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FDA to Review New Pfizer Vaccine on December 10

FDA to Review New Pfizer Vaccine on December 10
folder_openUnited States access_time 7 days ago
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By Staff, Agencies

An advisory committee in the US Food and Drug Administration [FDA] will meet on December 10 to study a request filed by pharmaceutical giant Pfizer and its German partner BioNTech regarding their newly developed COVID-19 vaccine.

Pfizer confirmed to have officially filed the request with the FDA on Friday, the first group to do so in the United States or Europe.

"We cannot predict how long the FDA review will last, but we will complete this mission as soon as possible," Agency Commissioner Stephen Hahn said in a statement.

Greeted with massive fanfare, Pfizer's coronavirus vaccine will be scrutinized by the FDA committee over its safety and efficacy and devise a recommendation based on the available scientific data. 

The agency also intends to make information documents, including the agenda for discussions and the list of participants, available to the public ahead of the meeting scheduled for December 10.

The vaccine has been developed with breathtaking speed – just 10 months after the genetic code of the novel coronavirus was first sequenced.

The announcement had been expected for several days, after the companies said that a completed study of trials of the product showed it was 95 percent effective in protecting people from infection. The announcement also confirms what BioNTech's CEO said on Thursday.