Summary

Influenza is associated with an average of 36,000 deaths and more than 200,000 hospitalizations each year in the United States. Persons aged 65 and older are involved in more than 9 of 10 deaths and 1 of 2 hospitalizations related to influenza. The best way to prevent influenza is to be vaccinated each fall. In the 2000-01 flu season, and again in the 2003-04 flu season, this country experienced periods when the demand for flu vaccine exceeded the supply, and there is concern about the availability of vaccines for this and future flu seasons. There is also concern about the prospect of a worldwide influenza epidemic, or pandemic, which many experts believe to be inevitable. Three influenza pandemics occurred in the twentieth century. Experts estimate that the next pandemic could kill up to 207,000 people in the United States and cause major social disruption. Public health experts have raised concerns about the ability of the nation's public health system to respond to an influenza pandemic. GAO was asked to discuss issues related to supply, demand, and distribution of vaccine for a regular flu season and assess the federal plan to respond to an influenza pandemic. GAO based this testimony on products it has issued since October 2000, as well as work it conducted to update key information.

Challenges persist in ensuring an adequate and timely flu vaccine supply. The number of producers remains limited, and the potential for manufacturing problems such as those experienced in recent years is still present. If a manufacturer's production is affected, those providers who ordered vaccine from that manufacturer could experience shortages, while providers who received supplies from another manufacturer might have all the vaccine they need. This potential for imbalance is what creates situations in which some providers might not have enough vaccine for persons at highest risk, while other providers might have enough supply to hold mass-immunization clinics even for persons at lower risk for flu-related complications. To help limit the potential for such situations, the Centers for Disease Control and Prevention (CDC) and others have taken such steps as adding flu vaccine to federal stockpiles and more aggressively monitoring the projected supply of vaccine. However, there is no system in place to ensure that seniors and others at high risk for complications receive flu vaccinations first when vaccine is in short supply. The Department of Health and Human Services' (HHS) draft "Pandemic Influenza Preparedness and Response Plan" provides a blueprint for the government's role but leaves some important decisions about the government's response unresolved. In addition to describing the federal role, responsibilities, and actions in collaboration with the states in responding to an influenza pandemic, the plan also provides planning guidance to state and local health departments and the health care system. The draft plan is comprehensive in scope, but it leaves decisions about the purchase, distribution, and administration of vaccines open for public comment and for the states to decide individually. In addition, the draft plan does not make recommendations for how population groups should be prioritized to receive vaccines in a pandemic. Difficulties encountered during the annual flu season in the purchase, distribution, and administration of flu vaccine highlight the importance of resolving these issues for pandemic preparedness. Officials from CDC provided technical comments on this testimony that GAO incorporated as appropriate.