The Pfizer vaccine is the first COVID-19 vaccine to be approved by the U.S. Food and Drug Administration as of Aug. 23.
The approval is supported by safety and effectiveness data collected since the vaccine was first approved for emergency use in Dec. 2020. Based on this data, the vaccine had a 91% effectiveness rate across 22,000 evaluated recipients.
Following the approval, the Pfizer vaccine will now be marketed under the name “Comirnaty,” for prevention in individuals 16 years of age and older, as well as for emergency use in individuals 12 to 15 years of age. The emergency stipulations also allow a third dose for immunocompromised individuals.
The FDA still cautions parents against administering Comirnaty to young children. “We do not have data on the proper dose nor do we have full data on the safety in children younger than what is in the EUA,” FDA Commissioner Janet Woodcock explained to CNN in a briefing call following the approval.
The FDA is conducting monitoring systems to address any safety concerns efficiently, assisted by the Centers for Disease Control and Prevention. The FDA is also requiring Pfizer to conduct post-marketing studies to identify and assess any possible further risks.
As for the other two major COVID-19 vaccines, the Moderna vaccine is currently pending FDA approval, while the Johnson & Johnson has yet to be submitted for approval. Both remain available for emergency use.
The FDA hopes that the approval will calm concerns about vaccinations moving forward. “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.,” said Peter Marks, director of the FDA’s Center of Biologics Evaluation and Research, in the press release following the approval.