Influenza and pneumonia rank as the  fifth leading cause of death among persons aged 65 and older. Currently, two  manufacturers—one in the United States and one in the United Kingdom— produce over 95 percent of the vaccine used in the United States. Production for the  2003-04 flu season was based on the previous year’s demand and was  about 87 million doses. HHS also has a role in planning to prepare for and respond to an influenza  pandemic. Planning is key to being prepared for and mitigating the  negative effects of the next influenza pandemic, including major illness,  death, economic loss, and social disruption. Challenges Exist in Ensuring an Adequate and Timely Flu Vaccine Supply

Ensuring an adequate and timely supply of vaccine is a difficult task. For the 2003-04 flu season, shortages of vaccine have been attributed to an  earlier than expected and more severe flu season and to higher than  normal demand, likely resulting from media coverage of pediatric deaths  associated with influenza. According to CDC officials, this increased  demand occurred in a year in which manufacturers had produced about  the same number of doses as in the previous season and that supply was  not adequate to meet the demand. This happened in the 2000-01  season, and it could happen again. When vaccine supply is limited relative to public demand for flu  shots, distributors and others who have supplies of the vaccine have the  ability—and the economic incentive—to sell their supplies to the highest  bidders rather than filling lower-priced orders they had already received. Our work has also found that there is no mechanism in place to ensure  distribution of flu vaccine to high-risk individuals before others when the  vaccine is in short supply. Including the flu vaccine in the Vaccines for Children (VFC) stockpile to  help improve flu vaccine supply. HHS’s Draft Pandemic Influenza Plan Defines Roles and Responsibilities but Leaves Some Important Issues Unresolved

HHS’s draft pandemic influenza plan describes federal roles and  responsibilities in responding to an influenza pandemic and provides  planning guidance to state and local health departments and the health  care system. In addition, the draft plan does not  make recommendations for how population groups should be prioritized  to receive vaccines in a pandemic. The draft plan also provides technical  background information on preparedness and response activities such as  vaccine development and production. Draft Plan Leaves Many Important Issues Unresolved, Making It Difficult for States to Plan

Although HHS’s draft pandemic influenza plan is comprehensive in scope,  it leaves many important decisions about the purchase, distribution, and  administration of vaccines unresolved. These decisions include  determining the public- versus the private-sector roles in the purchase and  distribution of vaccines; the division of responsibility between the federal  government and the states for vaccine distribution; and how population  groups will be prioritized and targeted to receive limited supplies of  vaccines. Only two manufacturers currently produce flu vaccine for  seniors and others at high risk for flu-related complications, and  manufacturing problems experienced in recent years illustrate the fragility  of the current methods of production. Despite efforts by CDC and others,  there remains no system to ensure that persons at high risk for  complications receive flu vaccine first when vaccine is in short supply. Agency Comments

Officials from CDC provided technical comments that we incorporated as  appropriate. Related GAO Products

SARS Outbreak: Improvements to Public Health Capacity Are Needed for  Responding to Bioterrorism and Emerging Infectious Diseases. Influenza Pandemic: Plan Needed for Federal and State Response.
Why GAO Did This Study

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.

What GAO Found

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.