Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) announce topline results from a longer-term analysis of the safety and efficacy of their COVID-19 vaccine in individuals 12 through 15 years of age.
The updated findings from Phase 3 trial show that a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per dose) was 100% (95% [CI, 87.5, 100.0]) effective against COVID-19, measured seven days through over four months after the second dose.
The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no serious safety concerns observed in individuals with at least 6 months of safety follow-up after the second dose.
These longer-term follow-up data will form the basis for a planned supplemental Biologics License Application (sBLA) to be submitted to the FDA to expand approval of the vaccine for use in individuals 12 years and older.