FDA May Issue Emergency Clearance for Pfizer's Vaccine Soon

U.S. officials insisted they’ll have enough Covid-19 vaccine doses to let most Americans get inoculated by next summer, downplaying reports that they passed up a chance to secure more of Pfizer Inc.’s shot.

The Trump administration is confident that the U.S. will have enough supply to vaccinate everyone, a senior administration official said Monday on a call with reporters. The government signed a deal last summer to obtain 100 million doses of Pfizer’s experimental vaccine with partner BioNTech -- enough for 50 million people, given the two-dose regimen -- and also has agreements in place with Moderna Inc., AstraZeneca Plc, Johnson & Johnson and others.

But only the shots made by Pfizer and Moderna are likely to be cleared by the Food and Drug Administration this month, while the others are still awaiting further trial data and could take months longer to be granted emergency-use authorizations. The U.S. government’s agreement with Moderna is also for 100 million doses, so the two deals would give the country enough supply to vaccinate 100 million people before it would need more from either company or a third provider.

Pfizer offered “multiple times” to reserve an additional allotment of vaccines for the U.S. in the second quarter of 2021, Scott Gottlieb, a Pfizer board member and former FDA commissioner, told CNBC Tuesday. The proposal, which didn’t require an upfront payment, was still available after Pfizer’s initial data showed how highly effective the vaccine was, Gottlieb said. The Washington Post reported Monday that the U.S. could have secured 100 million additional doses of Pfizer’s vaccine.

”I think the government made a bet that they are going to option or advance purchase vaccines from multiple manufacturers,” Gottlieb said. Meanwhile, Pfizer made deals with other governments for the doses it will have ready in the second quarter, he said.

Moderna could provide more doses to the U.S. in the second quarter, or perhaps a limited portion in the first quarter, a spokesperson for the company said Monday.

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