	Background

Influenza is associated with an average of more than 200,000  hospitalizations and 36,000 deaths each year in the United States. People who are aged 65 and older, people of any age with  chronic medical conditions, children younger than 2 years, and pregnant  women are more likely to get severe complications from influenza than  other people. Not everyone in these  high-risk and target groups, however, receives a vaccination each year. This nasal  spray vaccine is not recommended for individuals at high risk for flu- related complications. Challenges Exist in Ensuring an Adequate and Timely Flu Vaccine Supply

Ensuring an adequate and timely supply of vaccine is a difficult task. If production problems delay or disrupt the availability of vaccine in a  given year, the timing for an individual provider to obtain flu vaccine may  depend on which manufacturer’s vaccine it ordered. This happened in the  2000-2001 season, and there are reports of similar problems this season  after one manufacturer that had previously stated it expected to supply   46 million to 48 million doses announced that it would not deliver any flu  vaccine to the U.S. market. When vaccine supply is limited relative to public demand for flu  vaccinations, 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 the lower priced orders they had already  received. Following the 2000-2001 flu season, HHS undertook several initiatives to  address supply and demand of flu vaccine and to protect high-risk  individuals from flu-related complications when vaccine is in short supply. For the 2004-2005 flu season, despite early indications that one  manufacturer was having production difficulties, CDC published guidance  in September 2004 stating that it did not envision any need for tiered  vaccination recommendations or prioritization of vaccine for those at  higher risk of flu-related complications. Following the suspension of one  manufacturer’s license and the announcement it would not supply any  vaccine to the U.S. market this season, CDC revised its recommendations  and took steps to mitigate the vaccine shortage. Although HHS has limited authority to control flu vaccine distribution,  upon learning that nearly half of the nation’s expected flu vaccine supply  was in jeopardy, it took steps to help direct the available vaccine to help  providers get some vaccine for their high-risk patients. There are other media reports of anxious  seniors unable to get vaccinated in a timely fashion. We are beginning new work to analyze this year’s vaccine  shortage and the federal response. Under this system, some providers  can be left with little immediate recourse for meeting the needs of those  most at risk.
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 who are aged 65 and older, people with chronic medical conditions, children younger than 2 years, and pregnant women are more likely to get severe complications from influenza than other people. The best way to prevent influenza is to be vaccinated each fall. In early October 2004, one major manufacturer of flu vaccine for the United States announced that its facility's license had been temporarily suspended and it would not be releasing any vaccine for the 2004-2005 flu season. Because this manufacturer was expected to produce roughly one-half of the U.S. flu vaccine supply, the shortage resulting from its announcement has led to concern about the availability of flu vaccine, especially to those at high risk for flu-related complications. GAO was asked to discuss issues related to the supply, demand, and distribution of vaccine for this flu season in the context of the current shortage. GAO based this testimony on products we have issued since May 2001, as well as work we conducted to update key information.

What GAO Found

The current vaccine shortage demonstrates the challenges to ensuring an adequate and timely flu vaccine supply. Only three manufacturers produce flu vaccine for the U.S. market, and the potential for future manufacturing problems such as those experienced both this year and to a lesser degree in previous years is still present. When shortages occur, their effect can be exacerbated by the existing distribution system. Under this system, health providers and vaccine distributors generally order a particular manufacturer's vaccine and have limited recourse, even for meeting the needs of high-risk persons, if that manufacturer's production is adversely affected. By contrast, providers who purchased vaccine from a different manufacturer might receive more of their order and be able to vaccinate their high-risk patients. The current situation also reflects another concern: the nation lacks a systematic approach for ensuring that seniors and others at high risk for flu-related complications receive flu vaccine when it is in short supply. Once this year's shortage became apparent, the Centers for Disease Control and Prevention (CDC) took a number of steps to influence distribution patterns to help providers get some vaccine for their high-risk patients. These steps are still playing themselves out, and it will take more time to assess how well they will work. Problems have not been totally averted, however, as there have been media reports of long lines to obtain limited doses of vaccine and of high-risk individuals unable to find a flu vaccination in a timely fashion.