Moderna will submit its Covid-19 vaccine for emergency use approval in the U.S. Monday after new trial data showed it to be 94% effective at preventing the disease, findings that are consistent with earlier data from the Phase 3 clinical trial.
New findings from the Phase 3 clinical trial, which involved over 30,000 participants, showed the vaccine to be 100% effective at preventing severe Covid-19 and 94% at preventing the disease more broadly.
The company says the findings are consistent across various demographics, including age, gender and ethnicity. No serious safety concerns were identified, the company said, with side effects limited to injection site pain, headaches and fatigue.
We just announced the primary efficacy analysis in the Phase 3 COVE study for mRNA-1273, our COVID-19 vaccine candidate and that today, we plan to request an Emergency Use Authorization from the U.S. FDA & conditional approval from the EMA. Read more: https://t.co/90FbcVHdWN pic.twitter.com/36tpY0QeFl
— Moderna (@moderna_tx) November 30, 2020
Breaking News: Moderna is asking the FDA to authorize its coronavirus vaccine for emergency use. It could possibly begin reaching Americans by Dec. 21. https://t.co/v91hjO5V8d
— The New York Times (@nytimes) November 30, 2020