Pfizer and BioNTech to submit to FDA today for emergency authorization for their coronavirus vaccine
November 20, 2020. Summarized by summa-bot.
Pfizer and BioNTech said they will submit to the US Food and Drug Administration today for an emergency use authorization for their coronavirus vaccine candidate.
(CNN)Pfizer and BioNTech said they will submit to the US Food and Drug Administration today for an emergency use authorization for their coronavirus vaccine candidate.
The companies said in a statement that their vaccine candidate, known as BNT162b2, will potentially be available for use in high-risk populations in the United States by the middle to end of December.
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee, a group of outside experts, for December 8, 9 and 10, a source familiar with the process told CNN this week.
"It will make sense that in all likelihood the FDA will consider both applications together," the source said, considering that both the Pfizer and Moderna vaccines use the same technology and appear to have very similar safety and efficacy results from their large-scale clinical trials.