18 Vaccine Experts, Including Top FDA Scientists, Publish Review in The Lancet Saying Current Evidence Doesn’t Support Need for COVID-19 Vaccine Boosters for the Fully Vaccinated

By Jerri-Lynn Scofield, who has worked as a securities lawyer and a derivatives trader. She is currently writing a book about textile artisans.

Eighteen international vaccine experts published a review in The Lancet yesterday, Considerations in boosting COVID-19 vaccine immune responses, saying current evidence does not support a need for boosters for the fully vaccinated general population at this time.  The authors include Philip Krause and Marion Gruber, two top Food and Drug Administration (FDA) scientists who two weeks ago  announced their sudden and imminent departures from the agency, reportedly over frustration with how the FDA had been undermined on Biden booster policy and other issues.

In this post, I’ll quote at length directly from The Lancet. Yet I should mention that interested readers might start by reading the complete article rather than relying only on the passages I’ve included. It’s short and clearly-written.

From The Lancet:

A new wave of COVID-19 cases caused by the highly transmissible delta variant is exacerbating the worldwide public health crisis, and has led to consideration of the potential need for, and optimal timing of, booster doses for vaccinated populations.1 Although the idea of further reducing the number of COVID-19 cases by enhancing immunity in vaccinated people is appealing, any decision to do so should be evidence-based and consider the benefits and risks for individuals and society. COVID-19 vaccines continue to be effective against severe disease, including that caused by the delta variant. Most of the observational studies on which this conclusion is based are, however, preliminary and difficult to interpret precisely due to potential confounding and selective reporting. Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics. Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations [Jerri-Lynn here: citations omitted; my emphasis].

Publication of this mere days before an FDA advisory committee is to decide whether to approve booster doses of the BioNTech/Pfizer vaccine for individuals aged 16 and older, according to The New York Times in In Review, Top F.D.A. Scientists Question Imminent Need for Booster Shots. In August the Biden administration announced plans to start offering boosters to previous recipients of mRNA vaccines from September 20 before either vaccine manufacturer, BioNTech/Pfizer or Moderna, had made a formal application to authorize a third dose, according to The Financial Times in Scientists who quit FDA criticise plan for widespread Covid vaccine boosters. The agency is expected to consider Moderna’s booster application in coming weeks.

The NYT’s account highlights the “significant disagreement between career scientists at the agency and top Biden health officials, who have already started planning a broad booster campaign for this fall”:

Dr. Krause and Dr. Gruber, who lead the F.D.A.’s vaccine office and have regulated vaccines for decades, were not writing on behalf of the agency; the article stated that “opinions expressed are those of the authors, and do not necessarily represent the opinions of their respective organizations.” Still, the arguments they put forth suggested that regulators might raise objections to Pfizer’s application for approval of a booster dose at the advisory panel meeting, scheduled for Friday.

An F.D.A. spokeswoman emphasized that “the views of the authors do not represent the views of the agency,” adding: “We are in the middle of a deliberative process of reviewing Pfizer’s booster shot supplemental approval submission, and F.D.A. as a matter of practice does not comment on pending matters before the agency. We look forward to a robust and transparent discussion on Friday about that application.”

Last week, Yves posted about the shambolic rollout of the Biden booster campaign innFailed State: Covid Booster Shot Mess. I encourage those coming to this topic anew to read her post first.

The NYT provides further details:

Dr. Gruber and Dr. Krause were said to have disagreed with the Biden administration’s push for boosters before federal scientists could review all the evidence and make recommendations, a conflict that factored into their decisions to depart this fall. The two are likely to be crucial to any decisions the agency makes about boosters; Dr. Gruber would be expected to formally sign off on them.

But other top F.D.A. officials, including Dr. Janet Woodcock, the acting agency commissioner, and Dr. Peter Marks, a career regulator who oversees the vaccine office that Dr. Gruber and Dr. Krause lead, could overrule them.

The publication of the Lancet article raised questions about whether Dr. Woodcock, who signed on to the Biden administration’s booster announcement last month, had consulted Dr. Gruber or other career experts in the F.D.A. vaccine office before advising the administration and making clear her own position on the issue. Some public health experts said Dr. Woodcock’s endorsement of the plan boxed in her regulators.

The Biden administration announced in August a proposal to begin administering vaccine boosters eight months after people’s second shots, contingent on authorization from the F.D.A. and a recommendation from the Centers for Disease Control and Prevention. And the pandemic plan that Mr. Biden announced last week included booster-shot readiness, stating, “A booster promises to give Americans their highest level of protection yet.”

Many scientists, including the authors of the Lancet Review take issue with Biden’s plan:

But many scientists have opposed the plan, saying the vaccines continue to be powerfully protective against severe illness and hospitalization. The authors of the Lancet article included a compendium of dozens of studies from around the world that shows such a trend.

Why then has the Biden administration apparently gone all in on a booster strategy at this time? The simple answer appears to be that the administration doesn’t want to get behind the curve again, as has happened time and time again throughout this pandemic. Per the NYT:

Federal health officials have said that one reason they announced the booster plan was to stay ahead of the virus and be ready for when vaccines may no longer protect as well against severe cases of Covid-19. Those officials, including Dr. Anthony S. Fauci, Mr. Biden’s chief medical adviser, have relied heavily on data presented to them by Israeli officials, who have defended that country’s early, aggressive booster campaign.

Their data, Dr. Fauci and other administration officials have said, show a clear waning of immunity against infection, with enhanced protection from booster doses, but show only hints of waning immunity against hospitalization in people under 65.

Lancet Review Lays Out Arguments for Delaying Launching a Booster Campaign

The key issue as I understand is whether this “clear waning” of immunity matters, or whether public health officials should rely more on how effectively the vaccines protect from severe illness, even in the face of overall declining immunity against all infection. The Lancet review’s main point is that

Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high. Even if humoral immunity appears to wane, reductions in neutralising antibody titre do not necessarily predict reductions in vaccine efficacy over time, and reductions in vaccine efficacy against mild disease do not necessarily predict reductions in the (typically higher) efficacy against severe disease. This effect could be because protection against severe disease is mediated not only by antibody responses, which might be relatively short lived for some vaccines, but also by memory responses and cell-mediated immunity, which are generally longer lived The ability of vaccines that present the antigens of earlier phases of the pandemic (rather than variant-specific antigens) to elicit humoral immune responses against currently circulating variants indicates that these variants have not yet evolved to the point at which they are likely to escape the memory immune responses induced by those vaccines. Even without any changes in vaccine efficacy, increasing success in delivering vaccines to large populations will inevitably lead to increasing numbers of breakthrough cases, especially if vaccination leads to behavioural changes in vaccinees [Jerri-Lynn here: citations omitted].

These behavioural changes are of course one of the major flaws in the administration’s policy of relying on vaccines alone to control and ultimately overcome the pandemic. Vaccines are seen as a magic bullet – the magic bullet –  and this administration – just like its much maligned predecessor – hasn’t devoted nearly enough attention to other remedies, including effective treatments, standard public health measures, and systems to quarantine and support the sick. Instead, we waste resources on hygiene theater.

The Lancet review notes that providing boosters isn’t risk-free:

Although the benefits of primary COVID-19 vaccination clearly outweigh the risks, there could be risks if boosters are widely introduced too soon, or too frequently, especially with vaccines that can have immune-mediated side-effects (such as myocarditis, which is more common after the second dose of some mRNA vaccines, or Guillain-Barre syndrome, which has been associated with adenovirus-vectored COVID-19 vaccines). If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines. Thus, widespread boosting should be undertaken only if there is clear evidence that it is appropriate [Jerri-Lynn here: citations omitted].

The Lancet review specifically mentions the risk that endorsement of a booster strategy, in the absence of robust data and analysis, could further undermine public health messaging:

The message that boosting might soon be needed, if not justified by robust data and analysis, could adversely affect confidence in vaccines and undermine messaging about the value of primary vaccination. Public health authorities should also carefully consider the consequences for primary vaccination campaigns of endorsing boosters only for selected vaccines. Booster programmes that affect some but not all vaccinees may be difficult to implement—so it will be important to base recommendations on complete data about all vaccines available in a country, to consider the logistics of vaccination, and to develop clear public health messaging before boosting is widely recommended [Jerri-Lynn here: my emphasis].

WHO Calls for Holding Off on Booster Campaigns

Even more shambolic than U.S. deliberations on boosters is the woeful state of play in getting enough doses of COVID-19 vaccine to developing countries so they can vaccinate their populations. Last Wednesday, Covax cut its forecast for vaccine deliveries to the developing world by 25%, citing India’s April export ban, manufacturing problems, and delays in regulatory approvals, as the main reasons for the shortfall, according to the FT in Covax cuts vaccine delivery forecasts to developing world by 25%:

Deliveries under the scheme to provide vaccines to low- and middle-income countries are ramping up, with 1.1bn doses set to be available for the rest of the year.

But the World Health Organization-backed programme will fall short of its target of delivering 2bn vaccines this year, with a total of 1.4bn shots. Some 200m of the doses are reserved for so-called “self-financing” countries with higher-income populations.

Soumya Swaminathan, chief scientist at the WHO, said there were still about 10,000 deaths a day from Covid-19 that she called “entirely preventable” if vaccines were shared more equally.

These numbers are woeful. Experts estimate that 11 billion does are needed to slow the spread of COVID-19, according to the New York Times in Covax, a global program to distribute Covid vaccines, cuts its 2021 forecast for available doses by a quarter. Only two% of Africa’s population has been vaccinated, according to Human Rights Watch, Sharing Knowledge, Technology Critical to Curb Covid-19.

Shortly after the Covax announcement, the World Health Organization (WHO) extended its moratorium on boosters from September 30 until the end of the year, to enable every country to vaccinate at least 40 per cent of its population, according to the FT in WHO extends moratorium on Covid booster following Covax forecast cuts. Truthout reports in WTO Set to Meet as Rich Nations Continue to Block Vaccine Patent Waivers:

During a press conference last week, [WHO] Director-General Tedros Adhanom Ghebreyesus estimated that 80% of the 5.5 billion vaccine doses administered globally thus far have gone to people in upper-income countries. Tedros is demanding a moratorium on booster shots until at least the end of the year in order to free up vaccine supply for poor nations.

“Almost every low-income country is already rolling out the vaccines they have, and they have extensive experience in large-scale vaccination campaigns for polio, measles, meningitis, yellow fever, and more,” Tedros said. “But because manufacturers have prioritized or been legally obliged to fulfill bilateral deals with rich countries willing to pay top dollar, low-income countries have been deprived of the tools to protect their people.”

“There has been a lot of talk about vaccine equity,” Tedros added, “but too little action.”

Last month’s rapid collapse of the Afghan government occasioned much rending of garments  and gnashing of teeth over the decline of U.S. power in the mainstream media.  The pandemic has provided the opportunity for the United States to do the right thing and – if vaccines are seen as solution – to vaccinate the world. Such a soft power scheme would yield huge dividends. What has the U.S. done?Nothing much. And Biden has been president since January, so this lack of attention cannot be laid at Trump’s feet alone.

Getting the world vaccinated requires much more than merely sharing extra vaccine doses – the current desultory approach. What’s needed is a more ambitious plan to transfer technology and construct new production facilities. Although the public funded the research that produced these vaccines, governments have been unwilling to press companies to share the technology more widely – despite the significant benefits granted to vaccine makers, e.g. liability waivers, for example.

It’s been nearly a year since South Africa and India proposed a temporary patent waiver for COVID-19 vaccines under the World Trade Organisation’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). More than a hundred countries now support the proposal, including France and at least in theory, since May, even the United States. Yet the opposition of Big Pharma, channeled through Canada, the European Commission representing European Union member states, especially Germany, Switzerland, and the UK, among others, has thus far managed to block the plan. The WTO’s TRIPS Council convenes today to consider the proposed waiver in meetings that will continue throughout the week. According to Truthout:

“Despite the groundbreaking medical innovations delivered in the past year, and tall commitments by some powerful nations promising global solidarity and equity, access to these innovative Covid-19 medical tools remains scant in too many low- and middle-income countries,” Candice Sehoma, South Africa advocacy officer with Médecins Sans Frontières’ (MSF) Access Campaign, said in a statement Monday.

“People in these countries, facing life or death in this pandemic, can no longer rely merely on charitable or voluntary measures dictated by only a small number of high-income countries and the pharmaceutical industry they host,” Sehoma added. “We demand the countries opposing the TRIPS Waiver to stop blocking the will of the majority of the world to obtain this additional legal tool in the pandemic to achieve self-reliance in producing Covid-19 vaccines, treatments, and tests.”

Yuanqiong Hu, senior legal and policy adviser to MSF’s Access Campaign, said that adoption of the patent waiver would represent a “critical and historical step to remove monopoly barriers hindering increased global production and diversity of supplies — and all people’s access to desperately needed Covid-19 medical tools.”

In August, Human Rights Watch has published a paper on the subject, according to the Human Rights Watch link included above:

The paper, “COVID-19 Exposes Warped Global Health Power: The System Needs a Course Correction,” published on August 31, 2021 in the Business and Human Rights Journal, discusses how a handful of high-income countries that were lobbied by powerful pharmaceutical companies have stalled a proposal to temporarily waive global trade and intellectual property rules to expand access to lifesaving vaccines and other health care products. Drawing upon Human Rights Watch research and analysis on Covid-19 vaccine supply issues, it shows how governments have abdicated their responsibility to regulate pharmaceutical companies. Governments funding Covid-19 vaccine development with public money failed to condition these funds on affordability and sharing technology, leaving companies to decide how, when, and where they will manufacture, distribute, and price vaccines, Human Rights Watch said. Instead of sharing knowledge and technology, some governments are redistributing an inadequate amount of vaccines to poorer countries while letting companies set prices.

“Waiting for the benevolence of wealthy governments and pharmaceutical companies has dealt a deadly blow to basic rights,” said Aruna Kashyap, associate business and human rights director at Human Rights Watch and a co-author of the paper. “It’s unconscionable that wealthy governments are reducing life-saving health care to a tradeable commodity and using their power at the WTO to make the right to health subservient to pharma and trade interests.”

Will the WTO panel achieve anything anytime soon? Australia’s decision last week to throw its support behind the waiver provides some cause for optimism to those who see the need for vaccine equity. I hope so – but alas, I fear that nothing fundamental will change.

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51 comments

  1. JE

    Based on Biden’s recent speech, boosters in the US are a done deal regardless of this paper and any data existing or forthcoming. I’d like to see plans change in response to reality but the last year (century?) or so hasn’t given me much confidence in that. :\

    1. Societal Illusions

      From the Lancet, please note the equivocal language: “… Even if humoral immunity appears to wane, reductions in neutralising antibody titre do not necessarily predict reductions in vaccine efficacy over time, and reductions in vaccine efficacy against mild disease do not necessarily predict reductions in the (typically higher) efficacy against severe disease. This effect could be because protection against severe disease is mediated not only by antibody responses, which might be relatively short lived for some vaccines, but also by memory responses and cell-mediated immunity, which are generally longer lived.” (emphasis added)

      As with PlutoniumKun’s comment regarding politicization and monitoring, unless it’s accidental or coincidental better data is not being produced, what legitimate purpose could it serve?

      And what if early treatment repurposed drug protocols had not been taken seriously is some lesser developed countries? How many kore would have died? Or what if they had been taken seriously at all vs the contempt and suppression received? How many more would still be alive?

      “Soumya Swaminathan, chief scientist at the WHO, said there were still about 10,000 deaths a day from Covid-19 that she called “entirely preventable” if vaccines were shared more equally.”

      1. Jerri-Lynn Scofield Post author

        Note that Swaminathan is one of the authors of The Lancet article, one of five scientists listing a WHO affiliation (in Geneva).

  2. PlutoniumKun

    I wonder if we are seeing here a bit of a fightback from at least one group of scientists against the political pressures exerted by various national governments and agencies. I was listening yesterday to a radio interview here in Ireland by a vaccine expert making exactly the same arguments.

    But the one thing that really stood out for me from that article is the absolutely woeful state of post-vaccination monitoring in the general population. We are injecting millions of people with novel substances and not even bothering to systematically monitor a reasonable sample. As with the horse paste, we are all left trying to interpret dozens of deeply flawed studies leaving huge gaps in our knowledge. It really is an unforgiveable lapse.

    1. GM

      I wonder if we are seeing here a bit of a fightback from at least one group of scientists against the political pressures exerted by various national governments and agencies.

      It can be read the opposite way too — as a “move along, nothing to see here, everything is fine” reaction.

      You can’t be against boosters without denying that the current vaccines are already failing to an unacceptable degree.

      Recall what happened in Bahrain in May:

      https://www.worldometers.info/coronavirus/country/bahrain

      This is what failing vaccines look like — the equivalent of 600K cases a day in the US.

      And it is what awaits the US this winter too without boosters, probably in the optimistic scenario (Bahrain is a young population, and while they were using mostly Chinese vaccines, they were also only 2-3 months removed from administering them, not 9-10 months, as will be the case in the US when winter proper comes).

      1. PlutoniumKun

        Yes, once I posted that I was wondering if there was a counter argument. The vaccine specialists may well be loath to admit that their wonder of science isn’t all its cracked up to be. Its got to the point now where I find myself trying to read underlying motives in to every scientific paper, even one with multiple esteemed authors.

        As IM Doc puts it much better than I could below, its nothing but mass confusion. We seem to be in a situation where there has been so much gaslighting that even the gaslighters are confused and can’t remember what they are supposed to believe.

        1. Basil Pesto

          As IM Doc puts it much better than I could below, its nothing but mass confusion. We seem to be in a situation where there has been so much gaslighting that even the gaslighters are confused and can’t remember what they are supposed to believe.

          This really seems to be the nut of it around the world right now.

          I know people can be a bit wary of war metaphors vis à vis SARS2, but might “fog of war” be apt in the current context?

          1. PlutoniumKun

            If you extend the fog of war metaphor its probably a little like one of the early British offensives in North Africa in WWII (I can’t remember which one), where the British fired lots of smoke bombs in front of the German positions to hide an advance, but a shifting wind blew the smoke over the British tanks meaning they all got disoriented and went in the wrong direction, none of them actually making the enemy lines. The Germans were convinced it was some sort of cunning British ruse.

        2. ArvidMartensen

          Yes confusion abounds. And confusion abounded around smoking for decades. Was the science to be believed that smoking causes lung cancer? Or were more studies needed? Big Tobacco sold billions of cigarettes over decades while their well funded, anti-science media campaign rolled on.
          The Coal/Oil/Gas industry followed the same playbook and so climate change science “needed more studies” for decades. Scientists were just scammers looking for grants to buy their next tropical island.
          Both Tobacco and Coal/Oil/Gas funded the academics(for sale), and the media for sale (almost all), to stall the banning of their products. Wildly successful strategy.
          And so big Pharma knows what to do. Fund academics and the media to booster the case for more and more and more shots of their vaccines into arms (only for the countries that pay well though). Since when was business a charity for poor people?
          We are being drowned in a war of misinformation, run by the vaccine companies, on how the vaccines are losing potency (but are still effective, fine line to walk).
          For every independent scientific voice that says boosters aren’t necessary, 10 well credentialled voices will sound the alarm in major media headlines that yes they are.
          And the same voices will sound the alarm in big headline media stories around any treatment that is off-patent, and has suddenly become deadly and moronic, even though on the top 100 WHO list of essential medicines.
          It’s just business everyone, no hard feelings if your mother died, don’t take it to heart.

    2. fajensen

      They’re buying the data from Denmark instead.

      Our administration set up an enormous system for registration of all manner of health data, that can be traced back to every individual that ever touched the health care system. I think they got the idea from Iceland and then they really went to town with it.

      But, yes, it is crazy to run a so-called first word country mainly on hear-say, own propaganda and rumours.

  3. Eric377

    I think the booster announcement makes all kinds of sense if you think the Biden administration was planning on mandates shortly afterwards. Consider that those qualifying for the boosters in the next couple of months probably will will have a high proportion of those most motivated to take vaccines in the first place….the ones that lined up appointments as early as possible or drove to West Virginia or whatever. They love the needle and so dose them good and then the fight over mandated vaccinations at least happens when there are few reported breakthroughs, as simply having enough virus to be transmission vector is not going to be the measure of success or failure. When the much less enthusiastic July and August bunch hit their window, well we will deal with that later. If Paraguay and some other places need to lose 40% of their distribution for half-a-year, well it’s a price the Biden administration will be willing to put up with.

    1. GM

      If they have mandates, they will have to at some point also do what Israel did — start taking people out of the list of “vaccinated” after a certain period of time.

      In Israel right now you only count as “vaccinated” if you are less than 6 months removed from your last dose.

      You read that right — current official policy is everyone to get boosted twice a year

      Now that could work in a society with the military discipline and small size of Israel.

      In the US I have a hard time seeing more than 20-30% of the population keeping current on boosters indefinitely.

      There is also a strong ideological opposition to the boosters not only from the anti-vaxxers on the right but also on the left — because there they were fed lies about how the problem is truly and finally solved by the holy alliance of “science” and their favorite party, but now in order to agree to take boosters they will have to admit to themselves that their tribal leaders lied to them.

      And that is a hard pill to swallow. Denial is easier.

      Thus the vitriol online against those of us who have been warning about the need for boosters for months…

      There is of course also the “give me boosters, I will gigapolyvax myself with as many doses as I can” technoutopianist crowd, who will just ignore the fact that they were lied to, but that is where the bulk of that 20-30% will come from.

      1. Eric377

        Maybe I am foolish, but I almost think that in the not very distant future (like next 10 days) the Biden administration might actually hope to lose a lot of mandate court rulings. The tone of his speech was clear: “My administration sides with the vaccinated who distain the unvaccinated.” Now I am vaccinated and do not distain the unvaccinated, but I am not in Biden’s base I suspect. If they can make that idea stick, but not actually deal with 160,000 unvaxxed civilian federal workers telling him to go ahead and “PATCO” them if he wants to, or armed forces discovering that the readiness craters when their “resisters” also tell Austin that they are not doing it, or thousands of firms discover that their unvaxxed workforce is simply too big and hard to replace to do anything other than test. Sure, an airline may make this stick because they are looking for ways to cut headcount anyway, but many more are trying to find workers. Announcing it but not living with it may be the best way forward.

  4. Kevin

    “The Lancet review specifically mentions the risk that endorsement of a booster strategy, in the absence of robust data and analysis, could further undermine public health messaging”

    Further???
    I’m not sure that’s possible. Between the poor messaging and politicization – we’re at the end of the proverbial rope IMO.

    1. Louis Fyne

      yup. civic trust in the medical Establishment is broken—Fauci just doesn’t know it yet. when the military is the only institution left that has civic trust, that can’t be good in the long run.

      and losing the 2020 election may well have been the best thing that happened to Trump given that Biden owns covid and Afghanistan.

  5. Synoia

    The NYT’ account highlights the “significant disagreement between career scientists at the agency and top Biden health officials,”

    Thus we, the public, are bombarded with contention, and there is no guidance which appears uncontroversial or definitive, until well after the fact.

    And people will pick the advice which supports their individual preferences.

    1. juno mas

      Yes, of course! That’s not unsound thinking when so much seems in contention. If you’re over 65, have no choice to be around many unvaccinated/unmasked people of all ages, don’t like being sick (even mildly), then get a free booster if offered. YMMV.

  6. IM Doc

    I would dare anyone to follow in my steps every day and try to explain all of this contradictory information to patients. Yesterday, it was this paper where no one needs a booster. Friday before, it was only booster the Pfizer. Thursday, it was everyone needs a booster right now this minute.

    I have many patients who are very bright, who know how to read scientific studies, and who have very appropriate and often very piercing questions. Many of them have the papers in hand with yellow highlighted statistics.

    And they have every right to ask questions. I just have no way of telling them what the correct answers are.

    As a veteran of other pandemics like AIDS, I can assure you this level of national attention was never focused on all the conflicting data and papers that were coming out daily in that era. Never in a million years. All of this was debated vehemently behind closed doors in medicine and public health. It was only when consensus about validity was reached that things made it out to the public. Often, many studies with very dramatic conclusions were found to be deeply flawed when we were able to hash them out with one another first outside of the public eye. They never made it to primetime news.

    Somehow, I think that was a much better system. The effects of social media and instant distribution of medical papers to the entire world has really caused much much confusion and angst. I view it as one of the main contributors to the confidence problem we have today. I see tweets and web posts daily from this or that expert – making very scary statements about this or that table of numbers – with really no evidence or statistical power for their assertions. It literally scares people to death.

    I can tell you without hesitation that the past two weeks, confusion and chaos has reigned supreme about these boosters with my patients. They often show me the same MD on their Twitter feed saying two different contradictory things within 24 hours of one another. I see no one in charge at the federal level steering the ship. I see a hundred minions with a hundred agendas all over the place spinning things their way. The longer this ineffectual leadership is allowed – the more confusion it generates. That is why I comment here – trying to do my efforts to tell the truth the way I see it – hoping I can decrease the angst – but I have often thought that maybe I am adding to the chaos as well.

    Never thought I would ever see this in my country.

    1. Return of the Bride of Joe Biden

      Dear online Dr:

      Soooo… I got vaccinated in April, and then had Covid 3 weeks ago; it was three days of mild fever and chest congestion and then a couple of weeks of feeling tired.

      I don’t feel like I need a booster.

      Am I being cavalier?

      Sincerely,

      55 and confused

      P.S.

      I don’t read Facebook or Twitter.

      P.P.S.

      Is it acceptable to ask questions like this in an online forum such as this one?

      P.P.P.S.

      I was referring to the original question.

      1. The Rev Kev

        I regret to say that the sort of doctor that would answer a medical question on individual treatment without ever seeing that person in front of them is the same sort of doctor that you should never, ever take advice from.

    2. tennesseewaltzer

      No, IM Doc, you are not adding to the chaos. Your frontline reporting and analysis are beacons of light. Thank you beyond words.

    3. GM

      As a veteran of other pandemics like AIDS, I can assure you this level of national attention was never focused on all the conflicting data and papers that were coming out daily in that era. Never in a million years. All of this was debated vehemently behind closed doors in medicine and public health. It was only when consensus about validity was reached that things made it out to the public. Often, many studies with very dramatic conclusions were found to be deeply flawed when we were able to hash them out with one another first outside of the public eye. They never made it to primetime news.

      I’m not so sure about this in this case.

      AIDS was a relatively slow moving pandemic. It still demanded quick action, but on the scale of months and years.

      With COVID we are talking hours and days because if things are left to their own, it will infect nearly everyone within a few months (it has done that already in a few places with very young populations that allow the damage to be tolerated for long enough to get to that point).

      If it was left to the “scientific community” to hammer it out between themselves, everyone would have indeed gotten infected long ago.

      That is what the current “consensus” is anyway, in case people have not noticed. The big shot senior-level scientists are going along with the program, for completely non-scientific reasons, and are giving interviews about how we have to “learn to live with the virus” and how everyone will get infected multiple times. Some are even going as far as saying that this was always known from the beginning.

      If anything, it is the availability of things like Twitter that has allowed people to find the correct relevant information in real time. Which would not have been the case if there was the filter of the “scientific community”.

      Remember that WHO “Fact check: COVID is NOT airborne” tweet? Well, it has been that sort of thing from the beginning.

      How did regular people know that the pandemic is starting and it will be very serious? From social media, already in late 2019 and in early January 2020. The other key source of near-real-time information has been preprints. Not from official channels.

      When and where did every relevant development after the beginning of the pandemic become apparent? Long before it was noticed by the “scientific community” as a whole and mostly on Twitter — people in the affected areas noticed things and shared them, and those who followed the right sources of information took notice. Reinfections in Iran, second wave in Manaus, second wave in South Africa, B.1.1.7/Alpha appearing in England, the appearance of Delta (the start of the second wave was pointed by a few independent Indian researchers on Twitter in mid-February, that Delta is a beast first became apparent by statistical analysis from a scientist in Belgium posted on Twitter already in April, etc.), and many others. B.1.621/Mu was first noticed in a preprint. Etc.

      The “scientific community” has been soundly asleep on all such occasions, only awakening to record the damage long after it’s too late to stop it.

      People know COVID is airborne only because of social media, if it was left to the authorities, they would be herded into unsafe classrooms and workplaces without that knowledge. They still have been herded that way but at least the information is available out there.

      So yes, we do have the problem of social media drowning people in misinformation. But at least with social media there is also correct relevant info to be found within the general stream of noise. Without it and with the usual gatekeepers, we would not even have that…

      1. IM Doc

        I would add argue that in the AIDS pandemic, we had a much more functional CDC and a completely different FDA. There were all kinds of hiccups – but nothing like what we are witnessing today.

        There are a lot of good Twitter feeds out there today. They are literally drowned out by the minions of those whose main goal is clearly either panic porn or complete dismissal of the problem. People who do not really understand medical statistics and epidemiology are having a field day scaring people to death.

        I am now witnessing on Twitter the literal flaying alive of a doctor named John Mandrola. A cardiologist – who has dared to put his name on a paper concerning the incidence of vaccine-induced myocarditis in kids. Minions of Twitter folks are threatening him with his license, calling him all kinds of names and doing all possible to destroy his reputation. Interestingly, the paper he is on has found the incidence to be in exactly the same ball park as all the other papers. That is his sin. The fact that it is right on target with other papers does not matter to the Twitter mob – he has an Internet following, he has spoken against the narrative, he must be destroyed. Non-medical people reading this stuff are just overwhelmed with dissonance and all kinds of misinformation presented in very inappropriately emotional ways. This is not even the tenth time this year I have seen similar things occur. It is my absolute belief that because of this type of thing, Twitter and Facebook have been far more damaging than anything good that has come of them.

        As far as cable news, we did not have a death count ticker on the chryons for months on end during the AIDS epidemic either. Right in front of Rachel Maddow and Tucker Carlson with gleams in their eyes. That ghoulishness has set the emotional stage for so much of what has happened.

        And as far as the papers coming out daily – I long ago have tried to tune it all out. But last week, I saw a paper from the ID dept at a major US univ discussing the fact that the COVID virus has run out of places to mutate. All is well. This is almost over – SARS COV2 is out of its bag of tricks.
        Followed the next day by a paper from an equally excellent place stating these mutations could go on for eternity. As an MD after looking at both, it is easy to tell they are both garbage. But they were online and on Twitter and being hotly debated by people all over this country. They are papers – THEY ARE SCIENCE – THEY ARE GOSPEL TRUTH – when nothing could be further from the truth – when you have some experience with garbage papers all your life. The average Twitter user has no clue what to even look for. I have found most of the time they are arguing over headlines.

        During the AIDS pandemic, there was no Internet. We discussed the important papers of the day and had imminent visitors, and our own faculty helping us duke it out. It was a slower pandemic as you say – but I wonder how much of that “slower” has to do with the reporting of it as well. It was certainly not slower in the rate of death certificates for me personally.

        I will always contend that the AIDS media and public health environment in the 80s and 90s had its problems – but was much more sane – and did not cause near the problems among citizens as this morass is today. I deal with it every day of my life.

      2. IM Doc

        I forgot to add one more thing. And ask the other commenters if they have a different experience….

        Anyone old enough to be alive in the AIDS epidemic – Did you ever hear Johnny Carson mocking AIDS patients or laughing about AIDS deaths? I sure did not. That would have been considered a career killer back then.

        But look what happened this week. I sure do not watch this show – and I just happened to find out about this today because it was being replayed.

        Correct me if I am incorrect – but he is talking about Florida COVID deaths – and lamenting the fact that there will be 50000 orphaned ferrets. Funny. Real funny. On national TV – ABC.

        I cannot remember anyone on national TV making fun of all the death going on in NYC in MAR and APR of last year. Maybe I did not see it – but it would have surely made the zeitgeist if present. Why is it OK to make jokes about COVID victims now? Or is it just funny because he is “owning” Southern rubes? Who cares?

        I cannot even believe this man still has a job after that kind of thing. But that is yet another example of how mass media and social media memes are completely debasing our feelings and our response to this entire situation. And explicitly giving large swaths of our population permission to actively denigrate the unclean and unwashed. I find the whole thing deeply alarming.

        1. Tom Stone

          IM Doc, there were people who called AIDS God’s Judgement on homosexuals and there was shunning of AIDS caretakers in the workplace, but there was nothing like what is going on now.
          This is horrifying to anyone with an ounce of decency and it is being encouraged by truly evil people.

          1. IM Doc

            Yes indeed Mr. Stone.

            I spent many nights as an intern watching people die who had been tormented by those you describe. And karma was right there watching with me.

            Interestingly, as she often does, karma paid a visit to many of those tormenters. Sometimes very immediately as in Jimmy Swaggart. Sometimes, karma takes her time. Look at Jerry Falwell – and how just recently karma revealed that he raised one of the most horrible human beings in modern pop culture exposing him for all the world to see.

            Karma is whimsical. But I cannot help but think she is waiting in the wings thinking of next moves that she will one day spring on people like Mr. Kimmel.

            She never misses.

            I have learned as I have become older to just sit back and watch karma do her work. It takes so much anguish off my mind and soul.

          2. fajensen

            Yes. Crazy people, maybe a shock-jock or two. Never anybody employed on mainstream media. Not even our very worst politicians went there.

            Today it’s like any shit goes!

        2. Cuibono

          yep: need look no further than the language: “Pandemic of the unvaccinated”/ Language designed to shame and other and divide.

        3. Taurus

          Respectfully, GM, I am with IM Doc on the value of the Twitter/ Facebook information firehouse. It is very difficult to discern objective information from the garbage. You obviously have professional expertise in the field. I do not. I did, however grow up in a place long time ago which required daily triangulation of the news from several sources to determine what actually happened.

          When I read the lancet article, I see that at least one of the authors is in the camp of “boosters in the US and EU will materially affect supply to underserved poorer places”. This is reminiscent of the early-on “masks don’t work” (because we need to keep the supply for medical workers ). In my life experience, the motivation of the author usually trumps the extensive footnotes.

          The problem is that objective reality doesn’t care about any of this. In my particular case, the objective reality is that I will be responsible for making a medical decision for a 13 year old boy who resides smack in the middle of the risk group for Myocarditis. The boosters will roll down to their age group here in the US some time next year.

          In the absence of functional CDC, what business do I have reading the pre-prints? :)

      3. Karl

        People couldn’t get AIDS from sitting next to someone on the bus.
        It was a “pandemic” like the “crack” pandemic or the “opiod” pandemic.

        1. Yves Smith

          Huh? According to Maslow’s hierarchy of needs, sex is in the bottom tier, essential like shelter and food. And until well into the AIDS pandemic, experts thought that pretty much any exchange of bodily fluids could be contagious, so even oral sex and withdrawal were considered risky. We now know that the sperm recipient is at much greater risk than the sperm provider, and anal sex is particularly risky due to the propensity to produce small tears, unlike for vaginal sex (the vagina is designed to tolerate a lot of roughing up, between sex and childbirth).

          In addition, having grown up at the tail end of the “free love” era, people my age and older had more sex partners when they were young than kids do now. HIV has produced a lasting conservatism.

          And if sitting on a bus is risky, how does current policy, by emphasizing vaccines and not much else, address that? As has been discussed ad nauseum on this thread, the vaccinated are getting Covid, often asymptomatic cases. Many of the vaccinated also eschew wearing masks as a sign of their status as the (virtuous) vaccinated, so they are putting people in the “sitting on a bus” scenario at risk. The policy argument for pressuring citizens to get vaccinated with a vaccine that was based on a different variant and has shown itself to be less effective against Delta, is to reduce the load on hospitals. But I am also hearing of more and more cases of the fully vaccinated showing up at hospitals too. So that benefit is not as absolute as claimed either.

          As for transportation risk, even the airline mask policy is underpowered. I sat two down from a guy who had a face mask on that was a joke, basically open mesh over his mouth and nose. But unlike a bus, at least the air is very well filtered. So you mainly avoid travel and when you must, wear an N95.

      4. samhill

        Social media has positives and negatives but I’ll note the internet arose during the neo-liberal era. Neoliberaism is the real corrosive element.

      5. mike

        The big shot senior-level scientists are going along with the program, for completely non-scientific reasons, and are giving interviews about how we have to “learn to live with the virus” and how everyone will get infected multiple times. Some are even going as far as saying that this was always known from the beginning.

        I remember reading several articles in early 2020 matter-of-factly discussing that the virus would presumably become endemic. (Remember the original rationale behind “flatten the curve”?) The idea of wiping out the virus was a fairly late addition to the discourse-pool, and seemingly still a pretty marginal one.

      6. Daniel LaRusso

        I think on balnace (although some benfits), in this case socall media has been a bad thing. I think you’re wrong to say people have had access to the correct infomration. THat’s the exact point … we don’t know what is correct information. We’re drowning in information/data from a host of “verified” sources which often contradict, and that’s before we evaluate their “credibility”. And then we’ve got this thing called “anecdotal” evidence which might becoming from a house wife in Swansea with zero credibility … but if its true, what does that matter?

        It makes me laugh that two years ago I bet most people in GB couldn’t name their Director of county public health. Now they are practically celebrities with twitter accounts and round-robin appearences on TV. I’m surprised some haven’t been rumbled with political aspirations yet.

    4. Farmer Pete

      Do they ask you to list the ingredients and their potential dangers?

      Since there are declared and undeclared ingredients, how do you provide a complete answer?

      How does a patient give informed consent without all ingredients, toxicology results for each (and in combination), and incomplete long term safety data?

      An October 2020 slide presentation from the FDA ‘safety surveillance’ advisory committee listed over 20 possible adverse outcomes from the vaccine including everything from GBS (paralysis) to autoimmune reactions to thrombosis, to death. Are these possible events disclosed to every potential customer prior to injection? I doubt they are doing it down at the Krispy Kreme pop up clinic.

      When accurately displaying risk/reward to patients, are they given relative risk ratio numbers (vaccine advertising “95% effective”) or absolute risk reduction (real) numbers of around 1%?

      I would gather that not much more need to be discussed to get too fuzzy and complicated. By my lay assessment, true informed consent is an impossibility. No administrator of the current injections have every answer to the above. The best they could say is “I have no idea what I’m really injecting you with or what may or may not happen down the line….want to roll the dice?”

  7. Tom Stone

    Clusterfuck Nation.
    At least it’s a lot harder to conceal just how corrupt (In every sense) the USA has become.

  8. BeliTsari

    Had first Moderna a year after a mild infection (Mar ’20). I’d delayed my 2nd shot, after Spike protein & IgG testing, awaiting “targeted booster,” never offered. Masking, etc, unchanged: >KF-94 indoors, conveyances or around loud smug mouth breathing cretins. (Our super just brought a gnarly 2nd case via jet. He’d been vaccinated in April). It’s sort’ve what we’d been warned about, but many ignored, as indoctrinated by media (Catastrophe Capitalism 3.0). The pandemic, is specious gullibility.

    https://www.theverge.com/22667600/delivery-workers-seamless-uber-relay-new-york-electric-bikes-apps

    https://readsludge.com/2021/09/14/gates-foundation-was-major-donor-to-pro-biden-dark-money-network/

    https://khn.org/news/article/icu-filled-with-covid-and-regret-nashville-hospital/

  9. BeliTsari

    Had first Moderna a year after a mild infection (Mar ’20). I’d delayed my 2nd shot, after Spike protein & IgG testing, awaiting “targeted booster,” never offered. Masking, etc, unchanged: >KF-94 indoors, conveyances or around loud smug mouth breathing cretins. (Our super just brought a gnarly 2nd case via jet. He’d been vaccinated in April). It’s sort’ve what we’d been warned about, but many ignored, as indoctrinated by media (Catastrophe Capitalism 3.0).

    https://www.theverge.com/22667600/delivery-workers-seamless-uber-relay-new-york-electric-bikes-apps

  10. samhill

    Recent Jimmy Dore Show:
    https://www.youtube.com/watch?v=iwPKnOhJRYg

    This is timely and ties right into this discussion and soberly done on Jimmy’s part, I think worth linking to here – it was NC that turned me on to JD in the first place. My limited understanding is Malone is persona non grata on social media and youtube, he’s presently considered a scientist gone rogue, or loopy, like Francis Crick, Linus Pauling…Tesla… Newton… good company, actually. But, this discussion w/ Dore seems lucid and reasonable (except maybe for the Pepsid moment). I’m vaxxed and the reference to boosters and high zone tolerance seems important to know about and damn glad I learned about it, kudos JD.

    Salients:
    -boosters and high zone tolerance, @ 25:30min
    -that you can overwhelm any vax with enough virus and with Delta encountering these non-sterilizing vaxs we may actually have increased the number of super-spreaders, many fold. My aside here is these vaxs absolutely must therefore go hand in hand with good masks, social distancing, and a policy of eradication Chinese style. In this light Freedom Day and Biden/CDC statement that the vaxxed no longer needed masks was criminally incompetent.
    -These protective but non-sterilizing vaxs should have be approached more as a prophylaxis rather than promoted as a polio/small pox cure all and reserved for the old and fragile – world wide.
    -Much more attention is need to early therapeutic treatment to prevent ARDS and Cytokine storms, so positive field reports like IVM should not be thrown out so casually.

    My other two pennies are that all the pols care about is keeping the hospital curve down, which when exceeded is where the stark reality of their failure becomes evident. That’s the real reason behind the vaccine mandate and any upcoming booster policy. As these vaxxes don’t sterilize or can attain herd immunity an individual’s only societal obligation is toward keeping the hospital curve down with respect to others and your own self interest (cancer, heart attack, car accident etc) and we are not having an open and frank discussion of this. Below the curve it’s out of sight out of mind, much like the relentless wars with only minor and tolerable US casualties of a few thousand in two decades. The long term failure will become evident but by then those involved will have failed upwards, moved on and safely out of sight and out of mind.

  11. Skorn

    Highly recommend Jimmy Dore’s interview with vaccine development expert Dr Robert Malone. I suspect google will take it down since since unmentionable topics are discussed: vaccine risk reward considerations, big pharma regulatory capture, political corruption resulting in excess deaths by denying citizens access to Ivermectin and other repurposed drugs. The talk also frames vaccine mandates within the human rights violations framework.

    https://youtu.be/iwPKnOhJRYg

  12. Barry

    I suggest that we step back a bit from the confusion firing squad and from waiting until we know everything. There are some things we know now.

    1. In the San Francisco-Oakland Bay Area, where I live, we have high vaccination rates AND we have political and public health leaders who continue to press other infection control measures, especially indoor masking, indoor gathering cautions, remote work when possible, and so on. Our infection rates, and our hospitalization and death rates, are among the lowest in the US.. Our regional economy is doing comparatively well. Overall, the fear factor is much lower than elsewhere. I travel a fair amount (Pennsylvania, New Jersey, Missouri amongh other places), but we now have a Bay Area culture that accepts these measures as part of everyday living. If you walk into an urban supermarket without a mask, you will be quickly and nicely advised to get with the program.

    2. The morning after Newsom’s success in the California gubernatorial recall election there is a very loud message in the results. The alleged “freedom loving” Republican Party, exemplified by the anti-mandate nut-case Larry Elder, was crushed. Sure, California is two-to-one registered Democrats, but the result showed that voters made a choice about Newsom’s leadership, even though admittedly it has not been perfect over these many months. The alternative was ugly and scary. Voters knew it.

    3. We need to keep up the pressure to shame politicans who advocate policies that are killing people, especially loudmouths DeSantis and Abbott as prime examples. Do they know what they are doing? You bet they do. If you, the reader, want more than a vaccination as a single form of covid resistance, then they and people like them are your enemies, not scientists or public health adminstrators who at least are trying to find answers. The politician killers need to be called out when they say masks and all other preventive measures are a matter of personal choice. Maybe they are if you want to be a hermit, but not if you want to live in a functioning society.

    4. For my money, the only argument against a mass booster campaign in the U.S. in the next few months is that it is immoral to vaccinate the first-world populations in the U.S., Europe and elsewhere while most of the world is not vaccinated at all. The need is less here and greater elsewhere. This is a humanitarian issue (and also an economic problem). But why can’t we do both? Yes, let’s strip I.P. protections from the drug companies, at least for a period of time. And let’s subsidize production around the world. Maybe the Chinese and Russians will join the effort, in their own self-interest. This is a world-wide crisis and it needs to be treated as one. But to generate necessary domestic support, U.S. political leaders will need to secure safety at home in order to provide treasure abroad.

    Let’s keep our eye on the political ball and say “no” to those who are willing to accept death to achieve their political goals.

    1. Yves Smith

      Shaming is a backfire as a political/messaging strategy. Hillary’s “deplorables” remark galvanized her opposition, for instance.

      As for boosters, your enthusiasm is not well founded. We’ve been pointing for months to data from Moderna, whose shots are more effective v. Delta than Pfizer’s, that a booster produced antibody levels only 40% of the original two shots. We’ve just been told of a 71 old woman very healthy woman who got a booster in mid-August, contracted Covid last week, and died in two days.

      1. Barry

        The shaming I mention is for the politicians who deserve it because they know better and are willfully disregarding life saving measures.

        As for boosters, you are correct that it they are imperfect, but rejecting them entirely is poor risk management and worse as political public policy because it is premised on seeing our current status as a binary choice.

        1. Daniel LaRusso

          Joe Rogan swears by the horse drug. He;s almost 50 and was working out again a few days later according ot his instagram. Why not put pressure for that instead of boosters ?

        2. Yves Smith

          You seriously think shaming will work better on pols?!?!? You don’t run for office if you have a thin skin. And anyone who has staked a lot of brand cred on his Covid position in either vein (in the US, it seems to be limited to pro-vax v. anti mask) is not about to retreat because they are appealing to constituencies who like that position.

  13. Louis

    As for whether we need boosters, I’ll let the chips fall where they may, so to speak, as far as the science goes.

    The fact that so many people “know” we do or don’t need boosters shows just how politicized science has become.

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