This week’s publication by the FDA of its guidelines for emergency use authorization for COVID-19 experimental vaccines affirms the agency’s commitment to base good medicine on sound science. The American people should feel reassured, even though that means it will take longer to make a vaccine available.
The Food and Drug Administration issued the guidelines without waiting for a public comment period and with acknowledgement that the United States is experiencing an emergency that makes vaccine development extremely urgent. In other words, FDA is encouraging all deliberate speed toward testing and production of vaccines — while expressly avoiding the demand of President Trump for a Nov. 3 deadline.
There is no medical or scientific justification for that arbitrary deadline, which happens to be the day the president hopes more states will swing for his re-election than for his opponent, Democrat Joe Biden. Haste for political purposes could gravely worsen the effects of the pandemic if a vaccine were rushed into use and ended up causing serious side effects. Some people could be harmed and many more would refuse vaccination out of fear.
Rather, the agency’s regulators are in effect concurring with the stand of Pfizer CEO Albert Bourla, who told employees Oct. 1 that the company is “moving at the speed of science.” Pfizer is reportedly further along in its timeline than most other companies working on a vaccine. According to the New York Times, about 50 vaccines are in human trials worldwide. None has been approved for wider use.
The new guidance is stricter than earlier FDA guidelines. It requires researchers to monitor those who receive the vaccine in clinical trials for two months after administering the final dose. Even the companies whose testing started the earliest would not be at that point by Election Day. The White House had been blocking the release of the guidance for two weeks, and after the FDA published them Tuesday, the president tweeted his displeasure with what he regards as delay.
Never let it be said that Donald Trump allowed science or real-life conditions get in the way of his personal benefit — a supreme irony, given that research science and clinical care seem to have rescued him from the worst effects of his COVID infection.
Fortunately, the FDA is sidestepping the political confusion with this effort at clarity from Dr. Peter Marks, director of its Center for Biologics Evaluation and Research: “Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available. …We also hope the agency’s guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved.”
An emergency use authorization, which the drug industry shorthands as EUA, would be for an “investigational vaccine.” It is not the same as approval for full licensing but in the current emergency it could be the fastest safe route toward making millions of doses available, perhaps in mid-2021. The FDA says it will quickly schedule meetings when it gets an EUA request. The agency will decide on each application on a case-by-case basis.
All the best research and clinical data won’t do any good if people fear the vaccine as badly as they fear a COVID infection. Since late summer, various surveys have indicated that anywhere from a third to half of American adults say they would not get vaccinated. That coincides with the period in which the public has been bombarded with premature advice about the dispensing and effectiveness of a vaccine that is not even yet available. Much of that conversation has had more to do with creating a political sensation than with science, medicine or public health. It’s a relief that the FDA has grabbed the reins; both the drugmakers and the public urgently need the scientists to be in charge.
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