Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12–17

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.

V-safe is a voluntary, smartphone–based U.S. active safety surveillance system established to monitor adverse events after COVID-19 vaccination (https://vsafe.cdc.gov/en/). The v-safe platform allows current registrants to report receipt of a booster dose of COVID-19 vaccine and new registrants to enter information about all doses received. Registrants aged ≤15 years must be enrolled by a parent or guardian. Health surveys are sent daily during the first week after administration of each dose and include questions about local injection site and systemic reactions and health impacts.^§ CDC’s v-safe call center contacts registrants who indicate that medical care was sought after vaccination and encourages completion of a VAERS report, if indicated.

VAERS is a U.S. national passive vaccine safety surveillance system managed by CDC and FDA that monitors adverse events after vaccination (2). VAERS accepts reports from health care providers, vaccine manufacturers, and members of the public.^¶ VAERS reports are classified as serious if there are any reports of hospitalization, prolongation of hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death.** VAERS staff members assign Medical Dictionary for Regulatory Activities (MedDRA) preferred terms to the signs, symptoms, and diagnostic findings in VAERS reports.^†† Serious reports to VAERS were reviewed by CDC physicians to form a clinical impression based on available data. Reports of myocarditis and pericarditis, rare adverse events that have…