.US_FDA grants expedited review for moderna_tx RSV vaccine for 60 and older
The designation will expedite the development and review of Moderna's RSV vaccine candidate after data from a late-stage trial showed the vaccine was 83.7% effective at preventing RSV lower respiratory tract disease, defined as two or more symptoms, in older adults."The FDA's Breakthrough Designation for mRNA-1345 further emphasizes the significant health impact of RSV in older adults and the high unmet need," said Stephane Bancel, CEO of Moderna.
Moderna said it intends to file for regulatory approval with the FDA in the first half of this year. Breakthrough designation is granted to drugs that are intended to treat a serious condition and have evidence to show it would be a significant improvement over available therapies. There is currently no FDA-approved vaccine for RSV. Pfizer also has an investigative RSV vaccine in development, which is administered to mothers during the late stages of their pregnancies. The company said last November that the vaccine was about 80% effective at preventing severe RSV disease in the infant's first 90 days of life.The fast-tracked development of RSV vaccine candidates comes during a particularly rough respiratory season.
The "alarming surge" prompted the Children's Hospital Association and American Academy of Pediatrics to request President Joe Biden to issue an emergency declaration to free up federal resources.
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