US FDA gives EUA to Moderna’s mRNA vaccine against COVID-19

Moderna announced that the US Food and Drug Administration’s (FDA) has authorised the emergency use of mRNA-1273, Moderna’s vaccine against COVID-19 in individuals 18 years of age or older. The Moderna COVID-19 Vaccine is now authorised for distribution and use under an Emergency Use Authorization (EUA). Delivery to the US 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.

Stéphane Bancel, CEO of Moderna said, “I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorisation while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants.”

Under Operation Warp Speed, the Department of Defense (DoD), in partnership with the Department of Health and Human Services (HHS) and the US Centers for Disease Control and Prevention (CDC), will manage allocation and distribution of the vaccine in the United States. Allocation and distribution will be prioritised according to populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP). Approximately 20 million doses will be delivered to the US government by the end of December 2020. 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 US.

The FDA based its recommendation on the totality of scientific evidence shared by the company, including a 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 per cent.

The most common solicited adverse reactions (ARs) after the two-dose series included injection site pain (88.2%), erythema (8.6%), swelling (12.2%), and ipsilateral lymphadenopathy (14.2%). While the majority of these ARs were grade 1 (mild) or grade 2 (moderate), there was a higher occurrence of grade 3 (severe) reactions after the second injection. The majority of local solicited ARs occurred within the first one to two days after injection and generally persisted for a median of one to two days. 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.