As U.S. coronavirus cases have topped 6 million, the head of the Food and Drug Administration is saying his agency might authorize a vaccine before Phase 3 clinical trials are complete.
In an interview with the Financial Times that was published Sunday, Stephen Hahn said the FDA is prepared to fast-track a vaccine if officials believe the benefits outweigh the risks. But he again insisted his agency won’t allow politics to interfere with its approval process.
“It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn said. “If they do that before the end of Phase 3, we may find that appropriate. We may find that inappropriate. We will make a determination.”
Hahn said the FDA might issue an emergency-use authorization for a vaccine, which would likely be only available to a narrower group of higher-risk people.
“Our emergency use authorization is not the same as a full approval,” Hahn told the Financial Times. “The legal, medical and scientific standard for that is that the benefit outweighs the risk in a public health emergency.”
Hahn’s comments followed tumultuous week for him and his agency. On Aug. 23, the FDA issued an emergency-use authorization for blood plasma treatment for COVID-19. The move came a day after President Donald Trump tweeted that the “FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics.” And then Hahn issued an apology for overstating the effectiveness of convalescent plasma during a White House news conference announcing the emergency authorization.
There had already been concern among some that Trump, hoping to score political points in an election year, might pressure the FDA into rushing out a vaccine.
Several prominent doctors and experts are calling for the creation of an independent commission to review data from coronavirus vaccine trials before one hits the market, CNN reported. The physicians believe an additional layer of independent review could boost the public’s trust in a vaccine.
Dr. Anthony Fauci, the nation’s top infectious disease expert, has previously voiced his disapproval of issuing an emergency-use authorization for a coronavirus vaccine that has not definitively been proven safe and effective. He said such an order would make it difficult, if not impossible, for other companies developing vaccines, to enroll the 30,000 volunteers needed for their own clinical trials.
The number of confirmed coronavirus cases in the U.S. hit 6 million Monday, by far the most in the world. More than 183,000 Americans have died from the virus, according to data from Johns Hopkins University.
There are encouraging signs, though, that the pandemic is slowing. The number of new cases has been falling since late July, and only a handful of states — Iowa, North Dakota, South Dakota and Alabama — are seeing spikes. Hospitalizations are also down, while the daily death count is leveling off.