First U.S. cell-based flu vaccine plant set for dedication
Facility's ability to produce cell-based pandemic flu vaccine marks historic change
The first U.S. facility to use a faster and more flexible technology to make influenza vaccine was dedicated today, 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. This partnership will be maintained under contract for at least 25 years.
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.
"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."
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.
Investing in new vaccine technology to improve the time necessary to produce pandemic vaccine and increase the nation's surge capacity was recommended in two August 2010 reports, the Public Health Emergency Medical Countermeasures Enterprise Review released by Secretary Kathleen Sebelius and the President's Council of Advisors on Science and Technology Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza.
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.
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.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. ASPR is an HHS leader in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities' ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
Within ASPR, BARDA provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases.
For more information on pandemic preparedness efforts, visit www.phe.gov or www.flu.gov and to learn more about partnering with HHS ASPR's BARDA in public health preparedness visit www.medicalcountermeasures.gov. Contract opportunities are announced at www.fbo.gov.