Amid fears that the U.S. Food and Drug Administration will rush the introduction of a COVID-19 vaccine in response to pressure from President Donald Trump, Democratic presidential nominee Joe Biden wants clarification from the agency on how it will decide whether such a treatment is ready ― and a vow from Trump to do what the FDA’s scientists recommend.
The demands were among several conditions the Biden campaign on Tuesday said the federal government must satisfy in order to guarantee a “safe and effective COVID-19 vaccine.”
The list urged an uncensored report from the government scientists making the recommendation; a similarly uncensored report from an outside committee that advised FDA on vaccine safety; raw data from testing so that outside scientists can validate the results; and a public statement vouching for the vaccine from Anthony Fauci, the widely respected director of the National Institute of Allergy and Infectious Diseases who also serves on the White House coronavirus task force.
Biden also wants the administration to make clear ― now ― how it plans to distribute the vaccine, once it’s available. Trump needs to commit, that “every American — not just the wealthy and well-connected — receives the vaccine and communities of color are not left out,” the former vice president’s campaign said.
The backdrop for these demands is widespread concern that Trump, seeking a boost right before the Nov. 3 election, will push the FDA to approve a vaccine before scientists believe the data from clinical trials justifies such an OK.
Biden and his running mate, Sen. Kamala Harris of California, “feel very strongly that the scientific process needs to be independent and free of political interference,” David Kessler, a former FDA commission and an adviser to the Democratic ticket, said on a conference call.
Kessler went on to note instances when the FDA appeared to be buckling to White House pressure for a splashy announcement in its efforts to stem the coronavirus pandemic ― most recently, last month when FDA Director Stephen Hahn exaggerated the potential benefits of “plasma therapy,” which the agency approved on an “emergency use” basis.
Hahn subsequently apologized for those statements. But that episode rattled public health experts. So did the agency’s previous approval of hydroxychloroquine, a malaria drug, as a treatment for COVID-19.
Trump had touted hydroxychloroquine over and over again, calling it a “miracle” in mitigating the health effects of the disease. The FDA eventually revoked its authorization, following reports of some adverse reactions to it among COVID-19 patients and in the face of a lack of evidence that the drug was effective.
Vaccines normally go through years of development, and then years of testing. The development and current testing of COVID-19 vaccines have occurred at a highly accelerated pace, with several already past initial trials and into widespread “phase III” clinical testing under which tens of thousands of Americans will get the vaccine.
Similar testing of some of the vaccines is already underway overseas.
The FDA in theory could approve a vaccine quickly, using a special “emergency authorization,” if the agency is convinced that a shot is both safe and effective. Experts have said such a move is plausible ― if enough people sign up and if the early results show, very clearly, that the vaccine will reduce COVID-19 spread without causing harm.
But those are massive ifs, given that the trials are still enrolling people and the most promising vaccines require two dosages, weeks apart, and that it will take weeks after that to see results. Among other things, a substantial number of people would have to contract the virus, in order for researchers to see whether they were the trial subjects who got placebos (that is, shots with no vaccine) instead of the active vaccine.
“Nobody has a definitive answer,” Fauci told HuffPost in an interview on Tuesday. “It is possible ― conceivable ― that if there are enough infections that occur within the context of the clinical trial sites, then we could get an answer earlier, by October. I feel that is much less likely than November, December, January.”
The White House has denied reports that Trump is pushing government scientists to rush the process or skimp on efficacy or safety. “No one is pressuring the FDA to do anything,” press secretary Kayleigh McEnany said last week.
But Trump continued to tout hydroxychloroquine even after the FDA revoked its approval. And he has continued to hint at an early approval for a COVID vaccine ― as recently as Monday he did so ― despite public admonishments that in so doing he is jeopardizing the agency’s credibility at a time when large numbers of Americans already fear vaccines.
“We’re gonna have a vaccine very soon,” Trump said Monday. “Maybe even before a special date. You know what date I’m talking about.”
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