Pfizer Confirms COVID-19 Vaccine Safety, Efficacy in Adolescents

Pfizer and BioNTech recently announced that their COVID-19 vaccine, BNT162b2, was 100 percent effective in adolescents 12 through 15 years of age in a longer-term analysis. 

Researchers also found 30 cases of COVID-19 in the placebo group and no cases in the vaccine group, corresponding to vaccine efficacy of 100 percent. Notably, efficacy was high across all genders, races, and ethnicity demographics. 

The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no serious safety concerns observed in individuals at least six months after the second dose.

“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, CEO and co-founder of BioNTech, said in the announcement. 

“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,” Sahin continued. 

Results from the updated analysis of 2,228 trial participants build on and confirm previous data. In March, Pfizer and BioNTech announced that BNT162b2 was 100 percent effective and elicited robust antibody responses in adolescents with or without prior SARS-CoV-2 infection.

Researchers found 18 cases of COVID-19 in the placebo group versus none in the vaccine group. 

Although overall results exceeded those recorded earlier in vaccinated participants aged 16 to 25 years, the vaccine demonstrated strong immunogenicity in a subset of adolescents one month after the second dose. 

In the earlier analysis, these findings are comparable to geometric mean titers (GMTs) elicited by participants aged 16 to 25 years of age. 

The additional data provide further confidence in BNT162b2’s safety and efficacy, vital as COVID-19 cases in this age group increase and vaccine uptake slows. 

The longer-term follow-up data will form the basis for a planned supplemental FDA biologics license application to expand approval of the vaccine for use in individuals 12 years of age and older.