Moderna intends to submit for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in the coming weeks. Moderna also plans to apply for authorization from global regulatory agencies.
American biotechnology company Moderna released a press release on Monday announcing that their COVID-19 vaccine has an efficacy rate of 94.5 percent. An independent review by an NIH-appointed Data Safety Monitoring Board (DSMB) confirmed the results.
This news comes after a large test undertaking called the "COVE study" which enrolled more than 30,000 participants in the U.S.
Moderna intends to submit for an Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA) in the coming weeks. Moderna also plans to apply for authorization from global regulatory agencies.
This announcement comes just a week after US pharmaceutical company Pfizer announced their COVID-19 vaccine is 90 percent effective. Both of the vaccines require people to get two shots, several weeks apart.
On top of their promising announcement, Moderna also says the vaccine will be able to be stored for 30 days in warmer temperatures than that of many other vaccines in development. This allows longer shelf life and easier transportation of the vaccine.
Moderna says studies are ongoing and more information is incoming. Leading up to the final analysis, Moderna expects the point estimate for vaccine efficacy may change. The company plans to submit data from the full Phase 3 COVE study to a peer-reviewed publication.
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