Pfizer and BioNTech’s says COVID-19 vaccine was 100 percent effective in protecting adolescents between the ages of 12 and 15 four months after the second dose.
The updated analysis of the Phase 3 clinical trial in children from 12 through 15 years of age was collected from November 2020 to September 2021.
Results from the 2,228 trial participants build upon and confirm previously released data and demonstrate strong protection against COVID-19. From the 30 confirmed symptomatic cases of COVID-19 in the trial with and without evidence of prior infection with SARS-CoV-2, 30 cases of COVID-19 were in the placebo group and 0 cases were in the Pfizer-BioNTech vaccine group, corresponding to a vaccine efficacy of 100%.
Pfizer says that the effectiveness was consistently high across gender, race and ethnicity demographics, obesity and comorbidity status.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.
“These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a COVID-19 vaccine in individuals 12 through 15 years of age,” said Ugur Sahin, CEO and Co-founder of BioNTech. “The growing body of data we have compiled from clinical trials and real-world surveillance to date strengthen the base of evidence supporting the strong efficacy and favorable safety profile of our COVID-19 vaccine across adolescent and adult populations.”
The companies said that the new data will help support their application for full worldwide approval.