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

MMWR Morb Mortal Wkly Rep. 2021 Jan 1;69(5152):1653-1656. doi: 10.15585/mmwr.mm695152e1.

Abstract

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.

MeSH terms

  • Adolescent
  • Adult
  • Adverse Drug Reaction Reporting Systems
  • Advisory Committees
  • Aged
  • Aged, 80 and over
  • COVID-19 / epidemiology
  • COVID-19 / prevention & control*
  • COVID-19 Vaccines / administration & dosage*
  • COVID-19 Vaccines / adverse effects
  • Centers for Disease Control and Prevention, U.S.
  • Clinical Trials, Phase III as Topic
  • Drug Approval
  • Emergencies
  • Humans
  • Immunization / standards*
  • Middle Aged
  • Practice Guidelines as Topic*
  • Randomized Controlled Trials as Topic
  • United States / epidemiology
  • United States Food and Drug Administration
  • Young Adult

Substances

  • COVID-19 Vaccines