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First Flu Vaccine From Cell Culture Is FDA Approved

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

A new influenza vaccine, Flucelvax from Novartis, produced in cell culture has been approved by the FDA for individuals 18 years and older. In the past, vaccines have been produced from chicken eggs.

"The cell-based vaccine is as safe and effective as traditional egg-based vaccine and the technology used to manufacture it is more flexible and reliable than the traditional technology," said Health and Human Services Secretary Kathleen Sebelius in a statement Tuesday (November 20).

In cell culture technology, virus strains are grown inside mammalian animal cells, providing an option for those with egg allergies, as well as a new weapon should a new flu pandemic emerge.

Flucelvax was evaluated in clinical studies in the United States and Europe involving some 7,700 people ages 18 to 49. Common side effects included pain, redness, injection-site soreness, headache and fatigue -- reactions typically seen in people given egg-based flu vaccines, the FDA said.

The European Medicines Agency approved the same vaccine, called Optaflu, in 2007.

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