FDA Approves Novartis Flucelvax Vaccine
Novartis announced that the FDA has approved the use of Flucelvax (inactivated influenza vaccine [Types A and B]) for active immunization in the prevention of influenza in patients ≥18 years old.
Flucelvax vaccine is the first cell-culture-derived vaccine, an alternative to the traditional egg-based production. Cell-culture technology utilizes a well-characterized mammalian cell line rather than chicken eggs to grow virus strains. Flucelvax does not contain any preservatives, such as thimerosal or antibiotics.
The approval is based on data from a multinational, randomized, observer-blinded, placebo-controlled trial that assessed clinical efficacy and safety of Flucelvax during the 2007–2008 influenza season in adults aged 18–49 years in the U.S., Finland, and Poland. A total of 11,404 subjects received Flucelvax (n=3828), seasonal influenza vaccine Agriflu (n=3676) or placebo (n=3900) in a 1:1:1 ratio. Data found Flucelvax to be well tolerated, with an efficacy of 83.8% against antigenically-matched strains compared to placebo. In a separate study in adults aged ≥65 years, Flucelvax demonstrated comparable immunogenicity to Agriflu for all three strains post-vaccination.
Flucelvax will be produced once the manufacturing facility is ready for full-scale commercial production.
For more information call (800) 693-9993 or visit www.novartisvaccines.com.