MMWR Morbidity and Mortality Weekly Report · 2021 · 175 citations · 5 references
MedicineChild HealthPediatricsImmunizationPediatric Infectious DiseasesVaccinologyAdverse Events Following ImmunizationClinical Vaccine TrialsPediatric ImmunizationVaccinationVaccine SafetyVaccine Safety SurveillanceEmergency AuthorizationPediatric VaccinationPediatric Vaccine Safety SurveillancePediatric Vaccine TrialsSerious Adverse EventsVaccine Safety In InfantsVaccine Safety ReportingVaccine-associated Adverse Event
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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Julia W. Gargano, Megan Wallace, Stephen C. Hadler et al. · MMWR Morbidity and Mortality Weekly Report · 2021 · 602 citations · Full text
Kate R. Woodworth, Danielle Moulia, Jennifer P. Collins et al. · MMWR Morbidity and Mortality Weekly Report · 2021 · 172 citations · Full text