On October 5, 2004, however, Chiron announced that it  could not provide its expected production of 46–48 million doses—about  half the expected U.S. influenza vaccine supply. HHS has primary responsibility for coordinating the nation’s response to  public health emergencies. Within HHS, CDC is one of the agencies that  protect the nation’s health and safety. Preparing for and responding to an influenza pandemic differ in several  respects from preparing for and responding to an annual influenza season. Limited Contingency Planning Slows Response

One lesson learned from the 2004–05 season that is relevant to a future  vaccine shortage in either an annual influenza season or a pandemic is the  importance of planning before a shortage occurs. At the time the influenza  vaccine shortage became apparent, the nation lacked a contingency plan  specifically designed to respond to a severe vaccine shortage. The absence  of such a plan led to delays and uncertainty on the part of many state and  local entities on how best to ensure access to vaccine during the shortage  by individuals at high risk of severe complications and others in priority  groups. Over the past 5 years, we have reported on the importance of planning to  address critical issues such as how vaccine will be purchased and  distributed; how population groups will be given priority for vaccination;  and how federal resources should be deployed before the nation faces a  pandemic. We have also urged HHS to complete its pandemic  preparedness and response plan, which the department released in draft  form in August 2004. On  November 2, 2005, HHS released its pandemic influenza plan. We did not,  however, have an opportunity to review the plan before issuing this  statement to determine whether the plan addresses these critical issues. Streamlined Mechanisms for Expediting Vaccine Availability Are Key to Effective Response

A second lesson from the experience of the 2004–05 vaccine shortage that  is relevant to future vaccine shortages in either an annual influenza season  or a pandemic is the importance of streamlined mechanisms to make  vaccine available in an expedited manner. For example, HHS began efforts  to purchase foreign vaccine that was licensed for use in other countries  but not the United States shortly after learning in October 2004 that Chiron  would not supply any vaccine. Some states’ experience during the 2004–05 vaccine shortage also  highlighted the importance of mechanisms to transfer available vaccine  quickly and easily from one state to another; the lack of mechanisms to do  so delayed redistribution to some states. Effective Response Requires Clear and Consistent Communication

Experience during the 2004–05 shortage also illustrated the critical role  communication plays when demand for vaccine exceeds supply and  information about future vaccine availability is uncertain, as could happen  in a future annual influenza season or a pandemic. State and local officials, however, identified several  communication lessons for future seasons or if an influenza pandemic  occurred:    Consistency among federal, state, and local communications is critical for  averting confusion. Disseminating clear, updated information is especially important when  responding to changing circumstances. Using diverse media helps reach diverse audiences. Education can alert providers and the public to prevention alternatives. Concluding Observations

Experience during the 2004–05 influenza vaccine shortage highlights the  need to prepare the nation for handling future shortages in either an  annual influenza season or an influenza pandemic. Related GAO Products

Influenza Vaccine: Shortages in 2004–05 Season Underscore Need for  Better Preparation. GAO-05-984.
Why GAO Did This Study

Concern has been rising about the nation's preparedness to respond to vaccine shortages that could occur in future annual influenza seasons or during an influenza pandemic--a global influenza outbreak. Although the timing or extent of a future influenza pandemic cannot be predicted, studies suggest that its effect in the United States could be severe, and shortages of vaccine could occur. For the 2004-05 annual influenza season, the nation lost about half its expected influenza vaccine supply when one of two major manufacturers announced in October 2004 that it would not release any vaccine. GAO examined federal, state, and local actions taken in response to the shortage, including lessons learned. The nation's experience during the unexpected 2004-05 vaccine shortfall offers insights into some of the challenges that government entities will face in a pandemic. GAO was asked to provide a statement on lessons learned from the 2004-05 vaccine shortage and their relevance to planning and preparing for similar situations in the future, including an influenza pandemic. This statement is based on a GAO report, Influenza Vaccine: Shortages in 2004-05 Season Underscore Need for Better Preparation (GAO-05-984), and on previous GAO reports and testimonies about influenza vaccine supply and pandemic preparedness.

What GAO Found

A number of lessons emerged from federal, state, and local responses to the 2004-05 influenza vaccine shortage that carry implications for handling future vaccine shortages in either an annual influenza season or an influenza pandemic. First, limited contingency planning slows response. At the start of the 2004-05 influenza season, when the supply shortfall became apparent, the nation lacked a contingency plan specifically to address severe shortages. The absence of such a plan led to delays and uncertainties on the part of state and local public health entities on how best to ensure access to vaccine by individuals at high risk of severe influenza-related complications. Second, streamlined mechanisms to expedite vaccine availability are key to an effective response. During the 2004-05 shortage, for example, federal purchases of vaccine licensed for use in other countries but not the United States were not completed in time to meet peak demand. Some states' experience also highlighted the importance of mechanisms to transfer available vaccine quickly and easily from one state to another. Third, effective response requires clear and consistent communication. Consistency among federal, state, and local communications is critical for averting confusion. State and local health officials also emphasized the value of updated information when responding to changing circumstances, using diverse media to reach diverse audiences, and educating providers and the public about prevention alternatives. Over the past 5 years, GAO has urged the Department of Health and Human Services (HHS) to complete its plan to prepare for and respond to an influenza pandemic. GAO has reported on the importance of planning to address critical issues such as how vaccine will be purchased and distributed; how population groups will be given priority for vaccination; and how federal resources should be deployed before the nation faces a pandemic. On November 2, 2005, HHS released its pandemic influenza plan. GAO did not have the opportunity to review the plan before issuing this statement to determine the extent to which the plan addresses these critical issues.