HHS Secretary Kathleen Sebelius announced 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),” and that HHS “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.” Secretary Sebelius said, “Preparation and planning are critical to keep Americans safe in the face of a potential pandemic. 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.”

HHS said 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. HHS noted that 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.”

The funds will also support manufacturers which 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.”

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