First U.S. Cell-based Flu Vaccine Plant Opens in North Carolina

In an influenza pandemic, the new facility may be able to produce 25% of the vaccine needed in the United States.

In an effort to provide vaccine supplies sooner in an influenza pandemic, a public-private partnership of the U.S. Department of Health and Human Services, and Novartis Vaccines and Diagnostics, Inc. of Cambridge, Mass., opened a plant in Holly Springs, N.C on Dec. 12.

The plant, which can create vaccine using cultured animal cells instead of the conventional process of using fertilized eggs, is the first U.S. facility to use a faster and more flexible technology to make influenza vaccine, according to a statement released by the companies.

"Today we're marking the first change in influenza vaccine manufacturing in the United States in 50 years," said Robin Robinson, Ph.D., director of the Biomedical Advanced Research and Development Authority in HHS's Office of the Assistant Secretary for Preparedness and Response (ASPR). Robinson led the effort for HHS. "The pandemic readiness of this facility is a major milestone in national preparedness for pandemic influenza and other diseases." 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.

In an influenza pandemic, the new Novartis facility may be able to produce 25% 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.

In addition to partnering to bring cell-based flu vaccine and adjuvant technologies to the United States, HHS and Novartis are partnering with Synthetic Genomics Vaccines of Rockville, Maryland on new technologies to shorten the vaccine manufacturing timeline by optimizing vaccine virus seed strains used for flu vaccine production.

The Biomedical Advanced Research and Development Authority (BARDA) and Novartis also are working with North Carolina State University to train scientists from other countries to use cell culture based manufacturing techniques similar to what is used in the new facility. The training program is part of a World Health Organization initiative to strengthen the ability of developing countries to produce flu vaccine, potentially reducing the global threat from influenza.

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