US FDA pushes decision on Moderna's RSV vaccine to end of this month

"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 said. Moderna has been banking on its experimental shots to make up for vastly lower sales of its Spikevax COVID vaccine, its only marketed product, after the pandemic.

The U.S. drug regulator has pushed back its decision on Moderna's respiratory syncytial virus (RSV) vaccine due to "administrative constraints" and will complete the review by the end of this month, the company said on Friday.

Moderna's shares fell 3% to $119.02 in early trading. The Food and Drug Administration's move prolongs the wait for Moderna's second approved product, but the company said it remains on track to be reviewed by a panel of U.S. Centers for Disease Control and Prevention (CDC) advisers in late June.

The CDC panel is expected to vote on recommendations for the vaccine's use and the intended population, and success there is necessary for commercial launch. "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 said.

Moderna has been banking on its experimental shots to make up for vastly lower sales of its Spikevax COVID vaccine, its only marketed product, after the pandemic. The company is seeking the FDA's approval of the shot to prevent RSV-associated lower respiratory tract disease and acute respiratory disease in adults aged 60 or older.

While RSV symptoms are similar to a cold, it can be fatal in children and older adults and causes about 14,000 deaths annually in U.S. adults aged 65 and older, according to CDC data. Analysts expect Moderna's RSV vaccine to make roughly $340.8 million this year and more than $800 million in 2025, according to LSEG data.

If cleared, Moderna's shot will compete in the U.S. fall vaccination campaign against Pfizer and market leader GSK. Moderna filed for FDA approval based on data from a late-stage trial that showed its vaccine was 83.7% effective at preventing at least two symptoms of RSV. But new data in February showed faster declines in the vaccine's efficacy compared to the GSK and Pfizer shots.

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