Pfizer, BioNTech gain after saying they'll submit their COVID-19 vaccine to the FDA for emergency approval

Pfizer, BioNTech gain after saying they'll submit their COVID-19 vaccine to the FDA for emergency approval
Dogukan Keskinkilic/Anadolu Agency via Getty Images
  • Pfizer and BioNTech gained on Friday after saying they would submit their COVID-19 vaccine candidate to the FDA today for Emergency Use Authorization.
  • The submission will potentially enable use of the vaccine in high-risk populations in the US by the middle to end of December, the companies said.
  • The companies will be ready to distribute the vaccine within hours after authorization and expect to produce up to 50 million doses of its vaccine in 2020, and 1.3 billion doses by the end of 2021.
  • Visit Business Insider's homepage for more stories.

Pfizer and BioNTech gained on Friday after saying they would submit their COVID-19 vaccine candidate to the FDA today for Emergency Use Authorization.

Phase III trial results released earlier this month were encouraging, with the vaccine demonstrating an efficacy rate of 95% in a trial with 44,000 participants.

Pfizer rose as much as 3%, while BioNTech surged 8% at Friday intraday highs.
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The emergency submission will potentially enable use of the vaccine in high-risk populations in the US by the middle to end of December, and Pfizer will be ready to distribute the vaccine within hours of authorization, the companies said.

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On top of today's planned FDA submission, Pfizer and BioNTech have already initiated rolling submissions with a number of regulatory agencies around the world.
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As Pfizer continues to scale up its manufacturing capabilities for the vaccine, the company expects to produce up to 50 million doses in 2020, and up to 1.3 billion doses in 2021.

The companies "believe in their capability to distribute the vaccine globally upon approval or authorization," they said. Shares of Pfizer are down 3% year-to-date, while BioNTech is up 180% year-to-date.
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