Influenza Pandemic
Lessons from the H1N1 Pandemic Should Be Incorporated into Future Planning Gao ID: GAO-11-632 June 27, 2011The 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.
As of December 2010, HHS had spent about two-thirds of the $6.15 billion that it had available for the H1N1 pandemic response. HHS spent the majority of the funds on developing and purchasing H1N1 vaccine and providing grants to all the states and selected local jurisdictions. State and local health officials reported that the grant funding was critical to their response efforts but also noted challenges presented by the grants' administrative requirements. HHS's spending plans for the remaining $1.98 billion include longer-term pandemic preparation efforts, such as activities to reduce the length of time required to produce a vaccine. Several key issues were raised by the federal government's response to the H1N1 pandemic. (1) Prior pandemic planning efforts and federal funding paid off, although specific aspects of prior planning were not relied on because of the nature of the H1N1 pandemic. For example, interagency meetings and exercises built relationships that were valuable during the response. Prior funding built capacity in several areas, including vaccine production. (2) The credibility of all levels of government was diminished when the amount of vaccine available to the public in October 2009 did not meet expectations set by federal officials. However, state and local jurisdictions valued the flexibility that they had in deciding their distribution methods. Additionally, while the use of a central distributor for the vaccines was generally cited as an effective practice, the 100- dose minimum order was viewed to be problematic. (3) Public surveys generally found CDC's communication efforts to be successful in reaching a range of audiences; however, these messages fell short in meeting the needs of some non-English-speaking populations. (4) Deployment of the Strategic National Stockpile--a supply of medicines and medical supplies to be used for a national emergency--met the established goal. However, CDC and state officials identified gaps in planning, including disparities between the materials expected and those delivered, as well as the need for long-term storage plans for stockpile materials. The NSS asked federal agencies--including HHS and DHS--to complete after-action reports based on their involvement in the pandemic response. The NSS has not determined if these reports--and the associated lessons learned--will be shared with key stakeholders. Nevertheless, a DHS official commented that sharing lessons from the reports with key stakeholders would foster a spirit of government transparency and might help build stakeholder trust. 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.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Bernice Steinhardt Team: Government Accountability Office: Strategic Issues Phone: (202) 512-6543GAO-11-632, Influenza Pandemic: Lessons from the H1N1 Pandemic Should Be Incorporated into Future Planning
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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
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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
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http://www.gao.gov/products/GAO-09-334]. Washington, D.C.: February
26, 2009.
Influenza Pandemic: HHS Needs to Continue Its Actions and Finalize
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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
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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
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Influenza Vaccine: Shortages in 2004-05 Season Underscore Need for
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http://www.gao.gov/products/GAO-05-984]. Washington, D.C.: September
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[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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