Pfizer Vaccine Gets Full FDA Approval

The FDA formally approved the two-dose Pfizer-BioNTech COVID-19 vaccine for people 16 and over on Monday, opening the door for more vaccine mandates across the country.

Pfizer’s shot is the first COVID-19 vaccine to gain full FDA approval. Previously, the regulatory agency had allowed the shots to be administered under an emergency use authorization, a mechanism used during public health emergencies that requires companies to show that the vaccine is safe and effective, and that there is no available alternative. After an EUA is issued, vaccine manufacturers must continue collecting data on safety issues and monitor the vaccine’s efficacy over time in order to apply for FDA approval.

Pfizer submitted its application in May, and Moderna followed shortly afterward for its COVID-19 vaccine in June. Johnson & Johnson is expected to file its approval application later this year. FDA scientists reviewed hundreds of thousands of pages of clinical trial data to assess the safety, efficacy, and manufacturing quality of Pfizer’s vaccine ahead of Monday’s approval.

Pfizer’s vaccine will continue to be available under an emergency use authorization for kids aged 12 to 15 while the company continues to run clinical trials for those age groups.

More than 204 million doses of Pfizer’s COVID-19 vaccine have so far been administered in the US.

With the approval, health officials are optimistic that more schools, hospitals, and businesses will begin issuing vaccine mandates. While in July the Department of Justice’s Office of Legal Counsel issued an opinion arguing that it was legal to require vaccines with EUAs, it’s likely the FDA’s approval will convince public and private entities that were reluctant to put vaccine mandates in effect.

Shortly after the FDA’s announcement on Monday, New York City Mayor Bill de Blasio said he would be requiring all staff in the city’s public schools to be vaccinated. “We know this is going to help ensure that everyone is safe,” de Blasio said, noting that everyone would be required to have a single dose of the vaccine by Sept. 27, shortly after the start of the school year.

“This is a game-changing moment. We’ve been waiting for this for a long time,” de Blasio said of the FDA’s approval of Pfizer’s vaccine. “This helps us move forward.”

Health experts are also hoping the move will help sway some people who were hesitant to get a vaccine without full approval from the FDA.

“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,” acting FDA Commissioner Janet Woodcock said in a statement on Monday. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”

The move comes one week after a recommendation from top US health officials that booster shots be made available to most Americans starting in September amid concerns about waning immunity in the face of the highly contagious Delta variant. The recommendation was criticized by some scientists who said the available data did not suggest that boosters were needed, since the vaccines are still highly effective at preventing severe illness, hospitalizations, and deaths.

Pfizer’s application for approval was based on clinical trial data from 20,000 people 16 and over who got the vaccine and 20,000 who received placebo shots. More than half of the clinical trial participants were monitored for safety issues at least four months after the second dose. Approximately 12,000 vaccine recipients were followed for at least six months.

Matt Berman contributed reporting for this story.