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COVID-19 Vaccine Safety in Children Aged 5-11 Years - United States, November 3-December 19, 2021.
MMWR Morb Mortal Wkly Rep. 2021 Dec 31; 70(5152):1755-1760.MM

Abstract

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.

Authors

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Pub Type(s)

Journal Article

Language

eng

PubMed ID

34968370

Citation

Hause, Anne M., et al. "COVID-19 Vaccine Safety in Children Aged 5-11 Years - United States, November 3-December 19, 2021." MMWR. Morbidity and Mortality Weekly Report, vol. 70, no. 5152, 2021, pp. 1755-1760.
Hause AM, Baggs J, Marquez P, et al. COVID-19 Vaccine Safety in Children Aged 5-11 Years - United States, November 3-December 19, 2021. MMWR Morb Mortal Wkly Rep. 2021;70(5152):1755-1760.
Hause, A. M., Baggs, J., Marquez, P., Myers, T. R., Gee, J., Su, J. R., Zhang, B., Thompson, D., Shimabukuro, T. T., & Shay, D. K. (2021). COVID-19 Vaccine Safety in Children Aged 5-11 Years - United States, November 3-December 19, 2021. MMWR. Morbidity and Mortality Weekly Report, 70(5152), 1755-1760. https://doi.org/10.15585/mmwr.mm705152a1
Hause AM, et al. COVID-19 Vaccine Safety in Children Aged 5-11 Years - United States, November 3-December 19, 2021. MMWR Morb Mortal Wkly Rep. 2021 Dec 31;70(5152):1755-1760. PubMed PMID: 34968370.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - COVID-19 Vaccine Safety in Children Aged 5-11 Years - United States, November 3-December 19, 2021. AU - Hause,Anne M, AU - Baggs,James, AU - Marquez,Paige, AU - Myers,Tanya R, AU - Gee,Julianne, AU - Su,John R, AU - Zhang,Bicheng, AU - Thompson,Deborah, AU - Shimabukuro,Tom T, AU - Shay,David K, Y1 - 2021/12/31/ PY - 2021/12/30/entrez PY - 2021/12/31/pubmed PY - 2022/1/8/medline SP - 1755 EP - 1760 JF - MMWR. Morbidity and mortality weekly report JO - MMWR Morb Mortal Wkly Rep VL - 70 IS - 5152 N2 - 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. SN - 1545-861X UR - https://www.unboundmedicine.com/medline/citation/34968370/COVID_19_Vaccine_Safety_in_Children_Aged_5_11_Years___United_States_November_3_December_19_2021_ L2 - https://doi.org/10.15585/mmwr.mm705152a1 DB - PRIME DP - Unbound Medicine ER -