Moderna: FDA Extends RSV Vaccine Review, But No Issues Flagged

By Colin Kellaher

Moderna on Friday said the Food and Drug Administration won't meet its May 12 target action date for a decision on the company's proposed vaccine for respiratory syncytial virus, or RSV, but that the agency hasn't flagged any issues that would prevent an approval.

The company said the FDA cited administrative constraints for the delay, and that the agency is working to complete its review of mRNA-1345 by the end of the month.

Moderna said the FDA hasn't informed the Cambridge, Mass., vaccine maker of any issues related to vaccine safety, efficacy or quality that would prevent the approval of mRNA-1345 for RSV, a contagious virus that is the leading cause of respiratory illness in young children and also poses increased risk to older adults for severe outcomes.

Moderna has previously said it estimates the peak annual RSV market to be about $10 billion, and that it expects a strong RSV vaccine launch this year.

The company also said it remains on track for mRNA-1345 to be reviewed at the Centers for Disease Control and Prevention's advisory committee on immunization practices in late June, which is necessary prior to commercial launch.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

May 10, 2024 07:48 ET (11:48 GMT)

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