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Pfizer announced on Monday that its COVID-19 vaccine provided long-term protection against the virus in a late-stage clinical trial among adolescents ages 12-15.
A two-dose series was 100% effective against COVID-19, which was measured between 7 days and 4 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 safety and effectiveness profile in adolescents,” Albert Bourla, PhD, chairman and CEO of Pfizer, said in a statement.
The clinical trial researchers found no serious safety concerns while following patients for 6 months. The adverse events were consistent with other clinical safety data for the vaccine, the company said.
Pfizer will incorporate the data into its submissions for full regulatory approval of the vaccine for ages 12-15 in the U.S. and worldwide.
The company will request clearance for a 30-microgram dose of the vaccines for ages 12 and older. The shot received FDA emergency use authorization for ages 12-15 in May and full approval for ages 16 and older in August.
The study included 2,228 clinical trial participants who were monitored between November 2020 and September 2021. There were 30 confirmed symptomatic cases of COVID-19 in the placebo group that didn’t receive the vaccine and zero COVID-19 cases among the vaccinated group.
The efficacy was consistently high across gender, race, ethnicity, and health conditions, the company said.
“This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed,” Bourla said. “We look forward to sharing these data with the FDA and other regulators.”
Pfizer: “Follow-Up Data From Phase 3 Trial of Pfizer-BioNTech COVID-19 Vaccine Support Safety and High Efficacy in Adolescents 12 Through 15 Years of Age.”