FDA sets December 10 meeting to discuss Pfizer's vaccine authorization bid

WION Web Team
Washington Published: Nov 21, 2020, 10.24 PM(IST)

Pfizer Vaccine Photograph:( Others )

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 Pfizer had applied to the FDA on Friday for emergency use authorization (EUA) of its coronavirus vaccine after it said the vaccine was 95 per cent effective in preventing the virus with no side effects.

Afer US pharma giant Pfizer submitted its coronavirus vaccine, the US Food and Drug Administration (FDA) said its vaccines committee will meet on December 10 to discuss the request for emergency use authorization.

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"The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines," agency head Stephen Hahn said in a statement, adding," I want to assure the American people that the FDA's process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible."

Pfizer-BioNTech have developed the new vaccine as CEO Albert Bourla said it was a "critical journey" in its bid to combat the virus.

"While we cannot predict how long the FDA's review will take, the FDA will review the request as expeditiously as possible," FDA Commissioner Stephen Hahn said.

Pfizer had applied to the FDA on Friday for emergency use authorization (EUA) of its coronavirus vaccine after it said the vaccine was 95 per cent effective in preventing the virus with no side effects.

It is unclear how long the FDA will take to clear the vaccine, however, reports say it could give its green signal by mid-December.

Pfizer said it expects to produce 50 million vaccine doses this year to administer 25 million people.

CEO Bourla said: "Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine."

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