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Moderna Receives U.S. FDA Approval For RSV Vaccine, MRESVIA, In Adults Aged 18–59 At Increased Risk For RSV Disease

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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. 

Moderna Falls On Fears New CDC Vaccine Advisory Panel Could Cloud RSV Shot Prospects

By Mariam Sunny

(Reuters) -Moderna's shares fell 2.3% on Friday on concerns about whether a new CDC advisory panel would back the use of the company's respiratory syncytial virus vaccine in a broader age group.

The mRNA-based RSV shot, mRESVIA, secured U.S. Approval on Thursday for use in at-risk adults aged 18 to 59 years, but needs the U.S. Centers for Disease Control and Prevention's recommendation before it is made available for the age group. It is already approved for use in adults aged 60 or older.

However, that support is now in doubt after Health Secretary Robert F. Kennedy Jr. Replaced all 17 members of a key panel this week, with some of the new appointees having openly expressed anti-vaccine views.

"I do think there is a general fear that mRNA technology may not be viewed in a favorable light by the new ACIP," Morningstar analyst Karen Andersen said.

The panel, known as the Advisory Committee on Immunization Practices (ACIP), advises the CDC on who should get the shots after they are approved by the U.S. Food and Drug Administration.

The CDC currently recommends a single dose of the shot for adults aged 75 and older, as well as for at-risk adults aged 60 to 74.

"The biggest moving factor in this market is whether or not sometime in the future can we actually get that recommendation to revaccinate," William Blair analyst Myles Minter said.

U.S.-listed shares of GSK, which markets rival RSV shot Arexvy, fell 2.5% to $41.44, while those of Pfizer, which sells RSV shot Abrysvo, fell marginally.

Morningstar's Anderson projects the total RSV vaccine market to be worth about $3.9 billion by 2030 globally, with Moderna gaining about 19% market share by then.

(Reporting by Mariam Sunny in Bengaluru; Editing by Shinjini Ganguli and Anil D'Silva)

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