FDA’s New Moves Can’t Allay Coronavirus Vaccine Fears

FDA’s New Moves Can’t Allay Vaccine Fears; Weaker Standards and Political Pressures Worry Many Experts

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FDA's New Standards On Coronavirus Vaccine

WASHINGTON, D.C. (September 23, 2020) -  In an effort to repair its badly damaged reputation, and convince the public that they should take any vaccine it authorizes, the FDA is issuing new standards, but they probably will not convince either experts nor the public that it will be safe and effective, says public interest law professor John Banzhaf.

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Even with the new additions, the emergency authorization standards will still be far lower and less demanding than those ordinarily used to approve a vaccine or other new drug,  and the agency's recent serious mistakes, plus real concern that political pressures will affect its judgment, suggest that nothing short of review and approval by a body of impartial experts will convince many to line up for injections, suggests Banzhaf.

Indeed, he notes, even presidential candidate Joe Biden has joined a growing chorus of medical experts and others questioning the impartiality of the FDA in reviewing vaccine trials, and asking for the science to be reviewed by an impartial body before any release of a COVID-19 vaccine to the public, notes Banzhaf, who proposed a novel approach to the problem.

More precisely, Biden said: "I don't trust Donald Trump. . . It's one thing for Donald Trump to say the vaccine is safe.  OK, then give it to a board of scientists. . .  if the administration green lights a vaccine, who will validate that the decision was driven by science rather than politics? What group of scientists will that be?"

With these statements, Biden added to ever growing concerns that the FDA may approve a vaccine too quickly and without adequate testing - which could be deadly if there are adverse reactions to some segments of the population, and/or people rely upon it but it provides inadequate protection - but there is a remedy if major medical associations are willing to play a role, says Banzhaf.

Political Pressure To Approve The Release Of A Vaccine

Further adding to the recent growing concerns by experts and others that the FDA will rush to approve the release of a vaccine because of political pressure, Politico disclosed that HHS Secretary Alex Azar not only "led an escalating pressure campaign against his own Food and Drug Administration this spring and summer, urging the agency to abandon its responsibility for ensuring the safety and accuracy of a range of coronavirus tests as the pandemic raged," but ultimately "overriding objections from FDA chief Stephen Hahn, Azar revoked the agency's ability to check the quality of tests developed by individual labs for their own use, according to seven current and former administration officials with knowledge of the decision."

This comes on top of Hahn's recent announcement that he is willing to consider bypassing the usual approval process - including completion and evaluation of all-important stage three trials - to get a vaccine out to the public quickly, perhaps before Election Day as the President has suggested.

Among other things, if he uses the emergency use authorization [EUA] process which he suggested, it will mean a very significant lowering of the standards from the usual - that there is "substantial evidence" that the vaccine is safe and effective - to the much weaker "may be effective" given the "totality of scientific evidence standard," notes Banzhaf.

Moreover, approving a vaccine which may only be 50% effective, as Hahn has stated - rather than even coming close to the 95% confidence level ordinarily required in medicine - is like flipping a coin heads or tails, or playing Russian roulette when 3 out of 6 chambers in a gun have bullets.

Reasons To Distrust The FDA

Even before these recent developments, there was growing doubt among experts and members of the public that the FDA could be counted on during the pandemic, and with increasing pressure from the President, to provide adequate protection to the public.  The reasons for this growing distrust included, says Banzhaf:

  • the very name of the vaccine program - "Operation Warp Speed" - strongly suggests rushing to judgment at all costs with little or no long-term testing
  • the FDA bungled in initially getting COVID-19 tests on the market, and then also allowing antibody tests which proved inaccurate to be made available
  • it hastily approved hydroxychloroquine as a treatment but before it was fully tested, and then had to withdraw the authorization shortly thereafter
  • it authorized the use of convalescent plasma, likewise strongly recommended by the President, despite the strong and continuing reservations of many medical experts
  • Hahn recently made a clearly misleading public statement which greatly overstated the effectiveness of the convalescent plasma in treating COVID-19
  • the agency changed its testing guidelines in ways which concerned many public health experts, and without even consulting infectious disease expert Dr. Anthony Fauci
  • many observers have suggested that it appears that top governmental medical experts are being pressured to take scientifically unjustified positions

As a result, there is now a growing chorus within the public health community - as reported by CNN, the Washington Post, CBS, WebMD, STAT, The Independent, and others - calling for an independent commission, free from bias - including pressure from the President - to review the safety and effectiveness of any vaccine before it is widely distributed.

Calls For A New Independent Commission

To counter these calls 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" - although the committee's recommendations are not binding and can be ignored by the agency, notes Banzhaf.

But critics such as Dr. Kathryn Stephenson of Harvard Medical School, bioethicist Arthur Caplan of NYU, and many other experts say that a public already skeptical about vaccines and the FDA itself is unlikely to trust this FDA advisory committee because some of its members work for pharmaceutical companies or government agencies, and thus are subject to pressure from the President and others.

However, suggests Banzhaf, 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 consider recommending to its members that they not administer any vaccine unless a body of experts independent of pressures from the federal government or the President had endorsed it, that announcement would probably force the FDA to permit such a review, or effectively prevent premature widespread distribution of a potentially deadly vaccine, argues Banzhaf.

The recent pledge by nine vaccine makers that they will hold back seeking FDA approval until their product is proven to be both safe and effective is unlikely to persuade either the public or a growing number of skeptical experts, says Banzhaf, who predicts that it will be seen much like any assurance from the NRA that gun owners will use assault rifles responsibly, or from the Hell's Angles that its members will obey traffic regulations.

So Prof. Banzhaf suggests that it would be appropriate and perhaps necessary for major medical organizations 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, and not stand by passively in view of this growing concern and danger to the public health.