FDA grants approval to Pfizer’s COVID-19 vaccine for ages 16+
The U.S. Food and Drug Administration has approved the first vaccine against the virus that causes COVID-19.
“As the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D.
“We hope this approval can help remove any hesitancy that remains for Missourians that remain unvaccinated. We also expect that this approval will help employers as they continue to take the lead on vaccination,” said Missouri Chamber President and CEO Dan Mehan.
Pfizer, a Missouri Chamber member, begins the manufacturing process for each dose of the vaccine at their facility in Chesterfield, Mo.
Their vaccine was previously being administered under Emergency Use Authorization. To determine full approval, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up data in a larger clinical trial population. Read more about the FDA’s approval protocol and strict measures to determine safety here.