Moderna Submits Covid-19 Vaccine For Emergency Approval, Says It Is 100% Effective At Preventing Severe Forms Of Disease

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TOPLINE

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.  

KEY FACTS

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. 

Off the back of the results, and having collected the requisite two months of safety data, Moderna says it will apply for emergency use authorization from the U.S.’s Food and Drug Administration, as well as seek conditional marketing authorization from the European Medicines Agency.

The company says it has been informed that the FDA will meet to consider the vaccine on Dec. 17.

BIG NUMBER

20 million. That’s the total number of doses that Moderna expects to have ready to ship to the U.S. by the end of 2020, enough for 10 million people to be vaccinated as the vaccine requires two doses. The company says it is on track to manufacture between 500 million to 1 billion doses globally in 2021.

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