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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

Summary:
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

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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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