Details:

Alternative Title:
MMWR Morb Mortal Wkly Rep
Publisher's site:
http://dx.doi.org/10.15585/mmwr.mm705152a1
Personal Author:
Hause, Anne M. ; Baggs, James ; Marquez, Paige ; Myers, Tanya R. ; Gee, Julianne ; ... More +
Hause, Anne M. ; Baggs, James ; Marquez, Paige ; Myers, Tanya R. ; Gee, Julianne ; Su, John R. ; Zhang, Bicheng ; Thompson, Deborah ; Shimabukuro, Tom T. ; Shay, David K. ; Less -
Description:
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.
Subject:
[+]
Child
Child, Preschool
Coronavirus Infections
COVID-19 Vaccines
Female
Humans
Male

Source:
MMWR Morb Mortal Wkly Rep. 70(5152):1755-1760 ;
Pubmed ID:
34968370
Pubmed Central ID:
PMC8736274
Document Type:
Journal Article ;
Place as Subject:
United States ;
Collection(s):
Morbidity and Mortality Weekly Report (MMWR)
Main Document Checksum:
[+]
urn:sha256:0629c9267d21bfe2ac8d25b06667cfc5b344e8659c8c4980bfb1939df49ea7bb
File Type:

Supporting Files

• mm705152a1.nxml

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