Influenza Pandemic
HHS Needs to Continue Its Actions and Finalize Guidance for Pharmaceutical Interventions Gao ID: GAO-08-671 September 30, 2008The emergence of the H5N1 avian influenza virus (also known as "bird flu") has raised concerns that it or another virus might mutate into a virulent strain that could lead to an influenza pandemic. Experts predict that a severe pandemic could overwhelm the nation's health care system, requiring the rationing of limited resources. GAO was asked to provide information on the progress of the Department of Health and Human Services's (HHS) plans for responding to a pandemic, including analyzing how HHS plans to (1) use pharmaceutical interventions to treat infected individuals and protect the critical workforce and (2) use nonpharmaceutical interventions to slow the spread of disease. To conduct this work, GAO reviewed government documents and scientific literature, and interviewed HHS officials, state and local public health officials, and subject-matter experts on pandemic response.
HHS plans to make existing federal stockpiles of pharmaceutical interventions available for distribution once a pandemic begins. These interventions would include antivirals, which are drugs to prevent or reduce the severity of infection, and pre-pandemic vaccines, which are vaccines produced prior to a pandemic and developed from influenza strains that have the potential to cause a pandemic. HHS has established a national goal of stockpiling 75 million treatment courses of antivirals in the Strategic National Stockpile and in jurisdictional stockpiles. According to HHS, these public sector stockpiles are intended to be used primarily for the treatment of individuals sick with influenza. HHS intends to oversee the distribution and administration of pre-pandemic vaccine to individuals identified as members of the critical workforce. Members of the critical workforce--estimated to be about 20 million--include workers in sectors that are considered necessary to keep society functioning, such as health care and law enforcement personnel. HHS's strategy for using pre-pandemic vaccine is to keep society functioning until a pandemic vaccine--a vaccine specific to the pandemic-causing strain--becomes widely available. HHS anticipates that initial batches of a pandemic vaccine may not be available until 20 to 23 weeks after the start of the pandemic. As batches of the pandemic vaccine become available, HHS plans for state and local jurisdictions to provide it to members of targeted groups based on factors such as occupation and age, instead of making it available to the general public. HHS faces challenges implementing its strategy for using pharmaceutical interventions during a pandemic, including the lack of vaccine manufacturing capacity in the United States. HHS is currently making large investments to expand domestic vaccine manufacturing capacity. In 2008, HHS released guidance on prioritizing target groups for pandemic vaccine and draft guidance on antiviral use during a pandemic. HHS has not yet released draft guidance for public comment on prioritizing target groups for pre-pandemic vaccine. HHS will rely on state and local jurisdictions to utilize nonpharmaceutical interventions, such as isolation of sick individuals and voluntary home quarantine of those exposed to the pandemic strain. To assist state and local jurisdictions with implementing nonpharmaceutical interventions, HHS has developed guidance that describes the department's "community mitigation framework." The framework involves the early initiation of multiple nonpharmaceutical interventions, each of which is expected to be partially effective and to be maintained consistently throughout a pandemic. HHS faces difficulties, including helping jurisdictions develop ways to ensure community compliance. HHS is investing in several initiatives to increase the nation's knowledge about the general use and effectiveness of nonpharmaceutical interventions. The findings from this research will be used to update existing guidance.
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: Team: Phone:GAO-08-671, Influenza Pandemic: HHS Needs to Continue Its Actions and Finalize Guidance for Pharmaceutical Interventions
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
September 2008:
Influenza Pandemic:
HHS Needs to Continue Its Actions and Finalize Guidance for
Pharmaceutical Interventions:
HHS Influenza Pandemic Planning:
GAO-08-671:
GAO Highlights:
Highlights of GAO-08-671, a report to congressional requesters.
Why GAO Did This Study:
The emergence of the H5N1 avian influenza virus (also known as ’bird
flu“) has raised concerns that it or another virus might mutate into a
virulent strain that could lead to an influenza pandemic. Experts
predict that a severe pandemic could overwhelm the nation‘s health care
system, requiring the rationing of limited resources. GAO was asked to
provide information on the progress of the Department of Health and
Human Services‘s (HHS) plans for responding to a pandemic, including
analyzing how HHS plans to (1) use pharmaceutical interventions to
treat infected individuals and protect the critical workforce and (2)
use nonpharmaceutical interventions to slow the spread of disease. To
conduct this work, GAO reviewed government documents and scientific
literature, and interviewed HHS officials, state and local public
health officials, and subject-matter experts on pandemic response
What GAO Found:
HHS plans to make existing federal stockpiles of pharmaceutical
interventions available for distribution once a pandemic begins. These
interventions would include antivirals, which are drugs to prevent or
reduce the severity of infection, and pre-pandemic vaccines, which are
vaccines produced prior to a pandemic and developed from influenza
strains that have the potential to cause a pandemic. HHS has
established a national goal of stockpiling 75 million treatment courses
of antivirals in the Strategic National Stockpile and in jurisdictional
stockpiles. According to HHS, these public sector stockpiles are
intended to be used primarily for the treatment of individuals sick
with influenza. HHS intends to oversee the distribution and
administration of pre-pandemic vaccine to individuals identified as
members of the critical workforce. Members of the critical
workforce”estimated to be about 20 million”include workers in sectors
that are considered necessary to keep society functioning, such as
health care and law enforcement personnel. HHS‘s strategy for using pre-
pandemic vaccine is to keep society functioning until a pandemic
vaccine”a vaccine specific to the pandemic-causing strain”becomes
widely available. HHS anticipates that initial batches of a pandemic
vaccine may not be available until 20 to 23 weeks after the start of
the pandemic. As batches of the pandemic vaccine become available, HHS
plans for state and local jurisdictions to provide it to members of
targeted groups based on factors such as occupation and age, instead of
making it available to the general public. HHS faces challenges
implementing its strategy for using pharmaceutical interventions during
a pandemic, including the lack of vaccine manufacturing capacity in the
United States. HHS is currently making large investments to expand
domestic vaccine manufacturing capacity. In 2008, HHS released guidance
on prioritizing target groups for pandemic vaccine and draft guidance
on antiviral use during a pandemic. HHS has not yet released draft
guidance for public comment on prioritizing target groups for pre-
pandemic vaccine.
HHS will rely on state and local jurisdictions to utilize
nonpharmaceutical interventions, such as isolation of sick individuals
and voluntary home quarantine of those exposed to the pandemic strain.
To assist state and local jurisdictions with implementing
nonpharmaceutical interventions, HHS has developed guidance that
describes the department‘s ’community mitigation framework.“ The
framework involves the early initiation of multiple nonpharmaceutical
interventions, each of which is expected to be partially effective and
to be maintained consistently throughout a pandemic. HHS faces
difficulties, including helping jurisdictions develop ways to ensure
community compliance. HHS is investing in several initiatives to
increase the nation‘s knowledge about the general use and effectiveness
of nonpharmaceutical interventions. The findings from this research
will be used to update existing guidance.
What GAO Recommends:
GAO recommends that HHS expeditiously finalize guidance to assist state
and local jurisdictions to determine how to effectively use limited
supplies of antivirals and pre-pandemic vaccine in a pandemic,
including prioritizing target groups for pre-pandemic vaccine. In
comments on a draft of this report, HHS described additional actions it
has taken and plans to take relating to GAO‘s recommendation, including
releasing for public comment in the near future proposed guidance on
pre-pandemic vaccine allocation.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-671]. For more
information, contact Marcia Crosse at (202) 512-7114 or
CrosseM@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
HHS Plans to Make Federal Stockpiles of Pharmaceuticals Accessible to
State and Local Jurisdictions, but Faces Challenges with
Implementation:
HHS Efforts to Improve Surge Capacity of Health Care Providers Will Be
Challenged during a Pandemic:
HHS Has Provided Guidance to Help State and Local Jurisdictions
Overcome Difficulties with Implementing Nonpharmaceutical
Interventions:
HHS Is Developing Messages and Procedures for Communicating to the
Public during a Pandemic but Challenges Remain:
Conclusions:
Recommendation for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Summaries of Select Federal Documents Relevant for
Preparing for and Responding to Influenza Pandemic:
Appendix II: HHS Activities for Acquiring Pharmaceutical Interventions
for an Influenza Pandemic within the United States:
Appendix III: Comments from the Department of Health and Human
Services:
Appendix IV: GAO Contact and Staff Acknowledgments:
Related GAO Products:
Tables:
Table 1: Comparison of Pharmaceutical Interventions for a Pandemic:
Table 2: Some Types of Nonpharmaceutical Interventions and Their
Definitions:
Table 3: HHS Target Groups for Pandemic Vaccination for a Severe
Pandemic:
Table 4: Example of an HHS Message Map:
Table 5: Response Elements Needed for Preparing for and Responding to
an Influenza Pandemic and Examples of Priority Activities for Each
Response Element:
Table 6: HHS Goals for Amounts of Pharmaceutical Interventions to Be
Stockpiled Nationally:
Table 7: Approximate Number of Treatment Courses of Antivirals in the
Strategic National Stockpile as of May 2008:
Table 8: HHS Efforts to Acquire Pre-Pandemic Vaccine as of August 2007:
Table 9: HHS Efforts in Establishing Domestic Infrastructure for
Vaccine Manufacturing as of June 2007:
Table 10: HHS Progress on Vaccine Development Projects:
Figures:
Figure 1: Potential Effect of Nonpharmaceutical Interventions on a
Pandemic Outbreak:
Figure 2: Pandemic Vaccine Production Timeline:
Abbreviations:
CDC: Centers for Disease Control and Prevention:
DHS: Department of Homeland Security:
EMAC: Emergency Management Assistance Compact:
FDA: Food and Drug Administration:
FEMA: Federal Emergency Management Agency:
HHS: Department of Health and Human Services:
ICU: intensive care unit:
mcg.: Microgram:
PAHPA: Pandemic and All-Hazards Preparedness Act:
SARS: severe acute respiratory syndrome:
Stafford Act: Robert T. Stafford Disaster Relief and Emergency
Assistance Act:
SNS: Strategic National Stockpile:
United States Government Accountability Office:
Washington, DC 20548:
September 30, 2008:
The Honorable Edward M. Kennedy:
Chairman:
The Honorable Michael B. Enzi:
Ranking Member:
Committee on Health, Education, Labor, and Pensions:
United States Senate:
The Honorable Bennie G. Thompson:
Chairman:
Committee on Homeland Security:
House of Representatives:
The emergence of the H5N1 avian influenza virus (also known as "bird
flu") has raised concerns that it or another influenza virus might
mutate into a novel and virulent strain that could lead to a human
influenza pandemic[Footnote 1] that would pose a grave threat to global
public health. Pandemics occur when an influenza strain to which humans
have little or no immunity begins to cause serious illness and spreads
easily from person to person. In the United States alone, at least
675,000 people died during the 1918-19 pandemic, the deadliest pandemic
in the twentieth century. The Department of Health and Human Services
(HHS) has estimated that a pandemic similar to the severe 1918-19
pandemic would sicken 90 million people in the United States (30
percent of the population), of whom nearly 10 million would require
hospitalization and almost 2 million would die.[Footnote 2] Given that
as of 2005 there were approximately 950,000 staffed hospital
beds[Footnote 3] in the United States, HHS's estimates indicate that
the effects of a severe pandemic would far exceed the capacity of U.S.
hospitals.[Footnote 4]
HHS has made substantial progress in its preparedness for pandemic
influenza. For example, since 2000, we had been urging HHS to complete
its pandemic plan.[Footnote 5] HHS released the HHS Pandemic Influenza
Plan in November 2005. (See app. I for summaries of select federal
pandemic documents.) We recently reported that HHS has improved its
influenza surveillance and diagnostic testing capabilities.[Footnote 6]
Prompted by concerns regarding H5N1, HHS and its international partner
organizations have increased efforts to enhance animal and human
surveillance systems overseas. Additionally, in February 2006, the Food
and Drug Administration (FDA)--an agency within HHS--approved a
diagnostic test developed by the Centers for Disease Control and
Prevention (CDC)--another agency within HHS--that recognizes H5
influenza viruses within 4 hours of testing; it previously would have
taken 2 to 3 days.
Despite this progress, a severe pandemic would pose formidable
challenges to the federal government's efforts to minimize damage to
the public's health and the nation's economy. The single most important
pharmaceutical intervention during a pandemic--a pandemic vaccine that
is well-matched to the pandemic-causing strain--will not be available
in large quantities in the initial stages of a pandemic. Other
pharmaceutical interventions,[Footnote 7] such as antivirals[Footnote
8] and pre-pandemic vaccines (possibly less effective vaccines produced
prior to the pandemic and based on strains experts believe may cause a
pandemic) are also expected to be in limited supply and unavailable to
the population at large.[Footnote 9] In addition, although the ability
to quickly increase the number of health care providers, called surge
capacity, will be vital for treating the potentially large numbers of
infected individuals, efforts to do so must overcome existing shortages
of health care workers in the United States.[Footnote 10] Similarly,
because they are rarely used on a large scale, the effectiveness of
large-scale implementation of nonpharmaceutical interventions,
including closing schools and voluntary home quarantine, is uncertain.
In addition, throughout the initial stages of a pandemic, crucial
information--such as when and where to access medical care, and how to
reduce the chances of infection--will need to be communicated to the
public in a way that does not incite panic.
Given these obstacles and the possible risk that the best-made plans
may still be ineffective in a severe pandemic, the federal government
is taking steps to prepare the nation for a potential pandemic in hopes
of lessening its overall impact. The National Response Framework
charges the Secretary of the Department of Homeland Security (DHS) with
responsibility for overall management and federal coordination of
domestic incidents when needed,[Footnote 11] the Federal Emergency
Management Agency (FEMA) Administrator with responsibility as principal
advisor to the President regarding emergency management, and the
Secretary of HHS with responsibility for public health and medical
response.[Footnote 12] On November 2, 2005, the Secretary of HHS
released the HHS Pandemic Influenza Plan, which provides HHS's plans
for responding to a pandemic.[Footnote 13] The document also provides
pandemic response guidance to officials in state and local
jurisdictions[Footnote 14] and to health care facility officials. Since
then, HHS has released five updates regarding the department's
preparedness efforts and has released its Pandemic Influenza
Implementation Plan. Despite these efforts, influenza and public health
preparedness experts have raised concerns about the adequacy of HHS's
plans and guidance to state and local officials and to health care
facility officials.
Because of your interest in pandemic preparedness, we are providing
information on the progress of HHS's plans and its guidance to state
and local officials, and to health care facility officials, for
responding to a pandemic outbreak. The focus of our work is on 4 key
components taken from 5 of the 11 response elements critical for
preparedness as described in the HHS Pandemic Influenza Plan (see table
5 in app. I for a list of all the response elements). Three components
that we examined--pharmaceutical interventions (vaccines and
antivirals), surge capacity of health care providers, and public
communications--have repeatedly been found to need improvement by GAO
and outside experts. In prior work, we reported on potential problems
with pharmaceutical interventions during a pandemic, including vaccine
shortages and the need for identifying target groups in
advance.[Footnote 15] Health care provider shortages, including nurses
and physicians, have been reported for many years by GAO.[Footnote 16]
We reported that during the anthrax incidents of 2001, the media and
the general public looked to CDC as the source for health-related
information. However, CDC was not always able to successfully convey
the information that it had.[Footnote 17] We also reported on the
significance of communicating clearly on response efforts during a
pandemic.[Footnote 18] The fourth component we focus on in our work--
guidance for nonpharmaceutical interventions--is based on limited
scientific evidence.
Specifically, for this report we analyzed how HHS plans to (1) use
pharmaceutical interventions for treatment of infected individuals and
to protect the critical workforce, (2) improve surge capacity of health
care providers, (3) prepare state and local authorities to use
nonpharmaceutical interventions for slowing the spread of disease, and
(4) prepare to communicate with the public during a pandemic.
To determine how HHS plans to implement the four key components, we
reviewed government documents related to a pandemic response. (See app.
I for a description of each document.) In addition, to learn more about
the elements needed for an effective public health emergency response,
we reviewed related reports issued by GAO and HHS agencies, independent
studies (including those from the Institute of Medicine, Congressional
Research Service, and World Health Organization), and peer-reviewed
journals. We interviewed officials from HHS offices, including the
Office of the Assistant Secretary for Preparedness and Response, Office
of the Assistant Secretary for Public Affairs, CDC, National Vaccine
Program Office, National Institutes of Health, Agency for Healthcare
Research and Quality, Health Resources and Services Administration, and
FDA to learn more about their planning efforts. In addition, we
interviewed state and local public health officials and members of the
National Association of County and City Health Officials and the
Association of State and Territorial Health Officials. We also
interviewed officials from the American Hospital Association, American
Medical Association, American Society For Microbiology, Council of
State and Territorial Epidemiologists, Infectious Diseases Society of
America, and Association of Public Health Laboratories. We also
interviewed subject-matter experts to get their perspectives on HHS's
planning efforts. We participated in relevant public meetings on
pandemic preparedness, such as those sponsored by the Institute of
Medicine, to gain knowledge of new scientific evidence on the
effectiveness of planning efforts.
U.S. pandemic preparedness work is an ongoing process. The data in this
report were last updated on August 2008. However, changes have
continued to occur since completion of our data collection, and this
report may not reflect all these changes. We conducted our work from
April 2006 through September 2008 in accordance with generally accepted
government auditing standards.
Results in Brief:
Once a pandemic begins, HHS plans to make accessible to state and local
jurisdictions federal stockpiles of antivirals and pre-pandemic vaccine
until a pandemic vaccine becomes widely available. HHS has established
a national goal of stockpiling 75 million treatment courses of
antivirals in public-sector stockpiles--meaning those in the Strategic
National Stockpile (SNS) and in jurisdictional stockpiles. HHS expects
state and local jurisdictions to distribute antivirals received from
the SNS as well as from stockpiles maintained by the jurisdictions.
According to HHS, these public-sector stockpiles are intended to be
used primarily for the treatment of sick individuals. HHS intends to
oversee the distribution and administration of federally owned pre-
pandemic vaccine to individuals identified as members of the critical
workforce. Members of the critical workforce--estimated to be about 20
million--include workers in sectors that are considered necessary to
keep society functioning, such as health care and law enforcement
personnel. HHS's strategy for using pre-pandemic vaccine is to keep
society functioning until a pandemic vaccine becomes widely available.
However, HHS anticipates that initial batches of a pandemic vaccine may
not be available for as long as 20 to 23 weeks after the start of the
pandemic. HHS recommends that as batches of pandemic vaccine become
available, state and local jurisdictions provide it to members of
targeted groups based on factors such as occupation and age, instead of
making the vaccine available to the general public. HHS faces
challenges implementing its strategy for using pharmaceutical
interventions during a pandemic, including the lack of vaccine-
manufacturing capacity in the United States. HHS is currently making
large investments in domestic vaccine manufacturing capacity.
Additionally, we and others have reported since 2000 how problems can
arise if potential target groups are not established in advance. In
2008, HHS released guidance on prioritizing target groups for pandemic
vaccine and draft guidance on antiviral use during a pandemic. HHS has
not yet released draft guidance for public comment on prioritizing
target groups for pre-pandemic vaccine.
HHS has initiated efforts to improve the surge capacity of health care
providers, but these efforts will be challenged during a severe
pandemic because of the widespread nature of such an event, the
existing shortages of health care providers, and the potential high
absentee rate of providers. HHS is encouraging health care facilities
to be capable of increasing the number of health care providers in the
event of a pandemic through efforts such as using medical and nursing
students to treat patients directly and cross training health care
personnel. In addition, HHS's plans include using a national database
to enable state and local officials to quickly identify licensed
volunteers. However, there are concerns about the use of untrained
health care personnel. Given the uncertain effectiveness of efforts to
increase surge capacity, HHS has developed guidance to assist health
care facilities in planning for altered standards of care; that is, for
providing care while allocating scarce equipment, supplies, and
personnel in a way that saves the largest number of lives in mass
casualty events. For example, the HHS guidance recommends that, rather
than treat all patients equally, health care facilities determine how
to identify and treat the subset of patients who have a critical need
for treatment and are likely to survive.
HHS will rely on state and local jurisdictions to utilize
nonpharmaceutical interventions, such as isolation of sick individuals
and voluntary home quarantine of those exposed to the pandemic-causing
strain. To assist state and local jurisdictions with implementing
nonpharmaceutical interventions, HHS has developed guidance that
describes the department's "community mitigation framework." This
framework is based upon a targeted, layered strategy involving the
direct application of multiple nonpharmaceutical interventions, each of
which is partially effective, initiated early and maintained
consistently throughout a pandemic. However, HHS faces difficulties in
helping state and local jurisdictions overcome implementation
challenges, such as developing ways to help jurisdictions ensure
community compliance. HHS is also investing in several initiatives to
increase the nation's knowledge about the general use and effectiveness
of nonpharmaceutical interventions. The findings from this research
will be used to update existing guidance.
HHS has made progress in establishing roles, responsibilities, and
procedures for communicating with the general public during a pandemic.
For example, HHS's Office of the Assistant Secretary for Public Affairs
has responsibility for coordinating the public health and medical
communications effort aimed at the general public. In addition, HHS has
undertaken activities to better understand public perceptions and
knowledge of pandemics, developed pandemic educational materials to
communicate messages to the general public before and during a
pandemic, and identified ways to disseminate these materials.
Nevertheless, communications during a pandemic will be challenging, as
a pandemic will create an immediate, intense, and sustained demand for
information from the general public. HHS plans to communicate with the
general public about sensitive and technical issues, which may include
why a vaccine is not readily available to the population at large and
why a pandemic may require allocating scarce health care resources in a
way that saves the largest number of lives. The public may become
confused if they receive inconsistent information from other sources,
as HHS will not be able to ensure that messages delivered to the
general public by non-HHS entities are consistent with HHS messages.
Although HHS has made progress in identifying issues that need to be
addressed, significant challenges remain, many of which are beyond
HHS's control or cannot be quickly addressed, such as the length of
time it will take to develop a pandemic vaccine. However, among the
important activities within HHS's control that HHS could address before
a pandemic is finalizing the guidance on how limited pharmaceutical
interventions should be used during a pandemic. Therefore, we are
recommending that the Secretary of HHS expeditiously finalize guidance
to assist state and local jurisdictions to determine how to effectively
use limited supplies of antivirals and pre-pandemic vaccine in a
pandemic, including prioritizing target groups for pre-pandemic
vaccine.
In comments on a draft of this report, HHS described actions it has
taken and plans to take relating to our recommendation. HHS also
provided clarifications and additional details about its pandemic
preparedness activities, which we incorporated where appropriate.
Background:
Pandemics occur when an influenza virus mutates into a novel strain
that is highly transmissible among humans, leading to outbreaks
worldwide. Because there is little or no pre-existing immunity in the
population, the strain is highly pathogenic, thus causing disease among
those who become infected. Infected individuals may be capable of
transmitting the virus strain for 1 to 2 days before developing
symptoms. Pandemics arise periodically but unpredictably and can cause
successive waves of disease lasting for up to 3 years.
In recent years, the H5N1 strain and other strains of the influenza
virus have emerged or re-emerged. Experts are concerned because of
similarities between the H5N1 strain and the H1N1 strain, which caused
the 1918-19 pandemic. For example, research suggests that both the H5N1
and H1N1 strains prompt an over-reaction of the inflammatory response
in humans, causing rapid and severe damage to the lungs. Although the
H5N1 strain has not been easily transmitted among humans, influenza
experts believe that H5N1 or another new influenza strain may
eventually mutate to become highly transmissible.
Pharmaceutical Interventions during a Pandemic:
Pharmaceutical interventions available during a pandemic include
vaccines and antivirals. Pharmaceutical interventions are the primary
methods used to prevent the spread of disease as well as to reduce
morbidity and mortality caused by the influenza virus. See table 1.
Table 1: Comparison of Pharmaceutical Interventions for a Pandemic:
Pharmaceutical interventions: Antivirals;
How it works: Disrupts viral infection of cells, such as the ability to
bind to human cells or be released from an infected cell;
Time frame for development: Before a pandemic;
When it is expected to be available: Before and during a pandemic;
Dosage: Varies, depending on the type of antiviral used and age of
patient;
Known potential benefits: * May be used as a form of prophylaxis or
treatment;
* May be made and stockpiled in advance of a pandemic;
Known potential weaknesses: * Virus can develop resistance;
* Must be taken within 48 hours of developing symptoms for maximum
effectiveness[A].
Pharmaceutical interventions: Pre-pandemic vaccine;
How it works: Stimulates a human immune response;
Time frame for development: Before a pandemic;
When it is expected to be available: Early in a pandemic;
Dosage: Research on one type of vaccine suggests 2 doses of 90
micrograms (mcg.)[B];
Known potential benefits: * May prevent severe illness and death;
* May be made and stockpiled in advance;
Known potential weaknesses: * May or may not be well-matched to the
pandemic- causing strain.
Pharmaceutical interventions: Pandemic vaccine;
How it works: Stimulates a human immune response;
Time frame for development: During a pandemic;
When it is expected to be available: HHS estimates that initial doses
will not be available until 20 to 23 weeks after the start of the
pandemic;
Dosage: Unknown until actual pandemic-causing strain emerges;
Known potential benefits: * Will help prevent infection or serious
illness because the vaccine will be well-matched to the pandemic-
causing strain;
Known potential weaknesses: * Cannot be developed in advance;
* Will take months to develop.
Source: GAO analysis of HHS documents and journal articles.
[A] Effectiveness estimate is based on antiviral use during seasonal
influenza outbreaks.
[B] This dosing is based on the vaccine developed from an H5N1 strain
and was approved by FDA for use in humans in the United States in April
2007.
[End of table]
Vaccination is the primary method for preventing infection with the
influenza virus. Vaccines reduce the severity of disease or provide
immunity by causing the body to produce protective antibodies to fight
off a particular virus strain.[Footnote 19] In order for a vaccine to
be most effective, it needs to be well-matched to a particular strain
of the influenza virus so that the antibodies formed in response to the
vaccine protect against that strain. However, existing strains of the
influenza virus can mutate into new strains; in part, this is why a new
vaccine is created each year for the upcoming influenza season. Much of
what is known about the anticipated effectiveness of a pandemic vaccine
is based on evidence from the annual seasonal vaccine.
During a pandemic, it may be necessary to use a vaccine that was
developed prior to a pandemic and therefore may not be well-matched to
the pandemic-causing strain. This vaccine, called a pre-pandemic
vaccine, is developed using an influenza strain that experts believe is
likely to cause the next pandemic.[Footnote 20] Research exploring the
use of a pre-pandemic vaccine based on strains of the H5N1 virus
suggests that it may provide some protection against serious illness
and death.[Footnote 21] In contrast, a pandemic vaccine would be
developed against an identified pandemic-causing strain and would
likely provide better protection against the pandemic strain.
It is likely that seasonal influenza vaccine manufacturers will produce
the vaccine used during a pandemic.[Footnote 22] However, for the 2007-
08 influenza season, only five vaccine manufacturers were licensed to
produce seasonal influenza vaccine for the United States[Footnote 23]
and only one manufacturer produced its vaccine from start to finish in
facilities within U.S. borders.[Footnote 24] We also recently reported
that experts are concerned that countries without domestic
manufacturing capacity will not have access to vaccine in the event of
a pandemic if the countries with manufacturing capacity prohibit the
export of pandemic vaccine until their own needs are met.[Footnote 25]
Antivirals can reduce symptoms and help prevent the spread of influenza
by suppressing the growth of the influenza virus.[Footnote 26] Unlike
the immune response triggered by a vaccine, antivirals target the virus
itself. For example, some antivirals interfere with the virus's ability
to attach to cells, thereby preventing infection of human cells.
Antivirals also differ from vaccines in that they do not need to be
reformulated to match a specific influenza strain in order to be
effective. In addition, antivirals can be manufactured and stockpiled
in advance, making them potentially available at the beginning of a
pandemic. HHS currently maintains a stockpile of antivirals in the
SNS.[Footnote 27]
However, as we have previously reported, there are limitations
associated with relying on antivirals during a pandemic.[Footnote 28]
For example, the effectiveness of antivirals during seasonal influenza
has been limited if they are used more than 48 hours after the onset of
symptoms in an infected individual. For prophylactic use against
seasonal influenza in healthy individuals, antivirals may not be as
effective if they are not taken throughout the entire time an outbreak
is present in a community. Some influenza strains have become resistant
to the antivirals currently approved for prevention and treatment, and
thus, the antivirals may not always be effective in preventing
disease.[Footnote 29] In addition, antivirals, like vaccines, take
several months to produce, and the lead time needed to scale up
production capacity may make it difficult to meet any large-scale,
unanticipated demand immediately. As we recently reported, current
antiviral production capacity is inadequate to meet expected demand
during a pandemic.[Footnote 30] Further, antivirals can be expensive to
stockpile and difficult to administer, depending on the form in which
they are given. For example, Tamiflu is given as a capsule or liquid
and is relatively easy to administer, whereas, Relenza, is more
difficult to administer because it is a powder that must be inhaled
using a special device.
Since 2000, we and others have reported that federal, state, and local
officials need to have information on target groups that have priority
for receiving pharmaceutical interventions to know how, where, and to
whom to distribute the interventions. We reported that having
established target groups is particularly crucial in times of limited
supply, such as during a pandemic, when a lack of specific guidance
makes it difficult for federal, state, and local officials to plan. For
example, in a prior report, we noted that health officials in one state
did not know exactly how many individuals were considered a priority
for receiving a vaccine.[Footnote 31] In that case we found that it
took state officials nearly a month to compile data on high-risk
individuals, to decide how many doses of vaccine were needed in local
areas, and to receive and ship vaccine to counties. State and local
officials rely on federal guidance when making decisions on which
groups should be targeted first for vaccination. For example, in a
prior report on the 2004-05 influenza season, when the United States
lost approximately half of its seasonal vaccine supply because of
manufacturing difficulties, we found that CDC quickly revised its
recommendations on who should be prioritized for vaccine.[Footnote 32]
CDC's changes decreased the targeted population from approximately 188
million to 98 million. State and local officials we spoke with for this
report told us that they quickly adopted CDC's revised recommendations.
Surge Capacity of Health Care Providers:
Since the terrorist attacks on September 11, 2001, public health
departments and hospitals have been considered vital elements of
emergency preparedness and response efforts. Surge capacity in public
health departments and hospitals will be critical to pandemic response
given the large number of people expected to require medical care.
During a pandemic, hospitals will need to provide care for influenza
patients as well as continue providing care for other patients.
A pandemic will put a severe strain on the health care system, which
already is easily overwhelmed by seasonal influenza outbreaks. Seasonal
influenza results in more than 200,000 hospital admissions and 36,000
deaths in the United States every year, and hospitals were stretched to
capacity in some past seasonal influenza outbreaks. A severe pandemic
would overwhelm hospitals in the United States. For example, using
HHS's planning assumptions, authors of one study estimated that
influenza patients would need the equivalent of 191 percent of
available staffed non-ICU beds and 461 percent of available staffed ICU
beds.[Footnote 33]
A pandemic would occur in the context of existing health care provider
shortages. Shortages of health care providers, including physicians and
nurses, have been reported for many years by GAO and others.[Footnote
34] For example, the Association of American Medical Colleges recently
released a report summarizing studies issued by 15 states between 2000
and 2007 regarding physician shortages in the United States.[Footnote
35] That report found that many of these states reported shortages of
physicians in specialties such as primary care, cardiology, and
endocrinology. Similarly, a recent survey of chief executive officers
by the American Hospital Association found that as of December 2006,
hospitals across the country reported having an estimated 116,000
registered nurse vacancies.[Footnote 36] That survey also found that
nearly half of emergency departments are operating at or above
capacity.[Footnote 37]
Partly in response to these workforce shortages, Congress passed the
Pandemic and All-Hazards Preparedness Act (PAHPA) in December
2006.[Footnote 38] Among other things, the law requires the Secretary
of HHS by 2009 to identify strategies to recruit, retain, and protect
the public health workforce from workplace exposures during public
health emergencies, which would include pandemics.[Footnote 39] In
addition, PAHPA established the Office of the Assistant Secretary for
Preparedness and Response to coordinate activities between HHS and
other federal departments, agencies, and offices and state and local
officials responsible for emergency preparedness.[Footnote 40]
Nonpharmaceutical Interventions:
Nonpharmaceutical interventions are measures used to reduce the impact
of a communitywide infectious disease outbreak without the use of
pharmaceuticals. Examples of nonpharmaceutical interventions include
isolation, quarantine, social distancing, and infection control (see
table 2).
Table 2: Some Types of Nonpharmaceutical Interventions and Their
Definitions:
Type of Nonpharmaceutical Intervention: Isolation;
Definition: The separation or restriction of movement of individuals
ill with an infectious disease to prevent transmission to others.
Type of Nonpharmaceutical Intervention: Quarantine;
Definition: The separation or restriction of movement of individuals
exposed to an infectious disease, but not yet ill, who may become
infectious to others.
Type of Nonpharmaceutical Intervention: Social distancing;
Definition: Measures taken to decrease the frequency of contact among
people, such as school closures.
Type of Nonpharmaceutical Intervention: Infection control;
Definition: Hygiene measures to reduce the risk of transmission from
infected individuals to uninfected individuals, including hand washing,
cough etiquette, and disinfection.
Source: CDC.
[End of table]
Slowing the spread of disease during a pandemic will be particularly
important given anticipated shortages of pharmaceutical interventions
and the expectation that a severe pandemic will overwhelm the health
care system. Experts have suggested that nonpharmaceutical
interventions can help the health care system by reducing the
anticipated influx of patients by limiting the rate of disease
transmission (see fig. 1).
Figure 1: Potential Effect of Nonpharmaceutical Interventions on a
Pandemic Outbreak:
This figure is a an illustration showing potential effect of
nonpharmaceutical interventions on a pandemic outbreak.
[See PDF for image]
Source: HHS, Interim Pre-Pandemic Planning Guidance: Community Strategy
for Pandemic Influenza Mitigation in the United States - Early,
Targeted Layered Nonpharmaceutical Interventions, Atlanta, Ga., 2007.
[End of figure]
In the past, nonpharmaceutical interventions have been used in some
cases to successfully slow the spread of infectious disease outbreaks.
For example, during the 1918-19 pandemic, local public health officials
relied on nonpharmaceutical interventions--including rules forbidding
overcrowding in streetcars and bans on public gatherings--to slow the
spread of disease. More recently, during the global outbreak of severe
acute respiratory syndrome (SARS) in 2003, nonpharmaceutical
interventions were also implemented to slow the spread of disease. For
example, we reported that nonpharmaceutical interventions, such as
closing two hospitals to new admissions, appeared to be useful in
Canada's management of the SARS outbreak.[Footnote 41]
Communication with the Public:
Public health emergencies such as the SARS outbreak in 2003 and the
anthrax incidents in 2001 have demonstrated that communication with the
public about a public health emergency by federal officials is a
critical component of national preparedness. In July 2003, we reported
that effective communication between health care providers and the
public reinforced the need to adhere to infectious disease control
measures and that rapid and frequent communications regarding SARS
helped slow its spread.[Footnote 42] In addition, in October 2003, we
reported that the media and the public looked to CDC as the source for
health-related information during the anthrax incidents, but that CDC
was not always able to successfully convey the information that it
had.[Footnote 43]
As with the SARS outbreak and anthrax incidents, a pandemic will
generate immediate, intense, and sustained demand for information. The
public will want information quickly about the risks and status of the
pandemic, what they can do to stay healthy, what is being done by the
government to protect them, and where to go for medical services. Very
technical points and sensitive political issues will need to be
explained to the general public. If accurate and consistent information
is not available and disseminated in a timely and efficient manner,
rumors, myths, and misinformation may lead to unnecessary public
anxiety and could result in mistrust of, and noncompliance with, the
public health and medical measures that are recommended to save lives.
HHS Plans to Make Federal Stockpiles of Pharmaceuticals Accessible to
State and Local Jurisdictions, but Faces Challenges with
Implementation:
Once a pandemic begins, HHS plans to make accessible to state and local
jurisdictions[Footnote 44] federal stockpiles of antivirals and pre-
pandemic vaccine until a pandemic vaccine becomes widely available.
According to HHS, public-sector stockpiles of antivirals are intended
to be used primarily for the treatment of sick individuals. HHS intends
to oversee the distribution and administration of federally owned pre-
pandemic vaccine to individuals identified as members of the critical
workforce; that is, workers in sectors that are necessary for society
to continue functioning. HHS also plans to provide jurisdictions with
doses of the pandemic vaccine as they become available. HHS recommends
that state and local jurisdictions follow its list of targeted groups
in administering the pandemic vaccine. However, HHS faces challenges
with implementing its strategy for using pharmaceutical interventions,
such as the lack of vaccine manufacturing capacity within U.S. borders
and the length of time experts anticipate will be needed to manufacture
a pandemic vaccine. Additionally, we and others have reported since
2000 how problems can arise if potential target groups are not
established in advance. In 2008, HHS released guidance on prioritizing
target groups for pandemic vaccine and draft guidance on antiviral use
during a pandemic. HHS has not yet released draft guidance for public
comment on prioritizing target groups for pre-pandemic vaccine.
HHS Plans to Distribute Antivirals from the SNS to Jurisdictions and Is
Relying on Additional Stockpiles to Supplement These Drugs:
Until a pandemic vaccine becomes widely available, one part of HHS's
strategy for using pharmaceutical interventions involves distributing
antivirals in the SNS to state and local jurisdictions. HHS has
established a national goal of stockpiling 75 million treatment courses
of antivirals in public-sector stockpiles--meaning those in the SNS and
in jurisdictional stockpiles.[Footnote 45] As of May 2008, HHS had
stockpiled 44 million courses of antivirals for treatment in the SNS
and is subsidizing the purchase of 31 million treatment courses by
state and local jurisdictions for storage in their own
stockpiles.[Footnote 46] As of May 2008, state and local jurisdictions
had collectively stockpiled nearly 22 million treatment courses of
antivirals.[Footnote 47]
Of the federally stockpiled antivirals, HHS has reserved 6 million
courses for containment of an initial outbreak.[Footnote 48] For
example, these 6 million courses may be used to respond to initial
outbreaks abroad and parts of the United States experiencing the
earliest cases. Officials told us that after the department distributes
these initial 6 million courses of antivirals, it plans to deliver the
remaining antivirals in the SNS to all jurisdictions simultaneously for
treatment of individuals sick with influenza. According to HHS's
guidance, state and local jurisdictions will receive their allotments
of antivirals on a per-capita basis and should prepare to receive their
share of antivirals when a pandemic begins, either in the United States
or overseas. According to HHS officials, the decision to release
antivirals from the SNS will be made by the Secretary of HHS in
conjunction with the Director of CDC. HHS officials estimate that it
will take between 7 days and 1 month for all antivirals to be
distributed to jurisdictions. HHS officials also told us that they have
conducted several exercises to test HHS's plan to distribute antivirals
to these jurisdictions during a pandemic. Antivirals from the SNS will
be delivered to one location within each jurisdiction. According to HHS
officials, state and local jurisdictions will distribute both the SNS
antivirals and antivirals stored in their own stockpiles throughout
their respective areas using pandemic-specific distribution plans.
HHS officials told us that the stockpiles of antivirals owned by state
and local jurisdictions will provide the jurisdictions with more
immediate access to the drugs during the initial stages of a pandemic.
Because these stockpiles will be entirely under each jurisdiction's
control, officials there may choose to use some of these antivirals as
prophylaxis--as proposed in HHS's draft guidance on antiviral use
during a pandemic--in an attempt to slow the spread of the pandemic by
providing them to healthy individuals who have been exposed to the
pandemic-causing strain. However, to ensure that stockpiles are not
rapidly depleted, HHS currently recommends that jurisdictions use
antivirals only for treatment. HHS also advises jurisdictions to begin
deploying their respective antiviral stockpiles immediately when a
pandemic has been confirmed.
In June 2008, HHS released draft guidance for the use of antivirals
during a pandemic in the Federal Register for public comment. The draft
guidance is consistent with HHS's previous recommendation that public-
sector stockpiles be used primarily for treatment of individuals sick
with influenza. In its draft guidance, HHS also acknowledged that more
antivirals will be needed than will be available in public-sector
stockpiles particularly if antivirals are used for prophylaxis. HHS
proposes in its draft guidance that the private sector stockpile 110
million additional courses. HHS also suggests that antivirals in the
private-sector stockpile be targeted for prophylactic use for health
care and emergency services personnel, and in some circumstances, for
persons with compromised immune systems as well as those living in
group settings.[Footnote 49] The purchasing, allocation, and
distribution of private-sector stockpiles would be the responsibility
of the owner of those stockpiles.
HHS Intends to Make Available Federally Owned Pre-Pandemic Vaccine to
Protect the Critical Workforce:
HHS's strategy also involves releasing federally owned pre-pandemic
vaccine to specific locations in state and local jurisdictions for
administration when it has been determined that sustained transmission
of the pandemic virus has occurred. HHS intends to oversee distribution
and administration of pre-pandemic to members of the critical workforce
identified by a federal interagency group--the National Infrastructure
Advisory Council. Workers considered critical consist of those
necessary to maintain national or homeland security, economic survival,
and the public health and welfare. These employees include emergency
service providers, such as law enforcement, banking and financing
personnel, and health care providers. The National Infrastructure
Advisory Council estimates that the critical workforce includes about
20 million people.[Footnote 50] HHS has a goal of stockpiling enough
pre-pandemic vaccine to cover this group.[Footnote 51] As of May 2008,
HHS had purchased and stockpiled enough pre-pandemic vaccine for about
13 million people.[Footnote 52] HHS's strategy for using pre-pandemic
vaccine is to keep society functioning until a pandemic vaccine becomes
widely available.
State and local jurisdictions will receive allotments of pre-pandemic
vaccine on a per-capita basis. According to HHS officials, stockpiles
of pre-pandemic vaccine will be released for simultaneous distribution
to selected sites in each jurisdiction. Currently, each vaccine
manufacturer stores the doses of pre-pandemic vaccine that it produces.
According to HHS, each manufacturer is assigned to supply this vaccine
to certain jurisdictions using its established distribution channels.
HHS officials also told us that they have a longer-term plan to
distribute vaccine using a single distributor, based on CDC's Vaccine
Management Business Improvement Project.[Footnote 53] According to HHS
officials, this centralized distribution system would be incorporated
with its existing Vaccine Ordering and Distribution System, which
allows for federal tracking of vaccine distribution. HHS anticipates
having a centralized distribution system in place around 2010. HHS
officials told us that utilizing this type of system would be
beneficial during the early stages of a pandemic, when it is expected
that maintaining central control of and securing vaccine will be a high
priority.
HHS Plans to Distribute Pandemic Vaccine As It Becomes Available for
Vaccination of Target Groups:
HHS plans to provide pandemic vaccine as it becomes available to state
and local jurisdictions for use among target groups. HHS has developed
guidance for the prioritization system for administration of the
pandemic vaccine. HHS has divided the entire U.S. population into four
broad categories--homeland and national security, health care and
community support services, critical infrastructure, and the general
population. Within each category, groups are clustered into five tiers
that correspond to the vaccination priority--or target group--for that
specific category. (See table 3 for target groups for a severe
pandemic.) These targeted groups were derived through consideration of
four vaccination program objectives: (1) protecting those who are
essential to the pandemic response and provide care for persons who are
ill; (2) protecting those who maintain essential community services;
(3) protecting children; and (4) protecting workers who are at greater
risk of infection because of their job. In its guidance, HHS also
proposed that not all targeted groups be vaccinated in every pandemic,
depending on the severity of the pandemic.[Footnote 54] For a less
severe pandemic, for example, individuals in tiers 2 and 3 in the
category of critical infrastructure would not be targeted for
vaccination.[Footnote 55] HHS also noted that the guidance will need to
be reassessed periodically before a pandemic occurs to consider factors
such as changes in vaccine production capacity. During a pandemic,
guidance will also be modified based on additional factors that will
not be known until a pandemic occurs, including the characteristics of
pandemic illness.
Table 3: HHS Target Groups for Pandemic Vaccination for a Severe
Pandemic:
Tier: Tier 1;
Homeland and national security: * Deployed and mission critical
personnel;
Health care and community support services: * Public health personnel;
* Inpatient health care providers;
* Outpatient and home health care providers;
* Health care providers in long-term care facilities;
Critical infrastructure: * Emergency services sector personnel
(Emergency Medical Services, law enforcement, and fire services);
* Manufacturers of pandemic vaccine and antivirals;
General population: * Pregnant women;
* Infants and toddlers, 6 to 35 months old.
Tier: Tier 2;
Homeland and national security: * Essential support and sustainment
personnel;
* Intelligence services;
* Border protection personnel;
* National Guard personnel;
* Other domestic national security personnel;
Health care and community support services: * Community support
services and emergency management;
* Pharmacists;
* Mortuary services personnel;
Critical infrastructure: * Communications/information technology,
electricity, nuclear, oil and gas, and water sector personnel;
* Financial clearing and settlement personnel;
* Critical operational and regulatory government personnel;
General population: * Household contacts of infants under 6 months old;
* Children 3 to 18 years old with high-risk conditions.
Tier: Tier 3;
Homeland and national security: * Other active duty and essential
support;
Health care and community support services: * Other important health
care personnel;
Critical infrastructure: * Banking and finance, chemical, food and
agriculture, pharmaceutical, postal and shipping, and transportation
sector personnel;
* Other critical government personnel;
General population: * Children 3 to 18 years old without high-risk.
Tier: Tier 4;
Homeland and national security: * Not Applicable;
Health care and community support services: * Not Applicable;
Critical infrastructure: * Not Applicable;
General population: * Persons 19 to 64 years old with high-risk
condition;
* Persons over 65 years old.
Tier: Tier 5;
Homeland and national security: * Not Applicable;
Health care and community support services: * Not Applicable;
Critical infrastructure: * Not Applicable;
General population: * Healthy adults, 19 to 64 years old.
Source: HHS and DHS.
Note: Table was developed from Guidance on Allocating and Targeting
Pandemic Influenza Vaccine, Washington, D.C., 2008.
[End of table]
HHS officials told us that should a pandemic occur in the near future,
pandemic vaccine will likely be distributed from vaccine manufacturers
directly to state and local jurisdictions using the same distribution
systems the manufacturers regularly use for seasonal influenza
vaccine.[Footnote 56] As with pre-pandemic vaccine, HHS anticipates
that eventually multiple manufacturers will produce pandemic vaccine.
However, it anticipates utilizing a single, centralized distributor.
HHS expects to have a centralized distribution system in place around
2010.
HHS Faces Challenges with Implementing Its Strategy for Using
Pharmaceutical Interventions:
HHS faces three challenges with implementing its strategy for using
pharmaceutical interventions during a pandemic. The first challenge is
associated with uncertainties about the effectiveness and clinical
outcomes of the pharmaceutical interventions. For example, the
uncertainty concerning which influenza strain will cause the next
pandemic raises the possibility that the pre-pandemic vaccine currently
being developed will not offer protection against the pandemic strain.
Also, because the actual pandemic-causing strain has not yet surfaced,
researchers can only estimate what amount of vaccine will actually be
needed to stimulate a sufficient human immune response. Similarly, the
appropriate dosage of antivirals or the exact length of the treatment
course needed to make them effective will not be known until the actual
pandemic-causing strain emerges. Further, the ability of influenza
viruses to develop resistance to antivirals also raises questions about
their effectiveness. In 2005, a group of global experts on antivirals
noted that studies have suggested that different strains of the H5N1
avian influenza virus have developed resistance to different
antivirals.[Footnote 57]
There is also the potential for adverse outcomes that may result from
large-scale administration of a newly developed vaccine, such as what
occurred during the "swine flu" outbreak of 1976. The government's
success in vaccinating large numbers of the public with the swine flu
vaccine was negated by the development of Guillain-Barré syndrome among
hundreds of immunized individuals, leading to several deaths.[Footnote
58] This adverse event only became apparent when the vaccine had been
administered to large numbers of people.[Footnote 59]
A second challenge concerns difficulties with the production of
pharmaceutical interventions, particularly vaccines. The United States
lacks vaccine manufacturing capacity; for example, we found that for
the 2007-08 influenza season only one influenza vaccine manufacturer
had its production processes entirely within U.S. borders.
Additionally, in 2007 we found that the lack of U.S. vaccine
manufacturing capacity is cause for concern among experts because it is
possible that countries without domestic manufacturing capacity will
not have access to vaccine in the event of a pandemic if the countries
with domestic manufacturing capacity prohibit the export of the
pandemic vaccine until their own needs are met.[Footnote 60]
According to HHS, exacerbating the lack of manufacturing capacity is
the length of time experts anticipate will be needed to manufacture a
pandemic vaccine. HHS estimates that it may take as long as 20 to 23
weeks after the start of the pandemic for the first doses of pandemic
vaccine to become available.[Footnote 61] Figure 2 shows how
pharmaceutical manufacturers would proceed to develop and produce
pandemic vaccine as well as when initial batches of vaccine are likely
to become available.
Figure 2: Pandemic Vaccine Production Timeline:
This figure is a pandemic vaccine production timeline.
Pandemic strain emerges in country of origin:
Month 1:
* Detection of outbreak;
* Isolation of Virus
Develop reference virus:
Month 2:
* Development of reference virus;
Prepare for production:
Month 3:
* Manufactures adapt seed virus for mass production;
* Develop reagents;
Produce and test vaccines:
Month 4:
* Pandemic has spread;
* Production begins;
Produce and test vaccines:
Month 5:
First vaccines become available;
Produce and test vaccines:
Month 6:
First vaccines become available;
Produce and test vaccines:
Month 7:
First vaccines become available;
[See PDF for image]
Source: GAO analysis of HHS, International Federation of Pharmeceutical
Manufacturers & Associations, and World Health Organization data.
[End of figure]
In response to this lack of manufacturing capacity, HHS has established
the long-term goal of domestically producing enough pandemic vaccine
for 300 million people within 6 months of having a reference strain of
the pandemic virus. HHS expects to reach this level of manufacturing
capacity around 2010.[Footnote 62] The department is currently making
large investments in domestic vaccine manufacturing capacity for this
purpose. (See app. II for a description of these investments.) HHS is
doing this in part by supporting vaccine research with contracts that
require manufacturers to establish vaccine-producing facilities within
U.S. borders.[Footnote 63] Through these contracts, one U.S. facility
has expanded its manufacturing capacity and is expected to double its
existing capacity by 2009 and triple its capacity by 2011. A second
facility was recently established in the United States and is expected
to manufacture a licensed product in 2010. HHS officials told us there
had also been progress in expanding domestic manufacturing capacity for
antivirals.
The third challenge HHS faces involves difficulties in stockpiling and
distributing pharmaceutical interventions. The high costs of purchasing
and storing antivirals calls into question HHS's plan to rely on state
and local jurisdictions to acquire and store their own stockpiles of
antivirals. For example, officials from one state we spoke with told us
that the state was facing financial difficulty in determining how it
will purchase its share of antivirals and in identifying and paying for
adequate storage space. HHS officials have acknowledged that the cost
of purchasing antivirals is high, but have also noted that the contract
price HHS has negotiated for state and local jurisdictions is better
than the retail price. No federal funding has been made available to
aid state and local jurisdictions in building and maintaining storage
capacity. In addition, should a pandemic occur in the near future, HHS
plans to utilize multiple distributors for pre-pandemic and pandemic
vaccines, allowing manufacturers to use existing processes with which
they are familiar. However, HHS acknowledged that this process also has
multiple weaknesses. For example, the current distribution plan
requires extensive coordination between HHS and multiple manufacturers
and distributors. It also requires that states and local jurisdictions
manage vaccine shipments from multiple sources, which may complicate
receipt and storage activities. In response, HHS is planning to
centralize its distribution system through a single distributor.
HHS Has Made Progress on Revising Guidance for Target Groups for Use of
Pandemic Vaccine, but Has Not Finalized Guidance for Using Pre-Pandemic
Vaccine and Antivirals:
HHS has made progress on revising its 2005 guidance to state and local
jurisdictions for identifying target groups for the use of pandemic
vaccine, but has not finalized guidance for using antivirals and pre-
pandemic vaccine. Since 2000, GAO and others have reported on the
importance of having pre-established target groups for pharmaceutical
interventions to avoid problems deciding who should receive these
interventions. In addition, during times of shortage, state and local
public health officials look to the federal government for guidance,
including when making decisions on which groups should be targeted for
prioritization. For example, during the seasonal influenza vaccine
shortage of 2004-05, state and local officials immediately adopted the
revised guidance on who should be targeted for vaccination as
recommended by CDC.[Footnote 64] State and local public health
officials and others have stressed that federal guidance on target
groups is needed to aid in their pandemic planning efforts.
HHS first published target groups for pandemic vaccine and antivirals
in the HHS Pandemic Influenza Plan in November 2005.[Footnote 65] These
initial groups were identified to support a goal of reducing morbidity
and mortality among those at greatest risk for developing complications
from influenza, such as the elderly. Since the publication of the HHS
Pandemic Influenza Plan, there has been wide recognition that other
factors should be considered, such as protecting those critical workers
needed to keep society functioning, including health care and law
enforcement personnel. In addition, recent expansion in the production
of antivirals has increased the amount available. Thus, HHS, in
consultation with other federal agencies, was tasked by the National
Strategy for Pandemic Influenza Implementation Plan and the HHS
Pandemic Influenza Implementation Plan to revise the groups outlined in
the HHS Pandemic Influenza Plan.[Footnote 66] In July 2008, HHS
released guidance on prioritizing target groups for pandemic vaccine.
HHS released draft guidance for public comment in the Federal Register
on how antivirals may be used during a pandemic in June 2008.
However, HHS has not yet released draft guidance identifying target
groups for pre-pandemic vaccine. HHS officials told us they are working
on draft guidance for pre-pandemic vaccine in collaboration with other
federal agencies, such as DHS. According to officials, target groups
for pre-pandemic vaccine are likely to resemble those for pandemic
vaccine, but with more of a focus on the critical workforce rather than
on the general population. HHS officials said a tiered structure, such
as that used for the pandemic vaccine, would only be needed if a
pandemic occurs before HHS has reached its goal of stockpiling enough
doses for 20 million people.[Footnote 67]
HHS Efforts to Improve Surge Capacity of Health Care Providers Will Be
Challenged during a Pandemic:
HHS has initiated efforts to improve the surge capacity of health care
providers, but these efforts will be challenged during a severe
pandemic. Surge capacity of health care providers will be hindered by
existing shortages of health care providers and by the potentially high
absentee rates of providers during a pandemic. Inadequate staffing of
health care facilities will be likely, and the ability to deliver
health care consistent with established standards of care may be
compromised.[Footnote 68] HHS's efforts include plans to supplement the
number of health care providers with medical and nursing students.
Given the uncertain effectiveness of efforts to increase surge
capacity, HHS has developed guidance to assist health care facilities
in planning for altered standards of care; that is, for providing care
while allocating scarce equipment, supplies, and personnel in a way
that saves the largest number of lives in mass casualty events, such as
pandemics.
Surge Capacity during a Pandemic Will Be Hindered by the Potentially
High Absentee Rate of Health Care Workers:
In a severe pandemic, existing health-care provider shortages would
worsen as health care providers become infected through exposure to
infected patients or reach exhaustion because of longer working hours.
The federal government assumes absenteeism among all workers, including
health care providers, could be as high as 40 percent.[Footnote 69]
During the 2003 SARS outbreak (a disease that has a high mortality rate
and poses a high risk for health care workers similar to a pandemic),
health care workers accounted for more than 20 percent of the infected
cases. During the epidemics in Toronto and Hong Kong, 51 percent and
between 28 percent and 50 percent, respectively, of health care
providers who treated SARS patients became infected with the SARS
virus.[Footnote 70]
Studies have shown that during extreme public health emergencies, such
as a pandemic, some health care workers may be unable or unwilling to
report to work.[Footnote 71] For example, a survey of public health
department workers, including communicable disease staff, nurses, and
physicians, at three public health departments in Maryland found that
approximately 46 percent would be likely not to report to work during a
pandemic outbreak.[Footnote 72] Similarly, in a survey of hospital
personnel, including doctors and nurses, only half responded that they
would be willing to report to work during a pandemic. Those who said
they may be unlikely to report to work cited fear of contracting an
illness as the reason.[Footnote 73] These potential workforce shortages
during a pandemic will affect care for all patients, not just those
with influenza.
HHS's Efforts to Improve Surge Capacity during a Pandemic Will Face
Challenges:
HHS has initiated many efforts to increase the number of health care
workers during a public health emergency by supplementing the workforce
with federal response teams and by encouraging mutual aid between
states. However, HHS faces challenges in improving surge capacity
during a severe pandemic because of the widespread effects of a
pandemic and the existing shortages of health care providers.
HHS's Plans for Surge Capacity of Health Care Providers during a
Pandemic:
HHS has planned four types of efforts to improve surge capacity during
a pandemic. First, the HHS Pandemic Influenza Plan recommends that
health care facilities use personnel available locally to increase the
number of health care providers during emergencies. These
recommendations include using trainees (such as medical and nursing
students), patients' family members, and retired health care providers
to provide support for essential patient care at times of severe
staffing shortages. The plan recommends that hospital clinical
administrators take on patient care responsibilities and that
facilities recruit health care providers from other medical settings,
such as medical offices and day surgery centers, to assist with patient
care in the hospital setting. Additionally, the plan recommends that
health care providers be cross-trained to provide support for essential
patient care at times of severe staffing shortages. To assist with this
effort, HHS's Agency for Healthcare Research and Quality has developed
a video to help train health care workers who are not respiratory care
specialists to provide basic respiratory care and ventilator management
to adult patients during mass casualty events. In addition, the HHS
Pandemic Influenza Plan recommends deployment of federal medical
responders, such as members of the National Disaster Medical System,
during the early stages of a pandemic to supplement the number of
health care providers.
Second, the HHS Pandemic Influenza Plan encourages state and territory
officials to use the Emergency System for Advance Registration of
Volunteer Health Professionals program, which enables state and
territory officials to quickly identify licensed volunteer
professionals to work in areas with shortages. This program is state-
based systems that provide advanced registration and the credentialing
information of clinicians needed to augment health care facilities
during a declared emergency. The program enables the sharing of pre-
registered health care professionals across state lines. According to
HHS, as of February 2008, 40 state and territorial jurisdictions had
begun to implement the program; all states and territories are required
to have this program fully operational by August 2008.
Third, HHS has advised state officials to incorporate the Emergency
Management Assistance Compact (EMAC) in their plans as another vehicle
for obtaining medical assistance during a pandemic. Once a governor
declares a state of emergency, a state can request that EMAC address
its need for resources, such as health care providers. EMAC personnel
will find states that have health care providers who can be deployed
across state lines. EMAC was established in 1996 and is administered by
the National Emergency Management Association. All 50 states, the
District of Columbia, Puerto Rico, and the U.S. Virgin Islands have
enacted legislation providing authority to join EMAC.
Fourth, HHS encourages state and local officials to use other
mechanisms to expand surge capacity of health care providers for
providing care to less severely ill patients during a pandemic. These
mechanisms would encourage home care of less severely ill patients and
include "telehealth" (also known as "telemedicine"), which allows
health care providers in hospitals to care for and monitor patients at
home with the use of electronic information and telecommunications
technologies; and call centers (similar to nurse advice lines), which
will allow patients at home to contact health care providers in
hospitals in order to obtain medical advice regarding home care.
Challenges to Efforts to Increase Surge Capacity during the Initial
Outbreak of a Pandemic:
HHS faces several challenges in its efforts to increase surge capacity
of health care providers during a pandemic. There are concerns that the
use of untrained personnel may reduce the capacity of trained health
care providers to deliver needed care. For example, officials from one
professional association told us that using such individuals would
require training and supervision, which would actually increase the
workload of the health care facilities' staff. They also told us that
cross-training personnel to provide support for essential patient care
during a mass casualty event may be infeasible because health care
providers will be busy caring for patients in their own areas of
expertise. Cross-training of health care providers needs to be done in
advance, but this may be infeasible because it would take providers
away from their daily patient-care responsibilities, and this may be
difficult to do given current workforce shortages.
Furthermore, health care providers from other areas may not be
available for deployment in a severe pandemic. Members of response
teams, such as those of the National Disaster Medical System, already
have full-time jobs in health care. Therefore, these teams would not
necessarily add to the nation's overall number of health care providers
who would be available to treat influenza patients. We were told by HHS
and FEMA officials that the National Disaster Medical System response
teams will not likely be deployed during a pandemic outbreak because of
the widespread nature of a pandemic and the need for those responders
in their own regions. Similarly, while the EMACs make it easier for
health care providers to work in states other than those in which they
are licensed, given the widespread nature of pandemics, health care
providers likely will be needed in their own home regions.[Footnote 74]
HHS Has Issued Guidance Regarding Implementation of Altered Standards
of Care to Be Used If There Is Inadequate Staffing of Health Care
Facilities:
During a severe pandemic, inadequate staffing of health care facilities
will be likely despite efforts to improve surge capacity. Thus, the
ability to deliver health care consistent with established standards of
care for all patients may be compromised.[Footnote 75] HHS officials
told us they believe that decisions on the allocation of scarce
resources--such as equipment, supplies and personnel--are best made at
the local level.[Footnote 76] Therefore, the HHS Pandemic Influenza
Implementation Plan recommends that health care facilities plan ahead
for providing altered standards of care;[Footnote 77] that is, for
providing care while allocating scarce resources in a way that saves
the largest number of lives in mass casualty events.[Footnote 78] With
altered standards of care, instead of treating the sickest or most
injured patients first, health care providers would identify and treat
patients who have a critical need for treatment and would be likely to
survive. Complicating conditions, such as an underlying chronic disease
that may impact an individual's ability to survive, would be considered
in the decision-making process. Resources being used by current
patients, such as those recovering from surgery, would also become part
of the overall resource allocation decisions and might be re-allocated
to patients with a more critical need for treatment and a higher
likelihood to survive. Altered standards of care would be implemented
on a temporary basis. Once the event wanes and more resources become
available, provision of health care would return to established
standards of care used in normal situations.
HHS has issued two guidance documents, Altered Standards of Care in
Mass Casualty Events and Mass Medical Care with Scarce Resources: A
Community Planning Guide, to assist health care facilities to plan for
providing altered standards of care.[Footnote 79] Altered Standards of
Care in Mass Casualty Events provides health care facilities guiding
principles for developing altered standards of care. Additionally, it
includes a discussion of the authority to activate the use of altered
standards of care and the associated legal and regulatory issues,
including the possible need for liability protection for health care
providers and facilities.[Footnote 80] Mass Medical Care with Scarce
Resources expands on the Altered Standards of Care in Mass Casualty
Events report. It provides a discussion of the circumstances that
communities would face as a result of a mass casualty event, approaches
and strategies that could be used to provide the most appropriate
standards of care possible under the circumstances, examples of tools
and resources available to help state and local officials in their
planning process, ethical considerations in planning for a mass
casualty event, and a pandemic case study.
Long-Term Efforts to Increase the Number and Enhance the Preparedness
Level of Health Care Providers:
PAHPA calls for HHS's Assistant Secretary for Preparedness and Response
to lead and coordinate HHS emergency preparedness and response
activities.[Footnote 81] Accordingly, the Assistant Secretary is
engaged in efforts to increase the number and enhance the preparedness
level of health care providers for public health emergencies. As part
of this effort, HHS officials told us that they have begun to examine
issues related to recruitment, retention, and protection of the public
health workforce with the goal of identifying strategies to overcome
workforce shortages. In addition, to encourage health professionals to
enter employment in a state or local public health agency, PAHPA
authorizes HHS to award grants to states to assist in operating public
health workforce loan repayment programs for individuals who serve in
health professional shortage areas or in areas at high risk of a public
health emergency.[Footnote 82]
PAHPA also authorized HHS to develop Centers of Public Health
Preparedness at accredited schools of public health.[Footnote 83] HHS
intends that these centers will help to train and educate health
professionals to prepare for and respond to public health emergencies,
including a pandemic. As part of this effort, CDC will develop core
emergency preparedness and response curriculums, identify performance
goals, and develop health systems research projects. HHS has already
incorporated standardized benchmarks and performance measures into
existing grant programs.[Footnote 84]
HHS Has Provided Guidance to Help State and Local Jurisdictions
Overcome Difficulties with Implementing Nonpharmaceutical
Interventions:
HHS will rely on state and local jurisdictions to utilize
nonpharmaceutical interventions to help slow the spread of disease and
to lessen the burden on the nation's health care system until a
pandemic vaccine is widely available. HHS has developed guidance and is
investing in research on the general use and effectiveness of
nonpharmaceutical interventions, thereby helping jurisdictions make
more informed decisions. According to HHS, the findings from this
research will be used to update existing guidance. However, HHS faces
difficulties in helping state and local jurisdictions overcome
implementation challenges, such as identifying steps for ensuring
community compliance.
HHS Will Rely on State and Local Jurisdictions to Utilize
Nonpharmaceutical Interventions to Help Slow the Spread of Disease:
The authority to implement nonpharmaceutical interventions--such as
decisions on school closures--to slow the spread of disease and lessen
the burden on the nation's health care system until a pandemic vaccine
is available rests with state and local jurisdictions. To assist state
and local authorities with their current planning efforts for using
nonpharmaceutical interventions, HHS published a guidance document in
February 2007--the Interim Pre-pandemic Planning Guidance: Community
Strategy for Pandemic Influenza Mitigation in the United States -
Early, Targeted, Layered Use of Nonpharmaceutical
Interventions.[Footnote 85] HHS officials told us that the
recommendations in the guidance are for pre-pandemic contingency
planning and are intended to provide state and local jurisdictions with
a conceptual framework to guide their planning. In this guidance, HHS
introduces its "community mitigation framework" that is based upon a
targeted, layered strategy involving the direct application of
multiple, partially-effective nonpharmaceutical interventions,
initiated early and maintained consistently throughout a pandemic.
Specifically, HHS's guidance describes four interventions: (1)
isolation (either at home or in a health care setting) and treatment
(as appropriate) with antivirals of all individuals with confirmed or
probable infections; (2) voluntary home quarantine of members of
households exposed to the disease and consideration of combining this
intervention with antivirals, provided sufficient amounts are available
and can readily be distributed; (3) school closures (including public
and private schools as well as colleges and universities) accompanied
by closures of other public settings (e.g., shopping malls and movie
theaters) to prevent out-of-school social contacts; and (4) adult
social distancing to reduce contact among adults in the community and
workplace.
HHS officials and other experts have acknowledged the significance of
implementing certain nonpharmaceutical interventions in order to
maximize the available public health benefit while minimizing adverse
secondary effects of the interventions. Thus, HHS recommends that state
and local jurisdictions consider the severity of the pandemic when
making decisions about how to respond to the outbreak. For example, for
a less severe pandemic, HHS recommends voluntary home isolation of sick
individuals, but generally does not recommend measures that may be more
burdensome, such as voluntary quarantine of exposed household members,
school closures, and adult social distancing. HHS recommends that state
and local jurisdictions implement those additional measures and others
in a more severe pandemic.
Department officials and experts have also stressed the importance of
balancing the need to intervene early enough for nonpharmaceutical
measures to be effective, while at the same time not causing
unnecessary hardship by implementing them too early. HHS and other
federal agencies released guidance in March 2008--the Federal Guidance
to Assist States in Improving State-Level Pandemic Influenza Operating
Plans[Footnote 86]--that included information to assist state and local
jurisdictions in determining when to implement certain
nonpharmaceutical interventions. For example, this guidance recommends
implementing voluntary quarantine and administering antivirals to
individuals exposed to the pandemic virus when a case of novel
influenza is detected in an area, including before sustained human-to-
human transmission has been established.
Once a pandemic is underway, HHS anticipates providing technical
assistance to state and local jurisdictions on the implementation of
nonpharmaceutical interventions. This technical assistance would
include assessing the specific epidemiological characteristics of the
pandemic, such as how the pandemic-causing strain is transmitted, and
consulting with state and local jurisdictions on the effectiveness of
the nonpharmaceutical interventions that had been implemented. Because
it is not possible to accurately predict the severity of a pandemic,
HHS officials told us the recommendations in the guidance may change
significantly during an actual pandemic, based on data HHS gathered
from providing technical assistance as well as from data from initial
outbreak investigations or from routine surveillance systems.
HHS's Guidance on Nonpharmaceutical Interventions Is Based on
Inconclusive Scientific Evidence:
HHS officials acknowledge that the recommendations in its guidance are
not specific because the scientific evidence on the use and
effectiveness of nonpharmaceutical interventions is limited, and
therefore inconclusive. The research to date using mathematical
modeling and analysis of historical data of past pandemics suggests
that utilizing multiple nonpharmaceutical interventions simultaneously
and early in a pandemic may aid in slowing disease
transmission.[Footnote 87] For example, historical studies of the 1918-
19 pandemic describe how some cities reduced death rates by
successfully implementing multiple nonpharmaceutical interventions,
including social distancing, mandated mask wearing, and case
isolation.[Footnote 88] However, because of incomplete historical
records, researchers are not able to determine precisely, where, when,
and for how long these interventions were implemented.
HHS has supported several research initiatives to establish a stronger
evidence base concerning the implementation and effectiveness of
nonpharmaceutical interventions, thereby helping jurisdictions to make
more informed decisions. For example, in October 2006, HHS awarded $5.2
million to support eight research projects on topics ranging from the
role hand hygiene can play in reducing disease transmission to
examining upper respiratory infections in families. According to HHS,
the findings from this research will be used to update existing
guidance. HHS and other experts have stressed the need for additional
research to, for example, better inform the assumptions used in
mathematical models.[Footnote 89] HHS listed other key areas for
further research in its guidance, such as understanding fundamental
questions regarding influenza transmission and the potential
psychosocial effects of certain nonpharmaceutical interventions, such
as prolonged voluntary home quarantine and social distancing.
HHS Faces Difficulties in Assisting State and Local Jurisdictions to
Overcome Implementation Challenges:
HHS faces difficulties in helping state and local jurisdictions
implement nonpharmaceutical interventions. First, as HHS acknowledged
in its guidance, there is the potential for state and local
jurisdictions to implement these interventions in an uncoordinated,
untimely, and inconsistent manner, thereby dramatically reducing their
effectiveness. For example, if one jurisdiction implements a voluntary
quarantine of sick individuals and a neighboring jurisdiction does not,
the overall movement of sick individuals in the area may not be
sufficiently reduced. HHS hopes that state and local jurisdictions will
follow its guidance and act in concert, but HHS cannot compel
jurisdictions to do so.
Second, HHS faces the challenge of helping state and local
jurisdictions identify specific thresholds for implementing and ending
nonpharmaceutical interventions, such as at what point to close
schools. The Federal Guidance to Assist States in Improving State-Level
Pandemic Influenza Operating Plans provides general guidance to state
and local jurisdictions on when to consider beginning to implement
nonpharmaceutical interventions. However, this guidance does not
provide details on when to implement specific interventions. For
example, the guidance recommends state and local officials begin to
consider closing schools when transmission of a pandemic virus occurs,
but does not identify a specific absentee rate at which officials
should take action. Experts have noted that determining specific
triggers is difficult, partly because the data currently available are
imperfect and sparse, requiring decision-makers to make assumptions
regarding the transmission rate of the pandemic-causing strain as well
as the effects of other community behaviors during the pandemic. In
addition, state and local officials generally do not have the
capabilities to collect the data that federal authorities will need to
develop specific triggers during an actual pandemic. For example, one
local official noted that one method of determining specific community
triggers would be to use prevalence rates, which measure the percentage
of the population infected with disease. However, state and local areas
do not have surveillance systems capable of providing this level of
detail in real-time.
Third, HHS faces the challenge of helping state and local jurisdictions
convince residents to comply with its requests regarding
nonpharmaceutical interventions. This task is especially difficult
because restrictions on public activities to combat a pandemic may need
to be in place for several months. During the 1918-19 pandemic,
nonpharmaceutical interventions were implemented for 2 to 8 weeks.
However, researchers have suggested that such interventions would need
to be implemented for a longer period for a future pandemic in order to
prevent another increase in transmission after the interventions are
discontinued.[Footnote 90] In the 1918-19 pandemic, nonpharmaceutical
interventions were lifted. In some cases, the public became fatigued
with the interventions, leading to public opposition and noncompliance
when authorities found it necessary to reimpose the restrictions.
A fourth challenge HHS faces is that these restrictions may have
negative impacts on the nation's economy and on the financial well-
being of individual households. For example, nonpharmaceutical
interventions may exacerbate worker absenteeism as parents stay home to
care for their children when schools are closed. This could eventually
result in disruptions in the provision of essential services, such as
law enforcement. Similarly, lengthy nonpharmaceutical interventions
could financially strain individuals and families. For example, while
an HHS-sponsored study on public perceptions regarding a pandemic found
a generally high willingness to comply with public health
recommendations, it also found a decrease in reported ability to comply
with recommended measures when financial constraints were
considered.[Footnote 91] Thus, 57 percent of respondents said they
would have problems complying with recommended measures because of
financial difficulties if they had to be out of work for 1 month, with
76 percent reporting problems if they had to miss 3 months.
A fifth challenge for HHS is the lack of trust by U.S. citizens of
federal government public health authorities. A recent study found that
only 40 percent of the U.S. population would trust federal government
public health authorities as a source for accurate
information.[Footnote 92] The authors of this study assert that this
lack of trust may have been exacerbated by the public's negative
perceptions of the government's response to Hurricane Katrina in 2005
and that the U.S. population may now be less willing to cooperate with
some public health requirements in the future, including isolation of
sick individuals.
HHS Is Developing Messages and Procedures for Communicating to the
Public during a Pandemic but Challenges Remain:
HHS has made progress by establishing roles, responsibilities, and
procedures for communicating messages to the general public during a
pandemic. HHS has also developed pandemic educational materials to
communicate messages to the general public before and during a pandemic
and has identified ways to disseminate these materials. In addition,
HHS has engaged the general public on pandemic issues to better
understand public perceptions and knowledge. Nonetheless, communicating
sensitive and complex issues to the general public during a pandemic
will be challenging.
Roles, Responsibilities, and Procedures Have Been Established for How
HHS Plans to Communicate with the General Public about a Pandemic:
HHS has assigned roles and responsibilities, and developed procedures,
for how HHS plans to communicate with the general public about a
pandemic. Under the National Response Framework, HHS is the lead
federal agency for public health and medical services, and as such, HHS
is the federal agency responsible for communicating with the general
public about the public health and medical aspects of a pandemic before
and during an outbreak. In addition, the HHS Pandemic Influenza Plan
identified activities that should be undertaken to prepare HHS to
communicate with the general public before and during a pandemic.
In November 2006, HHS completed the U.S. Department of Health and Human
Services Pandemic Influenza Communications Plan which lays out detailed
roles, responsibilities, and procedures to guide HHS communications
with the general public.[Footnote 93] For example, this plan assigned
HHS's Office of the Assistant Secretary for Public Affairs
responsibility for coordinating pandemic health messages across all HHS
agencies and with state and local communications staff in order to
ensure that all HHS agencies work closely together to make public
statements that are timely, consistent, and accurate.
HHS has named spokespersons within HHS to deliver messages to the
public before and during an outbreak.[Footnote 94] HHS has trained
federal, state, local, and private sector public affairs officials to
communicate with the general public about a pandemic. The Crisis and
Emergency Risk Communication training modules developed by HHS clarify
the role of spokespersons, describe the psychology of communicating
during a crisis, and provide best practices for working with the media
during a crisis. HHS has held 10 Crisis and Emergency Risk
Communication training sessions for nearly 500 senior federal officials
and public affairs staff, and 11 regional training sessions for
approximately 900 state and local leaders. Two additional trainings are
scheduled in 2008. HHS also held Crisis and Emergency Risk
Communication training sessions in June 2007 for Red Cross leaders and
in January 2007 for stakeholders. Nearly 900 training sites
participated in these sessions via the Internet.
During a pandemic, the HHS communications effort will operate out of
its Emergency Communications Center. The center's capabilities include
originating or accessing video feeds, news conferencing, posting mass
electronic mailings, responding to media telephone inquiries,
receiving, vetting, and clearing messages to be released by HHS. HHS
will use a departmental public affairs conference line to provide
telephone connections for public affairs staff throughout the
department. These phone connections will allow HHS public affairs
personnel to work from dispersed sites during the crisis, coordinate
messages, receive guidance or direction, and provide information to
those needing it. The DHS National Incident Communications Conference
Line will also be used by HHS to exchange information with other
federal agencies.
In addition, the Office of the Assistant Secretary for Public Affairs
conducts media outreach to strengthen the relationship between the
media and HHS and to support pandemic planning and education. Periodic
briefings are scheduled between senior department officials, including
the HHS Secretary, and members of the press. For example, in early 2007
HHS held a series of roundtable discussions on pandemics with the major
broadcast and cable television networks, wire services, and bloggers to
raise awareness of pandemics; the secretaries of HHS and Department of
Agriculture participated. HHS press-office staff members also talk to
the media regularly to answer questions and provide updates on pandemic
planning and related issues. In January 2007, HHS began holding a
series of tabletop exercises[Footnote 95] with key media leaders and
senior government officials in six major cities to facilitate effective
communication to help insure the timely dissemination of accurate
information to the general public through the use of media outlets
during a pandemic.
HHS Has Developed Pandemic Educational Materials to Communicate
Messages to the General Public before and during a Pandemic:
HHS has developed and disseminated educational materials for
communicating critical information to the general public and is in the
process of developing additional materials. HHS has identified some of
the critical information that the general public will require during a
pandemic and has developed message maps--communications tools used to
help organize complex information--to convey that information in a
concise format before an outbreak. HHS has developed 82 message maps.
HHS's message maps are each designed to distill three primary, easily
understood messages on issues such as the differences between avian
influenza, pandemic influenza, and seasonal influenza, as well as what
HHS is doing to prepare for a pandemic. Each of these primary messages
has three supporting messages that can be used as appropriate to
provide context for the issue being mapped.[Footnote 96] HHS message
maps take the form of a series of questions and answers and are made
public so that spokespersons from across the government or from private
organizations can use the maps to convey accurate and consistent
background information to their constituents before an outbreak. Table
4 shows an example of an HHS message map.
Table 4: Example of an HHS Message Map:
1;
How fast would pandemic influenza spread?: * When a pandemic influenza
begins, it is likely to spread very rapidly;
* Influenza is a contagious disease of the lungs;
* Influenza usually spreads by infected people coughing and sneezing;
* Most people will have little or no immunity to pandemic influenza.
2;
How fast would pandemic influenza spread?: * Efforts to prepare for
pandemic influenza are continuing;
* Public health officials are building on existing disease outbreak
plans, including those developed for SARS;
* Researchers are working to produce additional vaccine more quickly;
* Countries are working together to improve detection and tracking of
influenza viruses.
3;
How fast would pandemic influenza spread?: * Public participation and
cooperation will be important to the response effort;
* Severe pandemic influenza could produce changes in daily life,
including limits on travel and public gatherings;
* Informed public participation and cooperation will help public health
efforts;
* People should stay informed about pandemic influenza and be prepared
as they would for any emergency.
Source: HHS.
Note: HHS Pandemic Influenza Pre-Event Message Maps, Washington, D.C.,
2006.
[End of table]
HHS has several means of disseminating information regarding a
pandemic. HHS manages [hyperlink, http://www.pandemicflu.gov], the
official U.S. government Web site for disseminating information on
pandemics to the public before and during a pandemic. The Web site is
updated with new information as it becomes available and provides the
public, public health and emergency preparedness officials, government
and business leaders, school systems, and local communities with
comprehensive governmentwide information on a pandemic. In addition,
HHS will use a variety of other information systems to distribute
pandemic information including telephone hotlines, such as 1-800-CDC-
INFO; educational sessions through teleconferencing, such as the
Clinician Outreach and Communication Activity to which the public can
call-in; satellite informational broadcasts; and radio and television
public service announcements.
HHS has developed public service announcements for use on television
and radio that urge the general public to learn about and prepare for a
pandemic and has created an archive of materials--video footage,
posters, and fact sheets--for conveying key pandemic messages to the
general public. HHS also has developed planning checklists for specific
audiences--such as medical providers, schools, and businesses--to raise
awareness and to assist these audiences in preparing for a
pandemic.[Footnote 97] For example, the planning checklists identify
issues that should be considered, such as storing additional infection
control supplies (such as hand cleansing products and tissues);
establishing pandemic-specific policies, procedures, and roles and
responsibilities; planning to maintain continuity of operations;
coordinating activities with local stakeholders; practicing infection
control; and developing communications plans.
Despite HHS's Preparations, Communicating with the General Public
during a Pandemic Will Be Challenging:
HHS officials told us that communicating messages to the general public
during a pandemic will be challenging despite the department's
preparations. The first challenge is that a pandemic will create an
immediate, intense, and sustained demand for information from both the
general public and the groups to whom the public will be turning for
information, such as the media and health care community. In addition,
the general public will likely turn to numerous sources other than HHS
for information, including other federal agencies, state and local
authorities, the media, health care providers, the Internet, hotlines,
employers, peers, family, and community leaders. HHS will not be able
to ensure that messages delivered to the general public by non-HHS
entities are coordinated and consistent with HHS messages, and the
communications may cause confuse the general public.[Footnote 98]
A second challenge concerns the public's reception to HHS's
communications. HHS has found a low level of public understanding on
pandemic issues, some unwillingness to comply under certain
circumstances with the messages that HHS plans to deliver, and anxiety
over particular messages (such as why pre-pandemic vaccines and some
antivirals will not be made available to the general public). For
example, a nationally representative survey on pandemic issues found
that 58 percent of the general public in the United States did not know
what a pandemic is.[Footnote 99] The survey also found that the public
is less willing or is unable to follow some of the recommendations that
HHS plans to communicate during a pandemic. For example, HHS plans to
recommend that sick individuals who do not require hospital care
observe voluntary home isolation and treatment; however, 24 percent of
the people surveyed said that they did not have someone to take care of
them in their homes. The same study also found that 35 percent of
respondents would go to work if requested by their employer even if
public health officials recommended that people stay at home during a
pandemic.
Furthermore, HHS tabletop exercises have identified several issues that
will prove challenging when communicating with the public during a
pandemic, particularly the sensitivity of certain messages, the use of
specialized public health terms in the messages, and the inadequacy of
HHS message maps to address the complexity of the issues being
communicated. Discussions during these tabletop exercises will help HHS
to develop plans to resolve these identified challenges. For example,
HHS's messages will have to communicate clearly the difference between
specialized terms such as isolation and quarantine, and the meaning of
the phrase "altered standards of care." Because of the complexity of
the issues in its message maps, HHS plans to develop additional
educational materials to distribute to the public before a pandemic in
order to make these complexities more comprehensible.
Conclusions:
Although HHS has made progress in identifying issues that need to be
addressed and in funding research and vaccine production, significant
challenges remain, many of which are beyond HHS's control or which
cannot be quickly addressed. Such challenges include coping with the
potentially high absentee rate among health care providers during a
pandemic and the length of time it will take to develop a pandemic
vaccine once the virus is identified. One important activity, however,
that is within HHS's control that HHS could address before a pandemic
is finalizing the guidance on how limited pharmaceutical interventions
should be used during a pandemic.
A severe pandemic, such as that of 1918-19, has the potential to result
in widespread illness and death and is expected to overwhelm the
nation's ability to respond. According to HHS, initial batches of the
most effective protective measure--a pandemic vaccine--may take as long
as 20 to 23 weeks after the start of the pandemic to become available.
Although the federal government has provided some guidance, final
decisionmaking will fall on state and local officials who will have to
decide how to allocate pharmaceutical interventions and whom
interventions should go to first, and when.
HHS, in consultation with other federal agencies, has been tasked with
revising guidance to assist state and local jurisdictions in
identifying groups that should be considered a priority for receiving
limited pharmaceutical interventions. In 2008, HHS released guidance on
prioritizing target groups for pandemic vaccine and draft guidance for
public comment on how antivirals may be used during a pandemic.
However, HHS has not yet released draft guidance for public comment on
prioritizing target groups for pre-pandemic vaccine. We and others have
reported since 2000 how problems related to pandemic planning--such as
those problems with the distribution and administration of
pharmaceutical interventions--can arise if target groups are not
established in advance. This lack of essential information could slow
the initial response at the state and local levels and complicate the
general public's understanding of the necessity for rationing these
interventions. Additionally, the general public should continue to be
engaged in the process of priority setting, as public participation is
an essential component for acceptance of tough decisions that will be
required unless and until greater capacity or a universal vaccine can
be developed.
Recommendation for Executive Action:
To improve the nation's preparedness for a pandemic, we are
recommending that the Secretary of HHS expeditiously finalize guidance
to assist state and local jurisdictions to determine how to effectively
use limited supplies of antivirals and pre-pandemic vaccine in a
pandemic, including prioritizing target groups for pre-pandemic
vaccine.
Agency Comments and Our Evaluation:
HHS provided written comments on a draft of this report which we have
reproduced in appendix III. HHS also provided technical comments, which
we have incorporated as appropriate.
In its comments, HHS noted that it has taken and plans to take
additional actions related to our recommendation since we provided the
draft report to the department for its review. HHS indicated that the
final guidance for pandemic vaccine allocation was released on July 23,
2008, and that this guidance describes the groups who should be
targeted and prioritized for receiving pandemic vaccine. HHS also
indicated that the department released draft guidance on how antivirals
may be used during a pandemic in June 2008, and that HHS will release
for public comment proposed draft guidance on pre-pandemic vaccine
allocation in the near future. We updated the text of the report to
reflect these developments. We also revised the wording of our
recommendation in light of HHS's comment that HHS recommends that
antivirals in public-sector stockpiles should be used primarily for the
treatment of individuals sick with influenza. We first identified the
need for finalized guidance on how limited pharmaceutical interventions
should be used during a pandemic, including target groups where
appropriate, in 2000. We believe that finalizing guidance on the use of
pharmaceutical interventions will be crucial for responding to a
pandemic outbreak and that the necessary guidance documents should be
finalized as soon as possible.
Throughout its comments, HHS described aspects of its pandemic
preparedness activities that it believed could be presented more
clearly in our report and presented additional details about its
activities. We have revised the language in the report to reflect HHS's
comments where it was necessary. In particular, we revised our
discussion of pharmaceutical interventions to clarify our presentation
of the three types of pharmaceuticals and how pre-pandemic vaccine will
be distributed and administered during a pandemic. We also revised the
report to reflect HHS's objection to our statement that the use of
antivirals early in a pandemic could slow the spread of the pandemic.
HHS commented that the magnitude of the impact of pharmaceuticals on
pandemic spread is uncertain given "...limited countermeasure supplies,
unclear effectiveness, and operational challenges—"
Many of HHS's comments addressed the scope of the department's actions
in relation to the responsibilities of states and local jurisdictions.
For example, HHS noted that it will directly oversee the administration
of pre-pandemic vaccine to members of the critical workforce, rather
than fully delegate that task. For antivirals, HHS agreed that states
are free to administer antivirals in their own stockpiles to anyone
they like, but also noted that state plans have been reviewed by CDC to
ensure that the plans reflect the national recommendation to use
antivirals primarily for treatment of individuals sick with influenza.
Thirdly, HHS emphasized that health care personnel surge capacity in a
pandemic is a local responsibility. Although the 2005 HHS Pandemic
Influenza Plan recommends deployment of federal medical responders to
supplement the number of health care providers, HHS noted that the
federal government does not have adequate health care personnel to
provide surge capacity. On that topic, HHS also noted that its planning
documents for allocating scarce health care resources were intended as
"—planning documents for consideration by communities, not for the
purposes of establishing definitive standards."
Finally, HHS proposed alternate terms for some of the concepts in our
report (we have noted these instances in the report). For example, HHS
disagreed with our use of the term "altered standards of care" and said
that the more appropriate term is "standards of care appropriate to the
situation." Because we believe that "altered standards of care" is an
accurate description of what may happen as the result of the allocation
of scarce health care resources in a pandemic emergency and because HHS
used this phrase in its guidance to state and local jurisdictions, we
did not make this change.
We are sending copies of this report to the Secretary of HHS and to
interested congressional committees. We will also make copies available
to others on request. In addition, the report will be available at no
charge on GAO's Web site at http://www.gao.gov.
If you or your staff have any questions about this report, please
contact me 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 IV.
Signed by:
Marcia Crosse Director, Health Care:
[End of section]
Appendix I: Summaries of Select Federal Documents Relevant for
Preparing for and Responding to Influenza Pandemic:
National Response Framework:
The National Response Framework lays out, in part, the manner in which
the federal government responds to domestic incidents.[Footnote 100]
The plan is a guide for an all-hazards response, categorizing the types
of federal assistance into specific emergency support functions.
Primary and supporting agencies are listed for each emergency support
function. "Emergency Support Function #8 - Public Health and Medical
Services Annex" of the National Response Framework directs the
Department of Health and Human Services (HHS) to provide support as the
primary agency, with 16 other agencies, including the Departments of
Homeland Security and Agriculture.
The National Response Framework replaced the National Response Plan in
March 2008, which, in turn, replaced the Federal Response Plan in April
2005. The Federal Response Plan, originally drafted in 1992 and revised
in 1999, established the process and structure for the federal
government's provision of assistance in response to any major disaster
or emergency declared under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act (Stafford Act). The purpose of the Stafford
Act is "to provide an orderly and continuing means of assistance by the
federal government to state and local governments in carrying out their
responsibilities to alleviate the suffering and damage which result"
from disasters and emergencies.[Footnote 101]
National Strategy for Pandemic Influenza:
On November 1, 2005, the President of the United States released the
National Strategy for Pandemic Influenza, which provides a framework
for future planning efforts for how the country will prepare for,
detect, and respond to an influenza pandemic.[Footnote 102] The
strategy reflects the federal government's approach to the pandemic
threat and is based on three main types of activities: (1) preparedness
and communication, (2) surveillance and detection, and (3) response and
containment.
National Strategy for Pandemic Influenza Implementation Plan:
On May 3, 2006, the President of the United States released the
National Strategy for Pandemic Influenza Implementation Plan, which
further clarifies the roles and responsibilities of governmental and
nongovernmental entities--including federal, state, local, and tribal
authorities and regional, national, and international stakeholders--
and provides preparedness guidance for all segments of
society.[Footnote 103] This plan addresses the following topics: U.S.
government planning and response; international efforts and
transportation and borders; protecting human health; protecting animal
health; law enforcement, public safety, and security; and institutional
considerations. The federal government has identified approximately 300
action items to address the threat of a pandemic. These items include
199 action items led or co-led by HHS. As stated in the plan's preface,
the plan will be reviewed on a continuous basis and revised as
appropriate to reflect changes in the understanding of the threat and
the development of new technologies.
Since the release of the implementation plan, the Homeland Security
Council released the National Strategy for Pandemic Influenza
Implementation Plan One Year Summary on July 17, 2007.[Footnote 104]
This document summarizes the federal government's efforts to prepare
for an influenza pandemic.
HHS Pandemic Influenza Plan:
Because HHS has primary responsibility for coordinating the nation's
response to public health emergencies under "Emergency Support Function
#8," the department has developed the HHS Pandemic Influenza
Plan.[Footnote 105] The first part of this plan provides HHS's
strategic plan for dealing with an influenza pandemic. This includes
information on recommendations on the use of vaccines and antivirals,
legal authorities, key HHS activities, HHS research activities, and
international partnerships on avian and pandemic influenza. Preparing
for and responding to a pandemic will not be purely a federal
responsibility; it will primarily be a local response. And because a
pandemic is likely to occur in multiple areas simultaneously, resources
cannot be geographically shifted as is often done with other
emergencies; every community will need to rely on its own planning and
resources to respond to the outbreak. Therefore, the second part of the
HHS Pandemic Influenza Plan consists of 11 supplements that provide
guidance to state and local officials on response elements necessary
for preparation for a pandemic (see table 5).
Table 5: Response Elements Needed for Preparing for and Responding to
an Influenza Pandemic and Examples of Priority Activities for Each
Response Element:
Response elements: Pandemic influenza disease surveillance;
Examples of priority activities: * Health departments provide weekly
reports on the overall level of influenza in their states and
territories;
* State and local officials implement virologic, outpatient, hospital,
and mortality surveillance.
Response elements: Laboratory diagnostics;
Examples of priority activities: * Clinical and hospital laboratories
work with state and local health departments to train personnel in
management of respiratory specimens during an influenza pandemic;
* Clinical and hospital laboratories will send selected specimens from
possible pandemic influenza patients to state or local health
departments.
Response elements: Healthcare planning;
Examples of priority activities: * Healthcare facilities' officials
will develop planning and decision-making structures for responding to
pandemic influenza;
* Healthcare facilities' officials will identify and isolate all
potential patients with pandemic influenza.
Response elements: Infection control;
Examples of priority activities:
* Patients with known or suspected pandemic influenza should be
isolated for a minimum of 5 days from the onset of symptoms;
* Follow standard facility procedures for post-discharge cleaning of an
isolation room.
Response elements: Clinical guidelines;
Examples of priority activities: * State and local public health
agencies will help educate health care providers about pandemic
influenza;
* Health care providers will report pandemic influenza cases or
fatalities as requested by health departments.
Response elements: Vaccine distribution and use;
Examples of priority activities: * HHS agencies will work with
manufacturers to expedite public-sector vaccine purchasing contracts
during a pandemic;
* HHS agencies will revise recommendations on vaccination of priority
groups, guided by epidemiologic information about the pandemic virus.
Response elements: Antiviral drug distribution and use;
Examples of priority activities: * HHS, in concert with the Congress
and in collaboration with the states in advance of an influenza
pandemic, will acquire sufficient quantities of antivirals to treat 25
percent of the U.S. population;
* HHS will revise recommendations for treatment and prophylaxis with
antivirals for priority groups, if necessary, guided by accumulating
data about the pandemic virus.
Response elements: Community disease control and prevention;
Examples of priority activities: * Community officials will help
identify potential isolation and quarantine facilities;
* Community officials will help ensure that legal authorities and
procedures exist for various levels of movement restrictions.
Response elements: Management of travel-related risk of disease
transmission;
Examples of priority activities: * State and local officials will work
with the Centers for Disease Control and Prevention quarantine stations
and federal partners to evaluate and manage arriving ill passengers who
might be infected with influenza strains with pandemic potential;
* State and local officials will evaluate the need to implement or
terminate travel-related containment measures as the pandemic evolves.
Response elements: Public health communications;
Examples of priority activities: * State and local officials will
assess and monitor readiness to meet communications needs in
preparation for an influenza pandemic, including regular review and
update of communications plans;
* State and local officials will tailor communications services and key
messages to specific local audiences.
Response elements: Psychosocial workforce support services;
Examples of priority activities: * HHS agencies will create, collect,
and provide educational and training materials on psychosocial issues
related to pandemic influenza for use by hospital administrators,
emergency department staff, safety and security professionals,
behavioral health providers, social workers, psychologists, chaplains,
and others; * Health care institutions, state and local agencies, first
responder organizations, and employers of essential service workers
will provide psychological and social support services for employees
and their families.
Source: HHS.
Note: HHS Pandemic Influenza Plan, Washington, D.C., Nov. 2005.
[End of table]
The third part of the plan, which details the critical actions items
for which HHS has the lead as described in the National Strategy for
Pandemic Influenza Implementation Plan, was produced as a separate
plan--the Pandemic Influenza Implementation Plan--and was released in
November 2006.[Footnote 106] The Pandemic Influenza Implementation Plan
also includes a second part that contains the HHS agencies' operational
plans.
The HHS Pandemic Influenza Plan will be reviewed on a continuous basis
and revised as appropriate to reflect changes in the understanding of
the threat and new technologies. HHS has released five updates
regarding the progress of the department's preparedness efforts on
March 13, 2006; June 29, 2006; November 13, 2006; July 18, 2007; and
March 17, 2008, respectively.
Homeland Security Presidential Directive-21: Public Health and Medical
Preparedness:
On October 18, 2007, the President of the United States released the
Homeland Security Presidential Directive-21: Public Health and Medical
Preparedness,[Footnote 107] which provides a strategy for protecting
the health of the U.S. population against all disasters, including a
pandemic. This directive describes four critical components of public
health and medical preparedness: biosurveillance, countermeasure
distribution (including pharmaceuticals), mass casualty care, and
community resilience. All four critical components will include
coordination of efforts at the federal, state, and local levels, as
well as with private sector, public health, and medical disaster
response resources.
Guidance on Allocating and Targeting Pandemic Influenza Vaccine:
On July 23, 2008, HHS, in coordination with DHS, released the Guidance
on Allocating and Targeting Pandemic Influenza Vaccine.[Footnote 108]
This guidance provides a framework to state and local jurisdictions on
how to allocate limited supplies of pandemic vaccine to targeted
groups, with the goal of providing this vaccine to all who choose to
receive it. According to the guidance, groups targeted for vaccination
varies depending on the severity of the pandemic.
[End of section]
Appendix II: HHS Activities for Acquiring Pharmaceutical Interventions
for an Influenza Pandemic within the United States:
According to HHS officials, it is important to have a stockpile of
pharmaceutical interventions, when possible, for use during the early
stages of a pandemic. HHS allotted portions of its total fiscal year
2006 appropriation for pandemic-related purposes--$5.683 billion--to
the acquisition and development of pharmaceutical
interventions.[Footnote 109] Specifically, approximately $1.1 billion
was targeted for investment in antivirals and approximately $3.2
billion was dedicated for vaccines.[Footnote 110] HHS has also
established goals for amounts of pharmaceutical interventions to be
stockpiled nationally (see table 6).
Table 6: HHS Goals for Amounts of Pharmaceutical Interventions to Be
Stockpiled Nationally:
Antiviral goal 1: Antiviral goal 2;
To provide 75 million treatment courses of antivirals: 6 million
treatment courses.
Antiviral goal 1: Vaccine goal 1;
To provide 75 million treatment courses of antivirals: To establish and
maintain a pre-pandemic influenza vaccine stockpile sufficient for 20
million persons[A] (at 2 doses per person).
Antiviral goal 1: Vaccine goal 2;
To provide 75 million treatment courses of antivirals: To provide
pandemic vaccine to all U.S.-600 million doses of pandemic vaccine.
Source: HHS.
Note: Statement by Gerald W. Parker, Principle Deputy Assistant
Secretary, Office of the Assistant Secretary for Preparedness and
Response on Pandemic Influenza Preparedness: Update on the Development
and Acquisition of Medical Countermeasures before the Committee on
Appropriations, Subcommittee on Labor, Health and Human Services,
Education, and Related Agencies, U.S. Senate, Jan. 24, 2007.
[A] In May 2006, the Secretaries of HHS and DHS tasked the National
Infrastructure Advisory Council with, among other things, providing
recommendations regarding the prioritization and distribution of
pharmaceutical countermeasures to the critical workforce. According to
this Council's report, the number of the most essential critical
infrastructure workers is approximately 12 million. See National
Infrastructure Advisory Council, The Prioritization of Critical
Infrastructure for a Pandemic Outbreak in the United States Working
Group: Final Report and Recommendations by the Council. Washington,
D.C.: Jan. 16, 2007. According to HHS, the 20 million people in the
critical workforce include the approximately 12 million identified by
the National Infrastructure Advisory Council as the most critical as
well as other essential personnel such as military personnel, including
the National Guard and critical government workers, such as border
protection personnel.
[End of table]
HHS has invested millions of dollars into the stockpiling of antivirals
to achieve its two goals for antivirals. Table 7 summarizes the
approximate number of courses stockpiled as of May 2008. In addition,
in March 2006, HHS allotted $200 million dollars to the development of
additional antivirals, and in January 2007, the department awarded a 4-
year contract of about $103 million for further development of the new
antiviral peramivir.
Table 7: Approximate Number of Treatment Courses of Antivirals in the
Strategic National Stockpile as of May 2008:
Antivirals: Neuraminidase inhibitors: Oseltamivir (Tamiflu);
Approximate number of treatment courses available: 40 million.
Antivirals: Neuraminidase inhibitors: Zanamivir (Relenza);
Approximate number of treatment courses available: 10 million.
Source: HHS.
[End of table]
HHS has also awarded contracts to purchase pre-pandemic vaccines from
manufacturers to add to the federal stockpile. See table 8 for HHS's
efforts to stockpile pre-pandemic vaccines. HHS officials told us that
the greatest challenge to preparing for an influenza pandemic and
implementing its plans for using pharmaceutical interventions is the
lack of vaccine manufacturing capacity within the United States. We
found in prior work that the lack of U.S. vaccine manufacturing
capacity is cause for concern among experts because it is possible that
countries without domestic manufacturing capacity will not have access
to vaccines in the event of a pandemic if the countries with domestic
manufacturing capacity prohibit the export of the pandemic vaccine
until their own needs are met.[Footnote 111]
Table 8: HHS Efforts to Acquire Pre-Pandemic Vaccine as of August 2007:
Viral strain for pre-pandemic vaccine: H5N1 Vaccine Clade 1[A]
(2004)[B]; Number of awarded contracts: 1;
Value of awarded contracts: $21 million;
Duration of contracts: 2004-08;
Goals: Provide 0.47 million doses at 90 micrograms (mcg.) per dose;
Progress: As of May 2008, HHS has stockpiled enough of this pre-
pandemic vaccine for at least 13 million people or 26 million doses.
Viral strain for pre-pandemic vaccine: H5N1 Vaccine Clade 1 (2005);
Number of awarded contracts: 2;
Value of awarded contracts: $243 million;
Duration of contracts: 2005-08;
Goals: Provide 8 million doses at 90 mcg. per dose;
Progress: As of May 2008, HHS has stockpiled enough of this pre-
pandemic vaccine for at least 13 million people or 26 million doses.
Viral strain for pre-pandemic vaccine: H5N1 Vaccine Clade 2 (2006);
Number of awarded contracts: 3;
Value of awarded contracts: $241 million;
Duration of contracts: 2006-08;
Goals: Provide 4.9 million doses at 90 mcg. per dose;
Progress: As August 2007, HHS has stockpiled enough vaccine for 3
million people or approximately 6 million doses.
Viral strain for pre-pandemic vaccine: H5N1 Vaccine (2007);
Number of awarded contracts: To be determined;
Value of awarded contracts: To be determined;
Duration of contracts: Intended to cover 2007-09;
Goals: Intended to provide doses for pre-pandemic stockpile using H5N1;
Progress: Not applicable.
Source: GAO analysis of HHS data.
[A] Clades refer to different circulating viral strains of a single
virus. For example, researchers have divided the H5N1 avian influenza
virus into 2 clades - clade 1 refers to the H5N1 virus strain
circulating in Cambodia, Lao People's Democratic Republic, Malaysia,
and Vietnam, while clade 2 refers to the H5N1 virus strain circulating
in Africa, Europe, Indonesia, and the People's Republic of China.
[B] In April 2007, HHS announced that the Food and Drug Administration
licensed the first vaccine based on the 2004 H5N1 strain for humans in
the United States.
[End of table]
Table 9 describes other HHS initiatives to establish domestic
manufacturing infrastructure for vaccine production.
Table 9: HHS Efforts in Establishing Domestic Infrastructure for
Vaccine Manufacturing as of June 2007:
Project: Retrofit existing manufacturing facilities;
Number of awarded contracts: 2;
Value of awarded contracts: $132.5 million;
Duration of contracts: 2007-13;
Goals: * Increase domestic influenza vaccine capacity to produce 125
million doses of egg-based pandemic vaccine;
Progress: * In June 2007, HHS announced it had awarded contracts to
provide funding for renovation of domestic manufacturing facilities and
for providing warm-base operations for manufacturing pandemic
vaccines.[A] Once operational, these facilities are expected to expand
domestic pandemic vaccine manufacturing capacity by 16 percent.
Project: Build new cell-based vaccine facilities;
Number of awarded contracts: Request for Proposal expected in fiscal
year 2007;
Value of awarded contracts: To be determined;
Duration of contracts: Intended to cover 2008-13;
Goals: * Intended for the building of domestic cell- based influenza
manufacturing capacity to support pandemic needs;
Progress: * Not applicable.
Source: GAO analysis of HHS data.
[A] In warm-base operations, the contractor provides year-round vaccine
production.
[End of table]
Other HHS activities to enhance domestic vaccine manufacturing capacity
include investing in vaccine development and research. For example, HHS
has invested over $1 billion in development of a cell-based approach to
influenza vaccine manufacturing, which it claims will modernize the
current egg-based production process (see table 10). The current
manufacturing process uses chicken eggs, and egg-based vaccines can
easily become contaminated. Cell-based technology does not have these
sterility issues and allows for faster development and greater
production capacity. Although cell-based vaccine production has been
used for other vaccines, it has not been approved for use in developing
influenza vaccines. However, according to HHS, it anticipates that a
licensed cell-based influenza vaccine will be manufactured in 2010.
Also, in January 2007, HHS awarded contracts totaling approximately
$133 million to vaccine manufacturers for development of pre-pandemic
vaccines, containing adjuvants--substances that may be added to a
vaccine to increase the body's immune response, thereby necessitating a
lower dose of vaccine.
Table 10: HHS Progress on Vaccine Development Projects:
Project: Egg-based supply;
Number of awarded contracts: 1;
Value of awarded contracts: $43 million;
Duration of contracts: 2004-2008;
Goals: * Provide year-round egg supply for influenza vaccine
manufacturing;
* Provide vaccines for use in clinical studies;
* Stockpile other vaccine manufacturing supplies, such as vials, caps,
and stoppers;
* Develop and manufacture pandemic vaccine candidates for clinical
investigation;
Progress: * In April 2005, a secure year-round egg supply for domestic
influenza vaccine manufacturing was established;
* Two pandemic vaccine candidates – H5N1 clade 2 and H7N7 - have been
produced for clinical investigations.
Project: Cell-based vaccine;
Number of awarded contracts: 6;
Value of awarded contracts: $1.1 billion;
Duration of contracts: 2005-2011;
Goals: * Expand domestic influenza manufacturing capacity;
* Establish capacity to produce 475 million doses of pandemic vaccine
by 2013;
* Require commitments from manufacturers to establish U.S.-based
manufacturing facilities with vaccine producing capacity of at least
150 million doses within 6 months of a pandemic;
Progress: * As of January 2007, six manufacturers were in Phase 1
clinical trials[A] in the United States using cell-based production
methods.
Project: Adjuvant-containing[B] vaccine;
Number of awarded contracts: 3;
Value of awarded contracts: $133 million;
Duration of contracts: 2007-2012;
Goals: * Reduce amount of vaccine needed in order to increase the
number of doses that can be produced;
* Support further development of adjuvant-containing vaccine for U.S.
licensure;
Progress: * Initial studies have shown that addition of adjuvants to
H5N1 vaccines have reduced 10-to-20 fold the amount of antigen needed
per dose in order to stimulate an immune response believed to be
acceptable during a pandemic.
Goals: * Require each company to build capacity to produce within 6
months of the onset of a pandemic either (1) 150 million doses of a
pandemic vaccine containing adjuvant or (2) enough adjuvant to be
stockpiled for 150 million doses of a pandemic vaccine;
* Require each company to provide its proprietary adjuvant for U.S.
government-sponsored, independent evaluation with influenza vaccines
from other manufacturers;
Progress: generation[D]: * Phase 1 and 2 clinical studies[C] are
planned in 2007 with three new adjuvants.
Project: Next generation[D];
Number of awarded contracts: Request for Proposal in fiscal year 2007;
Value of awarded contracts: To be determined;
Duration of contracts: 2007-2012;
Goals: * Diversify influenza vaccine manufacturing;
* Reduce manufacturing time;
Progress:
* Not Applicable.
Source: GAO analysis of HHS data.
[A] Clinical trials test potential treatments in human volunteers to
see if they should be approved for wider use in the general population.
In Phase 1 trials, researchers attempt to determine dosing, document
how a drug is metabolized and excreted, and identify acute side
effects. Usually, a small number of healthy volunteers (between 20 and
80) are used in Phase 1 trials.
[B] Adjuvants are substances that may be added to a vaccine to increase
the body's immune response to the vaccine's active ingredient, called
an antigen.
[C] Phase 2 trials include more participants (about 100-300) who have
the disease or condition that the product potentially could treat. In
Phase 2 trials, researchers seek to gather further safety data and
preliminary evidence of the drug's beneficial effects (efficacy), and
they develop and refine research methods for future trials with this
drug.
[D] Next generation vaccines refer to vaccines, such as DNA vaccines,
developed using new technologies.
[End of table]
[End of section]
Appendix III: Comments From The Department Of Health And Human
Services:
The Secretary Of Health And Human Services:
Washington, DC 20201:
August 7 2008:
Marcia Crosse:
Director, Health Care:
U.S. Government Accountability Office:
441 G Street, N.W.:
Washington, D.C. 20548:
Dear Ms. Crosse:
Enclosed are the comments of the U.S. Department of Health and Human
Services (HHS) on the Government Accountability Office's (GAO) draft
report entitled: "Influenza Pandemic: HHS Needs to Continue Its Actions
and Finalize Guidance for Pharmaceutical intervention" (GAO 08-671).
The Department appreciates the opportunity to comment on this draft
before its publication.
Sincerely,
Signed by:
Jennifer R. Luong:
for:
Vincent R. Ventimiglia, Jr.:
Assistant Secretary for Legislation:
Enclosure:
General Comments Of The US Department Of Health And Human Services
(HHS) On The Government Accountability Office's (GAO) Draft Report
Entitled: "Influenza Pandemic: HHS Needs To Continue Its Actions And
Finalize Guidance For Pharmaceutical Interventions" (GAO 08-671):
General Comments ” Overview:
The Department of Health and Human Services (HHS) appreciates the
opportunity to comment on the above-referenced Government
Accountability Office (GAO) draft report.
In the draft report HHS was given to review, GAO recommended that ".the
Secretary of HHS expeditiously issue final guidance to assist state and
local jurisdictions in identifying target groups for receiving supplies
of pandemic vaccine, antivirals, and pre-pandemic vaccine." On July 23,
2008, HHS and DHS released final guidance on pandemic vaccine
allocation. This Guidance on Allocating and Targeting Pandemic
Influenza Vaccine provides a planning framework to help state, tribal,
local and community leaders ensure that vaccine allocation and use will
reduce the impact of a pandemic on public health and minimize
disruption to society and the economy. The guidance's vaccination
structure defines four broad target groups: people who 1) maintain
homeland and national security, 2) provide health care and community
support services, 3) maintain critical infrastructure and 4) are in the
general population. Everyone in the United States is included in at
least one vaccination target group. People who are not included in any
occupational group would be vaccinated as part of the general
population based on their age and health status.
In the near future HHS will release for public comment proposed
guidance on pre-pandemic vaccine allocation.
In June 2008, HHS released for public comment three draft guidance
documents related to antiviral drugs and respiratory protection
devices: Proposed Guidance on Antiviral Drug Use during an Influenza
Pandemic, Proposed Considerations for Antiviral Drug Stockpiling by
Employers In Preparation for an Influenza Pandemic and Interim guidance
on the use and purchase of facemasks and respirators by individuals and
families, for pandemic influenza preparedness. HHS is now updating
these three guidance documents based on comments submitted by the
public.
General Comments ” Supplementary Information to Be Considered:
Medical Countermeasures:
The GAO draft report incorrectly asserts that the use of vaccines and
antiviral drugs early in an influenza pandemic is to slow the spread of
the pandemic. While there is some modeling work that suggests that the
use of vaccines or antiviral prophylaxis might have such an effect, a
2006 Institute of Medicine report pointed out the uncertainties
associated with the predictive ability of pandemic influenza modeling.
HHS strategies for vaccination and antiviral treatment are predicated
on their direct effects in reducing the health, societal and economic
impacts of a pandemic. Uncertainties regarding the magnitude of impact
on pandemic spread given limited countermeasure supplies, unclear
effectiveness and operational challenges support the recommended
approach.
HHS vaccine prioritization guidance, in addition to being firmly rooted
in the most up-to-date scientific information available, also directly
reflects the values of our society and the ethical issues involved in
planning a phased approach to pandemic vaccination. As a key part of
developing the guidance, HHS held day-long public engagement and
stakeholder meetings throughout the country and received more than 200
written public comments on the goals and objectives of pandemic
vaccination. In all the meetings, stakeholders and the public
identified the same four vaccination program objectives as the most
important:
* Protect persons critical to the pandemic response and who provide
care for persons with pandemic illness,
* Protect persons who provide essential community services,
* Protect persons who are at high risk of infection because of their
occupation, and:
* Protect children.
Using pandemic vaccine to slow the spread of a pandemic also was
considered but was rated by the public and stakeholders as a less
important objective.
It is important to distinguish HHS policies for the use of antiviral
drugs in public stockpiles from what it has proposed for private sector
stockpiles in Proposed Guidance on Antiviral Drug Use during an
Influenza Pandemic and Proposed Considerations. for Antiviral Drug
Stockpiling by Employers In Preparation for an Influenza Pandemic. As
published in the HHS Pandemic Influenza Plan and the Implementation
Plan. for the National Strategy public sector stockpiles are intended
to be used primarily for the treatment of ill individuals. Stockpile
targets were estimated based on the expected demand for treatment.
Treatment should be based on medical need and is not intended to be
allocated to target groups. In contrast, prophylactic antiviral drug
use in the proposed guidance and the guidance to employers outlines
occupational target groups that could be covered by private sector
stockpiles of antiviral drugs. The national stockpiling goal in support
of treatment is a combined (between Federal and Project Area
stockpiles) total of 75 million treatment regimens. HHS has stockpiled
an additional 6 million regimens of antiviral drugs to assist in
containment activities; these antiviral drugs may be used for both
treatment and prophylaxis and combined with the treatment stockpiles
round out our national goal of 81 million stockpiled regimens.
The GAO draft report discusses that State and Territorial stockpiles of
antiviral drugs, purchased in support of the HHS-established goal of 31
million state-owned treatment regimens, will not be in Federal hands,
and therefore, jurisdictions may choose to use these public stockpiles
of antiviral drugs for prophylaxis rather than for treatment. State
pandemic plans, which have been reviewed by CDC for compliance with
national guidance recommendations, focus on using antiviral drugs for
treatment, not prophylaxis. Should States decide to use antiviral drugs
for prophylaxis rather than for treatment, those States and/or
Territories would exhaust their stockpiles quickly and would not have
enough antiviral drugs to treat ill individuals as the pandemic
evolved. The same situation applies to those States and Territories
that do not stockpile their full proportion of the 31 million regimen
goal.
The GAO draft report states that "Once a pandemic begins, HHS expects
to make existing federal stockpiles of pharmaceutical interventions
available to state and local jurisdictions to distribute to targeted
groups. These interventions would include antivirals,... and pre-
pandemic vaccines," As outlined above, antiviral drugs from the HHS
Strategic National Stockpile (SNS) and other public stockpiles managed
by Project Areas are not intended for target groups, rather, they are
to be dispensed for treatment of ill individuals based on medical need.
The GAO draft report suggests that pre-pandemic vaccine will be
administered by State and local officials to targeted individuals who
have been identified to receive the vaccine based on HHS
recommendations. This process is not described correctly in the draft
report. Federal and State points of distribution (POD) will receive pre-
pandemic influenza vaccine from vaccine manufacturers under HHS
oversight and administer vaccination to critical workforce members as
described in the HHS pre- pandemic vaccine prioritization schedule,
which will be released soon for public comment. The GAO report should
be clear that the role of HHS, in coordination with DHS and other key
Federal partners, is to identify the categories of workers that should
be considered for vaccination. Work is ongoing to provide guidance to
critical infrastructure businesses on identifying individuals for pre-
pandemic and pandemic vaccination and to develop a system that will
identify them at sites where vaccine is administered.
Surge Capacity:
Although the GAO draft report makes no specific recommendation related
to surge capacity, the draft report fails to accurately capture a
number of key surge capacity concepts including strategies, roles and
responsibilities, and terminology.
The GAO draft report correctly states that HHS has initiated efforts to
improve surge capacity but incorrectly suggests that HHS is responsible
for healthcare personnel surge capacity. Providing for healthcare
personnel surge capacity for an influenza pandemic is a local
responsibility and will need to be built locally. The Federal
government can assist, but does not have adequate personnel to provide
for healthcare personnel surge during an influenza pandemic. The role
of HHS is to provide tools to support localities in developing their
healthcare personnel surge planning.
The GAO draft report states that two documents issued by HHS (1)
Altered Standards of Care in Mass Casualty Events; and (2) Mass Medical
Care with Scarce Resources: A Community Planning Guide provide a
"framework" for the allocation of scarce resources and standards of
care appropriate to the situation. HHS provided these documents as
planning guidance for consideration by communities, not for the
purposes of establishing definitive standards. States in conjunction
with professional societies will determine the appropriate standards of
care for the situation – not HHS or the Federal government. Also,
throughout the draft report, GAO report uses the phrase "altered
standards of care," rather than the more appropriate phrase, "standards
of care appropriate to the situation."
The GAO draft report states that HHS will deploy U.S. Public Health
Service (PHS) Commissioned Corps officers and National Disaster Medical
System (NDMS) personnel to support healthcare personnel surge capacity.
While HHS plans to utilize these personnel during the early stages of a
severe influenza pandemic, these personnel will not be available for
deployment once the pandemic is spreading within the United States.
Furthermore, NDMS personnel are primarily local healthcare providers
who will be needed by their local communities and healthcare systems
during a widespread influenza pandemic, and therefore, will unlikely be
deployed elsewhere. Likewise, PHS officers who provide healthcare to
tribal communities will be needed in those communities. PHS officers
also serve essential functions within HHS agencies, and considering
that personnel at HHS and other Federal Departments will be impacted by
the pandemic, many PHS personnel will not be available for deployment.
GAO may want to consider some of the other mechanisms HHS has been
exploring to expand healthcare personnel surge capacity. For example:
a. A new report that emphasizes the role of home care during a pandemic
was released by HHS in July 2008 and can be found at [hyperlink,
http://www.pandemicflu.gov/plan/healthcare/homehealth.html]. Home care
may keep the less-severely ill out of the hospitals. One of the major
points in this report is that telehealth can be used to support
personnel surge since the health care provider would not need to visit
each household and could provide care to more people.
b. In September 2007, HHS released a report that suggests the use of
call centers as intervention that can be used to keep the less severely
ill out of the hospital and enhance the ability of providers to
maximize the number of people who receive information that allows them
to receive the highest possible standard of care under the austere
conditions of the pandemic. The report can be found at [hyperlink,
http://www.ahrq.gov/prep/callcenters/callcenters.pdf.
c. Another approach to expanding personnel surge is just-in-time
training to assure that individuals are able to provide the highest
possible standard of care under the austere conditions of a pandemic.
One such program is Project Xtreme [hyperlink,
http://www.ahrq.gov/prep/projxtreme/].
[End of section]
Appendix IV: GAO Contact and Staff Acknowledgments:
GAO Contact:
Marcia Crosse (202) 512-7114 or CrosseM@gao.gov:
Acknowledgments:
In addition to the contact named above, Martin T. Gahart, Assistant
Director; George Bogart; Cathleen Hamann; Gay Hee Lee; and Deborah J.
Miller made key contributions to this report.
[End of section]
Related GAO Products:
Influenza Pandemic: Federal Agencies Should Continue to Assist States
to Address Gaps in Pandemic Planning. GAO-08-539. Washington, D.C.:
June 19, 2008.
Emergency Preparedness: States Are Planning for Medical Surge, but
Could Benefit from Shared Guidance for Allocating Scarce Medical
Resources. GAO-08-668. Washington, D.C.: June 13, 2008.
Influenza Pandemic: Efforts Under Way to Address Constraints on Using
Antivirals and Vaccines to Forestall a Pandemic. GAO-08-92. Washington,
D.C.: December 21, 2007.
Influenza Pandemic: Opportunities Exist to Address Critical
Infrastructure Protection Challenges That Require Federal and Private
Sector Coordination. GAO-08-36. Washington, D.C.: October 31, 2007.
Influenza Vaccine: Issues Related to Production, Distribution, and
Public Health Messages. GAO-08-27. Washington, D.C.: October 31, 2007.
Influenza Pandemic: Further Efforts Are Needed to Ensure Clearer
Federal Leadership Roles and an Effective National Strategy. GAO-07-
781. Washington, D.C.: August 14, 2007.
Emergency Management Assistance Compact: Enhancing EMAC's Collaborative
and Administrative Capacity Should Improve National Disaster Response.
GAO-07-854. Washington, D.C.: June 29, 2007.
Influenza Pandemic: DOD Combatant Commands' Preparedness Efforts Could
Benefit from More Clearly Defined Roles, Resources, and Risk
Mitigation. GAO-07-696. Washington, D.C.: June 20, 2007.
Influenza Pandemic: Efforts to Forestall Onset Are Under Way;
Identifying Countries at Greatest Risk Entails Challenges. GAO-07-604.
Washington, D.C.: June 20, 2007.
Emergency Management: Most School Districts Have Developed Emergency
Management Plans, but Would Benefit from Additional Federal Guidance.
GAO-07-609. Washington, D.C.: June 12, 2007.
Avian Influenza: USDA Has Taken Important Steps to Prepare for
Outbreaks, but Better Planning Could Improve Response. GAO-07-652.
Washington, D.C.: June 11, 2007.
The Federal Workforce: Additional Steps Needed to Take Advantage of
Federal Executive Boards' Ability to Contribute to Emergency
Operations. GAO-07-515. Washington, D.C.: May 4, 2007.
Influenza Pandemic: DOD Has Taken Important Actions to Prepare, but
Accountability, Funding, and Communications Need to be Clearer and
Focused Departmentwide. GAO-06-1042. Washington, D.C.: September 21,
2006.
Influenza Pandemic: Applying Lessons Learned from the 2004-05 Influenza
Vaccine Shortage. GAO-06-221T. Washington, D.C.: November 4, 2005.
Influenza Vaccine: Shortages in 2004-05 Season Underscore Need for
Better Preparation. GAO-05-984. Washington, D.C.: September 30, 2005.
Influenza Pandemic: Challenges in Preparedness and Response. GAO-05-
863T. Washington, D.C.: June 30, 2005.
Influenza Pandemic: Challenges Remain in Preparedness. GAO-05-760T.
Washington, D.C.: May 26, 2005.
Infectious Disease Preparedness: Federal Challenges in Responding to
Influenza Outbreak. GAO-04-1100T. Washington, D.C.: September 28, 2004.
Bioterrorism: Public Health Response to Anthrax Incidents of 2001. GAO-
04-152. Washington, D.C.: October 15, 2003.
Infectious Diseases: Gaps Remain in Surveillance Capabilities of State
and Local Agencies. GAO-03-1176T. Washington, D.C.: September 24, 2003.
SARS Outbreak: Improvements to Public Health Capacity Are Needed for
Responding to Bioterrorism and Emerging Infectious Diseases. GAO-03-
769T. Washington, D.C.: May 7, 2003.
Bioterrorism: Preparedness Varied across State and Local Jurisdictions.
GAO-03-373. Washington, D.C.: April 7, 2003.
Hospital Emergency Departments: Crowded Conditions Vary among Hospitals
and Communities. GAO-03-460. Washington, D.C.: March 14, 2003.
Nursing Workforce: Emerging Nurse Shortages Due to Multiple Factors.
GAO-01-944. Washington. D.C.: July 10, 2001.
Nursing Workforce: Recruitment and Retention of Nurses and Nurse Aides
Is a Growing Concern. GAO-01-750T. Washington, D.C.: May 17, 2001.
Flu Vaccine: Supply Problems Heighten Need to Ensure Access for High-
Risk People. GAO-01-624. Washington, D.C.: May 15, 2001.
[End of section]
Footnotes:
[1] In this report, the term "pandemic" will refer to a human influenza
pandemic.
[2] Department of Health and Human Services, HHS Pandemic Influenza
Plan (Washington, D.C.: November 2005). HHS also estimated that
1,485,000 people would require care in an intensive care unit (ICU) and
742,500 people would require mechanical ventilation.
[3] The term "staffed bed" means that there are health care staffs
available to attend to a patient occupying the bed.
[4] HHS estimates show that the effects of even a moderate pandemic
would exceed the capacity of U.S. hospitals, with 865,000 people
requiring hospitalization, 128,750 people requiring care in an ICU,
64,875 people requiring mechanical ventilation, and 209,000 deaths.
[5] GAO, Influenza Pandemic: Plan Needed for Federal and State
Response, GAO-01-4 (Washington, D.C.: Oct. 27, 2000), 27 and GAO,
Influenza Pandemic: Challenges Remain in Preparedness, GAO-05-760T
(Washington, D.C.: May 26, 2005), 17.
[6] GAO, Influenza Pandemic: Efforts Under Way to Address Constraints
on Using Antivirals and Vaccines to Forestall a Pandemic, GAO-08-92
(Washington, D.C.: Dec. 21, 2007), 30-32, 36.
[7] HHS refers to pharmaceutical interventions as medical
countermeasures.
[8] Antivirals are drugs designed to prevent or reduce the severity of
a viral infection, such as influenza. Vaccines are drugs used to
stimulate the response of the human immune system to help protect the
body from disease.
[9] For more detailed information on the use of antivirals and vaccines
in a pandemic, see GAO-08-92, 4.
[10] Surge capacity may also include the ability to acquire other
resources such as hospital beds, pharmaceuticals, and equipment, and to
allocate scarce resources and provide care outside of the normal health
care delivery system and infrastructure. For the purpose of this
report, we refer to surge capacity in the context of the ability to
increase the number of health care providers.
[11] Federal assistance can be provided to state, local, and tribal
jurisdictions through mechanisms and authorities that do not require
coordination of federal response activities and can be provided without
a Presidential declaration of a major disaster or emergency. For
example, federal assistance can be provided through the National Search
and Rescue Plan and the Maritime Security Plan.
[12] Department of Homeland Security, National Response Framework
(Washington, D.C.: 2008). The National Response Framework replaced the
National Response Plan in March 2008. See app. I for details regarding
the genesis of the plan.
[13] This is only part of the federal government's planning efforts for
responding to a pandemic. The President of the United States released
two documents for a broader response: (1) the National Strategy for
Pandemic Influenza, which provides a framework for future planning
efforts for how the country will prepare for, detect, and respond to a
pandemic and (2) the National Strategy for Pandemic Influenza
Implementation Plan, which further clarifies the roles and
responsibilities of governmental and non-governmental entities and
provides preparedness guidance for all segments of society. See app. I
for general descriptions of these documents.
[14] For this report, we use the term "state and local jurisdictions"
to refer to state, local, territorial, and tribal areas. For the
allocation of pharmaceutical interventions during a pandemic, "state
and local jurisdictions" refers to state, local, and territorial areas.
Tribal populations are included in states' populations. HHS uses the
term "Project Areas" when discussing the allocation of antivirals and
points of distribution when discussing pre-pandemic and pandemic
vaccines.
[15] See GAO-08-92, 4; GAO, Influenza Pandemic: Applying Lessons
Learned from the 2004-05 Influenza Vaccine Shortage, GAO-06-221T
(Washington, D.C.: Nov. 4, 2005), 2, 10; GAO, Influenza Pandemic:
Challenges in Preparedness and Response, GAO-05-863T (Washington, D.C.:
June 30, 2005), 6-9, 11-12; and GAO, Influenza Pandemic: Challenges
Remain in Preparedness, GAO-05-760T (Washington, D.C.: May 26, 2005),
12-15. For additional information, see Related GAO Products at the end
of this report.
[16] See GAO-05-863T, 13; GAO-05-760T, 16-17; GAO, Infectious Diseases:
Gaps Remain in Surveillance Capabilities of State and Local Agencies,
GAO-03-1176T (Washington, D.C.: Sept. 24, 2003), 9-10; GAO,
Bioterrorism: Preparedness Varied across State and Local Jurisdictions,
GAO-03-373 (Washington, D.C.: Apr. 7, 2003), 17-18, 21-22; GAO, Nursing
Workforce: Emerging Nurse Shortages Due to Multiple Factors, GAO-01-944
(Washington, D.C.: July 10, 2001), 6-12; and GAO, Nursing Workforce:
Recruitment and Retention of Nurses and Nurse Aides Is a Growing
Concern, GAO-01-750T (Washington, D.C.: May 17, 2001), 4-14.
[17] GAO, Bioterrorism: Public Health Response to Anthrax Incidents of
2001, GAO-04-152 (Washington, D.C.: Oct. 15, 2003), 24.
[18] GAO-05-863T, 9-11.
[19] An antibody is a molecule produced by the immune system that helps
fight infections. The ability of influenza vaccine to protect a person
depends on the age and health status of the person getting the vaccine
and the similarity or "match" between the virus strain(s) in the
vaccine and those in circulation. For example, when the seasonal
influenza vaccine and circulating virus strains are well-matched, the
vaccine will prevent illness in approximately 70 percent to 90 percent
of healthy adults under the age of 65. The protection drops to about 30
percent to 40 percent for the elderly. Vaccine effectiveness can also
be lower for individuals with medical conditions such as compromised
immune systems.
[20] Experts believe that a strain of the H5N1 influenza virus is the
most likely candidate to cause a pandemic; thus, pre-pandemic vaccines
currently under development are based on this virus. However, experts
remain concerned that other influenza viruses--such as the H2N2, H7N7,
and H9N2--have the potential to cause a pandemic.
[21] See, for example, Robert G. Webster and Elena A. Govorkova, "H5N1
Influenza--Continuing Evolution and Spread," New England Journal of
Medicine, vol. 355, no. 21 (2006) 2174-77 and Aleksandr S. Lipatov,
Richard J. Webby, Elena A. Govorkova, Scott Krauss, and Robert G.
Webster, "Efficacy of H5 Influenza Vaccines Produced by Reverse
Genetics in a Lethal Mouse Model," Journal of Infectious Diseases, vol.
191 (2005), 1216-20.
[22] We previously reported that seasonal vaccine manufacturers for the
U.S. market have agreed in principle to switch to production of
pandemic vaccine should the need arise and compensation and
indemnification be provided. Our prior work noted, therefore, that it
would probably be unnecessary for the federal government to nationalize
vaccine production, although a senior HHS official indicated that the
federal government has the authority to do so if circumstances warrant
it. GAO-05-863T, 5.
[23] The five vaccine manufacturers were GlaxoSmithKline plc (which
includes its subsidiary ID Biomedical Corporation of Quebec), MedImmune
Vaccines, Inc., Novartis Vaccines and Diagnostics Limited, sanofi
pasteur, Inc. (the policy of this company is to spell its name without
capital letters), and CSL Limited.
[24] This manufacturer is sanofi pasteur, Inc. in Swiftwater, Pa., and
it produces a vaccine that is injected into muscle. The injectable
vaccine represents the large majority of influenza vaccine administered
in this country. Throughout this report, vaccine refers to the
injectable form.
[25] GAO-08-92, 26.
[26] The amount of antiviral administered is measured in treatment
courses. One treatment course is the number of doses of the antiviral
needed to treat one person.
[27] The SNS is a federal repository of pharmaceuticals and medical
supplies that can be delivered to the site of a bioterrorist attack or
other event.
[28] See Related GAO Products at the end of this report.
[29] Two classes of antivirals are currently approved by the FDA for
prevention and treatment of influenza. The first, older class is called
adamantanes, which includes two drugs called amantadine and
rimantadine. This class of antivirals has been affected by the
emergence of drug-resistant influenza viruses. Antiviral resistance is
the result of viruses changing in ways that reduce or eliminate the
effectiveness of antiviral agents to prevent or treat infections. The
second class of antivirals is called neuraminidase inhibitors. This
relatively newer class of antivirals includes two drugs--oseltamivir
(Tamiflu) and zanamivir (Relenza)--and are associated with fewer side-
effects than the older class of antivirals. However, concerns regarding
Tamiflu and Relenza have recently increased. In 2006, FDA announced a
change to the prescribing information for Tamiflu to include a
precaution about neuropsychiatric events. The revision is based on
postmarketing reports of self-injury and delirium with the use of
Tamiflu primarily in pediatric patients with influenza. In 2007, FDA's
Pediatric Advisory Committee recommended stronger warning labels for
both Tamiflu and Relenza because of reports of neuropsychiatric
problems in children and teens.
[30] GAO-08-92, 23.
[31] GAO-05-863T, 8.
[32] GAO-05-984, 11-12.
[33] See Eric Toner and Richard Waldhorn, "What hospitals should do to
prepare for an influenza pandemic," Biosecurity and Bioterrorism:
Biodefense Strategy, Practice, and Science, vol. 4, no. 4 (2006).
[34] See GAO-05-863T, 13; GAO-05-760T, 16-17; GAO-03-1176T, 9-10; GAO-
03-373, 17-18, 21-22; GAO-01-944, 6-12; and GAO-01-750T, 4-14. Also,
Trust for America's Health, Ready or Not? Protecting the Public's
Health From Diseases, Disasters, and Bioterrorism (Washington, D.C.:
2006); and American Hospital Association, Taking the Pulse: The State
of America's Hospitals (Washington, D.C.: 2005).
[35] Association of American Medical Colleges, Recent Studies and
Reports on Physician Shortages in the U.S. (Washington, D.C.: 2007).
[36] To identify nursing shortages as of December 2006, the American
Hospital Association sent a survey to approximately 5,000 community
hospital chief executive officers in late February 2007 and collected
data through March 2007. The association received 840 responses for a
response rate of approximately 17 percent.
[37] Hospital capacity is the number of staffed beds.
[38] Pub. L. No. 109-417, 120 Stat. 2831 (2006).
[39] Pub. L. No. 109-417, § 103, 120 Stat. 2836.
[40] Pub. L. No. 109-417, § 101, 120 Stat. 2833.
[41] GAO, SARS Outbreak: Improvements to Public Health Capacity Are
Needed for Responding to Bioterrorism and Emerging Infectious Diseases,
GAO-03-769T (Washington, D.C.: May 7, 2003), 4.
[42] GAO-03-1058T, 15-16.
[43] GAO-04-152, 24.
[44] For the allocation of pharmaceutical interventions during a
pandemic, "state and local jurisdictions" refers to state, local, and
territorial areas. Tribal populations are included in states'
populations.
[45] In the draft guidance released for public comment in June 2008,
HHS proposed increasing the national goal to 79 million.
[46] HHS has allocated $170 million to subsidize state and local
jurisdictions in purchasing up to 31 million treatment courses of
antivirals at 25 percent off the federal contract price. According to
HHS officials, there is no current need for additional federal funding
to be allocated towards this subsidy program.
[47] Of this nearly 22 million, almost 21 million treatment courses
were purchased by state and local jurisdictions using the federal
government subsidy of 25 percent. Separately, jurisdictions have
purchased about 879,000 additional treatment courses without the use of
the federal subsidy but under the contracts governing the program.
Approximately 121,000 treatment courses of antivirals have been
purchased on the open market, that is, separately from the governing
contracts.
[48] These 6 million courses are included in addition to the 44 million
treatment courses already purchased by HHS for storage in the SNS, for
a total of 50 million courses of antivirals. The containment strategy
is based on studies suggesting that efforts centered on using
antivirals to prevent infection as well as to treat cases might contain
a pandemic at the site of the outbreak or at least slow its spread.
[49] HHS also released a second draft guidance that includes advice for
employers, other than health care providers and emergency services
personnel, to help employers determine if antivirals would be useful in
their plans to protect critical operations and personnel. The guidance
does not recommend that all employers use antivirals. Rather, it
recommends that maintaining critical infrastructure and operations
should be strongly considered in deciding how to allocate antivirals
for prophylactic use. Additionally, the guidance does not recommend all
employers use antivirals because other measures, such as
nonpharmaceutical measures, may be implemented instead.
[50] In May 2006, the Secretaries of HHS and DHS tasked the National
Infrastructure Advisory Council with, among other things, providing
recommendations regarding the prioritization and distribution of
pharmaceutical interventions to the critical workforce. According to
this Council's report, the number of the most essential critical-
infrastructure workers is approximately 12 million. See National
Infrastructure Advisory Council, The Prioritization of Critical
Infrastructure for a Pandemic Outbreak in the United States Working
Group: Final Report and Recommendations by the Council, (Washington,
D.C.: Jan. 16, 2007). According to HHS, the 20 million people in the
critical workforce include the 12 million identified by the National
Infrastructure Advisory Council as the most critical as well as other
essential personnel such as military personnel, including the National
Guard and critical government workers, such as border protection
personnel.
[51] The Office of Biomedical Advanced Research and Development
Authority within HHS manages contracts for the manufacturing and
stockpiling of pre-pandemic vaccine. See app. II for more information
on these contracts.
[52] Each individual would require two doses of vaccine, according to
the dosing instructions for the pre-pandemic vaccine developed from an
H5N1 strain and approved by FDA for use in humans in the United States.
Thus, in order to vaccinate 13 million people, HHS has stockpiled 26
million doses of vaccine. HHS has also awarded contracts to vaccine
manufacturers for the development of pre-pandemic vaccines containing
adjuvants--substances that may be added to a vaccine to increase the
body's immune response, thereby necessitating a lower dose of vaccine.
According to HHS officials, if FDA approves the use of adjuvants in
these vaccines and adjuvants were obtained, there would be enough pre-
pandemic vaccine in the current stockpile for more than 75 million
people.
[53] The Vaccine Management Business Improvement Project is a
collaborative effort between HHS, state and local immunization program
managers, and the private sector to improve vaccine management
processes at the federal, state, and local levels. Goals of the project
include simplifying processes for the ordering, distribution, and
management of vaccines to enhance response to public health
emergencies, such as vaccine shortages.
[54] HHS created the Pandemic Severity Index to aid in determining the
severity of a pandemic. This index is primarily based on case-fatality
ratios. CDC defines case-fatality ratio as the proportion of deaths
among clinically-ill persons.
[55] However, these individuals would be targeted under the category of
general population for this scenario.
[56] HHS has exercised this distribution plan for pandemic vaccine
several times. Also, HHS officials told us that manufacturers will
provide the syringes and needles needed for administration when the
pandemic vaccine is distributed.
[57] For example, the H5N1 viral strains in circulation in Thailand,
Vietnam, and Cambodia are resistant to the older class of antivirals,
adamantanes, which includes amantadine and rimantadine. In contrast,
the H5N1 virus strain that emerged in 2004 has shown in a few cases to
have some resistance to oseltamivir (Tamiflu), one of the relatively
newer classes of antivirals. However, all strains of H5N1 currently are
susceptible to zanamivir (Relenza). Frederick Hayden, Alexander Klimov,
Masato Tashiro, Alan Hay, Arnold Monto, Jennifer McKimm-Breschkin,
Catherine Macken, Alan Hampson, Robert G. Webster, Michèle Amyard, and
Maria Zambon, "Neuraminidase Inhibitor Susceptibility Network position
statement: antiviral resistance in influenza A/H5N1 viruses," Antiviral
Therapy, vol. 10 (2005), 873-77.
[58] Guillain-Barré syndrome is a disorder in which the body's immune
system attacks part of the peripheral nervous system. Symptoms include
varying degrees of weakness or tingling sensations in the legs, which
in many cases spreads to the arms and upper body.
[59] Elissa A. Laitin and Elise M. Pelletier, Drugs and Devices
Information Line, "The Influenza A/New Jersey (Swine Flu) Vaccine and
Guillain-Barré Syndrome: The Arguments for a Causal Association,"
(1997): p. 1-11 and David J. Sencer and J. Donald Millar, Emerging
Infectious Diseases, "Reflections on the 1976 Swine Flu Vaccination
Program," vol. 12, no. 1 (2006), 29-33.
[60] GAO-08-92, 26.
[61] The time required to produce vaccine depends, in part, on the
satisfactory growth and yield of the virus in chicken eggs, the number
of doses required to build immunity, and access to raw materials. Other
factors that affect timing of vaccine production include testing by FDA
and manufacturers to determine vaccine strength and the development of
a reagent for such testing. A reagent is a substance used in a chemical
reaction to detect, measure, examine, or produce other substances.
Reagents are used to determine the purity and strength of influenza
vaccine and must be developed each year for the specific new annual
influenza vaccine.
[62] In order to provide enough pandemic vaccine for 300 million
people, HHS has established a goal of producing 600 million doses to
provide two doses per person. The 2010-2011 time frame is based on
vaccine production without adjuvants. According to HHS officials, if
adjuvants were to be used, lowering the amount of vaccine needed to
promote an immune response, HHS could reach its production goal in 2008
or 2009.
[63] HHS's investments in research have also resulted in FDA-approved
products. In April 2007, FDA approved the first influenza vaccine based
on an H5N1 strain for human use in the United States.
[64] GAO-05-984, 11-12.
[65] Department of Health and Human Services, HHS Pandemic Influenza
Plan (Washington, D.C.: Nov. 2005).
[66] Homeland Security Council, National Strategy for Pandemic
Influenza Implementation Plan (Washington, D.C.: May 3, 2006) and
Department of Health and Human Services, Pandemic Influenza
Implementation Plan (Washington, D.C.: Nov. 2006).
[67] According to HHS, if adjuvants are approved for use in pre-
pandemic vaccine, it could in turn alter the prioritization and
increase the population groups included in receiving pre-pandemic
vaccine.
[68] A standard of care is the diagnostic and treatment process that a
clinician should follow for a certain type of patient, illness, or
clinical circumstance. It is how similarly qualified health care
providers would manage the patient's care under the same or similar
circumstances.
[69] Homeland Security Council, National Strategy for Pandemic
Influenza Implementation Plan (Washington, D.C., 2006), 13.
[70] Henry Masur, Ezekiel Emanuel, and H. Clifford Lane, "Severe Acute
Respiratory Syndrome: Providing Care in the Face of Uncertainty,"
Journal of the American Medical Association, vol. 289, no. 21 (2003):
2861-2863.
[71] Charlene Irvin, Lauren Cindrich, William Patterson, Angela
Ledbetter, and Anthony Southall, "Hospital Personnel Response during a
Hypothetical Influenza Pandemic: Will They Come to Work?" Academic
Emergency Medicine, vol. 14, no. 5, suppl.1 (2007): S13; K. Qureshi,
R.R.M. Gershon, M.F. Sherman, T. Straub, E. Gebbie, M. McCollum, M.J.
Erwin, and S.S. Morse, "Health Care Workers' Ability and Willingness to
Report to Duty During Catastrophic Disasters," Journal of Urban Health,
vol. 82, no. 3 (2005), 378-388; Kristine A. Qureshi, Jacqueline A.
Merrill, Robyn R. M. Gershon, and Ayxa Calero-Breckheimer, "Emergency
Preparedness Training for Public Health Nurses: a Pilot Study," Journal
of Urban Health, vol. 79, no. 3 (2002), 413-416; and Yaron Shapira,
Baruch Marganitt, Ilan Roziner, Tzippora Shochet, Yael Bar, and Joshua
Shemer, "Willingness of Staff to Report to Their Hospital Duties
Following an Unconventional Missile Attack: A State-Wide Survey,"
Israel Journal of Medical Sciences, vol. 27 (1991), 704-711.
[72] Ran D. Balicer, Saad B. Omer, Daniel J. Barnett, and George S.
Everly, Jr., "Local Public Health Workers' Perceptions Toward
Responding to an Influenza Pandemic," BioMedCentral Public Health, vol.
6, no. 99 (2006), 3.
[73] Irvin, Cindrich, Patterson, Ledbetter, and Southall, S13.
[74] GAO, Emergency Management Assistance Compact: Enhancing EMAC's
Collaborative and Administrative Capacity Should Improve National
Disaster Response, GAO-07-854 (Washington, D.C.: June 29, 2007), 32.
[75] Established standards of care are the allocation of appropriate
health and medical resources to improve the health status or save the
lives of all patients under normal conditions.
[76] GAO recently reviewed emergency preparedness planning documents
for 20 states and found that only 7 of the 20 states had adopted or
were drafting altered standards of care for specific medical issues.
See GAO, Emergency Preparedness: States Are Planning for Medical Surge,
but Could Benefit from Shared Guidance for Allocating Scarce Medical
Resources, GAO-08-668 (Washington, D.C.: June 13, 2008), 21-22.
[77] Altered standards of care are also referred to as "standards of
care appropriate to the situation."
[78] Altered standards of care can be thought of in terms of triage,
which refers to the process of sorting victims according to their need
for treatment and the resources available. Triage is often done in
emergency rooms, disasters, and wars when limited medical resources
must be allocated to maximize the number of survivors.
[79] Health Systems Research Inc., Altered Standards of Care in Mass
Casualty Events, a special report prepared at the request of the
Department of Health and Human Services, the Agency for Healthcare
Research and Quality (Rockville, Md.: 2005) and Health Systems Research
Inc., Mass Medical Care with Scarce Resources: A Community Planning
Guide, a special report prepared at the request of the Department of
Health and Human Services, the Agency for Healthcare Research and
Quality (Rockville, Md.: 2007).
[80] The uncertainty of emergency situations, the need for altered
standards of care, and the unpredictability of injuries during
emergencies may raise liability fears and may deter health care
providers and facilities from participating. Therefore, laws and
regulations governing the delivery of health care under normal
conditions may need to be modified or enhanced to address a mass
casualty event.
[81] Pub. L. No. 109-417, § 102, 120 Stat. 2833.
[82] Pub. L. No. 109-417, § 203, 120 Stat. 2849.
[83] Pub. L. No. 109-417, § 304, 120 Stat. 2860.
[84] See Department of Health and Human Services, Pandemic and All-
Hazards Preparedness Act Progress Report (Washington, D.C.: Nov. 2007),
11.
[85] Department of Health and Human Services, Interim Pre-pandemic
Planning Guidance: Community Strategy for Pandemic Influenza Mitigation
in the United States - Early, Targeted, Layered Use of
Nonpharmaceutical Interventions (Washington, D.C.: February 2007).
[86] U.S. government, Federal Guidance to Assist States in Improving
State-Level Pandemic Influenza Operating Plans (Washington, D.C.: Mar.
11, 2008).
[87] Martin C. J. Bootsma and Neil M. Ferguson, "The effect of public
health measures on the 1918 influenza pandemic in U.S. cities,"
Proceedings of the National Academy of Sciences of the United States of
America, vol. 104, no. 18 (2007), 7588-93; Richard J. Hatchett, Carter
E. Mecher, and Marc Lipsitch, "Public health interventions and epidemic
intensity during the 1918 influenza pandemic," Proceedings of the
National Academy of Sciences of the United States of America, (2007), 1-
6; Michael J. Haber, David K. Shay, Xiaohong M. Davis, Rajan Patel,
Xiaoping Jin, Eric Weintraub, Evan Orenstein, and William W. Thompson,
"Effectiveness of Interventions to Reduce Contact Rates during a
Simulated Influenza Pandemic," Emerging Infectious Diseases, vol. 13,
no. 4 (2007), 581-89; Howard Markel, Alexandra M. Stern, J. Alexander
Navarro, Joseph R. Michalsen, Arnold S. Monto, and Cleto DiGiovanni,
Jr, "Nonpharmaceutical Influenza Mitigation Strategies, US Communities
1918-1920 Pandemic," Emerging Infectious Diseases, vol. 12, no. 12
(2006), 1961-64; Robert J. Glass, Laura M. Glass, Walter E. Beyeler,
and H. Jason Min, "Targeted Social Distancing Design for Pandemic
Influenza," Emerging Infectious Diseases, vol. 12, no. 11 (2006): 1671-
81; and Joseph T. Wu, Steven Riley, Christophe Fraser, and Gabriel M.
Leung, "Reducing the Impact of the Next Influenza Pandemic Using
Household-Based Public Health Interventions," Public Library of
Science, vol. 3, no. 9 (2006), 1-9.
[88] Bootsma and Ferguson, 7588 and Hatchett, Mecher, and Lipsitch, 1.
[89] A report by the Institute of Medicine identified major limitations
with the current use of mathematical models, particularly with the
uncertainty associated with many of the assumptions made by researchers
regarding key parameters, such as the transmissibility of the virus,
the effectiveness of social distancing interventions, and compliance
with these interventions. For example, results from a model with the
assumption that most viral transmission occurs among children in
schools will differ from a similar model with the assumption that most
transmission occurs among households contacts. Committee on Modeling
Community Containment for Pandemic Influenza Board on Population Health
and Public Health Practice, Institute of Medicine of the National
Academies, "Modeling Community Containment for Pandemic Influenza, A
Letter Report." (Washington, D.C.: 2006).
[90] Hatchett, Mecher, and Lipsitch, 5, and Bootsma and Ferguson, 7592.
[91] R.J. Blendon, L.M. Koonin, J.M. Benson, M.S. Cetron, W.E. Pollard,
E.W. Mitchell, et. al, "Public response to community mitigation
measures for pandemic influenza, Emerging Infectious Diseases, vol. 14
(2008): 778-786.
[92] Robert J. Blendon, Catherine M. DesRoches, Martin S. Cetron, John
M. Benson, Theodore Meinhardt, and William Pollard, "Attitudes Toward
the Use of Quarantine In a Public Health Emergency in Four Countries,"
Health Affairs, vol. 25 (2006): W22.
[93] Department of Health and Human Services, U.S. Department of Health
and Human Services Pandemic Influenza Communications Plan (Washington,
D.C.: November 2006).
[94] The following individuals have been identified as primary
spokespeople for the medical response in a pandemic--HHS Secretary, HHS
Deputy Secretary, Assistant Secretary for Health, Assistant Secretary
for Preparedness and Response, Deputy Assistant Secretary for
Preparedness and Response, HHS Science Advisor, Director of the
National Vaccine Program Office, Director of CDC, Director of the
National Institute of Allergy and Infectious Diseases at the National
Institutes of Health, Assistant Secretary for Public Affairs, Deputy
Assistant Secretary for Public Affairs, Director of the HHS Press
Office, and Director of Media Affairs (regional media).
[95] A tabletop exercise is a facilitated analysis of a hypothetical
emergency situation. The purpose of the exercise is to have
participants examine problems based on current plans and to identify
where those plans need to be refined.
[96] Messages are written to a sixth grade reading level and presented
in 3 short sentences that convey 3 key messages in 27 words. The
approach is based on surveys showing that lead or front page media and
broadcast stories usually convey only three key messages, typically in
less than 9 seconds for broadcast media or 27 words for print.
[97] HHS has developed planning checklists for state and local
jurisdictions, medical offices and clinics, emergency medical service
and non-emergent (medical) transport organizations, home health care
services, individuals and families, businesses, school districts (K-
12), childcare and preschool facilities, colleges and universities,
faith-based and community organizations, long-term care and other
residential facilities, the travel industry, and health insurers.
[98] In addition, we have cited concerns about multiple and potentially
confusing or conflicting messages coming from many agencies at all
levels of government during a pandemic. See GAO-08-36, 5.
[99] Harvard School of Public Health Project on the Public and
Biological Security, "Pandemic Influenza and the Public: Survey
Findings," presentation at the Institute of Medicine (Oct. 26, 2006).
[100] Department of Homeland Security, National Response Framework
(Washington, D.C.: January 2008).
[101] Pub. L. No. 93-288 § 101, 88 Stat. 143 (1974) (as amended)
(codified as amended at 42 U.S.C. § 5121).
[102] Homeland Security Council, National Strategy for Pandemic
Influenza (Washington, D.C., Nov. 1, 2005).
[103] Homeland Security Council, National Strategy for Pandemic
Influenza Implementation Plan (Washington, D.C.: May 3, 2006).
[104] Homeland Security Council, National Strategy for Pandemic
Influenza Implementation Plan One Year Summary (Washington, D.C.: July
17, 2007).
[105] Department of Health and Human Services, HHS Pandemic Influenza
Plan (Washington, D.C.: November 2005).
[106] Department of Health and Human Services, Pandemic Influenza
Implementation Plan (Washington, D.C.: November 2006).
[107] White House, Homeland Security Presidential Directive-21: Public
Health and Medical Preparedness (Washington, D.C.: Oct. 18, 2007).
[108] Department of Health and Human Services and Department of
Homeland Security, Guidance on Allocating and Targeting Pandemic
Influenza Vaccine (Washington, D.C.: July 23, 2008).
[109] See Departments of Labor, Health and Human Services, and
Education, and Related Agencies Appropriations Act, 2006. Pub. L. No.
109-149, 119 Stat. 2833, 2857 (funds not limited to purposes related to
pandemic or avian influenza); Department of Defense, Emergency
Supplemental Appropriations to Address Hurricanes in the Gulf of
Mexico, and Pandemic Influenza Act, 2006, Pub. L. No. 109-148, 119
Stat. 2680, 2783, 2786; Emergency Supplemental Appropriations Act for
Defense, the Global War on Terror and Hurricane Recovery, 2006, Pub. L.
No. 109-234, 120 Stat. 479 (includes $30 million to be transferred to
the U.S. Agency for International Development). HHS also received
appropriations specifically available for pandemic-inflenza-related
purposes, among other purposes, totaling $50 million in fiscal year
2004, $182 million in fiscal year 2005, and $100 million in fiscal year
2007. 2004: Consolidated Appropriations Act, 2004, Pub. L. No. 108-199,
118 Stat. 3, 251; 2005: Consolidated Appropriations Act, 2005, Pub. L.
No. 108-447, 118 Stat. 2809, 3138, Emergency Supplemental
Appropriations Act, 2005. War on Terror, and Tsunami Relief, 2005, Pub.
L. No. 109-13, 119 Stat. 231, 276, 280; 2007: Revised Continuing
Appropriations Resolution, 2007, Pub. L. No. 110-5, 121 Stat. 8, 33.
Many of these appropriations are available without fiscal year
limitation.
[110] Also, approximately $179 million of the appropriated funds was
dedicated to international collaboration, with the remainder going to
other areas, such as state and local preparedness and risk
communications.
[111] GAO, Influenza Pandemic: Efforts Under Way to Address Constraints
on Using Antivirals and Vaccines to Forestall a Pandemic, GAO-08-92
(Washington, D.C.: Dec. 21, 2007), 26.
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