Issues & Insights
Yan Kennon

FDA Plays Defense On COVID-19 Vaccine Approvals

There is widespread anticipation of publicly available vaccines to prevent COVID-19 infections, so that we can “get back to normal.” Some three dozen, made with a variety of technology platforms, are in clinical trials. Several of the more promising vaccine development programs have been assisted by a White House crash program, “Operation Warp Speed,” which was launched in May. At the announcement, President Donald Trump said the goal would be to have 300 million doses of a vaccine available by the end of this year. 

Unfortunately, but inevitably, the pandemic has been infected by politics. We can expect intense pressure on the Food and Drug Administration from a White House desperate for good news to provide an “October Surprise” in the form of a vaccine approval, even if it’s premature. According to the New York Times, “the government’s researchers are fearful of political intervention in the coming months and are struggling to ensure that the government maintains the right balance between speed and rigorous regulation.”

It appears that FDA previously succumbed to such pressure, when, in March, regulators allowed at least 160 antibody tests for COVID-19 to enter the U.S. market without validation or FDA scrutiny, as the agency rushed to get them to the market. Many of the tests were fraudulent or otherwise flawed, and the FDA subsequently mandated stricter review. Another example was the FDA’s approval of the emergency use of hydroxychloroquine and chloroquine, two anti-malaria drugs promoted by the president as treatments for the coronavirus despite the objections of his public health advisers. The FDA later revoked the authorization, after concluding that the risks outweighed the benefits.

Interestingly, FDA Commissioner Stephen Hahn, formerly the chief medical executive of the MD Anderson Center in Houston, seems to have created an insurance policy for himself as a bulwark against such pressure: a policy statement, “Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry,” published on June 30. It specifies in excruciating detail the numerous 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 – in other words, in 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 safety.

Those criteria are extremely important, because they emphasize that regulators do not intend to consider cutting corners via “accelerated approval” based on “surrogate endpoints” – such as a vaccine’s ability to elicit antibodies to the virus – but short of actual prevention of infection.  

The guidance enables Hahn to fall back on that policy, if he is pressured by his bosses to adopt a lower standard. He went out of his way to emphasize the FDA’s independence and integrity on July 21, 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.”

And in a podcast interview with the editor of JAMA, Dr. Hahn repeated that theme: “Americans’ and the world’s public trust in the FDA is really important…People depend upon us every day of their lives, and we cannot do anything that would break that trust.  That’s a solemn promise.”

Only last Friday, in an article in the Journal of the American Medical Association, Hahn and two senior colleagues beat the drum yet again, promising “unequivocally” that “candidate COVID-19 vaccines will be reviewed according to the established legal and regulatory standards for medical products.” They added, “While Operation Warp Speed is an important initiative and FDA has lent technical expertise around end point selection and safety considerations to this public-private partnership for vaccine development, there is a line separating the government’s efforts to focus resources and funding to scale vaccine development from FDA’s review processes, which are rooted in federal statute and established FDA regulations.”

The companies working on vaccines, most of which are large and well-established, support Hahn’s position.

“They are acutely aware of the political dynamic here,” and it would not make sense “to take a huge reputational risk not just for your vaccine but for all the products across your portfolio to benefit the president politically,” according to Rob Smith, the director of Capital Alpha Partners, a research firm (as quoted in the New York Times).

Thus, the message from Hahn to several audiences – his bosses at the Department of Health and Human Services and the White House, the public, and the vaccine industry – is clear: Although regulators will streamline regulation and facilitate the development of COVID-19 vaccines, they won’t be stampeded into exposing Americans to inadequately tested, potentially dangerous products. 

Henry I. Miller, a physician and molecular biologist, was a research fellow at the National Institute of Child Health and Human Development, and the founding director of the FDA’s Office of Biotechnology.

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  • I will be surprised to see an effective vaccine this year or next. Pharma companies and scientists have been working on a vaccine for SARS CoV-1 since 2002, and MERS since 2012, with no success with either of them. Should one make it through all three phases of the clinical trials, the FDA approval process – even on a fast track can take more than a year; the average time is 2.5 years for approval.

    • First, the time for drug approval at the FDA is nowhere near 2.5 years now; it’s around 18 months, shorter for products that are fast-tracked (as COVID-19 vaccines are). Second, FDA is performing a “rolling review,” which means that they’re not waiting to start the review when the dossier is complete; they’re reviewing data as they become available. Third, when the data are high-quality and regulators are highly motivated (as they will be for COVID-19 vaccines), it’s possible to perform reviews quickly and efficiently. I should know: The regulatory group that I headed for the review and approval of human insulin (Humulin) still holds the record for the shortest time for approval — five months, at a time when the average was 30.5 months. See

  • Mr. Miller, you know nothing about President Trump which after 3 1/2 years is a shame on you for being intentionally blind. If the White House releases a vaccine you can bet it is because it works. Of course the media and Mr. Miller will poo poo it just like they have HCQ (or whatever that abbreviation is) despite the overwhelming evidence of how well it works when used immediately.

  • At last report, there were at least 53 studies that have shown that HCQ is effective, when used correctly. That’s the operative phrase, “when used correctly.” My personal doctor, who is heavily involved in the statewide fight against Covid, told me that HCQ, while not perfect, is a solid option. Unfortunately, like the politics getting entwined in the vaccines, the worst thing that ever happened to HCQ is the President taking the drug for a couple of weeks. Because of the sheer venom with which the press and the democrats(I know, the same thing), HCQ now has a poor reputation with those with an agenda. Btw, my doctor has told me she will and has prescribed the drug. I’m lucky to have not yet tested positive(tested four times, a fifth this very day) but it is nice to know there is a good treatment option.

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