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. 2022 Mar 4;71(9):347-351.
doi: 10.15585/mmwr.mm7109e2.

Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12-17 Years - United States, December 9, 2021-February 20, 2022

Anne M Hause, James Baggs, Paige Marquez, Winston E Abara, Babatunde Olubajo, Tanya R Myers, John R Su, Deborah Thompson, Julianne Gee, Tom T Shimabukuro, David K Shay

Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12-17 Years - United States, December 9, 2021-February 20, 2022

Anne M Hause et al. MMWR Morb Mortal Wkly Rep. .

Abstract

As of February 20, 2022, only BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine has been authorized for use in persons aged 12-17 years in the United States (1). The Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for Pfizer-BioNTech vaccine on December 9, 2021, to authorize a homologous* booster dose for persons aged 16-17 years ≥6 months after receipt of dose 2 (1). On January 3, 2022, authorization was expanded to include persons aged 12-15 years, and for all persons aged ≥12 years, the interval between dose 2 and booster dose was shortened to ≥5 months (1). To characterize the safety of Pfizer-BioNTech booster doses among persons aged 12-17 years (adolescents), CDC reviewed adverse events and health impact assessments during the week after receipt of a homologous Pfizer-BioNTech booster dose reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system managed by CDC and FDA. During December 9, 2021-February 20, 2022, approximately 2.8 million U.S. adolescents received a Pfizer-BioNTech booster dose.† During this period, receipt of 3,418 Pfizer-BioNTech booster doses were reported to v-safe for adolescents. Reactions were reported to v-safe with equal or slightly higher frequency after receipt of a booster dose than after dose 2, were primarily mild to moderate in severity, and were most frequently reported the day after vaccination. VAERS received 914 reports of adverse events after Pfizer-BioNTech booster dose vaccination of adolescents; 837 (91.6%) were nonserious and 77 (8.4%) were serious. Health care providers, parents, and adolescents should be advised that local and systemic reactions are expected among adolescents after homologous Pfizer-BioNTech booster vaccination, and that serious adverse events are rare.

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Conflict of interest statement

All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.

Figures

FIGURE
FIGURE
Adverse reactions and health impacts reported among persons aged 12–17 years (N = 3,274) who received a homologous Pfizer-BioNTech COVID-19 vaccine booster, by vaccine dose — United States, December 9, 2021–February 20, 2022 * Registrants aged ≤15 years must be enrolled by a parent or guardian. The odds of reporting an event after dose 2 and booster dose were compared for registrants who completed at least one v-safe health check-in survey on days 0–7 after each vaccination using a multivariable generalized estimating equations model. This model adjusted for demographic variables and accounted for repeated measures among doses reported by each registrant (needed medical care was not adjusted due to small numbers); p <0.05 was considered statistically significant. All dose 2 and booster dose comparisons were statistically significant, except any systemic reaction and needed medical care.
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