The U.S. Food and Drug Administration expanded its approval of Moderna's respiratory syncytial virus (RSV) vaccine on Thursday to include adults under the age of 60 at increased risk of the ...

The FDA expanded the approval of Moderna’s RSV vaccine, extending the license to include more adults and giving the company a welcome win.

Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in ...

The label expansion for Moderna’s jab arrives at a juncture in America’s changing vaccine regulatory landscape.

The expanded recommendation is good news for Moderna, Pfizer, and GSK, which all sell RSV vaccines for older adults. Moderna shares were up 5.9% on Wednesday, while Pfizer was up 1%. GSK’s American ...

This approval expands the previous indication of mRESVIA, which was approved in May 2024 for adults aged 60 years and older.

Moderna’s RSV vaccine is based on mRNA technology, which some of the new members have expressed skepticism about, especially in relation to COVID-19 vaccines.

This approval was supported by results from Moderna’s Phase 3 study (NCT06067230), which evaluated the safety and immunogenicity of mRESVIA in adults aged 18-59 with underlying health conditions.

This approval was supported by results from Moderna’s Phase 3 study (NCT06067230), which evaluated the safety and immunogenicity of mRESVIA in adults aged 18-59 with underlying health conditions.