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The first U.S. facility to use a more flexible technology to make influenza vaccine was dedicated this week, as part of an initiative that could provide vaccine supplies sooner in an influenza pandemic. The plant in Holly Springs, N.C., can create vaccine using cultured animal cells instead of the conventional process of using fertilized eggs. The facility is a public-private partnership of the U.S. Department of Health and Human Services, and Novartis Vaccines and Diagnostics, Inc. of Cambridge, Mass. The dedication signals that in an influenza pandemic the facility can produce cell-based influenza vaccine that could be authorized by the U.S. Food and Drug Administration for use during the emergency.

It’s the first major change in influenza vaccine manufacturing in the United States in 50 years. In an influenza pandemic, the new Novartis facility may be able to produce 25 percent of the vaccine needed in the United States.  In addition, cell-based technology used in this facility for manufacturing seasonal and pandemic influenza vaccines may be adapted to produce vaccines for other known and unknown emerging infectious diseases in an emergency. The United States joins several European countries with the capability to manufacture cell-based influenza vaccines on a large scale.

We didn’t reach this milestone overnight. The journey began nearly six years ago, in 2006, when HHS made key investments to support the development of multiple influenza vaccine candidates which used cell-based technology. That development led Novartis, on October 31 of this year, to submit the nation’s first application to the FDA for a cell-based vaccine for seasonal flu.

With this new technology and new facility now available in the U.S., we are better prepared as a nation for pandemic flu and other diseases. This major milestone shows how effective public-private partnerships can be. We’ll continue to push forward with tests to diagnose, track, prevent and treat pandemic influenza and a host of other diseases that could cause a public health emergency in our country. It’s part of our ongoing commitment to protecting the health of all Americans and supporting better public health worldwide.

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This is archived ASPR content.