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FDA delays decision on Moderna RSV vaccine

Moderna on Friday said the Food and Drug Administration has postponed an approval decision on its experimental vaccine for respiratory syncytial virus due to “administrative constraints,” extending a review the regulator had expected to complete by Sunday.

According to Moderna’s statement, the FDA will no longer be able to meet the May 12 decision deadline. But the regulator hasn’t communicated with Moderna any issues that would prevent approval of its application, and is working to complete its evaluation by the end of the month, Moderna said. 

The FDA’s decision is important for Moderna, which is counting on the shot, known as mRNA-1345, to become ts second marketed product. The vaccine is being developed to prevent disease related to respiratory syncytial virus, or RSV, a common lung infection. The company is asking for clearance in older adults. 

Moderna has been preparing to launch the shot before the fall immunization season. The company said it remains on track to hit that goal, as its shot could be approved in time for a Centers for Disease Control and Prevention advisory panel meeting in June. 

“We don’t expect major delays from here onwards and FDA should be able to approve this by end of May,” Jefferies analyst Michael Yee wrote in a note to clients Friday. Yee also added that, given the agency hasn’t required a “major amendment” or rejected Moderna’s application outright, investors’ “fears should now be lifted.”

Moderna is looking to its RSV shot to help offset sharply declining sales for its COVID-19 vaccine. However, some analysts are skeptical of its commercial prospects, given the vaccine is set to arrive a year after GSK and Pfizer began selling rival vaccines. Both had rapid uptake last fall, but GSK’s shot has been dominant, earning two-thirds of the total market share and generating over $1 billion pounds in sales last year.

The CDC panel is scheduled to meet starting June 26.