The Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Moderna’s coronavirus disease 2019 (COVID-19) vaccine, mRNA-1237, for active immunization to prevent disease in individuals 18 years of age and older.
The EUA was based on data from the placebo-controlled ‘COVE’ study that investigated the efficacy and safety of mRNA-1273 in more than 30,000 adults aged 18 years and older. Results as of November 21, 2020 showed that the vaccine was 94.1% effective based on 196 confirmed cases, of which 185 occurred in the placebo group and 11 occurred in the mRNA-1273 group.
Additional data from the trial will be collected and used to prepare the Biologics License Application for full regulatory approval, which is expected to be submitted to the FDA in 2021. Following the announcement of the EUA, the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) voted to recommend the use of the vaccine, prioritizing use in health care personnel and residents in long-term care facilities.
The first batches of the vaccine are currently being shipped across the country by McKesson; the allocation and distribution is being managed by the Department of Defense, in partnership with agencies within the Department of Health and Human Services, including the CDC. Initial supplies of the mRNA-1273 vaccine are expected to be delivered on Monday, December 21, 2020.
The mRNA-1273 (100μg) vaccine is administered intramuscularly as a series of 2 doses (0.5mL each), given 28 days apart. Patients who receive the Moderna COVID-19 vaccine should receive a second dose of the same vaccine to complete the series; there are currently no data available on the interchangeability of COVID-19 vaccines.
The product is supplied as a preservative-free frozen suspension in multi-dose vials. Unlike the Pfizer/BioNTech vaccine, which requires storage conditions of -70°C, unopened vials of mRNA-1273 vaccine remain stable at 2° to 8°C (36° to 46°F) for up to 30 days, -20° C (-4°F) for up to 6 months, and at room temperature for up to 12 hours.
As part of the EUA, a summary of instructions and important safety information is detailed in a fact sheet for health care providers. Following administration, adverse reactions that have been reported in clinical trials included pain/swelling/erythema at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, and fever. Patients who receive the vaccine should be monitored for the occurrence of immediate adverse reactions according to CDC guidelines.
- FDA takes additional action in fight against COVID-19 by issuing emergency use authorization for second COVID-19 vaccine. [press release]. December 18, 2020.
- Moderna announces FDA authorization of Moderna COVID-19 vaccine in U.S. [press release]. December 18, 2020.
- U.S. CDC Advisory Committee on Immunization Practices recommends vaccination with Moderna’s COVID-19 vaccine for persons 18 years and older. [press release]. December 19, 2020.
- McKesson fills initial government orders for Moderna’s COVID-19 vaccine. [press release]. December 20, 2020.