The USFDA expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include adolescents aged 12 to 15 years. The available safety data to support the EUA in adolescents down to 12 years of age, including 2,260 participants ages 12 through 15 years old enrolled in an ongoing randomized, placebo-controlled clinical trial in the United States. Of these, 1,131 adolescent participants received the vaccine and 1,129 received a saline placebo. More than half of the participants were followed for safety for at least two months following the second dose.
The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted 1-3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever, and joint pain. Except for pain at the injection site, more adolescents reported these side effects after the second dose than after the first dose. The effectiveness data to support the EUA in adolescents down to 12 years of age is based on immunogenicity and analysis of COVID-19 cases. The immune response to the vaccine in 190 participants, 12 through 15 years of age, was compared to the immune response of 170 participants, 16 through 25 years of age. In this analysis, the immune response of adolescents was non-inferior to (at least as good as) the immune response of the older participants.
An analysis of cases of COVID-19 occurring among participants, 12 through 15 years of age, seven days after the second dose was also conducted. In this analysis, among participants without evidence of prior infection with SARS-CoV-2, no cases of COVID-19 occurred among 1,005 vaccine recipients and 16 cases of COVID-19 occurred among 978 placebo recipients; the vaccine was 100% effective in preventing COVID-19.
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