U.S. Policy Regarding Pandemic-Influenza Vaccines

September 15, 2008

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:

  • Increase manufacturing capacity by refurbishing and expanding plants that produce vaccines using traditional egg-based processes (developed in the 1940s) and increasing more costly cell-based manufacturing technology.
  • Make vaccines available more quickly. The plan takestwo approaches to this objective. First, stockpile a relatively small amount of prepandemic vaccines that could blunt the worst effects of a pandemic by protecting particularly vulnerable groups and first responders. Second, develop so-called next-generation vaccines that can be produced more rapidly than currently available vaccines to more efficiently meet long term needs.

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:

  • The manufacturers of currently approved vaccines made in the United States cannot produce vaccines of sufficient effectiveness, in sufficient quantities, or in the time required to meet public health needs in the event of an influenza pandemic.
  • In the short term, adjuvanted vaccines offer the best hope for achieving HHSs goal of having enough vaccine to protect 300 million people within six months of the outbreak of an influenza pandemic.
  • CBO estimates that it would cost between $1.2 billion and $1.8 billion to build new facilities for producing adjuvanted cell-based vaccines and between $7.6 billion and $11.4 billion to build new production facilities for cell-based vaccines without adjuvants.
  • Manufacturing capacity needed to produce pandemic-influenza vaccine exceeds that necessary to make seasonal vaccine; ongoing federal support may be required to meet and maintain necessary capacity.

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.