White House orders FDA head to approve Covid vaccine on Friday or resign, report says

Commissioner Stephen Hahn calls report ‘untrue representation’ of conversation

White House Chief of Staff Mark Meadows told Stephen Hahn, commissioner of the Food and Drug Administration, to submit his resignation if his agency does not approve  the US’s first coronavirus vaccine on Friday.

Citing sources familiar with the situation, The Washington Post reports that the warning led the FDA to speed up its timetable to clear the Pfizer-BioNTech vaccine for use, moving it up from Saturday morning to later on Friday.

A White House official declined to comment on the report, but confirmed that the chief of staff requests updates on progress toward a vaccine.

According to NBC News, Mr Hahn says of the report: “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. The FDA is committed to issuing this authorisation quickly, as we noted in our statement this morning.”

Given that the authorisation was already on a fast track and the announcement was expected over the weekend, following Thursday recommendation by the advisory committee, moving the schedule forward by a day is unlikely to make any difference to when the first people receive the vaccine.

The Trump administration says that approximately 3 million doses of the Pfizer vaccine are ready to be shipped immediately.

Speaking on CNBC’s Power Lunch, Dr Paul Offit, a vaccine committee member, who voted in favour of the Pfizer vaccine, said that he didn’t think Mark Meadows was making the FDA do anything they weren’t going to do anyway. 

“The important thing is that we did a big phase three trial, we looked through a lot of data carefully … and we feel that there is enough information now to move forward on this, whether it happens today, or whether it happens tomorrow is not a big deal," he said.

“And Sunday the CDC is going to consider this and no doubt come to the same conclusion. So we did this the right way, we weren’t pushed to try and do all this before the election, which I think wouldn’t have been possible, so I do think that the political pressure on this at this point is meaningless."

Donald Trump has been pressing for quick approval for the vaccine and tweeted directly at Mr Hahn earlier on Friday, complaining that FDA “is still a big, old, slow turtle.” Mr Trump has publicly bashed the pace of the FDA’s vaccine review process.

“Get the dam vaccines out NOW, Dr. Hahn,” the president tweeted on Friday. “Stop playing games and start saving lives.”

On Thursday at the FDA, each member of the Vaccines and Related Biological Products Advisory Committee was asked if the benefits of Pfizer’s coronavirus vaccine “outweighs its risks for use on individuals 16 years of age or older” based on the “totality of scientific evidence available”.

The majority of the panel voted in favour of the FDA issuing emergency use authorisation to Pfizer for its vaccine, with 17 experts voting “yes”, four voting “no”, and one expert abstaining from the vote. 

Pfizer said it could ship an estimated 50 million doses of the vaccine by the end of the year, enough to vaccinate 25 million Americans.