CDC’s activities include efforts to prevent and control  diseases and to respond to public health emergencies. Initially for the 2004–05 influenza season, CDC in May 2004 recommended  that about 188 million Americans receive a vaccination—about 85 million  at high risk of severe complications and about 103 million in other priority  groups, such as people in close contact with high-risk individuals, healthy  people aged 50–64 years, and health care workers. Health Officials Took Steps to Vaccinate High-Risk Individuals and Others in Priority Groups

After the October 5, 2004, announcement of the sharp reduction in  expected influenza vaccine supply, federal, state, and local health officials  took steps to help ensure that those at high risk of severe complications  from infection had access to influenza vaccine. CDC Devised a Plan to Distribute the Limited Supply of Influenza to High-Risk Individuals and to Others in Priority Groups

In October and November, working with representatives from national  public health organizations and sanofi pasteur, CDC developed a plan to  distribute sanofi pasteur’s unshipped vaccine. At the federal level, CDC held frequent press conferences  beginning in early October 2004. Planning, Timely Action, and Communication Are Key to an Effective Response

Although the actions taken to address the influenza vaccine shortage  helped achieve vaccination rates approaching past levels for certain  priority groups (see fig. Lesson Learned: Unless Expedited, Actions to Boost Supply Are Likely to Have Little Effect

During the 2004–05 influenza vaccine shortage, federal, state, and local  officials needed to continually adapt to changing vaccine supply and  demand, to make decisions, and to take action quickly. For example, Minnesota tried to  sell its available vaccine to other states seeking additional vaccine for their  high-risk populations. Lesson Learned: Effective Response Requires Communication to Be Both Clear and Consistent

While part of the lesson learned about communication was positive, some  aspects of this lesson pointed to need for improvement. These officials noted that many people in priority  groups, including those aged 65 years and older who should have been  vaccinated, stepped aside. Drawing from experiences during the 2004–05 shortage, CDC has taken a  number of steps, including issuing interim guidelines in August 2005, to  assist in responding to possible future shortages. It is too early, however,  to assess the effectiveness of these efforts in coordinating actions of  federal, state, and local health agencies and others who play a part in the  annual influenza vaccination process. Agency Comments

In commenting on a draft of this report, HHS noted that the draft  summarized in detail the activities undertaken by CDC and its public- and  private-sector partners to deal with the influenza vaccine shortage of  2004–05, and the agency concurred with our finding that contingency  planning will greatly improve response efforts. The agency also provided  details on other actions, such as approval of additional influenza vaccines  for the U.S. market, that were under way.
Why GAO Did This Study

In early October 2004, the nation lost about half its expected influenza vaccine supply when one of two major manufacturers announced it would not release any vaccine for the 2004-05 season because of potential contamination. The Centers for Disease Control and Prevention (CDC) had earlier recommended vaccination for 188 million individuals, including those at high risk of severe complications from influenza (such as seniors and those with chronic conditions), and other groups (such as their close contacts). Although health officials took actions to distribute the limited supply of influenza vaccine, reports persisted of high-risk individuals and others in priority groups who could not find a vaccination, including those who were turned away and never returned when supplies became available. Such reports raised questions about the adequacy of U.S. preparedness to respond to significant vaccine shortages. GAO was asked to examine actions taken at federal, state, and local levels to ensure that high-risk individuals had access to influenza vaccine during the shortage, including any lessons learned.

What GAO Found

Federal, state, and local health officials took several actions beginning in October 2004 to help ensure that individuals at high risk of severe complications from influenza had access to vaccine. Federal officials, for example, quickly revised vaccination recommendations to target available vaccine to high-risk individuals and to other priority groups. Additional actions were aimed to distribute vaccine expeditiously and to communicate with providers and the public as events unfolded and vaccine supplies changed. Beginning in mid-December, health officials took steps to distribute additional vaccine, broadening recommendations on who should be vaccinated. Although these actions helped achieve vaccination rates approaching past levels for certain priority groups, such as those aged 65 years and older, several lessons emerged, including some that could help with future shortages. First, unless planning for problems is already in place, action is delayed. CDC's lack of a contingency plan contributed to delays and uncertainty about how to ensure that high-risk individuals had access to vaccine. Second, when actions occur late in the influenza season, they are likely to have little effect. Third, effective response requires communication that is both clear and consistent. CDC has taken a number of steps, including issuing interim guidelines in August 2005, to respond to possible future shortages. It is too early, however, to assess the effectiveness of these efforts in coordinating actions of federal, state, and local health agencies and others. In commenting on a draft of this report, HHS concurred with GAO's finding that contingency planning would improve response efforts, and the agency indicated that additional preparations were under way.