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On November 20, the FDA announced the approval of Flucelvax, an inactivated seasonal influenza vaccine indicated for patients aged ≥18 years. The vaccine is produced using cultured animal cells rather than fertilized chicken eggs. Although mammalian cell culture has long been used for production of other vaccines, Flucelvax is the first seasonal influenza vaccine manufactured by this method to be approved in the U.S.
In a randomized, placebo-controlled trial involving 7700 people aged 18 to 49, Flucelvax was 84% effective in preventing influenza. In a separate study involving about 1700 individuals aged >49, immunogenicity was similar to that of an egg-based vaccine. Safety evaluations revealed injection-site and general reactions typical of…