mRNA flu vaccine

The FDA approved the nation's first mRNA flu vaccine on Wednesday. The vaccine was manufactured by drugmaker Moderna.

The Food and Drug Administration (FDA) approved the nation’s first mRNA flu vaccine, which was manufactured by Moderna. The agency granted approval for two distinct age groups: individuals between 50 and 64, and those aged 65 years and older. Following the approval, Moderna announced plans to conduct a postmarket clinical trial.

The FDA approved Moderna’s mRNA flu vaccine. The agency had initially refused to review the application but subsequently reversed course after a public outcry.

The FDA is expected to decide on approving the first mRNA flu vaccine. The vaccine could mark a new approach to influenza immunization.

The FDA is set to decide on approving the first mRNA flu vaccine, which uses the same technology as COVID-19 shots. Health Secretary Robert F. Kennedy Jr. has expressed skepticism about mRNA vaccines.

An FDA panel recommended an mRNA flu vaccine for older adults. The final decision on Moderna’s flu shot is unclear due to the FDA lacking a permanent vaccine chief and commissioner.

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.

An FDA advisory panel unanimously endorsed Moderna's mRNA flu vaccine, concluding its benefits outweigh risks for adults aged 50-64 and those 65+. The FDA may license it via traditional and accelerated pathways, with existing vaccines having used similar routes. Wellington Sun, a former FDA employee who later worked for Moderna, commented on accelerated pathways during the meeting.

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.