Dec. 10 (UPI) — The Food and Drug Administration’s regulatory vaccines committee on Thursday voted to recommend the COVID-19 vaccine developed by Pfizer and BioNTech for emergency use authorization.
The vote by the FDA Vaccines and Related Biological Products Advisory Committee doesn’t mean the vaccine gets immediate approval by the FDA. That decision will be made at a future time that has yet to be announced.
If the FDA gives its full approval of an EUA, the U.S. Centers for Disease and Control must then give its OK. A CDC advisory committee is scheduled to meet Sunday.
The FDA often follows the guidance by the the VRBPAC and officials said they plan to make their decision quickly.
The advisory committee voted 17-4, with one abstention, in favor of the following language:
“Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh its risks for use in individuals 16 and older?”
The vote concluded an hours-long tele-meeting in which more than a dozen experts discussed the results of Pfizer’s advance trial.
Emergency use authorization is the final step necessary before millions of doses can be shipped to the American public.
The Pfizer-BioNTech coronavirus vaccine, which in late-stage clinical trials showed to have about 95% efficacy, has already been approved for emergency use in Britain and Canada.
