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.

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