White House reportedly threatens FDA chief over early approval of Pfizer-BioNTech vaccine

The agency head is disputing reports he was ordered to prepare his resignation if he did not approve the vaccine by Friday

Full FDA approval of the Pfizer-BioNTech Covid-19 vaccine by agency head Dr Stephen Hahn is expected following a vaccine review panel recommendation. AP

Stephen Hahn, head of the Food and Drug Administration (FDA) in the United States, was reportedly told by White House Chief of Staff Mark Meadows to approve the Pfizer-BioNTech Covid-19 vaccine by Friday or submit his resignation.

The conversation between Mr Meadows and Mr Hahn was first reported by The Washington Post, though Mr Hahn has denied the reports.

“This is an untrue representation of the phone call with the chief of staff," Mr Hahn said in a statement to AP.

"The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s [emergency use authorisation] request. The FDA is committed to issuing this authorisation quickly, as we noted in our statement this morning.”

The Pfizer-BioNTech vaccine was recommended for emergency use authorisation by an FDA vaccine review panel on Thursday and is currently awaiting approval by the full FDA and the Centres for Disease Control and Prevention.

Initial reports say full FDA approval could come as early as Friday following the panel’s recommendation.

“The US Food and Drug Administration has informed the sponsor that it will rapidly work towards finalisation and issuance of an emergency use authorisation,” said an agency statement issued on Friday.

“The agency has also notified the US Centres for Disease Control and Prevention  and Operation Warp Speed so they can execute their plans for timely vaccine distribution.”

This would be the first Covid-19 vaccine approval in the country, which is dealing with the world’s largest and deadliest coronavirus outbreak.

"We could see people getting vaccinated Monday, Tuesday of next week," said Alex Azar, the US secretary of health and human services, in an interview with Good Morning America on Friday.

It is not clear if an approval on either Friday night or at the weekend would affect expected immunisations starting early next week. The FDA does not have to follow the panel's recommendation but it often does. The vaccine still has to be reviewed by the Centres for Disease Control and Prevention (CDC), whose panel is meeting on Sunday.

The US is reporting about 200,000 new cases of Covid-19 each day and hospitals nationwide are struggling to provide care. So far, more than 290,000 Americans have died from the disease.

News of the reported conversation between Mr Meadows and Mr Hahn came after President Donald Trump tweeted on Friday about his desire to speed up the approval process.

Americans have expressed concern over the safety and efficacy of a Covid-19 vaccine who approval was rushed.

In a Kaiser Family Foundation survey, 62 per cent of Americans said they were worried about the possibility of political pressure accelerating approval of the vaccine, which could affect a review of its safety and efficacy.