SATURDAY, OCTOBER 1, 2016

U.S. facility to produce cell-based influenza vaccine

The FDA approved on Wednesday the manufacture of a seasonal influenza vaccine using cell-based technology in a U.S. facility for the first time.

The facility is located in Holly Springs, N.C., and is owned by Novartis. It was built in 2009 through a partnership between Novartis and the Biomedical Advanced Research and Development Authority (BARDA).

The vaccine, manufactured by the facility, will prevent seasonal influenza and pandemic influenza viruses.

The project is sponsored by BARDA, which is part o the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR).

The project supports a multi-use approach to emergency preparedness through drugs, vaccines, diagnostics and devices.

The Holly Springs facility is prepared to produce up to 200 million doses of the pandemic influenza vaccine within six months of the declaration of a pandemic.

The facility opened in 2012 for the purpose of providing an FDA approved cell-based influenza vaccine in the case of an emergency. The vaccine, called Flucelvax, was the first cell-based influenza vaccine approved by the FDA for use in the United States. It was made by Novartis in Germany.

The U.S. facility will be able to increase seasonal vaccine production by at least 50 million doses.