Flucelvax Quadrivalent Gets FDA Approval

Flucelvax becomes the first cell-culture-derived, inactivated seasonal influenza vaccine for ages ≥4
Flucelvax becomes the first cell-culture-derived, inactivated seasonal influenza vaccine for ages ≥4

The Food and Drug Administration (FDA) has approved Flucelvax Quadrivalent, the first four-strain (two influenza A strains + two influenza B strains), cell-culture-derived, inactivated seasonal influenza vaccine for patients 4 years of age and older. Cell-culture technology utilizes a well-characterized mammalian cell line rather than chicken eggs to grow virus strains.

Because both Flucelvax Quadrivalent and Flucelvax (a cell-based trivalent influenza vaccine approved in 2012) are manufactured using the same process and have overlapping compositions, the clinical efficacy and safety data from clinical trials with Flucelvax are relevant to Flucelvax Quadrivalent. 

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In clinical studies of adults aged 18–49 years, Flucelvax has been shown to be effective against influenza caused by vaccine-like strains (83.8%) and by all circulating influenza strains (69.5%). Its quadrivalent formulation was also shown to be immunogenic against the flu in adults aged 18 years and older and children aged 4 through 17. Flucelvax Quadrivalent produced stronger antibody responses to the influenza B virus strain, which was not contained in the trivalent comparator flu vaccine, and is well-tolerated with a safety profile similar to its comparator vaccines. 

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