MFLUSIVA
Coverage of MFLUSIVA in the Nexus archive.
- FDA panel recommends mRNA flu vaccine for older adults
An FDA advisory panel unanimously recommended Moderna’s mRNA-based flu vaccine, mFlusiva, for approval in adults aged 50-64 and 65+. The panel voted 9-0 that the benefits outweigh the risks for the vaccine.
- FDA panel backs first-of-its-kind flu vaccine using mRNA technology
An FDA panel recommended approval of Moderna's first mRNA-based flu vaccine, mFlusiva, for adults aged 50 and older, citing its benefits outweighing risks. The vaccine, developed using technology similar to COVID-19 vaccines, showed a 27% reduction in flu cases compared to traditional vaccines in clinical trials and is under final FDA review for potential approval by August.
- First-of-its-kind flu vaccine could be coming as FDA panel weighs historic shot
Moderna is seeking FDA approval for its new flu vaccine, mFlusiva, targeting individuals 50 and older. The FDA advisory committee meeting is a critical step toward a final decision before the winter flu season.
- FDA panel considers a first-of-its-kind flu vaccine using mRNA technology
The FDA is considering Moderna's first mRNA-based flu vaccine, mFlusiva, for people 50 and older. A study showed it reduced flu cases by 27% compared to a standard vaccine, but data on frail older adults and those with weak immune systems is lacking. A prior FDA official disputed the vaccine's comparison to a high-dose brand, but the application was later accepted.
- FDA panel considers a first-of-its-kind flu vaccine using mRNA technology
The FDA advisory panel is evaluating Moderna's first mRNA-based flu vaccine, mFlusiva, for approval in adults 50 and older. The vaccine, which showed a 27% reduction in flu cases compared to a standard-dose vaccine in a 40,000-person study, faces scrutiny over its study design but has received a favorable FDA review with no safety concerns noted.
- FDA panel considers a first-of-its-kind flu vaccine using mRNA technology
The FDA is considering Moderna's first mRNA-based flu vaccine, mFlusiva, for adults 50 and older. A study showed it reduced flu cases by 27% compared to a standard vaccine, but lacks data on very frail older adults. The decision follows a dispute with a former FDA official who questioned the study's design.
- Moderna mRNA flu vaccine to get FDA panel review
Moderna's experimental mRNA flu vaccine (MFLUSIVA) will undergo FDA advisory panel review on June 18. This development follows the departure of former FDA head Marty Makary and signals a return to more stable regulatory processes for drug reviews.