The emergence of H5N1, or "avian flu," motivated the Department of Health and Human Services' 2005 plan to prepare for and combat an influenza pandemic. Three years ago domesticmanufacturers were unable to rapidly produce enough vaccine to protect the more than300 million people living in theUnited States. That remains the case today. With current technology, a pandemic could circle the globemore quicklythan vaccines could be produced.
HHS's plan has enlarged the role of the federal government in the influenza vaccine market, and the paperreleased byCBO today examines that increasingly prominent role -- in developing new vaccines, expanding the capacity of the industry to manufacture them, and procuring stockpiles of prepandemic vaccines.
HHS's plan has multiple objectives, including to:
Ongoing research has changed the environment in which HHSs plan was originally formulated in at least one important regard. Adjuvantssubstances that may be added to influenza vaccines to reduce the amount of active ingredient (called antigen) needed per dose of vaccineare showing promise in clinical trials in the United States; some of them have been approved for limited uses in Europe. That promise may offer a basis on which to make adjustments to HHSs plan.
Specifically, CBO reached the following conclusions:
Adjuvants developed since 2005 could substantially reduce the amount of antigen needed per dose, raising the question about whether HHSs current policy is the most cost-effective approach to meeting its vaccine production goals. In light of this, the report briefly examines several other options to consider if adjuvanted vaccines prove successful, including reducing capacity targeted for manufacturing cell-based influenza vaccines while expanding resources available to support development of next-generation vaccines, entering into advance supply agreements (an approach used by several European nations that allows countries to make advance payments to manufacturers in exchange for a guaranteed supply of vaccine in the event of a pandemic); and modifying the size of the planned vaccine stockpile.