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entitled 'Influenza Pandemic: Lessons from the H1N1 Pandemic Should Be 
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United States Government Accountability Office:
GAO: 

Report to Congressional Requesters: 

June 2011: 

Influenza Pandemic: 

Lessons from the H1N1 Pandemic Should Be Incorporated into Future 
Planning: 

GAO-11-632: 

GAO Highlights: 

Highlights of GAO-11-632, a report to congressional requesters. 

Why GAO Did This Study: 

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. 

What GAO Found: 

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. 

* 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. 

* 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. 

* 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. 

* 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. 

What GAO Recommends: 

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. 

View [hyperlink, http://www.gao.gov/products/GAO-11-632] or key 
components. For more information, contact Bernice Steinhardt at (202) 
512-6543 or steinhardtb@gao.gov or Marcia Crosse at (202) 512-7114 or 
crossem@gao.gov. 

Contents: 

Letter: 

Background: 

HHS Funded a Range of Pandemic Influenza Activities with Supplemental 
Funds: 

Federal Response to the H1N1 Pandemic Highlighted a Number of Key 
Issues: 

Federal Agencies Are Completing After-Action Reports; Next Steps, 
Including Sharing with Key Stakeholders, Are Unclear: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Information on Selection Criteria for Five Selected States: 

Appendix II: Full Text for Figures 1, 2, and 4 on Lessons from the 
H1N1 Pandemic: 

Appendix III: Comments from the Department of Health and Human 
Services: 

Appendix IV: Comments from the Department of Homeland Security: 

Appendix V: Comments from the Department of Labor: 

Appendix VI: GAO Contacts and Staff Acknowledgments: 

Related GAO Products: 

Tables: 

Table 1: HHS Activities Supported by the 2009 Supplemental 
Appropriation: 

Table 2: HHS's Planned Spending for Remaining Influenza Pandemic Funds 
from the 2009 Supplemental Appropriation, as of December 31, 2010: 

Table 3: Data for Selected States: 

Figures: 

Figure 1: Key Events Related to the H1N1 Influenza Pandemic in the 
United States, April 2009 through August 2010: 

Figure 2: Examples of Ways That State and Local Jurisdictions Used the 
PHER Grants: 

Figure 3: H1N1 Influenza Activity and Vaccine Availability, October 
2009 through January 2010: 

Figure 4: Key Events Related to 2009 H1N1 Vaccine Production and 
Distribution in the United States, April 2009 through November 2009: 

Figure 5: CDC Communication Tools Used during the H1N1 Pandemic 
Response: 

Figure 6: Key Events Related to the H1N1 Pandemic in the United 
States, April 2009 through August 2010 (Printable Version): 

Figure 7: Examples of Ways That State and Local Jurisdictions Used the 
PHER Grants (Printable Version): 

Figure 8: Key Events Related to 2009 H1N1 Vaccine Production and 
Distribution in the United States, April 2009 through November 2009 
(Printable Version): 

Abbreviations: 

ACIP: Advisory Committee on Immunization Practices: 

ASPR: Office of the Assistant Secretary for Preparedness and Response: 

ASTHO: Association of State and Territorial Health Officials: 

BARDA: Biomedical Advanced Research and Development Authority: 

CDC: Centers for Disease Control and Prevention: 

DHS: Department of Homeland Security: 

EUA: emergency use authorization: 

FDA: Food and Drug Administration: 

HHS: Department of Health and Human Services: 

HSC: Homeland Security Council: 

IOM: Institute of Medicine: 

NACCHO: National Association of County and City Health Officials: 

NSS: National Security Staff: 

OSHA: Occupational Safety and Health Administration: 

PHER: Public Health Emergency Response: 

SNS: Strategic National Stockpile: 

WHO: World Health Organization: 

[End of section] 

United States Government Accountability Office:
Washington, DC 20548: 

June 27, 2011: 

The Honorable Fred Upton:
Chairman:
The Honorable Henry A. Waxman:
Ranking Member:
Committee on Energy and Commerce:
House of Representatives: 

The Honorable Bennie G. Thompson:
Ranking Member:
Committee on Homeland Security:
House of Representatives:
The Honorable Roy Blunt:
United States Senate: 

The Honorable Joe Barton:
House of Representatives: 

In response to the global spread of the H1N1 influenza virus, the 
United Nations' World Health Organization (WHO)[Footnote 1] declared 
the first human influenza pandemic in more than four decades on June 
11, 2009.[Footnote 2] Prior to this declaration, H1N1 influenza had 
spread across the United States after first being detected in 
California in April 2009.[Footnote 3] 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.[Footnote 4] 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)[Footnote 5]--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.[Footnote 6] 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.[Footnote 
7] 

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.[Footnote 8] The 
federal government--and particularly CDC--collaborated with state and 
local jurisdictions,[Footnote 9] 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). 
[Footnote 10] 

Because of the possibility of another influenza pandemic and our prior 
work on pandemic preparedness,[Footnote 11] 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.[Footnote 12] 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. 
[Footnote 13] 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.[Footnote 14] 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.[Footnote 15] 

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.[Footnote 16] 

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. 

Background: 

Pandemic Preparedness Prior to the H1N1 Pandemic: 

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.[Footnote 
17] 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.[Footnote 18] 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.[Footnote 19] 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.[Footnote 20] 

2009 H1N1 Pandemic: 

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 figure 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.[Footnote 21] 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. 

Figure 1: Key Events Related to the H1N1 Influenza Pandemic in the 
United States, April 2009 through August 2010: 

[Refer to PDF for image: interactive illustration] 

Interactive features: Roll your mouse over each month to see the result
For a printable copy of this figure, see appendix II. 

Sources: GAO analysis; James Gathany, Cade Martin (photos). 

Notes: The declaration of a public health emergency, pursuant to 42 
U.S.C. § 247d, provided the basis for the Secretary of Health and 
Human Services to exercise the authority under certain circumstances 
to approve the emergency use of unapproved drugs, devices, or 
biological products (or the emergency use of approved drugs, devices, 
or biological products for unapproved uses) through emergency use 
authorizations. 21 U.S.C. § 360bbb-3. 

The President's declaration of a national emergency pursuant to the 
National Emergencies Act provided the Secretary of Health and Human 
Services the authority to temporarily waive or modify certain 
requirements affecting the health care system throughout the duration 
of the public health emergency. 50 U.S.C. §§ 1621 and 1631; 42 U.S.C. 
§ 1320b-5. 

The release of 25 percent of the influenza supplies from the Strategic 
National Stockpile included antiviral drugs and equipment to protect 
against influenza transmission, such as face masks, respirators, 
gowns, and gloves. 

[End of figure] 

The H1N1 pandemic occurred in two waves in the United States.[Footnote 
22] 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. 

H1N1 Vaccine Production and Distribution: 

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.[Footnote 23] 
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.[Footnote 24] These five target groups, comprising about 159 
million persons, were recommended to be first to receive the H1N1 
vaccine.[Footnote 25] 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. 
[Footnote 26] 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.[Footnote 27] 

Strategic National Stockpile: 

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. 

HHS Funded a Range of Pandemic Influenza Activities with Supplemental 
Funds: 

Most Supplemental Funds Were Spent on Vaccine Purchase and Support of 
State and Local Pandemic Response Efforts: 

The Congress Appropriated Funds to HHS to Meet the Threat of Pandemic 
Influenza: 

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.[Footnote 28] 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.[Footnote 29] 

HHS Has Spent Almost 70 Percent of Available Supplemental Funds: 

From June 2009 through December 2010, HHS spent about $4.17 billion 
(about two-thirds)[Footnote 30] 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. 
[Footnote 31] 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,[Footnote 32] 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.[Footnote 
33] 

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.[Footnote 34] 
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.[Footnote 35] 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.[Footnote 36] (See figure 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. 

Figure 2: Examples of Ways That State and Local Jurisdictions Used the 
PHER Grants: 

[Refer to PDF for image: interactive illustrated U.S. map] 

Interactive features: Roll your mouse over each state to see the result
For a printable copy of this figure, see appendix II. Highlighted 
states are Georgia, Nebraska, Texas, Vermont, and Washington. 

Sources: GAO analysis of state data; Map Resources (map). 

[End of figure] 

Table 1: HHS Activities Supported by the 2009 Supplemental 
Appropriation: 

Activity: Vaccine production includes purchase of H1N1 vaccine, 
adjuvant,[A] and ancillary supplies for the H1N1 vaccine; 
Amount spent as of December 31, 2010: $1.719 billion; 
Percentage of total funds spent: 41.3%. 

Activity: PHER grants includes grants to state and local jurisdictions 
to upgrade state and local public health capacity; 
Amount spent as of December 31, 2010: $1.404 billion; 
Percentage of total funds spent: 33.7%. 

Activity: CDC vaccination campaign includes contracts to support the 
distribution of H1N1 vaccine and ancillary supplies, H1N1 vaccine 
safety and effectiveness monitoring, and a communications campaign on 
vaccination and prevention; 
Amount spent as of December 31, 2010: $340 million; 
Percentage of total funds spent: 8.2%. 

Activity: Antiviral drugs includes the purchase of pediatric doses of 
antiviral drugs in response to the disproportionate effects of H1N1 
influenza on children; 
Amount spent as of December 31, 2010: $231 million; 
Percentage of total funds spent: 5.6%. 

Activity: CDC domestic response includes funds for deployment of CDC 
staff to support investigations into the H1N1 outbreak along the 
borders and in the United States and production and distribution of a 
diagnostic test kit for H1N1 influenza; 
Amount spent as of December 31, 2010: $199 million; 
Percentage of total funds spent: 4.8%. 

Activity: Ongoing H1N1 activities includes funds to continue 
development of intravenous presentations of an antiviral drug for 
persons with influenza and a program to monitor the effects of use of 
H1N1 vaccine and antiviral drugs by pregnant women and the babies they 
bore; 
Amount spent as of December 31, 2010: $95 million; 
Percentage of total funds spent: 2.3%. 

Activity: Hospital Preparedness Program includes grants through states 
to hospitals for health care workforce protection and the development 
of plans to optimize usage of the health care system during an 
influenza pandemic; 
Amount spent as of December 31, 2010: $90 million; 
Percentage of total funds spent: 2.2%. 

Activity: CDC international response includes support for H1N1 
influenza surveillance, laboratory and research projects in over 13 
countries, and personnel support provided to WHO regional offices to 
handle H1N1 pandemic surge activities; 
Amount spent as of December 31, 2010: $44 million; 
Percentage of total funds spent: 1.1%. 

Activity: CDC communications includes funds for consumer behavioral 
research on messaging; 
use of a Web-based media monitoring system to assess message 
dissemination by the media about H1N1 influenza; 
support of pandemic influenza tabletop exercises involving national, 
regional, and local media outlets; 
and translation of pandemic influenza materials into various languages; 
Amount spent as of December 31, 2010: $31 million; 
Percentage of total funds spent: 0.7%. 

Activity: Countermeasure[B] development and regulation at FDA includes 
the development, evaluation, licensure, and safety monitoring of the 
H1N1 vaccine, and FDA activities to facilitate the availability and 
safety monitoring of H1N1 diagnostic tests, personal protective 
equipment, and antiviral drugs; 
Amount spent as of December 31, 2010: $9 million; 
Percentage of total funds spent: 0.2%. 

Activity: Compensation includes funds used to support the 
administration of the Countermeasures Injury Compensation Program, 
which will provide compensation to individuals with injuries caused by 
certain countermeasures administered to diagnose, mitigate, prevent, 
or treat harm from specified material threats[C]; 
Amount spent as of December 31, 2010: $4 million; 
Percentage of total funds spent: 0.1%. 

Activity: ASPR deployment/operations support includes costs associated 
with sending ASPR staff to states and territories during the H1N1 
pandemic; 
Amount spent as of December 31, 2010: $1 million; 
Percentage of total funds spent: 0.0%. 

Activity: Total; 
Amount spent as of December 31, 2010: $4.167 billion; 
Percentage of total funds spent: 100.0%. 

Source: GAO analysis of HHS data. 

Notes: Numbers may not sum to totals because of rounding. The 
information presented in this table is based on Department of Health 
and Human Services, Report to Congress: December 2010 Report, Pandemic 
Influenza Preparedness Spending (Washington, D.C., February 2011). HHS 
is submitting biannual reports to the Congress on the 2009 
supplemental appropriation. The February 2011 report covers spending 
through December 2010. 

HHS reported that it transferred $241 million to the Departments of 
Defense, Veterans Affairs, State, and Agriculture. Since HHS spent the 
majority of the 2009 supplemental appropriation, we did not determine 
how the $241.20 million transferred to these other departments was 
spent by them. We did not independently verify the amount that was 
transferred. The 2009 supplemental appropriation requires that all 
funds transferred to these departments go toward purposes related to 
preparing for or responding to an influenza pandemic. 

[A] Adjuvants are substances that may be added to a vaccine to 
increase the body's immune response. While adjuvants were purchased by 
HHS as a precautionary measure, they were not used in the H1N1 vaccine. 

[B] Medical countermeasures are medications, biological products, or 
devices that treat, identify, or prevent harm from a biological or 
other agent that may cause a public health emergency. Medical 
countermeasures for use during an influenza pandemic may include 
vaccines, antiviral drugs, personal respirators, and influenza 
diagnostic tests. 

[C] The Countermeasures Injury Compensation Program, administered by 
HHS's Health Resources and Services Administration, provides 
compensation for medical expenses, lost employment income, and/or 
death benefits for eligible individuals injured as a result of 
receiving certain countermeasures, such as vaccines, antiviral drugs, 
diagnostic tests, and personal protective equipment. 

[End of table] 

States Experienced Challenges with Grant Administration during the 
Pandemic Response: 

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.[Footnote 37] 

* 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.[Footnote 38] 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. 

HHS Plans for Remaining Supplemental Funds Include Efforts to Prepare 
for Future Pandemics: 

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.[Footnote 39] 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.[Footnote 40] 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. 

Table 2: HHS's Planned Spending for Remaining Influenza Pandemic Funds 
from the 2009 Supplemental Appropriation, as of December 31, 2010: 

Primary activity: Influenza vaccine production; 
Amount: $758 million. 

Subactivity: New vaccine production technologies includes supporting 
the development of new influenza vaccine technologies that would 
shorten vaccine production time; 
Amount: $431 million. 

Subactivity: Centers for Innovation in Advanced Development and 
Manufacturing includes the support of multiuse facilities that could 
be used to expand influenza vaccine production capacity during a 
pandemic; 
Amount: $108 million. 

Subactivity: H5N1 prepandemic vaccine storage and stability testing 
includes activities to enlarge the H5N1 prepandemic vaccine and 
antiviral drug stockpiles and conduct stability testing to determine 
the vaccine's shelf life; 
Amount: $54 million. 

Subactivity: Adjuvants[A] includes support for clinical tests of 
existing and new vaccines with adjuvants, development of regulatory 
guidance for adjuvants, and further research and development; 
Amount: $60 million. 

Subactivity: Domestic fill and finish manufacturing network includes 
activities to develop a network of facilities with sufficient capacity 
to rapidly fill the vials, syringes, and sprayers required for 
delivery of influenza vaccine during a pandemic; 
Amount: $50 million. 

Subactivity: Influenza vaccine potency and sterility test development 
includes activities to develop methods to improve and shorten the time 
needed for vaccine potency tests that determine the amount of antigen 
in a vaccine and sterility tests that ensure that a vaccine is not 
contaminated[B]; 
Amount: $30 million. 

Subactivity: Vaccine seed optimization includes support of activities 
that would hasten and standardize the process for generating the virus 
strains used to manufacture influenza vaccines; 
Amount: $24 million. 

Subactivity: H1N1 vaccine recovery project includes H1N1 vaccine 
storage and disposal; 
Amount: $1 million. 

Subactivity: Egg supply includes support for a year-round egg supply 
that could be used to develop an influenza vaccine in a pandemic.[C]; 
Amount: $1 million. 

Primary activity: Antiviral drugs; 
Subactivity: Antiviral drug advanced development includes funding for 
advanced development of Peramivir, an intravenously administered 
antiviral drug that was used during the H1N1 pandemic, plus other 
development activities at HHS; 
Amount: $435 million. 

Primary activity: Advanced development of diagnostics; 
Subactivity: Advanced development of diagnostic testing devices for 
influenza; 
Amount: $76 million. 

Primary activity: HHS/CDC; 
Amount: $623 million. 

Subactivity: CDC replenishment of supplies in the SNS includes 
supplies that are needed during an influenza pandemic; 
Amount: $257 million. 

Subactivity: CDC base influenza activities supports a portion of CDC's 
fiscal year 2011 SNS and influenza activities; 
Amount: $225 million. 

Subactivity: HHS/CDC Surveillance, Lab Capacity & Communications 
Activities supports the continuation and completion of activities 
begun in response to the H1N1 pandemic. This includes measures such as 
virus detection and countermeasure development; 
Amount: $141 million. 

Primary activity: National Institutes of Health; 
Subactivity: Pandemic influenza-related research activities; 
Amount: $33 million. 

Primary activity: Compensation; 
Subactivity: Countermeasures Injury Compensation Program, which 
provides compensation for eligible individuals injured as a result of 
receiving certain medical countermeasures; 
Amount: $58 million. 

Primary activity: Total; 
Amount: $1.983 billion. 

Source: GAO analysis of HHS data. 

Notes: Totals may not sum to totals because of rounding. The 
information presented in this table is based in part on Department of 
Health and Human Services, Report to Congress: December 2010 Report, 
Pandemic Influenza Preparedness Spending (Washington, D.C., February 
2011), and Department of Health and Human Services, Amended Spending 
Plan for 2009 Supplemental Funding, as reported to the Congress in 
August 2010. 

[A] Adjuvants are substances that may be added to a vaccine to 
increase the body's immune response. 

[B] An antigen is the active substance in a vaccine that provides 
immunity by causing the body to produce protective antibodies to fight 
off a particular influenza strain. 

[C] Current influenza vaccines are prepared from materials grown in 
chicken eggs. 

[End of table] 

Federal Response to the H1N1 Pandemic Highlighted a Number of Key 
Issues: 

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, 

* public communication, and: 

* the SNS. 

Not All Aspects of the Existing Strategy and Plan Were Relied on, but 
Earlier Funding and Planning Paid Off: 

Elements of National Pandemic Strategy and Implementation Plan Were 
Not Relied on Because of the Nature of the H1N1 Pandemic: 

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.[Footnote 41] 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.[Footnote 42] 

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[Footnote 43]. 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.[Footnote 44] 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. 

Prior Federal Funding and Planning Built Capacity and Interagency 
Relationships, Which Facilitated the Federal Response: 

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.[Footnote 45] 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.[Footnote 
46] 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.[Footnote 47] 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. 

Failure to Meet Public Expectations about Vaccine Availability 
Diminished Government Credibility, but Some Practices for H1N1 Vaccine 
Distribution Were Reported to Be Valuable: 

H1N1 Vaccine Was Not Widely Available When Expected nor When Demand 
Was Highest: 

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.[Footnote 48] (See figure 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.[Footnote 49] 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 
figure 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,[Footnote 50] but after the vaccine became available, 
CDC reported that only about 23 percent of adults actually were 
vaccinated.[Footnote 51] 

Figure 3: H1N1 Influenza Activity and Vaccine Availability, October 
2009 through January 2010: 

[Refer to PDF for image: multiple line graph] 

Date: October 16; 
Estimated Minimum number of H1N1 cases: 3,638,000; 
Estimated Maximum number of H1N1 cases: 8,444,000; 
Weekly number of vaccine doses shipped: 5,886,000. 

Date: October 23; 
Estimated Minimum number of H1N1 cases: 5,017,000; 
Estimated Maximum number of H1N1 cases: 8,922,000; 
Weekly number of vaccine doses shipped: 5,396,000. 

Date: October 30; 
Estimated Minimum number of H1N1 cases: 6,230,000; 
Estimated Maximum number of H1N1 cases: 9,177,000; 
Weekly number of vaccine doses shipped: 5,588,000. 

Date: November 6; 
Estimated Minimum number of H1N1 cases: 5,147,000; 
Estimated Maximum number of H1N1 cases: 8,639,000; 
Weekly number of vaccine doses shipped: 9,378,000. 

Date: November 13; 
Estimated Minimum number of H1N1 cases: 3,621,000; 
Estimated Maximum number of H1N1 cases: 7,419,000; 
Weekly number of vaccine doses shipped: 9,198,000. 

Date: November 20; 
Estimated Minimum number of H1N1 cases: 1,916,000; 
Estimated Maximum number of H1N1 cases: 5,618,000; 
Weekly number of vaccine doses shipped: 8,644,000. 

Date: November 27; 
Estimated Minimum number of H1N1 cases: 1,246,000; 
Estimated Maximum number of H1N1 cases: 4,091,000; 
Weekly number of vaccine doses shipped: 7,783,000. 

Date: December 4; 
Estimated Minimum number of H1N1 cases: 945,000; 
Estimated Maximum number of H1N1 cases: 2,284,000; 
Weekly number of vaccine doses shipped: 9,575,000. 

Date: December 11; 
Estimated Minimum number of H1N1 cases: 596,000; 
Estimated Maximum number of H1N1 cases: 1,274,000; 
Weekly number of vaccine doses shipped: 8,868,000. 

Date: December 18; 
Estimated Minimum number of H1N1 cases: 583,000; 
Estimated Maximum number of H1N1 cases: 848,000; 
Weekly number of vaccine doses shipped: 14,178,000. 

Date: December 25; 
Estimated Minimum number of H1N1 cases: 485,000; 
Estimated Maximum number of H1N1 cases: 725,000; 
Weekly number of vaccine doses shipped: 8,167,000. 

Date: January 1; 
Estimated Minimum number of H1N1 cases: 482,000; 
Estimated Maximum number of H1N1 cases: 722,000; 
Weekly number of vaccine doses shipped: 6,703,000. 

Date: January 8; 
Estimated Minimum number of H1N1 cases: 331,000; 
Estimated Maximum number of H1N1 cases: 550,000; 
Weekly number of vaccine doses shipped: 9,654,000. 

Date: January 15; 
Estimated Minimum number of H1N1 cases: 300,000; 
Estimated Maximum number of H1N1 cases: 781,000; 
Weekly number of vaccine doses shipped: 5,488,000. 

Date: January 22; 
Estimated Minimum number of H1N1 cases: 401,000; 
Estimated Maximum number of H1N1 cases: 706,000; 
Weekly number of vaccine doses shipped: 1,318,000. 

Date: January 29; 
Estimated Minimum number of H1N1 cases: 183,000; 
Estimated Maximum number of H1N1 cases: 459,000; 
Weekly number of vaccine doses shipped: 3,100,000. 

Source: GAO analysis of CDC data. 

Notes: This figure presents CDC estimates on the range of H1N1 
influenza cases and CDC reports of H1N1 vaccine doses shipped each 
week. HHS allocated doses of vaccine to each state for distribution 
based on the overall population of the state. The states, in turn, 
placed orders for their allocated doses and decided which providers 
should receive the vaccine. Not all distributed doses were 
administered. 

[End of figure] 

Figure 4: Key Events Related to 2009 H1N1 Vaccine Production and 
Distribution in the United States, April 2009 through November 2009: 

[Refer to PDF for image: interactive illustration] 

Interactive features: Roll your mouse over each month to see the result
For a printable copy of this figure, see appendix II. 

Sources: GAO analysis; James Gathany (photos). 

[End of figure] 

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.[Footnote 52] 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.[Footnote 53] 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. 
[Footnote 54] 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. 

State and Local Jurisdictions Valued Flexibility in Implementing 
Vaccination Campaigns, but Differences across Neighboring 
Jurisdictions Led to Public Confusion: 

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.[Footnote 55] 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.[Footnote 56] 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. 

Use of a Central Vaccine Distributor Was Generally Cited as an 
Effective Practice, but Limitations in Sizes of Vaccine Orders Was 
Cited as Problematic: 

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.[Footnote 57] 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.[Footnote 58] 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.[Footnote 59] 
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.[Footnote 60] 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. 

Public Surveys Generally Found CDC's Public Communication Campaign to 
Be Effective, but Communication Materials Were Not Accessible for All 
Populations: 

Public Surveys Found CDC's Communication Campaign to Be Effective: 

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).[Footnote 61] 
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.[Footnote 62] 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 figure 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. 

Figure 5: CDC Communication Tools Used during the H1N1 Pandemic 
Response: 

[Refer to PDF for image: list] 

CDC officials reported using a number of different tools to reach the 
public with their messages: 

* CDC used traditional media outlets, such as newspapers, television, 
and radio. 

* CDC used the flu.gov Web site to provide a single source of 
information about the H1N1 pandemic. 

* CDC introduced content syndication, which allowed CDC to 
automatically update entities that subscribed to CDC and CDC’s Web 
sites when CDC updated its own information. 

* CDC used social media, such as Twitter and blogs, to share 
information. 

Source: GAO analysis. 

[End of figure] 

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.[Footnote 63] 
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. 

State and Local Jurisdictions Cited Need for More Timely Communication 
Materials for Non-English-Speaking Populations: 

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.[Footnote 64] 

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.[Footnote 65] 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. 

Deployment of the SNS Met the Established Goal, but Gaps in Planning 
Were Identified: 

SNS Deployment Met Goal, but State and Local Jurisdictions Cited Need 
for Improved Communication from CDC on the Timing and Content of 
Shipments: 

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. 
[Footnote 66] 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.[Footnote 
67] 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. 

Not All Models of Respirators in the SNS Were Commonly Used, and 
Guidelines Were Conflicting: 

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.[Footnote 68] 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.[Footnote 69] 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.[Footnote 70] 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.[Footnote 71] 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,[Footnote 72] 
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.[Footnote 73] 
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. 

SNS Planning Did Not Account for the Need for Long-Term Storage or 
Recovery of Unused SNS Materials: 

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. 

Federal Agencies Are Completing After-Action Reports; Next Steps, 
Including Sharing with Key Stakeholders, Are Unclear: 

Federal Agencies Were Asked to Complete H1N1 Pandemic After-Action 
Reports by the NSS: 

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.[Footnote 74] 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.[Footnote 75] 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. 

NSS Reported Plans for a Broad Approach to Preparedness: 

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.[Footnote 76] 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.[Footnote 77] 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.[Footnote 78] 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.[Footnote 79] It notes that improvement 
planning should develop specific recommendations for changes in 
practice, timelines for implementation, and assignments for 
completion.[Footnote 80] 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.[Footnote 81] 

Conclusions: 

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. 

Recommendations for Executive Action: 

* 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. 

Agency Comments and Our Evaluation: 

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 [hyperlink, 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. 

Signed by: 

Bernice Steinhardt: 
Director, Strategic Issues: 

Signed by: 

Marcia Crosse: 
Director, Health Care: 

[End of section] 

Appendix I: Information on Selection Criteria for Five Selected States: 

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. 

Table 3: Data for Selected States: 

State: Georgia; 
Interim vaccination rate for initial target groups (percentage)[A]: 
22.7%; 
Census region: South; 
First week of reported widespread influenza activity[B]: 5/09/2009; 
PHER grant funding[C]: $39,253,852; 
2008 Population[D]: 9,686,000; 
Public health structure[E]: Hybrid. 

State: Nebraska; 
Interim vaccination rate for initial target groups (percentage)[A]: 
39.6%; 
Census region: Midwest; 
First week of reported widespread influenza activity[B]: 7/11/2009; 
PHER grant funding[C]: $10,251,928; 
2008 Population[D]: 1,783,000; 
Public health structure[E]: Hybrid. 

State: Texas; 
Interim vaccination rate for initial target groups (percentage)[A]: 
20.8%; 
Census region: South; 
First week of reported widespread influenza activity[B]: 5/09/2009; 
PHER grant funding[C]: $93,258,556; 
2008 Population[D]: 24,327,000; 
Public health structure[E]: Hybrid. 

State: Vermont; 
Interim vaccination rate for initial target groups (percentage)[A]: 
52.5%; 
Census region: Northeast; 
First week of reported widespread influenza activity[B]: 10/17/2009; 
PHER grant funding[C]: $5,882,237; 
2008 Population[D]: 621,000; 
Public health structure[E]: Centralized. 

State: Washington; 
Interim vaccination rate for initial target groups (percentage)[A]: 
37.5%; 
Census region: West; 
First week of reported widespread influenza activity[B]: 9/19/2009; 
PHER grant funding[C]: $27,920,746; 
2008 Population[D]: 6,549,000; 
Public health structure[E]: Decentralized. 

Source: GAO analysis of Department of Health and Human Services, 
Association of State and Territorial Health Officials, and U.S. Census 
Bureau data. 

[A] Interim vaccination rate for initial target groups is based on 
reported vaccination rates from October 2009 through January 2010. See 
Centers for Disease Control and Prevention, "Interim Results: 
Influenza A (H1N1) 2009 Monovalent Vaccination Coverage - United 
States, October through January 2010," Morbidity and Mortality Weekly 
Report, vol. 59, no. 12 (April 2010), 363. 

[B] This is the first week that the state reported widespread 
influenza activity based on CDC's FluView from April 11, 2009, through 
December 26, 2009. 

[C] This shows the total PHER grant funding for PHER phases one 
through three, as reported in CDC guidance to states. 

[D] This is based on data reported by the U.S. Census Bureau in the 
Statistical Abstract of the United States, 2008. 

[E] This is based on the Association of State and Territorial Health 
Officials' Profile of State Public Health, Volume 1. In a centralized 
structure, state health departments provide local public health 
services. In a decentralized structure, local health departments often 
collaborate with, but are organizationally independent of, state 
public health departments. In a hybrid structure, consumers may 
receive public health services from either the state or through 
agencies organized or operated by local governments, depending on the 
jurisdiction. In some cases, in hybrid structures state and local 
health departments share responsibility for providing services at the 
local level. 

[End of table] 

[End of section] 

Appendix II: Full Text for Figures 1, 2, and 4 on Lessons from the 
H1N1 Pandemic: 

The following information appears as interactive content in the body 
of the report when viewed electronically. 

Figure 6: Key Events Related to the H1N1 Pandemic in the United 
States, April 2009 through August 2010 (Printable Version): 

[Refer to PDF for image: timeline] 

April 15, 2009: 
The first U.S. case of H1N1 influenza is detected in California. 

April 23, 2009: 
CDC holds its first press briefing to address its response to the 
increasing number of U.S. H1N1 influenza cases. 

April 26, 2009: 
The Acting Secretary of Health and Human Services declares H1N1 
influenza a U.S. public health emergency; CDC releases 25 percent of 
influenza supplies from the Strategic National Stockpile to states and 
local jurisdictions for the H1N1 influenza response. 

April 28, 2009: 
CDC issues interim guidance recommending that schools close for up to 
7 days in cases of students with confirmed or suspected H1N1 influenza. 

April 29, 2009: 
The first U.S. H1N1 influenza death is reported in Texas. 

May 5, 2009: 
CDC revises school closure guidance to recommend against school 
closures in cases with students with confirmed or suspected cases of 
H1N1 influenza. 

June 11, 2009: 
WHO declares the H1N1 outbreak a human influenza pandemic. 

June 24, 2009: 
The President signs the Supplemental Appropriations Act, which 
provides HHS with as much as $7.65 billion in supplemental funding to 
address the H1N1 pandemic. 

July 9, 2009: 
The White House, DHS, HHS, and Education hold an H1N1 Preparedness
Summit for state and local governments during which the National 
Framework for 2009-H1N1 Influenza Preparedness and Response is 
discussed. 

July 10, 2009: 
The Secretary of Health and Human Services announces the availability
of $350 million in funding for states for the H1N1 pandemic response. 

September 15, 2009: 
HHS’s FDA approves four manufacturers to produce H1N1 vaccine. 

October 5, 2009: 
The first H1N1 vaccine doses are administered. 

October 24, 2009: 
The President declares a national emergency based on the National 
Emergencies Act. 

November 10, 2009: 
FDA approves a fifth manufacturer to produce a H1N1 vaccine. 

June 24, 2010: 
U.S. public health emergency declaration ends. 

August 10, 2010: 
WHO declares an end to the H1N1 pandemic. 

Source: GAO analysis. 

[End of figure] 

Figure 7: Examples of Ways That State and Local Jurisdictions Used the 
PHER Grants (Printable Version): 

[Refer to PDF for image: illustrated U.S. map] 

Georgia: 
The Georgia Department of Public Health hired a liaison to work with 
school nurses across the state on vaccine clinics, family education, 
and school policies. 

Nebraska: 
In Nebraska, the Douglas County Health Department contracted with 
nurses to administer the H1N1 vaccine at mass vaccination clinics and 
with a company that helped local law enforcement provide security at 
these clinics. 

Texas: 
Texas funded a public education campaign. The campaign was developed 
in English and Spanish and included television and radio messages, use 
of social media and webinars, and a variety of printed materials that 
could be downloaded from the texasflu.org Web site. 

Vermont: 
Vermont purchased lab equipment and paid for the incineration costs of 
medical waste generated by school-based vaccination clinics. The state 
also hired a CDC public health advisor and 10 temporary employees to 
enter vaccination data into the state’s vaccine registry. 

Washington: 
Washington funded an H1N1 influenza outreach coordinator at the state’
s education agency. The outreach coordinator managed the 
communications that went out to school districts through the state 
education agency’s Web site and conducted a survey of school nurses 
regarding the H1N1 pandemic response. 

Sources: GAO analysis of state data; Map Resources (map). 

[End of figure] 

Figure 8: Key Events Related to 2009 H1N1 Vaccine Production and 
Distribution in the United States, April 2009 through November 2009 
(Printable Version): 

[Refer to PDF for image: timeline] 

April: 
The first U.S. H1N1 influenza case is detected. CDC begins working to
develop the H1N1 vaccine. 

May: 
The first wave of H1N1 activity peaks in the United States. HHS 
contracts with vaccine manufacturers to produce an H1N1 vaccine for 
clinical tests. 

June: 
On June 11, WHO declares the H1N1 outbreak a pandemic. HHS begins 
holding weekly calls with states and localities to provide vaccine-
related updates. H1N1 vaccine production is under way. 

July: 
The first wave of H1N1 activity begins to decline. CDC issues 
recommendations to states for H1N1 influenza vaccination and the ACIP 
makes recommendations on H1N1 vaccine target groups. HHS issues 
initial estimates of H1N1 vaccine availability for October. 

August: 
The National Institutes of Health starts clinical trials of the H1N1 
vaccine. 

September: 
CDC begins allocating expected vaccine supplies to states. 
FDA approves four manufacturers to produce H1N1 vaccines. At the end 
of the month, states are able to place their first orders for their 
allocations of H1N1 vaccine. 

October: 
The second wave of H1N1 influenza activity peaks. The first H1N1 
vaccine doses are administered in the first week of October, with states
administering initial vaccine doses to ACIP target groups. By the end 
of the month, about 23.2 million vaccine doses are allocated to 
states, and about 16.9 million doses are shipped to states. 

November: 
Reports of H1N1 influenza activity begin to decline. FDA approves a 
fifth manufacturer to produce an H1N1 vaccine. States begin expanding
vaccination to the general public. By the end of the month, over 61 
million vaccine doses are available. 

Source: GAO analysis. 

[End of figure] 

[End of section] 

Appendix III: Comments from the Department of Health and Human 
Services: 

Department Of Health & Human Services:  
Office of the Assistant Secretary for Legislation 
Washington, DC 20201: 

June 1, 2011: 

Bernice Steinhardt: 
Director, Strategic Issues: 
Marcia Crosse: 
Director, Health Care: 
U.S. Government Accountability Office: 
441 G Street N.W. 
Washington, DC 20548: 
 
Dear Ms. Steinhardt and Ms. Crosse: 
'
Attached are comments on the U.S. Government Accountability Office's 
(GAO) draft report entitled, "Influenza Pandemic: Lessons From HIN1 
Pandemic Should Be Incorporated into Future Planning" (GA0-11-632).  

The Department appreciates the opportunity to review this report 
before its publication. 

Sincerely,  

Signed by: 

Jim R. Esquea: 
Assistant Secretary for Legislation:  

Attachment:  

[End of letter] 

General Comments of The Department of Health And Human Services (HHS) 
On The Government Accountability Office's (GAO) Draft Report Entitled, 
"Influenza Pandemic: Lessons Learned From Hin1 Should Be Incorporated 
Into Future Planning" (GAO-11-632) 

The Department appreciates the opportunity to review and comment on 
this draft report. We generally concur with the report and support the 
lessons highlighted in the report. 

The forthcoming HHS Retrospective will in fact highlight several of 
these key themes: the value of planning and preparedness, the 
necessity of effective communication for a successful response, the 
importance of timely and accessible information, and deployment 
planning of the Strategic National Stockpile. Pandemic planning 
efforts going forward address these and other issues.
Below arc a few examples of efforts currently underway to make systems 
improvements that will aid in pandemic response and the way the 
Department works with partners and improves capabilities for all 
threats: 

* HHS is leading efforts to align preparedness grants across the 
Federal government, including the Hospital Preparedness Program (HPP) 
and Public Health Emergency Preparedness (PHEP) programs, to ensure 
more consistent administrative requirements. This will have the dual 
effect of making the process less burdensome to states and grantees 
and providing a unified Federal message on preparedness. 

* The August 2010 Medical Countermeasures Review describes a plan for 
developing a nimble, flexible capability to produce not only pandemic 
vaccine but medical countermeasures (MCMs) for any threat. These 
recommendations are currently being implemented. The Biomedical 
Advanced Research and Development Authority (BARDA), the Centers for 
Disease Control and Prevention (CDC), the Food and Drug Administration 
(FDA), National Institute of Allergy and Infectious Diseases (NIAID) 
and vaccine industry partners are working together to address 
manufacturing and product release requirements that will speed 
availability of vaccines for distribution by up to 4-6 weeks. Also, 
BARDA awarded two more contracts supporting advanced development of 
recombinant influenza vaccines towards US licensure. Each of these 
contracts stipulate US-based manufacturing with the first dose of 
pandemic influenza vaccine available by 12 weeks post-onset and 50 
million doses within 4 months. 

* The 2010 President's Council of Advisers on Science and Technology's 
"Report to the President on Reengineering the Influenza Vaccine 
Production Enterprise to Meet the Challenges of Pandemic Influenza" 
made recommendations on ways to speed the availability of influenza 
vaccine during a pandemic. The Public Health Emergency Medical 
Countermeasures Enterprise (PHEMCE) has acted on many of these 
recommendations. For example, BARDA has issued advanced research and 
development contracts to several manufacturers developing next-
generation recombinant influenza vaccines that may shorten development 
times considerably, and BARDA, CDC, and the National Institutes of 
Health (NIH) are working together and with industry to optimize 
vaccine seed strain production and develop faster approaches to 
required sterility and potency testing that together could speed 
availability of vaccines for distribution by up to 4-6 weeks. 

* Learning from the challenges related to pandemic vaccine 
availability estimates early in the 2009 1-11N1 response, efforts are 
underway to improve situational awareness of vaccine production for 
future events. As mentioned in the report, increased coordination 
between HHS staff and vaccine manufacturers in November 2009 resulted 
in improved vaccine availability estimates. HHS is incorporating the 
need for better communication and coordination into several areas: our 
planning efforts; between federal officials and vaccine manufacturers 
to ensure real-time situational awareness for vaccine production and 
availability; and between federal agencies, states, and local health 
departments to adequately convey uncertainties in initial vaccine 
estimates. 

Based on experiences from the 2009 HI N1 pandemic and other recent 
emergencies, such as the Deepwater Horizon Oil Spill and the Haiti 
Earthquake, the Department recognizes the need to examine and 
potentially refine how financial resources are made available during 
an emergency event, and is currently identifying relevant barriers and 
challenges. Once complete, this analysis should identify additional 
administrative flexibilities for using federal funds during future 
emergencies. Additionally, recipients of the Public Health Emergency 
Preparedness Cooperative Agreement have also been asked to examine 
their jurisdiction's administrative processes and approaches to 
receive and use emergency funds to respond to emergency situations in 
a timely manner, identify relevant barriers, and planned actions to 
address those challenges. 

[End of section] 

Appendix IV: Comments from the Department of Homeland Security: 

U.S. Department of Homeland Security: 
Washington, DC 20528: 

May 31,2011: 

Bernice Steinhardt: 
Director, Strategic Issues: 
Marcia Crosse: 
Director, Health Care: 
U.S. Government Accountability Office: 
441 G Street, NW: 
Washington, DC 20548: 

Re: Draft Report, GAO-11-632, "Influenza Pandemic: Lessons from H1N1 
Pandemic Should be Incorporated Into Future Planning" 

Dear Ms. Steinhardt and Ms. Crosse: 

Thank you for the opportunity to review and comment on this draft 
report. The U.S. Department of Homeland Security (DHS) appreciates the 
U.S. Government Accountability Office's work in planning and 
conducting its review and issuing this report, The Department is 
pleased to note the report's positive acknowledgment that through 
interagency planning efforts, federal officials, including DHS, have 
built relationships that helped facilitate the federal response to the 
HIN1 pandemic—the first human influenza pandemic in more than four 
decades. 

Although the report does not contain any recommendations specifically 
directed at DHS, the The Department remains committed to continuing to 
work with the Homeland Security Council, National Security Staff, the 
Department of Health and Human Services, and other relevant 
stakeholders to fulfill its shared federal leadership responsibility 
for pandemic influenza response. 

Again, thank you for the opportunity to review and comment on this 
draft report. Technical comments are being provided under separate 
cover. We look forward to working with you on future Homeland Security 
issues. 

Sincerely, 

Signed by: 

Jim H. Crumpacker: 
Director: 
Departmental GAO/OIG Liaison Office: 

[End of section] 

Appendix V: Comments from the Department of Labor: 

U.S. Department of Labor: 
Assistant Secretary for Occupational Safety and Health: 
Washington, D.C. 20210: 

June 6, 2011: 

Ms. Bernice Steinhardt, Director: 
Strategic Issues: 
Ms. Marcia Crosse, Director: 
Health Care: 
U.S. Government Accountability Office: 
441 G Street, N.W. 
Washington, D.C. 20548: 

Dear Ms. Steinhardt and Ms. Crosse: 

Thank you for the opportunity to comment on the Government 
Accountability Office's (GAO) proposed report, Influenza Pandemic: 
Lessons from HINT Pandemic Should be Incorporated Into Future 
Planning. The Occupational Safety and Health Administration (OSHA) 
would like to make a few points we believe are important and deserve 
more attention in the report. 

On page 6 of the report, it states that in preparing this report, GAO 
reviewed documents and interviewed officials from OSHA "regarding 
guidance on the use of personal protective equipment". This short 
phrase minimizes OSHA's contribution to the federal pandemic response. 
In addition to the "guidance on the use of personal protective 
equipment", GAO could at least add "and the protection of workers' 
safety and health." OSHA served on the 2009 NSS-created 2009 H1N1 Flu 
Sub-Interagency Policy Committee and OSHA's draft After-Action Report 
states 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 this pandemic." 

OSHA appreciates the opportunity to review and respond to GAO's draft 
report. 

Sincerely, 

Signed by: 

David Michaels, PhD, MPH: 

[End of section] 

Appendix VI: GAO Contacts and Staff Acknowledgments: 

GAO Contacts: 

Bernice Steinhardt, (202) 512-6543 or steinhardtb@gao.gov: 

Marcia Crosse, (202) 512-7114 or crossem@gao.gov: 

Staff Acknowledgments: 

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. 

[End of section] 

Related GAO Products: 

Disaster Response: Criteria for Developing and Validating Effective 
Response Plans. [hyperlink, http://www.gao.gov/products/GAO-10-969T]. 
Washington, D.C.: September 22, 2010. 

Influenza Pandemic: Monitoring and Assessing the Status of the 
National Pandemic Implementation Plan Needs Improvement. [hyperlink, 
http://www.gao.gov/products/GAO-10-73]. Washington, D.C.: November 24, 
2009. 

Influenza Pandemic: Gaps in Pandemic Planning and Preparedness Need to 
Be Addressed. [hyperlink, http://www.gao.gov/products/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. 
[hyperlink, http://www.gao.gov/products/GAO-09-404]. Washington, D.C.: 
June 12, 2009. 

Influenza Pandemic: Continued Focus on the Nation's Planning and 
Preparedness Efforts Remains Essential. [hyperlink, 
http://www.gao.gov/products/GAO-09-760T]. Washington, D.C.: June 3, 
2009. 

Influenza Pandemic: Sustaining Focus on the Nation's Planning and 
Preparedness Efforts. [hyperlink, 
http://www.gao.gov/products/GAO-09-334]. Washington, D.C.: February 
26, 2009. 

Influenza Pandemic: HHS Needs to Continue Its Actions and Finalize 
Guidance for Pharmaceutical Interventions. [hyperlink, 
http://www.gao.gov/products/GAO-08-671]. Washington, D.C.: September 
30, 2008. 

Influenza Pandemic: Federal Agencies Should Continue to Assist States 
to Address Gaps in Pandemic Planning. [hyperlink, 
http://www.gao.gov/products/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. [hyperlink, http://www.gao.gov/products/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. [hyperlink, 
http://www.gao.gov/products/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. [hyperlink, 
http://www.gao.gov/products/GAO-08-36]. Washington, D.C.: October 31, 
2007. 

Influenza Vaccine: Issues Related to Production, Distribution, and 
Public Health Messages. [hyperlink, 
http://www.gao.gov/products/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. 
[hyperlink, http://www.gao.gov/products/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. [hyperlink, 
http://www.gao.gov/products/GAO-07-604]. Washington, D.C.: June 20, 
2007. 

Influenza Pandemic: Applying Lessons Learned from the 2004-05 
Influenza Vaccine Shortage. [hyperlink, 
http://www.gao.gov/products/GAO-06-221T]. Washington, D.C.: November 
4, 2005. 

Influenza Vaccine: Shortages in 2004-05 Season Underscore Need for 
Better Preparation. [hyperlink, 
http://www.gao.gov/products/GAO-05-984]. Washington, D.C.: September 
30, 2005. 

Influenza Pandemic: Challenges in Preparedness and Response. 
[hyperlink, http://www.gao.gov/products/GAO-05-863T]. Washington, 
D.C.: June 30, 2005. 

Influenza Pandemic: Challenges Remain in Preparedness. [hyperlink, 
http://www.gao.gov/products/GAO-05-760T]. Washington, D.C.: May 26, 
2005. 

[End of section] 

Footnotes: 

[1] As part of its overall mission to protect public health, this 
international entity monitors global influenza outbreaks and declares 
pandemics based on the pattern of outbreaks in its regions. 

[2] Influenza pandemics occur when a new influenza virus emerges and 
spreads around the world, and most people do not have immunity. This 
definition is based on spread of the disease, not severity. Three 
pandemics occurred in the 20TH century: the "Spanish flu" of 1918, 
which caused 500,000 deaths in the United States; the "Asian flu" of 
1957, which caused 70,000 deaths in the United States; and the "Hong 
Kong flu" of 1968, which caused 34,000 deaths in the United States. 

[3] Throughout this report, we use "H1N1 influenza" to refer to the 
2009 H1N1 influenza. We also use "H1N1 pandemic" to refer to the 2009 
H1N1 influenza pandemic. 

[4] See Centers for Disease Control and Prevention, "Updated CDC 
Estimates of 2009 H1N1 Influenza Cases, Hospitalizations, and Deaths 
in the United States, April 2009 - April 10, 2010," [hyperlink, 
http://www.flu.gov/individualfamily/about/h1n1/estimates_2009_h1n1.html]
 (accessed Dec. 7, 2010). 

[5] The HSC was established pursuant to Executive Order 13228, on 
October 8, 2001, for purposes of advising and assisting the President 
with respect to all aspects of homeland security and serving as a 
mechanism for ensuring (1) coordination of homeland security-related 
activities of executive departments and agencies and (2) effective 
development and implementation of homeland security policies. The 
Congress subsequently established the HSC for the purpose of more 
effectively coordinating the policies and functions of the federal 
government relating to homeland security. See Homeland Security Act of 
2002, Pub. L. No. 107-296 (Nov. 25, 2002), 6 U.S.C. § 491 and § 494. 

[6] Medical countermeasures are medications, biological products, or 
devices that treat, identify, or prevent harm from a biological or 
other agent that may cause a public health emergency. Medical 
countermeasures for use during an influenza pandemic may include 
vaccines, antiviral drugs, personal respirators, and influenza 
diagnostic tests. Vaccine, considered the first line of defense 
against influenza, is used to stimulate the production of an immune 
system response to protect the body from disease. Antiviral drugs are 
medications that can prevent or reduce the severity of a viral 
infection, such as influenza. 

[7] On May 26, 2009, the President established the NSS, under the 
direction of the National Security Advisor, to integrate White House 
staff supporting national security and homeland security. The 
President stated that the NSS would support the HSC, and that the HSC 
would be maintained as the principal venue for interagency 
deliberations on issues that affect the security of the homeland, such 
as pandemic influenza. See Statement by the President on the White 
House Organization for Homeland Security and Counterterrorism, 
[hyperlink, http://www.whitehouse.gov/the_press_office/Statement-by-
the-President-on-the-White-House-Organization-for-Homeland-Security-
and-Counterterrorism] (accessed May 9, 2011). 

[8] Supplemental Appropriations Act, 2009, Pub. L. No. 111-32, 123 
Stat. 1859, 1884-1886 (June 24, 2009). A supplemental appropriation is 
an act appropriating funds in addition to those already enacted in the 
annual appropriation act. Supplemental appropriations provide 
additional budget authority usually in cases where the need for funds 
is too urgent to be postponed until enactment of the regular 
appropriation bill. 

[9] For this report, we use "states and local jurisdictions" to refer 
to state, local, and tribal governments, as well as territorial and 
insular areas. 

[10] 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. 

[11] Related products are listed at the end of this report. 

[12] To measure spending, we reviewed the department's obligations. 
"Obligation" refers to a definite commitment by a federal agency that 
creates a legal liability to make payments immediately or in the 
future. Agencies incur obligations, for example, when they award 
grants or contracts. 

[13] In states without a centralized public health structure, we also 
met with at least one local jurisdiction's health department. 

[14] "Personal protective equipment" encompasses the specialized 
clothing and equipment worn by workers for protection against health 
and safety hazards. For health care personnel, personal protective 
equipment may include respirators, face masks, gloves, eye protection, 
face shields, gowns, and head and shoe coverings. 

[15] The Center for Infectious Disease Research and Policy addresses 
public health preparedness and emerging infectious diseases response. 
The Association of Immunization Managers represents state, local, and 
territorial immunization program managers. The National Indian Health 
Board represents tribal governments--both those operating their own 
health care delivery systems through contracting and compacting and 
those receiving health care directly from the Indian Health Service. 

[16] Department of Homeland Security, National Response Framework 
(Washington, D.C., January 2008), 32. 

[17] The National Strategy for Pandemic Influenza (national pandemic 
strategy), released in 2005, provides a framework for planning efforts 
for how the country will prepare for, detect, and respond to an 
influenza pandemic. The strategy reflects the federal government's 
approach to the pandemic threat and is based on three pillars: (1) 
preparedness and communication, (2) surveillance and detection, and 
(3) response and containment. The National Strategy for Pandemic 
Influenza Implementation Plan (national pandemic implementation plan) 
published in 2006, further clarifies the roles and responsibilities of 
federal and nonfederal entities--including state, local, and tribal 
governments; the private sector; international partners; and 
individuals--to prepare themselves and their communities. The national 
pandemic implementation plan includes 324 action items to address the 
threat of a pandemic, most of which have been reported as completed. 

[18] Pub. L. No. 109-148, 119 Stat. 2680, 2783, 2786 (Dec. 30, 2005), 
and Pub. L. No. 109-234, 120 Stat. 418, 479-80 (June 15, 2006). 

[19] The federal stockpile of antiviral drugs includes oral 
formulations (Tamiflu), inhaler formulations (Relenza), and doses for 
pediatric patients. 

[20] For a more detailed discussion of how the 2006 supplemental funds 
were spent for pandemic preparedness, see GAO, Influenza Pandemic: 
Sustaining Focus on the Nation's Planning and Preparedness Efforts, 
[hyperlink, http://www.gao.gov/products/GAO-09-334] (Washington, D.C.: 
Feb. 26, 2009), 30. 

[21] According to HHS officials, they received this document from the 
NSS in July 2009. 

[22] Influenza pandemics can have successive waves of disease and last 
for up to 3 years. 

[23] Specifically, FDA determined that a monovalent influenza vaccine, 
which protects against a single strain of influenza, manufactured 
according to the same process as licensed seasonal influenza vaccines--
but formulated to contain the pandemic 2009 H1N1 influenza virus 
strain antigen--could be approved as a strain change supplement to 
existing licensed influenza vaccines. An antigen is the active 
substance in a vaccine that provides immunity by causing the body to 
produce protective antibodies to fight off a particular influenza 
strain. To be effective, an influenza vaccine must be created to match 
a specific influenza strain because influenza strains undergo minor 
genetic changes from year to year. The 2009 H1N1 influenza vaccine was 
separate from, and in addition to, the seasonal influenza vaccine for 
the 2009-2010 influenza season. In addition, manufacturers and the 
National Institutes of Health conducted clinical trials to determine 
the optimal dosage and number of doses that would be required to 
generate an immune response to 2009 H1N1 infection. 

[24] Centers for Disease Control and Prevention, "Use of Influenza A 
(H1N1) 2009 Monovalent Vaccine: Recommendations of the Advisory 
Committee on Immunization Practices (ACIP)," Morbidity and Mortality 
Weekly Report, vol. 58, no. RR-10 (August 2009), [hyperlink, 
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e0821a1.htm] (accessed 
Apr. 25, 2011). ACIP develops written recommendations for the routine 
administration of vaccines to children and adults in the civilian 
population. These recommendations include age for vaccine 
administration, number of doses and dosing interval, and precautions 
and contraindications. 

[25] These recommendations, based on the epidemiology of H1N1 
influenza and projected vaccine supply, were made to assist in 
planning and to alert providers and the public about who should be 
first to receive the vaccine. ACIP recommended the following five 
initial target groups: pregnant women, household contacts and 
caregivers for children younger than 6 months of age, health care and 
emergency services personnel, individuals from 6 months through age 
24, and persons aged 25 through 64 with health conditions associated 
with higher risk of medical complications from influenza. 

[26] The subset of the target groups included pregnant women, 
individuals living with or caring for children younger than 6 months 
of age, health care and emergency medical services personnel with 
direct patient contact, and children aged 6 months through 4 years or 
aged 5 through 18 years with chronic medical conditions. 

[27] Centers for Disease Control and Prevention, "Final Estimates for 
2009-10 Seasonal Influenza and Influenza A 2009 (H1N1) Monovalent 
Vaccination Coverage - United States, August 2009 through May 2010," 
[hyperlink, 
http://www.cdc.gov/flu/professionals/vaccination/coverage_0910estimates.
htm] (accessed Oct. 8, 2010). 

[28] HHS reported that it transferred about $241.20 million to the 
Department of Defense, Department of Veterans Affairs, Department of 
State, and Department of Agriculture. Since HHS spent the majority of 
the 2009 supplemental appropriation, we did not determine how the $241 
million transferred to these other departments was spent by them. We 
did not independently verify the amount of money that was transferred. 
The 2009 supplemental appropriation requires that all funds 
transferred to these other departments go toward purposes related to 
preparing for or responding to an influenza pandemic. 

[29] Section 1826 of the Department of Defense and Full-Year 
Continuing Appropriations Act, 2011, rescinded $1.259 billion in 
contingent 2009 supplemental funds that the President had not yet 
designated to the Congress as emergency funds. Pub. L. No. 112-10, 125 
Stat. 10, 162 (Apr. 15, 2011). 

[30] To measure spending, we looked at the agency's obligations. 
"Obligation" refers to a definite commitment by a federal agency that 
creates a legal liability to make payments immediately or in the 
future. Agencies incur obligations, for example, when they award 
grants or contracts. Because payments are typically made as goods or 
services are received, the funds listed may not have been expended. 
Upon termination of a contract, unexpended funds may be deobligated 
and, depending on the terms of their appropriation, may remain 
available to the agency. 

[31] Department of Health and Human Services, Report to Congress: 
December 2010 Report, Pandemic Influenza Preparedness Spending 
(Washington, D.C., February 2011). We did not independently verify 
information on obligations provided in the report. 

[32] Adjuvants are substances that may be added to a vaccine to 
increase the body's immune response to the vaccine. While adjuvants 
were purchased by HHS as a precautionary measure, they were not used 
in the H1N1 vaccine. 

[33] HHS purchased over 190 million doses of vaccine. Of these doses, 
over 156 million were made available for distribution to the U.S. 
public and the Department of Defense, 17 million were distributed 
internationally, and the remainder were not distributed. 

[34] CDC awarded PHER grants to each of the 50 states; 4 local health 
departments (Chicago, Los Angeles County, New York City, and 
Washington, D.C.); and American Samoa, Guam, the Marshall Islands, 
Micronesia, Northern Mariana Islands, Palau, Puerto Rico, and the U.S. 
Virgin Islands. HHS also provided funds to hospitals, through states, 
as part of the Hospital Preparedness Program. 

[35] Specifically, the first funding phase was for state and local 
jurisdictions to assess their capabilities for pandemic influenza 
response and to address gaps in vaccination, antiviral distribution 
and dispensing, community mitigation, laboratory, epidemiology, and 
surveillance activities. The second funding phase was for state and 
local jurisdictions to plan for the vaccination campaign. The third 
funding phase was for states to implement the mass vaccination 
campaign. The fourth and final funding phase was for targeting 
special, hard-to-reach populations for vaccination. 

[36] Association of State and Territorial Health Officials, Assessing 
Policy Barriers to Effective Public Health Response in the H1N1 
Influenza Pandemic (Arlington, Va., June 2010), 25. 

[37] ASTHO, Assessing Policy Barriers to Effective Public Health 
Response in the H1N1 Influenza Pandemic, 25. 

[38] National Association of County and City Health Officials, H1N1 
Policy Workshop Report (Washington, D.C., June 2010), 5. 

[39] Office of the Assistant Secretary for Preparedness and Response, 
The Public Health Emergency Medical Countermeasures Enterprise Review: 
Transforming the Enterprise to Meet Long-Range National Needs 
(Washington, D.C., August 2010), [hyperlink, 
http://www.hhs.gov/nvpo/nvac/meetings/upcomingmeetings/korch_presentatio
n.pdf] (accessed June 21, 2011). 

[40] Department of Health and Human Services, Amended Spending Plan 
for 2009 Supplemental Funding, as reported to the Congress in August 
2010. 

[41] GAO, Influenza Pandemic: Monitoring and Assessing the Status of 
the National Pandemic Implementation Plan Needs Improvement, 
[hyperlink, http://www.gao.gov/products/GAO-10-73] (Washington, D.C.: 
Nov. 24, 2009). 

[42] For more information, see GAO, Influenza Pandemic: Opportunities 
Exist to Address Critical Infrastructure Protection Challenges That 
Require Federal and Private Sector Coordination, [hyperlink, 
http://www.gao.gov/products/GAO-08-36] (Washington, D.C.: Oct. 31, 
2007). 

[43] See GAO, Influenza Pandemic: Further Efforts Are Needed to Ensure 
Clearer Federal Leadership Roles and an Effective National Strategy, 
[hyperlink, http://www.gao.gov/products/GAO-07-781] (Washington, D.C.: 
Aug. 14, 2007). 

[44] At the onset of the H1N1 outbreak, the President's nominee for 
Secretary of Health and Human Services had not yet been confirmed. She 
was confirmed on April 28, 2009. 

[45] Department of Health and Human Services, Report to Congress: June 
2010 Report, Pandemic Influenza Preparedness Spending (Washington, 
D.C., June 2010). 

[46] The antiviral drug Peramivir was made available under an 
emergency use authorization (EUA) during the H1N1 pandemic. Peramivir 
was the first investigational drug to be made available under an EUA. 
During the Peramivir EUA period, CDC reported that it received 1,371 
requests for Peramivir and delivered a total of 2,129 5-day adult 
treatment courses from the SNS to 563 hospitals in the United States 
within 24 hours of receipt of request. A study found that Peramivir 
was associated with recovery in most patients hospitalized with severe 
pneumonia associated with H1N1 influenza. See J.E. Hernandez et al., 
"Clinical Experience in Adults and Children Treated with Intravenous 
Peramivir for 2009 Influenza A (H1N1) Under an Emergency IND Program 
in the United States," Clinical Infectious Diseases, vol. 52, no. 6 
(2011), 695-706. 

[47] GAO, Disaster Response: Criteria for Developing and Validating 
Effective Response Plans, [hyperlink, 
http://www.gao.gov/products/GAO-10-969T] (Washington, D.C.: Sept. 22, 
2010). 

[48] The geographic distribution of H1N1 influenza activity was most 
widespread during the weeks ending October 24, 2009, and October 31, 
2009, when 48 of 50 states reported widespread influenza activity. 
Centers for Disease Control and Prevention, "Update: Influenza Activity 
- United States, 2009-10 Season," Morbidity and Mortality Weekly 
Report, vol. 59, no. 29, (2010). 

[49] See Homeland Security Council, National Strategy for Pandemic 
Influenza Implementation Plan, (Washington, D.C., May 2006). 

[50] J. Maurer, K.M. Harris, et al., "Does Receipt of Seasonal 
Influenza Vaccine Predict Intention to Receive Novel H1N1 Vaccine: 
Evidence from a Nationally Representative Survey of U.S. Adults," 
Vaccine, vol. 27 (2009), 5732-5734. 

[51] Centers for Disease Control and Prevention, "Final Estimates for 
2009-10 Seasonal Influenza and Influenza A 2009 (H1N1) Monovalent 
Vaccination Coverage - United States, August 2009 through May 2010," 
[hyperlink, 
http://www.cdc.gov/flu/professionals/vaccination/coverage_0910estimates.
htm] (accessed Oct. 8, 2010). 

[52] As of December 2010, HHS allocated 138 million doses to states 
and local jurisdictions, provided 2.7 million doses to the Department 
of Defense, and donated 16 million doses internationally. About 127 
million doses were distributed to states and local jurisdictions, 11 
million less than the amount allocated. Not all distributed vaccines 
were administered. 

[53] Gallup, In U.S., 20% of Parents Unable to Get H1N1 Vaccine for 
Child (Nov. 10, 2009), [hyperlink, 
http://www.gallup.com/poll/124220/Parents-Unable-H1N1-Vaccine-
Child.aspx] (accessed Apr. 26, 2011). 

[54] ASTHO, Assessing Policy Barriers to Effective Public Health 
Response in the H1N1 Influenza Pandemic, 20. 

[55] NACCHO, H1N1 Policy Workshop Report, 11. 

[56] Institute of Medicine, The 2009 Influenza Vaccination Campaign: A 
Summary of a Workshop Series (Washington, D.C.: The National Academies 
Press, October 2010), 31. 

[57] Vaccines for Children is a federally funded program that provides 
vaccines at no cost to children who might not otherwise be vaccinated 
because of their families' inability to pay. The program, administered 
by CDC, distributes pediatric vaccines to states and health care 
providers. 

[58] According to CDC officials, CDC's contract with the distributor 
specified that all doses of H1N1 vaccine needed to be shipped out on 
the day the order was placed. 

[59] ASTHO, Assessing Policy Barriers to Effective Public Health 
Response in the H1N1 Influenza Pandemic, 17. 

[60] Because initial information suggested that two doses of H1N1 
vaccine might be required, initial estimates for the number of H1N1 
doses that would need to be shipped included the possibility of up to 
600 million doses. 

[61] R. Blendon, G. SteelFisher, M. Bekheit, and M. Herrmann, "The 
Public's Response to H1N1: A Multiethnic Perspective," Harvard Opinion 
Research Program, Harvard School of Public Health, [hyperlink, 
http://www.hsph.harvard.edu/research/horp/project-on-the-public-
response-to-h1n1/] (accessed Jan. 6, 2011). 

[62] CDC developed an internal H1N1 communications plan to guide its 
communications efforts during the response. 

[63] CDC's Emergency Operations Center is the agency's command center 
for monitoring and coordinating CDC's emergency response to public 
health threats in the United States and abroad. 

[64] ASTHO, Assessing Policy Barriers to Effective Public Health 
Response in the H1N1 Influenza Pandemic, 28. 

[65] According to CDC officials, CDC's guidance is typically 
translated into 5 languages--Spanish, Vietnamese, Chinese, French, and 
Tagalog--but that during the H1N1 pandemic, documents were also 
translated regularly into the following 12 languages determined in 
consultation with HHS's Office of Minority Health: Arabic, Russian, 
Japanese, Korean, German, Burmese, Italian, Somali, Khmer, Kirundi, 
Amharic, and Oromo. 

[66] According to CDC's SNS officials, this time frame met CDC's 
established goal for timely release of the SNS supplies. 

[67] Institute of Medicine, Medical Countermeasures Dispensing: 
Emergency Use Authorizations and the Postal Model: Workshop Summary 
(Washington, D.C.: The National Academies Press, October 2010), 16. 

[68] IOM, Medical Countermeasures Dispensing: Emergency Use 
Authorizations and the Postal Model: Workshop Summary, 14. 

[69] ASTHO, Assessing Policy Barriers to Effective Public Health 
Response in the H1N1 Influenza Pandemic, 23. 

[70] CDC officials explained that the SNS respiratory devices they had 
purchased for the SNS were based on perceived urgency to rapidly 
acquire and store the first available N95 respirators and surgical 
masks using earlier pandemic preparedness funds. They acquired N95 
respirators and surgical masks based on product availability and were 
not able to plan to procure specific models to match local hospital 
needs. During the H1N1 pandemic, the SNS shipped these N95 respirators 
and surgical masks to augment state and local capabilities. 

[71] See Institute of Medicine, Respiratory Protection for Healthcare 
Workers in the Workplace Against Novel H1N1 Influenza A: A Letter 
Report (Washington, D.C.: The National Academies Press, Sept. 1, 
2009), 4. 

[72] Generally, intubation is the introduction of a tube into an 
individual's airway to facilitate breathing. 

[73] ASTHO, Assessing Policy Barriers to Effective Public Health 
Response in the H1N1 Influenza Pandemic, 23. 

[74] The National Vaccine Plan focuses on all vaccines, not solely 
influenza vaccines. 

[75] In May 2009, the Secretary of Homeland Security submitted a 
memorandum to the White House with lessons learned from the first wave 
of the H1N1 pandemic and next steps to undertake in preparation for 
the expected second wave in the fall of 2009. 

[76] The White House released Presidential Policy Directive 8 on March 
30, 2011. This directive aims to facilitate an integrated, all-of- 
nation, capabilities-based approach to preparedness. 

[77] [hyperlink, http://www.gao.gov/products/GAO-07-781]. 

[78] [hyperlink, http://www.gao.gov/products/GAO-07-781] and 
[hyperlink, http://www.gao.gov/products/GAO-10-73]. 

[79] Issued by DHS in January 2008, the National Response Framework is 
the doctrine that guides how federal, state, local, and tribal 
governments, along with nongovernmental and private sector entities, 
will collectively respond to and recover from all hazards, including 
catastrophic disasters such as Hurricane Katrina. 

[80] DHS, National Response Framework, 32. 

[81] Department of Homeland Security, National Preparedness Guidelines 
(Washington, D.C., September 2007). 

[End of section] 

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