FDA Approvals
FluBlok – The First FDA-Approved Recombinant Seasonal Influenza Vaccine
On November 20, 2012, Novartis announced that the U.S. FDA had approved Flucelvax, the first cell culture-derived seasonal influenza vaccine for use in individuals >18 years of age. Flucelvax was produced by culture of virus in cell culture, making it the first approved influenza vaccine not grown in embryonated hen’s eggs. In the production process, whole virions are harvested, inactivate, and disrupted by detergent, followed by antigen extraction. Protein Sciences have taken influenza vaccine technology a step further.
On January 17, 2003, the FDA approved FluBlok for individuals 18 – 49 years of age, making it the 11th influenza vaccine registered in the U.S. FluBlok is manufactured using a baculovirus expression vector system in insect cell culture (Sf9 cells of the fall armyworm, Spodoptera frugiperda). The ability to produce vaccine product in approximately 2 months makes it better suited to deal with influenza virus evolution necessitating yearly reassessment of the vaccine composition. The vaccine contains no adjuvant but does contain approximately 3 times the amount of hemagglutinin antigen present in traditional egg-based vaccines (135 mcg per 3-component dose). Despite significant mismatch between vaccine antigens and circulating viruses, clinical trials demonstrated that FluBlok was 44.6% (95% CI, 18.8%, 62.6%) effective in preventing culture-confirmed influenza meeting the CDC case definition of influenza-like illness.2
While the approval of an influenza vaccine utilizing recombinant technology is a significant advance, the need to change the vaccine in response to changes in circulating influenza types is still present. We continue to await the goal of a universal influenza vaccine that provides protection without regard to changes in viral surface antigen.
References
- http://tisvaccines.com/downloads/flucelvax/GLOBAL_Press_Release.pdf
- Treanor JJ, et al. Protective efficacy of a trivalent recombinant hemagglutinin protein vaccine (FluBlok®) against influenza in healthy adults: a randomized, placebo-controlled trial. Vaccine 2011; 29:7733-9.
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