Top infectious diseases expert Dr. Anthony Fauci on Monday warned against distributing a COVID-19 vaccine under special emergency use guidelines before it has been proved safe and effective in clinical trials, saying that it could jeopardize the testing of alternatives.
The cautioning follows pressure from President Donald Trump on the Food and Drug Administration to deliver a vaccine before November to boost his prospects for a second term.
Fauci who is the director of the National Institute of Allergy and Infectious Diseases, told Reuters that jamming through a vaccine comes with its own risks, adding that a “signal of efficacy” is a critical step ahead of any vaccine getting emergency use authorization.
“One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial,” Fauci told Reuters.
Top vaccine contenders including Moderna Inc, Pfizer Inc and AstraZeneca Plc, have launched large clinical trials in recent weeks hoping to enlist tens of thousands of volunteers.
Meanwhile Trump in tweets has sought to undermine the FDA, suggesting that the agency has deliberately delayed progress on vaccine trials until after the Nov. 3 election in order to damage his shot at re-election.
Trump’s effort to undercut the agency as a campaign tactic expands on a months-long effort to warp science and undercut scientific inquiry to fit his political objective just as the United States reports that roughly 177,000 people have died because of coronavirus.
On Sunday, the President announced emergency use authorization for plasma from recovered COVID-19 patients to treat current patients in a rush to curry electoral favor before its benefits have been assessed in randomized, placebo-controlled clinical trials.
Much like Fauci, many vaccine experts are concerned that White House pressure on the FDA could cause the agency to deliver a vaccine through emergency use authorization before it has been fully tested for safety and efficacy. The FDA’s EUA mechanism has not historically been used to approve a vaccine intended for widespread use.
Fauci said the FDA’s guidance on vaccines explicitly requires a demonstration that it is both safe and effective.
He added that an EUA is typically used for products to “diagnose, prevent and treat serious or life-threatening diseases where the known benefits outweigh the potential risks of the product,” Fauci said.
The immunologist told Reuters that if studies demonstrate safety and effectiveness an EUA could eventually be appropriate, but only if “you definitively show that a vaccine is safe and effective.”
While Fauci has remained consistent in his refusal to smear the President he added that he hoped that nothing “interferes” with the full demonstration of any potential vaccine’s safety and efficacy.
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