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Pfizer/BioNTech plan to use this data to support submissions for full approval of the vaccine in those 12 to 15 years old.
Results from a longer-term analysis of the safety and efficacy show that Pfizer/BioNTech’s COVID-19 vaccine in adolescents 12 through 15 years of age is 100% effective against COVID-19.
Results from analysis of 2,228 adolescents enrolled in the phase 3 trial confirm previously released data and demonstrate strong protection against COVID-19. Of the 30 confirmed symptomatic cases of COVID-19 in the trial, all were in the placebo group.
This data will form the basis for a planned supplemental biologics license application (sBLA) to expand approval of the vaccine for use in people 12 years and older. The vaccine is currently available this age group under an emergency use authorization, granted by the FDA in May 2021.
“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,” Albert Bourla, chairman and chief executive officer, Pfizer.
Efficacy was consistently high across gender, race and ethnicity demographics, obesity and comorbidity status. Pfizer and BioNTech plan to submit these data for scientific peer review for potential publication.
Adverse events were consistent with other clinical safety data for the vaccine, with no serious safety concerns observed.
Last month, the FDA issued an EUA for the Pfizer/BioNTech COVID-19 vaccine for use in children 5 to 11 years of age. The dose give to this age group is one-third the dose given those over the age of 12.