The Medical Letter on Drugs and Therapeutics
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In Brief: Pfizer/BioNTech COVID-19 Vaccine Authorized for Adolescents 12-15 Years Old
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On May 10, 2021, the FDA expanded its Emergency Use Authorization (EUA) for the Pfizer/BioNTech mRNA-based COVID-19 vaccine to include adolescents 12-15 years old.1 The vaccine has been authorized for use in persons ≥16 years old since December 2020.2

Expansion of the EUA was based on the results of an observer-blind trial (summarized in the FDA Fact Sheet) in 2260 adolescents 12-15 years old who were randomized 1:1 to receive the Pfizer/BioNTech vaccine or placebo at 0 and 3 weeks. There were 0 cases of COVID-19 with onset ≥7 days after the second dose among SARS-CoV-2-naive subjects who received the vaccine and 16 cases among those who received placebo. Compared to persons 16-25 years old who received the Pfizer/BioNTech vaccine, vaccinated adolescents 12-15 years old had numerically higher geometric mean titer levels of SARS-CoV-2 neutralizing antibodies (1239.5 vs 705.1) and similar adverse effects.3

With the expansion of the EUA, the FDA has added a warning to the vaccine Fact Sheet describing a risk of syncope following injection; the risk is higher in adolescents than in adults.3 Clinical trials evaluating use of the vaccine in children 6 months to 11 years old are ongoing.4

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