The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine — United States, December 2020 School Year

Details

• Personal Author:
  Oliver, Sara E. ; Gargano, Julia W. ; Marin, Mona ; Wallace, Megan ; Curran, Kathryn G. ; Chamberland, Mary ; McClung, Nancy ; Campos-Outcalt, Doug ; Morgan, Rebecca L. ; Mbaeyi, Sarah ; Romero, José R. ; Talbot, H. Keipp ; Lee, Grace M. ; Bell, Beth P. ; Dooling, Kathleen
  More +
• Corporate Authors:
  United States. Advisory Committee on Immunization Practices. ; CDC COVID-19 Response Team. ; Centers for Disease Control and Prevention (U.S.). Epidemic Intelligence Service. ; General Dynamics Information Technology. ; University of Arizona College of Medicine. ; McMaster University. Faculty of Health Sciences. Department of Health Research Methods, Evidence, and Impact. ; Arkansas. Department of Health. ; Vanderbilt University School of Medicine. ; Stanford University School of Medicine. ; University of Washington.
• Description:
  What is already known about this topic? On December 11, 2020, the Food and Drug Administration issued an Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine. ; What is added by this report? On December 12, 2020, after an explicit, evidence-based review of all available data, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19. ; What are the implications for public health practice? The recommendation for the Pfizer-BioNTech COVID-19 vaccine should be implemented in conjunction with ACIP’s interim recommendation for allocating initial supplies of COVID-19 vaccines. ; On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine (Pfizer, Inc; Philadelphia, Pennsylvania), a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 doses (30 μg, 0.3 mL each) administered intramuscularly, 3 weeks apart. On December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework,† using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.§ The recommendation for the Pfizer-BioNTech COVID-19 vaccine should be implemented in conjunction with ACIP’s interim recommendation for allocating initial supplies of COVID-19 vaccines (2). The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available. ; Since June 2020, ACIP has convened nine public meetings to review data on the epidemiology of COVID-19 and the potential use of COVID-19 vaccines, including the Pfizer-BioNTech COVID-19 vaccine (3). Within the EtR Framework, ACIP considered the importance of the public health problem of COVID-19, as well as issues of resource use, benefits and harms, patients’ values and preferences, acceptability, feasibility, and equity for the Pfizer-BioNTech COVID-19 vaccine. To inform the EtR Framework, the COVID-19 Vaccines Work Group, comprising experts in infectious disease, vaccinology, vaccine safety, public health, and ethics, held 27 meetings to review COVID-19 surveillance data, evidence for vaccine efficacy and safety, and implementation considerations for COVID-19 vaccines, including the Pfizer-BioNTech COVID-19 vaccine. After a systematic review of the literature, the Work Group used the GRADE approach to assess the certainty of evidence for outcomes related to the vaccine, rated on a scale of 1 (high certainty) to 4 (very low certainty) (4). Work Group conclusions regarding the evidence for the Pfizer-BioNTech COVID-19 vaccine were presented to ACIP at public meetings. ; Suggested citation for this article: Suggested citation for this article: Oliver S, Gargano J, Marin M, et al. The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine — United States, December 2020. MMWR Morb Mortal Wkly Rep. ePub: 13 December 2020. ; mm6950e2.htm?s_cid=mm6950e2_w ; mm6950e2-H.pdf
• Subjects:
  • Coronavirus Infections/prevention & control
  • COVID-19 Vaccines/supply & distribution
  • COVID-19/prevention & control
  • Immunization Programs
  • Pandemics
  • Vaccination
  • Viral Vaccines
• Source:
  MMWR: Morbidity and Mortality Weekly Report 2020; v. 69 Early Release
• Series:
  Weekly Report: Morbidity and Mortality Weekly Report (MMWR)
• ISSN:
  0149-2195 (print) ; 1545-861X (digital)
• Document Type:
  Journal Article
• Corporate as Subject:
  Pfizer-BioNTech COVID-19 Vaccine ; Pfizer-BioNTech COVID-19 Vaccine
• Place as Subject:
  United States
• Location:
  North America
• Pages in Document:
  3 pdf pages
• Volume:
  69
• Download URL:
  https://stacks.cdc.gov/view/cdc/98737/cdc_98737_DS1.pdf
• File Type:
  [PDF - 299.31 KB]
• Collection(s):
  Morbidity and Mortality Weekly Report (MMWR) ; Advisory Committee on Immunization Practices (ACIP)
• Main Document Checksum:
  urn:sha-512:9a321a4ff19d9f0334c8712ab23c79670e6f40a7dffe18053e654131b93f6bb2e402761896c1b8a58e1766c701d748432f364679bf7eb9574d7d4fb50b103f1c