Pfizer and BioNTech announced topline clinical trial results, showing that a two-dose series of the companies’ COVID-19 vaccine was 100% effective in people 12-15 years of age.
The updated findings come from the companies’ pivotal Phase 3 trial, which evaluated the safety and efficacy of the vaccine (30-µg per dose) at seven days through over four months after the second dose.
“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. This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed,” said Albert Bourla, Chairman and Chief Executive Officer of Pfizer.
Based on the data, the companies said they plan to submit an application to the U.S. Food and Drug Administration (FDA) for full approval of the COVID-19 vaccine in people 12 years and older.
The vaccine is currently available for people 12-15 years of age under emergency use authorization (EUA) granted by the FDA in May 2021. The companies said they also plan to submit these data to pursue regulatory approvals for this age group in other countries where emergency use authorizations or equivalents were initially granted.
Results from this analysis of 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 zero cases were in the Pfizer-BioNTech vaccine group, corresponding to vaccine efficacy of 100%.