As part of its mission, the department has a  role in the planning needed to prepare for and respond to an influenza  pandemic. CDC’s activities include efforts to prevent  and control diseases and to respond to public health emergencies. FDA, another HHS agency, also plays a role in preparing for  the annual influenza season and for a potential pandemic. For the 2004–05 influenza season, CDC estimated as late as September  2004 that about 100 million doses of vaccine would be available for the  U.S. market. HHS has not  finalized planning for an influenza pandemic, leaving unanswered  questions about the nation’s ability to prepare for and respond to such an  outbreak. Key questions  about the federal role in purchasing and distributing vaccines during a  pandemic remain, and clear guidance on potential groups that would likely  have priority for vaccination is lacking in the current draft plan. One challenge is that the draft pandemic plan does not establish the  actions the federal government would take to purchase or distribute  vaccine during an influenza pandemic. Communicating Information about the Situation and Response Plan Clearly and Effectively

Another challenge in responding to a pandemic will be to clearly  communicate information about the situation and the nation’s response  plans to public health officials, providers, and the public. State  officials emphasized that these mixed messages created confusion. In the   2004–05 influenza season, individuals seeking vaccine could have found  themselves in a communication loop that provided no answers. During the 2004–05  influenza season, public health officials reported the importance of  different methods of communication. Ensuring Supply of Influenza Vaccine and Antiviral Drugs

Challenges in ensuring an adequate and timely supply of influenza vaccine  and antiviral drugs—which can help prevent or mitigate the number of  influenza-related deaths until an pandemic influenza vaccine becomes  available—may be exacerbated during an influenza pandemic. Particularly  given the time needed to produce vaccines, influenza vaccine may be  unavailable or in short supply and may not be widely available during the  initial stages of a pandemic. The shortages of influenza vaccine in 2004–05 and previous seasons have  highlighted the fragility of the influenza vaccine market and the need for  its expansion and stabilization. Hospital and Workforce Capacity to Respond to Large- Scale Infectious Disease Outbreaks

The lack of sufficient hospital and workforce capacity is another challenge  that may affect response efforts during an influenza pandemic. Public health  officials we spoke with said that a large-scale outbreak, such as an  influenza pandemic, could strain the available capacity of hospitals by  requiring entire hospital sections, along with their staff, to be used as  isolation facilities. Concluding Observations

Important challenges remain in the nation’s preparedness and response  should an influenza pandemic occur in the United States. This is a work of the U.S. government and is not subject to copyright protection in the  United States.
Why GAO Did This Study

Shortages of influenza vaccine in the 2004-05 and previous influenza seasons and mounting concern about recent avian influenza activity in Asia have raised concern about the nation's preparedness to deal with a worldwide influenza epidemic, or influenza pandemic. Although the extent of such a pandemic cannot be predicted, according to the Centers for Disease Control and Prevention (CDC), an agency within the Department of Health and Human Services (HHS), it has been estimated that in the absence of any control measures such as vaccination or antiviral drugs, a "medium-level" influenza pandemic could kill up to 207,000 people in the United States, affect from 15 to 35 percent of the U.S. population, and generate associated costs ranging from $71 billion to $167 billion in the United States. GAO was asked to discuss the challenges the nation faces in responding to the threat of an influenza pandemic, including the lessons learned from previous annual influenza seasons that can be applied to its preparedness and overall ability to respond to a pandemic. This testimony is based on GAO reports and testimony issued since 2000 on influenza vaccine supply, pandemic planning, emergency preparedness, and emerging infectious diseases and on current work examining the influenza vaccine shortage in the United States for the 2004-05 influenza season.

What GAO Found

The nation faces multiple challenges to prepare for and respond to an influenza pandemic. First, key questions about the federal role in purchasing and distributing vaccines during a pandemic remain, and clear guidance on potential priority groups is lacking in HHS's current draft of its pandemic preparedness plan. For example, the draft plan does not establish the actions the federal government would take to purchase or distribute vaccine during an influenza pandemic. In addition, as was highlighted in the nation's recent experience responding to the unexpected influenza vaccine shortage for the 2004-05 influenza season, clear communication of the nation's response plan will be a major challenge. During the 2004-05 influenza season, state health officials reported that mixed messages created confusion. For example, CDC advised vaccination for persons aged 65 and older, and at the same time a state advised vaccination for persons aged 50 and older. Further challenges include ensuring an adequate and timely supply of influenza vaccine and antiviral drugs, which can help prevent or mitigate the number of influenza-related deaths. Particularly given the length of time needed to produce vaccines, influenza vaccine may be unavailable or in short supply and might not be widely available during the initial states of a pandemic. Finally, the lack of sufficient hospital and health care workforce capacity to respond to an infectious disease outbreak may also affect response efforts during an influenza pandemic. Public health officials we spoke with said that a large-scale outbreak, such as an influenza pandemic, could strain the available capacity of hospitals by requiring entire hospital sections, along with their staff, to be used as isolation facilities.