A healthcare worker holds a vial of the Moderna COVID-19 Vaccine at a pop-up vaccination site operated by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in New York, January 29, 2021.
Mike Segar | Reuters
Moderna‘s Covid-19 vaccine was more than 90% effective at protecting against Covid and more than 95% effective against severe disease up to six months after the second dose, the company said Tuesday, citing updated data from its phase three clinical trial.
The update brings Moderna a step closer to filing its request for full U.S. approval for its vaccine. Full approval requires a more rigorous review process to show the shot is safe and effective for its intended use. Once it gets full approval, Moderna can begin marketing the shots directly to consumers and selling them to individuals and private companies in the U.S.
The new data included Covid-19 cases through April 9 and evaluated over 900 cases, including more than 100 severe cases, it said. The vaccine is currently authorized for emergency use by the Food and Drug Administration for people who are age 18 and older, and the agency can revoke the emergency use authorization, or EUA, at any time. Moderna submitted only two months of follow-up safety data for the EUA. The FDA usually requires six months for full approval.
The company said its results are preliminary. Moderna said throughout the year it will share updated data on efficacy against asymptomatic infection as well as the persistence of antibodies.
The new data comes after a study published in the New England Journal of Medicine showed antibodies induced by the Moderna vaccine were still present six months after the second dose. It also comes after Pfizer said earlier this month its vaccine, which uses technology similar to Moderna’s, was also shown to be highly effective six months after the second dose.
Dr. Isaac Bogoch, an infectious disease specialist who has sat on several drug data and safety monitoring boards, called Moderna’s update “amazing news” and said he’s glad to hear that both mRNA vaccines are highly effective at six months.
“I think it is fair to estimate that they will both have decent efficacy for many months beyond this,” he said.
Moderna is still evaluating its vaccine in people ages 17 and younger.
The company said Tuesday its trial testing the vaccine in adolescents ages 12 to 17 is now fully enrolled, with about 3,000 participants in the U.S.
It said its trial testing the vaccine in children 6 months to 11 years old is currently enrolling participants. It expects to enroll 6,750 healthy pediatric participants in the U.S. and Canada. As in Pfizer’s study, kids will begin by receiving a low dose of the vaccine before progressively moving to higher doses.