Influenza Pandemic: Lessons from the H1N1 Pandemic Should Be Incorporated into Future Planning
Published: 2011-06-27T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: The 2009 H1N1 influenza pandemic was the first human pandemic in over four decades, and the Centers for Disease Control and Prevention (CDC) estimate that there were as many as 89 million U.S. cases. Over $6 billion was available for the response, led by the Departments of Health and Human Services (HHS) and Homeland Security (DHS), with coordination provided by the Homeland Security Council (HSC) through its National Security Staff (NSS). In particular, HHS's CDC worked with states and localities to communicate with the public and to distribute H1N1 vaccine and supplies. GAO was asked (1) how HHS used the funding, (2) the key issues raised by the federal response, and (3) the actions taken to identify and incorporate lessons learned. GAO reviewed documents and interviewed officials from five states about their interaction with the federal government. GAO also reviewed documents and interviewed officials from HHS, DHS, the Department of Labor's Occupational Safety and Health Administration (OSHA), NSS, and others, such as associations.
section_title: What GAO Found
paragraphs: As of December 2010, HHS had spent about two-thirds of the $6.15 billion that it had available for the H1N1 pandemic response. HHS spent the majority of the funds on developing and purchasing H1N1 vaccine and providing grants to all the states and selected local jurisdictions. State and local health officials reported that the grant funding was critical to their response efforts but also noted challenges presented by the grants' administrative requirements. HHS's spending plans for the remaining $1.98 billion include longer-term pandemic preparation efforts, such as activities to reduce the length of time required to produce a vaccine. Several key issues were raised by the federal government's response to the H1N1 pandemic. (1) Prior pandemic planning efforts and federal funding paid off, although specific aspects of prior planning were not relied on because of the nature of the H1N1 pandemic. For example, interagency meetings and exercises built relationships that were valuable during the response. Prior funding built capacity in several areas, including vaccine production. (2) The credibility of all levels of government was diminished when the amount of vaccine available to the public in October 2009 did not meet expectations set by federal officials. However, state and local jurisdictions valued the flexibility that they had in deciding their distribution methods. Additionally, while the use of a central distributor for the vaccines was generally cited as an effective practice, the 100- dose minimum order was viewed to be problematic. (3) Public surveys generally found CDC's communication efforts to be successful in reaching a range of audiences; however, these messages fell short in meeting the needs of some non-English-speaking populations. (4) Deployment of the Strategic National Stockpile--a supply of medicines and medical supplies to be used for a national emergency--met the established goal. However, CDC and state officials identified gaps in planning, including disparities between the materials expected and those delivered, as well as the need for long-term storage plans for stockpile materials. The NSS asked federal agencies--including HHS and DHS--to complete after-action reports based on their involvement in the pandemic response. The NSS has not determined if these reports--and the associated lessons learned--will be shared with key stakeholders. Nevertheless, a DHS official commented that sharing lessons from the reports with key stakeholders would foster a spirit of government transparency and might help build stakeholder trust.
section_title: What GAO Recommends
paragraphs: GAO recommends that the HSC direct the NSS, in concert with HHS and DHS, to incorporate lessons from the H1N1 pandemic into future planning and share these lessons with key stakeholders. NSS agreed to take the recommendations under advisement. HHS, DHS, and OSHA provided comments and generally agreed with our findings.

section_title: Letter
paragraphs: In response to the global spread of the H1N1 influenza virus, the United  Nations’ World Health Organization (WHO) declared the first human  influenza pandemic in more than four decades on June 11, 2009. Prior to  this declaration, H1N1 influenza had spread across the United States after  first being detected in California in April 2009. The Department of Health  and Human Services’ (HHS) Centers for Disease Control and Prevention  (CDC) estimated that there were as many as 89 million U.S. cases of H1N1  influenza from April 2009 to April 2010. CDC estimated that these cases  led to as many as 403,000 hospitalizations and 18,300 deaths during that  period, with a disproportionate number of children affected as compared  to typical influenza seasons. WHO declared that the 2009 H1N1 influenza  pandemic ended on August 10, 2010.
Prior to the H1N1 pandemic, federal, state, and local governments were  involved in national pandemic planning and preparedness activities. At the  federal level these activities—which were largely coordinated by the  Homeland Security Council (HSC)—included releasing a national  pandemic strategy and a national pandemic implementation plan in 2005  and 2006, respectively, and holding regular interagency meetings.  Additionally, as part of pandemic planning, HHS funded the development  of medical countermeasures, such as vaccines and antiviral drugs. The  national pandemic strategy and the national pandemic implementation  plan designated HHS and the Department of Homeland Security (DHS) as  the two agencies that would lead a federal response to an influenza  pandemic. However, because these planning and preparedness activities  were geared toward responding to an avian influenza pandemic that  originated overseas and had a higher fatality rate, some adjustments  during the H1N1 pandemic response were necessary. Accordingly, the  National Security Staff (NSS), which supports the HSC, developed an  additional document, the National Framework for 2009-H1N1 Influenza  Preparedness and Response.
To aid in the response to the H1N1 pandemic, the federal government took  a variety of measures. The Congress appropriated funds to HHS  specifically to prepare for and respond to an influenza pandemic as part of  a supplemental appropriation in June 2009. The federal government—and  particularly CDC—collaborated with state and local jurisdictions,  professional associations, and private health care providers, among others,  to take a variety of measures to mitigate the spread of disease, such as  communicating with the public, distributing vaccines, conducting  surveillance, and distributing items from the Strategic National Stockpile  (SNS).
Because of the possibility of another influenza pandemic and our prior  work on pandemic preparedness, you asked us to examine the lessons  learned from the federal response to the H1N1 pandemic and identify how  the federal government is incorporating these lessons into future  pandemic planning. As agreed, this report examines (1) how HHS used  2009 supplemental funding to respond to the H1N1 pandemic, (2) the key  issues raised by the federal government’s response to the H1N1 pandemic,  and (3) the actions that federal agencies are taking to identify and  incorporate lessons learned from the issues that arose from the H1N1  pandemic into planning.
To examine how HHS used the 2009 supplemental funding to respond to  the H1N1 pandemic, we reviewed the Supplemental Appropriations Act,  2009; HHS’s reports to the Congress detailing the ways that HHS spent  funds; and HHS’s amended spending plans that were also submitted to the  Congress. To determine the reliability of the data in these reports, we  reviewed the reports for internal consistency and resolved questions with  appropriate HHS officials; we did not independently verify the information  provided in these reports. We believe that the data are sufficiently reliable  for our purposes. While HHS used funds from other appropriations in the  H1N1 pandemic response effort, we focused our review on the   $6.15 billion available to HHS that was provided through the 2009  supplemental appropriation. Because this appropriation required that a  portion of the supplemental funds be directed toward upgrading state and  local public health capacity, we reviewed requirements of the grants that  were awarded to state and local jurisdictions for this purpose. To examine  how state and local jurisdictions used the grant funds, we reviewed  documents and interviewed officials from CDC’s Division of State and  Local Readiness, the Association of State and Territorial Health Officials  (ASTHO), and the National Association of County and City Health Officials  (NACCHO). We also interviewed officials involved in the H1N1 pandemic  response in a sample of five states—Georgia, Nebraska, Texas, Vermont,  and Washington—to learn about how their jurisdictions used the response  funds. We chose these states to provide insight into the experiences of a  range of states; however, their experiences are not generalizable to all 50  states. We selected states that reflected a range of key characteristics,  including when the state first reported experiencing widespread H1N1  influenza activity, interim state-specific H1N1 vaccination rates among the  initial target groups for the H1N1 vaccine, population in 2008, census  region, total grant amount awarded to the state for the H1N1 pandemic  response, and the state’s public health structure. Appendix I includes  information on the five selected states. In general, within each state, we  spoke with officials from the governor’s office, the state health agency, the  state emergency management agency, and the state education agency. In  addition, to provide an example of how the territories and insular areas  used pandemic grant funds, we contacted officials from the U.S. Virgin  Islands based on the same criteria that we used to select the states in our  sample.
To examine the key issues raised by the federal government’s response to  the H1N1 pandemic, we focused on the actions of HHS and DHS because  they share federal leadership responsibilities for pandemic influenza  response. Within HHS, we reviewed documents and interviewed officials  from the Office of the Assistant Secretary for Preparedness and Response  (ASPR), ASPR’s Biomedical Advanced Research and Development  Authority (BARDA), the Food and Drug Administration (FDA), and CDC.  Within DHS, we reviewed documents and interviewed officials from the  Office of Health Affairs, Directorate for Management, Office of Operations  Coordination, and Federal Emergency Management Agency. Because of  their respective roles in the H1N1 pandemic response, we also reviewed  documents and interviewed officials from the Department of Education’s  (Education) Office of Safe and Drug Free Schools regarding school  closure policies and the Department of Labor’s Occupational Safety and  Health Administration (OSHA) regarding guidance on the use of personal  protective equipment and the protection of workers’ safety and health.  To learn about the federal government’s interaction with state and local  jurisdictions, we interviewed officials from the same judgmental sample of  five states. We also reviewed reports and interviewed officials from the  U.S. Virgin Islands, ASTHO, NACCHO, the National Governors  Association, the Center for Infectious Disease Research and Policy, the  Association of Immunization Managers, the Institute of Medicine (IOM),  and the National Indian Health Board.
To examine the actions that federal agencies are taking to identify and  incorporate lessons learned from the issues that arose from the H1N1  pandemic into planning, we interviewed officials and reviewed documents  from HHS, DHS, Education, and the Department of Labor. We interviewed  officials from the NSS, which was responsible for developing the National  Framework for 2009-H1N1 Influenza Preparedness Response and for  holding interagency coordination meetings during the H1N1 pandemic  response. We also examined the National Response Framework—a guide  for the federal government to use in responding to domestic incidents— which specifies that evaluation and continual process improvement are  cornerstones of effective preparedness. The framework notes that  improvement planning should develop specific recommendations for  changes in practice, timelines for implementation, and assignments for  completion.
We conducted this performance audit from April 2010 to June 2011 in  accordance with generally accepted government auditing standards. Those  standards require that we plan and perform the audit to obtain sufficient,  appropriate evidence to provide a reasonable basis for our findings and  conclusions based on our audit objectives. We believe that the evidence  obtained provides a reasonable basis for our findings and conclusions  based on our audit objectives.
subsections: section_title: Background
subsections: section_title: Pandemic Preparedness Prior to the H1N1 Pandemic
paragraphs: The emergence of H5N1 avian influenza (also known as avian influenza or  bird flu) in Asia in 2003 raised concerns among experts that it or another  influenza virus might significantly mutate, resulting in a human influenza  pandemic. This led to the development of the national pandemic strategy  and national pandemic implementation plan. This strategy and plan  established that the Secretary of Health and Human Services is to lead the  federal public health and medical response to a pandemic and the  Secretary of Homeland Security is to lead the overall domestic incident  management and federal coordination.
Additionally, prior to the H1N1 pandemic, the Congress appropriated  funds to support the federal government’s influenza pandemic  preparedness and improve related state and local public health  capabilities. In fiscal year 2006, the Congress appropriated about   $5.60 billion to HHS through supplemental appropriations to support  pandemic preparedness and response efforts, such as vaccine and antiviral  drug development and stockpiling, state and local preparedness, and  international collaboration. HHS reported spending more than half of the  funds (about $3.10 billion) on activities related to vaccine development,  stockpiling, and infrastructure improvement. For example, the department  awarded contracts to two domestic influenza vaccine manufacturers to  retrofit their facilities—that is, to upgrade existing facilities to optimize  and enhance their ability to produce influenza vaccines. HHS spent nearly  a quarter of the funds (about $1.30 billion) on activities related to  developing and stockpiling antiviral drugs. For example, the department  completed the purchase of 50 million courses of antiviral drugs for the  SNS and provided funding to states to increase state stockpiles as part of  its goal of ensuring the availability of antiviral drug treatment courses for  25 percent of the U.S. population in case of an influenza pandemic. HHS  invested in the development of Peramivir, an intravenously administered  antiviral drug for seriously ill patients with influenza. HHS also funded the  development and clinical trials of influenza diagnostic testing devices that  allow for the diagnosis of influenza in a variety of settings.
section_title: 2009 H1N1 Pandemic
paragraphs: The first case of H1N1 influenza was detected in the United States on   April 15, 2009. Cases of H1N1 influenza first appeared in California and  Texas, and soon spread across the country and around the world. (See fig.  1 for a timeline of key events.) At the same time, an outbreak of H1N1  influenza was occurring in Mexico. In response, the NSS developed the  National Framework for 2009-H1N1 Influenza Preparedness and  Response as a tool to guide the federal response efforts. The framework  was built on the existing national pandemic strategy and national  pandemic implementation plan and contained four pillars for the response:  surveillance, mitigation measures, vaccination, and communication and  education.
The H1N1 pandemic occurred in two waves in the United States. The first  wave occurred during spring 2009 and the second wave during fall 2009,  with H1N1 influenza activity peaking in October 2009, based on the  number of new cases. A greater proportion of children and young adults,  as well as pregnant women, were adversely affected by the H1N1 influenza  virus as compared to the typical influenza season.
section_title: H1N1 Vaccine Production and Distribution
paragraphs: When the H1N1 influenza outbreak occurred in April 2009, HHS began  working to isolate the H1N1 influenza strain and worked with five vaccine  manufacturers to develop a 2009 H1N1 influenza vaccine (H1N1 vaccine)  to protect the public against H1N1 influenza. The H1N1 vaccines were  manufactured using the same methods that these manufacturers used for  seasonal influenza vaccine production.
In anticipation of the availability of the H1N1 vaccine and the possibility  that initial supply might not meet demand for the vaccine, in July 2009,  CDC’s Advisory Committee on Immunization Practices (ACIP) issued  recommendations for the target groups for the H1N1 vaccine. These five  target groups, comprising about 159 million persons, were recommended  to be first to receive the H1N1 vaccine. ACIP also identified a subset of  the initial target groups, comprising about 42 million persons, to whom  providers should give priority if H1N1 vaccine availability was too limited  to initiate vaccination for all people in the five initial target groups.  However, at the time it made the recommendations, ACIP did not predict  that there would be a need to limit vaccine to the subset of the target  groups in most areas of the country.
Unlike seasonal influenza vaccine, which is largely purchased by the  private sector, the federal government purchased all of the H1N1 vaccine  licensed for use in the United States. HHS allocated doses to each state for  distribution based on the overall population of the state. The states, in  turn, placed orders for their allocated doses and determined which  providers should receive the vaccine. CDC estimated that from October  2009 through May 2010, 27 percent of the U.S. population over the age of 6  months (about 81 million people) was vaccinated against H1N1 influenza,  including about 34 percent of individuals in the initial target groups.
section_title: Strategic National Stockpile
paragraphs: In addition to the production and distribution of the H1N1 vaccine,  another federal action in response to the H1N1 pandemic was the  deployment of influenza response supplies from the SNS. The SNS,  managed by CDC, contains large quantities of medicine and medical  supplies intended to protect and treat the public if there is a public health  emergency that is severe enough that local supplies may be exhausted.  Each state has plans to receive materials from the SNS and distribute them  to local communities as quickly as possible. The H1N1 pandemic marked  the largest deployment of materials from the SNS to date in an emergency  situation, according to CDC.
section_title: HHS Funded a Range of Pandemic Influenza Activities with Supplemental Funds
subsections: section_title: Most Supplemental Funds Were Spent on Vaccine Purchase and Support of State and Local Pandemic Response Efforts
subsections: section_title: The Congress Appropriated Funds to HHS to Meet the Threat of Pandemic Influenza
paragraphs: HHS had $6.15 billion available from the 2009 supplemental appropriation  to spend on pandemic influenza activities. Specifically, the Congress  appropriated $1.85 billion immediately to HHS in June 2009, shortly after  WHO declared the start of the pandemic. The Congress also appropriated  up to $5.80 billion in additional contingent funding. These contingent  funds would only be available in the amounts designated by the President,  in written notices to the Congress, as emergency funds required to address  critical needs related to emerging influenza viruses. In July and September  of 2009, the President notified the Congress of the need for additional  funding, and accordingly, $4.54 billion of the contingent funds became  available to HHS. From this $4.54 billion, HHS transferred about   $241 million to other departments, which left about $4.30 billion available  for HHS. As of December 2010, the remaining $1.259 billion from the  contingent fund was not designated by the President as required to  address critical needs related to emerging influenza viruses; however,  these funds were rescinded under the fiscal year 2011 continuing  appropriations act.
section_title: HHS Has Spent Almost 70 Percent of Available Supplemental Funds
paragraphs: From June 2009 through December 2010, HHS spent about $4.17 billion  (about two-thirds) of the $6.15 billion that it had available from the 2009  supplemental appropriation, according to HHS’s report to the Congress on  pandemic influenza preparedness spending. Of the $4.17 billion spent by  HHS, about $1.72 billion (41 percent) was spent on vaccine production,  which includes the purchase of H1N1 vaccine from five influenza vaccine  manufacturers, adjuvants, and ancillary supplies, such as needles and  syringes, distributed along with the H1N1 vaccine. Specifically, HHS  funded the development of and purchased over 190 million doses of the  H1N1 vaccine and purchased 200 million ancillary supply kits.
Of the $4.17 billion spent by HHS, about $1.49 billion (36 percent) was  spent on supporting state and local jurisdictions’ response to the H1N1  pandemic. The majority of these funds were provided to the states through  Public Health Emergency Response (PHER) grants. The PHER grant  funds were distributed in four phases beginning in August 2009, with each  phase of funding targeting specific focus areas, such as vaccination or  communication efforts with high-risk populations. A report by ASTHO  concluded that state and local jurisdictions could not have responded as  effectively to the H1N1 pandemic without the PHER grant funds,  particularly given the ongoing budgetary constraints of states. (See fig. 2  for examples of how states and local jurisdictions used the PHER grants.)  HHS spent the remaining $1 billion (24 percent) on other purposes. See  table 1 for information on HHS activities supported by the 2009  supplemental appropriation.
Nebr.
Ga.
Tex.
While the PHER grants were critical to state and local jurisdictions,  officials from state and local jurisdictions reported experiencing  challenges with the administrative requirements of the PHER grants.
ASTHO reported that state officials found the need to submit multiple  applications for the various phases of the grant, and the time spent  waiting for approvals, to be time consuming during the response.  Additionally, the different limitations on the use of funds in each phase  made it difficult for states to plan and manage their response  activities.
Some of the local officials we interviewed reported that the specific  spending requirements of the PHER funding were heavily weighted  toward vaccination activities and that funds were neither flexible nor  sufficient enough to address epidemiology and laboratory expenses.  Officials from Washington’s Department of Health, for example,  echoed this concern and told us that some local health jurisdictions in  the state did not have enough funding for surveillance and laboratory  expenses, but had more than enough designated for vaccination  activities. Almost half of states applied for the last phase of funding— and 15 states received the funds—which were available in early 2010  for targeting special, hard-to-reach populations for vaccination. In  most cases, the states were not eligible for these funds because they  had sufficient funds left over from the previous three phases to  conduct vaccination outreach to hard-to-reach, high-risk populations.
CDC officials who worked on the PHER grant program said they were  aware of the challenges that states faced with the grant process and were  working on addressing some of these challenges in preparation for the  next public health emergency. To reduce the time that it takes for funding  to reach the states, CDC officials identified ways to save time for various  procedures, such as preparing draft grant guidance in advance of public  health emergencies. Additionally, CDC officials told us that they are  working with ASTHO to help states be better prepared to quickly use  federal funding that might become available in an emergency situation.  For example, CDC officials noted that states with independent local health  jurisdictions could establish draft contracts with these local health  jurisdictions so that funding could flow more quickly down to the local  level. In addition to these measures, CDC officials are working with their  General Counsel’s office to look at any authorities that they may have to  move funds through existing cooperative agreements in an emergency.  CDC officials also agreed that the phases of the PHER grants were heavily  weighted toward vaccination, but noted that they made that decision  because of the anticipation that the vaccination campaign would be the  largest component of the public health response. In August 2010, the state  and local jurisdictions received a no-cost extension that allows them to  spend the PHER grant funds through July 2011. CDC expects to have  detailed data regarding the ways that states spent these funds after the  grant program expires.
section_title: HHS Plans for Remaining Supplemental Funds Include Efforts to Prepare for Future Pandemics
paragraphs: When WHO declared the H1N1 pandemic over in August 2010, HHS had  not spent about $1.98 billion of the 2009 supplemental funds. Plans for the  remaining funds include efforts that HHS identified to prepare for future  pandemics. (See table 2 for additional information on how HHS plans to  use these funds.) These longer-term preparations were primarily identified  by an HHS review of public health emergency medical countermeasures.  This review found, for example, that continued, long-term investment is  needed to improve domestic influenza vaccine production capacity and to  shorten the amount of time needed to produce an influenza vaccine during  a pandemic. According to HHS’s August 2010 amended spending plan, a  portion of the remaining funds will be spent on efforts to reduce the length  of time required to produce a pandemic vaccine. Specifically, HHS  planned to spend $431 million—or 22 percent of these funds—on the  development of new influenza vaccine technologies. Further, about   $50 million (3 percent) is planned for enhancing the available domestic fill  and finish capacity—the final stage in the vaccine production process that  places the vaccine in the appropriate delivery device—which has been  cited as a bottleneck in the existing influenza vaccine production process.
section_title: Federal Response to the H1N1 Pandemic Highlighted a Number of Key Issues
paragraphs: Several key issues were raised by the federal government’s response to the  H1N1 pandemic. These relate to    prior planning and funding,  availability of vaccine and related plans for distribution,  the SNS.
subsections: section_title: Not All Aspects of the Existing Strategy and Plan Were Relied on, but Earlier Funding and Planning Paid Off
subsections: section_title: Elements of National Pandemic Strategy and Implementation Plan Were Not Relied on Because of the Nature of the H1N1 Pandemic
paragraphs: Given the specific characteristics of the H1N1 pandemic, the federal  government did not rely on some aspects of the national pandemic  strategy and national pandemic implementation plan, such as critical  infrastructure protection and border and trade measures. The national  pandemic strategy and national pandemic implementation plan were  based on a scenario of a severe 1918-like pandemic, as well as the existing  threat that an avian influenza strain, originating overseas, would cause the  next pandemic. During the early months of the H1N1 outbreak, officials  from DHS and other departments reported that the action items in the  national pandemic implementation plan for which their respective  departments had responsibility—such as border and trade measures— were not relevant for the H1N1 outbreak, and therefore were not  activated. Federal officials noted, however, that while these actions were  not taken in the H1N1 pandemic response, they could be important in a  future pandemic with different characteristics, such as if there is a severe  pandemic that affects critical infrastructure.
Another aspect of the national pandemic strategy and national pandemic  implementation plan that was not fully tested was the shared leadership  roles and responsibilities for both HHS and DHS in responding to an  influenza pandemic. We previously reported that it was unclear how this  shared leadership would work in practice. Under the national pandemic  strategy and national pandemic implementation plan, both departments  share leadership responsibilities—HHS to manage the federal public  health and medical response and DHS to lead domestic incident  management and federal coordination. As a result, we recommended that  HHS and DHS work together to develop and conduct rigorous testing,  training, and exercising for pandemic influenza to ensure that the federal  leadership roles are clearly defined and understood and that leaders are  able to effectively execute shared responsibilities. HHS officials told us  that they are planning to exercise these roles with DHS.
The shared leadership roles between HHS and DHS were not fully  implemented during this pandemic. Officials from both HHS and DHS told  us that once it became clear that the H1N1 pandemic required primarily a  public health response, HHS was responsible for most of the key  activities. Nevertheless, some state officials cited concerns about the  shared federal leadership roles in the early days of the pandemic response.  Specifically, officials we interviewed in four of the five states said that  during that period, HHS and DHS did not effectively coordinate their  release of information to their state contacts. As a result, state officials  reported receiving large volumes of information—often through multiple  daily conference calls or via e-mail—from both federal agencies. The  amount of information—which was sometimes the same information and  sometimes inconsistent—was overwhelming, according to these state  officials. For example, representatives from the Georgia Emergency  Management Agency told us that at one point DHS officials were telling  states that confirmation of H1N1 influenza cases needed to be completed  by a laboratory, which was the initial CDC guidance, while HHS officials  were telling states they could confirm H1N1 cases by laboratories or an  analysis of symptoms that the patient was experiencing, which was the  revised CDC guidance at the end of August 2009. Officials in Vermont,  Washington, and Georgia told us that over time it appeared to them that  HHS—and primarily HHS’s CDC—took the lead in communicating about  H1N1 and, accordingly, the number of calls and information sources  decreased.
section_title: Prior Federal Funding and Planning Built Capacity and Interagency Relationships, Which Facilitated the Federal Response
paragraphs: Federal funding and planning for pandemic preparedness prior to the  onset of the H1N1 pandemic paid off by building capacity in several areas,  including (1) vaccine production, (2) influenza diagnosis, and (3) antiviral  drug development and stockpiling. First, the retrofitted influenza vaccine  manufacturing facilities that HHS funded doubled the production capacity  for H1N1 vaccine at two vaccine manufacturers, according to HHS. These  two manufacturers told us that the expanded capacity enabled them to  start production of the H1N1 vaccine while they finished their production  of seasonal influenza vaccine. Second, one of the influenza diagnostic tests  that HHS’s pandemic planning efforts helped fund detected the first case  of H1N1 influenza as part of a clinical trial at the Naval Health Research  Laboratory in San Diego, California. Third, the antiviral drug Peramivir— which was developed using pandemic preparedness funds—was made  available for the first time during the H1N1 pandemic, and CDC delivered  about 2,100 5-day treatment courses to hospitals. Also, according to CDC  officials involved in the response, no national shortage of adult antiviral  drugs occurred during the H1N1 pandemic, which may have been due in  part to prior federal and state stockpiling efforts. There was, however, a  shortage of pediatric antiviral drugs in the fall of 2009.
Through interagency planning efforts, federal officials built relationships  that helped facilitate the federal response to the H1N1 pandemic. Officials  from HHS’s ASPR and CDC, DHS, and Education stated that these  interagency meetings, working together on existing pandemic and  nonpandemic programs, and exercises conducted prior to the H1N1  pandemic built relationships that were valuable for the H1N1 pandemic  response. Specifically, HHS officials said that federal coordination during  the H1N1 pandemic was much easier because of these formal networks  and informal relationships built during pandemic planning activities and  exercises. For example, in developing the national pandemic strategy and  national pandemic implementation plan, the HSC convened regular  interagency meetings to facilitate cooperation and coordination across the  federal government to prepare for an influenza pandemic. The NSS  continued to hold these interagency meetings during the H1N1 pandemic  response. Also, Education and CDC officials told us that in addition to  these formal meetings, they had existing working relationships with each  other that had been built while developing and managing a range of  programs. Finally, officials from HHS, DHS, and other agencies held joint  pandemic exercises to test various parts of the plan. As we have  previously reported, DHS officials have said that exercises offer the best  opportunity—short of actual emergencies—to determine if plans are  understood and work. DHS officials stated that as a result of pandemic  planning and exercises, DHS and other federal agency officials knew  whom to contact within federal agencies when H1N1 influenza emerged.  NSS and HHS officials reported to us in April 2011 that many of the same  departments and officials are meeting regularly as part of a new group to  discuss emerging pandemic threats.
Planning efforts also allowed federal and state officials to build upon  preexisting relationships that were useful during the pandemic response.  These relationships had been built through daily interactions  implementing grant programs, developing state and local pandemic plans,  and working together in pandemic planning exercises. For example, CDC  held a pandemic planning exercise with other federal officials and 11 state  and local jurisdictions in October 2008. During this exercise, officials  practiced responding to a pandemic influenza situation. A senior CDC  official said that preexisting relationships with states and localities  allowed them to be frank, informal, and comfortable with each other when  responding to the H1N1 pandemic. Georgia health officials told us that  they spoke to CDC project officers daily during the H1N1 response to  provide real-time situational awareness because of their relationships  formed prior to the pandemic. Washington health officials also said that  existing relationships with CDC officials helped their response efforts.  Specifically, CDC revised school closure guidance based in part on  experiences with school closures in Seattle, Washington. This revised  guidance recognized that because the disease severity of H1N1 influenza  was similar to that of seasonal influenza and the virus had already spread  within communities, the focus was on keeping sick children and staff at  home rather than closing schools as a way to stop the spread of the virus.
section_title: Failure to Meet Public Expectations about Vaccine Availability Diminished Government Credibility, but Some Practices for H1N1 Vaccine Distribution Were Reported to Be Valuable
subsections: section_title: H1N1 Vaccine Was Not Widely Available When Expected nor When Demand Was Highest
paragraphs: By the time H1N1 vaccine was widely available, the peak of H1N1  influenza activity had passed and many individuals were no longer as  interested in getting vaccinated. (See fig. 3.) The national pandemic  implementation plan established a goal of expanding influenza vaccine  manufacturing surge capacity for the production of pandemic vaccines to  allow for the entire domestic population to be able to receive a vaccine  within 6 months of a pandemic declaration. During the H1N1 pandemic,  the H1N1 vaccine was first available in the United States in October 2009,  or almost 4 months after WHO’s pandemic declaration, but was not widely  available for all who wanted to be vaccinated until late December 2009.  (See fig. 4 for a timeline of key events related to H1N1 vaccine production  and distribution.) A RAND Corporation study found that at the onset of  influenza activity, about half of adults were willing to get vaccinated, but  after the vaccine became available, CDC reported that only about 23  percent of adults actually were vaccinated.
The credibility of all levels of government was diminished when the  amount of vaccine available to the public in October 2009 did not meet  expectations set by federal officials. During the summer of 2009, HHS  conveyed to state and local jurisdictions, and to the public, that a robust  H1N1 vaccine supply, about 120 million to 160 million doses, was expected  to be available in October 2009. Ultimately, only about 23 million doses of  H1N1 vaccine were allocated for ordering by states and local jurisdictions  at the end of October 2009, and because of the time required to order and  ship the vaccine, fewer than 17 million doses were shipped out that month. Consequently, the public had an unfavorable view of the federal  government’s ability to provide the country with the H1N1 vaccine. A  Gallup survey of U.S. adults from early November 2009, found that 54  percent of adults said the federal government was doing a poor (41  percent) or very poor (13 percent) job of providing the country with  adequate supplies of the vaccine. An ASTHO report echoed that loss of  government credibility also was a concern at the state level. ASTHO  concluded that state health department officials felt that dealing with slow  and variable vaccine delivery and shifting messages about vaccine  availability overshadowed all of their other response activities. For  example, when vaccine availability was less than anticipated, state and  local health departments had to cancel planned and publicized mass  vaccination clinics and change their messages to the public about  vaccination at a time when H1N1 influenza activity was peaking. Also, at  the local level, health department officials in Fulton County, Georgia,  stated that they canceled several school-based vaccination clinics because  they lacked the H1N1 vaccine. According to these officials, once the H1N1  vaccine became available, parents were not interested in vaccinating their  children because H1N1 influenza activity had already peaked in the area.
HHS has acknowledged that the H1N1 vaccine arrived too late in the  response and noted the department is actively looking for ways to shorten  the time required for vaccine production. The agency plans to use a  portion of the remaining 2009 pandemic supplemental funds for these  efforts. According to the Director of BARDA—who during the H1N1  pandemic response was responsible for overseeing the largest  development and production of vaccine in U.S. history—once HHS staff  were positioned at the vaccine manufacturing plants and manufacturers  were required to report their time frames in a standard manner, HHS had a  better understanding of the vaccine manufacturing process and the  estimates for vaccine availability became more accurate in November  2009. A senior CDC official acknowledged that the uncertainty in the initial  vaccine estimates was not adequately conveyed to state and local  jurisdictions in the early days of the response effort.
section_title: State and Local Jurisdictions Valued Flexibility in Implementing Vaccination Campaigns, but Differences across Neighboring Jurisdictions Led to Public Confusion
paragraphs: Officials from state and local jurisdictions valued the flexibility that they  had to implement their vaccine distribution plans. Although the federal  government purchased the H1N1 vaccine and ACIP recommended that  states and local jurisdictions initially provide it to individuals in the target  groups, CDC allowed for state and local flexibility over vaccine  distribution plans. NACCHO, as well as participants in a series of IOM  workshops, reported that officials from state and local jurisdictions  welcomed the flexibility to determine their own vaccine distribution plans.  At the same time, state officials acknowledged that the flexibility, while  appreciated, also led to confusion or the appearance of inequity, especially  when the public became aware of different approaches taken in  neighboring jurisdictions. Participants in an IOM workshop reported that  officials from jurisdictions that had approaches different from neighboring  jurisdictions found it hard to communicate to the public about why one  county or state was vaccinating a certain subset of their population while  another was not. For example, Snohomish County, Washington, initially  included teachers in its target groups and conducted mass vaccination  clinics, while neighboring Seattle-King County did not include teachers  and distributed its initial supply of vaccine to physicians who were to  vaccinate their patients. An official from the Seattle-King County health  department reported that the public was confused by the differences.  Washington health officials told us that they attempted to coordinate use  of the target groups at the state level, but because local jurisdictions  ultimately have control of local public health policies in the state, there  were still differences between counties in implementation. Also, Vermont  officials told us that the neighboring state of New York began vaccinating  the general public beyond the target groups while Vermont was still  waiting for guidance from CDC to widen its distribution.
CDC attempted to minimize confusion and anxiety by alerting the public  that there would be differences in distribution methods. CDC’s  spokespeople emphasized this variation in the majority of the 18 press  briefings that the agency held from September 2009 through December  2009 that we reviewed. A senior CDC official acknowledged the confusion  resulting from allowing state and local flexibility, but noted that the  agency would make the same decision again because of the importance of  local public health decision making.
section_title: Use of a Central Vaccine Distributor Was Generally Cited as an Effective Practice, but Limitations in Sizes of Vaccine Orders Was Cited as Problematic
paragraphs: CDC used a central vaccine distributor—building off the existing Vaccines  for Children program—and this practice was generally cited as effective by  association and state officials. The Vaccines for Children program’s  central distributor shipped the H1N1 vaccine from regional distribution  centers that received the H1N1 vaccines from five vaccine manufacturers  to individual providers or organizations identified by state and local  jurisdictions. State and local health officials, in conjunction with  professional associations such as the American Medical Association,  identified providers who signed agreements to administer the H1N1  vaccine, including providers who had not previously participated in the  Vaccines for Children program, such as obstetricians, gynecologists, and  other physicians who treat and immunize adults. According to CDC  officials, once H1N1 vaccine arrived at the central distributor’s regional  distribution centers, 95 percent of the ordered doses of H1N1 vaccine were  shipped out in accordance with CDC’s contract. An official with the  Association of Immunization Managers, which represents immunization  program managers in state and local jurisdictions, involved in the response  reported that use of the central distributor was a “best” practice during the  H1N1 pandemic response because the central distributor was already in  place and in operation. This official noted that she did not hear any issues  or complaints from her association’s members about the use of the central  distributor. Officials from four of the states we contacted also noted that  the central distributor worked well. Alternatively, CDC could have shipped  the H1N1 vaccine out to SNS receiving sites in states; CDC’s prior  pandemic planning had focused on direct distribution by manufacturers to  a limited number of state health department–designated sites. However,  officials had decided that using a private distributor—that routinely  distributes seasonal influenza and other vaccines—was a preferable  method. CDC officials stated that because of the success of the central  distributor during the H1N1 pandemic, CDC now views this method as the  most efficient and effective method of vaccine distribution. State officials  in two states reported that using the SNS sites instead of the central  distributor would have caused logistical challenges.
While the use of a central vaccine distributor was generally cited as an  effective practice by state and local health officials during the H1N1  pandemic, some state health officials noted challenges with the  distribution process. Specifically, some state officials said that the central  distributor’s 100-dose minimum shipment requirement caused problems.  As part of its contract with CDC, the central distributor required that  shipments to each site include a minimum of 100 doses of H1N1 vaccine.  Officials in three of the five states we contacted, as well as the U.S. Virgin  Islands, told us that the 100-dose minimum ordering requirement caused  difficulties because they had to break down the 100-dose shipments into  smaller shipments so they could be shipped to smaller vaccine providers.  Texas officials told us that the state hired a third-party contractor to  receive and repackage the shipments for smaller vaccine providers.  ASTHO also cited this issue as a challenge, noting that the dosage order  requirements caused delays in some providers receiving the H1N1  vaccine. According to CDC officials, at the time that they were  negotiating the distribution contract, the possibility existed that up to 600  million doses of H1N1 vaccine would need to be distributed as quickly and  efficiently as possible, a magnitude that was unprecedented and  untested. At that time, CDC and the distributor determined that it would  be inefficient and even cost prohibitive for the contractor to hire the  additional staff to break packages into smaller units for distribution.
section_title: Public Surveys Generally Found CDC’s Public Communication Campaign to Be Effective, but Communication Materials Were Not Accessible for All Populations
subsections: section_title: Public Surveys Found CDC’s Communication Campaign to Be Effective
paragraphs: Public surveys, state officials, and representatives from professional  associations generally found CDC’s public communication campaign to be  effective. To gauge the effectiveness of its communication campaign and  other aspects of the H1N1 response, CDC and others contracted with the  Harvard School of Public Health to conduct regular surveys of the public  regarding the H1N1 response. One study, conducted as part of this  initiative in March 2010 and April 2010 with a nationally representative  sample of U.S. adults aged 18 years and older, found that 70 percent of  adults rated CDC’s H1N1 influenza communication campaign as excellent  (25 percent) or good (45 percent). Ratings of the communication  campaign did not differ considerably among different ethnic groups.  Further, more than half of adults reported seeing or hearing the key H1N1  protection and prevention messages, which included messages suggesting  that people should get the H1N1 vaccine, wash their hands or use hand  sanitizer frequently, stay home from work or school if sick, and cough or  sneeze into one’s elbow or shoulder. A professional association official as  well as state health officials from three of the states we contacted also  credited these personal infection control messages when we asked them  about CDC’s communication with the public. The same survey found that  89 percent of adults said they would trust CDC a great deal (59 percent) or  somewhat (30 percent) for information about protecting themselves or  their families from H1N1 influenza.
According to CDC officials, the agency’s communication with the public  was based on the agency’s decision to be transparent and open with the  public about both known and unknown information. CDC’s crisis  communication principles—which it formally articulated in its H1N1  communication plan—emphasize transparency and acknowledgment of  uncertainty, as well as a commitment to frequent updates as new  information emerges. Specifically, CDC established four goals during the  pandemic to guide communication efforts:    Provide timely, accurate, and credible information about the public  health threat and government actions to prevent 2009 H1N1 influenza  and mitigate its impact.
Increase public awareness, knowledge, and adoption of influenza  prevention, mitigation, and treatment recommendations. These  recommendations included promotion of vaccines, community  measures, personal and institutional infection control, and the correct  use of antiviral drugs.
Guide public expectations for change and variability related to  prevention and mitigation recommendations.
Protect the health of the public while minimizing social, economic, and  educational disruption.
CDC held frequent press briefings to provide timely dissemination of new  information on the evolving situation. For example, during the early days  of the H1N1 outbreak, CDC held almost daily press briefings. Officials  from all five states we contacted and the National Governors Association  noted that the agency’s spokespeople throughout the H1N1 pandemic  were generally effective. The Director of the Center for Infectious Disease  Research and Policy at the University of Minnesota noted that CDC’s  communication campaign gave the public the sense that the federal  government was in charge of the pandemic response. CDC also held a 2- day conference in August 2009 to educate the media about influenza and  what the fall influenza season could entail. CDC officials said the  conference provided context for the media representatives in attendance,  fostered an environment of transparency, and established a relationship  between media and CDC officials. In addition to the interactions with the  media, CDC used a variety of tools to reach the public directly (see fig. 5).  According to CDC officials, communications was an integrated part of the  response, with senior communications officials from across the agency  represented when all major decisions were made. These officials noted  that the inclusion of these representatives when decisions were being  made allowed for a two-way conversation where policy experts took into  consideration the perceptions and concerns of the public.
In addition, state and local jurisdictions appreciated CDC’s efforts to keep  them informed of ongoing changes. For example, CDC had representatives  from professional associations representing state and local health officials  at its Emergency Operations Center during the second wave of the  pandemic, which occurred in fall 2009. This was the first time that this  type of involvement had happened, according to the association and CDC  officials. According to CDC officials, the inclusion of these organizations  helped foster transparency and allowed for the federal government to  better understand the perspectives of state and local jurisdictions.  Officials from Texas’s health department noted that CDC shared talking  points with them before conference calls. These officials told us that this  gave them credibility because they were aware of information before it  was shared broadly. In addition, Georgia health officials told us that they  appreciated the frequent information sharing from sources such as CDC  phone calls with states and the Web site flu.gov, which disseminated  information during the H1N1 pandemic.
section_title: State and Local Jurisdictions Cited Need for More Timely Communication Materials for Non-English-Speaking Populations
paragraphs: State and local jurisdiction officials we spoke with wanted CDC to provide  more communication materials for non-English-speaking populations.  Specifically, three of the states we contacted—as well as the National  Indian Health Board—reported that in order to serve their populations,  they needed CDC communication materials, including posters and public  service announcements, translated into additional languages in a more  timely manner. Some state officials and ASTHO also expressed that it  would be more efficient for CDC to translate materials once than for each  state or local jurisdiction to spend the resources to do so individually or to  rely on nonexperts for translation. Officials in Seattle-King County,  Washington, reported that they had to translate materials into 20  languages to meet their jurisdiction’s needs. Similarly, in Vermont, health  officials reported that they needed to translate and print materials into 7  languages, only 2 of which were included in CDC’s translated materials.  The Vermont health officials told us that the process of translation took  several weeks, which they said affected the vaccination rates among these  populations. Following the H1N1 pandemic, an ASTHO report  recommended that the federal government routinely take the lead in  translating pandemic materials into multiple languages.
CDC officials explained the range of translation services they offered, but  also noted that they could take additional measures to assist states with  translation. CDC communications officials said that the agency translated  its television and radio public service announcements about the H1N1  pandemic into Spanish and translated written materials into a range of  languages. CDC officials explained that they select the range of  translation services they will offer from a list of over 100 languages and  explained that these selections are based on the geography of the  situation, input from state and local public information officers, input from  stakeholders, and information from the searches that users complete on  the CDC Web site. CDC officials also told us that because information  about the pandemic was changing so quickly, it was challenging for CDC  to translate all of the information in a timely manner. A CDC official noted  that the agency could serve some additional roles in facilitating translation  for states, such as working with state partners to establish a clearinghouse  for already-translated materials as well as a plan to identify and address  translation gaps that avoids duplication of effort and helps ensure  consistency and accuracy. For translation into additional languages, CDC  officials noted that states could use the PHER grant funds.
section_title: Deployment of the SNS Met the Established Goal, but Gaps in Planning Were Identified
subsections: section_title: SNS Deployment Met Goal, but State and Local Jurisdictions Cited Need for Improved Communication from CDC on the Timing and Content of Shipments
paragraphs: While deployment of supplies from the SNS met the established goal,  officials from state and local jurisdictions reported a need for improved  communication about the timing and contents of shipments. Five days  after the initial diagnosis of H1N1 influenza, on April 26, 2009, CDC  released a quarter of the antiviral drugs and other supplies—including 11  million courses of antiviral drugs and 39 million face masks and  respirators, gowns, and gloves. Seven days later, on May 3, 2009, all states  and local jurisdictions—except two of the Pacific Island territories—had  received their SNS allocations. Officials we interviewed in three states  and participants in a series of IOM workshops noted that officials from  state and local jurisdictions did not always know when SNS shipments  would be arriving or what would be included in the shipments. For  example, Nebraska officials reported that they were told a shipment would  be arriving at 6:30 a.m., but the materials arrived earlier—at 2:30 a.m.  Nebraska officials were able to meet the delivery trucks with a team of  staff, but the shipment contained only two cases of gloves, which was not  what they anticipated. Officials from Texas reported that SNS delivery  schedules were often not adhered to and the lists of what would be in the  shipments were incorrect. Georgia officials reported that they were not  informed before the SNS supplies arrived at state warehouses, which  meant that they were not able to provide the planned security for the  supplies.
CDC officials told us that they took a variety of steps during the second  wave of the pandemic to improve collaboration with the states about the  timing and contents of the SNS shipments. Specifically, they noted that  they recognized that states were not operating on 24-hour schedules, as  had been assumed in prior SNS planning efforts. Accordingly, CDC’s SNS  officials explained that they changed their delivery schedules to only  deliver supplies during working hours. They also told us that when they  contacted the states to coordinate the timing of SNS shipments, they also  provided more information on the contents of the shipments. These  officials also told us that they revised the SNS procedures to  institutionalize these measures.
section_title: Not All Models of Respirators in the SNS Were Commonly Used, and Guidelines Were Conflicting
paragraphs: According to some state and local officials, one gap in SNS planning was  that the respirators provided through the SNS were different from those  used by state and local jurisdictions. IOM reported in its summary of a  series of workshops that the respirator models—also called N95  respirators—that state and local jurisdictions (and subsequently hospitals  and other health care facilities) received from the SNS were not the same  as the models hospitals regularly used, nor was a standard model  provided, which necessitated additional fit testing by recipients. To be  optimally effective, respirators require a tight facial seal, thus individual  “fit testing” is required. In Washington, state officials and Snohomish  County officials told us that they received an unfamiliar brand of  respirators in their SNS shipment that required fit testing of equipment  that they did not have available. ASTHO also reported that state and local  officials found the SNS respirators problematic and reported that states  did not know which models of respirators were in the SNS or which  models would be delivered. CDC officials responsible for the SNS  acknowledged problems with familiarity with the models of respirators in  the SNS and reported that they are looking into a range of solutions,  including standardizing the type of respirators included in the SNS and  providing a catalog of stored supplies to states. An official from CDC’s  National Institute for Occupational Safety and Health told us that the  institute is also researching the next generation of respirators for health  care workers. Another CDC division is also working with partners to  develop reusable masks specifically designed for health care settings.
State and local government officials were also confused by conflicting  federal and nonfederal guidance on the need for health care workers to  wear respirators. In 2007, HHS and the Department of Labor issued joint  guidance recommending that health care workers use respirators when in  close contact with patients who have confirmed or suspected influenza  during a pandemic. In May 2009, CDC released infection control guidance  for clinicians to use during the H1N1 outbreak that was consistent with the  2007 guidance. Further, a September 2009 study by IOM, which was  requested by CDC and Department of Labor’s OSHA, agreed with the  existing 2007 guidance in the specific case of H1N1 influenza. However,  conflicting guidance by other groups caused confusion during the H1N1  pandemic. The Infectious Disease Society of America and WHO  recommended that health care workers only be required to wear  respirators during health care procedures that involve specific types of  exposure, such as intubation, resuscitation, or open suctioning of the  respiratory tract. According to HHS officials, many clinicians preferred to  adhere to the infection control procedures that they use for seasonal  influenza. An ASTHO report noted that conflicts in guidance left health  care and other affected organizations wondering which guidance to  follow. Further, ASTHO reported that the requirement for health care  workers to wear respirators resulted in supply shortages and required  extra time and resources by health care facilities for fit testing. Officials  from OSHA told us, and IOM reported, that the available guidance is  contradictory because scientific research about routes of disease  transmission and respirator efficacy is inconclusive. Additionally, OSHA  officials acknowledged that there is currently an inadequate supply of  respirators to meet demand if all health care workers followed the existing  guidance.
section_title: SNS Planning Did Not Account for the Need for Long-Term Storage or Recovery of Unused SNS Materials
paragraphs: Another gap identified in SNS planning was related to long-term storage of  unused SNS materials. During the response to the H1N1 pandemic, some  of the state officials that we interviewed told us that they did not use all of  their SNS supplies. Nebraska officials, for example, told us that they only  used a few cases of SNS materials that they received and were storing the  remaining SNS materials in a state facility. Vermont officials reported that  they did not use all of their SNS supplies and, as a result, were paying for  storage as of June 2010. These state officials told us that they did not know  what to do with the remaining SNS items. A CDC official who works on  SNS issues acknowledged that the federal government did not have plans  for the handling of states’ unused SNS materials. He said that long-term  inventory management or return of SNS items to the federal government  was not a part of SNS exercises because distribution plans were based on  a more severe pandemic scenario or other emergencies where all available  supplies would be used quickly after distribution. The CDC official said  that the agency needs to plan for alternative scenarios when the  commercial market may be able to handle the demand for items in the  SNS.
In June 2010, HHS’s FDA provided guidance to CDC on the disposal of  materials in anticipation of the end of emergency use authorizations,  which allowed potentially helpful countermeasures to be used for  unapproved uses to protect the public health. For example, FDA advised  that states could hold on to respirators for a possible future public health  emergency or distribute the respirators to be used in a manner consistent  with their clearances. In its guidance, FDA also advised that state officials  could continue to hold onto FDA-specified antiviral drugs for use in a  future emergency situation, provided that they are stored appropriately.
section_title: Federal Agencies Are Completing After- Action Reports; Next Steps, Including Sharing with Key Stakeholders, Are Unclear
subsections: section_title: Federal Agencies Were Asked to Complete H1N1 Pandemic After-Action Reports by the NSS
paragraphs: According to the NSS, all federal agencies were asked to complete after- action reports appropriate to their level of involvement in the H1N1  pandemic response. The NSS relayed to us in November 2010 that while it  did not establish guidelines for these after-action reports, it was  monitoring the status of the reports. HHS officials told us that NSS last  requested that HHS report on the status of its H1N1 after-action reports  and follow-up activities in September 2010.
The NSS stated in April 2011 that it had not determined whether it would  synthesize the federal agency after-action reports into a single  governmentwide after-action report or if it will make the after-action  reports available to key stakeholders, such as state and local governments.  Nevertheless, a DHS official commented that sharing lessons from the  reports with stakeholders would foster a spirit of government  transparency and might help build stakeholder trust.
Officials from HHS, DHS, and Education confirmed that they are  completing their H1N1 pandemic after-action reports. The departments  took different approaches to collecting information for these reports, and  as of spring 2011, it was unclear whether the final reports will be made  publicly available or shared with key stakeholders.
HHS’s process for completing its after-action report involved soliciting  information from other federal and state agencies, as well as other  response partners, such as health care providers. The process included  a survey of experts across the federal government who had knowledge  of HHS’s H1N1 pandemic response; in-depth interviews with experts to  assess the agency’s H1N1 pandemic response; and stakeholder  engagement sessions, conducted via webinars, with entities such as  states, localities, private sector partners, and national trade  associations. According to HHS officials, as of April 2011, the HHS  after-action report was being reviewed within the department. HHS  officials also reported that the dissemination plans for the report were  not finalized. HHS officials did report that the agency incorporated  lessons learned from the H1N1 pandemic into its update of the  National Vaccine Plan, which describes initiatives to enhance  education on the safety of vaccines and vaccination practices and to  assist providers and the public in making informed decisions regarding  vaccination. In addition to the department’s activities to prepare an  after-action report, individual agencies have also taken steps to  incorporate lessons learned into their planning activities. For example,  in March 2011, CDC held an exercise to incorporate lessons learned  from the H1N1 pandemic into planning for a possible future pandemic.  During this exercise, CDC officials worked with representatives from  other parts of HHS, associations, as well as states and local  jurisdictions to simulate a response to an avian influenza pandemic,  which would likely have a higher fatality rate than the H1N1 pandemic.  FDA also revised its Emergency Operations Plan to reflect lessons  from the agency’s response to the pandemic. In addition, HHS officials  told us that they plan to hold exercises with DHS to test shared  leadership roles.
DHS’s after-action report process was led by the department’s Office  of Health Affairs. The Office of Health Affairs collected its information  through a series of planning conferences, after-action discussions, and  online surveys of agency officials. The after-action report includes  both strengths and areas for improvement to enhance future  departmental performance during a pandemic or other all-hazards  incident and is accompanied by a formal improvement plan. The DHS  after action report was signed by the Secretary of Homeland Security  on May 20, 2011, and DHS officials told us that they have shared the  report with the NSS.  DHS officials also told us that they are in the  process of developing their dissemination plans for the report’s  findings, including plans for sharing the findings with state and local  governments.
Education’s after-action report will be based on information gathered  during a working group meeting in February 2010 that included  discussions of how Education responded to the H1N1 pandemic, what  lessons were learned, and what the agency would do differently during  another pandemic. As of March 2011, Education’s after-action report  had not been finalized, and Education did not have dissemination  plans.
OSHA officials also told us that they have completed an H1N1 after- action report.
section_title: NSS Reported Plans for a Broad Approach to Preparedness
paragraphs: In April 2011, a senior NSS official reported that the NSS had no plans to  update the national pandemic implementation plan to incorporate lessons  learned from the H1N1 pandemic response; however, these lessons may be  incorporated into departments’ individual operational plans. Instead of  updating the national pandemic implementation plan, NSS officials  reported that they are coordinating a larger effort to transition national  preparedness from a dependence on fixed plans for specific threats to an  approach based on the capabilities needed for a variety of hazards, or an  all-hazards approach. Furthermore, the NSS did not indicate how the  after-action reports—and the associated lessons learned—will be used in  future planning and preparedness efforts. Specifically, as discussed above,  the NSS has not yet determined if it will share the lessons from the after- action reports with key stakeholders, such as state and local governments.  As we have previously reported, stakeholder involvement during the  planning process is important to ensure that both the federal government’s  and key stakeholders’ responsibilities and resource requirements are  clearly understood and agreed upon. We have previously recommended  that the HSC, which is supported by the NSS, update the national  pandemic implementation plan to incorporate information from exercises  and other experiences, such as the H1N1 pandemic. Indeed, the National  Response Framework—which outlines the manner in which the federal  government responds to domestic incidents—specifies that evaluation and  continual process improvement are cornerstones of effective  preparedness. It notes that improvement planning should develop  specific recommendations for changes in practice, timelines for  implementation, and assignments for completion. In addition, DHS has  defined the national preparedness system as a continuous cycle that  involves four main elements: (1) policy and doctrine, (2) planning and  resource allocation, (3) training and exercises, and (4) an assessment of  capabilities and reporting.
section_title: Conclusions
paragraphs: The H1N1 pandemic was the first human influenza pandemic in more than  four decades. As such, it provided the first real-life opportunity to test and  implement key aspects of the federal government’s plans to respond to a  pandemic, including those in the 2005 national pandemic strategy and the  2006 national pandemic implementation plan. Thus, it is important to  capture the lessons from the experiences of this event, both in terms of  response actions that worked as well as those that could be improved.
It is also imperative to learn from these lessons by incorporating them into  future planning and exercising efforts so that the nation can be better  prepared when the next influenza pandemic occurs. These lessons may  also be more broadly applicable to other hazards or emergencies that  require response measures, such as activation of the SNS. They are also  relevant to key stakeholders, such as state governments, which were  instrumental in this response and would play a key role in a future  response. All sectors of society, including governments, nonprofit  organizations, and the private sector, will need to be involved in  preparedness for a future pandemic. Accordingly, key stakeholders will  need to adjust their own plans and understand their critical roles in order  to be prepared to work effectively under difficult and challenging  circumstances.
These lessons also have some important limitations. Specifically, while the  H1N1 pandemic provided the opportunity to test and implement many  aspects of the federal government’s plans to respond to a pandemic, not all  parts of these plans—such as those dealing with critical infrastructure  protection and implementing border and trade measures—were tested. In  addition, the shared leadership structure was not fully tested, and states  raised concerns about their brief experience with these shared leadership  roles. HHS’s and DHS’s plans to test this structure will be an important  step to addressing this gap. These aspects may prove to be necessary in  response to a future pandemic, given that avian and other strains of  influenza remain a threat.
Our review of the federal government’s response to the H1N1 pandemic  highlighted several key lessons:    Planning and preparedness pay off. While the actual H1N1 outbreak  and pandemic differed from the avian influenza pandemic scenario  that was the basis for the planning, many of the funding and planning  activities—including funding for vaccine production capacity, planning  exercises, and interagency meetings prior to the H1N1 pandemic— positioned the government to respond effectively. The interagency  working group, convened by the NSS, fostered relationships that  proved advantageous during the response.
Effective communication on the availability of vaccine is central to a  successful response. Although the federal government was able to  purchase and distribute millions of doses of H1N1 vaccine, the vaccine  was not widely available when the public expected it and at the peak  of demand. Because the failure to effectively manage public  expectations can undermine government credibility, it is essential that  vaccine production efforts be paired with effective communication  strategies regarding the availability of the vaccine.
Timely, accessible information from CDC is valuable. The public  proved to be highly receptive to the information CDC disseminated  regarding the pandemic and what individuals could do to reduce their  susceptibility to H1N1 influenza. However, the effectiveness of  communication materials was diminished for some non-English- speaking populations when translated materials were not available to  them in a timely manner. We heard from state and local health  jurisdictions that they need materials in more languages, and they  suggested that communications would be more accurate and  translated more efficiently if key materials were translated centrally.
Given the key role of the SNS in a public health emergency,  consideration of logistics, inventory, and different scenarios is  important in planning for SNS deployment. The largest deployment of  the SNS to date occurred during the H1N1 pandemic response, but  several issues emerged because scenarios arose that had not been  anticipated. Resolving these issues now—in planning for future SNS  deployment—will allow for better use of SNS resources during the  next public health emergency.
Novel strains of influenza, including avian influenza strains, will continue  to pose the threat of an influenza pandemic that could be more severe than  the H1N1 pandemic. Accordingly, the failure to learn from the federal  government’s response to the H1N1 pandemic could be costly in terms of  lives and resources, regardless of whether future planning is specific to a  pandemic scenario or if it is incorporated into a broader   “all-hazards” planning scenario. Although the NSS has requested that  federal agencies prepare after-action reports, NSS officials have not  decided how they will work with HHS and DHS to incorporate these  lessons into any future planning, as called for by the National Response  Framework, or how they will share these lessons with key stakeholders.
section_title: Recommendations for Executive Action
paragraphs: We recommend that the Homeland Security Council direct the National  Security Staff to take the following two actions: In order to help the federal government prepare for a future influenza  pandemic, work with the Departments of Health and Human Services  and Homeland Security—as well as other federal agencies and state  and local jurisdictions, as applicable—to update planning and  exercising by incorporating lessons learned from federal agencies’  H1N1 after-action reports and the lessons we identified from the H1N1  pandemic. These lessons may include    developing communication strategies for better managing public  expectations about pandemic vaccine availability while working to  reduce the length of time required to produce a pandemic vaccine;  identifying state and local jurisdictions’ need for materials for non- English-speaking populations and examining ways to facilitate the  timely and efficient translation of key communication materials;  and    updating SNS plans by identifying tools for tracking SNS supplies,  ensuring that the supplies in the SNS meet the needs of states and  local jurisdictions, and accommodating previously unanticipated  scenarios, such as the need for possible long-term storage or  recovery of unused supplies.
In order to help key stakeholders prepare for a future influenza  pandemic or other public health emergencies, work with the  Departments of Health and Human Services and Homeland Security— as well as other federal agencies, as applicable—to share the relevant  findings of their after-action reports with key stakeholders, such as  state and local governments.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided a draft report for review and comment to the Associate  General Counsel for the NSS, which works on behalf of the HSC, as well as  the Secretaries of Health and Human Services, Homeland Security, Labor,  and Education. The Secretary of Education did not provide any formal  comments.
A legal advisor to the NSS did not provide written comments to be  included in the final report, but agreed that the NSS would take the report  and its recommendations under advisement.
In written comments, the HHS Assistant Secretary for Legislation  responded that HHS generally agreed with our findings, and stated that its  forthcoming after-action report will highlight several of the key themes  that we address in our report. He also noted that HHS is already taking  actions to address some of our findings, such as, reducing the time needed  to make a pandemic influenza vaccine available and examining ways to  make financial resources available during an emergency to states and local  jurisdictions. He also provided technical comments, on behalf of HHS,  which we incorporated as appropriate.
In written comments, the Director of the DHS GAO/Office of the Inspector  General Liaison Office stated that DHS remains committed to working  with the HSC, the NSS, HHS, and other relevant stakeholders to fulfill its  shared leadership responsibility for pandemic influenza response. He also  provided technical comments, on behalf of DHS, which we incorporated  as appropriate.
On behalf of the Department of Labor, the Assistant Secretary for  Occupational Safety and Health responded that OSHA provided an  important contribution to the federal pandemic response by protecting  workers’ safety and health during the H1N1 pandemic. The Assistant  Secretary further explained that OSHA has drafted an after-action report,  which explains that the full range of OSHA’s training, education,  enforcement, and public outreach programs were used to help employers  and workers protect themselves at work during the H1N1 pandemic.
HHS, DHS, and OSHA’s comments are reprinted in appendices III through  V.
We are sending copies of this report to the HSC, the Secretary of Health  and Human Services, the Secretary of Homeland Security, the Secretary of  Education, the Secretary of Labor, and appropriate congressional  committees. The report also is available at no charge on the GAO Web site  at http://www.gao.gov.
If you or your staff have any questions about this report, please contact  Bernice Steinhardt at (202) 512-6543 or steinhardtb@gao.gov or Marcia  Crosse at (202) 512-7114 or crossem@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on the  last page of this report. GAO staff who made major contributions to this  report are listed in appendix VI.
section_title: Appendix I: Information on Selection Criteria for Five Selected States
paragraphs: To examine how states and local jurisdictions used the grant funds and  interacted with federal departments during the response, we interviewed  officials involved in the H1N1 pandemic response in a sample of five  states: Georgia, Nebraska, Texas, Vermont, and Washington. We chose  these states to provide insight into the experiences of a range of states;  however, their experiences are not generalizable to all 50 states.
The sample of five states was selected to reflect a range of six  characteristics:  Interim vaccination rate for initial target groups    Census region    First week of reported widespread influenza activity    Public Health Emergency Response (PHER) grant funding    The 2008 population (in thousands)    Public health structure Table 3 lists data for each state on each characteristic.
section_title: Appendix II: Full Text for Figures 1, 2, and 4 on Lessons from the H1N1 Pandemic
paragraphs: The following information appears as interactive content in the body of  the report when viewed electronically.
section_title: Appendix III: Comments from the Department of Health and Human Services
section_title: Appendix IV: Comments from the Department of Homeland Security
section_title: Appendix V: Comments from the Department of Labor
section_title: Appendix VI: GAO Contacts and Staff Acknowledgments
subsections: section_title: GAO Contacts
section_title: Staff Acknowledgments
paragraphs: In addition to the contacts named above, Sarah Veale, Assistant Director;  Kim Yamane, Assistant Director; Lori Achman; Mallory Barg Bulman;  George Bogart; Helen Desaulniers; Karin Fangman; David Fox; Cathleen  Hamann; Seta Hovagimian; and Susan Sato made key contributions to this  report.
section_title: Related GAO Products
paragraphs: Disaster Response: Criteria for Developing and Validating Effective  Response Plans. GAO-10-969T. Washington, D.C.: September 22, 2010.
Influenza Pandemic: Monitoring and Assessing the Status of the  National Pandemic Implementation Plan Needs Improvement.  GAO-10-73. Washington, D.C.: November 24, 2009.
Influenza Pandemic: Gaps in Pandemic Planning and Preparedness  Need to Be Addressed. GAO-09-909T. Washington, D.C.: July 29, 2009.
Influenza Pandemic: Increased Agency Accountability Could Help  Protect Federal Employees Serving the Public in the Event of a  Pandemic. GAO-09-404. Washington, D.C.: June 12, 2009.
Influenza Pandemic: Continued Focus on the Nation’s Planning and  Preparedness Efforts Remains Essential. GAO-09-760T. Washington, D.C.:  June 3, 2009.
Influenza Pandemic: Sustaining Focus on the Nation’s Planning and  Preparedness Efforts. GAO-09-334. Washington, D.C.: February 26, 2009.
Influenza Pandemic: HHS Needs to Continue Its Actions and Finalize  Guidance for Pharmaceutical Interventions. GAO-08-671. Washington,  D.C.: September 30, 2008.
Influenza Pandemic: Federal Agencies Should Continue to Assist States  to Address Gaps in Pandemic Planning. GAO-08-539. Washington, D.C.:   June 19, 2008.
Emergency Preparedness: States Are Planning for Medical Surge, but  Could Benefit from Shared Guidance on Allocating Scarce Medical  Resources. GAO-08-668. Washington, D.C.: June 13, 2008.
Influenza Pandemic: Efforts Under Way to Address Constraints on  Using Antivirals and Vaccines to Forestall a Pandemic. GAO-08-92.  Washington, D.C.: December 21, 2007.
Influenza Pandemic: Opportunities Exist to Address Critical  Infrastructure Protection Challenges That Require Federal and Private  Sector Coordination. GAO-08-36. Washington, D.C.: October 31, 2007.
Influenza Vaccine: Issues Related to Production, Distribution, and  Public Health Messages. GAO-08-27. Washington, D.C.: October 31, 2007.
Influenza Pandemic: Further Efforts Are Needed to Ensure Clearer  Federal Leadership Roles and an Effective National Strategy.  GAO-07-781. Washington, D.C.: August 14, 2007.
Influenza Pandemic: Efforts to Forestall Onset Are Under Way;  Identifying Countries at Greatest Risk Entails Challenges. GAO-07-604.  Washington, D.C.: June 20, 2007.
Influenza Pandemic: Applying Lessons Learned from the 2004–05  Influenza Vaccine Shortage. GAO-06-221T. Washington, D.C.: November 4,  2005.
Influenza Vaccine: Shortages in 2004–05 Season Underscore Need for  Better Preparation. GAO-05-984. Washington, D.C.: September 30, 2005.
Influenza Pandemic: Challenges in Preparedness and Response.   GAO-05-863T. Washington, D.C.: June 30, 2005.
Influenza Pandemic: Challenges Remain in Preparedness. GAO-05-760T.  Washington, D.C.: May 26, 2005.