December 9, 2023

A healthcare worker holds a vial of the Moderna COVID-19 vaccine at a pop-up vaccination facility operated by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in New York on January 29, 2021.

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Moderna’s Covid-19 vaccine was more than 90% effective against Covid and more than 95% effective against serious diseases up to six months after the second dose, the company said Tuesday, referring to updated data from its clinical Phase 3 study.

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 shot is safe and effective for its intended use. With full approval, Moderna can begin marketing the recordings directly to consumers and selling them to individuals and private companies in the United States

The new data included Covid-19 cases through April 9 and assessed over 900 cases, including more than 100 serious cases. The vaccine is currently approved for emergency use by the Food and Drug Administration for those aged 18 and over. The authority can revoke the emergency permit (EUA) at any time. Moderna only submitted safety data to the EEA for two months. The FDA typically takes six months for full approval.

The company said its results are preliminary. Moderna announced that updated data on effectiveness against asymptomatic infections and antibody persistence will be released later this year.

The new data comes from a study published in the New England Journal of Medicine that 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 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 served on various drug data and safety monitoring boards, described Moderna’s update as “amazing news” and is pleased to hear that both mRNA vaccines are highly effective after six months.

“I think it’s fair to estimate that both will have decent effectiveness over many months,” he said.

Moderna is still evaluating its vaccine in people aged 17 and younger.

The company announced Tuesday that its study testing the vaccine in adolescents ages 12 to 17 is now fully enrolled and has approximately 3,000 participants in the United States

Participants are currently enrolling in his study, which is testing the vaccine in children aged 6 months to 11 years. It is expected that 6,750 healthy pediatric participants will be enrolled in the US and Canada. As in Pfizer’s study, children first receive a low dose of the vaccine before gradually moving on to higher doses.