Moderna Wins FDA Authorization for COVID-19 Vax

By Contract Pharma Staff | 12.21.20

The primary efficacy analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1%.

Moderna, Inc. received authorization from the U.S. FDA for the emergency use of mRNA-1273, Moderna’s vaccine against COVID-19 in individuals 18 years of age or older. The vaccine is now authorized for distribution and use under an Emergency Use Authorization (EUA). Delivery to the U.S. Government will begin immediately. Moderna 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 (HHS) and the U.S. Centers for Disease Control and Prevention (CDC), will manage allocation and distribution of the vaccine in the U.S. Approximately 20 million doses will be delivered to the U.S. government by the end of December 2020. The company expects to have between 100 million and 125 million doses available globally in 1Q21, with 85-100 million of those available in the U.S.

The FDA based its recommendation on data analysis from the pivotal Phase 3 clinical study announced on November 30. The primary efficacy analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1%.

The most common solicited adverse reactions after the two-dose series included injection site pain (88.2%), erythema (8.6%), swelling (12.2%), and ipsilateral lymphadenopathy (14.2%). Safety data continue to accrue, and the study continues to be monitored by an independent Data Safety Monitoring Board (DSMB) appointed by the National Institutes of Health (NIH). All participants in the COVE study will continued to be monitored for two years for the duration of the study to assess long-term protection and safety.