HealthDay News — The FDA has approved Flucelvax (Novartis), the first seasonal flu vaccine using a manufacturing method called cell culture technology, the agency said.
Other flu vaccines are produced inside eggs, but that process takes longer than the newer method and could be harmful to people with egg allergies. In cell culture technology, virus strains are grown inside mammalian animal cells, the FDA explained in a press release.
This technology has been used for decades to produce other vaccines and since it is quicker, it can be used more efficiently to develop flu vaccines rapidly in the event of a pandemic.
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The approval comes after a placebo-controlled clinical trial conducted during the 2007-2008 flu season in the U.S., Finland and Poland, showed the vaccine had an efficacy of 83.8% in preventing infection — similar to a conventional flu vaccine — among adults 18 to 49 years old.
A separate study in individuals 65 and older also demonstrated efficacy comparable with a conventional product.
Common side effects include pain, redness, injection-site soreness, headache and fatigue — reactions typically seen in people given egg-based flu vaccines, the FDA said.
The U.S. Centers for Disease Control and Prevention recommends the annual flu shot for anyone 6 months and older. Neither the FDA, nor Novartis indicated when Flucelvax will be commercially available.
