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

Analysts expect Moderna's RSV vaccine to make $340.8 million this year and build up to more than $800 million in 2025, according to LSEG data. If approved by the FDA and recommended for use by the CDC, Moderna's shot will compete in the U.S. fall vaccination campaign against Pfizer and market leader GSK.

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

The Food and Drug Administration's move prolongs the wait for Moderna's second approved product, but the company said the vaccine remains on track to be reviewed by a panel of advisers at the U.S. Centers for Disease Control and Prevention (CDC) on June 26 and 27. The CDC panel is expected to vote on recommendations for the vaccine's use and the intended population at the meeting, and success there is necessary for commercial launch.

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. Moderna was seeking the FDA's approval for using the shot to prevent RSV-associated lower respiratory tract disease and acute respiratory disease in adults aged 60 or older.

RSV, which produces symptoms similar to a cold but can be fatal for young children and older adults, causes about 14,000 deaths annually in the United States in adults aged 65 and older, according to the CDC. Analysts expect Moderna's RSV vaccine to make $340.8 million this year and build up to more than $800 million in 2025, according to LSEG data.

If approved by the FDA and recommended for use by the CDC, 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, such as cough and fever.

The company's shares, which were down 1% in premarket trading on Friday, fell in February when new data showed faster declines in the efficacy of its RSV vaccine when compared to the GSK and Pfizer shots.

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)