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The White House on Friday ordered the head of the United States Food and Drug Administration (FDA) to authorize the Pfizer / BioNTech Covid-19 vaccine on the same day or resign, according to the Washington Post.
The FDA’s decision was expected by the weekend anyway, but the FDA itself President Donald Trump tweeted this Friday morning that the agency was a “big slow turtle.”
“Get the damn vaccine out NOW!”Trump wrote. The United Kingdom has already started vaccinating and other countries have already given their approval.
According to the newspaper, Trump’s chief of staff, Mark Meadows, directly asked Stephen Hahn, the FDA director, to either end the process on Friday or to resign. The New York Times He reported that he would have advised him to redo his resume if he did not pass it that day.
It is expected that pressure leads regulator to make marketing authorization decision on Friday night instead of Saturday morning, making it one of the fastest clearances in the agency’s history for a vaccine – it’s only been three weeks since the manufacturers submitted their application.
This should not change the start schedule for vaccinations, announced on Friday morning by the Secretary of Health Alex Azar, for Monday in the country.
“We are going to work with Pfizer on the distribution (of the vaccine) so that we can see people getting vaccinated on Monday or Tuesday next week “he told ABC.
There are no more obstacles to authorization: the FDA itself has concluded in a summary that the vaccine is safe and effective, and an advisory committee of independent experts from the agency formally recommended the authorization Thursday.
The doses will be delivered directly to hospitals and pharmacies to vaccinate the two priority groups: residents of nursing homes and health professionals.
The FDA will have to say in its approval for which populations the vaccine would be licensed, and specify any contraindications.
