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Green Signal Obtained by Novartis from the US FDA for cell-culture flu vaccines
- Updated: June 17, 2014
The Biologic License Application for getting marketing approval for Bexsero meningitis B vaccine in the United States has been submitted by Novartis. Their vaccine has already received approval from 34 other countries. Novartis came up with this drug after researching for over 20 years. This vaccine was introduced in 2013 and Novartis has distributed over half a million doses across the globe. The FDA has awarded them with a breakthrough Therapy Status for this cell-culture vaccine.
The disease that causes viral or bacterial infection to occur in the membranes that cover the brain and spinal cord is referred to as meningitis. This type of disease is rare but can be life-threatening. The symptoms resemble those of flu and if not treated within 24 hours can kill or cause a serious disability. Bexsero has been administered to staff as well as students in some Universities in the U.S when an outbreak of meningitis B occurred. The US health authorities continue to work with Novaratis to provide Bexsero for any age groups.
The U.S Food and Drug Administration have also given their approval for introducing a facility in North Carolina called Holly Springs. They will produce pre-pandemic and seasonal influenza vaccines. This facility that uses cell-culture technology will have the capacity of ramping up production if a pandemic should occur. The U.S Department of Health and Human Services, Biomedical Advanced R&D authority and Novartis are in joint partnership of the Holly Spring facility. They were privileged to win the 2013 ISPE Facility of the Year Award.
Flucelvax is also producing using cell-culture technology by Novartis. This type of technology offer numerous benefits over the traditional vaccine for influence that is manufactured with chicken eggs. Novartis was able to develop a vaccine for the H7N9 influenza associated with the avian virus in China in March 2013.