Novartis Seeks US Approval for Meningitis B Drug

Novartis Seeks US Approval for Meningitis B Drug

Seeking approval for its meningitis B vaccine Bexsero for adolescents and young people, Swiss drug-maker Novartis has submitted the vaccine to the U.S. Food and Drug Administration.

The vaccine has been already approved in 34 countries, including the European Union, Canada and Australia. The drug-maker said the vaccine has been provided to students and staff at Princeton University and the University of California Santa Barbara at the time of meningitis B outbreak in their respective campuses.

In addition, the FDA has also given green signal to Novartis' manufacturing facility in Holly Springs, North Carolina, for the production of cell-culture influenza vaccines. The facility is considered to be one-of-its-kind and has also got approval for commercial production.

Seasonal and pre-pandemic vaccines will be produced at the site. At the time of need, the site will be able to increase its production as well. For the first time in the US, Flucelvax will be produced in the nation.

"Cell-culture technology is the first major advancement in influenza vaccine production in the US in more than 40 years. We are proud to be at the forefront of this innovation", affirmed Andrin Oswald, Division Head, Novartis Vaccines.

Oswald said with the state-of-the-art facility, they will be able to accomplish dual purpose. Firstly, they will be able to offer US consumer an antibiotic and preservative-free alternative for seasonal flu vaccination. Secondly, they will be better prepared for future pandemic threats.

The Holly Springs facility has been formed due to the partnership between Novartis and the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS, BARDA).

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