ISSUE1625
- Mark Abramowicz, M.D., President: no disclosure or potential conflict of interest to report
- Jean-Marie Pflomm, Pharm.D., Editor in Chief: no disclosure or potential conflict of interest to report
- Brinda M. Shah, Pharm.D., Consulting Editor: no disclosure or potential conflict of interest to report
- Michael Viscusi, Pharm.D., Associate Editor: no disclosure or potential conflict of interest to report
- Review the efficacy and safety of the Pfizer/BioNTech mRNA-based COVID-19 vaccine in adolescents 12-15 years old.
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
- FDA News Release. Coronavirus (COVID-19) update: FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic. May 10, 2021. Available at: https://bit.ly/3y4KYhO. Accessed May 11, 2021.
- FDA authorizes Pfizer-BioNTech COVID-19 vaccine. Med Lett Drugs Ther 2021; 63:1.
- FDA. Fact sheet for health care providers administering vaccine (vaccination providers). Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). Available at: https://bit.ly/37fX1NG. Accessed May 11, 2021.
- Pfizer Press Release. Pfizer-BioNTech announce positive top-line results of pivotal COVID-19 vaccine study in adolescents. March 31, 2021. Available at: https://bit.ly/3h3i1MT. Accessed May 11, 2021.
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