FDA Approves Cell Culture Seasonal Flu Vaccine

The Food and Drug Administration approved yesterday Flucelvax, the first seasonal influenza vaccine cleared for use in the U.S., produced with cultured animal cells, instead of fertilized chicken eggs. Flucelvax is made by the  global pharmaceutical company Novartis, based in Basel, Switzerland.

The virus strains in the vaccine are grown in animal cells of mammalian origin instead of in eggs, the method used to manufacture flu vaccines up to now. Mammalian cell lines are currently being used to produce other types of vaccines, such as those for polio, rubella, and hepatitis, as well as the H1N1 vaccine.

Traditional influenza vaccine production requires a large number of fertilized chicken eggs to grow virus strains, a complex process that takes months for virus incubation and actual production before the vaccine is delivered to physicians or pharmacies. The mammalian cell process makes it easier to maintain an adequate supply of production-ready cells for vaccine manufacturing, and reduce the time needed to start up vaccine production in the event of a pandemic.

Flucelvax was tested in randomized, controlled clinical trials in the U.S. and Europe with some 7,700 people, age 18 to 49, who received either Flucelvax or a placebo. The vaccine was shown to be effective in 84 percent of the cases in preventing influenza compared to a placebo. For people older than 49, use of Flucelvax is supported by a study of antibody responses in 1,700 adults indicating Flucelvax to be comparable to Agriflu, an egg-based seasonal influenza vaccine approved by FDA for use in people 18 years and older. Safety studies of Flucelvax show pain, redness, and soreness at the injection site and headache and fatigue were the most common reactions.

The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, helped fund development of cell-culture technology. BARDA is also contributing to construction of a vaccine production facility in Holly Springs, North Carolina, where Flucelvax will be manufactured.

Read more:

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• Vaccine Developer Awarded Countermeasures Center Contract
• Microemulsion Shows Promise for Extending Vaccine Shelf 
• Biotech, Pharma Companies to Collaborate on New Vaccines
• Patent Issued for Protein-Engineered Flu Vaccine 

Photo: Umberto Salvagnin/Flickr

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