U.S. FDA approves Moderna’s lower-dose COVID-19 vaccine for some

[TallGuyJohninBKK]

June 02, 2025

 

The FDA approved Moderna’s lower-dose COVID-19 vaccine, but only for individuals aged 65 years or older and people aged 12 to 64 years at high risk for severe disease, aligning with the agency’s new restrictions for COVID-19 shots.

 

“The FDA approval of our third product, mNexspike, adds an important new tool to help protect people at high risk of severe disease from COVID-19,” Moderna CEO Stéphane Bancel, MSc, MBA, said in a press release announcing the approval. “COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA’s timely review.” [emphasis added]

...

When compared with a 50 µg dose of Moderna’s original COVID-19 vaccine, a 10 µg dose of the new vaccine showed a 9.3% higher relative vaccine efficacy in people aged 12 years or older. Among a subgroup of people aged 65 years and older, the lower-dose vaccine showed a 13.5% higher relative vaccine efficacy, Moderna said. ... The company said it expects the newly approved low-dose vaccine to be available this fall.

 

(more)

 

https://www.healio.com/news/infectious-disease/20250602/fda-approves-modernas-lowerdose-covid19-vaccine-for-some

 

 

[Red Phoenix]

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