After decades: New flu vaccine approved that may change the game

The FDA has approved Moderna's mRESVIA, the first mRNA-based flu vaccine. In a trial with 40,703 participants, it showed a relative efficacy 26.6% higher than a standard vaccine. Approval was granted via two pathways, for ages 50-64 and 65+. Side effects were more common but mild to moderate. Not yet approved in Israel.

The U.S. Food and Drug Administration (FDA) has approved Moderna's new flu vaccine, mRESVIA, based on mRNA technology. This is the first seasonal flu vaccine of its kind. Approval was granted via two pathways: a standard approval for ages 50 to 64, and an accelerated approval for ages 65 and older, which requires further research. In a clinical trial involving 40,703 people aged 50 and above, a relative efficacy 26.6% higher than a standard-dose flu vaccine was found. The vaccine targets two influenza A strains and one influenza B strain, and does not contain a live virus. A potential advantage is shortening production time to two to three months, but it has not yet been proven that this leads to better clinical protection. Side effects were more common, including injection site pain in about 66% of recipients, but most were mild to moderate. In Israel, the vaccine has not yet been approved for use.