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 vaccine is the first to gain 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, 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 and BioNTech submitted their application in May, and Moderna followed shortly afterwards for its COVID-19 vaccine in June. The approval process can take months, as FDA scientists review all of the clinical trial data for any safety issues or discrepancies. Johnson & Johnson is expected to file its approval application later this year.
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 approval will convince public and private entities that were reluctant to put vaccine mandates in effect. 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.
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 amidst 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.