Manufacturing Problems Caused Temporary Shortages and Spikes in Price

Overall, manufacturing problems led to vaccine production and distribution delays of about 6-8 weeks in 2000-01. Two main factors contributed to the delay. Providers of flu vaccine also represent a diverse group. When the supply of vaccine was delayed in the fall of 2000, the manufacturers and distributors we interviewed reported that it was difficult to determine which of their purchasers should receive priority vaccine deliveries in response to the ACIP’s July and October 2000 recommendations to vaccinate high-risk groups first. For example, although one manufacturer shipped available vaccine to the nursing homes it could identify in its customer base as first priority, this did not ensure that all nursing homes received vaccine for their high-risk patients on a priority basis. HHS Has Initiatives Under Way to Prepare for Future Vaccine Delays and Shortages

While HHS has no direct control over how influenza vaccine is purchased and distributed by the private sector and local governments during the annual influenza season, it has several initiatives under way to help mitigate the adverse effects of any future shortages and delays. As shown in table 5, these initiatives include (1) conducting clinical trials on the feasibility of using smaller doses of vaccine for healthy 18- to 49-year-olds, (2) working with public and private sector entities involved in vaccine distribution to explore ways of better targeting vaccine to high-risk groups, (3) recommending state and local health department actions to prepare for a vaccine delay or shortage, and (4) revising guidelines to expand the recommended timing of influenza immunizations. Conclusions

The circumstances that led to the delay and early shortage of flu vaccine during the 2000-01 flu season could repeat themselves in the future.
Why GAO Did This Study

Until the 2000-2001 flu season, the production and the distribution of flu vaccine generally went smoothly. In the fall of 2000, however, stories began to circulate about delays in obtaining flu vaccines. GAO reviewed (1) the circumstances that contributed to the delay and the effects the delay had on prices paid for vaccine, (2) how effectively current distribution channels ensure that high-risk populations receive vaccine on a priority basis, and (3) what the federal government is doing to better prepare for possible disruptions of influenza vaccine supply.

What GAO Found

GAO found that manufacturing difficulties resulted in an overall delay of about 6-8 weeks in shipping vaccine to most customers and a temporary price spike. Manufacturers experienced unprecedented problems growing a new viral strain, while two of four manufacturers halted production--one permanently--to address safety and quality control concerns. There is currently no system to ensure that high-risk patients have priority when the supply of vaccine is short. Although the federal government has no direct control over how influenza vaccine is purchased and distributed by the private sector and state and local governments, the Department of Health and Human Services (HHS) has several efforts underway to help cope with future influenza vaccine shortages and delays. For example, the Centers for Disease Control and Prevention (CDC) revised guidelines to extend the recommended timeframe for receiving immunizations. CDC is also helping to bring together manufacturers, distributors, providers, and others in the private and public sectors to explore ways to improve distribution to high-risk individuals.