Novartis’ Flucelvax, which gained FDA approval last Tuesday, is set to make a big impact on manufacturing processes in the vaccines market while creating a splash as the first seasonal vaccine produced by cell culture, states healthcare industry analysts GlobalData.

“The propagation of influenza virus in chicken eggs has been the standard in the influenza vaccine manufacturing process for decades, but this process takes months, and the egg-based process is difficult to scale-up,” explains Brad Tebbets, Ph.D., GlobalData’s Analyst covering Infectious Diseases.

“Producing influenza vaccines via cell culture–based technology requires less manufacturing time and is more amenable to increasing the production scale over the egg-based method.”

The 2009 swine flu outbreak highlighted the inability of egg-based influenza vaccines to meet demand in response to pandemics or other shortages in supply.

In response, the US Department of Health and Human Services made a concerted effort to encourage cell culture influenza vaccine development by offering contracts to interested pharmaceutical companies – one being Novartis, which is now positioned to reap the rewards.

“We expect that this novel production method will enable Flucelvax to steal market share from egg-based influenza vaccines such as CSL Biotherapies’ Afluria and Novartis’ own Fluvirin,” says Tebbets.

GlobalData also predicts that Flucelvax will initially steal sales from Sanofi’s Fluzone and GlaxoSmithKline’s intramuscular vaccines, but the anticipated launch of quadrivalent formulations in 2013 and 2014, respectively, are expected to cut short the dominance of Novartis’ trivalent vaccine option.
 

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NOTES TO EDITORS

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