Last week, the U.S. Food and Drug Administration (FDA) approved Pfizer and BioNTech’s supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, Comirnaty, for 12–15-year-olds.
Previously, the regulatory agency issued emergency use authorization (EUA) for the vaccine’s use in this age range. Over 9 million teenagers have received the original immunization regimen.
Comirnaty is the first COVID-19 vaccine to be approved by the FDA for use in adolescents.
The approval is based on a clinical trial that included 2,260 teenagers who received the two-shot messenger RNA vaccine, the companies explained. The vaccination induced an immunological response that was comparable to the results of earlier research in young people aged 16 to 25. Based on the results of the trial with teenagers, the second dose of the vaccine prevented COVID-19 infection 100 percent of the time between one week and more than four months after the second dose.
These results were also sent to the European Medicines Agency (EMA) and other regulatory agencies around the world.
Because the analysis was completed between November 2020 and May 2021, before the Delta and Omicron surges, the only SARS-CoV-2 variation of concern discovered from verified COVID-19 patients in this age range was Alpha, the companies said.
There were no occurrences of serious illness in either the COMIRNATY or placebo groups. The adverse event profile was largely similar to other clinical data for the vaccine, with a positive safety profile reported after the second dosage and after 6 months of safety follow-up data.