Moderna wins FDA OK to widen use of RSV vaccine

The Food and Drug Administration has approved wider use of Moderna’s respiratory syncytial virus vaccine in a boost for a company that’s been negatively impacted by the recent leadership changes atop U.S. public health agencies.  

The shot, dubbed mResvia, was cleared on Thursday for adults aged 18 to 59 who are at high risk for increased risk of RSV-related disease. Prior to the label expansion, Moderna’s shot was only available to adults 60 or older. 

“RSV poses a serious health risk to adults with certain chronic conditions, and today’s approval marks an important step forward in our ability to protect additional populations from severe illness from RSV,” Moderna CEO Stéphane Bancel said in a statement. 

The expansion is a much-needed win for Moderna, which has been among those hardest hit by the changes in vaccine policy enacted by new FDA leaders Martin Makary and Vinay Prasad, as well as Health and Human Services Secretary Robert F. Kennedy Jr. 

Makary and Prasad, for instance, have outlined stricter approval standards for COVID-19 vaccines and called for developers to perform more placebo-controlled trials. Kennedy Jr., who has long been critical of the kind of messenger RNA vaccines Moderna is known for, has said the Centers for Disease Control and Prevention would remove COVID shots from the recommended immunization schedules for pregnant women and healthy children.

He also, this week, overhauled the CDC panel that determines who should get which vaccines and shapes private insurance coverage for inoculations. Some of the new members of the eight-person panel include vaccine skeptics and doctors with different focus areas.

The changes at the CDC could have important implications for Moderna. In April, the CDC panel recommended broadening use of RSV shots to enable adults 50 to 59 years of age who are at a higher risk of severe RSV-related disease to get vaccinated. But the agency still doesn’t have an acting director, and Kennedy Jr. has yet to endorse that recommendation. Without a formal clearance, insurers are not required to cover the cost of the shot.

The newly constituted panel’s first meeting is scheduled for June 25-27, and will be closely watched by investors. In a research note Friday, William Blair analyst Myles Minter noted that the gathering will be “important for sentiment in the vaccine sector, which continues to decline.”

Minter believes Moderna, which has seen its share price plummet more than 80% over the last year, will need to significantly cut costs to meet its objective of breaking even financially by 2028. 

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