WEDNESDAY, June 2, 2021 (HealthDay News) -- The BNT162b2 COVID-19 vaccine is safe and effective for adolescents aged 12 to 15 years, according to a study published online May 27 in the New England Journal of Medicine.
Robert W. Frenck Jr., M.D., from Cincinnati Children's Hospital, and colleagues randomly assigned 2,260 adolescents aged 12 to 15 years in a 1:1 ratio to receive two injections, 21 days apart, of BNT162b2 or placebo (1,131 and 1,129, respectively) to examine the safety and effectiveness of the vaccine in this age group.
The researchers found that BNT162b2 had a favorable safety and side-effect profile, with mainly transient mild-to-moderate reactogenicity (primarily injection-site pain [79 to 86 percent of participants], fatigue [60 to 66 percent], and headache [55 to 65 percent]); no vaccine-related serious adverse events were reported, and there were few serious adverse events overall. In 12- to 15-year-olds, relative to 16- to-25-year-olds, the geometric mean ratio of severe acute respiratory syndrome coronavirus 2 50 percent neutralizing titers after dose 2 was 1.76, which met the noninferiority criterion and indicated a greater response among 12- to 15-year-olds. No COVID-19 cases with an onset of seven or more days after dose 2 were noted among BNT162b2 recipients without evidence of previous infection compared with 16 cases among recipients of placebo. Vaccine efficacy was 100 percent.
"A demonstration of efficacy and safety in 12-to-15-year-old adolescents is important in order to expand the emergency use authorization to include children 12 years of age or older and make a critical step toward achieving herd immunity," the authors write.
Several authors disclosed ties to the pharmaceutical industry, including Pfizer and BioNTech, which funded the study.