Voting today that “the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh its risks for use in individuals 16 years of age and older,” the FDA’s Vaccines and Related Biological Products Advisory Committee pushed emergency use of the vaccine over a major hurdle.
The next step is a review by FDA career staff, who will also “refine the instructions for use and the informational materials to be provided to those receiving the vaccine,” the FDA said. Following that comes a review by the CDC’s Advisory Committee on Immunization Practices, scheduled for Friday, December 11.
Although the FDA said it would move “as quickly as possible,” it did not estimate when the vaccine might be released to the states. Read more.