The data comes from a phase 3 clinical trial involving 2,228 participants. No serious side effects were observed.
“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,” Pfizer CEO Albert Bourla, PhD, said in a statement. “We look forward to sharing these data with the FDA and other regulators.”
Pfizer will use the data to support its planned submission for the vaccine’s full FDA approval for teenage recipients.
The FDA granted emergency use authorization for the vaccine’s use in children ages 12-15 in May. The agency granted full approval for the vaccine’s use in people ages 16 and older in August.
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