Pfizer and BioNTech have submitted a supplemental Biologics License Application to the Food and Drug Administration (FDA) for Comirnaty (COVID-19 vaccine, mRNA) to include individuals 12 to 15 years of age for active immunization to prevent COVID-19.
The application is supported by data from a randomized, placebo-controlled phase 3 trial which included 2228 participants 12 to 15 years of age enrolled in the United States. Participants were randomly assigned to receive either a 2-dose series (30µg per dose) of the Pfizer-BioNTech COVID-19 vaccine (n=1131) or placebo (n=1129).
Findings from data collected between November 2020 and September 2021 showed that the vaccine was 100% effective (95% CI, 87.5-100.0) against COVID-19, measured 7 days through over 4 months after the second dose. There were 30 confirmed symptomatic cases of COVID-19 reported in the placebo group and 0 cases in the vaccine group.
The safety profile of the vaccine was consistent with that reported in other clinical safety data. There were no serious safety concerns observed in participants with at least 6 months of safety follow-up after the second dose.
- A 2-dose primary series to individuals 5 years of age and older.
- A third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.
- A single booster dose to individuals 16 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 vaccine or Comirnaty.
- A single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine.
Pfizer and BioNTech submit supplemental Biologics License Application for US FDA approval of Comirnaty® in adolescents 12 through 15 years of age. News release. Pfizer Inc. and BioNTech SE. December 16, 2021. Accessed December 17, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-supplemental-biologics-license.