WASHINGTON | The White House on Friday ordered the head of the United States Medicines Agency (FDA) to authorize Pfizer / BioNTech’s COVID-19 vaccine on the same day, or to resign, according to the Washington post.
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The FDA decision was expected by the weekend anyway, but President Donald Trump himself tweeted on Friday morning that the agency was a “big slow turtle.”
“Get out the damn vaccine NOW,” the leader wrote, as the UK has already started vaccinations and other countries have granted clearance.
According to the daily, Mr. Trump’s chief of staff, Mark Meadows, directly asked Stephen Hahn, the director of the FDA, to finalize the process on Friday or to resign. The New York Times reports that he would have advised her to redo her CV if permission was not given on Friday.
The pressures should lead the regulator to take the marketing authorization decision as early as Friday evening, instead of Saturday morning, which would make it one of the fastest authorizations in the agency’s history for a vaccine: only three weeks have passed since the manufacturers filed their application.
This should hardly change the planning of the start of vaccinations, announced Friday morning by Minister of Health Alex Azar for Monday in the country.
“We’re going to work with Pfizer on the distribution (of the vaccine) so we could see people getting vaccinated on Monday or Tuesday next week,” he told ABC.
No more obstacles stand for authorization: the FDA itself considered in a summary that the vaccine was safe and effective, and an advisory committee of the agency composed of independent experts formally recommended authorization on Thursday.
The doses will be delivered directly to hospitals and pharmacies which will vaccinate the two priority groups: residents of retirement homes and professionals in the health sector.
The FDA will have to say in its authorization for which populations the vaccine would be authorized, and specify any contraindications.
An FDA official said Thursday that it would not be recommended for people with a known severe allergy to any of its ingredients, after two cases of severe allergies in the UK this week.
The United States is, in absolute value, the country most affected by the pandemic in the world, with 15.6 million recorded cases and more than 292,000 deaths, according to figures from Johns Hopkins University, which are the benchmark.