Safety of COVID-19 Vaccination in United States Children Ages 5 to 11 Years.
Pediatrics
; 150(2)2022 08 01.
Article
in English
| MEDLINE | ID: covidwho-1974395
ABSTRACT
BACKGROUND AND OBJECTIVES:
Limited postauthorization safety data for the Pfizer-BioNTech coronavirus disease 2019 vaccination among children ages 5 to 11 years are available, particularly for the adverse event myocarditis, which has been detected in adolescents and young adults. We describe adverse events observed during the first 4 months of the United States coronavirus disease 2019 vaccination program in this age group.METHODS:
We analyzed data from 3 United States safety monitoring systems v-safe, a voluntary smartphone-based system that monitors reactions and health effects; the Vaccine Adverse Events Reporting System (VAERS), the national spontaneous reporting system comanaged by the Centers for Disease Control and Prevention and Food and Drug Administration; and the Vaccine Safety Datalink, an active surveillance system that monitors electronic health records for prespecified events, including myocarditis.RESULTS:
Among 48 795 children ages 5 to 11 years enrolled in v-safe, most reported reactions were mild-to-moderate, most frequently reported the day after vaccination, and were more common after dose 2. VAERS received 7578 adverse event reports; 97% were nonserious. On review of 194 serious VAERS reports, 15 myocarditis cases were verified; 8 occurred in boys after dose 2 (reporting rate 2.2 per million doses). In the Vaccine Safety Datalink, no safety signals were detected in weekly sequential monitoring after administration of 726 820 doses.CONCLUSIONS:
Safety findings for Pfizer-BioNTech vaccine from 3 United States monitoring systems in children ages 5 to 11 years show that most reported adverse events were mild and no safety signals were observed in active surveillance. VAERS reporting rates of myocarditis after dose 2 in this age group were substantially lower than those observed among adolescents ages 12 to 15 years.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
COVID-19 Vaccines
/
COVID-19
/
Myocarditis
Type of study:
Observational study
Topics:
Vaccines
Limits:
Adolescent
/
Adult
/
Child
/
Child, preschool
/
Humans
/
Male
/
Young adult
Country/Region as subject:
North America
Language:
English
Year:
2022
Document Type:
Article
Affiliation country:
Peds.2022-057313
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