Novartis to Build First U.S. Plant for Cell-Based Flu Vaccine

The U.S. Department of Health and Human Services said it has given a $487 million contract to Novartis Vaccines and Diagnostics, Inc., to build the first U.S. facility to manufacture cell-based vaccine for seasonal and pandemic flu. The plant is to be built in Holly Springs, N.C., with HHS paying 40 percent of its cost and Novartis paying 60 percent, the federal agency said.

Cell-based influenza vaccine can be made faster and in larger quantities than traditional vaccine, and the new plant is expected to increase the U.S. capacity to make pandemic flu vaccine by at least 25 percent, according to HHS. It will help with response to surge capacity needs becaose cells can be frozen and stored or developed quickly in response to an epidemic. "Cell-based vaccine production also dramatically reduces the possibility for contamination and promises to be more reliable, flexible, and expandable than egg-based methods," said HHS. "Currently, influenza vaccines licensed by the U.S. Food and Drug Administration (FDA) are made in specialized chicken eggs using a process that has changed little in over 50 years. In place of eggs, cell-based vaccine production uses laboratory-grown cells that are capable of hosting a growing virus. The virus is injected into the cells where it multiplies. The cells' outer walls are removed, harvested, purified, and inactivated. Using this technology, a vaccine can be produced in a matter of weeks."

"Today we are taking an important step in our ongoing commitment to pandemic preparedness," said Dr. Robin Robinson, director of the HHS Biomedical Advanced Research and Development Authority, which will oversee the contract. "In a pandemic, we would need vaccine ready within six months. That's why the National Strategy for Pandemic Influenza set domestic surge capacity as a goal in preparing the nation for a pandemic. That goal could not be accomplished using the traditional egg-based method of producing flu vaccine."

The contract calls for Novartis to provide two new flu vaccines for seasonal flu or pre-pandemic use, and the contract will fund clinical bridging studies to compare existing Novartis vaccines to new ones, including those developed in the Holly Springs plant -- thought to be a faster way to demonstrate the new ones are safe and effective.

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