British Medical Journal: “Researcher Blows the Whistle on Data Integrity Issues in Pfizer’s Vaccine Trial”

So far, no major US or UK press outlet has taken up an article at the British Medical Journal that calls the integrity of the Pfizer clinical trials for the Covid-19 vaccine into question. At a minimum, the results for 1 000 of the roughly 44,000 participants were compromised.

IM Doc, who was the first of several to send this link along, said it was also discussed at a conference yesterday. A participant told him a speaker said: “If true, this is terminally damning and none of the data of that trial can be believed.”

The BMJ substantiated the claims of a former regional director and trained clinical trial auditor Brook Jackson of Ventavia Research Group, which was running a portion of the Pfizer Covid-19 clinical trials in several sites in Texas. In the two weeks she was involved, she saw data falsification, unblinding, poorly trained vaccinators, negligence via not following up on some serious adverse events, and large scale failure to complete test on participants who reported Covid-type symptoms. Jackson first escalated internally, and when that got nowhere, reported to the FDA. She was fired the same day.

The BMJ published this list of half the concerns Jackson reported to the FDA:

Participants placed in a hallway after injection and not being monitored by clinical staff

Lack of timely follow-up of patients who experienced adverse events

Protocol deviations not being reported

Vaccines not being stored at proper temperatures

Mislabelled laboratory specimens, and

Targeting of Ventavia staff for reporting these types of problems.

Jackson received a follow-up call from the FDA but there was no indication the agency took action. In fact, 11 months later, when the Pfizer vaccine received full approval, the FDA had peculiarly not inspected the Ventavia research sites despite the company fully expecting an inspection and being in fear of it before Jackson filed her complaint. From the BMJ:

… after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”

Allowing Pfizer to withhold data is simply outrageous. As IM Doc said by-mail:

This is exactly why I spent so much time in the original Pfizer research guest post about the fact that my mentors would have literal carts full of binders of just the kind of data being discussed in this BMJ report. That was back in the day when peer review meant just that. They would have gone over these data in fine granular detail. This kind of thing would have been caught.

I am not sure that level of access was even provided to the peer reviewers in this case – or pretty much most anything these days – it is all proprietary. And as I pointed out in the guest post, Dr Rubin a member of the FDA committee admitted in the radio interview that he had not even bothered to look at the material for Moderna just a day or two before the vote. This BMJ article is bringing to light what happens when people just simply do not care and do not do their jobs. But gladly accept paychecks and favors for their companies or interests.

We pointed out late last year that STAT, which is hardly an anti-drug company publication, had criticized the FDA for obvious and grotesque corners-cutting on its data validation when the Emergency Use Authorization was issued. STAT came down on the FDA because it assumed the FDA had not allowed enough time and had not assigned enough manpower to the task. Reading between the lines with the benefit of the new BMJ report, it instead appears the FDA let Pfizer provide very little data and the FDA tolerated that and hence didn’t have much of a data-scrubbing/testing task. From its Did the FDA understaff its review of the Pfizer/BioNTech vaccine?:

In what is arguably the most important decision the Food and Drug Administration has made this year — its emergency use authorization of the Pfizer/BioNTech Covid-19 vaccine — the agency apparently assigned only a single reviewer in each of two key scientific disciplines (clinical and statistics) to do the work in three weeks that usually takes months to do….

Unlike its counterparts in other countries, the FDA is believed to be the only drug regulator in the world that consistently receives and reviews patient-level data from the clinical trials that underpin drug and vaccine approvals. To perform such rigorous analyses, the FDA typically spends around 10 months (a mere six months for applications given “priority review” designation) in an effort that involves reviews by experts representing various scientific disciplines: clinical medicine, statistics, pharmacology, chemistry, pharmacovigilance, and more…

Given the urgency of the pandemic, the review of the Pfizer/BioNTech vaccine was conducted far faster than usual. The centerpiece of the analysis was data from the company’s 44,000-participant Phase 3 trial. FDA reviewers had just three weeks, from Nov. 20 to Dec. 11, to complete their analyses. It was a monumental task, which raises the question: Why didn’t the FDA devote additional reviewers to it? According to the FDA’s review memo, some scientific disciplines, such as pharmacovigilance, had multiple reviewers involved. But the two disciplines tasked with examining the clinical trial data and results, the clinical and statistical reviewers, were seemingly left to do their work solo.

This seems wholly inadequate on at least two levels. First, without additional reviewers it is hard to comprehend how the work of several months could be squeezed into a matter of 22 days (including Saturdays and Sundays). In-depth review calls for examining patient-level data — a large feat that involves auditing and reviewing individual case records as well as independently rerunning analyses on the raw data.

I find this section the most troubling:

After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)

477 missed test results out of 40,000ish participants may not sound like much until you recall the very small number of infections that served as the basis of Pfizer’s efficacy claims. From the New England Journal of Medicine paper on the Pfizer clinical trial:

Among 36,523 participants who had no evidence of existing or prior SARS-CoV-2 infection, 8 cases of Covid-19 with onset at least 7 days after the second dose were observed among vaccine recipients and 162 among placebo recipients.

I don’t see how anyone can believe the efficacy claims in light of the much larger number of possible Covid cases that Pfizer never bothered to diagnose.1

The BMJ report also warns that the unblinding that took place at the Ventavia sites could have been a large-scale problem:

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

As Lambert tartly observed: “If so, we don’t really have an RCT at all.”

As IM Doc summed up:

This is exactly the reason I recoil from “evidence based medicine”. As a profession, we no longer understand that the “evidence” is literally just what Pharma wants you to see. I learned that the hard way with Vioxx and also the opiates. The scales fell off the eyes when it became clear how much they had lied and manipulated.

This Pfizer research is “pristine” in the eyes of the evidence based medicine folks. It has been peer-reviewed. It was an RCT. It had more than sufficient power. It was accompanied by an editorial in one of the world’s leading medical journals describing it as a triumph. EVIDENCE – on a grand scale. Nobel potential. And yet – it may have been fatally compromised by laziness on Pfizer’s part and everyone that reviewed it. And the motivation of these independent research companies is to keep the cash coming – no matter how sloppy they do their work. I have been involved in more than one complete audit of trials in their hands that have gone bad like this. This is why I have a problem with “evidence based medicine”. EBM is nothing more than Pharma’s way to control the minds of physicians.

No one who has been paying attention should be surprised that vaccination rates have no correlation with Covid case levels. These vaccines were falsely sold as magic bullets for the pandemic. Politicians desperately wanted a solution. Medical professionals and investigators had long accepted Big Pharma giving them the mushroom treatment. So we have vaccines that do have utility in protecting individuals from the worst outcomes, but don’t do much good in preventing contagion.

And this mis-selling of what the vaccines do is of critical importance. GM has made this argument repeatedly:

The existence of vaccines will kill more people than vaccines will save directly.

Because it gives the politicians the excuse to let it rip.

Without vaccines the daily death toll becomes unacceptable and someone has to do something about it and contain the contagion. Which we know how to do, we just don’t want to.

With vaccines it either becomes “tolerable” (even if it is nothing but; see the UK) or even if it does break hospitals (as happened in many states in the US in August and is still happening in various places), it can be ignored by blaming the “anti-vaxxers”.

But in the long term it is the area under the curve that matters.

Welcome to a world run for the benefit of Big Pharma.

_____

1 And remember, before you say, “Oh, Pfizer couldn’t have done anything nefarious,” we pointed out last December that the study was effectively unblinded to the participants and the study nurses who kept on top of reactions and were tasked with determining if someone who reported Covid-like symptoms needed to be tested. They could identify a fair number who’d gotten the vaccine by virtue of the high level that had bad reactions to the first and even more often to the second shot, the prototypical feeling really sick for 6 to 48 hours. As we wrote:

Epidemiologist Ignacio had already raised another concern: that the high frequency of strong adverse reactions meant the study was unblinded to those patients:

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.

STAT agreed that the effective unblinding was a concern:

One of us (P.D.) raised questions about potential unblinding in the trials through the vaccine’s side effects, as well as about the confounding effects of fever- and pain-reducing medications, which participants in the vaccine arm took three to four times more often than those in the placebo arm. Yet the FDA’s review shows no evidence that any of its scientists investigated either of these issues, and without more scientific staff devoted to the task it is hard to imagine how they could.

Print Friendly, PDF & Email

102 comments

  1. cocomaan

    The vaccine was brought to me by the same generation of political elites that got the US involved in the Iraq war/stayed in Afghanistan for 20 years, missed the housing crisis (or caused with with repealed glass steagall), blew up American citizens with drones with no due process, and any number of other atrocities and crimes against the public I can’t remember, all while giving themselves accolades and awards.

    I play it safe by not believing anything they say from the get go.

    I remember arguing with other commenters on this blog when I saw that the 95% efficacy number was based on a case count in the hundreds. Yves even came to my defense at one point.

    I’ve been doing IRB administration and serving on an IRB for years, mostly just social/behavioral, and I’m not a researcher. But if I had a whistleblower report like this in my hands, I’d be screaming bloody murder. I’d be reporting this to the OHRP and the Office of Research Integrity. Surely someone would be interested?

    This report blows out of the water the claim that vaccines prevent hospitalization. I cannot believe that assertion.

    Stay healthy, everyone. Take your zinc, vitamin D, and exercise the body God gave you.

    1. OnceWereVirologist

      This report blows out of the water the claim that vaccines prevent hospitalization. I cannot believe that assertion.

      No, this report blows out the water the claim that Pfizer conducted a full and above-board trial of its vaccine. But the fact of the matter is that whether the vaccine deserved it or not, it was approved and used by millions which has since given evidence of its ability to prevent serious illness (at least until the efficacy wanes). Admittedly, it would be the last of the vaccines I’d choose.

      1. cocomaan

        What data do we now have to prove that the Pfizer vaccine is particularly good at preventing hospitalization?

        The point of a clinical trial is to study safety and then efficacy. It is the most controlled data-collection mechanism we have for studying interventions. It is how we know whether a claim is true or not.

        Now that we have reason to believe the clinical trial data is compromised, perhaps even bunk, we effectively do not have data demonstrating the claims of the pharmaceutical.

        And if this is isolated to Pfizer, I’ll give $50 to your favorite charity.

        ETA Look at it this way: if I inject thousands of people with saline and then claim it’s 95% effective at preventing a disease, proving I’m wrong later is extremely difficult and requires millions of dollars to run a second trial.

        1. Yves Smith Post author

          You are now displaying the cognitive bias of halo effect thinking, of treating something as all bad or all good.

          They measured efficacy for the purposes of getting the EUA as preventing severe outcomes, and the study defined it as really severe outcomes:

          Major secondary end points included the efficacy of BNT162b2 against severe Covid-19. Severe Covid-19 is defined by the FDA as confirmed Covid-19 with one of the following additional features: clinical signs at rest that are indicative of severe systemic illness; respiratory failure; evidence of shock; significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; or death. Details are provided in the protocol.

          There have been many large scale, real world confirmations that the vaccines do reduce hospitalizations, at least for Pfizer for 5-6 months. For instance, see this JAMA study published just a month ago using vets…oh, and vets skew male and men do worse with Covid on average than women.

          The problem is this study is pre Delta but it does show that despite Pfizer cutting corners, its vaccine did a reasonable job of living up to its headline claims (the clinical trial was obviously pre-Delta).

          https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784769

          This study from the NY Dept of Public Health estimated the decline in vaccine efficacy due to Delta (which is hard to unpack from the decline in efficacy due to the passage of time). Nevertheless:

          The analysis found that between May and August, decreases in vaccine effectiveness against confirmed infections were greatest for Pfizer (-24.6% for 18-49, -19.1% for 50-64 and-14.1% for 65 and older).

          https://cnycentral.com/news/local/study-by-department-of-health-finds-decline-in-vaccine-effectiveness-due-to-delta-variant

          Due to the hour, I need to turn in and so have not read the full study, which is here:

          https://www.medrxiv.org/content/10.1101/2021.10.08.21264595v1

          1. cocomaan

            Thanks for the studies. I fully admit to my bias.

            The VA study appears rigorous, but celebrating a single quarter of success feels like a cheap, MBA-esqe accomplishment.

            1. Yves Smith Post author

              That was all the data they had! Come on. It takes time to do this right, particularly for publication. The data needs to be compiled and reviewed by the authors and then the pub. That creates normally a 6 month delay.

        2. PlutoniumKun

          The data from Ireland is pretty clear (despite what Irish health authorities will admit in public) Ireland has vaccinated approximately 88% of the population over 12, mostly using Pfizer. Most vaccinations took place over the summer, so they are still ‘fresh’. Only the most vulnerable are approaching the 6 month need for a booster.

          The result: There is a huge surge of Delta underway right now, right across the country (with noticeable hotspots in tourist and border areas). This, despite generally good mask and social distancing observances (I was on a train this morning, all apart from one person wore masks). The surge is going exponential. Hospitalisations are low, however – its clear that the vaccines are almost certainly saving lives and keeping the hospitals reasonably free. However, if you extrapolate the current surge into possible hospitalisations over the next 3-4 weeks, it doesn’t look good.

          Ireland has generally been among the ‘best’ countries in the world with vaccinations, and the strictest with lockdowns and mask wearing (including in schools). But the key weaknesses in policy has been a refusal to address ventilation (yes, droplet theory is still a thing among Irish public health officials), and a leaky and poorly implemented track and trace and isolation system (anecdotally, it works much less efficiently than is officially admitted, and maybe worse than senior managers and officials realise). There is more or less free movement now with our lovely competently governed neighbours. There has also been a very strong reluctance to have localised lockdowns to address isolated hotspots.

          My Japanese friends who live here continually talk about their surprise that Japan has done so well in contrast to Ireland (they were very impressed at how quickly and without fuss they got their vaccines, in contrast to their worries about their parents and grandparents at home). They are as baffled as most people as to why rates have gone down so quickly in Japan in comparison. They tell me that mask and hygiene discipline is still very strong, but people have been going to bars and restaurants for months now without an apparent problem (In Ireland, you need a vaccination pass, in theory anyway).

          So if you want to extrapolate from the Irish experience the lesson is – vaccination (with Pfizer) saves lives, but does nothing to stop delta spreading. Masks and social distancing isn’t enough either. You need very aggressive testing and isolation policies (i.e., do what the Japanese and South Koreans and Chinese do).

          1. The Rev Kev

            Thanks for that Ireland sitrep. When I was reading about the situation in Ireland the other day, the thought occurred to me that you could have 100% of a population vaccinated but that this virus would still be circulating – until it came across a person whose vaccination was wearing off. But to me, that would suggest that it is only a matter of time until a variant arose that could break through these vaccinations meaning that we would be back in January of 2020 as far as protection is concerned.

            Thing is, it is so profitable for the pharma corporations to produce boosters which will be required for years if not decades, that they may not be seriously researching a sterilizing vaccine as it would put an end to their gravy train. And if one was developed in a place like Cuba, there would be a massive coordinated campaign to label it as “dangerous” and governments would ban its import as their ‘experts’ would agree.

            1. Greg

              the thought occurred to me that you could have 100% of a population vaccinated but that this virus would still be circulating

              This is what we’re expecting to see in .au over the coming months isn’t it? The NZ press and business lobbies have been using Australia’s relatively high rates of vax and earlier relaxation of other health protections as a stick to beat the NZ government with.

              1. Basil Pesto

                I don’t think we’re going to get to 100%, but I think >90% is realistic. I think we’ll be fine (I say ‘fine’ but that’s overlooking that hundreds have already died and thousands become infected in the last few months) throughout summer but I think things will start to become hairy late autumn next year. It
                could be sooner though, given the staggered early rollout of the vaccines to the vulnerable this year, and depending on how the boosters go. The booster question is a pretty open one at this point. If stories like the Pfizer whistleblower get traction, it’s hard to imagine boosters being as widespread as they probably will ideally need to be, as trust will consequently diminish, presumably.

                The other open question is the variant situation. I saw an article in The Age this week (no link, sorry) from a prominent Australian immunologist who did important work on the C19 genome (iirc) saying that he thinks immune escape variants are inevitable, but that it’s okay because we’ll be able to tweak the vaccines pretty easily to work against them. Which is kind of a weird thing to say, when you consider that delta has been out and about for six months now, yet not specifically targeted by any vaccine as far as I’m aware?

          2. Ahimsa

            Ventilation, indoor socialising and seasonality all go hand-in-hand in climates such as Ireland. Last winter Ireland’s peak was in early January.

            Despite very high vaccination uptake, the year-on-year data from Ireland (i.e. start of November 2021 vs 2020) is not looking good.
            https://covid19ireland-geohive.hub.arcgis.com

            However, we are comparing Alpha in unvaccinated population with Delta in vaccinated.

            November 1st (2020 -> 2021):
            Positivity (wkly): ~5% -> ~12% (and rising!)
            Confirmed cases: ~750 -> 2,850
            Hospitalised: 325 -> 515
            Intensive care: 44 -> 91
            Deaths (weekly): 2 -> ~70

            Clearly evident, vaccinations have not halted spread!

            What exactly is the point of vaccination passports?
            Something politicians can pound the table with and blame the unvaccinated?

            1. PlutoniumKun

              It should be said that if getting people vaccinated is your goal, then insisting on vax passports for pubs is a highly effective way of getting 100% coverage in Ireland. It was particularly effective at encouraging younger males to get their shots.

          3. Yeti

            It is hard to separate fact from fiction these days but I believe that Japan has started using ********* since around the end of Olympics. I have been trying to find out the truth but keep getting mixed results. Maybe someone here with better research skills could find the facts.

            1. Basil Pesto

              Ivermectin was recommended as part of treatment protocol by the Tokyo Medical Association, an affiliation of doctors based in the capital. It’s not a government organisation. As far as I’m aware, Ivermectin has not been a pillar in Japan for fighting Covid, and hasn’t been formally endorsed by public health bodies, although it certainly seems like Ivermectin use might be less taboo there.

              1. PlutoniumKun

                Interestingly, if you use Qwant to search under ‘ivermectin’ and ‘Japan Covid’ you find alternating claims – the fringe elements of ivermectin proponents claiming this is the basis for Japans success, with lots of fact checking arguments saying its irrelevant. None of them seem reliable. Unfortunately, my written Japanese isn’t good enough for searching original documents. But I’m pretty sure that whatever the reasons for Japans low rates of Delta, its not Ivermectin, because its certainly not being used as a prophylactic on a large scale.

                I joked recently about Ivermectin to a Japanese friend (I was telling her that some Irish sheep farmers we’d met are immune to Covid because they have such big stocks of Ivermectin in their sheds) and to my surprise she asked me ‘whats Ivermectin?’ Later on, she had obviously done some research and told me she’d found all sorts of interesting things on Japanese sites about it. I must ask her someday what exactly she found out.

                1. EarlyGray

                  I haven’t heard much about Ivermectin in Japanese media, it is not a major plank in the treatment strategy, as far as I can tell. As you say, it certainly is not being used widely as a prophylatic here.
                  Here is a NHK report (in japanese) which basically comes to the conclusion that at this stage, it has not yet been clearly demonstrated to be effective.

                2. Yves Smith Post author

                  Japanese are clean freaks and use masks at the slightest sniffle.

                  They also use povidone iodine gargles (at least one OTC brand) so that might be contributing too.

          4. Jen

            “You need very aggressive testing and isolation policies (i.e., do what the Japanese and South Koreans and Chinese do).”

            This is what my small liberal arts college has been doing, as well as improving ventilation. Cases were in the single digits until 2 weeks ago, now 18 case/week for the last two weeks. It’s starting to get cold, though (finally), so we’ll see if this holds as everyone starts spending more time indoors.

            Fall term ends right before Thanksgiving, and all the undergrads go home until January.

          5. EarlyGray

            > You need very aggressive testing and isolation policies (i.e., do what the Japanese and South Koreans and Chinese do).

            I can’t speak to the South Koreans and Chinese, but as an Irishman living just outside Tokyo, I can tell you that the Japanese isolation polices are not particularly aggressive. If you test positive, you are asked to isolate, but are not particularly aggressive about enforcement. I think social pressure induces most citizens to behave though.
            It’s considered a mystery here about why numbers declined dramatically since the summer. Despite a slow start, vaccination has progressed quickly to the extent that it is now has one of the highest rates in the world, so that maybe a factor, as well as the generally high level of compliance. But as you say, both of these factors are also in place in Ireland. Japan does not have the UK as a neighbour, that could be a big reason for the difference.

            1. PlutoniumKun

              I think you put your finger on it when you talk about the social pressure to conform in Japan being a lot stronger. I think a lot of it comes down to the small details. I know a young woman starting her Jet program next week and she was telling me recently all the things the school is insisting she do before she’s allowed start – this is in stark contrast to people I know travelling in the other direction. As you say, Ireland has a big disadvantage in that travel is far too leaky so we are importing a lot of infections from the UK. But I think there is also an element here whereby maybe 80% of people are doing the right thing, while the remainder are doing whatever they want (I know two people working in track and trace, and they say there is an ‘element’ that they’ve just given up on).

              It may also be that demography is a factor – simply a lot more young people in Ireland, and they are far more likely to mix in close proximity.

              1. EarlyGray

                > I think there is also an element here whereby maybe 80% of people are doing the right thing, while the remainder are doing whatever they want

                On a related issue, I remember a friend from home visiting here commenting on the lack of litter, and the general good manners of people in public. We noted that most Irish people also don’t litter and behave well, but for whatever reason, Japan managed to avoid having that “element” that f**ked things up for everyone else.

          6. VietnamVet

            Thanks. It is a puzzle why Japan is doing so well but other nations with high vaccination rates aren’t. Yes, effective contact tracing would lower the transmission which the mRNA vaccines don’t stop (in families the vaccines lowering infections from 38% to 25%). Social compliance (masking and social distancing) helps. Plus, Japan is an island chain and its neighbors have a long history of hostility so the border controls likely are working unlike elsewhere in the world. Are the Japanese ventilating/air filtering schools and workplaces? Still half a century later after two visits there, my remembrance is how crowed it is.

            The Emergency Authorization almost a year ago in the USA was criminal for no other reason than it did not require extensive scientific follow-up monitoring to answer all of these questions. Besides the documented injection side-effects, encapsulated mRNA jabs cause heart-inflammation in young males. The lack of through monitoring is the reason why the other adverse effects reported in the VAERS data cannot be dismissed. Plus, any long-term effects are still a known unknown.

            The only conclusion is that public health is of no concern to the ruling Elite only higher profits. The “vaccines” are messaging theater that the problem is being addressed. But it isn’t. In addition, there other huge problems; shortages of goods and workers, inflation too. I am convinced the haughtiness of the global jet-set imposing their beliefs on Loudoun County Schools and the pointless vaccine mandates firing essential workers plus the general uneasiness, defeated the Clinton Democrat Virginia governor candidate yesterday. The Democrats must address this by the 2022 mid-terms or they will be wiped out. But they can’t because eradicated coronavirus is verboten by their donors, it requires a government that works.

          7. TimeToACT

            Maybe the dreaded “horse dewormer” ivermectin with early treatment is Japan’s secret. Japan’s success is simply censored or ignored by health agencies, politicians and main stream media just as they did with the stunning success in Uttar Pradesh (India) and many other countries. Even WHO commended Uttar Pradesh….but failed to mention ivermectin!

        3. AdamK

          I rely on Israeli numbers, and they prove that the vaccine is effective in preventing hospitalization and serious illness. I was sceptic at first but the numbers, and they have an efficient public system to follow up with the citizenry, prove them right.

      2. Samuel Conner

        Your “handle” reminds me of the title of a book about a US defeat in Vietnam, “We were soldiers once, and young”.

        I suggest a title for IM Doc’s book, if he writes one:

        “We were physicians once, and young.”

        1. The Rev Kev

          To riff off another Vietnam saying, how about

          “It Wasn’t Much Of A Pandemic, But It Was The Only One That We Had.”

        2. OnceWereVirologist

          If you want the truth it’s in tribute to the great New Zealand film “Once Were Warriors”. There’s a lot to be learnt & comparisons to be drawn from the societal decay of native cultures under imperialism and our own under rampant capitalism.

          1. Greg

            Ha, that was my guess, but I have local advantage. Fortunately I haven’t yet seen evidence that covid is cooking anyone’s eggs, but given the menstruation links it’s conceivable.

    2. vlade

      Pfizer conducted a mass trial – not blind one, mind – in Israel, by vaccinating a few million people there and getting all the data on it from the Israeli govt.

      The indication of that trial are that it does work, and that there are no common very serious side effects that show in short-term (I’ll stress again – “short term”, and “common very serious”. For example, there is no side effect comparable to AZ blood clotting risk for certain age females as far as I know).

      As for what, if any, long-term side effects it has , well, we’ll have to wait a few more years (looking not only at Israel’s data).

  2. Ian Perkins

    These vaccines were falsely sold as magic bullets for the pandemic. … So we have vaccines that do have utility in protecting individuals from the worst outcomes, but don’t do much good in preventing contagion.

    Whatever the merits of Pfizer’s trials, I don’t think they claimed their vaccine would prevent contagion. I understood their claims as being all about death, hospitalisation and disease, with basically nothing about infection or contagion.

    1. Yves Smith Post author

      If you read the Pfizer paper, it appears there was goalpost shifting:

      The first primary end point was the efficacy of BNT162b2 against confirmed Covid-19 with onset at least 7 days after the second dose in participants who had been without serologic or virologic evidence of SARS-CoV-2 infection up to 7 days after the second dose; the second primary end point was efficacy in participants with and participants without evidence of prior infection.

      https://www.nejm.org/doi/full/10.1056/NEJMoa2034577

      Moderna actually tested all clinical trial participants each week, so they knew who got Covid and who didn’t.

      Pfizer tested ONLY those who reported symptoms to the study nurse and THEN the study nurse deemed that they needed to be tested.

      So Pfizer would never find asymptomatic cases and could have some mild symptomatic cases drop through the cracks.

      So it is mighty curious that the basis for the EUA was reduction of severe cases, not reduction of all cases, which BTW has nevah been reported.

      1. Dave in Austin

        “Moderna actually tested all clinical trial participants each week, so they knew who got Covid and who didn’t.”

        Sorry. That is incorrect. I was in the Moderna study starting in March, 2020. I had to self-report via an application on my phone. Two questions, if I remember correctly. First, exposed to someone with Covid?; second, Covid symptoms?. Once every month or so I got a call asking how I was doing. My first blood test, if I remember correctly, was after or just before I got my first real shot in March, 2021. I didn’t keep a record, so this is just my recollection.

        The subcontractor site in Austin was well-run and professional.

        1. Ian Perkins

          I nearly wrote “I think Moderna did test participants regularly” in my comment below, and now I wish I had! Thank you for that.

        2. Yves Smith Post author

          Apologies, it was reported somewhere which due to the state of Google I cannot find, that Moderna was testing weekly. Perhaps it was only a subset of sites as a control v. “the self-reporting + test if seems warranted” that you got and was presumably prevalent.

      2. Ian Perkins

        Moderna did test participants regularly, thus knowing not only who got COVID but also who got infected. However, I don’t think they released information about infections, which they’d presumably have been keen to do if they’d found a significant reduction. Like Pfizer, they made basically no claims about infection or contagion, and their EUA was also based on clinical disease, hospitalisation and so on.

        It might be “curious that the basis for the EUA was reduction of severe cases,” but it shouldn’t be a surprise that “we have vaccines that do have utility in protecting individuals from the worst outcomes, but don’t do much good in preventing contagion.” As I recall, the former was the claim at the time, and the latter but a hope (albeit one presented by many politicians as fact, as Basil Pesto points out below).

      3. Ezequiel

        I was in the AZ/Oxford trial and we did get tested weekly, I got a bag of PCR tests every two months and I would get a sample and send it through Royal Mail weekly. I saw it as one of the perks of the trial.

        They also used a different vaccine as placebo, I believe it was a meningitis vaccine made with the same technology, so you could not unblind just with the reaction. I think in some countries they did use the usual saline as placebo, maybe because of overregulation of test procedures?

    2. Basil Pesto

      sold by political leadership collectively pretty much worldwide, with no voluble collection from the drug companies best positioned to correct them and disabuse people of such a notion.

    3. Mark

      They couldn’t claim that because it wasn’t part of the study design (a feature, not a bug, as it’s standard for pharma companies to try to set the bar for a positive result as low as possible). The FDA, as it usually does, accepted the study designs given to them by the companies. The only Covid vaccine study that I’m aware of that looked for infection in addition to symptomatic disease as part of the study design was the AZ/Oxford vaccine. Could be wrong but I’ve always assumed this was because that study design had to be approved by the UK authorities who are at least a smidge less industry friendly than the FDA.

      1. Yves Smith Post author

        Do not Make Shit Up. See my quote from the Pfizer paper. It was part of the study’s “end points” but then (unlike Moderna) they didn’t set up a fairly foolproof method of measurement. And on top of that, neither Pfizer nor Moderna reported efficacy v. infection.

        As we pointed out, Sinovac DID report much more detailed study results: 100% reduction of deaths, IIRC 84% reduction of severe cases/hospitalization (lower than mRNA vaccines but not wildly so) and 50% reduction of cases. They Western press loudly went apples to stinky fruit and compared the 50% reduction of cases to the Pfizer/Moderna reduction of severe cases to discourage use in other countries. Appalling.

        1. Ian Perkins

          If you mean this quote,
          “The first primary end point was the efficacy of BNT162b2 against confirmed Covid-19”,
          than infections weren’t part of the endpoints. From that same paper,
          “Confirmed Covid-19 was defined according to the Food and Drug Administration (FDA) criteria as the presence of at least one of the following symptoms … combined with … nucleic acid amplification–based testing.” In other words, as Mark says, they weren’t looking for all infections, only for COVID, by definition symptomatic.

          1. Yves Smith Post author

            First, relying on self reporting could have missed mild symptomatic cases.

            Second, and more important, Pfizer did not, no where, no how report on performance in reducing symptomatic cases. So I stand by my claim that the goalposts were moved.

            1. Ian Perkins

              Pfizer did not, no where, no how report on performance in reducing symptomatic cases

              I don’t get you. They may not have picked up on all symptomatic cases, as you say, but they did look at confirmed Covid-19 cases, meaning trial participants reporting at least one of a list of symptoms, with a positive PCR test. Those symptomatic cases were the basis for their efficacy claims:
              “9 cases of Covid-19 at least 7 days after the second dose were observed among vaccine recipients and 169 among placebo recipients, corresponding to 94.6% vaccine efficacy” (from the same paper).
              Whatever the flaws in their trials and analyses, that looks to me like reporting on performance in reducing symptomatic cases. The reporting may not have been entirely accurate, complete, or honest, but I don’t see how that means “did not, no where, no how report.”

              1. Yves Smith Post author

                This is the only data that Pfizer published about clinical trial outcomes. These are the figures that generate the 95% reduction in the risk of severe cases and hospitalization.

                If this was only symptomatic cases, and not severe cases and hospitalization, then why did Pfizer and the FDA oversell the results by rebranding it as severe case/death reduction, as opposed to symptomatic case reduction?

                The total case number also seems light when compared to the 477 (!!!) unprocessed swabs from participants reporting symptoms. You’d expect tests positivity to be higher than the study group that the population as whole because asymptomatic people were taking tests too (I took 4 Covid tests for travel and surgery, for instance). So if you assume say a test positivity rate of 20%, you’d have nearly 100 Covid cases out of that bunch. Could easily change results radically, particularly if you are correct and the results were all cases, not severe cases (you’d assume they made damned sure to test all serious cases).

                One set of statements has to be untrue. You can pick which. Perhaps I picked the wrong one, but there was no separate data on severe cases/deaths.

  3. Jackiebass63

    It is difficult to trust research anymore. Money has negatively corrupted the process. Research for the most part is no longer independent but corrupted by funders.

    1. mtnwoman

      And Pfizer has a reputation as a serious problem with breaking the law to get what they want — profits.

      In 2009 the DOJ fined Pfizer $2.3billion for healthcare fraud — the largest fine in history. https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history

      Pfizer didn’t learn a thing. In 2015 Pfize was fined $15million for foreign bribery .https://www.justice.gov/opa/pr/pfizer-hcp-corp-agrees-pay-15-million-penalty-resolve-foreign-bribery-investigation

      To corporations who’s bottom line are profits, these fines are just the price of doing business.

    2. Bun

      Medical research. Please do not conflate all research with medical research.

      That conflation is yet another adverse side effect of big pharma malfeasance.

      (As a physicist, I am particularly sensitive to this…)

      1. Jackiebass63

        Even some non medical research is contaminated by the money interest that finance research. The problem seems to be getting worse. Far too often funding has many strings attached so that it isn’t independent. Condition are imposed to arrive at a favorable outcome for the finder. Basic research is probably for the most part independent of funders. Much other research is always subject to close scrutiny about it’s independence. With research like this from Pfizer the regulators hav an awesome responsibility in scrutinizing the research for flaws. Unfortunately this responsibility has become corrupted by politics.

          1. John Anthony La Pietra

            How about “corrupted by money, politics, and sometimes money AND politics overlapping”?

  4. Henry Moon Pie

    The FDA has been behaving like this for some time. In the last 20 years, how many approved drugs have ended up being unapproved after significant numbers of citizens were injured or even killed by them?

    For me, this is the key point:

    Politicians desperately wanted a solution.

    and

    Because it gives the politicians the excuse to let it rip.

    Politicians do the bidding of our billionaires. I dare anyone to find an example in the last 30 years of any implemented policy that was actually opposed by the billionaire class. Our billionaires demand return on their capital no matter what the situation is, including a pandemic. They would not countenance shut downs, with or without a temporary UBI, and demanded two things: 1) back to work; and 2) back to school because that’s required by 1). The only concern was that hospitals would be over-run, but even that was a worthwhile risk in order to keep our absolutely essential bars and restaurants open.

    The same holds true for our ecological catastrophe. The billionaires demand return on their capital right up to the day society collapses under the multiple strains of climate disasters, strains on outrageously long supply chains (created for the billionaires), widespread precarity regarding all essentials and social dissolution. Manchin and Sinema and Pelosi and Biden are just the billionaires’ stand-ins. They don’t design the policies. They don’t make decisions. They simply work together to represent the billionaires’ interests while covering their corruption with completely unentertaining kabuki.

    These folks are sick, but we’re the ones who experience the symptoms of their illness.

    1. tegnost

      speaking of billionaires, was it not said recently that gates, bezos and musk increased their wealth by over a trillion which could be used to pay for part of the flagging infra bill. What was not noted, and I was too busy to point to it myself, was that the infra trillion trickles out over ten years, while for gates, bezos and musk it’s money already in the bank. They could actually pay for all of the infra for years and still come out on top, but that’s not enough, is it? They want it all.

      1. Henry Moon Pie

        It’s an illness. Kate Raworth argues in Doughnut Economics that the image of homo economicus has been imposed on us through both academia and the Madmen, and that we have been changed as a result, and not in a good way. Those people who continue to hoard more and more wealth and power are those most deeply affected by it. It’s way beyond self-interest.

    2. flora

      Many of my friends are older with co-morbidities. They took the jab as soon as it was available, and I’m happy for them that they did. The risk/benefit seems to tilt to overall benefit in that age/risk group. (Still too soon to know long term.) Most of them then mentioned in passing, “The pandemic is over for me! I got the jab!” They wouldn’t consider it was too soon to make that judgement. I think that’s part of the “let ‘er rip” phenomena.

  5. THEWILLMAN

    As a direct result of policy, 30% of American lives (unvaccinated adults) are ruined. They can’t work. They don’t get healthcare (tied to work). They can’t participate in huge parts society. They are banned from social media. Losing relationships with friends and family who buy the blame bubba narrative.

    And to the degree some are able to get around these issues for now – at a minimum they’re living in constant anxiety at the threat of them. That’s the price we’re paying to “enforce” any kind of vaccine mandate.

    And now it’s clear that both safety and efficacy data (“the vaccine is safe and effective”) has been manipulated.

    1. Hank George

      Just so.

      Unvaccinated persons pose no greater risk of COVID-19 spread than vaccinated people.

      Mandates and all the other craven strategies they’ve deployed are nothing more than a crock of fecaliths.

    2. flora

      Yes to all 3 of your points. As to your last point: many years ago I watched a dear older relative stroke out and die about a year after her Doc switched her arthritis med from what she’d taken for years to Vioxx. It might have been pure coincidence, it might not. Since that time, the FDA’s seal of approval “safe and effective” means nothing to me. I need long term use with good results before I believe any new drug is safe and effective. The last time I needed a prescription for something I asked my Doc, “How long has this drug been on the market? When was it approved? Is there a generic”? That’s my personal due diligence. Maybe I’m crazy, but I don’t trust FDA pronouncements anymore.

    3. ks

      Yes. It’s so disorienting to have acquired natural immunity (more protective than vaccination according to Israeli statistics) before masking was a thing and now be treated as a bio-hazard. The inflammatory, manipulative and often irrational official response to the pandemic has been bad enough, but the public response seems to be dominated by magical thinking. And everyone’s an amateur epidemiologist now.

  6. tegnost

    So we have vaccines that do have utility in protecting individuals from the worst outcomes, but don’t do much good in preventing contagion. while making wall st and congress boatloads of money
    There, added to it…
    Seems to me and seemed to me that the mRNA tech was too precious to leave to chance…

  7. tegnost

    The existence of vaccines will kill more people than vaccines will save directly.

    It also killed a lot of people that actuaries wanted to die

    1. outside observer

      I’ve been wondering where the actuarial studies are regarding vaccine and covid illness effects on mortality, morbidity, and costs. Presumably health and life insurers would by now have some preliminary data to work with. Medicare, Medicaid and the VA should also be able to conduct studies on risk matched populations.

  8. Regulus regulus

    No study is perfect. 2.3% of the sample is null. So? The erroneous methodology has been exposed, which is why studies are published. The beef appears ideological: because Pfizer paid for the study the results are tainted. If a university ran the study, then somehow the vendors would have performed better. However… This story is synchronous with Pfizer releasing sales figures. Coincidence?

    1. Objective Ace

      The problem is it is not a random 2.3 percent of the sample. Pfizer had every incentive and opportunity to ensure the 2.3 percent skewed towards those whom the vaccine did not protect as well as Pfizer wants us to believe

    2. Yves Smith Post author

      No, we only know for sure that 1000 of the 40,000 ish participants (I commented at the time that Pfizer kept reporting results on different #s of participants for different outcomes, without explaining they the numbers were different) should have been excluded.

      Did you miss that the whistleblower was fired immediately? The incentives not to escalate to the FDA (which did NOTHING) and then the media are high. There may have been other sites with similar deficiencies.

  9. curlydan

    Hopefully the BMJ or an enterprising journalist will submit or have already submitted a FOIA for FDA records about the contact with the whistleblower and the Ventavia sites. It could be interesting to see just how much the FDA was willing to overlook or ignore these allegations.

    Unfortunately, FOIA requests can be the slow train to ???? due to delays and redactions, but it’s probably better to get the story sometime than never. More shame for the FDA.

  10. chris

    The biggest problem from all this is that it will destroy the already crumbling foundation of public health in the US. Why would anyone trust medicine produced by the government now? This report combined with the craziness of how Moderna is getting away with their claims of ownership and plans for dramatically increasing prices for their mRNA vaccine that was almost entirely funded by public money, we’re done. Throw a few tortured puppies as logs on this fire and all the crazies who have been making outrageous claims about the vaccines and the research behind them will seem reasonable.

    Good job Deep State. Your medicine killed the patient :(

    1. GM

      The biggest problem from all this is that it will destroy the already crumbling foundation of public health in the US.

      The COVID fiasco as a whole will do that.

      Why have OSHA standards at all if no additional OSHA standards were passed for COVID?

      It it’s fine to have workers forcefully infected with SARS-CoV-2, and nobody made much of a fuss about it, then we can probably roll back a lot of the existing regulations, right?. And we probably will…

      If it’s fine to have children forcefully infected with this virus, then we can start abusing children again in many other ways. Child labor looks appealing…

      If we did not do anything to stop SARS-CoV-2, then why bother trying to stop other infectious diseases? Most of them are harmless in comparison.

      Note that right now in the human population there is only one virus that is more dangerous and is circulating within it (as opposed to coming from time to time from an animal reservoir), and that’s HIV. Everything else is either milder, or we can treat effectively (in the case of most bacteria). Or it is in mosquitos and rodents and, while we do try to keep it out, it is just not possible to eliminate.

      But you can keep yourself from getting HIV with simple behavioral changes, and even without them it’s kind of hard to catch it when overall prevalence is low.

      SARS-CoV-2 on the other hand is an extremely contagious airborne virus.

      The only thing more dangerous that we had and that was also highly contagious was smallpox, and we eliminated that. But smallpox does not reinfect, while this virus we will catch many times until we die (it will be a major reason for most non-violent deaths in the future).

      So again, we let this rip, then why bother trying to control TB, measles, polio, intestinal parasites, etc.?

      Oh, and we made vaccination a hot political issue.

      So expect mass vaccination programs to be gutted over time.

      And we will accelerate our return to Dickensian England-like conditions that had already started economically decades ago.

      When life expectancy was below 30 for industrial town workers and more than double that for the rich people living in countryside mansions.

      P.S. By my rough estimates, with endemic COVID and no vaccines, we were looking at life expectancy in the 40s (because of the accumulated damage from reinfections, and assuming a doubled chance of an adverse outcome for each subsequent one, which does seem to be reflected in the current, though still limited data on reinfections). With the current vaccines that probably gets pushed back into the 60s. But that’s still a 15+ years reduction, and it’s still very conveniently below the retirement age…

  11. Joe Well

    “Evidence based medicine” reminds me of “evidence based instruction” in education.

    Of course you want practices that are proven (in more words, “evidence based”).

    But more often then not, “evidence based” gets recited as a mantra when anyone asks what exactly is the evidence, or even, what exactly are you saying the evidence is telling us (because most administrators haven’t really done the reading).

    1. KLG

      I am stuck in an endless loop of loops on this. Despite a load of “qualitative research,” the only reasonable conclusion is that the structure of the curriculum itself makes no difference, IF the curriculum is complete and well delivered and expectations of both faculty and students remain high…And the “assessment gurus” are kept in the basement where they can sort and re-sort their spreadsheets to their hearts’ content.

    2. anon y'mouse

      according to someone i know who taught them (admin of ed) in their post grad study courses, most of them can barely write either and they are “moving out of teaching” because they can’t hack it in the classroom.

    3. PKMKII

      It often ends up being a fig leaf for particular institutions. We get told it’s evidence because this particular institution vetted it as evidence, so it must be evidence. Which devolves into a circular logic where its acceptance as the purveyors of evidence is taken to be proof of its own validity. And then any critique of said institutions gets lumped in with the conspiracy theorists.

      Of course, this cuts the other way as well; the institution having faults does not automatically mean everything it has shot down is actually true.

  12. Cheryl

    Struggled to find a link in this standalone. Will repeat it here:

    https://www.bmj.com/content/375/bmj.n2635

    Covid-19: Researcher blows the whistle on data integrity …
    [Search domain bmj.com] https://www.bmj.com › content › 375 › bmj.n2635

    Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight.

  13. Terry Flynn

    Search Vioxx and Paul Dieppe. The latter was my ultimate boss for 8 years. He was kicked out of the (American led) professional society in his field (rheumatology – and he wrote the family blogging textbook for med students!) then given their medal of honour when his whistle blowing was proven correct.

    BTW working “properly” in the NHS is interesting…… ;-)

  14. Iseeyoudock

    Falsus in uno, Falsus in omnibus.

    Contamination of the double blind contaminates the study. It casts doubt on methodology used to obtain the result.

    I have been straining to reconcile the discordances in data around the vaccines for some time, and have been unable to do so. It is very disappointing.

    The collateral damage has been a loss of credibility in our major institutions which dictate public health policy.

    Benifits oversold, risks underreported. Deliberate conflation of sterilizing and non sterilizing vaccines to the point of them changing the very definition of vaccination, and then a mandate predicated upon the presumption of community benefit and herd immunity being obtained through vaccination when this was not obtainable.

    Rational for people with risk factors and age? Yes. 84 long term care resident with Parkinson’s and COPD? Yup. For a healthy 22 yo? Hmmm.

    To me the worst part is the push for pediatric vaccination. What is the NNT? The number needed to treat to save a life. I think that is the key question. This is a key metric around evaluating a treatment for a disease. Given the very low morbidity in the healthy pediatric population, I would think it would be astronomical.

    Weigh this against the adverse event profile, especially the myocarditis risk in teenage males, I don’t see how you can rationalize a mandate to extend to school age kids.

    For kids who are Immunocompromised? Sure. CVID, lymphoma, leukemia, HIV, cancer, congenital defects? Sure. But healthy kids? Let’s do some math first….

    There seems to be no impetus to stratify and tailor subgroup risk/benefit in either the adult or pediatric population.

    I wonder how history will treat this chapter. I think unkindly.

    1. Objective Ace

      >changing the very definition of vaccination

      You can use the wayback machine to see that the definition has been changed many years ago prior to Covid on various online dictionaries like Webster’s. There’s plenty to be upset about without making stuff up and repeating unsubstantiated right wing talking points

      1. IM Doc

        With all due respect – I would not pay any attention at all to Webster’s Dictionary in this case. The definition of vaccine was indeed changed on the CDC website itself sometime in early September of this year. That is not in dispute. I have been at a lecture in the past 2 weeks decrying this fact – showing the two definitions side by side – listening to the speaker, a vaccinologist, demonstrating complete chagrin that the new definition the CDC has put forth made no historical sense whatsoever.

        I would also direct your attention to a recently FOIAd email chain from the CDC officials themselves in early September.

        https://www.scribd.com/document/536749738/CDC-Emails#from_embed

        My question would be – “What do “certain people” and their statements have a thing to do with how the CDC defines a scientific/medical term like vaccine?” When do “certain people” have a say in what has been decided science for generations? Who indeed are “certain people”? If “certain people” are causing such confusion by their statements, why is the CDC not directly addressing those statements, instead of this kind of run-around – guaranteed to further erode their credibility?”

        I am not one for falling for right wing conspiracy theories or talking points. But when one of them goes out of the way to produce a FOIA – and you can clearly see that the definition was changed strictly for political or “messaging” reasons by high level officials at the CDC almost as a lark – well – a reasonable person left or right can deduce that we have a problem.

        Why is our main stream media not ALL OVER this kind of thing. If we are going to change the definition of vaccine for valid reasons – let’s have a discussion and a conversation about it. If we are doing it because “certain people” are making us look bad or asking tough questions – well, that is straight out of Orwell – and does not make the CDC look good at all.

        Can you point to me where these CDC emails have been denied or refuted? It would make me feel much better if you could.

        1. pjay

          Iseeyoudock has basically reproduced my own views on the vaccines completely, including this: “To me the worst part is the push for pediatric vaccination.”

          As I have stated before, while my wife and I are fully “vaxxed” (whatever that means today), the idea of forcing my grandchildren to get the “jab” infuriates me. This is certainly not based on partisan ideology, but on my own understanding of the evidence. Although I have no background in medicine, I do have considerable experience in statistics and research methodology. I have reviewed numerous peer articles and research proposals over the years, including grant proposals for the NSF. To the extent that I have been able to understand the Pfizer trials for children 5-11, they seem like a farce. To the extent that it is at all possible to make a risk-benefit calculation for kids under 12, there seems to be very little pressing reason to rush this through, and some good reasons to slow down. Yet nearly every day on the local news (and of course the national media), I see physicians urging us to get our kids in to get the jab; some have small kids of their own whom they can’t wait to vaccinate. Are they reading they same information as I am? On what do they base their certainty? I am sincerely asking this question, especially to the NC commenters in the medical profession. It truly does seem like the Twilight Zone these days.

          1. Objective Ace

            This is obviosly just anecdotal, but my pediatrician was aghast at the possibility of mandating vaccines in children. I’m not so sure actual doctors mirror the ones featured on TV

          2. CloverBee

            Another anecdote… my pediatrician is opposed to kids getting the jab unless they have a heart condition or are immune compromised. Especially the boys.

  15. Maritimer

    I am reminded of an abusive relationship, at some point the abused walk away, don’t bother me anymore. Over and over and over, abuse. Look up the hallmarks of an abusive relationship.

    Beyond that, what did anyone expect? Here is the criminal record of PFIZER and it speaks volumes about those who would even associate with Pfizer, let alone defend them.:
    https://www.corp-research.org/pfizer

    Anyone being compelled, coerced, forced to take any of these experiments should carefully document their objections, the Day Of Reckoning may come.

  16. Kevin Carhart

    Here’s an excellent background on the CROs – such as Vetavia, if that’s accurate?

    Here are two links to the full PDF, since both look a bit parametery and prone to bitrot.

    psu.edu
    ualberta.ca

  17. zagonostra

    And yet after even after this report has been published, which by the way has been making the rounds in “Right Leaning” media today, it is full speed ahead with vaccine mandates.

    What I haven’t seen much analysis on is how the vaxmandates influenced, if they did, and I think they did, the recent Republican electoral wins. Which in and of itself, seems odd to me. People aren’t likely to forget or forgive the one who yanked his livelihood out from under him regardless of what banner or flag the politician responsible is flying.

  18. Ven

    We now know:
    1. Pfizer and others have a track record of racketeering. And the medical establishment receives a lot of money from big Pharma
    2. The Pfizer vaccine trials were fabricated – faulty to be charitable
    3. The vaccine has rapidly waning efficacy
    4. The Lancet paper shows that it does not prevent infection of or transmission by the vaccinated
    5. Public Health England data indicates the vaccinated are more likely to contract the infection than unvaccinated, though paradoxically, the fatality rate for vaccinated is lower – but this may be because of issues in calculating the dominator, ie, the total number of unvaccinated
    6. The VAERS, Eurovigilance and Yellow Card system all indicate vaccine-caused deaths and side-effects, far in excess of anything recorded for a prior vaccine – which the medical establishment is refusing to acknowledge / investigate
    7. Recent analyses of VAERS data shows that the majority of deaths / side effects are concentrated in certain manufacturing lots, indicating that the scaling-up of manufacturing is not sufficiently quality controlled to be consistent.
    8. There has been a concerted campaign by governments, media and the medical establishment to prevent early treatment protocols and mention of them
    9. Uncertain longer term affects including ADE, etc
    10. And in spite of all of the above emerging evidence, governments are doubling down on efforts to enforce vaccine mandates.

    Move along, nothing to see here.

    1. vidimi

      this is a pretty good summary.

      after receiving my two doses of the Pfizer Biontech, I’ve had two scary nights with a searing, burning pain in my chest. This has made me worried about damage to my heart. My reaction to the second dose was very intense, as between roughly 6 and 32 hours I had a fever and aches, and the day afterwards dull liver pain.

      I thought i was making an informed decision, but much of the data were kept obscured.

  19. Ping

    What is the point of vaccine passports with jabs that largely expire after 6-8 months ???

    And when testing for travel etc is the true indicator?

    I can only conclude vax passports are part of Orwellian control scheme since efficacy of jabs is short lived for major illness only, not for contagion or mild symptomatic.

    I doubt the majority public will be compliant on a hamster wheel of boosters to be considered “fully vaccinated” if that goal post changes, especially if/when the immune system negative impact is manifested.

    The dems are going to pay politically for mandates and vaccine passports.

    1. Yves Smith Post author

      “Never attribute to malice that which can be explained by incompetence.”

      First, the officialdom has gone all in with vaccines because they see it as the path to keeping the economy open. They are too committed to that path, and not engaging in lockdowns long enough to get infections down, and THEN use quarantines and contact tracing. The US has been utterly unserious about quarantines. They are perceived to be too punitive and perhaps too likely to produce a backlash.

      So the vaccine passports are basically a confidence scheme as well as part of a denial mechanism (that contagion is due to being unvaxxed, not the vaccines doing little to prevent contagion and fading over time).

      Our GM has said that top scientists in his professional circle have made astonishingly false statements about the vaccines, the biggest being they believe the vaccines to confer sterilizing immunity. So this delusion goes to the very top of the scientific discipline.

      Second, having a testing regime that was effective in reporting would be a lot of work. Our government has been in the business of not knowing much starting in the Reagan era, when government data collection and reporting started to be gutted.

      Vaccine passports are less difficult and can be outsourced to the private sector, thus buying friends.

  20. Robert Wilson

    Can anyone confirm whether the Valneva vaccine candidate can be classed as a sterilising vaccine? I understand the based on the deactivated whole virus? (also manufactured near my home in Scotland!)

  21. Anon

    I comfort myself with the logic, that the study was conducted long before the pandemic.

    I’m half joking. Like I half-know i’m wrong.

    So many pedantic issues have been turned into existential crises: I mean, there’s a bad bug going around… does it exist? There’s a cure… are you a horse? There’s a prophylactic… are you a test-tube? You have a penis… are you female? Its like everybody became philosophers overnight, and society is awash with the resulting uncertainty. Hard to really “know” anything any more, as reality is so siloed and contentious… ripe for a new religion. One ring to rule them all.

  22. vidimi

    wow, this is damning and, if it gets out to the public, it will shatter what’s left of public trust.

    anyone have a link to the BMJ article?

Comments are closed.