In recent years, the H5N1 strain and other strains of the influenza virus  have emerged or re-emerged. During a pandemic, it may be necessary to use a vaccine that was  developed prior to a pandemic and therefore may not be well-matched to  the pandemic-causing strain. HHS Plans to Make Federal Stockpiles of Pharmaceuticals Accessible to State and Local Jurisdictions, but Faces Challenges with Implementation

Once a pandemic begins, HHS plans to make accessible to state and local  jurisdictions federal stockpiles of antivirals and pre-pandemic vaccine  until a pandemic vaccine becomes widely available. According to HHS,  public-sector stockpiles of antivirals are intended to be used primarily for  the treatment of sick individuals. HHS intends to oversee the distribution  and administration of federally owned pre-pandemic vaccine to individuals  identified as members of the critical workforce; that is, workers in sectors  that are necessary for society to continue functioning. However, HHS  faces challenges with implementing its strategy for using pharmaceutical  interventions, such as the lack of vaccine manufacturing capacity within  U.S. borders and the length of time experts anticipate will be needed to  manufacture a pandemic vaccine. HHS has established a  national goal of stockpiling 75 million treatment courses of antivirals in  public-sector stockpiles—meaning those in the SNS and in jurisdictional  stockpiles. Because these  stockpiles will be entirely under each jurisdiction’s control, officials there  may choose to use some of these antivirals as prophylaxis—as proposed in  HHS’s draft guidance on antiviral use during a pandemic—in an attempt to  slow the spread of the pandemic by providing them to healthy individuals  who have been exposed to the pandemic-causing strain. The National Infrastructure Advisory Council  estimates that the critical workforce includes about 20 million people. The department is currently making large investments in  domestic vaccine manufacturing capacity for this purpose. HHS Has Made Progress on Revising Guidance for Target Groups for Use of Pandemic Vaccine, but Has Not Finalized Guidance for Using Pre-Pandemic Vaccine and Antivirals

HHS has made progress on revising its 2005 guidance to state and local  jurisdictions for identifying target groups for the use of pandemic vaccine,  but has not finalized guidance for using antivirals and pre-pandemic  vaccine. Since the publication of the HHS Pandemic  Influenza Plan, there has been wide recognition that other factors should  be considered, such as protecting those critical workers needed to keep  society functioning, including health care and law enforcement personnel. HHS Has Provided Guidance to Help State and Local Jurisdictions Overcome Difficulties with Implementing Nonpharmaceutical Interventions

HHS will rely on state and local jurisdictions to utilize nonpharmaceutical  interventions to help slow the spread of disease and to lessen the burden  on the nation’s health care system until a pandemic vaccine is widely  available. HHS has developed guidance and is investing in research on the  general use and effectiveness of nonpharmaceutical interventions, thereby  helping jurisdictions make more informed decisions. In this  guidance, HHS introduces its “community mitigation framework” that is  based upon a targeted, layered strategy involving the direct application of  multiple, partially-effective nonpharmaceutical interventions, initiated  early and maintained consistently throughout a pandemic. According to HHS, the findings  from this research will be used to update existing guidance. A severe pandemic, such as that of 1918-19, has the potential to result in  widespread illness and death and is expected to overwhelm the nation’s  ability to respond. According to HHS, initial batches of the most effective  protective measure—a pandemic vaccine—may take as long as 20 to   23 weeks after the start of the pandemic to become available. In 2008, HHS released guidance on  prioritizing target groups for pandemic vaccine and draft guidance for  public comment on how antivirals may be used during a pandemic.
Why GAO Did This Study

The emergence of the H5N1 avian influenza virus (also known as "bird flu") has raised concerns that it or another virus might mutate into a virulent strain that could lead to an influenza pandemic. Experts predict that a severe pandemic could overwhelm the nation's health care system, requiring the rationing of limited resources. GAO was asked to provide information on the progress of the Department of Health and Human Services's (HHS) plans for responding to a pandemic, including analyzing how HHS plans to (1) use pharmaceutical interventions to treat infected individuals and protect the critical workforce and (2) use nonpharmaceutical interventions to slow the spread of disease. To conduct this work, GAO reviewed government documents and scientific literature, and interviewed HHS officials, state and local public health officials, and subject-matter experts on pandemic response.

What GAO Found

HHS plans to make existing federal stockpiles of pharmaceutical interventions available for distribution once a pandemic begins. These interventions would include antivirals, which are drugs to prevent or reduce the severity of infection, and pre-pandemic vaccines, which are vaccines produced prior to a pandemic and developed from influenza strains that have the potential to cause a pandemic. HHS has established a national goal of stockpiling 75 million treatment courses of antivirals in the Strategic National Stockpile and in jurisdictional stockpiles. According to HHS, these public sector stockpiles are intended to be used primarily for the treatment of individuals sick with influenza. HHS intends to oversee the distribution and administration of pre-pandemic vaccine to individuals identified as members of the critical workforce. Members of the critical workforce--estimated to be about 20 million--include workers in sectors that are considered necessary to keep society functioning, such as health care and law enforcement personnel. HHS's strategy for using pre-pandemic vaccine is to keep society functioning until a pandemic vaccine--a vaccine specific to the pandemic-causing strain--becomes widely available. HHS anticipates that initial batches of a pandemic vaccine may not be available until 20 to 23 weeks after the start of the pandemic. As batches of the pandemic vaccine become available, HHS plans for state and local jurisdictions to provide it to members of targeted groups based on factors such as occupation and age, instead of making it available to the general public. HHS faces challenges implementing its strategy for using pharmaceutical interventions during a pandemic, including the lack of vaccine manufacturing capacity in the United States. HHS is currently making large investments to expand domestic vaccine manufacturing capacity. In 2008, HHS released guidance on prioritizing target groups for pandemic vaccine and draft guidance on antiviral use during a pandemic. HHS has not yet released draft guidance for public comment on prioritizing target groups for pre-pandemic vaccine. HHS will rely on state and local jurisdictions to utilize nonpharmaceutical interventions, such as isolation of sick individuals and voluntary home quarantine of those exposed to the pandemic strain. To assist state and local jurisdictions with implementing nonpharmaceutical interventions, HHS has developed guidance that describes the department's "community mitigation framework." The framework involves the early initiation of multiple nonpharmaceutical interventions, each of which is expected to be partially effective and to be maintained consistently throughout a pandemic. HHS faces difficulties, including helping jurisdictions develop ways to ensure community compliance. HHS is investing in several initiatives to increase the nation's knowledge about the general use and effectiveness of nonpharmaceutical interventions. The findings from this research will be used to update existing guidance.