COVID-19 Vaccine Safety in Children Aged 5–11 Years — U.S. November 3–December 19, 2021
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COVID-19 Vaccine Safety in Children Aged 5–11 Years — U.S. November 3–December 19, 2021

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    MMWR Morb Mortal Wkly Rep
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    On October 29, 2021, the Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 (BNT162b2) mRNA vaccine to expand its use to children aged 5-11 years, administered as 2 doses (10 μg, 0.2mL each) 3 weeks apart (1). As of December 19, 2021, only the Pfizer-BioNTech COVID-19 Vaccine is authorized for administration to children aged 5-17 years (2,3). In preauthorization clinical trials, Pfizer-BioNTech COVID-19 Vaccine was administered to 3,109 children aged 5-11 years; most adverse events were mild to moderate, and no serious adverse events related to vaccination were reported (4). To further characterize safety of the vaccine in children aged 5-11 years, CDC reviewed adverse events after receipt of Pfizer-BioNTech COVID-19 Vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety Surveillance system co-managed by CDC and FDA, and adverse events and health impact assessments reported to v-safe, a voluntary smartphone-based safety Surveillance system for adverse events after COVID-19 vaccination,* during November 3-December 19, 2021. Approximately 8.7 million doses of Pfizer-BioNTech COVID-19 Vaccine were administered to children aged 5-11 years| during this period; VAERS received 4,249 reports of adverse events after vaccination with Pfizer-BioNTech COVID-19 Vaccine in this age group, 4,149 (97.6%) of which were not serious. Approximately 42,504 children aged 5-11 years were enrolled in v-safe after vaccination with Pfizer-BioNTech COVID-19 Vaccine; after dose 2, a total of 17,180 (57.5%) local and 12,223 systemic (40.9%) reactions (including injection-site pain, fatigue, or headache) were reported. The preliminary safety findings are similar to those from preauthorization clinical trials (4,5). The Advisory Committee on Immunization Practices (ACIP) recommends the Pfizer-BioNTech COVID-19 Vaccine for children aged 5-11 years for the Prevention of COVID-19 (6). Parents and guardians of children aged 5-11 years vaccinated with Pfizer-BioNTech COVID-19 Vaccine should be advised that local and systemic reactions are expected after vaccination. Vaccination is the most effective way to prevent COVID-19. CDC and FDA will continue to monitor vaccine safety and will provide updates as needed to guide COVID-19 vaccination recommendations.
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