Public health experts are concerned that the government may put pressure on the FDA to approve a COVID-19 vaccine before it is determined to be safe and effective, The Hill reported.
Political officials have predicted a vaccine will be available this year. Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said July 31 that he is "cautiously optimistic" a vaccine would be ready this year and widely distributed next year, The Hill reported.
Public health experts told The Hill they worry politicians could seize on early positive results from drugmakers on their experimental vaccines to pressure the FDA to approve a vaccine too early.
"You saw the issue of politicization around hydroxychloroquine and the pressure that was put on FDA then. There's a legitimate concern that does not happen again," Jesse Goodman, MD, a Georgetown University professor and formerly the FDA's chief scientific officer, told The Hill.
The White House has also reportedly put pressure on the CDC to change its guidance on reopening schools, leaving experts worried it may do the same for vaccines.
"We are way ahead on vaccines, way ahead on therapeutics. And when we have it, we’re all set up with our platforms to deliver them very, very quickly. We’re all set to deliver them as soon as we have them, and that’s going to be very soon," President Donald Trump said at a recent White House news conference, according to The Hill.
The FDA has said it will not let political pressure influence its approval of a COVID-19 vaccine.
"Data and science. Those are what's going to guide us," FDA Commissioner Stephen Hahn told the Journal of the American Medical Association. "We cannot have a situation where people lose trust in the FDA and the clinical trials process."
The FDA requires any vaccine to be at least 50 percent more effective than a placebo at preventing disease before it's approved. But the agency has the power to issue an emergency use authorization, which requires less rigorous data.
Experts told The Hill they are also worried about a large population of people refusing to get a vaccine if one is approved too soon out of distrust for its safety and effectiveness.
"This is not a place that politicians really need to insert themselves. This is a medical decision between doctors and patients," Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, told The Hill.
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