The USDA has given approval for the manufacture of a seasonal influenza vaccine in the US using cell based technology. This milestone marks the first approval of using cell based technology in a stateside facility. The company, Novartis of Basel, Switzerland, has located the manufacturing facility in Holly Springs, N.C.
The facility can now produce more than one type of cell based influenza protection- the seasonal flu vaccine, and a more pandemic type vaccine. The USDA believes the 2 step vaccine production improves the country’s ability to be better prepared in the event of a widespread flu outbreak.
The new facility is a step in marrying a public-private partnership in the genre of emergency preparedness to increase the manufacture of medical countermeasures in the US in case of a terrorist attack or other emergency on US soil. If medications, vaccines, and other medical related productions are not reliant on import from European or other areas of manufacture, sources can more easily be produced and stockpiled. In the event of an emergency, such as a bioterrorism attack, supplies of medical countermeasures can be more easily and quickly produced and distributed to the general population.
According to the USDA, the facility in North Carolina has a vaccine production capacity of 200 million doses in a six month period after the declaration of a pandemic. The increase in potential production capability of the flu vaccines is one area the government is pursuing in exploring new technologies for emergency preparedness and public health oversight.
The vaccine designated for production in North Carolina is Flucelvax, made by Novartis in Germany. It was first approved for US production in 2012. The new facility increases US production annually by 50 million doses.
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