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The results from a long-term trial of 2,228 youth, measured from seven days through more than four months after the second dose, will form the basis for a planned supplemental application to the Food and Drug Administration (FDA) to expand approval of the vaccine for use in individuals in that age group, the companies said.
The data were collected from November 2020 to September 2021, during the period when the delta variant began infecting large swaths of the U.S. population.
The vaccine is available for individuals ages 12 through 15 under emergency use, which was granted in May.
“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,” Pfizer CEO Albert Bourla said in a statement.
Efficacy was consistently high across gender, race and ethnicity demographics, obesity and comorbidity status, the companies said.
Additionally, there were no serious safety concerns over a follow-up period of at least six months after the second dose of the vaccine.
There were 30 symptomatic infections in the trial, all in the placebo arm.
“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,” Ugur Sahin, the CEO and co-founder of BioNTech, said. “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.