The U.S. Food and Drug Administration issued its full approval Monday of the Pfizer-BioNTech COVID-19 vaccine, marking the first approval of a COVID vaccine outside of its emergency use authorization.
An FDA advisory panel issued the approval for people age 16 and up based on clinical trial and follow-up data on the vaccine’s effectiveness from roughly 20,000 vaccine and 20,000 placebo recipients age 16 and older.
The FDA also analyzed safety data from roughly 22,000 people who received the vaccine and 22,000 people who received a placebo. The trial data found that the vaccine was 91 percent effective at preventing COVID-19 disease, according to the FDA.
Acting FDA Commissioner Dr. Janet Woodcock called the approval a “milestone” in the ongoing pandemic.
“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, 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,” she said in a statement.
The Pfizer vaccine will now be marketed as Comirnaty, according to the FDA, and will continue to be available to people ages 12 to 15 under the FDA’s emergency use authorization.
The FDA is expected to issue a subsequent approval for the vaccine developed by Moderna in the coming weeks, while Johnson & Johnson is expected to apply soon for approval of the one-dose vaccine developed by its pharmaceutical subsidiary Janssen.
In California, state officials celebrated the Pfizer vaccine’s approval and urged people to get vaccinated if they have yet to do so to drastically reduce the likelihood of developing serious illness or dying from COVID-19.
“We know the vaccines work. We know vaccines are safe. We know they save lives,” California Department of Public Health Director and state Public Health Officer Dr. Tomas Aragon said in a statement. “If you are not vaccinated, let this be the milestone that gets you there.”
The FDA issued its original emergency use authorization for the Pfizer vaccine Dec. 11, 2020, for people age 16 and up. In May, it expanded that authorization to children ages 12 to 15.
While some 362 million vaccine doses have been administered in the U.S. and more than 200 million Americans have gotten at least one vaccine dose, state and local officials expressed optimism that the FDA’s full approval will spur more people to get vaccinated in the coming weeks.
“We hope this FDA approval removes another barrier for vaccine-hesitant members of our community to protect themselves and their loved ones,” Santa Cruz County Health Officer Dr. Gail Newel said. “The Delta variant is significantly impacting our unvaccinated population, and these vaccines, along with wearing face coverings in public, are the best tools we have to protect ourselves.”
In California, just over 46 million vaccine doses have been administered to roughly 25 million residents. Last week, FDA advisors and state officials also issued their respective approvals of booster vaccine doses for immunocompromised people who received the two-dose Pfizer and Moderna vaccines.
“I encourage all Californians to trust the science and protect themselves and their community by getting vaccinated,” Gov. Gavin Newsom said in a statement. “With more than 80 percent of Californians 18 and up having received at least one dose, our work continues to close the gap in our most impacted communities and bring an end to this pandemic.”