears this nurse has completely recovered. From the best I can tell, this encounter occurred in late August and early September, putting it well within the trial’s recruitment of arms as detailed in the paper.
This JAMA article impinges directly on Figure 2 on page 7 of the paper, a graphic that that lays out all the major side effects during in the trial.
It is very important to note that based on the trial’s own data, conveniently laid out on the very top of the figure in green, blue, orange and red, a temperature of 104.9F or 40.5 C is described as a Grade 4 event. The definition of a Grade 4 event is anything that is life-threatening or disabling. A fever of 104.9 can have grave consequences for any adult and is absolutely a Grade 4 event.
By law, a grade 4 event must immediately be reported to the FDA, and to the Institutional Review Board (the entity charged with overseeing the safety of the subjects) and to the original investigators. THERE IS NO EXCEPTION. One would think that would also be reported in the research paper to at least alert clinicians to be on the lookout.
I could not find any mention of this event in the text of the paper. NOT ONE. Let’s take a closer look at Figure 2 on page 7 where adverse events are reported in a table form. Please note: this is a very busy image, and in the browser version, with very low resolution graphics that are profoundly difficult to read (they are a bit clearer if you download the PDF). This is a time-tested pharmaceutical company tactic to obscure findings that they do not want you to see. My mentor warned me about ruses like these years ago, and finding one raises the possibility that deception is in play.
The area for the reporting of this Grade 4 reaction would be on the 2nd row down at the left of the set called B, titled systemic events and use of medication. The area of concern would be where the graph is marked with the number 16. Do you see a red line there? It would be at the very top. I have blown this up 4 times on my computer and see no red there. I am left to assume that this Grade 4 “Life Threatening or Disabling” event that was clearly within the time parameters of this trial was not reported in this study.
To those who say that I am making way too much out of one patient with a severe fever, let’s do a little math. There are 37,706 participants in the “Main Safety Population” (from Table 1), of which 18.860 received the vaccine.2 Let us assume that this individual was the only one that had a GRADE 4 reaction. Let us also assume that the end goal is to vaccinate every American a total of 330,000,000 people. So if we extrapolate this 1 out of 18,860 into all 330,000,000 of us, it suggest that roughly 17,500 could have this kind of fever. Now assume a 70% vaccination rate, and you get that would be approximately 12,250. I hope you now understand that in clinical medicine related to trials like this – a whole lot of nothing can turn into a whole lot of something quickly when you extrapolate to the entire targeted group. Does anyone not think that the clinicians of America should be prepared for anything like this that may be coming?
A couple more questions for NEJM and the editorial writers:
Were you ever made aware that this Grade 4 reaction occurred? Now that we have a reliable report that it occurred, has there been any attempt to investigate?
Did the Research Nurse actually report this event? If not, was she just simply not trained or was there deliberate efforts to conceal such reactions? How many more reactions were reported anywhere this trial was conducted and that did not make it to the FDA, the IRB or possibly the investigators? Is that not a cause for concern?
As if this is not enough, there is so much more wrong with this editorial. Now we are going to talk about corruption.
I want to reiterate my concern that over the past generation, as my profession has lost its way, its medical journals have turned into cheering sections for Big Pharma rather than referees and safety monitors. We all should relish the great things medical science is doing, but we should be doing EVERYTHING we can to minimize injury and death. Too often our journals have become enablers of Big Pharma deceiving our physicians and the public. Unfortunately, this paper and its editorial look troublingly like a case study of this development.
To provide context, I looked over the last month of the NEJM, the issues from November 12, 19 and 26th and December 3rd. Based on having read the NEJM over the years, I believe these four weeks are representative.
During this period, there were 15 original articles published in the fields of Oncology, General Surgery, Infectious Disease, Endocrinology, Renal, Cardiology, Pulmonary and Ear Nose & Throat. Of these 15 articles, the editors thought that eight were important enough to have an editorial from an acknowledged expert. I have read every one of these studies and the editorials as I do every week. All eight in the past month were indeed by leading experts in the field of the underlying studies. They included a COVID vaccine overview reviewed by an leading figure in vaccinology, and two COVID papers about Plaquenil and other approaches discussed by top infectious disease experts.
It was unlikely that those papers were going to get national media attention. All medical stuff.
But here we have our Pfizer vaccine paper. We have 300,000 fatalities in the USA alone and millions of cases. We have whacked our economy, we are in the depths of a national emergency. And we have a paper, the first, that may offer a glimpse of hope. Certainly this would be a landmark paper, and certainly it was treated in that manner? Right?
One would think that the doctors of America would have this study explained to them by a world-known vaccinologist? NOPE…..Maybe a virologist? NOPE….. Maybe a leading government official? Dr. Fauci? Dr. Birx? Dr. Osterholm? NOPE…..Maybe an expert in coronaviruses? NOPE…
We get the Pfizer ad glossy editorial treatment from Eric Rubin MD, the editor-in-chief of the NEJM. And Dr, Longo, an associate editor. Dr. Longo is an oncologist. Dr. Rubin is at least a recognized infectious disease doctor, but his specialty based on my Google search is mycobacterium, not virology. Again, one would normally anticipate for a paper of this importance, the editorial would be from someone with directly on point expertise.
Why would this fact been important to my mentor? (and I had the privilege of hearing him trash a paper in an open forum about a very similar issue, a paper introducing a drug to the world that later was the disaster of the decade, Vioxx) Why is this important to me and all the other physicians in my review group here in flyover country yesterday?
Because the choice of authorship of the editorial leads you to one of only several conclusions:
• Pfizer would not release the source data because of proprietary corporate concerns and no self-respecting expert would review without it
• Pfizer knew there are problems and did not want anyone with expertise to find out and publicize them
• The editors could not find a real expert willing to put their name on a discussion
• Drs. Rubin and Longo are on some kind of journey to Vanity Fair and wanted their names on an “article for the ages”
• This is a rush job, and no one had time to do anything properly, and so we just threw it all together in a flash
Readers, pick your poison. If anyone can think of a sound reason, please let me know. I am all ears.
But let’s open up the can of worms a bit more. Pfizer supports NEJM. Just a brief swipe through of recent editions yielded several Pfizer ads. A Pfizer ad appeared on my NEJM website this AM. I do not know how much they pay in advertising but appears to be quite a bit.
Americans, have we devolved so far in our grift that it is now appropriate for the EDITOR-IN-CHIEF of our landmark medical journal to be personally authoring “rah rah” editorials about a product of a client that supports his journal with ad dollars? And he has the gall to not present this conflict on his disclosure form? Really? Am I the only one worried about this type of thing?
Now we travel from the can of worms to the sewer. And this impacts every single one of us. I want you to Google the names of the people on the FDA committee that voted 17-4-1 two days ago to proceed with the Emergency Use Declaration. Go ahead – Google it. On that list, you will find the name Eric Rubin, MD. Why yes indeed, that is the very same Eric Rubin MD who wrote this editorial. Who is the Editor-in-Chief of the NEJM. A publication that certainly takes ad dollars from Pfizer. And he was one of the 17 to vote for the Pfizer product to be immediately used in an emergency fashion. Oh yes, oh yes he was.
Am I the only one who can recognize that Pfizer and other pharma companies may have some influence on Dr. Rubin thanks continued support of his employer, the NEJM? Am I the only one concerned that Dr. Rubin’s “rah rah” editorial may have been influenced by Pfizer? Is anyone else troubled that the Editor-in-Chief of the NEJM, supported by Big Pharma advertising dollars, is sitting on an FDA board to decide the fate of any pharmaceutical product? Is this not the very definition of corruption? Or at least a severe conflict of interest? I strongly suspect that a thorough evaluation of members of that committee will reveal other problems. As my grandmother always used to say, “There is never just one roach under a refrigerator.”
I looked in vain all day today for media discussions of conflicts of interest with Dr. Rubin or anyone else in a position of authority. I found nothing.
What I did find was the Boston NPR affiliate WBUR discussing Dr. Rubin’s Yes vote. You can listen yourself:
This interview left me much more concerned about Dr. Rubin’s role and what exactly he read in the raw data from Pfizer. In this interview, he admits that he as an FDA advisory member has seen no data from the Moderna trial coming up for a vote this week:
These two vaccines are fairly similar to one another, so I am hoping the data will look good, but we haven’t seen the data yet, so I reserve judgement.
Excuse me, but should not the members already have the data and be mulling over it to ask intelligent questions?
These statements left me more worried about the issues I have already brought up with the Pfizer vaccine:
We don’t know if there are particular groups that should or should not get the vaccine…We do not know what will happen to safety over the longer term.
When finally asked specifically about the UK allergic reactions and if they came up in the FDA meeting (emphasis mine):
It did come up and this was a bit of a surprise because in the trial, that trial was limited to specific kinds of participants, there were apparently no incidents like that, nevertheless this suggests it is something we are going to have to look out for.
There is absolutely not a word in the published data to suggest there was a limit to SPECIFIC PARTICIPANTS – what on earth is he talking about? Are there limited specific kinds of patients that we as physicians should be looking to vaccinate?
In a fine finish, toward the end of the interview Dr. Rubin states he is a bit relieved that low risk patients will be getting the vaccine later after we know more about the side effects with the first patients. I am really not trying to be a jerk – but are you kidding me? I thought this vaccine was a triumph with minimal side effects.
Dr. Rubin, kind sir, I really feel that you owe a clarification about your statements in the WBUR interview to the patients and caregivers of America. We are the ones with lives on the line.
First, I have the privilege of sitting on an Institutional Review Board (an independent entity that protects patient safety) and I know something about Grade 4 side effects. Just for 1 Grade 4 side effect in one subject, the accompanying documentation would often be a half a ream of paper. Because I agreed to do that job, it was my obligation to look through that documentation. That half a ream was for one side effect in one trial. Yet, you state unequivocally in this interview, that you, as a sitting member of the FDA committee that oversees the safety of the nation in this affair, have not seen any of the Moderna documentation for that upcoming meeting this week.
For readers to fully understand what I am saying, this Moderna documentation is going to be reams and reams of documents that need to be evaluated carefully to ask the right questions. And you have not yet studied this? For a meeting in just a few days? I find this deeply troubling. Your statements create the appearance the committee you are sitting on is nothing more than a rubber stamp for a decision that has already been made. This would be an absolute tragedy.
Second, Dr. Rubin, you in your position as the Editor-in-Chief of the NEJM and the editorial writer for this research, may be one of the few people on earth that have seen the original Pfizer research. Despite calling this a triumph, you state in the interview that you are relieved that younger people less likely to get the vaccine early so you will have time to wait to see if complications develop in the first patients. You have stated, despite your assertion in the editorial that the side effects were consistent with other vaccines, that “we don’t know if there are particular groups that should or should not get the vaccine”. Have you seen something in that “triumph” research that is concerning enough to you to make such statements? As a physician, I would really like a clarification on this statement, given that the shots are already rolling out today.
Now that we are past the editorial, a few words about the nuts and bolts of the paper.
I look for very specific red flags – usually making the data difficult to interpret. This study did not disappoint.
On page 5, in Table 1, the Demographic Description of the participants, go down to the AGE GROUP area. Note it is divided into only two cohorts 16-55 and >55. This is a real problem. My mentor said an honest paper should never deploy such a tactic.
You see, more than half of my patients are over 70. Why is this kind of obfuscation a real problem for my ability to trust the vaccine? Well, the intro papers to many pharmaceuticals that have gone down the drain in recent years have used this very same device. It is their way of hiding the fact that they did not put many older patients in the trial, certainly not representative of the population, and certainly not representative of who is seemingly going to get this vaccine in the first round. Do I know that 90% of the >55 group is actually between 55-58? I don’t. How hard would it be for them to do a breakdown in decades? 16-25 26-35 36-45 46-55 56-65 66-75 76-85? We have lots of computers in this country and the population breakdown is done this way on studies I read all the time. Why not do provide this information on a study that is this critically important, particularly one where elderly patients will be near the head of the line?
What are they trying to do here? Unfortunately, too often drugmakers resort to this practice to hide their failure to test their drug on the elderly to an appropriate or safe degree, knowing there would likely be lots of problems. Because of their past behavior, I ALWAYS assume this is true until proven otherwise and act accordingly with my elderly patients.
That is the world these companies have made for themselves.
Now for the tables on pages 6 and 7 about immediate side effects.
Just a brief look shows that local soreness and tenderness is very common, up to 75% with this vaccine. That is a bit high, but not that far out of range from my experience with other vaccines.
The tables on page 7 are the whoppers.
Headaches, fatigue, chills, muscle pain and joint pain appear to be very common, way more common than other vaccines I am used to, as in an order of magnitude higher. It is very clear from this table that about half the patients, especially the younger ones, are going to feel bad after this vaccine. That is extraordinary.
We are told nothing about how long these symptoms last or the amount of time at work lost. The “minimal side effects comparable with other viral vaccines” in the editorial and press releases is just not consistent at all with my experience of 30 years as a primary care physician. There was universal agreement with this assessment among my MD colleagues. They had great concern about this as a matter of fact: great concern that it will cause bad publicity and decrease administration and great concern that given this already high side effect profile, it may be much worse when it gets out to the public.
Given the fact that this virus is largely asymptomatic in more than half the people infected, what exactly are we doing here?
Furthermore, unlike other pharmaceutical papers that try to explain variances in symptoms like this, there is not a word offered about possible underlying causes of these outcomes.
The numbers of COVID cases in the placebo group vs the vaccine group have been widely publicized, from 162 cases in the placebo group down to 8 in the vaccine group, giving a relative reduction of 95%. It seemed to all of us in our review group that we do not have nearly enough patients to really make assessments. That is not a criticism. The researchers have done admirably in my opinion to get this many patients this quickly. That is still the problem: they are going to be using the first million patients or so in the general public to get a real gauge on numbers and side effects.
Another issue of grave concern to us all on Friday was the asymptomatic cases. The only subjects counted in the 162 and the 8 numbers above were patients with symptoms. Who knows how many in each cohort were asymptomatic.
This to me leads to the most important question of all, and it was again completely untouched….. How many asymptomatic patients are there? And how many who were vaccinated are still able to spread the virus? Not even an attempt to answer that question. This is critical, and is one of the ways a vaccine can backfire. If a vaccine does not provide sterilizing immunity, ie stop transmission, it is of limited use for disease control. It is great for the individual, but if they can remain without symptoms and still spread it all around it does not help from a public health standpoint.
I have described my concerns and red flags about this study. I would like to add one more thing. Pharmaceuticals that go bad rarely do so in the first few weeks or months. Rather, the adverse effects take months or years. It is a known unknown of not just vaccines but any kind of drug. Our pharma companies have become notorious for having inklings or indeed full knowledge that there is a problem early on, and saying nothing until many are maimed or killed. I will assume that this is the case in this class of drugs until proven otherwise. They are such deceivers I have no choice.
Due to sense of urgency my colleagues and Ifeel about this vaccine rollout, we had an ad hoc meeting of our Journal Club to discuss the NEJM article. Of the nine physicians at the meeting, three have already had very mild cases of COVID. Of the nine, only one is enthusiastic about these vaccines. I have a wait and see stance. I will not be taking it myself. I have too many scars, too many staring at me from the grave to take any other approach.
My patients’ feeeback on the COVID vaccine has been very different than the polls finding that 60% are ready to take it. About half my patients are in the professional/managerial classes and feature a higher level of the 0.1% than the US overall. They tend to be more blue. Most prefer to wait and thankful that health care workers were getting it first. The other half who are working class, more red, and they feel the whole thing is a hoax. They will not be getting the vaccine – likely ever.
The only enthusiasts I would call elderly Rachel Maddow fans. That really makes no sense to me at all since Operation Warp Speed was a Trump project and even Kamala Harris said she would not take a vaccine that Trump recommended.
I would say AT BEST 25% of my patients will be getting this vaccine shortly after being available. There is widespread skepticism that is not being acknowledged by our media. The pharmaceutical industry has worked tirelessly to earn every bit of that disrespect.
Please look at Dr. Angell’s seminal article from 2009. She predicted in her works, all of this and more. My profession has been captured by a cabal of corporatist MBA clones, rapacious and unethical pharmaceutical entities, and an academic elite addicted to credentialism and cronyism. They have over the years bought off and infiltrated all of our government health care regulating agencies and our public health system. And they are completely incestuous. I believe where we are now to be worse than Dr. Angell could have ever dreamed. Even more depressing, I see no way out.
1 As a special homage to the polio patient described above, a truly exceptional woman, let me underscore that the disastrous rollout of the this polio vaccine came at a time similar to ours. Panic and malaise were in the air. The children of America and the world were being stricken with polio at an alarming rate. Dr. Alton Ochsner, a leading figure in medicine of the day, vaccinated both of his grandchildren in public in an attempt to bolster confidence in the vaccines. Within 8 days his grandson was dead of bulbar polio. All the celebrities and politicians lining up to take this vaccine on national TV should remember this tragedy. “Stupid human tricks” like this have no place in this kind of situation, and can backfire in unexpected ways. Unlike that era’s polio vaccine, there is no way on earth this vaccine can transmit COVID. However, there are those of us in the medical profession who treat the plan to make population-wide use of messenger RNA, which before these trials had been repeatedly investigated but never reached the human trial stage save in a small scale Zika vaccine study. This is no time for machismo. This is also no time for anything less than complete transparency on the part of everyone involved in the quest for safe and effective vaccines. To behave in any other way is an affront to patients like mine who have suffered and died in the past.
2 If you read the paper, you might well have wondered about that 18,860 number and even checked Table 1 to make sure it’s accurate (it is), since the third paragraph of the Abstract, under the headline “Results,” has very different figures:
A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo.
So how did the researchers get from 21,720 injected with the vaccine to the 18,860 in the “Main Safety Population”? This sort of thing confirms the impression that this is a very incomplete or sloppy study. It is really not clear where the difference between the 37,706 and the 43,548, or for that matter, the 36,520 total subjects in the Tables 2 and 3 (Efficacy) come from. I used the 37,706 and hence the 18,860 that went with it from Table because it gave slightly smaller numbers than using the Table 2 and 3 figures, but they would be close to each other.
My concern here is the 6000ish discrepancy between the figures in the main text compared to the tables. Were they excluded? If so, why? I could not make heads or tails out of this, and accordingly kept it out of the body of this post. This kind of inconsistency really needs to be hashed out with the actual source data in hand, and should have been explained in the article, even if just in footnotes.
Bravo! I teach first-year medical students, and this is going into the curriculum. Somehow.
I am not sure how you and your staff do it.
I have read this guy’s comments for the past two months on this site.
This should be in the national media somehow. Why are docs like this not all over the news as a counterpoint to the winking, nodding, crying-on-cue Barbie & Ken dolls?
It is amazing that he writes with such clarity about these very complicated issues. I am certain there are going to be mistakes with this analysis or any analysis – but man does he bring home some points.
He also clearly cares about his own patients and patients in general.
I nominate this guy, IM Doc, for the head of the FDA.
Do I have a second?
I’ll second that!
What about having to be transported and stored at -180c?
This logistical concern has not been mentioned in the last month or so.
“Appendicitis was reported as a serious adverse event for 12 participants, and numerically higher in the vaccine group, 8 vaccine participants and 4 placebo participants. Currently available information is insufficient to determine a causal relationship with the vaccine.”
“From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy were imbalanced with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. Throughout the safety follow-up period to date, Bell’s palsy (facial paralysis) was reported by four participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of Bell’s palsy were reported in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine.”
Could be someone is going to make a lot of money taking care of the logistical and storage end of this deal…
@foghorn: The temperature I saw originally was -80° C, which is about -121° F. After the initial announcement of this requirement the number stayed the same for a couple of days, but then started going down. I think it was today I saw (on Rising, IIRC) a claim that it was -79° F!!! And that dry ice was sufficient to maintain that temperature as long as the container was not opened more than twice a day. I haven’t been paying much attention because there’s no way the vaccine will be used in Thailand (the government has already purchased the Oxford/Astra-Zeneca vaccine for delivery in [I think] May next year).
Thanks for the correction, Procopius.
How could you ‘open’ something that is essentially a ‘frozen brick’ is the question then?
There was talk a month ago of having to purchase super refrigerators to maintain the extreme cold temperature, doesn’t really seem to be an issue any longer tho.
I second the nomination.
Coming into this late but I give it a fourth and final nomination.
Yes the clarity of the article is brilliant. Thanks very much IM Doc for producing it and Yves for creating the environment for it to come to light. Another example of why NC is the best site on the web, it always seems there’s a humble top draw expert in whatever field you care to pick lurking in the comments when the time comes for a highly experienced voice to be heard.
I just want to say thank you for putting your own career at risk to publish this. This type of piece is the kind of piece that gets one blacklisted, but you have forged ahead anyway. You’ve done the brave thing.
Having had some experience with inclusion/exclusion criteria and adverse event reporting, this wouldn’t have passed my IRB. And if my IRB found out about that potential advertising dollars conflict of interest after the fact, we would have called a meeting with the PI on finding out about it, and then had a closed meeting to discuss the implications.
How does this put his career at risk? It’s completely anonymous! I’m grateful for the read and warning but I have no way to verify this guy, or gal’s credentials.
You assume someone highly motivated might not be able to succeed. He did provide a fair bit of biographical detail, and I left his writing style largely intact. The supposedly anonymous author of Primary Colors was identified via computer analysis of his style.
This article is even better as it is long. Thanks to the author for writing it, and for NC for publishing it.
Is this physician willing to go public, i.e., speak on the record?
Only if he’s ready to lose his business. It seems like being outspoken against the official narrative is very career limiting right now. Many examples in the news lately of doctors and nurses (and data scientists) being dropped for publicizing the wrong answers.
Great article, btw. I’ll probably forward links to my friends and family.
People who have gone against the Medical-Industrial Complex have face multi-million lawsuits and have lost their livelihood. I don’t blame him for being incognito. I have to remember what happened to Snowden who went against the Military-Industrial-Espionage Complex.
Supply a want like money or sex and you are rewarded; do the responsible and honorable thing of protecting the people and get ruined. How nice that I live in a country where Epstein was rewarded for decades while Snowden is an exile and Assange is in solitary.
Well said, JBird4049!
Why should (s)he go on the record? (S)He pointed to the red flags… you can do the additional legwork to verify.
“This to me leads to the most important question of all, and it was again completely untouched….. How many asymptomatic patients are there? And how many who were vaccinated are still able to spread the virus? Not even an attempt to answer that question. This is critical, and is one of the ways a vaccine can backfire. If a vaccine does not provide sterilizing immunity, ie stop transmission, it is of limited use for disease control. It is great for the individual, but if they can remain without symptoms and still spread it all around it does not help from a public health standpoint. ”
Thank you, IM Doc. THIS is what the vast majority of people don’t seem to get. They’re buying the idea of a vaccine that is “safe” and “95% effective.” But effective at what? Most people think it means the virus will stop spreading and life can return to normal, but we don’t know that at all, because it’s not part of the study.
What do I know? I’m just an english major who ended up in finance and admin in a medical school. But it does seem to me that IF the goal is to end the spread of the disease, than whether or not any vaccine on offer actually stops the transmission is kind of the whole [family blogging] point, is it not?
Not to mention that asymptomatic carriers of COVID have still been recorded having lung and other tissue damage:
So if you’re potentially still getting hurt, still spreading disease, well, is this still a vaccine?
I’m not a fan of Webmd. How do we know that these asymtomatic patients did not have lung problems before they got Covid?
Because the abnormalities are not common. These alarms were not first to be raised by WebMD. Lambert and I have linked to numerous studies finding abnormal post Covid brain scans, heart scans, lung scans, signs of impaired kidney function, elevated levels of depression, even cognitive impairment.
Hi, I’m not an MD but I do work in healthcare and am following this with interest. Can you rule out acute radiation exposure as a cause of the Covid complications? In particular I am thinking of the blood issues, hypoxia. I suspect this possibility might not be on everyone’s radar when they think they are dealing with a virus. I am of course referring to 5G as Wuhan was the site of first rollout in China. Also I don’t know how many hospitals have 5G installed to date…
I’m not a MD but given that 5G hasn’t been meaningfully deployed in the US, and certainly not disproportionately among nursing homes or in rural areas, where the infection is spiking now, this idea is wildly at odds with available evidence.
as an MD I agree. that is not to say that there might not be other factors at work to account for the vast differences in mortality from this virus. Immune factors surely. Dietary surely. Air quality surely. there are so many in fact it will be hard and harder to sort it out.
BCG status. Other vaccines status. etc etc
GG opacities are actually not that uncommon. Anyone who has had pneumonia can present with these.
> I’m not a fan of Webmd
Here is the study from the Annals of Internal Medicine to which WebMD links
“This to me leads to the most important question of all, and it was again completely untouched….. How many asymptomatic patients are there?”
This was discussed at the FDA Advisory meeting. The reason that PCR tests were not done regularly on participants who were asymptomatic was because the study designers did not want to subject the participants to the extra burden of coming into the clinics every week (they were trying to maximize enrollment, after all). Only participants who had symptoms got PCR testing. My understanding from the discussion at the meeting (which is on YouTube) is that a follow up study is ongoing to test the question of asymptomatic infection in vaccinated patients.
“a follow up study is ongoing to test the question of asymptomatic infection in vaccinated patients”
A follow up study after the vaccine has been released? The follow up study is on the population.
“We had to”jab ’em” to find out what was in it…”
+1, I laughed
They learned this from Mr Gates. Early adopters as beta testers. Microsoft has been doing this for years.
Yes! I was thinking the same thing, having worked in both fields (medical sociology and epidemiology, and later, technology).
In a hideous echo of the Iraq debacle, “….how will we know if there are WMD’s unless we invade and find out,” asymptomatic data will be gathered from field results. Also known as a stroll through the corpses.
If this article’s author hadn’t chosen medicine, they could have been a first class journalist.
“could have been a first class journalist”
And probably unemployed.
“The (PURPORTED) reason that PCR tests were not done regularly ..”
“The reason that PCR tests were not done regularly on participants who were asymptomatic was because the study designers did not want to subject the participants to the extra burden of coming into the clinics every week (they were trying to maximize enrollment, after all). ”
Translation: We did not design the study with that endpoint in mind.
Yes. Additional translation: The FDA did a rush job, was responding to what we wanted to do, and therefore did not require us to test.
Seriously – give all participants a bag of swabs. They swab every day and throw the swabs into the refrigerator for mass testing.
ah but all the work!
I don’t know if the countries in which the trials were done had the antigen tests, but if so, this comes off lame.
The antigen test is very accurate in symptomatic cases and not nasty to take, and you get results in ~20 mins. And what about coming in only if you are symptomatic, fer Chrissakes? And if they are worried about false positives, then do the PCR.
This is just bullshit. Extra burden my ass. Pay the subjects more for the hassle. AstraZeneca tested weekly.
My sister is a teacher who lives her husband and—since the pandemic—with her nine-year-old step-daughter. Before the pandemic they had the daughter for a week, and the mother, who is a healthcare worker, had the daughter for a week. This arrangement broke when my sister was diagnosed with stage IV appendix cancer in March at the beginning of the pandemic. They all agreed that, for the safety both of the daughter and my sister, it was better for the daughter to stay with my sister and her husband, and see her mother when she could get tested twice and then taken a day off.
My sister, who recently had surgery that removed her spleen, and chemotherapy (and now has a good prognosis but is has long, tough recovery) was so happy for her daughter’s mother because she would able to get the vaccine, and then could see her daughter more.
It has been covered in the news that the vaccine doesn’t necessarily prevent COVID, just symptomatic Covid. I honestly was a little surprised that my sister didn’t know. But my sister is a teacher, her husband works with unemployment insurance for a state that…lets say is larger and facing a crisis with COVID, and her step-daughter’s mother is a healthcare work. They are all intelligent, informed, but very over-worked people who do not always have the time to read the news in detail, and where over whelmed by the positive messaging. Even if it were confirmed that the vaccine prevented symptomatic cases as well, 95% is perhaps not good enough for my sister’s risk category, especially given that her daughter’s mother works in hospitals. But given vaccinated people may still be contagious, well, the risk to my sister would be huge. I just feel that these busy people were not getting the information they needed from the propaganda-ridden press coverage to make good decisions. It is distressing.
> It is great for the individual, but if they can remain without symptoms and still spread it all around it does not help from a public health standpoint.
The World’s First Neoliberal Vaccine™!
Paid for by tax dollars, so it def fits the NeoLib mold.
MSNBC and their guests have reported from the start that getting the vaccine doesn’t mean you can’t infect others, and they say the science/medical community don’t know if it does or not. They said that’s why we need to keep wearing masks and socially distancing.
And yet for some unfathomable reason, people keep acting like it’s a slam-dunk that it does — including most of the medical field.
I haven’t had time to wade through this in full detail but I wonder if the author has read the FDA and Pfizer Briefing Books posted on the FDA’s website. Among the many details in the FDA analysis of the vaccine data is Table 17 on page 35 in which a singe case (one out of 2045) of fever of greater than 40 degrees C is recorded. Presumably this is the case referred to. It is not hidden, but it is clearly an uncommon event. https://www.fda.gov/media/144245/download There is also considerable data on patient age broken down by deciles. While I would like to have seen more data on patients over 75 (over 1600 in total in the treatment and placebo groups) the study was originally designed with the thought that workers in hospitals and nursing homes would be the first vaccinated, rather than residents themselves. It was the CDC that recommended (over the objection of a couple of panel members) that residents themselves be vaccinated.
I went looking for the vaccine adjuvants the other day and found this (not the FDA publication you linked to, but a similar report–forgot to bookmark the source) regarding geriatric patients:
Clinical studies of Pfizer-BioNTech COVID-19 Vaccine include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy [see Overall Safety Summary (6.1) and Clinical Trial Results and Supporting Data for EUA (18.1)]. Of the total number of Pfizer-BioNTech COVID-19 Vaccine recipients in Study 2 (N=20,033), 21.4% (n=4,294) were 65 years of age and older and 4.3% (n=860) were 75 years of age and older.”
Whenever I look at medical studies, I always ask myself “How many of the participants have a personal profile similar to mine?” I don’t consider 4.3% to be very representative. I would also like to see greater age breakdown than 10-year intervals. I can say from personal experience that at age 65 my health was excellent; by age 67 I encountered major problems. You’d be amazed how quickly medical problems arise after age 66-67, no matter how healthy you’ve been.
Good question, Hana. This post is about the NEJM article published on Friday, its accompanying editorial, and IM Doc’s review and subsequent consultation with his fellow doctors. The FDA’s decision came late Friday, after browbeating by Don the John, foremost practitioner of trumpery. Probably the FDA’s download was made available sometime after the decision, but how long after? Does anyone here know?
In any case, the problems so well explained in this article are or should be an instigation to other (many, I hope) qualified critics to take a very hard look at what Pfizer actually knows and how long they’ve known it.
The Pfizer and FDA briefing books with all the relevant data were posted in full on the FDA website on Tuesday, Dec.8, well before the Thursday, Dec.10 meeting. The Moderna data has now been posted in full on the FDA website. The Modern mRNA vaccine review will be held starting at 9 AM on Thursday, Dec. 17.
Front line medical practitioners should not have to be medical researchers. As IM Doc VERY clearly explained, going through stuff like that is the editorial writer’s job, and they are expected to volunteer if they see anything in the relevant materials that they think the article didn’t cover adequately.
you say the data has been posted in FULL? what do you mean by the word “FULL” ?
Normally, that would mean we could see the detailed data the underlies the assessments. that data has surely NOT been posted in FULL to my knowledge but i might have simply missed it.
Isn’t the real issue that a Grade 4 adverse reaction wasn’t listed where is should be? It’s all fine and well to say it’s listed “somewhere”, but if it falls to follow proper protocols it is akin to hiding bad news.
Maybe it was a mistake, maybe intentional. With everything I’ve seen so far, this falls into the later for me.
If this backfires, COVID-19 will be with us for a long time.
My fear that many people will swear off vaccines if the rollout of the current vaccines goes bad. People already know that they can’t trust authority and if something so important like these vaccines are botched especially if we find out greed and a coverup was involved…
I keep thinking of Mitch McConnell persistent efforts of getting a liability shield for all things COVID lasting until 2024. Would the warp speed vaccines be covered?
it also says this:
” lasted a median duration of 1 day. ” I could not see a break out of the range though. Median Duration can cover a LOT of ground, right? I mean it does sound highly reassuring.
Hmmm, am I missing something? I don’t understand the angst about exclusion criteria. It’s on page 34 of the protocol document.
Things like this make me question the rest of the assertions which are all above my pay grade. Also,
anonymity is never a good sign. We criticize wapo for sourcing “people familiar with the matter”, after all.
If I may be so bold, I think you may be missing the point of the contentions. If you look at this doc’s very first paragraph – you can see how busy his life is. He repeatedly asserts that practicing physicians in America, the ones who are on the front line of this entire situation, are dependent on the publishing journal and the accompanying editorials to point out all the important issues. He and tens of thousands like him do not have time like the pointy-headed brethren in Boston and Wash DC to go through piles of documents for answers. It should be readily available to them – and clearly is not.
About your second contention, I would direct you to the Links just from today – where another doc bites the dust for opening his mouth. He was fired. So far this year, we have seen lost licenses, social media bias, professional discipline and loss of income. Why would he willingly put his name out there. If Yves knows who he is – and has looked him up – I am content with that in our current environment. There are consequences to the extreme cancel culture we have created – this is just one of them.
Rick’s citation of the protocol is important, though. The article cited itself is a summary of a kid, the graphs and figures are a summary, and if there’s serious questions about the evidence presented in the study, it’s best to go read the protocol, which is not long. If you are versed in Pharma research, looking at the protocol is not a big deal, you will probably read them all the time.
Hana also posted the paperwork the FDA received, which has further information. It goes into depth on the Bell’s palsy and such.
It doesn’t eliminate all of the IM doc’s concerns (like about the public health figures who are at the center of this and whether they have a conflict of interest), but seems to me that concerns over lack of data on adverse events and lack of data on exclusion criteria are partially addressed in the deep dive.
Thank you, Rick. Very helpful link and note.
I went looking for this in the supplemental material for the article and did not find it, and remember I look for information for a living. I looked again just now. You can’t find a link from the article or the editorial. IM Doc also reports that none of his eight colleagues were able to find this document. This is a group that regularly reviews new medical papers.
It should not be so difficult to find the exclusion criteria. They should have been clearly flagged in the paper proper and the editorial, and not require doctors, for whom this is critical information for a medication intended to be taken by the public at large, to go on a treasure hunt to find information that is of paramount importance to them in ascertaining whether or not to recommend the vaccine to patients.
As for anonymity, IM Doc has said in previous comments that his colleagues from his former life at Big Teaching Hospital and other major hospital systems have been instructed not to say a negative word about the vaccines. This has the smell of an active effort to maintain a positive spin about it.
I will add an update to the post and IM Doc will make further comments when he has reviewed the exclusion criteria.
18.1 Efficacy in Participants 16 Years of Age and Older
Study 2 …. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19.
Thank you, Yves.
Thanks for the info. I found Rick’s critique and comparison to the Washington Post quite comical and biased. The Post is a big newspaper and is responsible to its readers and gets paid for the publication!
“But the plans were on display…”
“On display? I eventually had to go down to the cellar to find them.”
“That’s the display department.”
“With a flashlight.”
“Ah, well, the lights had probably gone.”
“So had the stairs.”
“But look, you found the notice, didn’t you?”
“Yes,” said Arthur, “yes I did. It was on display in the bottom of a locked filing cabinet stuck in a disused lavatory with a sign on the door saying ‘Beware of the Leopard.”
Ha! Perfect comparison. Thank you for that.
Love that series. Others here must, also. We’ve got Arthur Dent and Ford Prefect commenting.
Is it possible the protocol was added to the website LATER, after people raised questions?
Also in there is the data regarding the “missing” population.
Page # please?
That’s good, an anonymous commenter dissing someone for anonymity, unless you’re the only rick in oregon… It’s possible that the brain trust of NC knows who the poster is…
The post definitely reflects my own real world experience with “Big Medical”
> as one would expect for a medication intended for the public at large.
From 30,000 feet, it’s clear that these project deliverables were not top-notch, which is why the nine doctors had trouble with it. This extends from the Pfizer material all the way through the NEJM content.
As a former tech doc person, that concerns me. When creating tech doc — and you can look at these materials as tech doc, it’s just that the tech is medical, as opposed to, say, aircraft maintenance — the documentation is never the driver (much as the writers would like it to be). The institution that commissioned the documentation is the driver. So, deliverable glitches are always a sign of institutional issues.* That’s not a reassuring sign for a vaccine.
NOTE * This idea is akin to Conway’s Law.
So if I am reading this right, exclusion criteria include potential participants who have had with flu vaccines, like old people in nursing homes who will be getting flu shots around the same time as the Covid vaccine rolls out.
It’s actually listed under Methods:
TRIAL OBJECTIVES, PARTICIPANTS AND OVERSIGHT
We assessed the safety and efficacy of two 30-μg doses of BNT162b2, administered intramuscularly 21 days apart, as compared with placebo. Adults 16 years of age or older who were healthy or had stable chronic medical conditions, including but not limited to human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus infection, were eligible for participation in the trial. Key exclusion criteria included a medical history of Covid-19, treatment with immunosuppressive therapy, or diagnosis with an immunocompromising condition.”
…albeit not a comprohensive list and does not include individuals with a history of ‘allergic reactions
I thank you, thousands of children and young people thank you, thousands of intelligent citizens thank you….. and God thanks you, IMO (“Satan is the father of lies”)
Thank you for this. I noted the UK anaphylaxis cases with concern. Mr. LaRuse has severe allergies – to the tune of two immuno-theraphy shots a week just to keep them under modest control. I occasionally joke that he is allergic to anything that casts a shadow and a few things that don’t, but honestly, it is nearly the absolute truth. His allergies are severe enough that there are rescue injectors sitting right here in my living room because it is the most central place in the house and not subject to occasional lockouts, like say the bathroom medicine cabinet. Every family member has trained on the training injector – our daughter was taught at age 5 how to “jab Daddy in the leg”.
It is extremely concerning to me that no one is talking about the allergic reaction these nurses had – what other things are they allergic to? Was it a component of the vaccine that caused their reaction or a reaction of the vaccine with their immune system? How long after the vaccine was administered did the anaphylactic reaction occur? These are critical questions for the severely allergic crowd and I am hearing NO answers.
Due to his long list of co-morbidities and allergies, we are very very careful about COVID. He is immuno-suppressed plus has decades of history of chronic bronchitis, and so naturally, we have been watching and waiting for the vaccine for his sake. I am going to ask him to talk to his allergist’s nurse this week when he gets his usual weekly shots and see what she has heard or knows.
For people like him, just suggesting we “watch carefully” when they get the vaccine doesn’t feel like they take the risks very seriously.
Excellent! The author lets you think along with him, giving credit where it’s due. The way that indications of possible severe reactions were deep-sixed is astonishingly short-sighted. Don’t they think they will be reported, deservedly adding to mistrust?
Dr. Zubin Demania has been posting useful interviews about the pandemic and public health and medical responses for months now. This is his excellent interview with Dr. Paul Offit who developed a breakthrough rotavirus vaccine. Offit is a member of the FDA Vaccine Advisory panel. This interview took place a couple of days before last week’s meeting but many of the issues discussed in the NC article are addressed. There is a transcript for those who would rather read than watch.
Went searching through the interview for his comments on adverse events.
“Adverse events” aren’t a matter of public relations, they’re a matter of law.
The term “adverse event” is used because human subjects research deals with anything from new devices to new drugs. Strangely, he’s fine using the phrase “adverse reactions” when it comes to run-ins with bad dietary supplements, as Offit is a major critic of dietary supplementation.
Thanks. I’ve listened to many interviews with Offit for the past 8 months, including the one you post. I am getting disappointed in him. He was very clear in an interview about 2 months ago that no less than 4 months post jab #2 could be required of Pfizer, because “its a novel pathogen with a novel vaccine platform.” That changed quickly to conform to the FDA’s requirement of 2 months. In another earlier interview he averred that in no way should the Pfizer vaccine every be made mandatory because “this vaccine platform has never been population-tested before.” He has walked that back as well.
I am a retired Astrophysicist, and not a Physician. But I have lived around Physicians my entire life (Father, Ex-Wife, Current-Wife, friends), and I know more than the average citizen about anatomy and physiology.
At any rate, I have serious concerns about the required low storage temperature of the current vaccine. When theory hits practice, I expect to see many instances of mistakes, foul-ups, goofs. And some vaccines will be administered in a spoiled state.
From that I expect to see stories in the coming weeks and months about ineffective inoculations, increased episodes of allergic reactions due to spoiled media, etc.
Thankfully, I am in a position to wait and see. It is a sad time. And incidents due to human foibles are inevitable.
I agree with you! Even if we assume the vaccine is a wonder vaccine that works flawlessly when ‘properly’ stored and administered … what are the chances it will be ‘properly’ stored and administered by a system that so badly handles and has handled the onset of this pandemic?
It’s easy to add a temperature logger to each package to track the package’s history and prevent it from being unsealed if the contents slip out of compliance. Now, whether this will actually be done is another matter.
For hundreds of millions or even billions of doses?
I don’t think so. In the race to the bottom for most shipping/delivery companies, asking for this level of compliance seems unrealistic.
Tag Sensors make disposable logging labels.
Based in Arctic Norway appropriately enough.
You could put one on a small box without hurting margins.
That’s cool, I’ve used similar devices. But the one you linked to here is good to -30 C. Far short of what we need.
From your first link:
“It is accurate from -30°C to +50°C.”
In other words, this will do nothing to assure the vaccine has been kept below -70 degrees Celsius. This is the problem with a vaccine that requires the extraordinary capability of an expensive laboratory-grade -80°C freezer. Those are not available on the “last mile”. This is why injecting degraded chemicals is a safety issue with this vaccine.
It’s easy to add a temperature logger to track the package’s history, and prevent release of doses if it goes out of compliance. Now, whether this will actually be done is another matter.
I’m not so sure about that. Given the target temp of -70 C or so, you’d want a data logger that’s good to -200 C about so that the target temp is in the middle of the sensor range. You’d have to have a way to check it without compromising the casing or seal on the unit that the product is shipped in. You’d need people who knew how to do that and could use wireless methods to download and verify data. The loggers would have to be pretty robust too so that any jostling or damage to the outer shell wouldn’t damage them too. You’d need people at the initial shipping location who knew all about the sensors and could calibrate them properly… so yes, this could happen. But without a protocol in place and without a lot of training prior to shipping the vaccines? None of which we’ve heard about yet? I’m not optimistic here.
I’ve been thinking about the aspect of improper storage too. So much can go wrong. A friend’s daughter and son-in-law both contracted auto-immune disease Multiple Sclerosis due to a “bad batch” of the anthrax vaccine they were required to get in the Navy. I’ve got so many unanswered questions myself with no clarity on who should be excluded. What “allergies” or inflammation conditions ect should be excluded?? It’s vague. Just jab millions of people and the pharm companies have no legal liability….
It seems the goal of this non-stop media cheerleading is to create a mania sufficient to overlook so many unanswered questions.
I have no intention of getting this mRNA technology vaccine, I don’t want to re-program my immune system as it is in good condition. I’m rarely sick. And I’m not an anti-vaxxer, I got a flu shot last year and the early version of shingles vax several years ago (not Shingrex with debilitating side effects)
I’ll also add that media harping on the cause of vaccine suspicion by people of color is the Tuskegee Experiment is slyly dismissive; then going on to explain it is not a reason for suspicion because it was so long ago when the world was different.
Hello!! Entire communities are still devastated from pharma aggressively marketing synthetic heroin as non-addictive and a long list of well documented examples of pharma HIDING the dangers of drugs that should not be on the market.
The constant referencing to Tuskegee is also intellectually-dishonest, not to mention insulting of our intelligence, as if we have not the faculty to read current data and have legitimate questions about this process. “Look, a Black person took part in its development! See? Everything’s fine!” Ugh.
Not to mention that it is only one of a number of such examples going unbroken in time for the past century. Finding this history is not hard. Yes, the subject is often obscured by neglect, but there have been a number of books, documentaries, and articles for at least twenty years.
> re-program my immune system
Can somebody smarter than me explain whether this pithy framing is good science, or not?
Not smarter than you, but I’ll explain the metaphor as best I can. I understand a bit of one field and more of the other… make your own conclusion:
To the extent that the immune system can be viewed as a complex computational system dedicated to recognizing intruders inside an organism, the mRNA vaccine adds a module, or a few lines of code, to the programming. It doesn’t exactly ‘reprogram’ the whole immune system if the new code works correctly. However, one bad module can crash a whole program, in fact, a misplaced punctuation mark can crash a whole computer program. A misplaced piece of code can have cascading effects in a computer program or in the immune system.
mRNA adds a few lines of code to the immune system program, which shouldn’t be problematic if you understand the behavior of the program, or system you are adding the code to. But we don’t completely understand the behavior of the immune system, and everyone has a different one.
I deem the metaphor valid, your mileage may vary….
The above analogy is not accurate. There is no ‘re-programming’
The flow of information in the body is generally DNA -> RNA -> protein. In other words, DNA is the reference code, and for the parts of the DNA the cell wants, it’ll make an RNA copy and use that as a working template to create the proteins in the cell. These RNA copies are usually short lived and disposable and eventually get degraded once the protein is generated.
The RNA vaccine for Covid is an RNA copy that encodes for the ‘spike’ protein that is displayed on the surface of the virus. This allows the cells to use this RNA template to create the spike protein, which is recognized as foreign by our immune system and we generate an immune response. In effect, our immune system is partly a repertoire of various ‘responses’ that we have generated over time to various foreign invaders… we build those up as we are infected and overcome disease and/or are immunized against various diseases.
I think you are glossing over the issue and potential risks. From an earlier comment:
I think trying to conflate multiple myeloma into covid is dangerous, but a brief discussion would be instructive to understand how cells (malignant or not) produce proteins versus how the vaccine induces production of proteins.
As mentioned before, information flow in the a cells is primarily DNA -> RNA -> protein. The reason malignant cells continue to proliferate, and in some instances secrete proteins, is because they have mechanisms that have either amplified DNA gene copy number or are persistently driving transcription (the process of making RNA from the DNA blueprint) of RNA from specific genes in the DNA.
The driving force for all of these is de novo transcription from the DNA – without it, you don’t have the RNA to translate into protein. In essence, having the DNA template provides an infinite resource for malignant cells to activate the aberrant signaling pathways (comprised of proteins) that drive malignancies. If you *only* have RNA template without a DNA blueprint from which to create more RNA, you end up with a *finite* source and it gets exhausted rapidly. There are teams of scientists working on RNA stability, turnover, and degradation. Lifetimes of RNA in cells in the order of minutes to hours depending on the transcript (happy to cite literature here).
It is not analogous to disease like myeloma and M protein or amyloid cardiomyopathies where you can measure the uncontrolled protein secretion *driven* by increased transcriptional activity from DNA. For example, in multiple myeloma, an abnormal antibody-like protein called M protein is produced in excess by malignant cells and can be detected in the blood. The reason it is produced in excess is driven by aberrant plasma cells that rely on their DNA template to drive M protein production (via RNA). Absent the availability of the DNA template, the RNA would eventually be degraded and M protein would disappear. And intuitively, this is how regression of cancers are generally monitored: if someone goes into remission from myeloma, it’s not because we targeted and removed the RNA from their system, it’s because we eliminated the aberrant cells that contain the DNA blueprints.
Injection of lipids with RNA message (which is what the vaccine is) is a *finite* source. Once the cell uses those transcripts to make the covid “spike” protein, those transcripts are eventually degraded. There is no DNA blueprint for the cell to return to and create more ‘spike’ RNA (and subsequently, spike protein).
I think your experts are not aware of the molecular biology behind these mechanisms – it is not a case of crickets chirping. The scientific literature is actually teeming with crickets describing and researching these processes. Your concerns should have been readily alleviated by careful explanation of how cells generally regulate the flow of information.
Quite. Indeed, this is the big problem with RNA vaccines: RNAses are so ubiquitous both inside cells (to degrade your own mRNA) and outside (to degrade viral RNA) that the damn stuff is really hard to work with: it degrades in no time flat because RNAses are ubiquitous in the environment and are some of the most efficient enzymes known. We secrete fiercely potent RNAses from our skin! RNA does not stick around. (It says something about the sheer replicative potency of viruses that they’re able to survive this constant onslaught at all, let alone thrive.)
I appreciate the further illumination of the exact mechanism by which the mRNA functions, but I do not see it as invalidating the original commenter’s concerns – which I support.
I’m not sure what you don’t understand about the word ‘metaphor.’ I did not choose the word ‘analogy’ for a reason – there are differing connotations. ‘Analogy’ implies a more precise one-to-one correspondence of features. ‘Metaphor’ implies a looser illustrative comparison. If I describe someone as the ‘black sheep’ of my family, it does not mean that she stands out by virtue of her color – everyone in my family might have dark skin. ‘Black sheep’ is a metaphor, not a strict analogy. A more strict analogy would be like comparing the heart to a pump, where you have a pump handle that corresponds to a heartbeat and certain valves that one could equate between the two that create fluid flow. In spite of a simple dictionary definition that might start with “a metaphor is an analogy” I assure you they are different, otherwise we wouldn’t have such commonly used separate words for them.
Let me say it once again:
If I create a computer program to generate a medical report and the doctors come back with a request for a new number to be included in the report, I add some code to generate that new number and add it to the report. I call that re-programming the report. Likewise, if we wish to induce the immune system to produce a new attack vector, we have to send it instructions about how to do that, don’t we? In this case the mRNA is the injected code that stimulates the immune system to produce new outputs against the spike protein. We have added new ‘programming’ to the immune system.
One might say, to extend the metaphor, that we are using artificial intelligence in the form of mRNA to reprogram the immune system rather than using the traditional method of using a disabled or partial form of the actual infectious intruder. Regardless, if the mRNA + adjuvants injected do not behave exactly according to plan, and/or the immune system you are injecting it into does not react precisely as expected, then you have the chance that a cascading ‘gremlin’ is introduced into the system. Yves has highlighted this in another reply to your comment.
The metaphor is intact and I deemed it a useful way to consider the proposition that something could go wrong.
This metaphor is not necessarily exclusive to mRNA vaccines, but it is applicable to them. Traditional vaccines can also go wrong by introducing ineffective or bad reprogramming into the immune systems of recipients. Failed traditional vaccine candidates are not uncommon. The difference here is that we are using relatively untested methods to achieve the reprogramming.
Problems with any new technology, in vaccines or in computer programming, arise when things are not as well characterized as we might wish for them to be and things don’t go according to expectations. I’m reminded of recent comments here at NC about the problems Uber had when they reprogrammed their app in a new language.
I appreciate that you think the metaphor is intact.
What I am saying is that the metaphor necessarily relies on properly understanding biological concepts – and I can infer from your reply that the understanding of how mRNA works is not correct.
The crux of your re-programming metaphor is that the aberrant code that you inject needs to remain in the system. This is not true of this biological mechanism – it is transient.
And I think it’s worth stepping back and considering your comment:
What happens when a vaccine fails? It doesn’t provide immunity. Where are the injected gremlins? Seasonal flu vaccine technically ‘fails’ a large number of people every year, and if each year we hypothetically inject these permanent gremlins via the flu vaccine, our bodies would have long ago been a large piece of dysfunctional code.
It isn’t necessarily a safe assumption, though, that the “aberrant code” will not remain in the system. That isn’t the intent, to be sure. But I would point out that even your own comments refer to “how cells generally regulate the flow of information.” Generally.
But sometimes things malfunction. And in this case, if the cell malfunctions and incorporates the new code, it’s permanently coded to make something the body is not supposed to contain.
It would be overstating things to say that it’s going to do this to everyone or nearly everyone. IMO, it’s not overstating things to call it a legitimate concern about something that could happen in a subset.
Considering we’ve never had a viable mRNA vaccine in the general population before, I think it’s premature to confidently state that it won’t do that in any recipients.
The cell cannot “malfunction and incorporate… the new code.”. RNA will not bond to DNA: their backbones are too different. It needs to be transcribed into DNA first, and mammalian cells contain *no* machinery to do this. Even SARS-CoV-2 contains no machinery to do this: it lugs its own replication machinery around, but that machinery transcribes RNA to *more RNA*.
The only risk is cross-infection of a cell that uptook the vaccine RNA with a virus that encodes a reverse transcriptase, which does transcribe RNA to DNA and incorporate it into your genome. These are fairly common (and viruses that work this way can lurk in the body indefinitely), but firstly this would have to happen in a time window of only a few hours before the vaccine mRNA degraded, secondly you’d have to be very unlucky to have it in the DNA in a place that’s “switched on” (most of the genome is not expressed as mRNA in any given cell in any quantity: and this would land in a different place in every unlucky cell’s genome), and secondly… honestly if you end up with a few cells that are spitting out SARS-CoV-2 spike indefinitely because they’ve got DNA coding for it in just the wrong place… what happens? The immune system, already sensitized to spike, interprets this as a cell infected with SARS-CoV-2 and kills it, ending the problem.
And of course killing cells that appear infected is exactly the response we’re hoping for from a vaccine!
This problem, if it was a problem, would be self-correcting. And that’s why nobody is talking about it.
That is part of the plan. All the bad stuff happening will be assigned to “mishandling”.
Meanwhile, the options are exercised, promotions are granted and people continue to die.
thank you, Doc.
This leapt at me:”… they are going to be using the first million patients or so in the general public to get a real gauge on numbers and side effects.”
end stage neoliberalism, where we are all commodified(Morpheus holds up a C battery) and rendered into literal “inputs”…like so many tons of ore, or pulpwood.
early this am, i read this, from 2017, which was linked in the hill or politico or somewhere in an article about these vaccines:https://www.nature.com/articles/nrd.2017.243.pdf (hope i snipped that in the right place).
i admit, it’s gee whiz cool, and this tech has potential to revolutionise medical care…but we ain’t anywhere near that stage, yet.
i am a skeptical and suspicious person…i have major trust issues with authority and institutions…based on where i’ve been and where i’ve come from…still…
i’ll not be taking these rna drugs…i’ll wait til oxford or one of the other old fashioned vaccines is available.
thankfully, my lifestyle out here is conducive to avoiding the disease ridden herd…but there’s a whole lot of folks out there who don’t have that luxury.
since february, i’ve pushed down the disturbance in the Force i’ve felt…that something terrible was afoot.
i pushed it down because the shit i can more or less prove is bad enough, and has grown worse….and this disturbance/tingle/raised hackles is definitely not provable…at least not yet.
I fear the worst…not just with this damned disease, but with our rulers’ efforts to monetise it, and get as much bang for their buck as possible.
how banal is the evil, today?
up until a week ago, i was having growing difficulty in keeping wife and boys(14 and 19) on board with my repeated warnings and what they often perceive as hair-on-fire….”thankfully”(this is what its come to) , local trumper thumpers have instigated a superspreader event matrix in my isolated county…a good number of folks are suddenly taking it seriously(based on my fb duck blinds)…but those people don’t venture out, i guess…because everyone i see in town is still without a mask.
nevertheless, the local outbreak has made my job lighting my hair on fire a whole lot easier.
I’m happy to hunker down indefinitely…it was how i rolled before all this.
i worry about keeping my eldest on board..and i worry incessantly about the shape of the world i’m leaving them both.
thanks, again, Doctor.
(and all of y’all, here)
> since february, i’ve pushed down the disturbance in the Force i’ve felt…that something terrible was afoot.
i pushed it down because the shit i can more or less prove is bad enough, and has grown worse….and this disturbance/tingle/raised hackles is definitely not provable…at least not yet.
I have more or less the same feeling. By rule 2 of neoliberalism…
> local trumper thumpers have instigated a superspreader event matrix
Any insights into the mentality? Seriously, as people, not as “ZOMG Trump!!!!!”?
i’ve been reluctant to try to nail down any of the overt trumpers i know…and i don’t really hang out with the thumpers, save in a friendly wave and howdydo kind of way.
it feels like an Act of Faith….but it may be a fatalism that even they are unaware of….like a passive suicide…which would likely put it into the Deaths of Despair column.
best insight is one of my neighbors…a mile away, where my dead end dirt meets the highway: cowboy church….has a rodeo arena at his house where they bring their horses to church,,,not overtly political in interacting with me. I bring him eggs(michele obama turned him off of veggies) and he brings me horse manure. we’re friendly, and look out for one another, but he knows i’m paganish and strange…
i get the feeling that it’s much like Muslims during the Black Death…who thought that it was God’s Will, and therefore shouldn’t be avoided or treated.*
this has been the subject of much discussion with wife, sons, sons’ friends(some of whom are peripheral to the trumper thumper cohort) and even my 3 hunters from austin.
whatever…i definitely resent it. they are the main reason, as far as i can tell, that this is still ongoing, and unlikely to be over any time soon.
(*”Muslim religious scholars taught that the pandemic was a “martyrdom and mercy” from God, assuring the believer’s place in paradise. For non-believers, it was a punishment. Some Muslim doctors cautioned against trying to prevent or treat a disease sent by God”–https://en.wikipedia.org/wiki/Black_Death )
I’ll answer to this.
I don’t know if I’m a ‘Trumper Thumper’ (which sounds a little derogatory), but I’m definitely a ‘Conservative’ (unless you consider my agnosticism counting me out of that group). I voted for Trump twice. I like how he’d poke the establishment in the eye. That’s all he did, too. I knew nothing of consequence would be changed under his watch (except, to my surprise, he did not start any new foreign wars!)… and I knew that going in. We’ll be dealing with the same mundane, banal mismanagement of society by ‘government’ (really the Technocracy) as we always did, no matter who is president. I’m an avid NC reader. I find the large majority of the posts and the commenters intriguing, thought provoking and often right-on-the-money. I don’t have a closed mind.
It’s funny that you use the term ‘passive suicide’. I’ve used that EXACT term to describe my attitude in certain philosophical discussions with people I know well. Let me flesh that out for you a little:
1. I don’t intend to live forever. I’ve read enough very good SciFi to know that’s not a great thing to achieve (see Niven’s Ringworld trilogy).
2. I’m an old guy. I’ve done everything in this life I really wanted to achieve. Raised two very decent, hard-working men, enjoy a long, loving marriage with their mother, have secured my future domicile and creature needs for our foreseeable life expectancy.
3. I’m ready to enjoy my golden years. Enjoyment of said golden years does NOT include hiding from a virus, or even trying very hard to avoid it on even a superficial basis.
4. I know for a fact that ALL of us, no matter how hard we try, are DEFINITELY going to get exposed to it. To think you can avoid said exposure is completely magical thinking.
5. Pursuant to item 4, I’m willing to trust the universe and take my chances.
Don’t get me wrong… I have no intention of being a purposeful ‘super spreader’, and I don’t harbor any disrespect to those who’d wear a mask in my presence, or keep their distance from me; that’s fine. BUT… That is THEIR responsibility, not mine.
I drink. I smoke. I gamble. I eat really well so I can stay as healthy as I can as long as I can. My wife goes to great lengths to keep us on a healthy regimen. I rarely get ill. In spite of my ‘bad habits’, I perform at a high level in ten-pin bowling and saber fencing. I’m quite active, not overweight and feel really good. I go head-to-head with teenagers on the fencing piste twice a week and beat them on the regular. I’m a good enough tournament bowler that I essentially do that hobby for free.
I haven’t stepped foot in a doctor’s office for 20 years. I’m sure there’s all sorts of shit they could find wrong with me and attempt to ‘treat’. No thanks. I’ll take my chances.
So, here’s the upshot to answer Amfortas’ puzzlement about my ilk… If I dropped dead tomorrow, that’d be fine. I don’t WANT that to happen, but if it DID… Well, that’s the breaks, man! Far as I recall, I was not presented with any warranty or guarantee paperwork when I fell out of my Mom’s belly. Perhaps I misplaced that bit of documentation. Either way, I’ve had a nice life. Had some defeats, had some victories, had some pain, had some pleasure. As Epictetus said, “It’s not your circumstances, it’s your reaction to them that counts”. There’s a thousand ways I could get picked off at any given moment, and this Covid thing is just one of those myriad. So, I’m going to go on with my life and enjoy things no matter how hard the PTB make it for me. Once they’ve taken away everything I enjoy (and they’ve been steadily ticking them off the list), then I’ll decide if I’m done. I have all the means at my disposal to end this journey any time I like… I don’t need to wait on God for that, and I don’t particularly care what God thinks about should I come to that decision. As it stands now, I’m pretty sure I’ll die an unnatural death at the hands of the government you all seem to love so much, so I’m not particularly worried about having to make that decision anyway.
I’m a Gen-X. You’re an old hippy, and I respect that. I’m an old Punk Rocker. We’re more alike than you might believe… Except for the expectation of living forever. On that, we diverge a bit. ;-)
So, Amfortas my friend, that’s probably about where your neighbors are at; perhaps with some brighter colors painted in certain areas. I wish you well on your personal journey and implore with all my heart… Don’t worry about us. We got this.
“how banal is the evil, today”?
Nail on the head.
wow. Thank you Yves and IM Doc for providing a window into a seemingly un touchable world ripe with corruption.
What will happen to the people whose employers, schools, and others require the shot despite it overwhelmingly being unreliable? There will be protests and people will be labeled as outcasts, anti-vaxxers, etc, despite doing their due diligence and reading about these vaccines. I imagine if IM Doc’s 25% willing to take the shot group turns into only 40% nationwide, there will be massive problems.
My new doc is a young, 40ish mother with kids. I told her I’m pretty sure I had intestinal Covid late last Feb. She said she did too and she described my exact symptoms. Said it went through the whole family. I told her I had no intention of taking any slap-dash vaxx and I advised her (yes, I’m old enough to tell her to be careful) not to take it either. She just smiled and said that all the docs would be “required” to take it. I think that’s insane. And how was this little protocol already established before they even set up the vaxx labs? As in compounding labs? A little snippet of mRNA dipped in a batter of lipids goes in this solution and is mixed with this solution and put in a zillion vials and instantly frozen to a minus 200 degrees. Did they even have time to experiment with the recipe? It’s as if the “science” was ready to roll. Living through this last year has been too strange. And way too fast.
Thank you IM Doc!
I’m a big pharma cynic (anyone interested should consider reading “Bad Pharma” by Ben Goldacre), and my family mostly agrees with my reluctance to take new medicines or receive novel surgical procedures. After 2-5 years, maybe then we really know what the side effects and problems are.
Yet I get tarred as an anti-vaxxer when I express an equivalent caution about these new vaccines. It could very well turn out that, even with significant side-effects and counter-indications, that they were better than Covid-19 itself, in terms of numbers of people made ill or maimed.
We can’t make that determination if all we get is cheer leading, data fudging, obfuscation and manipulation. The only moral and ethical way that choice should be made is with a full understanding of the results of both options. We have a clear history of rushing vaccines in this country during emergencies, and sometimes this results in iatrogenic injury. If this is happening again, it will backfire mightily when the truth eventually comes out.
Just think: with the expensive health care system here, how many people are walking around not knowing how bad some of their conditions may be or even if they have them.
So many people actually need a battery of tests before they jump in front of this needle and they could never afford those tests. Or maybe because of the lack of sick pay leave have the time….
THey came out with this plan like everybody was and is making yearly trips to the doctor!
Yep. The unmentioned (by our PMC) elephant in the room.
Can’t call it a solution if millions can’t afford to “access” it.
This is great information that is sadly lacking in the discussion of the Pfizer vaccine–does it work, has it been properly tested, what side effects should we be expecting, and who is safe or not safe to take it? No one article can answer every question, but this is the best review of the approval process that I’ve read to date. Thank you!
Many thanks to Yves and to IM Doc for this important post. Thanks also to commenters for additional links. I’m sharing it widely. Everybody stay well.
Oops, didn’t mean to hit send! You would have to double the numbers of people that that get that kind of fever from your estimate, around 30K.
But I also just wonder about their reporting. Call me paranoid, but these numbers would feel better to me if it were a 3rd part, not Pfizer who were handling the reporting. There are too many incentives for these pharma companies to fudge, and I don’t know how reporting directly to the company can be good practice.
Thank you for all your work and comments!
No, you have this completely backwards. The larger the population number from which the person with the fever came, the lower the ratio and hence the lower the number in the overall population that might experience a similar adverse event.
no, no, sorry this was attached to a larger post that I somehow messed up sending. My point is that paper indicates there were 2 people–not one– who had a report of 40 degrees C.
Thank you IM Doc for sharing both your review of the Pfizer paper and for describing the process for reviewing a medical paper. I am heartened that there are still some true physicians in the Medical profession as I judge you to be.
I believe learning to read and evaluate a research paper using the process you have demonstrated will be a useful and necessary skill for laymen to acquire and master as best they are able. As you indicate in your post even the premier journals have curtailed and corrupted their peer review process so much that their journal articles and reviews ever more closely resemble vendor press releases and marketing literature. Where there is money to be made I believe this is not a corruption isolated to medical journals.
Thanks doc for a very detailed analysis of what you see as red flags about this vaccine. I’m very suspicious of all the “rah rahing” going on the media – with absolutely NO questions being asked about anything. Not to even know if the vaccine stops the spread of the virus (very basic info) is pretty stunning. I, like so many, don’t trust the medical profession or big pharma to tell us the truth – it’s all about profits and greed. It’s very sad how far this country has fallen and failed in so many ways.
Thanks again for your time and analysis.
Yves has just informed me that there is a list of exclusion criteria. That is an oversight on my part. When I have a moment today – I am going to look through this. I am rather busy right now with patients.
Right up front, this is to make my point exactly. I have never been this busy in my life. I am seeing sick patients like never before in my life. My colleagues all across America are as well. All of the nine docs that I discussed this with had no idea of the presence of this document – likely because we do our sessions from paper hard copies. These pages and pages of documents are simply not readily accessible to any of us nor do we have the time to sift through it all. This is my point – These types of issues should be in the research paper or editorial itself. It should not be an Easter Egg Hunt. I would think it appropriate that NEJM the minute there was an issue about exclusion criteria in the UK should place a black box on the front for all to see – “Please look at pages XX-YY regarding exclusion criteria in this study – This is a patient safety issue.” If this was noticably placed on the front page of the trials website – there would not be an issue.
To the readers here – I am sorry for this oversight – I will look through this the minute I have a moment.
No apology needed. Thank you again for this post.
You have done a huge service and no apologies are necessary.
Thanks, IM Doc.
Highly recommend the book White Coat, Black Hat for more harrowing medical test stories
How does the vaccine get from a low temperature and into an arm without degrading? What temperature is it when it is injected?
I am puzzled by how a modified mRNA vaccine is thought to work in detail. How does a lipid shell protect the modified mRNA on its way through the blood and why don’t virus particles use a similar strategy? Why do cells pick up the modified mRNA and incorporate it into their protein making machinery (mitochondria?) and start producing Corona virus spicule proteins? Do the spicule proteins assemble into a spicule inside the cell? How do the spicule particles get out of the cell and into the blood stream to trigger an immune response? Do the spicule proteins not self-assemble and if not how do the proteins get out of the cell?
The Corona non-symptomatic patients bother me too. What little I’ve read about viruses they enter a cell, and take over the cell’s protein making capability to manufacture a hundred or so virus particles. When the cell is full of virus particles the virus lyces the cell wall releasing virus particles and other cell contents. I would think having bunch of cells lyce might cause some symptoms. Does the Corona virus have some trick that works on the cells of some people so that instead of lycing the cell the cell is tricked into secreting the virus particles? For example: “An altogether different phage type, the filamentous phages, make the host cell continually secrete new virus particles.” Can the Corona virus do that in some cases?
RNA, particularly mRNA, is not stable at high temperature for extended periods (hours-days). And “high temperature” means warmer than -70C (-94F). Part of that is due to the 2′-hydroxyl group on the ribose (not present in deoxyribonucleic acid) and part of that is due to the presence of ribonucleases, which are everywhere and degrade long RNA molecules to subunits very fast. Having worked with mRNA, this requires ultra-clean water and solutions, centrifuge tubes, pipettors to transfer small volumes. Rubber (nitrile) gloves are essential at every step. The vaccine will be thawed to room temperature and injected, probably within minutes. Still, the logistics of keeping the material so cold are daunting. Unless the shipping container still has visible dry ice when opened by the user, the vaccine cannot be assumed to be functional. It then must be immediately stored at -70C or below. Very few medical practices outside of teaching hospitals attached to a medical school are likely to already have these freezers, which are expensive and not particularly reliable.
How this mRNA vaccine works:
I’ll leave the other questions to an NC virologist ;-)
One other point about this post, which is the primary lesson: The manufacturers of this vaccine are not disinterested scientists. They cannot be while expecting to make billions! Maybe this vaccine is the answer. No reasonable person hopes for anything else. But I have read the NEJM paper and the Supplementary Appendix linked at the NEJM webpage (12 pages, 40 of which are the list of names associate with the work). It is schematic at best. No one should be required to dig through archival data deposited at FDA, CDC, WHO, or anywhere else to determine whether a study is convincing.
“4 pages” not 40.
One of my PE friends who has invested in medical suppliers and has a wife who is an academic MD says that medical supplies that have to be kept at cold temps have sensors on the boxes that will register if the package has gotten too warm, so the recipient can readily see if it has been compromised in transit.
While working as a hospital oncology pharmacist we routinely received international shipments of tiny drug packages in huge foam insulating crates, accompanied by a little USB thermometer that when plugged in to the computer will generate a PDF report and graph of its entire temperature history since reset.
Pretty nifty devices. I think TempTale was the one I most often saw.
Granted, I doubt those models go to such low temperatures. And now that I’m back in a drug store I don’t deal with this stuff as much. I think our standard 0-8 degree C cold-chain for insulin and flu shots is managed with fridge and truck thermometers, at least on the last mile.
Oh that’s an interesting point, that readily available devices aren’t designed for these temps. But they do freeze embryos this cold, so if they ever were to be shipped, there would presumably be some, but potentially not enough for this sudden increase in demand.
The accuracy and range of the devices will be entirely determined by the accuracy of the digital thermometer chip used in the device.
The lowest value for minimum temperature I can find when looking for a normal, off-the shelf, low-cost part is the DS18B20 chip:
• Measures Temperatures from -55°C to +125°C (-67°F to +257°F)
• ±0.5°C Accuracy from -10°C to +85°C
The curve shows an increasing error rate below 0°C, but doesn’t show the end of the sensor range. Even if it’s off by 5 degrees at -55°C it would still be useful to detect gross failure of refrigeration during shipping.
These are $3 parts on EBay. I would bet there is a niche market for a chip that could do -100°C, maybe with some lack of sensitivity above 0°C as a tradeoff. But I’m not enough of an electronics guy to know where to look to confirm they exist.
The TempTale referenced above has a range of -30ºC to +55ºC (-22ºF to +131ºF)
Actually, the weird thing is:
it needs to be stored at-70C but then can be stored at -2-8C. for up to 5 days.
Thank you explaining the temperatures involved in storing and administering the vaccine. Proteins are very sensitive to temperature and pH and I suppose other conditions of the solution they reside in. Changing the pH alone can change the rate of folding and I suspect variously change the rates that different portions of an amino acid chain folds or mis-folds into it native configuration. What about RNA chains? Are there bio-compatible buffers that might slow their tendency to fold? Do RNA chains normally arrive at mitochondria in a folded configuration? Is mis-folding a problem for the modified mRNA vaccine molecules? The virus RNA is folded in the virus shell and somehow configured for protein manufacture after the virus fuses with a cell. Virus particles do their job at body temperature, and the RNA they contain works well in the less than ultra-clean solution in a cell. What do they know that we don’t know about working with RNA? If any of this wild speculation makes sense — is it a mistake to wonder whether the vaccine makers are taking some short-cuts in their efforts.
I appreciate the CDC reference explaining how an mRNA vaccine works … but I understood that much about the vaccine already. I am an old engineer and programmer and I cannot count how many times I got into trouble ignoring the old saying that the Devil is in the details.
At this point I don’t expect detailed answers though I appreciate your efforts. I am deeply prejudiced toward believing Science lacks full understanding of all the details of the processes the mRNA vaccine hijacks. I suspect there are many unknown details about how conventional vaccines work but there is a lot more experience with using them, making heuristic explanations more palatable.
Thank You IM-Doc. I finally feel vindicated. It’s true that capitalism (Big Medical) plays the odds. No question. It’s also true that evolution plays the odds. Diversity, diversity, diversity. BUT political/social institutions which govern medical/scientific corporations are not allowed, under black letter law, to play the odds. And that means that all the protocols get fudged – first for profit and second for population control. I’m really not a lunatic so don’t discount me. Medicine is required to do sufficiently understood experiments so that there is a very low/controllable percentage of problems. It now looks as if that just might be impossible because we are approaching the border between the speed natural evolutionary diversity on the molecular scale which we call “epic-genetics” and which happens almost in real time for our own survival advantage – or otherwise it’s extinction. And our hysteria is being hyped on every TV channel in the world. We all are wondering, Is extinction the goal? Because if it is not the goal then the precautions are not meeting the challenge – in fact there really are no precautions, and there are about 5 billion too many of us. And if human depopulation is the goal, it makes sense because our overpopulation and extreme consumption is on a fatal trajectory. What do we believe? Capitalist consumption or population control – because they are diametrically opposed. And in the meantime wouldn’t it be wise for us all – all 8 billion of us – to adhere to a living standard, a standard of consumption – that served to preserve the viability of life on this planet. Isn’t that the standard we must all meet until we can get our population under control? And isn’t full disclosure required in any event?
As someone still nursing a sore arm from my second shingles shot three days ago, I really felt this article. I also am old enough to remember having both Salk and Sabin polio vaccines as a child. One of my neighbors was a living reminder of the horror of polio, as she had a withered arm from prior polio. I also heard that there was another child nearby in an iron lung. Yes, the oral Sabin vaccine used a weakened live virus, which meant a vaccinated child could take resistance home to his whole family, even as it also brought a small but controversial risk of paralysis. That said, most people I knew were very glad vaccines had come.
So, I am distressed to read the many “red flags” IM Doc has found, and afraid of the parallels he sees to the criminal opioid crisis. I hope other medical specialists will review this data and help establish a consensus. Since the shadow of anti-vaxxers also hangs over this, I doubt anonymous IM Doc can accomplish too much, even with Yves’ help. Of course, Anita Hill and Christine Blasey Ford know what can happen when you go public. In the meantime, I am concerned about medical people being vaccinated first, especially if significant numbers are treated at the same place and time. I basically had the equivalent of a moderate case of the flu, with a very sore arm, that has greatly limited my activity for the last two days. I had a couple of good hours after the shot, but what happened next with my shingles shot has me concerned that if a number of people get a similar reaction to the COVID vaccine, an already stretched hospital or nursing home could be rendered a disaster area in just a few hours.
They used a novel adjuvant in this vaccine, and I know a person who developed recurrent hives as well as an allergy to chocolate in the month after the second shot of the shingles vaccine. Please be aware of possible adverse reactions! I hope all goes well, though.
I had already decided to hang on for the Oxford vaccine & the above only strengthens my resolve on this issue, although what I can only describe as a constantly growing deep lack of trust leads me to wonder whether that when I get the time I should try & find out more in regard to the long list of peers listed at the beginning of this Oxford vaccine paper.
Thank you IM Doc & Yves.
Fun facts on who was excluded from Phase I trials by Pfizer:
Individuals with high blood pressure (estimated by HHS to be 30% of U.S. population)
Individuals with asthma, COPD and/or using corticosteroids for breathing issues (according to ODPHP, 25 million Americans have asthma and almost 15 million American adults have COPD)
Individuals with a BMI greater than 30 (according to WHO, over 36% of all Americans are obese)
Aren’t these supposed to be some of the people who need Covid protection the most?
Actually, if you read the document that you linked to, it states that the groups you cite (people with high blood pressure, respirator issues and obesity) were excluded in Phase 1 ONLY. They were included in later phases, so that there is data on the effects and efficacy to those groups
I am not sure my comment is exactly in line with your comment and question –
But here it goes –
This list is in referral to PHASE I – or STAGE I trials –
These types of lists are very very common – as STAGE I or PHASE I trials – are where the investigator is trying to find out the doses that are safe – and what the immediate side effects of all kinds of dosing range – the same basically goes for STAGE II. This type of exclusion does not concern me at all –
This type of experimenting can be hard on the human body – and it is always better to have 30 year old healthy jocks – not 70 year old COPD diabetics. This is perfectly within line.
PHASE III trials like this pfizer one – are and should be open to much more patients to give a full spectrum – these are going to have trials with real drugs (the dosing and SE distilled from the PHASE I and II trials) and placebo arms.
You can rest assured that many obese and diabetic patients were in this study – by looking at the results and safety tables- their numbers are right there.
Thanks for the explanation. It was clear that this data was only for Phase I, but I didn’t realize that it carried over into Phase II and that the base of recipients was only enlarged for Phase III.
You should see the list of exclusions for the Moderna…Phase II, I think…trial. It’s nuts.
Thank you for this. It really echoes what I have observed during my life re the corporatism and corruption of the medical industry – and it’s gotten noticeably worse in recent years. I have a healthy skepticism, tend to trust my gut, and it just feels like something is off…
Question: Given the pre-ordering of vaccine doses by the US and other countries, are the vaccine developers going to get paid regardless of whether there are problems or not?
Agree with Rick in Oregon, exclusion criteria are listed in the phase 1 trial protocol, which was published online on NEJM some time ago. Takes three clicks to get there from the paper. It appears owing to the linked nature of the 1/2/3 phase design, the same exclusion criteria was used for the phase 3 study.
As they say in the Royal Navy, always choose the lesser of two weevils. COVID is bad (and I’m treating it too!) If you believe that the vaccine is potentially worse than COVID, the odds of that being true are reduced after the publication of this study, despite (I fully acknowledge this point) the well characterized inter penetration of academic medicine and biggety-big-big pharma. Not finding higher SAEs in the active arm vs placebo in a 30,000 plus sample is actually pretty reassuring. I agree that there will be new serious adverse events discovered as this rolls out, and some of them will be bad, but this is true of all therapeutics. Often despite unanticipated rare severe adverse events, the good of an intervention outweighs the bad.
Three clicks? You’ve effectively proven the point.
It should have been one click and clearly labeled, as well as discussed in the editorial and/or paper proper. This is not a medication targeted to a narrow audience, like most drugs. Vaccines and antibiotics are the only drugs meant to be taken by the public at large, and therefore critical information needs to be accessible to generalist MDs, since they will be the ones interacting with patients about the vaccines. Since when has a medication been hyped almost nightly in the news?
You gloss over that IM Doc and his fellow eight MDs meet regularly to review medical research, so the fact that he and they both were unable to find information they regarded as essential suggests that it was less accessible to clinicians than it should have been. The most important validators of these vaccines, as far as the general public is concerned, is doctors, and not scientists who regularly dig through the hundreds of pages of backup for the purposes of their own research and drug development. IM Doc was explicit that the purpose of the editorial is to help practicing doctors navigate the paper and highlight issues from all the backup material, that MDs are too time pressed to read the voluminous backup themselves and need summaries, indexes, and guides.
Moreover, you are trying to talk over a key point in the post, that there was one apparent Grade 4 event that was not reported in the data. It’s apparent exclusion is bad enough, but it raises concerns that there could have been others. The interaction of the Research Nurse reported in JAMA with the patient that had the 104.9 degree fever indicates she was out to minimize reporting of reactions. At best, it’s not a good look and it may be a sign of an effort, even if based on misunderstandings among the Research Nurses, to underplay adverse reactions.
The article itself states:
“Two participants each in the vaccine and placebo groups reported temperatures above 40.0°C”
What I am not getting here? Are these other known fevers, and the one he claims knowledge of is missing?
Why was it not in the table?
That is the concern – it is called sloppy work.
What part of the study do I believe – the table? the chart? the text? who knows?
The fact that proper adverse reactions reports were not filed, but buried elsewhere?
Right, there was one line about in the text buried in a list of many less serious reactions. They seem to be mentioning it by way of dismissing it. It should have been listened along with information about why this might have happened in these people, and what the risks for wide release. As IM doctor notes, they have taken a grade 4 reaction and classified at as ‘severe,’ and moved on. Nothing to see here!
It is further worth nothing that there were 2 people with 105 degree fevers in the trial arm from which people with severe allergies and autoimmune problems were excluded. It is impossible to know without testing, but there is a fair chance that these people with overactive immune systems (e.g strong allergies, autoimmune conditions) are more likely than the people in the trail to have that severe adverse reaction. So a realistic estimate of the number of people who will have 105 degree fevers cannot really even be given at this point.
As IM Doc stressed in his article, a temperature that high is a Grade 4 reportable event. A mere in passing admission in the text, with no indication in other parts of the document of anything of the kind, looks like obfuscation. This is a side effect and should have been included in the side effects chart as a Grade 4 event. Instead, a mere text reference, along side a mention the placebo group had cases of similar temps looks like an effort to pretend those two Grade 4 events were nothingburgers. They should have been clearly flagged and discussed.
As I said, “there was one apparent Grade 4 event that was not reported in the data.” A minimizing sentence in the narrative that does NOT flag that a 40C temp is a Grade 4 reportable event does not cut it.
So i can understand your point here, it is that we are offered the choice between getting covid and rarely getting side effects from the vaccine?
I may misunderstand, but I think the point here is that there are troubling indications that the vaccine may (low probability, granted) be dangerous, even if at a lower level than COVID-19 — or maybe not. And by the way, not discussed here, depending on circumstances there is a good chance you will not catch COVID-19. Do you really want to risk it?
I think Covid is very bad and don’t want to catch it. But I don’t think we should be setting up false choices between, ‘Take this vaccine that we know very little about about or live with Covid forever!” I’m not even sure the vaccine has problems. I think continuing to test it disclose information about the results (including allowing reporting to third parties) is fine. But I decry the the lack of transparency and communication strategy (rather than disclosure of facts and data gaps) that the government has been pushing. This isn’t a way to win trust, it isn’t even a way to do real science.
Thank you IMDoc! I have been very conflicted about taking this vaccine and this is the kind of information I need to know!
Some days I think I should take it and worry about side effects later, kind of like when taking radiation and chemo for cancer. I want to live and I will deal with the side effects later. Unfortunately, there seems to be no way that I can completely self-isolate.
But then, this is a whole experimental treatment with no history. Do I really want to subject my body to that?
But after looking at the exclusion data, this vaccine apparently is not for me – so I guess I will have to wait for a more standard vaccine.
Granted it wasn’t touted as a vaccine, but I’m old enough to remember and to have had my trust in pharmaceutical companies permanently scarred by thalidomide – I was still at school when one of the less badly affected children joined the roll.
Some expecting women in the USA were able to get their mitts on thalidomide, as I went to grade school with a student a year older than me, who had a flipper arm birth defect.
I went to high school with a girl who had a leg. That was her only limb. She had two prosthetic arms and a prosthetic leg.
What happened? Thalidomide. Her mother took it during pregnancy.
It was created by former Nazi death camp doctors. Surprise?
I’m reposting writing this as I’m not sure if my first version of this got submitted. A few things–
Thank you for highlighting the exclusion criteria. When I looked at the NEJM article, I was also unable to find them. I noticed that I reader has since posted them, and you updated the post. I also found the on Pfizer’s website. https://www.pfizer.com/science/find-a-trial/nct04368728-0
The list of people not included in the trial is long and concerning. It includes pregnant women, people with autoimmune disorders, immunocompromised, and a rather broad catch all category, “other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study. These are normal exclusions until phase 4. But because we have had an EUA, and not a real approval, there is no Phase IV. People with these conditions who are getting the vaccines are essentially volunteering as participants, without informed consent. WE are in an emergency, fine. But every interview and news article talking about this should caveat that there are categories of people this vaccine has not been tested on instead of allowing people to just take it in ignorance. As IM doctor points out, the coverage has been downright propagandistic. You should not have to be an expert researcher to find exclusion criteria that are essential for making critical decisions about your health. I have child idiopathic arthritis, an autoimmune disorder. Right off the bad, the ‘moderate side effects’ were of concern to me. If you have lived your life with an autoimmune disorder, you learn to be wary of jolting your immune system like that and setting a flare. But I assumed, until I read about the anaphylactic reactions in the UK, that people with autoimmune conditions were in the trial. This did not ease my concerns about longer term effects, but…I did not think it was bad as it was until I saw the news Tuesday morning and immediately understood that there had been some serious omissions from, ‘This is being tested on people with a wide range of health conditions.’ The doctors and and NIH/CDC officials who are talking to the press are being too casual about saying this is safe. They are not forthcoming with the facts, and in the process will further erode trust in their institutions.
I also found buried between paragraphs of the NEJM a mention of two reports of “over 40C fevers.” So they were mentioned in the document, but not in the tables. Still, two. So your estimated numbers of 12-17k people having these types of events should be 2X as high. Providing Pfizer’s reporting is accurate. I certainly think here is a conflict in having these events reported to a pharma company instead of to a third party, but I supposes that could also be prone to corruption through a principal-agent problem.
Here is the only news article I was able to find on the issue: https://www.dailymail.co.uk/health/article-9026685/Nurse-took-Pfizers-coronavirus-vaccine-trial-said-highest-fever-life.html. Published in the daily mail, because apparently more respectable publications find this to be fake news? Not sure.
>As IM doctor points out, the coverage has been downright propagandistic.
A few days ago Scott Simon of NPR interviewed the Griffiths, an elderly couple who had been touted in the UK as the one of the first married couples to receive the Covid-19 vaccine. The octagenerians — both long-time employees of the NHS — regaled Scott with glowing accounts of how pleased they were to receive the jabs, how they didn’t feel a thing, how they were positively “over the moon” with how the whole thing went.
Toward the end of the interview, Simon chuckled as he noted that the couple were amateur ballroom dancers and wondered if they were now ready to hit the dance floor once again.
The whole nauseating interview was so clearly a designed bit of propaganda that I couldn’t help but think of Wag the Dog. The Griffiths are this narrative’s version of the refugee girl fleeing the bombing of her village while holding a bag of potato chips.
Today in the U.S. we see the widely circulated clips of employees of Pfizer employees cheering as the first trucks, packed with vaccine, leave the Michigan storage facility en route to beleagured citizens across the land. The other widely circulated pic was of a African American healthcare worker getting the vaccine. They are stage-managing the hell out of this roll out and apparently appearances are what matters most.
National Propaganda Radio (NPR) is just doing its job, especially that creep Scott Simon.
Love the “Wag the Dog” reference. Best film about cynical politics & media collusion ever IMO. De Niro and especially Hoffman at the top of their comedic games.
On a more serious and sad note, the late John Le Carré stated after doing research for his novel “The Constant Gardener” that he had never met a group so cynical and evil as Big Pharma. RIP.
IM Doc plans to say more once he and his buds have looked at the protocols, but a lot of people are confusing the Phase 1exclusion criteria (a lot!!) with the Phase 3 ones. I had trouble on a fast skim with that too, the Phase 1 ones are much easier to find.
Allergies, pregnant and breast-feeding, autoimmune and immunosuppressed, steroids, all Phase III exclusions.
This is SOP for drug trials, fortunately or unfortunately, since the sponsor is the drug company. However the IRB is supposed to review the protocol as an independent body.
I know. I am sensitive to the consequence of this as I was given Vioxx in my teens and twenties. I don’t think that the conflict is unique to the COVID vaccines, but I think that the potential harm for this MO going wrong is….particular.
For some odd reason the protocol link is no longer working for me, but one of the things I noticed was the requirement that participants practice strict birth control during the study. I’ve certainly seen this in clinical trials for cancer treatments but for a vaccine you’re planning to roll out to millions of people?
It is because they have not studied developmental and reproductive toxicity, also a normal phase IV item. Here is an article in the NYT from two days ago that very casually mentions that pregnant people were excluded.
“Regulators in the United Kingdom recommended against these women receiving the shots even while acknowledging that the evidence so far “raises no concerns for safety in pregnancy.””
But of course it wouldn’t have it hasn’t been studied. The logic of the article is that pregnant women are high risk, and so women who can’t stay home should have to take it. I am am sure that plenty of them will have no better option. But this is part of the strange logic that runs through this rollout–we are going to protect the most vulnerable people who don’t have the opinion to stay at home. Except that this hasn’t been tested on a huge chunk of the most vulnerable people.
A humane government would provide support for the most economically and physically vulnerable people to stay at home while it ran a proper phase 4 trial, and let healthier people take advantage of the EUA if they choose to. But that is not what this is. This a sacrificial policy that pretends to be helping the vulnerable while keeping them uninformed of the risks.
F—————-! Echos of Thalidomide. I think I can see the clusterflock right now.
Well the protocol is the first item in the supplementary data so it’s quite hard to miss. But it will take some reading and I havent.
From reading the paper I don’t see any any cause for being quite so negative except that the excluded groups clearly needed better publicising. This seems a fair point but the rest is far too speculative in my view. I did find the adverse events in the paper, I’m not sure I could understand why IM Doc found them under-reported.
I don’t think the freezer thing is much of an issue. More likely the issues that could arise are on the QC on the production side with batches which are not 100% RNase free. Actually RNA is quite stable in aqueous solution.
“Actually RNA is quite stable in aqueous solution.” Sometimes, in a molecular laboratory full of highly trained scientific workers who maintain the strictest quality control imaginable, for milligram to microgram quantities of RNA. Working with RNA does not require a BSL-4 lab (think Ebola) but precautions are as rigorous (without the isolation) regarding preparation and handling of the harmless RNA. And yes, the freezer thing is very much an issue. I heard so on NPR this morning! The University of Kentucky Medical Center has invested in many of these ultra-cold freezers to keep their vaccine stocks stable. My question is this: Are the residents of Pike and Perry Counties expected to come to UK or is UK going to them?
I’m an IM physician as well. Myself and many physicians I know are absolutely NOT going to inject any of the new mRNA experiments into our bodies. We will need decades of data to be able to study the long term effects (autoimmune diseases, leukemia/lymphomas, fertility issues…).
One thing that amazes me is that the media repeats “masks, distancing, lockdowns” — but never talks about what actually does increase your chance of beating covid: eating plants, getting good sleep, exercise, and if you are overweight, lose weight.
People also forget all of the lies Pfizer was spinning on statins in the late 90s early 2000s — and that Bill Gates was a sociopath monopolist in the 90s who didn’t care at all for any of his customers. The first tell on covid was how the news media gave all their air time to Fauci (a 40-year bureaucrat, and Gates, a monopolist businessman) and not any real scientists.
Science is eternally skeptical — that is the definition of science: question all and try to prove otherwise.
The other thing no one wants to talk about — with the fatality rate of 1.8% today (based on cdc numbers in USA) — What is the difference between a 98.2% chance of survival and a cure? How many lives ruined to try to push that to 99%? Future people will look back in horror over the idiocy of our current leaders. No one is using their frontal lobes.
One issue we have stressed is that the fatality rate from Covid is not the entire story. Unlike a winter flu, which also kills some people, Covid appears to have lasting symptoms in quite a few: long Covid, lung abnormalities, heart inflammation, altered kidney function, brain abnormalities and elevated levels of depression. They may abate over time but they are non-trivial impairments to normal functioning.
Yes, the reports are completely focused on mortality and ignore morbidity.
Recent studies of Ivermectin have shown effectivness in short-terming the long haul symptoms. Chris Martenson’s YT on the over 30 recent studies, RCT’s, etc. showing it’s effectiveness, was yanked, and now I see that Vimeo has also taken it down. I think Dr. Kory’s recent testimony before Senate hearing referenced this. So… long haulers, you (among others) may be being sacrificed to the ‘end point’ of this vaccination crusade.
Also, regarding the stated ‘endpoint’ of the vaccines… how could it not be 95% effective?
Regarding ”The dozens upon dozens of twenty and thirty-something patients who have been rendered emotional and spiritual zombies by the SSRIs, antipsychotics and amphetamines they have been taking since childhood. Their brain never learned what emotions were, much less how to process them and we are left with empty husks where people never developed. The SSRIs and antipsychotics were NEVER approved for anyone under 18. EVER. While there are some validated uses for stimulants in children, they are obviously overprescribed, as confirmed by long-standing media reports of their routine use as a study/performance aid. It is all about the lucre.”
I was imprisoned in a Juvenile Hall in California in 2005 for crimes I did not commit when I was 13 years old. They forced me to take Prozac on a daily basis. There are 100 points you get everyday on your ‘behavior scorecard.’ If your daily score is 100/100, that means you are behaving well. The guards dock points for whatever reason they feel like, it is totally arbitrary, there is no appeals process. Once they docked my points for wiping blood and pus from multiple infected wounds on my ass/thighs on the wall…I had no gauze and I didnt want the stinky pus on my bed/clothes. I had to wipe it on the wall. Anyway, when deciding to let you out of the cage or not on your court date, the judge looks at your scorecard. Low points=more time in the cage. If you do not follow your program by taking whatever chemicals they demand you ingest, you lose points. So obey and take the SSRI or more prison time is the rule. So I was wondering if someone knowledgeable could tell me more about this sentence from the article, ”The SSRIs and antipsychotics were NEVER approved for anyone under 18. EVER.”
So was this known in 2005 and they did it anyway, or is this new info that has come to light in recent years? Also, and more importantly, can I sue the Juvenile Hall or the city that it is housed in for forcing me by the threat of violence to take SSRIs that, ”were NEVER approved for anyone under 18. EVER.”? Would I have any success at litigation in the California courts?
Finally, if anyone can provide some info/links to medical articles with documented effects of these drugs on children, I would love to read them. Thank you
What a country we live in!
Yep-it’s the ‘standard of care’.
This whole thing makes me sick.
And thanks to IM doc for bringing up Marsha Angell over at the NYRB. Her articles about pHarma and SSRIs/psych meds and review of Robert Whitaker’s book “Anatomy of an Epidemic” and Irving Kirsch’s work that made me take a hard look at all the drugs I had been prescribed after my traumatic divorce.
Still dealing with the damages 7 years later…
I know this is a very late response, but here it is anyway. Are you familiar with Dr. Peter Breggin…might be a place to start to look. He is a reputable critic of most psychoactive drugs…
LOTS of $ involved.
Being first out the gate has value even if you are “Firstest with the worstest” .
Especially when you’ve got a big, fat liability exemption to cover your vax.
Thanks for this. I just called a Chicago-area covid hotline for advice about my mother, as she is in a nursing facility and likely to be among the first to be offered the vaccine. She has a number of autoimmune issues and is very wary of being a guinea pig, so I called her doctor’s answering service to try to talk to him for some advice. The receptionist immediately told me the doctors weren’t answering questions about the covid vaccine and directed me to the medical group’s covid hotline. I called them and the woman there said I should talk to my mom’s doctor about it (well duh, that would indeed be ideal). But then she said that her honest advice is to wait. She said she and others were being told to push the vaccine to patients as the medical group and everyone else in the industry is profiting from it, but that she was in a higher risk group (age 60+), didn’t trust the rushed vaccine, and would not take it until more is known. My mom has asked a couple nurses in the nursing facility whether they would get the vaccine when it became available. They said they would not. I know these are just a few people, but they are people working at a hospital’s covid hotline and a nursing home. I was pretty startled.
Many hotlines/support phone lines are recorded for “quality control purposes” and I’d be interested if that was the case here. Probably not. If it is this woman runs the risk of “not being a team player” and being shown the door. I heartily salute her honesty.
Thanks to IM Doc and Yves for this- and to all the commenters. This comment section is a great place to learn.
Yeah exactly. The recording before I spoke with her did say something about it being recorded. My mom and I were theorizing about why the doctors in the hospital can’t answer questions about it. We concluded they are either afraid of being swamped with questions and/or they are afraid of being sued later on if things go bad.
Trust is fine, as long as the requisite accountability accompanies that same trust, in the reciprocal relationship dance between individuals. Sometimes, caveat emptor is hardly enough, since; we cannot all be expected to have the same expertise and/or experience as the individuals we so often have to put our unqualified trust in.
And sometimes, that same accountability fails to materialize when things go horribly wrong. That is not to say that it is the case, or that it will be the case in this instance, but it certainly has been the case in the past, for some people who have experienced the results of medical error, or the adverse effects of medical intervention personally, i.e., iatrogenesis more generally. Where iatrogenesis is understood as the risks and side effects associated with medical intervention.
Because, “A recent Johns Hopkins study claims more than 250,000 people in the U.S. die every year from medical errors. Other reports claim the numbers to be as high as 440,000.”
Our neighborhood MD quoted 100,000 iatrogenic deaths in the US about 1980. I wonder how the percent increase in deaths correlates with the increase in procedures, scrips, surgeries over those 40 years.
A different study provides a decidedly lower patient mortality numbers estimate, noting that there are “Strengths and Limitations” for those same provided estimates.
“Association of Adverse Effects of Medical Treatment With Mortality in the United States
A Secondary Analysis of the Global Burden of Diseases, Injuries, and Risk Factors Study”
Jacob E. Sunshine, MD, MS1,2; Nicholas Meo, MD4; Nicholas J. Kassebaum, MD2,3; et alMichael L. Collison, BA2; Ali H. Mokdad, PhD2; Mohsen Naghavi, MD, PhD2
The Johns Hopkins study, “Medical error—the third leading cause of death in the US
BMJ 2016; 353 doi: https://doi.org/10.1136/bmj.i2139 (Published 03 May 2016)”
can be found here,
The numbers in the JAMA study appear to be low, to myself, based on evidence for Canada and then extrapolating for population in the USA. See for example,
Hopefully, the links work. If not, follow the bread crumbs.
A very belated thank you!
I know it is true that negative effects could take years to appear, and I understand that, and the worst effects are probably long-term. But in addition to that I’m also worried about something happening within 3-6 months. Not out of personal fear, but rather the fear that within half a year the medical personnel intended to take it early will be the first ones who would begin experiencing any of these problems. I do NOT intend to be callous when saying this, as long term health conditions like that woman who got Polio from the vaccine are absolutely terrible, but the idea of much of the nations doctors experiencing side effects before 2022 is rather terrifying to me in and of itself.
I am not a medical practitioner and I know nothing about this vaccine, just a person with anxiety over… Well, the entire process, as well illustrated in IM Doc’s account here.
Sputnik V! I’m waiting for that one to journey to some of the ‘border’ towns in MX so I can take a day trip and get vaccinated.
I’m asking this question assuming you’re not joking. Why would you put more faith in Sputnik V when you know that leaders in all countries use these issues for political purposes. If things go wrong, the poor truck driver who took the shipment of vaccines to the airport will be blamed and the guilty will go uncharged. Much the same as here but at least we have from prior info on the poor study from gentlemen like IMDOc.
I hear what you’re saying. I just think that my demographic will be toward the end of the line for vaccinations. NYT estimates that I’ll be eligible to get a ‘jab’ (Love that term) after 93% of my fellow Angelinos have gotten theres. I believe I’ll be so far to the back of the line that I’ll be able to see all of the issues with all of the various vaccines ( Moderna, Sinovac, Sputnik V, CBGB (whatever it’s called), Pfizer, or the two other Chinese versions that I can’t remember right now.) So I think that planning a trip to the very southern area of CA as a contingency is OK in my book.
Sputnik V … I believe I’ll be so far to the back of the line that I’ll be able to see all of the issues with all of the various vaccines
I don’t think Sputnik V is necessarily a bad idea. The Russian vaccine technology uses as its vector a human adenovirus — a common cold virus (two of them, in fact) — that carries the gene that expresses the spike protein of COV19 in order to stimulate an immune response.
So, like the mRNA vaccines, it targets the coronavirus’s spike protein. Unlike them, an adenovirus vector is, relatively speaking, a tried-and-true technology.
My guess is, it will most likely work fine.
The Russians are far from unsophisticated about this stuff. The state institution that developed their coronavirus vaccine, the Gamaleya Research Institute in Moscow, has developed other coronavirus vaccines using this technology and has done government-sponsored R&D since its founding in 1891. In 2020, the Gamaleya is tied in to both the Vector Institute and the Russian Ministry of Defense, which means the government thinks of it as part of its necessary defense spending.
As I say, the Russians aren’t unsophisticated about this stuff. From 1971 to 1990-91, the old U.S.S.R. ran a Manhattan Project-sized bioweapons program, Biopreparat, that had some 100,000 personnel on its payroll, with some 40,000 of those having actual scientific expertise. I had the chance to talk to a few Russian scientists who were high up in Biopreparat.
I mention this because, even assuming those Russians were talking their book, they not only did some remarkable, scary things but also achieved certain biotechnological milestones maybe twenty years ahead of the West or anywhere else. Even in 2020, the Russians may conceivably know a few things we don’t .
Interesting. Not least of all to read about the cooperation required to achieve all this.
Thank you so much, IM Doc!
Thanks again IM Doc for so much insight, written in a fashion that a high school student could comprehend it, bravo!
A small quibble with the statements surrounding the Salk vaccine. It was not the vaccine, but the quality control in the manufacturing process that was at fault. The producing company tested its vats for ‘live virus’ and disposed of vats that tested ‘positive’, releasing the other vats for vaccination. The fact that some samples tested positive SHOULD have been the flag that the manufacturing process was flawed and no vaccine should have been released until this was resolved. The failure here was that in testing any vat, only a sample was used, and was not indicative of the entire vat and the contaminated vats should have raised these concerns.
Good clarification. Glad that sort of error cant happen nowadays! Or at least with mRNA
That is made clear in the Washington Post article linked to in the mention of the patient who had gotten polio from the vaccine, that the dangerous vaccine came from only one maker. I didn’t want to have the post go into more detail about the damage resulting from the rushed polio vaccine effort and relegated most of that to a footnote when I edited the post. IM Doc was very clear about his reasons for Big Pharma skepticism and I didn’t think overegging that pudding would help.
A sobering read. Thanks for your time IM Doc. Having married a biomed researcher and been her sometime lab assistant when she needed extra labor, I’m sympathetic that what may have happened here is a rush to publish and that the data is there but has been cracked open yet. But even with that generous assumption what you’re saying still isn’t good. Here’s hoping we don’t muck this up. Because if this vaccine turns out to be poisonous we will have many more problems than an extended pandemic. This will be the thing that causes all trust in these institutions to collapse.
> a rush to publish and that the data is there but has been cracked open yet.
I would like to think so, but the choice of personnel to write the Editorial argues against that.
For what it is worth, Singapore is to my knowledge the first country where the government has committed (with the caveat “if all goes to plan”) to a timeline for vaccination of the whole population (by the end of 22, with availability for everybody by Q32022). Vaccination is voluntary, but I would expect it will become compulsory for crossing the border, which, for a Singapore resident, is practically equivalent to being compulsory, as a vast majority of the population crosses borders to go in Malaysia or elsewhere.
They authorised Pfizer vaccine, but with more exclusions than FDA :
– over 16 (Like FDA),
– no history of serious allergic reaction,
– no immunocompromised ,
– no pregnant women.
The PM mentions in his address that the whole cabinet will be vaccinated including himself (he is a two times cancer survivor). Other tidbits is that vaccination will be free and that the govt committed more than $800 million on various vaccines, which is about $140 per resident…
Other datapoint I could find : the FDA fact sheet for health workers for the Pfizer vaccine gives the profile of the tested population. 17.4% are in the 65-74, 4.4% above 75.
Finally, I was not impressed by the “casual” statistical argument than roughly 20k persons in the population would get a potentially lethal fever caused by the vaccine. It completely ignores the “base rate” of high fever in the population therefor one cannot therefore make any prediction based solely on that datapoint. This is really statistics 101. Actually, the FDA fact sheet reports a few fevers over 40C in the placebo group as well !
I agree however with the author that long term risks of an entirely new form of vaccine are unknown, so the first ones to be vaccines are going to be the guinea pigs. View it on the bright side : as vaccines will become certainly compulsory for international travel, and the 1%ers are practically all compulsive international travellers, whether for business or for pleasure, they are going to be the guinea pigs ! It doesn’t happen so often these days that leaders actually lead in battle…
The argument was not “would get” but “could get” a severe fever.
And the one case we mentioned, the case written up in JAMA, was very clear that her fever was triggered by the vaccine due to the speed and severity of onset. The reaction of the Research Nurse confirms that the Research Nurse accepted the fever as vaccine-induced.
Not everybody that travels internationally is in the 1% or does it compulsively. You seem eager for compulsory vaccination to be instituted. Absent proof of sterilizing immunity, I don’t see the basis for it. Correct me if I’m wrong.
Yes, it is fair point that the study says that there were also 2 incidences of 40C + fevers in the placebo arm, so in that way this was not above the base rate of fever in the population. That might be why they did not feel the need to report it in their data, or at least felt they could get away with not reporting it. But the numbers are too small, and is this is an instance where the qualitative information matters. IM Doc also highlighted, in talking about needed to know how many work days were lost from side effects, the importance of qualitative information. Data can serve to inform or to obscure. In a minimum of one of the cases in the test arm, the narrative context provided by the clearly indicates that the fever was caused by the vaccine. That alone should demand more investigation.
What I was saying was just 1%er => compulsive international travellers. I was not making the assertion that all international travellers are compulsive or in the 1%. Logic 101.
I am not really eager to compulsory vaccination, but I realise that :
first, international travel is not a right but a privilege that is granted by the receiving countries;
second, it operates on a reciprocity basis.
As many nations are going to require vaccination for incoming travellers, reciprocity will make it an universal requirement. For instance, Singapore will be the venue for the WEF in May. I expect the government to require vaccination for all participants and the accompanying press coming from all over the world.
I am also worried by the female fertility aspect, especially now that Pfizer officially denied it, but there seem to be also some informed people who think it is a nothingburger, so I would put that in the low risk category. I would also add that there are some recent results that suggest an impact of COVID on male fertility. So it looks like there are only bad choices there…
Yves, thank you for highlighting some of the issues that I pointed out in my last comments. But the fight to keep people fully informed about the risks of vaccines that were supposedly tested in less than one year rather than the normal five to seven year period continues.
I want to highlight two really obvious things based on what IM Doc mentioned at the very beginning. She is tired of this “pandemic” and I completely agree with him or her. But the problem of the pandemic goes not just to the misinformation and massaging of data that I mentioned before but to inherent problems of the health systems in the western world. I note the willingness of Asian countries to use natural remedies such as the Chinese who use high doses of vitamin C along with other supplements such as vitamin D, zinc, etc which studies have shown is strongly associated with better resistance and recovery for those who happen to get covid-19. I still note a reluctance of doctors to use oxygen therapy more extensively as in Germany and Austria where the impact of covid-19 is far less severe. I finally note that months ago Professor Tom Borody told the world that Ivermectin was highly effective against covid-19. Of course he was threatened and silenced by the health bureaucrats. What the study showed was of 1,196 health care workers recruited from 4 major hospitals in Argentina, 788 were given IVERCAR and PPEs while the remaining group of 407 were only given PPEs. Overall infection rate for health care workers was 20% with 237 testing “positive” for covid-19 (it doesn’t say if and what symptoms they had) during the 3 month study. Of those infected, all of those were from the baseline group of 407 (i.e. 237 out of 407). No patients given IVERCAR tested postive for covid-19 during the study. You can find the study in the Journal Of Biomedical Research and Clinical Investigations. Volume 2 Issue 1.1007. The title is Study of the efficacy and safety of Topical Ivermectin + Iota-Carragenan in the Prophylaxis against Covid-19 in Health Personnel”. I know that Dr. Pierre Kory M.D., a pulmonary and critical care specialist who is also an Associate Professor of Medicine at St. Luke’s Aurora Medical Center in Milwaukee, Wisconsin informed the US congress of how effective a treatement invermectin is in treating covid-19 during a hearing on the pandemic about a month ago but of course nothing was done. So there is already a number of highly effective treatments for covid-19 be it drug based or natural interventions. They are just not being used to push everyone into using only cursorily tested vaccines. It is a major red flag!
While I appreciate your comment, I must caution you that that Argentina study is garbage. No randomization, no blinding, no placebo controls. It was so poorly designed and conducted that it has to be tossed as evidence.
This is harsh. It is not because a study is observational that it is garbage. There were no randomised double blind placebo controlled study on smoking, yet medicine has indeed proven beyond reasonable doubt that smoking kills !
Read the Book of Why by Judea Pearl, it is an illuminating book..
Sorry, there were experiments on mice that showed that the chemicals in cigarettes caused cancer. And scientists had identified mechanisms, as in they had a theory as to why this occurred:
Unlike the ethical and practical obstacles to doing a study on humans on smoking (you can’t come up with a credible fake cigarette, it takes years to decades for cancer to develop), there are no such big barriers to validating Ivermectin. Placebo effect has repeatedly been demonstrated to have a powerful effect on study results. You can’t rely on anything less than a blinded placebo controlled study for a medication. That has yet to be done with ivermectin.
There are some much more recent scientific studies and clinical trials of Ivermectin being used as both a prophylactic and treatment for covid 19. I don’t know if they would meet the exacting criteria or standards of whatever scientific governing body or authority determines such things. The fact that one of the clinical trials in Bangladesh was sponsored by a pharmaceutical company would be enough to arouse the suspicions of many, and perhaps rightly so. I’m not advocating its use, but it is being widely used, especially throughout South America and apparently with considerable effectiveness, if the articles and the studies are accurate. These recent, ongoing studies and articles are available on trialsitenews.com. Anecdotally I offer this; a coworker of mine in his early sixties contracted covid 19. He survived a widowmaker heart attack a decade ago, after which he gave up cigarettes. His comorbidities include obesity and COPD. He almost died from the covid 19, and he swears that the only reason he didn’t is because he was administered Ivermectin by his MD, a practitioner of internal medicine. He’s absolutely convinced of it. I’m not going to rain on his recovery parade by disagreeing with him or ascribing it all to the placebo effect.
> You can find the study in the Journal Of Biomedical Research and Clinical Investigations.
Dude. I linked to this study five days ago here. We don’t catch everything but we do try to keep up.
I really appreciate the time and thoughtfulness this site’s authors and readers put into the dialogue. You all give me hope. Many blessings to you!
Thanks so much for this IM Doc. I hope we’ll see a repeat performance for Moderna + Oxford + anything else that comes down the pipeline.
The experimental Pfizer vaccine sounds pretty dubious. It is astonishing that the trial didn’t bother to look for asymptomatic cases. This raises the question of whether the other vaccines have been developed properly, or if they too have been tainted with improper practices. I read somewhere that the different vaccines were tested in Brazil, and that the Sinovac vaccine performed the best. Maybe we need to nationalize the pharmaceutical industry.
I agree, but would re-phrase: it is astonishing that the FDA did not require Pfizer to test for asymptomatic carriage of infection.
This could have been done very easily by giving participants multiple swabs, having them swab daily then throw each weeks’s worth of swabs into the refrigerator for mass testing weekly.
Thanks for the report. What I could understand, Bell’s Palsy occurred in four people given the vaccine. I have had Bell’s Palsy twice. Both times my doctors at my HMO said they believed the Palsy is caused by a viral infection related to cold sores: herpes simplex. The infection essentially inflamed the facial nerves causing the dysfunction. Maybe the vaccine works, but there is something about a vaccine causing very particular symptoms of another very particular viral infection that puzzles me. I can see like soreness, fatigue, etc, but inflamed facial nerves???
And I thought I was going to have a leisurely stroll through NC today!!!
Yves, there is no day that this website doesn’t inspire me to be a critical thinker.
I thank the IM Doc for his unparalleled attempt to expose sloppy work.
Your comment is utterly out of line. The mainstream media, in many accounts prior to this post, depicted the exclusion precisely as IM Doc did. From Associated Press (emphasis ours):
From USA Today:
Slaoui is the former head of head of GlaxoSmithKline’s vaccines department, yet he didn’t deem the distinction you are exercised about to be important. And unlike IM Doc, who was up front about not having found the exclusion criteria, Slaoui presumably was familiar with them or re-examined them before speaking to the press, and thus deemed this to be accurate for his purposes.
From Asthma Center (By Dr. Marc F. Goldstein, Board-Certified Allergist at The Asthma Center (Philadelphia PA, Mt. Laurel NJ):
There are more examples but that should settle the matter.
And you also have no basis for questioning IM Doc’s status or insinuating that we didn’t check it. So you have a lot of nerve to sling mud.
Other doctors pointed out how rare allergies to vaccines are, and the UK reactions (it turns out there was a third first day reaction but not as bad as the two publicized) suggest the screening for vaccine allergies and allergies to vaccine components excluded candidates with more general severe allergies. I once passed out after a penicillin shot (the only other time I have passed out was due to a concussion), and generally feel like crap when I take it. Whenever I have told doctors this, and I stress that I am not allergic, that I just don’t like penicillin and its derivatives, they nevertheless list me as allergic despite my specifically having said otherwise.
This is a strange defence. You’re saying that because the mainstream media made a mistake of interpretation, it’s OK that IM Doc (who is supposedly an expert at interpreting medical papers) also made the same mistake?
Do you have a reading comprehension problem? The “mainstream media” directly quoted Moncef Slaoui, former head of the vaccine operation at GlaxoSmithKline and co-head of Operation Warp Speed. The final example was from an MD who appears to be a professional medical writer, either full time or part time. They summarize the findings (and the Associated Press report is written as if they read the source material) and all rendered it the same way.
You are also straw manning, both in the remark I addressed and in your mischaracterization of IM Doc, which is a violation of our written site Policies. Neither IM Doc nor I presented him as an expert in interpreting medical papers. IM Doc him as having been trained at a top teaching hospital, and specifically also specifically training how to read medical journal articles by a top expert and in reading them regularly with his group of eight other doctors. In other words, he is likely to be in top half, and perhaps the top quartile, of practicing doctors in his care in reading a medical paper.
Page 6 of 13 (NEJM article) explains the missing participants, but I do not know how to interpret. To wit, “At the data cut-off date of October 9, a total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set.”
Thanks. This post and comments illuminate perfectly the problem with for-profit medical care and the dysfunction that occurs with regulatory capture.
NBC News last night was pure corporate propaganda on the rollout of the new vaccine and the beginning of the end of the pandemic.
I have a stake in this. I meet all the criteria for exclusion. I will be sheltering at home for months longer. What is disconcerting is that we are told to accept that FDA said that it is safe. There is no media scientific background information on the new injection method using nano-lipids to get messenger mRNA inside the cell to take over protein production and stimulate the immune system to the foreign coronavirus protein.
There are a lot of valid questions that seem to be ignored. Why is the Pfizer vaccine not expected to produce an immune response to other human proteins? Is the coronavirus spike that unique? Are there any animal tests on the nano-lipids? If not. Why not? Dengue fever vaccines failed due to the heightened immune response when infected with different serotypes. With less than 10% of the participants infected with coronavirus and 42,000 injected twice, is this a sufficient to detect any adverse excessive human immune responses?
Time will tell. But with the Proud Boys picking fights in DC and a replay of the Great Depression ongoing; honesty and an informed public, are the only way the nation will stay united. Profiteering guarantees secession.
Thank you IMDoc for taking the time to lay it out in clear precise words what the situation is. We all appreciate how busy and pressed for time you are. And thanks for Yves too in highlighting this important story. As I write this, the news is playing in the background as they talk about the first lot of people getting their jab and it sounds like a PR campaign. Biden has just promised that 100 million people will get the jab in his first 100 days. What a legacy that could prove to be. What does not get mentioned is the real reason for this rushed vaccine – the economy. The economy has to come first regardless of the cost and that has been made plain and clear by a host of people over the past few months, including by more than a few doctors. To repeat a Star Wars quote – “I’ve got a bad feeling about this!”
You nailed it, Rev Kev. It’s all about the economy. I was sickened listening to the news the other night. The CEO of Perdue (poultry, not pharma), sent a letter to Maryland’s Governor Hogan asking him to prioritize his workers, ostensibly for national food security, but it’s clear it’s to protect his profits. I, too, have a bad feeling about this.
In my view it’s more than the “economy”. The IM Doc has exposed the sloppy work on the vaccine that is the “Hail Mary” pass to try and steal victory from the jaws of cultural defeat
The US was wholly unprepared to deal with the novel coronavirus: an unconcerned President, a disorganized public health system, privatized medicine, preference of personal “freedom” instead of collective protection, politicized messaging and pressure on virus experts, etc.
The IM Doc is simply noting the chaotic line of scrimmage before making the long pass to the end zone. Let’s hope that there are no serious consequences to the general public in this attempt to contain the pandemic.
Thank you IM Doc, great post.
The tips for how to read a research paper will come in handy.
You have taught someone how to fish better.
I appreciate all the time and information from the community as well.
I think most intelligent people will have concerns about the Pfizer vaccine. The first red flag is that it requires cold storage and so to get a return on investment it really had to be early to market. I am a little bit more sanguine about the testing results because a number of regulators across different countries will have looked at the data.My concern is more about the immune response from the second injection which to some limited extent seems to effect many who are vaccinated. COVID-19 seems to have three components, with the first being the initial flu like symptoms, the second where the virus attacks some internal organs (cough ,loss of smell) and a third where the immune system goes haywire and also attacks internal organs (really bad). It worries me that the vaccine could increase the propensity for the third component to take effect. I am inclined to wait for the Astra Zeneca vaccine until I have more information on the effects of the second injection and whether it causes issues when people are exposed to the virus.
I am also a little concerned about the new variant of COVID-19 in the UK which is reported to have a change in the spike protein and may have an impact on vaccine efficiency. The new variant has a change to the N501 (reportedly) spike protein (probably N501T although it has not been specified) which I think (I am no expert) increases the ability of the virus to infect cells (the binding affinity between 2019-nCoV RBD and human ACE2) and would increase transmission with a lower dosage of the virus.It also has the H69/V70 deletion (reportedly) which if I understand correctly means it can suppress the immune system so that it can infect more cells and delay onset of symptoms whilst still being transmitted. Maybe not as bad as some of the variants identified in South America but not what you expect from a supposed slowly mutating virus.
Three steps forward and two steps back as the saying goes.
In the 1790s the French progressively more and more fed up began their reign of terror a mere 30 years after British colonials, fed up with taxation without representation booted a major power and took control of their own destiny. What I don’t think people (politicians) realize is the care of the people, just like I care for my dog, is not a red or blue issue but one which can blow up in their collective faces as we the people rise up, not as Democrats or Republicans but as the fed up because caring is a function of government just like an Army, police force, or the corp of teachers educating our young. It’s going to dawn on them that just as Florida Power & Light is not allowed to rape me on the cost of a KWh that Assurant Health isn’t either. Utilities exist for a reason, and controlling the instincts of unfettered capitalism is one of them. Better they get ahead of the crowd than wait for the sound of wheels sharpening guillotine blades, eh?
Someone remarked that we are entranced by the idea of a magic potion. Here’s an imagination: On a day back in March when the stock market plunged, the ruler Donald the Orange turned red with rage and demanded that his wizards deliver a potion, whatever the cost, that would make the graph look like a “V” and before November 3. (He had a bit of a history of a market manipulator, loved to do it and all his friends loved him for it.) Because the Donald had promised that one day the plague would “just go away,” nobody dared think of anything that was for all intents and purposes not 100%, and that was more important even than the deadline. Safety, well PR about the high tech angle could take care of that. Details, not his style. Logistics, well we are good at logistics. An option like a really safe vaccine that was only 50% effective and easy on the logistics, not considered even for a minute. Like maybe a nasal spray to wash that bug outa your nose. Like with a lot of other things, like maybe the climate disaster, your options are limited by extraneous decision factors. For me, a bit too much of the doctor’s points were inferential, although I share his grounds for discomfort. What would it take to make a MD like this feel good about vaccinating his patients?
i hope that this post doesn’t affect how this website is treated by the search algorithms.
But it’s too easy to imagine a scenario in which this entire website gets put on a Kafka-esque list by a low-level staffer and never gets off.
Look up Naked Capitalism’s experience with “prop or not”. This has already happened to Yves and the gang once. The website was evidently a hotbed of Russian disinfo. In other words, thinking for yourself means you are a Russian agent!
I’m late to the party here, thanks again IM Doc.
On exclusionary groups – my understanding is that nobody under 18 (or maybe 16?) was included in any of the trials, phases 1-3. I am thereby stunned that the FDA did not at least qualify their EUA with a statement to the effect of, “this authorization is limited to individuals over the age of N (N= whatever age of the youngest persons in the phase 3 trials.)
I am going to bring this up with my kids pediatrician and listen to their response quite carefully.
Peds here. I wouldn’t let any children or pregnant women anywhere near this vaccine without way more safety data.
I brought this up with my pediatrician and essentially her response was the same. No chance she would let any child get this vaccine for years, until more data come in.
Funny how the media fail to even tread within a country mile of this issue.
Now you know why vaccines take so many years to develop and bring to the market. The Covid 19 Pandemic has been deemed severe enough to speed the process way up. The initial receivers of the vaccine will be taking on some risk, but as front line HC workers and nursing home patients are so drastically at risk form the virus, most likely a risk worth taking. Time will soon tell.
Peds here. With *adequate* PPE, ie reliably-manufactured and used once as intended, healthcare workers are quite well-protected. Why is participation in a phase iv trial better than providing us with what we know works well? I’m asking somewhat rhetorically as someone who wonders how long I’ll have access to properly fit-tested n95s.
Thanks for the info. I am immuno-compromised and over 65. I will be taking my patient, sweet time staying on top of the vaccine situation. That said, I laugh at the US Deathcare System. I have had to be my own medical advocate for nearly 20 years. I have not contracted COVID and will not in the future.
OK, this post made me stop in my activities and take a break to look at it carefully. First thanks a lot to IM Doc and Yves Smith for a worthy post.
First I did the exercise of reading the NEJM editorial before reading IM Doc’s comments and I have to say that I concur with his reaction. It didn’t look as a scientific review but as a political praise and it is quite disturbing to see how shallow is the review of vaccines made on it to come up with a triumphalism which is at odds with the precautionary principle and the cumulative knowledge on vaccine development, and deployment and the corresponding regulation that in the past was put in place to avoid premature triumphalism turn into a big blunder. It goes with the 95%, 95%, 95%! meme that tries to misdirect our attention about the limits of the result and the risks. Some discovered and some still to be discovered.
There is the issue of allergic reactions and for what I have read it was known in advance that one of the ingredients that make the nanoparticle delivered RNA vaccine was previously known to have potential to elicit allergic adverse effects. It is the lipid ALC-0315, one of the 4 lipids used to make the nanoparticles that stabilises interactions with the lipid coated RNA. (See here). Such adverse has to be reviewed in depth and determine exactly what is the population at risk of suffering the reaction and decide rules to identify them before vaccination. A vaccine should not be approved until this is resolved (IMO, even for emergency use but here I am not sure about the normative).
For me, the most important paragraph that I subscribe to the letter is this:
The numbers of COVID cases in the placebo group vs the vaccine group have been widely publicized, from 162 cases in the placebo group down to 8 in the vaccine group, giving a relative reduction of 95%. It seemed to all of us in our review group that we do not have nearly enough patients to really make assessments. That is not a criticism. The researchers have done admirably in my opinion to get this many patients this quickly. That is still the problem: they are going to be using the first million patients or so in the general public to get a real gauge on numbers and side effects.
How on hell it is possible to approve a vaccine that uses a platform with 0 experience on the basis of so little data? Have we forgotten, again and again, the precautionary principle? These 8 infected after a couple of months from the trial start compared to 168 in the placebo group is enough to approve something for thousands of millions? Have we forgotten previous mistakes? Is 8 enough to have any information on adverse effects and serious adverse effects? Can we rule out antibody-enhanced disease on the basis of 8 reported infections? No way, no way, no way. Please, remember this, RNA vaccines have NO history of deployment, these are a big unknown and, if anything, the most thorough research and follow up of the trials should be carefully done before approval, before delivering an unknown to the masses.
We have to bear in mind these facts: even if the trials are double blinded there are three strong biases in these trials and in the reported results:
First and foremost, we are looking to very transient results obtained in a period too short to be relevant to evaluate the efficacy of the vaccine. It is well known that vaccines induce antibody peaks just about 12 days after the second shot. We are looking at this peak. Very relevant regarding the possibility of some short lived sterilizing protection in the upper mucosa.
Second, the high reactogenicity of the vaccine, way higher than the placebo, removes one of the blindnesses of the trial. You know if you are a recipient of the vaccine. As IM Doc says, the reactogenicity is way above what can be considered normal or standard and with potential to be problematic, and a behaviour changer in the recipients which can have very significant effects in the numbers observed obtained in so short times after vaccination. This effect will be diluted by time in later reviews but it can be quite important in the first review.
Third. The trial is done in a masked world were lots of precautions are in place and the results will be VERY DIFFERENT if, as a result of mass vaccination such precautions are removed.
The only paragraph with which I disagree is that about of vaccinated infected not showing symptoms. I take for granted that there will be many vaccinated that, as a consequence of vaccination, only pass a very short infection, asymptomatic or nearly asymptomatic. We cannot ask for a vaccine against a respiratory disease that starts in the upper respiratory to ask for sterilizing immunity except for a very short period since we know that antibodies only stay transiently in the upper mucosa. Please, stop asking for that outcome, it is a ‘vaccinotopia’. Enough if there is protection against disease development (and almost certainly a reduction in the ability of vaccinated to act as virus vectors since they will produce less titres during shorter times).
Thank you Ignacio. I think I’ll just drink more red wine. This whole fiasco makes me think of the early diabetes research done in Denmark wherein they found that in the late 1800s (?not sure on the date) that the beginning of the diabetes that occurred 2 generations later was probably caused by a very innocent bumper crop of wheat in c. 1850. It was a good year and everyone ate too many pastries and dumplings. Two generations hence diabetes started showing up all over the place. The victims were the grandchildren of the kids who had the blessing of too much wheat. I think that’s one of the most interesting pieces of research out there. And even more interesting is the fact that this was no ordinary “epidemic”. It was in fact an environment-factor. No virus. No bacteria. Maybe just a snippet of random RNA somewhere and the rest is history. We actually exist by such a delicate balance.
Apparently there is no consensus on how long vaccine immunity lasts with estimates of 2-12 months?
Weeks ago, NPR did an unsettling interview with Peter Hotez; director of Texas Children’s Center for Vaccine development and Dean of National School of Tropical Diseases. He described the need for ongoing boosters for this Covid and vaccines for Covids on the horizon.
Is the trajectory then to continually modify the mRNA code instructions perhaps under the same license or without the same review as initial issue? Clarity?
Here in Arizona with extreme contagion, I understand the urgency but it all sounds very Pandora’s Box to me.
Ant there is a known problem with boosters as seen with the flu vaccine: with time their effects fade. We should pray that after massive vaccination the virus evolves into what other coronavirus are: restricted mild respiratory viruses with very infrequent complications like severe pneumonia.
Anyway, so far the biggest social-pharma experiment so far undertaken has been in China. To my knowledge, about 1 million Chinese citizens have already been vaccinated. They are not following international standards for mass deployment.
I shared this post with my wife, who chats regularly with a couple of friends who are doctors. She commented that it was, almost word for word, the same as what they have been telling her for some time now (the exclusion criteria, concerns about the drug companies, all of it).
I skimmed the beginning of this post prior to the decision whether it was worth it to read the whole thing. I noticed that early on the anonymous author stated “I reiterate, the paper is silent on this question of exclusion criteria, as is the editorial.” This seemed odd. Most RCTs in big journals do not put the full inclusion/ exclusion criteria in the article, but in an appendix to which the article refers. This is annoying to critical reviewers but it saves space in the print journal.
Sure enough, at the end of the article is a list of supplementary material. This list includes the full protocol, available as a PDF. The full protocol includes full inclusion/exclusion criteria. They are typical of those in many other RCTs I have reviewed. That is to say, they could be much more complete and detailed, but they are no worse than most.
So does this article have the same problems as most of the big RCTs published in the last 20 years? Yes. Does it appear any worse than average? No.
I think the fact that this vaccine is being rolled out rapidly to millions of Americans (who may or may not fit the trial criteria) is what concerns the good doctor. He states up front that his training is from an era (30 years ago) that was much more meticulous than is apparent today. My kind of caution.
I am replying here because you are the only one I see who actually seems to be a real MD – assuming you are the real Roy M Poses. My wife is a graduate of Stanford Medical School and is a subspecialist in Internal Medicine. Not infectious disease. She was at the top of her class. She graduated a bit more than 10 years ago. I was so intrigued by this doctor’s post that I wanted to do a little test, admittedly with just one subject. As you can see I was an early commenter and have skin in the game because I live with a doctor.
I wanted to see if she could identify quickly the exclusion criteria just like this doc has now admitted was confusing but actually there. She could not do so quickly – and it took her about 45 minutes to do so and then she stated to me when looking through them how reckless they were spelled out. She was surprised. phase 1 stuff all mixed in with the others. She was also very concerned about the fact that there were so many common conditions that had not been studied or included in a wide population impact drug like a vaccine. concerned about why these are not being more publicized given the fact that we will be trying to vaccinate presumably everyone. Should this not be publicized more with both docs and patients.
What got her attention was all the ethical issues that IM doc discusses. She thought he was exaggerating, and did her own research and found stuff that was even worse. She is very concerned. She is very concerned that the backlash will be enormous if there is a problem with this vaccine because it is becoming increasingly obvious to American citizens that are well read that this push is not normal and it is like the fix is in. She is very concerned for the retribution for IM doc and others like him if they lose there anonmous status. I just wondered if you come back and read this if you would be willing to comment.
Yes, I am a real doctor, and have taught journal clubs/ critical review of articles/ evidence based medicine for year. I will try to get the time to review the NEJM article on my own and see what I find.
Thank you IM Doc for this analysis. Quite the read. I read the New Republic cover story by Marcia Angell, MD. “America’s Other Drug Problem” New Republic, December 16, 2002. The cover noted America’s other drug problem. Highly recommend it. She wrote “Numerous studies have shown that claims by pharmaceutical companies of the cost of developing new drugs are grossly exaggerated. In fact, over 95% of the basic research is funded by the government and even 50% of new classes of drugs”.
Some of the issues of interest Dr. Bauchner of JAMA discussed with Drs. Hahn and Marks of the FDA. Expand the JAMA Network description for a timed index.
Thank you for posting this. From the start it has been clear to me that:
1) the media (even here in NZ) has been portraying a vaccine as inevitable, and our saviour
2) no one in the media has been questioning this.
I am a recently retired physician: IM internship, four years emergency physician before there was a residency in EM, board certified ophthalmology, and 31 years afflicted with a medical school in the south. I have NO relationship to big Pharma nor any of the principals involved with the NEJM article or vaccine research; I have no agenda or axe to grind. My views are those of Dr. Poses. The IM physician’s essay is not without merit but there are major flaws in her/his argument. Should we be skeptical of the medical-industrial complex? Of course we should. Do the clinical, interventional trials in question deserve clear headed scrutiny? Of course they do. But consider these points as they relate to the IM doc’s essay:
The inclusion / exclusion criteria were published in April on a government sponsored website as part of Pfizer’s recruiting effort: https://clinicaltrials.gov/ct2/show/NCT04368728. It took me all of two minutes to locate it. Pfizer published the same on their website in September.
Why have inclusion and exclusion groups? So the outcome measures will NOT be confounded by characteristics of a unique population group.
Tight control of the characteristics of the study population was in part dictated by the large number of outcome measures; 24 primary and 18 secondary outcome endpoints. This is a large number which the investigators must have understood were needed to get an emergency use authorization.
I don’t think it reasonable to try to determine if the vaccine prevents asymptomatic spreading also; that needs to be its own study. But it was apparently not needed for a safety and efficacy study. The primary goal was to demonstrate the ability and effectiveness of preventing illness in the VACCINATED individual, not whether that person could continue to spread the virus. If everyone is vaccinated and highly protected from illness, spreading becomes a secondary issue.
My only experience with a prospective multi center trial was one I did as a “participating investigator”, not the primary investigator. It was a 6 year study looking at outcomes for a type of surgical intervention for a complication during cataract surgery. There were 14 participating centers. I think we had 3 or 4 outcome measures when combining both primary and secondary outcome measures. It was incredibly labor intensive even though every center had their own study coordinator to make sure that we captured all the data points. These data points were required to have enough statistical power to confirm or deny the hypothesis the outcome measures were constructed to demonstrate. My point, the vaccine study was a monumental undertaking, and apparently reasonably well done by people with far more experience than lesser physician mortals like me.
Let finalize my comment with the question about those severe allergic events. We don’t know much now, but for transparency’s sake I hope we do. We do know that fear of COVID19 and a hope to get the vaccine arm may be motivation enough to withhold such information as a prior severe allergic reaction. Was it forgotten or thought to be unrelated? Did the intake study coordinator fail to ask the question of the participant or record the answer incorrectly? We do know that the number of such reactions appear to be very small. Acceptably small is the answer needed for the EUA. Will there be some surprise adverse reactions or reaction rates as the virus goes into wide use? Almost certainly there will be; there are no absolutely safe interventions in medicine. Is the risk to benefit ration acceptable? It seems so to physicians and scientists who know MUCH more than me.
We have the good fortune to live in a time when genomes are understood, can be deconstructioned with tools like Crisper, and a small segment that codes for an antigenic protein be made into a vaccine.
I have found this thread very good food for thought, thank you all.
I am weary of such a new vaccine approach being rolled-out on such a massive scale; other vaccines using more time prooved methods are at the same stage of development but will inherently take longer to produce.
We are living a terrible pandemic. The vaccine will most likely save many more people than it will harm but it is also true that ‘first, do no harm’. Difficult decisions.
It is also true that the vaccine is for personal protection but with such a widespread abuse of the idea of herd immunity for this disease and people coming forward with values of vaccination coverage to achieve it, it becomes a relevant question if those vaccinated can transmit the virus. The truth is that most likely herd immunity is unachieveable for this disease, but that should be made clear because there will be no return to normal life to people who aren’t vaccinated and are at high risk of serious disease.
Tough call. I guess Pfizer knows it can call the shots, and we just have to suck it, every week delay costs how many lives?
I do have a question, I wonder if someone could help. What about people who already had Covid? I understand they were also excluded from the trials? Can they safely get the vaccine? Any info on that?
The CDC, it’s reputation in shambles, has taken a pass on this question, which is an excellent question: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html
Dr. Faucci says even if you have had COVID 19, take the vaccine. https://www.cbsnews.com/news/covid-vaccine-fauci-what-to-know/
I am not qualified to render a personal opinion, but I lean heavily toward Dr. Faucci’s advice
Thanks so much for your reply and links.
I wish that all doctors were as committed to critical thinking, and worried about facts and actual patient outcomes, rather than being Pharma groupies bent on hanging with the “in crowd.” I’d love to have a doctor like you as my PCP.
In addition to all the red flags you pointed out, I wanted to add that “suspected Covid-19,” unconfirmed, is a whole separate category in the study. It’s in the publicly-available report to the FDA, but I don’t remember seeing it in the NEJM paper (‘though I could have overlooked it). This is notable, because the balance is vastly different from that of the confirmed cases reported in the NEJM.
Rachel, that is indeed interesting, but I’m not sure that your characterization of it is accurate.
There were ~1,600 suspected COVIDs in vaccine group, vs ~1,800 in the placebo group, which is more or less in line with confirmed COVID results.
Secondly in the Pfizer PDF you cite below (thanks!), they note that it’s possible that the increased cases of suspected covid in the vaccine arm in the 7 days after the vaccine could simply be due to “reactogenicity” to the vaccine, since symptoms overlap with those of COVID.
For anyone interested there were also 2 cases of severe “unconfirmed” COVID requiring hospitalization in the vaccine arm, with negative PCR tests.
The FDA EUA said that only 409 of those 1600 suspected cases in the vaccine group might be attributed to “reactogenicity” because they occurred within 7 days of the shot. So even Pfizer does not attempt to attribute the majority of suspected cases to reactions.
As we’ve noted, “suspected but not confirmed” cases, per the FDA’s EUA, were participants that developed severe respiratory symptoms (note other Covid symptoms, like loss of smell, weren’t considered) but tested negative on a PCR test. The reason this isn’t dispositive is that per Johns Hopkins, the PCR test has a 20% false negative rate. I fail to understand why Pfizer didn’t retest the negatives given this high a false negative rate, say in 12 to 24 hours.
So this is interesting. There are apparently multiple versions of the FDA briefing documents. They don’t all contain the same data.