A healthcare worker holds a Modern COVID-19 vaccine bottle at a pop-up vaccination site operated by SOMOS Community Care during the coronavirus disease pandemic (COVID-19) in New York, January 29, 2021.
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The modern Covid-19 vaccine was more than 90% effective in protecting against Covid and more than 95% effective against severe diseases up to six months after the second dose, the company said on Tuesday, citing updated data from its third-phase clinical trial. .
The update brings Moderna one step closer to filing its application for full US approval for its vaccine. Full approval requires a more rigorous review process to show that the photo is safe and effective for its intended use. Once it obtains full approval, Moderna can begin selling the photos directly to consumers and selling them to individuals and private companies in the US.
The new data included Covid-19 cases through April 9 and assessed more than 900 cases, including more than 100 severe cases, he said. The vaccine is currently authorized for emergency use by the Food and Drug Administration for persons 18 years of age and older, and the agency may revoke its emergency use authorization or EUA at any time. Moderna sent only two months of follow-up safety data to EUA. The FDA usually requires six months for full approval.
The company said its results are preliminary. Moderna said throughout the year that it will share up-to-date data on the effectiveness 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 that antibodies induced by the Moderna vaccine were still present six months after the second dose. It also comes after Pfizer said earlier this month that its vaccine, which uses a technology similar to Moderna’s, proved to be extremely effective six months after the second dose.
Dr. Isaac Bogoch, an infectious disease specialist who has been on several data and drug safety monitoring boards, called the Modern update “amazing news” and said he was glad to hear that both mRNA vaccines are extremely effective at six months.
“I think it’s fair to estimate that both will have decent effectiveness for several months beyond that,” he said.
Moderna is still evaluating its vaccine for people aged 17 and under.
The company said Tuesday that its vaccine test for teens between the ages of 12 and 17 is now fully enrolled, with about 3,000 participants in the U.S.
He said his vaccine testing process in children aged 6 months to 11 years is currently registering participants. It is expected to enroll 6,750 healthy pediatric participants in the US and Canada. As in the Pfizer study, children will start by receiving a low dose of vaccine before gradually switching to higher doses.