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.
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.
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.
Speaking about the results, CEO Stéphane Bancel emphasized the vaccine’s high success rate and, in particular, its ability to prevent severe disease. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” Bancel said.
Moderna’s announcement Monday is significant for a number of reasons. Foremost, it is another proven vaccine heading towards authorization that will help tackle the Covid-19 pandemic that has infected and killed millions of people around the world. In this manner, it is more promising than the vaccine candidate from Pfizer and BioNTech, which has also been submitted for regulatory approval after promising trial results, as it requires much less onerous storage requirements. For science it is also a significant milestone, using RNA technology that has not yet managed to make it to market (Pfizer and BioNTech’s vaccine is also built using RNA). Finally, it is a big milestone for Moderna, should the vaccine be approved, as the company has not yet brought a vaccine to market.