The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Moderna COVID-19 Vaccine - United States, December 2020

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:
  CDC COVID- 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 18, 2020, the Food and Drug Administration issued an Emergency Use Authorization (EUA) for the Moderna COVID-19 vaccine. ; What is added by this report? On December 19, 2020, after a transparent, evidence-based review of available data, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the Moderna COVID-19 vaccine in persons aged ≥18 years for the prevention of COVID-19. ; What are the implications for public health practice? Use of all COVID-19 vaccines authorized under an EUA, including the Moderna COVID-19 vaccine, should be implemented in conjunction with ACIP's interim recommendations for allocating initial supplies of COVID-19 vaccines. ; On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Moderna COVID-19 (mRNA-1273) vaccine (ModernaTX, Inc; Cambridge, Massachusetts), a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). This vaccine is the second COVID-19 vaccine authorized under an EUA for the prevention of COVID-19 in the United States (2). Vaccination with the Moderna COVID-19 vaccine consists of 2 doses (100 μg, 0.5 mL each) administered intramuscularly, 1 month (4 weeks) apart. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Moderna COVID-19 vaccine in persons aged ≥18 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.§ Use of all COVID-19 vaccines authorized under an EUA, including the Moderna COVID-19 vaccine, should be implemented in conjunction with ACIP's interim recommendations for allocating initial supplies of COVID-19 vaccines (3). The ACIP recommendation for the use of the Moderna COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available. ; Since June 2020, ACIP has convened 10 public meetings to review data on the epidemiology of COVID-19 and the potential use of COVID-19 vaccines, including the Moderna COVID-19 vaccine (4). Within the EtR Framework, ACIP considered the importance of the public health problem of COVID-19, as well as resource use, benefits and harms, patients' values and preferences, acceptability, feasibility, and equity for the Moderna COVID-19 vaccine. To inform the EtR Framework, the COVID-19 Vaccines Work Group, comprising experts in infectious diseases, vaccinology, vaccine safety, public health, and ethics, held 28 meetings to review COVID-19 surveillance data, evidence for vaccine efficacy and safety, and implementation considerations for COVID-19 vaccines, including the Moderna COVID-19 vaccine. After a systematic review of available data, 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) (5). Work Group conclusions regarding certainty of evidence for the Moderna COVID-19 vaccine were presented to ACIP at public meetings. ; Suggested citation for this article: Oliver S, Gargano J, Marin M, et al. The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Moderna COVID-19 Vaccine - United States, December 2020. MMWR Morb Mortal Wkly Rep. ePub: 20 December 2020. ; mm695152e1.htm?s_cid=mm695152e1_w ; mm695152e1-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:
  Moderna COVID-19 vaccine
• Genre:
  Guidance
• Place as Subject:
  United States
• Pages in Document:
  4 pdf pages
• Volume:
  69
• Download URL:
  https://stacks.cdc.gov/view/cdc/99154/cdc_99154_DS1.pdf
• File Type:
  [PDF - 84.83 KB]
• Collection(s):
  Morbidity and Mortality Weekly Report (MMWR)
• Main Document Checksum:
  urn:sha-512:44022d54422a4d15554de83dad9a7a1e42e06ba20fffa53b7848b4d8766f99c8ddaf4e87ff9fd4d6dc472be2de840453b679a05c8e60f83e26c9ab4c1c4bc9b8