On Dec. 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.

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).

The body of evidence for the Moderna COVID-19 vaccine was primarily informed by one large, randomized, double-blind, placebo-controlled Phase III clinical trial that enrolled approximately 30,000 participants aged 18–95 years. Interim findings from this clinical trial, using data from participants with a median of 2 months of follow-up, indicated that the Moderna COVID-19 vaccine efficacy after 2 doses was 94.1% in preventing symptomatic, laboratory-confirmed COVID-19 among persons without evidence of previous SARS-CoV-2 infection, which was the primary study endpoint. High efficacy (≥86%) was observed across age, sex, race, and ethnicity categories and among persons with underlying medical conditions.