Pfizer Asks FDA for Emergency Use Authorization Of Its Coronavirus Vaccine

Pfizer on Friday said it asked the Food and Drug Administration to grant emergency use authorization for its coronavirus vaccine, The Associated Press reports.

Pfizer and the German-based pharmaceutical firm BioNTech, which first developed the vaccine, announced earlier this week that its large clinical trial found that the vaccine is 95% effective.

The companies said 170 of its thousands of volunteers contracted the virus -- 162 in its placebo group and eight who received the actual vaccine. One of those eight developed a severe illness.

“This is an extraordinarily strong protection,” Dr. Ugur Sahin, BioNTech’s CEO and co-founder, told the AP.

The company, which has not released detailed data from the trial, said the FDA should grant authorization before final testing is complete. The company is also seeking authorization in Europe.

“Our work to deliver a safe and effective vaccine has never been more urgent,” Pfizer CEO Albert Bourla said in a statement.

Pfizer estimates 50 million doses by end of year:

If the vaccine received emergency use authorization, another government agency will still have to decide how to ration out initial supplies.

Pfizer estimates it can deliver 50 million doses by the end of the year.

People will need to get two doses of the vaccine spread out over three weeks.

The vaccine is expected to be reserved for frontline medical workers and high-risk groups like retirement community residents and should be widely available by the spring.

Moderna is also expected to seek authorization for its similar vaccine in the coming weeks.

How does authorization work?

The FDA will review the data from the trial and release an internal analysis ahead of a public meeting in December.

Advisers will then hold a daylong debate to discuss potential safety concerns and any other details like, whether it works as well for older adults as it does for younger people.

Data will be made public at the meeting as well.

The bigger challenge will be distributing it widely enough -- and convincing enough people to take it -- to starve the virus.


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