HHS Takes On Swine Flu H1N1 Vaccine Development
HHS Secretary Kathleen Sebelius announced today that the department will take important steps necessary to prepare for potential commercial-scale production of a candidate vaccine for the novel Influenza A (H1N1). The Secretary is directing approximately $1 billion in existing funds that will be used for clinical studies that will take place over the summer and for commercial-scale production of two potential vaccine ingredients for the pre-pandemic influenza stockpile.
"Preparation and planning are critical to keep Americans safe in the face of a potential pandemic," Secretary Sebelius said. "Our goal throughout this new H1N1 outbreak has been to stay one step ahead of the virus. An important part of this effort has been our work to develop a potential vaccine because vaccines can help prevent and control influenza virus outbreaks. The actions we are taking today will help us be prepared if a vaccine is needed."
The funds will be used to place new orders on existing contracts with companies that hold U.S. licenses for flu vaccines. With these orders, they will produce a bulk supply of vaccine antigen and adjuvant. Antigen is the active ingredient in a vaccine that causes the human body's immune system to develop antibodies that help fight an invading virus. Depending on the results of clinical studies, adjuvants could be added to a vaccine to improve the immune system's response and potentially reduce the amount of antigen necessary for the body to recognize and fight a virus.
Having both antigen and adjuvant on hand provides maximum flexibility in a future immunization program, if a program is recommended. For example, if needed these ingredients could be used in vaccine to help protect health providers and other members of the critical workforce, as recommended by the National Strategy for Pandemic Influenza.
With these funds manufacturers will also prepare pilot lots of potential vaccine for use in clinical studies to determine the proper dose for a vaccine, determine if adjuvants are appropriate and ensure a vaccine is safe and effective. The U.S. government will share as much information as possible from the results of these clinical studies with the World Health Organization and the global community so that other countries can benefit from the U.S. efforts to determine dosage, safety and effectiveness.
The Biomedical Advanced Research and Development Authority (BARDA) in the HHS Office of the Assistant Secretary for Preparedness and Response established the existing contracts with these companies in 2004 as part of the National Strategy for Pandemic Influenza.