Issues & Insights

COVID-19 Vaccines Must Be Fully Vetted For Safety And Efficacy Before Release

There is widespread anticipation of the availability of vaccines to prevent COVID-19 infections so that Americans can get their lives back to some semblance of normal. About four dozen, made with a variety of technology platforms, are now in clinical trials, nine in large-scale safety/efficacy testing.

It was hardly a secret that there would be intense pressure on the FDA from a White House desperate for good news to provide an “October Surprise” in the form of a vaccine approval before the Nov. 3 election, even if that approval was premature. When I wrote about this subject for Issues & Insights a month ago, I described the wall that the head of the FDA, Dr. Stephen Hahn, and his colleagues had constructed in order to resist that pressure. Well, watch out for falling debris, because the wall is crumbling.

The Centers for Disease Control and Prevention has notified public health officials in every state and five large cities to prepare to distribute a coronavirus vaccine to health care workers and other high-risk groups as soon as late October or early November. The UPS and other delivery partners are reportedly planning to perform test runs in September, in preparation for actually beginning to ship a coronavirus vaccine by Nov. 1.

For months, FDA Commissioner Hahn has been emphasizing the agency’s independence, commitment to evidence-based approvals, and unwillingness to cut corners.

First came an FDA policy statement, “Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry,” published on June 30. It specifies in great detail the criteria for FDA approval of coronavirus vaccines, but the overarching principle is simple: “The goal of development programs should be to pursue traditional approval via direct evidence of vaccine efficacy” in protecting humans from COVID-19 – through clinical trials – and a vaccine must be at least 50% more effective than a placebo in preventing the disease.”

The clinical trials would also need to demonstrate that the vaccine is safe, and manufacturers would need to show that they can produce batch after batch of vaccine of the appropriate purity and potency.

On July 21, Hahn emphasized the FDA’s independence and integrity, tweeting, “Americans should know that we are steadfast in maintaining our regulatory independence & ensuring our decisions for treatments & vaccines for #COVID19 are based on science & data. This is a commitment that the American public can have confidence that I will continue to uphold.”

However, two recent actions by the FDA and its sister agency, the CDC have raised doubts.

The first was the FDA’s issuance of an Emergency Use Authorization (EUA) for convalescent plasma, an antibody-rich blood product obtained from patients who have recovered from COVID-19. In theory, infusing a sick patient with the antibodies should neutralize the virus and spur recovery, but many in the medical community – including senior National Institutes of Health and FDA scientists – felt the EUA was predicated on insufficient evidence (which has made the completion of rigorous clinical trials difficult or impossible). Notably, the EUA came a day after President Donald Trump accused “deep state” bureaucrats at the FDA of trying to sabotage him by delaying approval of a COVID-19 vaccine.

The second was the CDC’s new guidance on testing for the SARS-CoV-2 virus, released on Aug. 24. It amended the agency’s guidance to recommend that people who have been exposed to the virus – typically defined as being within six feet of an infected person for at least 15 minutes – “do not necessarily need a test” if they do not have symptoms. This flies in the face of evidence that the time of highest virus shedding and infectivity is in the days shortly before symptoms emerge and would seem to represent an abandonment of any attempt at contact tracing and isolation of infected persons.

The above two examples are credible precedents for a possible, far more drastic action – a premature Emergency Use Authorization for a COVID-19 vaccine not adequately tested for safety and efficacy. Hahn may be moving toward that: In an interview published by the Financial Times on Aug. 30, he said his agency was prepared to authorize a vaccine before Phase 3 clinical trials (the final, definitive stage of testing) were complete, if regulators become convinced that the benefits outweigh the risks.

But even more worrisome is the existence of a loophole in federal law (U.S. Code, Title 21, Chapter 9) that could be exploited by Hahn’s boss, Secretary of Health and Human Services Alex Azar, a political appointee and lawyer who has hardly been a reassuring presence during the pandemic.

The relevant section of the law, “Authorization for medical products for use in emergencies,” specifies that

The Secretary may issue an authorization under this section with respect to the emergency use of a product only if, after consultation with the Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention … the Secretary concludes (1) that an agent referred to in a declaration under subsection (b) can cause a serious or life-threatening disease or condition; (2) that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that (A) the product may be effective in diagnosing, treating, or preventing (i) such disease or condition.

Note that the secretary is required only to consult with, but not obtain agreement from, the three subordinates specified in the law. It would surprise me not at all if Azar was already having and documenting conversations with them, and if staffers in the White House and the Department of Health and Human Services were preparing the necessary decision documents for an emergency authorization for one or more of the COVID-19 vaccine candidates.

Lending credence to that scenario are reports that top administration officials told congressional leaders in July that they were likely to issue emergency authorization for a vaccine before the end of Phase 3 clinical trials in the U.S.

For several reasons, that would be unwise. The perception that the authorization was rushed and issued via an unorthodox pathway would fan the passions of the anti-vaccine movement and undermine public confidence in COVID-19 vaccines; but, more important, the short-circuiting of the usual evaluation mechanisms could endanger vaccine recipients. 

There is a reason that vaccines intended to be administered to hundreds of millions of healthy people are extensively tested and the results carefully evaluated. This is a time that science, meticulously applied, and experience with vaccine evaluation must prevail. The proximity of elections should not guide life or death medical decisions.

Henry I. Miller, a physician and molecular biologist, was a research associate at the National Institutes of Health, the founding director of the FDA’s Office of Biotechnology, and the co-discoverer of a critical enzyme in the influenza virus.

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  • As long as the administration follows the law as written, what basis would this doctor have for accusations the vaccine was being released prematurely? If Trump can be accused of seeking political gain by a “premature” release, can those favoring Biden not be accused of delaying release for political again as well? We are a country based country on the rule of law. If the good doctor wants a different law, by all means, go pass one.

    • I agree with your thesis but we are no longer a country of laws. We are a two tier system that can best be described as the Rules are for Thee and not for Me. The recent fiasco with Pelosi is a darn good example. Not to mention that McCabe, Rosenstien, Comey, et. al have gotten a free pass the rest of us serfs would never ever get

    • The law (Public Health Service Act) also says that a drug or vaccine can’t be sold unless it has been judged to be safe and effective by the FDA (which includes passing an inspection of the manufacturing facility), so different legal pathways offer OPTIONS for releasing a vaccine. The point of the article is that using the Secretary’s discretion would be a bad option. We don’t need to change the law, just rely on good judgement, instead of political exigencies.

  • Not surprised to hear a former bureaucrat say this. Does he honestly think Hahn, Trump, the producers of the vaccine would risk mass casualties?

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