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COVID-19 Vaccine Safety First Year Findings in Adolescents
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5 01 2023
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Source: Pediatrics. 151(5)
[PDF-267.84 KB]
Details:
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Alternative Title:Pediatrics
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Personal Author:
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Description:Background/Objectives:
The Food and Drug Administration (FDA) expanded Emergency Use Authorization (EUA) for use of Pfizer-BioNTech (BNT-162b2) COVID-19 vaccine to include people ages 12 years and older on May 10, 2021. Early post-authorization safety data were limited, especially for rare outcomes of concern. We describe adverse events observed during the first full year of the U.S. COVID-19 vaccination program for adolescents ages 12–17 years.
Methods:
We conducted descriptive analyses using data from 2 complementary U.S. 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 12–17 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 39 cases of MIS-C (1.2 cases per million vaccinations), 33 (84.6%) of which had evidence of prior SARS-CoV-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 12–17 years, most adverse events reported to v-safe and VAERS 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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Pubmed ID:37082919
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Pubmed Central ID:PMC10262343
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