White House presses FDA chief to approve vaccine by end of day

National Coronavirus Coverage

WASHINGTON (NewsNation Now) — White House chief of staff Mark Meadows on Friday pressed Food and Drug Administration chief Stephen Hahn to grant an emergency use authorization for Pfizer’s coronavirus vaccine by the end of the day.

The vaccine won approval Thursday from an FDA panel of outside advisers, and signoff from the FDA is the next step needed to get the shots to the public.

Meadows spoke to Hahn by telephone on Friday, according to a senior official familiar with the call but not authorized to discuss private conversations.

Hahn signaled that he would tell regulators to do so, the official said.

President Donald Trump has been pressing for quick approval for the vaccine as more than 290,000 Americans have died from COVID-19, according to Johns Hopkins University.

In an emailed statement to NewsNation, Hahn denied a report from The Washington Post claiming that he was ordered to authorize the vaccine Friday or resign.

“This is an untrue representation of the phone call with the Chief of Staff. The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning.”

The FDA also said in a statement Friday that it has notified the Centers for Disease Control and Prevention and Operation Warp Speed so that they can execute their plans for timely vaccine distribution.

Earlier Friday, Health and Human Services Secretary Alex Azar told Good Morning America that emergency use authorization for the Pfizer vaccine could come as soon as Monday or Tuesday.

“The FDA informed Pfizer that they do intend to proceed towards an authorization for their vaccine,” Azar said. “So in the next couple of days probably as we work to negotiate with Pfizer, the information doctors need to prescribe it appropriately, we should be seeing the authorization of this first vaccine.”

Depending on how quickly the FDA acts, the vaccine could be distributed within days.

The government advisers on Thursday concluded that the vaccine from Pfizer and its German partner BioNTech appears safe and effective for emergency use in adults and teenagers 16 and over.

That endorsement came despite questions about allergic reactions in two people who received the vaccine earlier this week when Britain became the first country to begin dispensing the Pfizer-BioNTech shot.

While there are a number of remaining unknowns about the vaccine, in an emergency, “the question is whether you know enough” to press ahead, said panel member Dr. Paul Offit of Children’s Hospital of Philadelphia. He concluded that the potential benefits outweigh the risks.

The decision came as the U.S. recorded its highest daily death toll from the virus. The country set an all-time one day record of more than 3,100 deaths on Wednesday.

Pfizer has said it will have about 25 million doses of the two-shot vaccine for the U.S. by the end of December. But the initial supplies will be reserved primarily for health care workers and nursing home residents, with other vulnerable groups next in line until ramped-up production enables shots to become widely available on demand — something that will probably not happen until the spring.

Next week, the FDA will review a second vaccine, from Moderna and the National Institutes of Health, that appears about as protective as Pfizer-BioNTech’s shot.

A third candidate, from Johnson & Johnson, which would require just one dose, is working its way through the pipeline. Behind that is a candidate from AstraZeneca and Oxford University.

READ THE FDA’S FULL STATEMENT ON PFIZER’S VACCINE

“Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”

FDA COMMISSIONER STEPHEN HAHN AND CBER DIRECTOR PETER MARKS

Copyright 2021 Nexstar Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Trending Stories

Don't Miss

More Don't Miss