Pfizer, BioNTech to submit emergency use request to FDA

Pharmaceutical giants Pfizer and BioNTech announced today the companies would submit a request to the U.S. Food and Drug Administration (FDA) for emergency use authorization of their mRNA vaccine candidate, BNT162b2, against SARS-CoV-2, the virus that causes the novel coronavirus (COVID-19).

If the request is granted, the vaccine would be the first in the United States and could potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.

A final efficacy analysis of the vaccine found it is 95 percent effective in preventing infections across patient populations with no serious safety concerns, according to an announcement made earlier this week.

The analysis of the Phase 3 clinical trial of the mRNA-based vaccine candidate, BNT162b2, found a vaccine efficacy rate of 95 percent in participants without prior SARS-CoV-2 infection as well as  participants with and without prior SARS-CoV-2 infection in each case measured from seven days after the second dose, according to the announcement.

The data will also be submitted to other regulatory agencies around the world, the companies said.

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