The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5–11 Years — United States, November 2021

Details

• Journal Article:
  Morbidity and Mortality Weekly Report (MMWR)
• Personal Author:
  Woodworth, Kate R. ; Moulia, Danielle ; Collins, Jennifer P. ; Hadler, Stephen C. ; Jones, Jefferson M. ; Reddy, Sujan C. ; Chamberland, Mary ; Campos-Outcalt, Doug ; Morgan, Rebecca L. ; Brooks, Oliver ; Talbot, H. Keipp ; Lee, Grace M. ; Bell, Beth P. ; Daley, Matthew F. ; Mbaeyi, Sarah ; Dooling, Kathleen ; Oliver, Sara E.
• Description:
  The Pfizer-BioNTech COVID-19 (BNT162b2) vaccine is a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the Virus that causes COVID-19. On August 23, 2021, the Food and Drug Administration (FDA) approved a Biologics License Application (BLA) for use of the Pfizer-BioNTech COVID-19 Vaccine, marketed as Comirnaty (Pfizer, Inc.), in persons aged ≥16 years (1). The Pfizer-BioNTech COVID-19 Vaccine is also recommended for adolescents aged 12-15 years under an Emergency Use Authorization (EUA) (1). All persons aged ≥12 years are recommended to receive 2 doses (30 μg, 0.3 mL each), administered 3 weeks apart (2,3). As of November 2, 2021, approximately 248 million doses of the Pfizer-BioNTech COVID-19 Vaccine had been administered to persons aged ≥12 years in the U.S.* On October 29, 2021, FDA issued an EUA amendment for a new formulation of Pfizer-BioNTech COVID-19 Vaccine for use in children aged 5-11 years, administered as 2 doses (10 μg, 0.2 mL each), 3 weeks apart (Table) (1). On November 2, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation| for use of the Pfizer-BioNTech COVID-19 Vaccine in children aged 5-11 years for the Prevention of COVID-19. To guide its deliberations regarding Rec.for the vaccine, ACIP used the Evidence to Recommendation (EtR) Framework| and incorporated a Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.| The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 Vaccine in children aged 5-11 years under an EUA is interim and will be updated as additional information becomes available. The Pfizer-BioNTech COVID-19 Vaccine has high efficacy (>90%) against COVID-19 in children aged 5-11 years, and ACIP determined benefits outweigh risks for vaccination. Vaccination is important to protect children against COVID-19 and reduce community Transmission of SARS-CoV-2.
• Subjects:
  Advisory Committees Child CoronaVirus Infections COVID-19 COVID-19 Vaccines Drug Approval Humans Immunization Immunization Schedule Practice Guidelines As Topic
• Source:
  MMWR Morbidity Mortal Weekly Rep. 70(45):1579-1583
• Series:
  Weekly Report: Morbidity and Mortality Weekly Report (MMWR)
• DOI:
  http://dx.doi.org/10.15585/MMWRmm7045e1
• ISSN:
  0149-2195 (print) ; 1545-861X (digital)
• Pubmed ID:
  34758012
• Pubmed Central ID:
  PMC8580204
• Document Type:
  Journal Article
• Place as Subject:
  United States
• Pages in Document:
  5 pdf pages
• Volume:
  70
• Issue:
  45
• Collection(s):
  Morbidity and Mortality Weekly Report (MMWR)
• Main Document Checksum:
  urn:sha-512:29d73cbc2e7ffe894744c53a3a389cf9cee2b420d4ab374cc04fa948039964b9465a434517f10f4226fba1a8d85373ccc1063537d09b1c2c23848eb230648664
• Download URL:
  https://stacks.cdc.gov/view/cdc/111856/cdc_111856_DS1.pdf
• File Type:
  [PDF - 216.11 KB ]