An updated analysis of the phase 3 trial evaluating the Pfizer-BioNTech COVID-19 vaccine in adolescents 12 to 15 years of age continues to demonstrate the safety and efficacy of the vaccine in this patient population.
The randomized, placebo-controlled trial included adolescent participants 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 or placebo.
Findings from data collected between November 2020 and September 2021 showed that among 2228 participants, 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.
The updated data will be submitted to the Food and Drug Administration (FDA) to form the basis for approval of the vaccine in individuals 12 years of age and older. The vaccine is currently authorized for emergency use in individuals 12 to 15 years of age.
“As the global health community works to increase the number of vaccinated people around the world, these additional data provide further confidence in our vaccine’s safety and effectiveness profile in adolescents,” said Albert Bourla, Chairman and CEO, Pfizer. “This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed.”
Follow-up data from phase 3 trial of Pfizer-BioNTech COVID-19 vaccine support safety and high efficacy in adolescents 12 through 15 years of age. News release. Pfizer Inc. and BioNTech SE. Accessed November 22, 2021. https://www.businesswire.com/news/home/20211122005249/en/Follow-Up-Data-From-Phase-3-Trial-of-Pfizer-BioNTech-COVID-19-Vaccine-Support-Safety-and-High-Efficacy-in-Adolescents-12-Through-15-Years-of-Age.