The Food and Drug Administration approved an emergency use authorization for a coronavirus vaccine developed by Pfizer (PFE) - Get Pfizer Inc. Report and BioNTech (BNTX) - Get BioNTech SE Report late Friday marking a key milestone in the battle against the Covid-19 pandemic.
The move came a day earlier than expected, after a White House ultimatum to the head of the agency.
The White House ordered Stephen Hahn, the commissioner of the FDA, to approve the Pfizer coronavirus vaccine Friday or submit his resignation, according to published reports. White House Chief of Staff Mark Meadows issued the ultimatum in a phone call Friday to Hahn, The Washington Post reported.
The Covid-19 vaccine candidate from Pfizer and Germany's BioNTech received a recommendation from an FDA advisory committee Thursday for an emergency use authorization, clearing a path for its approval by the full FDA.
On Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee recommended the agency approve emergency use authorization for the vaccine in a 17-4 vote, with one abstention. The panel said the shot appears safe and effective against the coronavirus in people 16 and older.
The disease is now “essentially out of control,” Kathrin Jansen, Pfizer’s head of vaccine research and development, told the committee. “Vaccine introduction is an urgent need.” The U.S. death toll from Covid-19 was approaching 300,000.
Distribution of the vaccine in the U.S. could begin within 24 hours of approval, promised Health and Human Services Secretary Alex Azar. First priority for the vaccine will go to healthcare workers and nursing home residents. The general public isn’t expected to get widespread access to the vaccine until the spring.
The initial shipment of 6.4 million doses will leave warehouses within 24 hours of being cleared by the FDA, The New York Times reported, citing federal officials. About half of those doses will be sent across the country, and the other half will be reserved for the initial recipients to receive their second dose about three weeks later, according to the Times.
The vaccine was approved in the U.K. this month and went into use earlier this week.
Large-scale trials have shown the Pfizer vaccine is safe and 95% effective in combating Covid-19, the disease caused by the coronavirus.
Pfizer said Thursday it plans to file for full approval of the vaccine by next April.