US regulators positively review Pfizer COVID-19 vaccine

Grant Boone
January 16, 2021

The order also requires national security officials to co-ordinate an interagency strategy for the implementation of global access to the vaccines within 30 days, provided a "sufficient supply" exists "for all Americans who choose to be vaccinated".

Since then, other countries have signed vaccine deals with Pfizer, so the US may not be able to receive a second major allotment until the summer of 2021, The Washington Post reported.

U.S. President Donald Trump delivers a speech in Valdosta, Georgia, on December 5, 2020, during a rally which he attended for the first time since the November 3 presidential election.

"They say it's somewhat of a miracle and I think that's true", Trump said at the event on Operation Warp Speed, the administration's program for pushing vaccine development.

Watch live above via the White House.

"It's clear that Pfizer made plans with other countries".

The agency released two different analyses on Tuesday - one from its staff scientists and another from the manufacturers of the vaccine, Pfizer Inc. and its German partner BioNTech SE.

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The FDA will also ask the experts to weigh in on what additional studies should be done by the companies to further elucidate the safety and effectiveness of the vaccine after it is available under an EUA.

Just as thousands of Brits were lining up to get Pfizer's mRNA COVID-19 vaccine yesterday, a troubling question emerged in the U.S.: Did the United States government fail to lock in enough doses of the vaccine to ensure a broad and quick rollout here?

U.S. National Security Adviser Robert O'Brien said in a separate statement that a strategy for other nations getting vaccine access will be crafted. "Pfizer, for example, has many manufacturing facilities in Europe as well as the United States".

The new FDA analysis emphasized several "known benefits" from the vaccine - including "reduction in risk of confirmed COVID-19 occurring at least seven days after Dose 2".

He also said he would sign an order on day one to require masks in federal buildings and interstate travel on planes, trains and buses while working with governors and mayors to do the same in their states and cities.

Pfizer had offered 200 million doses in its first contract with the USA -enough to vaccinate 100 million people-but Operation Warp Speed opted for half that amount, added the Washington Post, which also cited anonymous sources.

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