Novartis says cell-based flu vaccine facility ready to produce

From Robert Roos at CIDRAP, excerpt :

" Novartis's new cell-culture based influenza vaccine factory in North Carolina has begun making a prepandemic H5N1 flu vaccine and is ready to start producing vaccines for a real pandemic when needed, the company and federal health officials announced yesterday.

The facility in Holly Springs, N.C., billed as the first of its kind in the United States, was dedicated yesterday after a long testing process.

As part of the testing, last week the plant produced two lots of "prepandemic" H5N1 flu vaccine for the Strategic National Stockpile, and another lot will be completed this week, for a total of 6.5 million doses, said Liz Power, a spokeswoman for Novartis Vaccines and Diagnostics, Cambridge, Mass.

"The dedication signals that in an influenza pandemic the facility can produce cell-based influenza vaccine that could be authorized by the US Food and Drug Administration for use during the emergency," the US Department of Health and Human Services (HHS) said in a press release.

Dr. Robin Robinson, director of HHS's Biomedical Advanced Research and Development Authority (BARDA), called the plant's dedication "a major milestone" in national pandemic preparedness. "Today we're marking the first change in influenza vaccine manufacturing in the United States in 50 years," he said in the release.

Cell-based vaccine production involves growing flu viruses in mammalian cell cultures instead of in chicken eggs, the conventional method. It is regarded as more flexible and somewhat faster than egg-based production. No cell-based flu vaccine has yet been approved by the FDA, though such vaccines, including one made by Novartis, are licensed in Europe.

In a flu pandemic, the Novartis plant may be able to produce up to 25% of the vaccine doses needed in the United States, HHS said. The facility is designed to produce 150 million doses of a monovalent vaccine within 6 months after declaration of a pandemic, according to Power."