Pfizer and BioNTech COVID-19 vaccine positive results in adolescents
Pfizer and BioNTech’s two-dose novel coronavirus (COVID-19) vaccine showed 100 percent efficacy and robust antibody responses in adolescents ages 12 to 15 years old, according to a statement released by the company earlier today.
The results come from a phase 3 trial including 2,260 adolescents ages 12 to 15 years old in the United States. In the trial, 18 cases of COVID-19 were observed in the placebo group versus none in the vaccinated group. The vaccination elicited SARS-CoV-2–neutralizing antibody geometric mean titers (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. The efficacy results exceed those recorded earlier in vaccinated participants ages 16 to 25 years old, which elicited 705.1 GMTs, the company said.
Overall, the vaccine well tolerated by the 12 to 15 years of age group, with side effects generally consistent with those observed in participants 16 to 25 years of age, the statement said. All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Company representatives said they plan to submit the data to the U.S. Food and Drug Administration, requesting expanded emergency use authorization for its vaccine candidate.
Last week, Pfizer and BioNTech dosed the first healthy children in a global study to further evaluate the safety, tolerability, and immunogenicity of its vaccine on a two-dose scheduke in children 6 months to 11 years old. The study includes three age groups, children ages 5 to 11 years old, 2 to 5 years old, and 6 months to 2 years old. The 5 to 11 years old cohort started dosing last week and the companies plan to initiate the 2 to 5 years old cohort next week.