First cell-culture-derived influenza vaccine has been approved by US FDA

Hannah Blake

pharmaphorum

Novartis’ influenza virus vaccine, fluxelvax, has been approved for use in the United States by the FDA. Flucelvax is the first cell-culture-derived vaccine for individuals aged 18 years and older.

Cell-culture manufacturing technology is an alternative production method to the traditional egg-based production. Cell-culture production occurs in a closed, sterile, controlled environment, which significantly reduces the risk of potential impurities. It’s been successfully used to manufacture other vaccines, such as for polio, rubella, hepatitis A and flu vaccines distributed during the H1N1 pandemic.

“The approval of Flucelvax is an important milestone for our influenza franchise and brings an innovative vaccine to the US. Modern cell-culture technology will likely become the new standard for influenza vaccine production and we are proud to lead the way.”

Andrin Oswald, Division Head, Novartis Vaccines and Diagnostics.

In any given season, influenza may cause between 3,000 and 49,000 deaths in the US alone. The Centers for Disease Control and Prevention (CDC) recommends that everyone 6 months of age and older get vaccinated for seasonal influenza every year.

Novartis has partnered with the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS, BARDA) for the development of the cell-culture manufacturing technology, as well as for construction of a state-of-the-art manufacturing facility in North Carolina. This facility, which is the first of its kind in the US, will produce flucelvax as soon as it is ready for full-scale commercial production.

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