COVID-19 Vaccine Safety in Children Aged 5–11 Years — U.S. November 3–December 19, 2021
Advanced Search
Select up to three search categories and corresponding keywords using the fields to the right. Refer to the Help section for more detailed instructions.

Search our Collections & Repository

For very narrow results

When looking for a specific result

Best used for discovery & interchangable words

Recommended to be used in conjunction with other fields

Dates

to

Document Data
Library
People
Clear All
Clear All

For additional assistance using the Custom Query please check out our Help Page

i

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

Filetype[PDF-275.53 KB]


English
Details Supporting Files You May Also Like

Details:

  • Alternative Title:
    MMWR Morb Mortal Wkly Rep
  • Personal Author:
  • 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.
  • Subjects:
  • Source:
    MMWR Morb Mortal Wkly Rep. 70(5152):1755-1760
  • Pubmed ID:
    34968370
  • Pubmed Central ID:
    PMC8736274
  • Document Type:
    Journal Article
  • Place as Subject:
    U.S.
  • Volume:
    70
  • Issue:
    5152
  • Collection(s):
  • Main Document Checksum:
  • Download URL:
  • File Type:

Supporting Files

More +

You May Also Like

Checkout today's featured content at stacks.cdc.gov