COVID-19 Vaccine Makers’ Pledge May Not Quell Uprising; Many Seek Independent Commission Review Before Distribution
WASHINGTON, D.C. (September 5, 2020) - A planned public pledge by Covid-19 vaccine manufactures that they will not seek government approval until their product is shown to be safe and effective isn't likely to quell the growing demands for some kind of independent commission - entirely free of political, economic, or other biases - to review the data if approval for widespread distribution is sought before normal and extensive phase three trials are completed, says public interest law professor John Banzhaf, who has proposed an alternative.
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The Distribution Of A Covid-19 Vaccine
A fierce debate has erupted, reports the Washington Post, over whether the Food and Drug Administration [FDA] should use its emergency authority to authorize the distribution of a Covid-19 vaccine before it is thoroughly tested and finally approved - a move which many warn could pose safety dangers (if the vaccine triggered adverse reactions in some recipients, or failed to provide adequate protection), and also inflame existing anti-vaccination sentiment and cause even fewer people to be willing to be vaccinated.
As a result, there is a growing caucus within the medical community - as reported by CNN, the Washington Post, CBS, WebMD, STAT, and others - calling for an independent commission, free from bias, including pressure from the President - to review the safety and effectiveness of any Covid-19 vaccine before it is widely administered.
This concern comes in response to a statement by FDA Commissioner Stephen Hahn that the FDA could well consider emergency use authorization or approval for a COVID-19 vaccine before phase three trials are complete - and much earlier than virtually all experts believe that safety can be reliably established - and a letter from the FDA suggesting that it might grant such an approval just prior to election day ("late October").
This is despite warnings, such as this from the New York Times, that "if a vaccine turns out to have dangerous side effects for some people, the fallout could be catastrophic, damaging their corporate reputations, putting their broader portfolio of products at risk and broadly undermining trust in vaccines, one of the great public health advances in human history."
Also of concern is a statement by the FDA that it would approve a COVID-19 vaccine found to be only 50% effective; in contrast, most routine childhood vaccines are effective for 85% to 95% of recipients.
Fifty percent is like flipping a coin, or like playing Russian roulette with a revolver loaded with 3 out of 6 bullets, suggests Banzhaf.
Substantial Evidence Of Safety And Efficacy
The companies' draft statement says the drug makers will submit applications for government emergency-use authorization or licensure of vaccines based on "substantial evidence of safety and efficacy" from apparently interim results from phase 3 clinical trials.
But "substantial evidence" is far short of the standard of proof often sought in medical and scientific studies, or even political polling, which is to a confidence level of 95%, notes Banzhaf, an expert in statistics and the creator of the "Banzhaf Index."
Also, he argues, because of their undeniable self interest, and hundreds of millions of dollars at stake, such pledges from vaccine companies are like assurances from the NRA that gun owners will use assault rifles responsibly, or from the Hell's Angles that its members will obey traffic regulations, argues Banzhaf.
While pleas for an independent commission are unlikely to be effective at an agency which - unlike independent federal agencies such as the FCC, FTC, etc. - is headed by a commissioner who serves at the pleasure of the President and can be fired by him at any time, there is a way to protect the public from a possibly ineffective or even harmful vaccine, notes Prof. Banzhaf.
Indeed, he points out that any physician, hospital, medical insurance company, or other entity which took part in administering a vaccine which had not been fully tested as it normally is through large scale phase three trials - and where there was reason to suspect that any premature FDA emergency authorization was rushed for political reasons and not based upon established medical testing procedures - could be held legally liable if a person receiving the vaccine suffered an adverse reaction (including coming down with COVID-19 as a direct result), or whose reasonable reliance on the vaccine caused them (e.g., hospital workers) to risk exposure to the virus which then turned out to be harmful if not deadly.
Permanent Medical Problems
These potentially very costly legal risks are multiplied many times by recent medical findings that, in addition to killing a tiny percentage of those (mostly elderly and with pre-existing medical conditions) who become infected, many if not most even healthy victims who experience symptoms of COVID-19 suffer permanent medical problems - including some disabilities - because of damage to their hearts or lungs, and perhaps also to kidneys and even brains (now beginning to be called "brain fog").
However, if one or more major medical organizations - such as the American Medical Association, American College of Physicians, American Academy of Family Physicians, National Medical Association, etc. - were to announce that it would recommend that its members not administer any vaccine which had not fully completed phase three trials unless a responsible body independent of the federal government and the President had endorsed it, that announcement would probably force the FDA to permit such a review or effectively prevent premature distribution of a potentially deadly Covid-19 vaccine., argues Banzhaf.
The same result would probably occur if several of the major hospital chains, or large health insurance carriers, were to take the same position, he adds.
Why Distrust The FDA
Among the reasons for many reasonable members of the public to distrust the FDA and its head regarding the pandemic, Prof. Banzhaf lists the following:
- the very name of the Covid-19 vaccine program - "Operation Warp Speed" - strongly suggests rushing to judgment at all costs, and possibly not insisting upon sufficient testing for safety and effectiveness
- the FDA bungled in initially getting COVID-19 tests on the market, and then allowed antibody tests which proved inaccurate to be made available
- it hastily approved hydroxychloroquine as a treatment after it was touted by the President but before it was fully tested, and then had to withdraw the authorization only shortly thereafter
- it authorized the use of convalescent plasma, likewise strongly recommended by the President, despite the reservations of many medical experts
- FDA Commissioner Hahn just made a clearly misleading public statement which greatly overstated the effectiveness of the plasma in treating COVID-19
- the agency recently changed its testing guidelines in ways which upset many experts, and without even consulting infectious disease expert Dr. Anthony Fauci
- many observers have suggested that it appears that top governmental pandemic experts are being pressured to take unjustified positions because they are favored by the President
To counter the call for a new independent commission, the FDA has argued that it "has committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public."
But critics such as Dr. Kathryn Stephenson of Harvard Medical School, bioethicist Arthur Caplan of NYU, and others say that a public already skeptical about vaccines and the FDA itself is unlikely to trust any existing advisory committee within the FDA because some of its members work for pharmaceutical companies and government agencies, and thus are subject to pressure from the President.
The same is probably true of the growing number of FDA employees - such as Dr. Moncef Slaoui and Dr. Peter Marks - who claim that they would resign rather than permit an unsafe vaccine to be distributed.
The Approval Process For A Covid-19 Vaccine
Indeed, in a recent survey, 78% of respondents said they were worried that the approval process for a COVID-19 vaccine was being influenced more by politics than by science.
While getting and distributing a safe and effective Covid-19 vaccine as early as possible is obviously important, virtually all of the experts said that it would almost certainly not be ready before the end of the year.
To now rush it for release just prior to election day, without completing the phase three trials necessary to show whether it is both safe and effective, would only increase the existing distrust of the public regarding the government's handling of the entire COVID-19 crisis, and could substantially prolong the hardship of the pandemic if even more people simply refused to use the vaccine once the FDA authorized it on an emergency basis, says Banzhaf.
Public Citizen agrees, arguing that such a rush to prematurely approve a vaccine could fuel existing vaccine hesitancy.
It could also make it more difficult to find people willing to participate in any more clinical trials for that Covid-19 vaccine - or the many other experimental vaccines still being tested - because participants might not want to take the risk of getting a placebo offering no protection when they could get a shot of an arguably effective vaccine authorized (at least on an emergency basis) by the FDA.
So Banzhaf suggests that it would be appropriate for major medical organizations, large hospital chains, and big medical insurance companies to consider what their role should be regarding the distribution and administration of any vaccine without the satisfactory completion and unbiased evaluation of clinical trials.