Moderna announced that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommended the use of the Moderna COVID-19 vaccine in people 18 years of age and older under the emergency use authorization (EUA) issued by the U.S. Food and Drug Administration (FDA) on Friday, according to press releases.
The Moderna vaccine is the second COVID-19 vaccine to be distributed for use during the pandemic, following a similar approval for a COVID-19 vaccine from Pfizer-BioNTech.
The CDC committee’s recommendation awaits approval by the CDC, Moderna said. The FDA’s EUA allows Moderna's vaccine to be shipped to states, but the CDC is responsible for recommending the vaccine’s use in people, according to the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota.
The CDC committee based its recommendation on clinical evidence supporting Moderna’s COVID-19 vaccine, including data from Moderna’s 30,000-participant Phase 3 study and ACIP’s interim guidance on the allocation of initial vaccine doses. Moderna said it will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021.
Under Operation Warp Speed, the Department of Defense (DoD), in partnership with the Department of Health and Human Services and the CDC, will manage allocation and distribution of the Moderna vaccine in the United States. Approximately 20 million doses are slated to be delivered to the U.S. government by the end of December 2020, Moderna said. The company expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those available in the United States.
The vaccine, called mRNA-1273, is a messenger RNA (mRNA) vaccine against COVID-19, encoding a prefusion stabilized form of the spike protein of SARS-CoV-2, co-developed by investigators from Moderna and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
