Infectious diseases expert Dr. Anthony Fauci warned Monday that he opposes the distribution of a COVID-19 vaccine as a component of special emergency use rules before it has been demonstrated and effective in clinical trials, saying it could compromise election testing.
Caution follows pressure from President Donald Trump on the Food and Drug Administration to factor a vaccine before November for its customers for a period of time.
Fauci, director of the National Institute of Allergy and Infectious Diseases, told Reuters that the interference of the vaccine carries its own risks, adding that a “sign of effectiveness” is a step before any vaccine gets an emergency license.
“One of the possible risks if a vaccine is released is that it would be difficult, if not impossible, for other vaccines to recruit others in their trial,” Fauci told Reuters.
Leading vaccine candidates, Moderna Inc, Pfizer Inc and AstraZeneca Plc, have introduced primary clinical trials in recent weeks in the hope of recruiting tens of thousands of volunteers.
Meanwhile, Trump, in tweets, tried to undermine the FDA, suggesting that the firm intentionally delayed progress from vaccine trials until the end of the November 3 election to undermine his re-election.
Trump’s effort to undermine the company as a crusade tactic encompasses months of distorting science and undermining clinical research to fit its political goal, just as the United States reports that about 177,000 more people have died of coronavirus.
On Sunday, the president announced the emergency use of plasma from recovered COVID-19 patients to treat existing patients eager to win electoral favors before they have been evaluated in randomized placebo-controlled clinical trials.
Like Fauci, many vaccine experts are concerned that the White House’s tension over the FDA may lead the company to deliver a vaccine through an emergency use authorization before its protection and effectiveness has been fully proven. The FDA’s U.S. mechanism has not been used to approve a vaccine for widespread use.
Fauci said the FDA’s recommendation on vaccines explicitly requires a demonstration that they are effective.
He added that an AOA is used for products to “diagnose, save and treat serious or life-threatening diseases where known benefits outweigh the potential dangers of the product,” Fauci said.
The immunologist told Reuters that if studies showed quality and efficacy, an UCA might be appropriate in all likelihood, but only if “it definitely proves that a vaccine is effective.”
While Fauci remained consistent in his refusal to defame the president, he added that he hoped nothing would “interfere” with the full demonstration of the protection and efficacy of any possible vaccine.