(The Hill) – Pfizer and BioNTech’s COVID-19 vaccine was 100% effective in protecting teens between the ages of 12 and 15, the companies said on Monday.
The results of a long-term trial of 2,228 young people, measured from seven days to over four months after the second dose, will form the basis of a planned additional request to the Food and Drug Administration (FDA) to expand the vaccine approval. for use in people in this age group, the companies said.
The data was collected from November 2020 to September 2021, during the time when the delta variant began to infect large swathes of the American population.
The vaccine is available to people ages 12 to 15 for emergency use, which was granted in May.
“As the global health community strives to increase the number of people vaccinated globally, this additional data strengthens confidence in the safety and efficacy profile of our vaccine in adolescents,” said Albert Bourla, CEO of Pfizer, in a statement.
Efficacy was consistently high based on gender, race and ethnicity, obesity and comorbid status, the companies said.
In addition, there were no serious safety concerns during 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 long-term data demonstrating the safety and efficacy of a COVID-19 vaccine in individuals aged 12 to 15,” said Ugur Sahin, CEO and co-founder of BioNTech. “The growing body of data that we have compiled from clinical trials and real-world surveillance to date strengthens the evidence base supporting the high efficacy and favorable safety profile of our COVID-19 vaccine in adolescent and adult populations.
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