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Review
. 2023 May 1;151(5):e2022060295.
doi: 10.1542/peds.2022-060295.

COVID-19 Vaccine Safety First Year Findings in Adolescents

Elisabeth M Hesse  1 , Anne Hause  1 , Tanya Myers  1 , John R Su  1 , Paige Marquez  1 , Bicheng Zhang  1 , Margaret M Cortese  1 , Andrea Thames-Allen  1 , Christine R Curtis  1 , Susan A Maloney  1 , Deborah Thompson  2 , Narayan Nair  2 , Meghna Alimchandani  2 , Manette Niu  2 , Julianne Gee  1 , David K Shay  1 , Tom T Shimabukuro  1 ; MIS-C REVIEW GROUP
Affiliations
Review

COVID-19 Vaccine Safety First Year Findings in Adolescents

Elisabeth M Hesse et al. Pediatrics. .

Abstract

Background and objectives: The Food and Drug Administration expanded Emergency Use Authorization for use of Pfizer-BioNTech (BNT-162b2) coronavirus disease 2019 vaccine to include people ages 12 years and older on May 10, 2021. We describe adverse events observed during the first full year of the US coronavirus disease 2019 vaccination program for adolescents ages 12 to 17 years.

Methods: We conducted descriptive analyses using data from 2 complementary US vaccine safety monitoring systems: v-safe, a voluntary smartphone-based system that monitors reactions and health impacts, and the Vaccine Adverse Event Reporting System (VAERS), the national spontaneous reporting system. We reviewed reports and calculated adverse event reporting rates using vaccine administration data.

Results: Among 172 032 adolescents ages 12 to 17 years enrolled in v-safe, most reported reactions following BNT-162b2 were mild to moderate, most frequently reported on the day after vaccination, and more common after dose 2. VAERS received 20 240 adverse event reports; 91.5% were nonserious. Among adverse events of interest, we verified 40 cases of multisystem inflammation syndrome in children (1.2 cases per million vaccinations), 34 (85%) of which had evidence of prior severe acute respiratory syndrome coronavirus 2 infection; and 570 cases of myocarditis (17.7 cases per million vaccinations), most of whom (77%) reported symptom resolution at the time of report.

Conclusions: During the first year BNT-162b2 was administered to adolescents ages 12 to 17 years, most reported adverse events were mild and appeared self-limited. Rates of myocarditis were lower than earlier reports. No new serious safety concerns were identified.

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Conflict of interest statement

Conflicts of Interest: No authors have any conflicts of interest to disclose

Figures

FIGURE 1:
FIGURE 1:
Reports of Multisystem Inflammatory Syndrome in Children (MIS-C) made to the Vaccine Adverse Event Reporting System (VAERS), December 14, 2020–May 10, 2022. a Potential reports were those identified by the VAERS search (Supplemental information) and in which the individual’s onset of illness was <90 days after receipt of their last BNT-162b2 COVID-19 vaccine dose. b See Supplemental Information for CDC MIS-C case definition. For this investigation, only SARS-CoV-2 serology results from serum obtained before IVIG administration were used to the meet the serology component; we allowed any prior history of a positive SARS-CoV-2 NAAT or antigen test to meet the NAAT/antigen component (i.e., without a time cut-off); the exposure criterion was not used. c Defined as past or recent positive SARS-CoV-2 NAAT/antigen test, history of past positive NAAT/antigen test, or positive anti-nucleocapsid antibody test on serum obtained before IVIG administration. d Four individuals with an illness after vaccination meeting the CDC MIS-C clinical and inflammatory criteria, a negative anti-nucleocapsid antibody test and negative NAAT test during MIS-C evaluation, and anti-spike antibody test not obtained
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