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COVID-19 vaccination was approved for U.S. children (age range, 5–11 years) in October 2021. Investigators analyzed three major vaccine adverse-event (AE) monitoring systems to evaluate outcomes.
v-safe (voluntary reporting via smartphone): Among almost 50,000 children, the most common AEs within 7 days after dose 1 were injection site reactions (55%); systemic reactions (35%; most commonly, fatigue and headache); and any health effect (11%; most commonly, unable to attend school). The most serious AE was hospitalization in 0.02% of recipients. All AE rates increased slightly after dose 2, except for hospitalization (0%).
Vaccine Adverse Events Reporting System (VAERS; voluntary reporting to U.S. FDA and CDC): Of 7400 nonserious reports, the most common were vaccine administration errors. Of 194 serious reports, multisystem inflammatory syndrome in children (MIS-C; 13%), seizure (11%), and myocarditis (10%) were most common. Myocarditis was verified in 2.2 cases per 1 million doses (for comparison, the rate in 12- to 15-year-old males is 45.7 per 1 million doses).
Vaccine Safety Datalink (health record surveillance): Among 889,000 children, serious AEs within 21 days of vaccination included 7 potential cases of myocarditis and 5 potential cases of MIS-C.
Hause AM et al. Safety of COVID-19 vaccination in United States children ages 5 to 11 years. Pediatrics 2022 Jul 14; [e-pub]. (https://doi.org/10.1542/peds.2022-057313)
Comment
Although these three reporting systems capture different types of data, the findings converge on a common message: Serious AEs after COVID-19 vaccination are exceedingly rare among children 5 to 11 years of age. This favorable safety profile should be presented during the shared decision-making process with parents about COVID-19 vaccination.