Pandemic Influenza: Domestic Preparedness Efforts
Domestic Preparedness Efforts
Updated February 20, 2007
Sarah A. Lister
Specialist in Public Health and Epidemiology
Domestic Social Policy Division
Pandemic Influenza: Domestic Preparedness Efforts
In 1997, a new avian influenza (“flu”) virus emerged in Asia and jumped
directly from birds to humans, killing six people. The virus has since spread to more
than 50 countries in Asia, Europe and Africa, where it has killed millions of birds and
infected more than 270 people, killing more than 160 of them. The virus bears some
similarity to the deadly 1918 Spanish flu, which caused a global pandemic estimated
to have killed more than 50 million people worldwide. The current spread of avian
flu raises concerns about another human flu pandemic.
Global pandemic preparedness and response efforts are coordinated by the
World Health Organization (WHO). Domestic preparedness efforts are led by the
White House Homeland Security Council, with the U.S. Department of Health and
Human Services (HHS) playing a major role. Domestic response efforts would be
carried out under the all-hazards blueprint for a coordinated federal, state and local
response laid out in the National Response Plan, overseen by the Department of
Homeland Security (DHS). HHS officials would have the lead in the public health
and medical aspects of a response. The federal government has released several
pandemic flu plans to govern federal, state, local and private preparedness activities.
There are concerns about how a domestic public health and medical response
would be managed during a flu pandemic. There is precedent, under the Stafford Act,
for the President to declare an infectious disease threat an emergency (which provides
a lower level of assistance), but no similar precedent for a major disaster declaration
(which provides a higher level of assistance). In any case, many of the needs likely
to result from a flu pandemic could not be met with the types of assistance provided
pursuant to the Stafford Act, even if a major disaster declaration applied.
Vaccination is the best flu prevention measure. But because of continuous
changes in the genes of flu viruses, vaccines must be “matched” to specific strains
to provide good protection. A pandemic flu strain would, by definition, be novel.
Stockpiled vaccine would not match, so stockpiling in anticipation of a pandemic is
of limited value. In addition, global and domestic capacity to produce flu vaccine is
limited. The U.S. government, primarily through HHS, has launched an aggressive
effort to expand domestic vaccine production capacity, and to develop technologies
to support more rapid production of a matched vaccine at the onset of a pandemic.
Since matched vaccine would not be available at the outset of a flu pandemic
that occurred within the next several years, planning efforts focus on measures to
slow the spread of disease, and mitigate its effects. These include stockpiling of
antiviral drugs to prevent or treat flu infection, planning for medical surge capacity,
and continuity planning for businesses and utilities.
This report discusses pandemic flu in general, WHO and U.S. preparedness and
response plans, and a number of relevant policy issues. The focus of this report is
U.S. domestic public health preparedness and response planning, and the projected
impacts of an influenza pandemic on Americans. This report will be updated to
reflect changing circumstances.
In troduction ......................................................1
Understanding Pandemic Influenza....................................4
What Is Pandemic Influenza?....................................4
Influenza Pandemics in the 20 Century............................6
H5N1 Avian Influenza......................................8
Other Flu Strains with Pandemic Potential......................9
Potential Impacts of an Influenza Pandemic........................10
Deaths and Hospitalizations.................................10
Pandemic Influenza Planning........................................12
WHO Global Influenza Preparedness Plan.........................12
U.S. Federal Pandemic Plans....................................13
National Pandemic Plans...................................13
Health Sector Pandemic Plans...............................14
Department of Defense Planning.............................15
Department of Veterans Affairs Planning......................15
State Pandemic Plans..........................................16
Private Sector Planning........................................16
Issues in Pandemic Influenza Planning................................17
Could an Influenza Pandemic Be Stopped?.........................17
Who’s in Charge?............................................17
Emergency Declarations and Federal Assistance.....................19
Limited Surveillance and Testing Capability........................21
Isolation and Quarantine.......................................22
Medical Surge Capacity........................................24
Rationing Scarce Resources.....................................25
Influenza Vaccine Supply and Use...............................27
Limited Vaccine Production Capacity.........................28
Vaccine Research and Development..........................28
Global Vaccine Availability.................................29
Intellectual Property Issues.................................30
Vaccine Tracking and Distribution...........................31
Antiviral Drug Supply and Use..................................31
Liability and Compensation for Pandemic Countermeasures ...........33
Status of Current Planning Efforts............................33
Smallpox Vaccine Injury Compensation.......................34
The 1976 Swine Flu Affair.................................35
Influenza as a Weapon.........................................35
Table 1. WHO Pandemic Phases.....................................6
Table 2. NVAC and ACIP Recommendations
for Pandemic Vaccine Priority Groups............................26
Domestic Preparedness Efforts
Between pathogens and humans it is a race of their genes against our wits.
— Joshua Lederberg, winner of the 1958 Nobel Prize in Medicine
for his work on genetic recombination in bacteria
The U.S. Department of Health and Human Services (HHS) defines the
following influenza (flu) terms:
!Seasonal (or common) flu is a respiratory illness that can be
transmitted person to person. Most people have some immunity, and
a vaccine is available.
!Avian (or bird) flu is caused by flu viruses that occur naturally in
wild birds. The H5N1 strain of current concern is highly pathogenic
in birds, deadly to domestic fowl, and can be transmitted from birds
to humans. There is no human immunity, and no human vaccine is
!Pandemic flu is virulent human flu that causes a global outbreak, or
pandemic, of serious illness. Because there is little natural immunity,
the disease can spread easily from person to person. Currently, there
is no pandemic flu.1
In this report, unless otherwise noted, the term pandemic will be used to refer to
In 1997 a new strain of avian flu jumped from poultry directly to humans in
Hong Kong, causing several human deaths. This was the first documented occurrence
of direct transmission of an avian flu virus from birds to people. Despite efforts to
contain the virus through culling of poultry flocks, the virus (designated as H5N1 for
specific proteins on its surface) re-emerged in 2003. It has since been reported in
domestic poultry and/or wild birds in more than 50 countries in Asia, Europe and
Africa.2 Also since 2003, it has infected more than 270 people (and killed more than
1 Adapted from HHS, “Flu Terms Defined,” at [http://www.pandemicflu.gov].
2 World Organization for Animal Health (known by its French acronym, OIE), “Update on
Avian Influenza in Animals in Asia (Type H5),” at [http://www.oie.int/downld/AVIAN%
160 deaths) in ten countries.3 As of yet the virus has not developed the ability to
transmit efficiently from person to person. Were that to occur, a global influenza
pandemic could ensue.
The high lethality of the H5N1 strain and its tendency to affect healthy young
people remind health authorities of the deadly 1918 Spanish flu, which is estimated
to have killed up to 2% of the world’s population, and was a substantial cause of
mortality in U.S. military personnel in World War I. The World Health Organization
(WHO) says, “If an influenza pandemic virus were to appear again similar to the one
that struck in 1918, even taking into account the advances in medicine since then,
unparalleled tolls of illness and death could be expected.”4
U.S. and world health authorities believe that while periodic influenza
pandemics are inevitable, their progress may be slowed, and their impacts blunted,
by rapid detection and local control efforts. The added time would allow affected
countries to better manage the situation, and countries not yet affected to better
prepare. To realize these benefits, countries affected by avian flu must be able to
track the spread of the virus in birds, and quickly detect and investigate suspected
human cases. Hence, a country’s capabilities in epidemiology, laboratory detection
and other public health services affect the welfare of the global community as well
as the country itself. This presents developed nations with novel policy challenges.
For example, should they reserve scarce health resources such as antiviral drugs for
themselves, or deploy them to other countries at the center of an emerging pandemic?
WHO released an updated pandemic preparedness plan in early 2005. The
United States released a draft pandemic plan in August 2004, and has since released
a number of documents addressing government-wide planning, public health and
medical preparedness, planning for critical infrastructure readiness, and others. (See
the subsequent section, “Pandemic Influenza Planning,” for plans and descriptions.)
States were required to prepare pandemic plans as a condition of their federal
bioterrorism preparedness grants. The Administration has created a government-wide
public website to disseminate information on pandemic flu preparedness and
A recurring theme in planning documents and consultations is the need to
engage sectors beyond healthcare and public health in planning. The Secretary of
HHS, Michael Leavitt, has said, “If a pandemic hits our shores, it will affect almost
every sector of our society, not just health care, but transportation systems,
20INFLUENZA/A_AI-Asia.htm]. OIE is an intergovernmental organization of 167 nations
and is not part of the United Nations system.
3 World Health Organization, “Confirmed Human Cases of Avian Influenza A/(H5N1),” as
of Feb 19, 2007, at [http://www.who.int/csr/disease/avian_influenza/country/en/].
4 WHO, “Global Influenza Preparedness Plan: The Role of WHO and Recommendations for
National Measures before and during Pandemics,” 2005, (hereafter called the WHO
pandemic plan), p. 3, at [http://www.who.int/csr/disease/influenza/pandemic/en/].
5 See [http://www.pandemicflu.gov/].
workplaces, schools, public safety and more. It will require a coordinated
government-wide response, including federal, state and local governments, and it will
require the private sector and all of us as individuals to be ready.”6 A 1918-style
pandemic could be so severe that non-health-related essential services would be
impaired by high absenteeism or supply chain disruptions, and health services could
be in such short supply that law enforcement protection might be required for them.
Though WHO does not recommend it, except in some narrow circumstances for
pre-pandemic control, countries might seal their borders or take similar measures,
with impacts on trade and commerce.7
If a flu pandemic were to occur in the next several years, the U.S. response
would be affected by the limited availability of a vaccine (the best preventive
measure for flu), as well as by limited availability of certain drugs used to treat severe
flu infections, and by the general lack of surge capacity within our healthcare system.
The U.S. healthcare system is largely private, while the public health system is
largely based in state, rather than federal, authority. This structure creates numerous
challenges in assuring the needed response capacity, and coordinating the various
response elements. Planning is further complicated by the fact that while periodic
influenza pandemics have been seen over the years, their timing and severity have
Domestic planning efforts presume that the National Response Plan (NRP), an
all-hazards plan developed by the Department of Homeland Security (DHS), would
be activated if needed to streamline the federal response to a pandemic. Pandemic
flu is unlike most other threats, though. Since flu is communicable, there is no scene
to secure, and all states might be affected nearly simultaneously. Thus, while a
pandemic could cause catastrophic levels of illness and death, the nation’s traditional
disaster response mechanisms — using geographical declarations of emergency and
disaster, and state-to-state mutual aid — may be ill-suited for this threat.8
This report discusses pandemic influenza in general, previous pandemics and
their global and domestic impacts, and the possible impacts of another pandemic
caused by the H5N1 avian flu strain. It also discusses WHO and U.S. preparedness
plans and their context in broader emergency preparedness efforts. Finally, the report
looks at a number of policy issues in pandemic influenza preparedness and response.
While reference is made when relevant to global preparedness efforts and to animal
health impacts, this report focuses on U.S. domestic public health preparedness and
response planning, and the projected impacts of an influenza pandemic on
Americans. This report will be updated to reflect changing circumstances.
6 Remarks of HHS Secretary Michael Leavitt on “Avian Flu,” National Press Club, Oct. 27,
7 See CRS Report RS22453, Avian Flu Pandemic: Potential Impact of Trade Disruptions,
by Danielle Langton.
8 For more information, see CRS Report RL33579, The Public Health and Medical
Response to Disasters: Federal Authority and Funding, by Sarah A. Lister.
For more information on avian, pandemic and seasonal flu preparedness, see the
following CRS Reports:
!RL33219, U.S. and International Responses to the Global Spread of
Avian Flu: Issues for Congress, by Tiaji Salaam-Blyther;
!RL33795, Avian Influenza in Poultry and Wild Birds, by Jim Monke
and M. Lynne Corn;
!RL33871, Foreign Countries’ Response to the Avian Influenza
(H5N1) Virus: Current Status, Emma Chanlett-Avery, coordinator;
!RS22576, Pandemic Influenza: Appropriations for Public Health
Preparedness and Response, by Sarah A. Lister.
!RL32655, Influenza Vaccine Shortages and Implications, by Sarah
A. Lister and Erin D. Williams.
Understanding Pandemic Influenza
What Is Pandemic Influenza?
A pandemic (from the Greek, for “all of the people”) is an epidemic of human
disease occurring over a very wide area, crossing international boundaries and
affecting a large number of people. Though it does so with some regularity,
influenza is not the only pathogen that can cause pandemics. A pandemic of the
“Black Death,” which affected most of Europe in the 14th century, is generally
attributed to plague (technically Yersinia pestis). The global spread of HIV/AIDS is
often referred to as a pandemic. Literature offers numerous examples of such
episodes of widespread contagion.
Influenza is a virus that causes respiratory disease in humans, with typical
symptoms of fever, cough, and muscle aches, and, rarely, pneumonia and death.
Though primarily a human pathogen, influenza viruses also circulate and cause
illness in swine, horses, mink, seals, and domestic poultry, and may be carried
without apparent illness in these species as well as a number of species of waterfowl.
Influenza is highly contagious in humans, spreading through direct contact and
airborne exposure. The virus can also persist for several hours on inanimate objects
such as toys or doorknobs. In addition, influenza is infectious before symptoms
appear in its victims, which also enhances its spread.9
Influenza viruses have a genome composed of eight segments of RNA. In
addition to random mutation, flu viruses also undergo change by shuffling or
reassorting these gene segments among different strains. Human flu viruses are of
two types: Influenza A and B. Influenza A strains are further identified by two
important surface antigens (proteins) that are responsible for virulence:
hemagglutinin (H) and neuraminidase (N). Fifteen different H antigens and nine
different N antigens have been identified in birds and mammals. Not all possible
9 David L. Heymann, Control of Communicable Diseases Manual, 18th ed., an official report
of the American Public Health Association, 2004; and the Centers for Disease Control and
Prevention (CDC) influenza home page, at [http://www.cdc.gov/flu/].
combinations of H and N antigens have been documented, and very few
combinations have been shown to cause human illness. The avian flu strain causing
great concern at this time is designated as H5N1 for its surface antigens.
New influenza strains typically circle the globe within three to six months of
emergence. New strains circulate each year, changing slightly from prior strains
(called antigenic drift). Each year the virus, its genome in constant flux, typically
makes healthy people sick, but is generally not deadly. Healthy adults typically have
partial immunity to new strains, but a newly formulated vaccine is required each year
to provide full immunity. Now and then, often several times in a century, the virus
changes enough through mutation or reassortment (called antigenic shift) that there
is no partial immunity in the population. This event, an influenza pandemic, results
in severe illness and death, even in healthy people. The extent and severity of illness,
and the disabling impact on healthy young people, could cause serious disruptions
in services and social order.
According to WHO, the hallmarks of an influenza pandemic are: (1) the
emergence of a novel influenza virus strain; (2) the finding that the strain can cause
human disease; and (3) sustained person-to-person transmission of the strain. Novel
influenza viruses typically acquire these characteristics in phases. Table 1 shows the
phases of an influenza pandemic as described by WHO. In the interpandemic period,
there is no human circulation of novel viruses. During this period, there is annual
circulation of common influenza viruses, which cause outbreaks each winter. In the
pandemic alert period, a new strain is present, with increasing ability for human-to-
human spread. During a pandemic period there is sustained human-to-human
transmission of the new strain. Table 1 also shows the public health goals WHO
recommends to slow the development and spread of novel virus strains as much as
possible. WHO reports the current global status at “Pandemic Alert Level 3:” a new
virus is causing human cases of illness, but with no or very limited human-to-human10
10 WHO, Current WHO Phase of Pandemic Alert, as of February 20, 2007, at
[ ht t p: / / www.who.i nt / c sr / di s ease/ avi a n_i nf l uenza / phase/ e n/ i ndex.ht ml ] .
Table 1. WHO Pandemic Phases
PhaseDescriptionOverarching public health goals
Phase 1No new influenza virus strains haveStrengthen global influenza pandemic
been detected in humans. A virus strainpreparedness at the global, regional and
that has caused human infection may benational levels.
present in animals. If so, the risk of
human infection is considered to be
Phase 2No new influenza virus strains haveMinimize the risk of transmission to
been detected in humans. However, ahumans; detect and report such
circulating animal influenza virus straintransmission rapidly if it occurs.
poses a substantial risk of human
Pandemic alert period
Phase 3Human infection(s) with a new strain,Ensure rapid characterization of the new
but no human-to-human spread, or atvirus strain, and early detection,
most rare instances of spread to a closenotification and response to additional
Phase 4Small cluster(s) with limited human-to-Contain the new virus within limited
human transmission, but spread isfoci or delay spread to gain time to
highly localized, suggesting that theimplement preparedness measures,
virus is not well adapted to humans.including vaccine development.
Phase 5Larger cluster(s), but human-to- humanMaximize efforts to contain or delay
spread still localized, suggesting thatspread, to possibly avert a pandemic,
the virus is becoming increasinglyand to gain time to implement pandemic
better adapted to humans, but may notresponse measures.
yet be fully transmissible (substantial
Phase 6Pandemic: increased and sustainedMinimize the impact of the pandemic.
transmission in the general population
Source: WHO Global Influenza Preparedness Plan, 2005, at [http://www.who.int/csr/disease/
i n fl ue nz a / p a nd e mi c / e n/ i n d e x. ht ml ] .
Influenza Pandemics in the 20th Century11
Historical records suggest that influenza pandemics have occurred periodically
for at least four centuries. In the 20th century there were three influenza pandemics,
and several “pandemic threats.”
11 Unless otherwise noted, information for this section is found on the U.S. federal
government pandemic flu website, at [http://www.pandemicflu.gov/].
The 1918 Spanish Flu (H1N1) pandemic is estimated to have killed more than
50 million people worldwide, and at least 675,000 in the United States.12 Illness and
death rates were highest among adults 20-50 years old. HHS notes that “the severity
of that virus has not been seen again.” Similarities between the 1918 pandemic and
the current H5N1 avian flu situation have the global public health community on
The 1957Asian Flu (H2N2) was first identified in Asia in February 1957 and
spread to the United States during the summer. Health officials responded quickly
and vaccine was available in limited supply by August. This pandemic killed about
The 1968 Hong Kong Flu (H3N2) became widespread in the United States in
December of that year. It is estimated that 33,800 people died from this pandemic
in the United States, (affecting those over the age of 65 disproportionately), making
it the mildest pandemic of the 20th century.
The 1976 Swine Flu Scare13 (H1N1) began when a novel virus, identified in
New Jersey, was thought to be related to the Spanish flu virus of 1918 and to have
pandemic potential. Federal officials mounted a vaccination campaign, and Congress
provided liability protection for the manufacturer and federal injury compensation for
those harmed by the vaccine. Ultimately, the virus did not spread, but the vaccine
was linked with a rare neurological condition that affected more than 500 people and
killed 32. The episode damaged confidence in public health officials.
The 1977 Russian Flu Scare (H1N1) involved a virus strain that had been in
circulation prior to 1957. As a result, severe illness was generally limited to those
without prior immunity (i.e., children and young adults). The epidemic is not,
therefore, considered a true pandemic.
In 1997, H5N1 Avian Flu, emerged in Hong Kong and appeared to have been
stamped out by mass culling of poultry. The virus re-emerged in 2003 and has spread
to three continents. Global containment efforts continue.
In 1999, an H9N2 flu strain was found to have caused human illness in Hong
Kong. This strain continues to circulate in birds and remains of concern to public
health officials, but has not as yet shown the same lethal potential as the H5N1 strain.
In August, 2004, the National Institutes of Health (NIH) awarded a contract to the
12 The U.S. population in 1918 was about one-third its current size, based on decennial
census reports of more than 92 million in 1910, and more than 106 million in 1920. The
U.S. population is currently slightly more than 300 million. See [http://www.census.gov].
13 Sources for this section are: Richard E. Neustadt and Harvey V. Fineberg, The Swine Flu
Affair, a report to the Secretary of Health, Education and Welfare, June, 1978; and HHS
Draft Pandemic Influenza Preparedness and Response Plan, Annex 11: “Lessons Learned
from 1976 Swine Influenza Program,” Aug. 2004. This incident is discussed further in a
later section on vaccine liability and compensation issues.
Chiron corporation to produce up to 40,000 doses of an investigational vaccine
against this strain, should it develop the capacity for human-to-human transmission.14
H5N1 Avian Influenza. WHO maintains a Web page with a cumulative count
of human H5N1 cases.15 As of February 19, 2007, WHO reported 274 cases, 167 of
them fatal, in 11 countries: Azerbaijan, Cambodia, China, Djibouti, Egypt, Indonesia,
Iraq, Nigeria, Thailand, Turkey and Vietnam. The WHO describes pandemic16
influenza and the situation with H5N1 as follows:
... outbreaks ... caused by H5N1 are of particular concern because of their
association with severe illness and a high case fatality. Of even greater concern
is the uniqueness of the present H5N1 situation in Asia. Never before has an
avian influenza virus with a documented ability to infect humans caused such
widespread outbreaks in birds in so many countries. This unprecedented
situation has significantly increased the risk for the emergence of an influenza
… The risk (of a pandemic) … remains so long as H5N1 is present in an animal
reservoir, thus allowing continuing opportunities for human exposure and
infection. … Most experts agree that control of the present outbreaks in poultry
will take several months or even years. … The recent detection of highly
pathogenic avian influenza in wild birds adds another layer of complexity to
… The world may therefore remain on the verge of a pandemic for some time to
come. At the same time, the unpredictability of influenza viruses and the speed
with which transmissibility can improve means that the time for preparedness
planning is right now. Such a task takes on added urgency because of the
prospects opened by recent research: good planning and preparedness might
mitigate the enormous consequences of a pandemic, and this opportunity must
not be missed.
The H5N1 strain now circulating has been especially virulent in both human and
avian hosts. Studies suggest that the virus prompts an over-reaction of the
inflammatory response in some human victims, causing rapid and severe damage to17
the lungs. This primary damage cannot be remedied with antibiotics or antiviral
14 NIH, National Institute for Allergy and Infectious Diseases (NIAID), “H9N2 Avian Flu
Vaccine Paired with Adjuvant Provokes Strong Human Immune Response at Low Doses,”
Sept. 25, 2006, at [http://www.nih.gov/news/].
15 WHO, “Confirmed Human Cases of Avian Influenza A (H5N1),” at
[ ht t p: / / www.who.i nt / c sr / di s ease/ avi a n_i nf l uenza / c ount r y/ e n/ ] .
16 WHO pandemic plan, p. 3.
17 This phenomenon is often called a “cytokine storm,” named after molecules in the
immune system that are produced in excess. See Zhou, J, et al., “Differential Expression
of Chemokines and their Receptors in Adult and Neonatal Macrophages Infected with
Human or Avian Influenza Viruses,” Journal of Infectious Diseases, vol. 194(1), pp. 61-70,
drugs. Victims may require mechanical ventilation, and may succumb despite swift
and capable care. In 2004, scientists published the results of research in which they
sequenced several genes from the 1918 pandemic strain. These genes, when inserted
into flu viruses and used to infect mice, were found to have a similar property.18
Recently, scientists re-created and published the entire genome of the 1918 strain,
reinforcing this finding.19 This property may explain the high lethality of both the
The H5N1 avian flu may never slip its moorings as a bird pathogen and become
a serious human threat. But that possibility is a worst-case scenario for the world’s
public health experts. Should H5N1 become a pandemic strain, scientists are
concerned that it may retain much of its virulence as it changes to a more
transmissible form. In the face of such a deadly pathogen, miracles of modern
medicine, unavailable in much of the developing world, may not be of much help in
developed countries either. Such a scenario would challenge governments around
Other Flu Strains with Pandemic Potential. While H5N1 is the most
worrisome, it is not the only recent flu strain with pandemic potential. Several novel
strains of avian influenza associated with human transmission have resulted in
pandemic alert status in the past several years. For example, in 2003 an H7N7 strain
affecting commercial poultry flocks in the Netherlands resulted in 89 cases of human20
illness. Most illnesses were mild, but there was one death. In 2004 in the Canadian
province of British Columbia, an H7N3 avian influenza strain in commercial poultry
was found to have infected at least two people. While both recovered, WHO issued
a pandemic alert for the Canadian outbreak.21 A government worker who became ill
while involved in culling flocks of poultry during a 2002 outbreak of H7N2 avian flu
in Virginia was later shown to have antibodies to that strain, providing suggestive but22
not conclusive evidence of infection.
July, 2006; and De Jong MD, et al., “Fatal Outcome of Human Influenza A (H5N1) is
Associated with High Viral Load and Hypercytokinemia (letter), Nature Medicine, vol. 12,
pp. 1203-1207, Nov. 2006.
18 D. Kobasa, et al., “Enhanced Virulence of Influenza A Viruses with the Haemagglutinin
of the 1918 Pandemic Virus,” Nature vol. 431, Oct. 7, 2004, pp. 703-707.
19 See Jeffery K. Taubenberger, et al., “Characterization of the 1918 Influenza Virus
Polymerase Genes,” Nature, vol. 437, pp. 889-893, Oct. 6, 2005; and Terrence M. Tumpey,
et al., “Characterization of the Reconstructed 1918 Spanish Influenza Pandemic Virus,”
Science, vol. 310, Oct. 2005, pp. 77-80.
20 Bosman, et al., “Final Analysis of Netherlands Avian Influenza Outbreaks Reveals Much
Higher Levels of Transmission to Humans than Previously Thought,” Eurosurveillance
Weekly, vol. 10(1), Jan. 6, 2005, at [http://www.eurosurveillance.org/index-02.asp].
21 WHO, “Avian Influenza A(H7) Human Infections in Canada,” Apr. 5, 2004, at
[http://www.who.int/csr/don/en/]; and CDC, “Avian Influenza Infections in Humans,” Oct.
22 A.J. Hostetler and Calvin Trice, “Va. Worker May Have Caught Avian Flu,” Richmond
These cases demonstrate a newer understanding of the potential for direct bird-
to-human transmission of avian flu viruses, and the fact that while the H5N1 strain
is of special concern, public health officials can not neglect other strains. The
Centers for Disease Control and Prevention (CDC) has noted several outbreaks of
various strains of avian flu in North American poultry flocks in 2003 and 2004, and
publishes guidance and recommendations for the protection of persons potentially
exposed during such outbreaks.23
Potential Impacts of an Influenza Pandemic
Deaths and Hospitalizations. In its pandemic flu plan, HHS estimates that
about 209,000 U.S. deaths could result from a moderate pandemic, similar to those
in 1957 and 1968, while 1.9 million deaths could result from a severe pandemic like24
that in 1918. (CDC estimates that on average, about 36,000 die of influenza during
an annual flu season.)
Estimates of impacts of a future pandemic are generally based on experience
from past pandemics, which varied considerably in their severity. Trust for
America’s Health (TFAH), a non-profit public health advocacy group, published a
report estimating deaths and hospitalizations in the United States based on mild,
moderate and severe pandemic scenarios. The report presents death estimates that25
range from 180,000 to more than 1 million. The report also contains estimated
state-by-state health impacts.
Predicted hospitalization rates provide an idea of the potential burden on the
U.S. healthcare system, but they are prone to the same degree of uncertainty. In its
final pandemic plan, HHS estimates of hospitalizations range from 865,000 to 9.9
million. TFAH estimates that U.S. hospitalizations would range from almost
800,000 to more than 4.7 million, and cites a statistic from the American Hospital
Association that in 2003 there were 965,256 staffed hospital beds in registered
hospitals. These projected impacts would occur over a compressed time frame of
several weeks or a few months, rather than spread over a full year.
Simple extrapolations of health effects from events in 1918 do not account for
advances in medical care that have occurred since then. Antibiotics are now available
to treat bacterial pneumonia that often results from influenza infection, and
sophisticated respiratory care is now available to treat those with severe pneumonia.
Times-Dispatch, Feb. 28, 2004.
23 See CDC website on avian flu outbreaks in North America at [http://www.cdc.gov/
24 HHS “Pandemic Influenza Plan,” Part 1: Strategic Plan, p. 18, Nov. 2005, at
25 Trust for America’s Health (TFAH), A Killer Flu?, June 2005, at
[http://healthyamericans.org/reports/flu/], applies a set of assumptions and ranges of severity
to a CDC-developed computer model, FluAid 2.0, to generate death, hospitalization and
outpatient rates based on populations with different age distributions.
Experts caution, though, that the H5N1 avian flu virus can cause severe primary
damage to the lungs. If this strain were to launch a pandemic and retain this trait,
large numbers of victims may require intensive care and ventilatory support, likely
exceeding national capacity to provide this level of care. In any event, such
specialized care is not available in most developing countries, and access to it is
uneven within the United States.
Economic Impacts. An analysis published by CDC in 1999, based on the
relatively mild 1968 pandemic, estimated the cost of a pandemic in the United States
at between $71.3 and $166.5 billion.26 The study modeled direct healthcare costs,
lost productivity for those affected, and lost expected future lifetime earnings for
those who died. Loss of life accounted for the majority of economic impact. The
model did not include the potential effect of disruptions in commerce.
In December 2005, the Congressional Budget Office (CBO) prepared an
assessment of the possible macroeconomic effects of a mild flu pandemic, such as
those in 1957 and 1968, and a severe pandemic, such as the one in 1918. CBO
estimated from the severe pandemic scenario that real Gross Domestic Product
(GDP) would be about 4-1/4 percent lower over the subsequent year than it would
have been had the pandemic not taken place, similar to a typical U.S. recession.
From the mild pandemic scenario, CBO estimated about a 1 percent reduction in
GDP, which might not be distinguishable from normal economic variation.27
In November 2005, the World Bank estimated the overall U.S. economic
impacts of a potential pandemic of moderate severity at $100 to $200 billion, and
global impacts at around $800 billion, if certain impacts were to last for a full year.28
Subsequently, the International Monetary Fund commented that while the global
economic and financial impacts of a severe pandemic were likely to be significant,
economic activity would likely recover quickly once the pandemic had run its
course.29 CBO provided a synopsis of several recent studies of the macroeconomic
effects of a possible pandemic, noting that the estimates span a wide range of effects,
reflecting the considerable uncertainties involved.30
There have been several studies of the economic impacts of Severe Acute
Respiratory Syndrome (SARS) in 2003. One analysis showed significant short- and
long-term decreases in Gross Domestic Product (GDP) in China and Hong Kong,
26 M. I. Meltzer et al., “The Economic Impact of Pandemic Influenza in the United States:
Priorities for Intervention,” Emerging Infectious Diseases, vol. 5(5), Sept.-Oct. 1999.
27 Congressional Budget Office, “A Potential Influenza Pandemic: Possible Macroeconomic
Effects and Policy Issues,” Dec. 8, 2005, revised July 27, 2006.
28 The World Bank Group, “Avian Flu: Economic Losses Could Top US$800 Billion,” Nov.
29 International Monetary Fund, “The Global Economic and Financial Impact of an Avian
Flu Pandemic and the Role of the IMF,” Feb. 28, 2006, at [http://www.imf.org/external/
pubs/ft/afp/2006/eng/ 022806.htm] .
30 CBO, “A Potential Influenza Pandemic: An Update on Possible Macroeconomic Effects
and Policy Issues,” p. 1, May 22, 2006, revised July 27, 2006.
attributing most of the losses to “the behavior of consumers and investors” rather
than to actual medical costs.31 The World Bank economic analysis of a possible flu
pandemic discusses the likely interplay between government actions, public behavior,
and economic effects. Similarly, CBO notes in its assessment that government
actions could either amplify or mitigate economic impacts, saying that attempts to
quarantine people would probably amplify the reductions in trade, travel and tourism,
but that rapid disease detection, vaccine development and deployment, and other
actions, including quarantine, if effective in controlling the spread of disease, could
blunt adverse economic impacts as a pandemic progressed.32
Pandemic Influenza Planning
The United States has engaged in pandemic flu planning activities for several
decades, with heightened activity in recent years in response to the threat posed by
H5N1 avian flu. In addition to response efforts in the public health and medical
sectors, a serious pandemic would trigger the National Response Plan (NRP),
developed by the Department of Homeland Security (DHS) as a blueprint for the
coordination of federal agencies during an emergency. The NRP, discussed in
greater detail in later sections of this report, is an all-hazards plan for emergencies
ranging from hurricanes to wildfires to terrorist attacks.
Described below are a number of preparedness and response plans to assist U.S.
federal, state and local agencies in specific preparedness and response for a flu
pandemic. U.S. plans reflect the timelines, goals and international capabilities
described by the WHO in its pandemic plan. In addition, U.S. federal, state and local
plans for this specific threat are intended to be consistent with the all-hazards
principles in the NRP.
WHO Global Influenza Preparedness Plan
In order to guide country planning efforts, the WHO released a revised
pandemic preparedness plan in early 2005.33 The plan lays out goals and actions to
be taken by WHO, as well as recommended actions for individual nations, at each of
the pandemic phases (shown in Table 1). For each phase, actions are grouped into
five categories: (1) planning and coordination; (2) situation monitoring and
assessment; (3) prevention and containment; (4) health system response; and (5)
communications. In addition, recommended actions for individual nations are
grouped according to whether the country is affected or not at a particular phase. For
Phase 6 (Pandemic Phase), when it is assumed that all countries will inevitably be
affected, there are recommended immediate actions for all countries, and specific
31 Warwick J. McKibben, “SARS: Estimating the Economic Impacts,” Institute of Medicine,
Forum on Microbial Threats, Workshop, “Learning from SARS: Preparing for the Next
Disease Outbreak,” Sept. 30, 2003, at [http://www.iom.edu/event.asp?id=14647].
32 CBO, “A Potential Influenza Pandemic: Possible Macroeconomic Effects and Policy
Issues,” p. 11, Dec. 8, 2005, revised July 27, 2006.
33 WHO pandemic plan, at [http://www.who.int/csr/disease/influenza/pandemic/en/].
actions for those affected, those not yet affected, and those for which the pandemic
has subsided, noting that subsequent pandemic waves may follow the first one.
The WHO pandemic plan contains an annex of recommendations to nations for
“nonpharmaceutical public health interventions,” actions such as isolation, quarantine
and travel restrictions. The annex stresses the use of voluntary rather than
compulsory measures, noting the lack of demonstrated utility of certain practices, or
that enforcement is considered impractical for others. The annex also notes that
certain practices used to control SARS, such as temperature screening at airports, are
not necessarily recommended for control of pandemic influenza, depending on
pandemic phase. The plan and annex also stress avoiding stigmatization of persons
affected by pandemic influenza or its control measures.
U.S. Federal Pandemic Plans
In November 2005, the Administration unveiled a central federal website, run
by HHS, containing interagency pandemic preparedness and response information.34
The following section describes a number of government pandemic flu planning
documents. Unless otherwise noted, plans discussed in this section are available on
the central website, along with other information about national pandemic
National Pandemic Plans. In November 2005, the White House Homeland
Security Council released the National Strategy for Pandemic Influenza (the
National Strategy). The strategy lays out three goals: (1) stopping, slowing or
otherwise limiting the spread of a pandemic to the United States; (2) limiting the
domestic spread of a pandemic, and mitigating disease, suffering and death; and (3)
sustaining infrastructure and mitigating impact to the economy and the functioning
of society. In order to meet those goals, the strategy lays out three “pillars” of
!Preparedness and Communication: Activities that should be
undertaken before a pandemic to ensure preparedness, and the
communication of roles and responsibilities to all levels of
government, segments of society and individuals.
!Surveillance and Detection: Domestic and international systems that
provide continuous “situational awareness,” to ensure the earliest
warning possible to protect the population.
!Response and Containment: Actions to limit the spread of the
outbreak and to mitigate the health, social and economic impacts of
34 See [http://www.pandemicflu.gov/].
Finally, roles and responsibilities are laid out for the federal government, state and
local governments, the private sector, individuals and families, and international
In May 2006, the White House Homeland Security Council released the
National Strategy for Pandemic Influenza: Implementation Plan (the
Implementation Plan), containing more than 300 required actions — with timelines
and performance measures — to be taken by federal departments and agencies, state
and local governments, communities, and the private sector, to prepare for a possible
pandemic. Required actions span six functional areas, as follows:
!International Efforts: Prevent and contain outbreaks abroad;
!Transportation and Borders: Slow the arrival and spread of a
!Protecting Human Health: Limit spread and mitigate illness;
!Protecting Animal Health: Control influenza with human pandemic
potential in animals;
!Law Enforcement, Public Safety, and Security: Ensure civil order
during a pandemic;
!Planning by Institutions: Protect personnel and ensure continuity of
The White House released a six-month status report in December 2006, stating that
92% of all actions due within six months of release of the Implementation Plan in
May 2006 had been completed.
Health Sector Pandemic Plans. In August 2004, HHS released the Draft
Pandemic Influenza Preparedness and Response Plan. The draft plan articulated
steps to be taken by HHS agencies and offices, and by state and local public health
authorities, in preparing for and responding to a pandemic. Specific activities
discussed included surveillance, vaccine development and use, antiviral drug use, and
communications. The draft plan was criticized by some as being vague, and for
delegating certain critical activities — such as designating priority groups for
rationing of vaccine and antiviral drugs — to states.
The draft plan was superceded by the HHS Pandemic Influenza Plan (the HHS
Pandemic Plan), published in November 2005. The final plan built on elements in
the draft plan, and has three parts: (1) a Strategic Plan, which outlines key planning
assumptions and HHS agency roles; (2) a Public Health Guidance for State and Local
Partners, which lays out activities on such matters as surveillance, laboratory testing,
and quarantine at the borders; and (3) a part currently under development, to consist
of detailed operational plans for HHS agencies involved in pandemic response.
According to the plan, the HHS Secretary would direct, and the Assistant Secretary
35 With the release of the strategic plan, President Bush sent a request to Congress for $7.1
billion in emergency spending for the departments of HHS, Agriculture, Defense, Homeland
Security, Interior, State and Veterans Affairs, and the U.S. Agency for International
Development. For more information, see CRS Report RS22576, Pandemic Influenza:
Appropriations for Public Health Preparedness and Response, by Sarah A. Lister.
for Public Health Emergency Preparedness36 would coordinate, all HHS pandemic
The final plan addressed some of the gaps in the draft plan, such as the
designation of priority groups to receive limited vaccine and antiviral drugs.37 Other
elements of the final plan received immediate criticism. For example, the section on
healthcare planning focuses on individual healthcare facilities and refers to plans for
surge capacity. Some experts have commented that there is little surge capacity in
the healthcare sector under normal circumstances, and that officials might have to
resort to the use of alternate facilities (e.g., convention centers) to care for large
numbers of flu patients. The HHS Pandemic Plan does not address that contingency.
Department of Defense Planning. Shortly after the release of the HHS
draft pandemic plan in August 2004, the Assistant Secretary of Defense for Health
Affairs released the Department of Defense (DOD) Pandemic Influenza
Preparation and Response Planning Guidance.38 The DOD guidance follows
many of the assumptions used in civilian planning, modifying them to protect a
highly mobile military force during wartime. Frequent mention is made of the
extremely high mortality suffered by U.S. troops during World War I as a result of
the 1918 pandemic. The guidance notes that 43,000 uniformed soldiers, more than
one third of all U.S. military casualties in the war, died of pandemic influenza, most
of them during one 10-week period in 1918.
The DOD guidance notes that the military will use the same vaccine formulation
as that developed for civilian use, though DOD will be responsible for securing its
own supplies of vaccine and antiviral drugs. Priority for countermeasures in limited
supply would be given to forward-deployed troops. The guidance does not set out
strict tiers of priority recipients. The guidance discusses the limited utility of
individual control measures such as isolation and quarantine, and suggests that
larger-scale adjustments (such as extending the tour of ships at sea) could slow
disease transmission. The guidance also mentions the consideration of coalition
forces from other nations, and the possibility that countermeasures such as vaccine
and antiviral drugs may be provided to them under certain conditions.
Department of Veterans Affairs Planning. The Department of Veterans
Affairs (VA) released a comprehensive pandemic flu plan in March 2006. The plan
notes that the VA owns a supply of approximately 500,000 treatment courses of the
antiviral drug Tamiflu.
36 This position has been redesignated as the Assistant Secretary for Preparedness and
Response, pursuant to P.L. 109-417.
37 Though the plan includes specific tiers of priority groups, and estimates of the number of
people in each group, the designations may be modified in light of the actual behavior of a
pandemic flu strain. For example, if atypical groups such as healthy young people were
found to be at increased risk of severe illness, the tiers could be adjusted accordingly.
38 Department of Defense, “Pandemic Influenza Preparation and Response Planning
Guidance,” Sept. 15, 2004, at [http://www.geis.fhp.osd.mil/GEIS/SurveillanceActivities/
State Pandemic Plans
All states were required to have submitted plans for pandemic flu preparedness
to HHS (through CDC) by July 2005, as a condition of receipt of public health
preparedness funding for FY2005.39 This deadline pre-dated the publication of the
National Strategy and the HHS Pandemic Plan. The plans of all 50 states and the
District of Columbia are available on the central federal pandemic flu website. Many
states continue to update their plans.
Private Sector Planning
In September 2006, the Department of Homeland Security released the
Pandemic Influenza Preparedness, Response, and Recovery Guide for Critical
Infrastructure and Key Resources. The guide provides business planners with
guidance to assure continuity, during a pandemic, for facilities comprising critical
infrastructure sectors (e.g., energy and telecommunications) and key resources (e.g.,
dams and nuclear power plants).
Domestic and global corporations have adopted specific pandemic flu plans to
varying degrees. In July 2006, the Conference Board, a global business membership
and research organization, reported the findings of its survey of pandemic
preparedness in 553 global companies. The Board found that nearly three-fourths of
respondents reported either having a pandemic plan, or being well along in
developing one. But the Board commented that “... the effectiveness of business
plans and the quality of relationships necessary for their successful implementation
in times of extreme public, private and social stress remains open to question.”40
According to the report, “the most significant disadvantage in not conducting formal
pandemic preparedness planning may be the virtually total absence of coordination
with the public sector. An overwhelming 94% of participating companies report that
they have not had discussions with any level of government officials about their
organization’s ability to provide essential services or access to facilities, equipment,
or staff during a pandemic.”41
39 According to cooperative agreement guidance for FY2004 funds, states were required to
submit pandemic plans along with their applications for FY2005 funds. See CDC,
“Cooperative Agreement Guidance for Public Health Emergency Preparedness,” Program
Announcement AA154, May 13, 2005, at [http://www.bt.cdc.gov/planning/guidance05/].
40 The Conference Board, “Most Companies Planning for an Avian Flu Pandemic, but
Outcomes Remain Uncertain,” press release, July 6, 2006, at [http://www.conference-board.
org/ utilities/press.cfm] .
Issues in Pandemic Influenza Planning
Could an Influenza Pandemic Be Stopped?
Public health experts note that vaccine, the primary measure for influenza
prevention, will be available in very limited supply at the start of a pandemic.
Antiviral drugs are also likely to be available in a limited supply. For both, there is
limited global surge capacity for production during a pandemic. Conventional
wisdom once held that there was an inevitability to the global wave of disease that
a pandemic would bring, but lately this notion has been challenged. WHO and many
national experts believe that scientific advances in studying and detecting flu viruses
may make it possible to detect the spread of the virus early, and rein in localized
clusters of infection. While not suggesting that a pandemic could necessarily be
averted, they posit that if progression were slowed enough, a vaccine could be
available by the time worldwide infection ensued. While there still might not be
enough vaccine for everyone, if countries had at least enough for essential personnel,
it would soften the impact somewhat.
Realizing this hope rests on two conditions: first, exceptional “pandemic
intelligence” in countries at the epicenter of a developing pandemic; and second, an
effective response in these epicenter countries. In hopes of having the best possible
information in real time, WHO, along with the U.S. State Department, CDC, DOD,
other U.S. federal agencies, and health officials from many other nations, are building
epidemiology and lab capacity in Southeast Asia and other regions affected by H5N1
avian flu, when countries have requested assistance. The U.S. government has also
participated in global pandemic response planning, through the International
Partnership on Avian and Pandemic Influenza.42
Who’s in Charge?
A serious flu pandemic would affect many sectors of society, not just the public
health and medical communities. As such, it is useful to consider federal efforts to
meet this threat across sectors, and to consider those efforts in the contexts of
preparedness and response. Federal leadership may be somewhat different for each
of these phases, but the nature of the threat may blur the line between them.
WHO monitors the spread of H5N1 avian flu and other novel flu viruses, and
will make formal announcements of changes in pandemic threat status including,
were it to occur, the onset of pandemic, defined as sustained human-to-human
transmission of a novel flu virus. At that point, global response activities would
ensue. However, since this threat can be anticipated, the federal government has
launched a specific, comprehensive, long-term preparedness strategy. Of the more
than 300 tasks in the Implementation Plan, 27 were to have been completed within
three months of the plan’s publication in May 2006, while others, such as
42 For more information, see CRS Report RL33219, U.S. and International Responses to the
Global Spread of Avian Flu: Issues for Congress, by Tiaji Salaam-Blyther. See also,
Department of Defense Global Emerging Infections Surveillance and Response System
(DoD-GEIS), at [http://www.geis.fhp.osd.mil/aboutGEIS.asp].
establishing domestic capacity for rapid, large-scale pandemic vaccine production,
may take many years to achieve.43 If a pandemic were to occur before then,
unfinished preparedness activities would be completed, if appropriate, as part of the
WHO urges that countries plan for a pandemic as a multi-sector threat, not
merely a health challenge. However, federal relationships that support state and local
jurisdictions traditionally operate sector-by-sector (e.g., HHS with health services,
and the Department of Transportation with transit agencies). While HHS had been
the lead federal agency for pandemic planning prior to 2005, the White House
Homeland Security Council appears now to be the hub through which federal
preparedness activities are coordinated.
Following release of the National Strategy and the HHS Pandemic Plan in
November 2005, HHS Secretary Michael Leavitt and other federal officials hosted
pandemic planning summits in all 50 states, to support states’ multi-sector planning
activities. Nonetheless, state plans were required as a condition of CDC grants to
state health departments, and many of them remain predominantly focused on health
sector preparedness. For example, many plans don’t mention a possible role for the
National Guard during a pandemic. Since the National Guard is a state response asset
under the control of the Governor, and since a flu pandemic could be catastrophic,
there has been considerable discussion of the possible role of law enforcement in
pandemic response. Hence, it could be helpful if state plans specifically described
how the National Guard might be used during a pandemic.
The National Response Plan (NRP), published by DHS, is a blueprint for the
coordinated efforts of federal agencies during disasters.44 In the event of a significant
influenza pandemic, the NRP may be activated to coordinate federal agency
activities. Responsibilities for specified activities (e.g., transportation, energy, and
public works) are set out in 15 Emergency Support Functions (ESFs). When the
NRP is activated, the Secretary of Homeland Security serves as the overall lead for
a coordinated federal response, while the Secretary of HHS serves as the lead for
ESF-8, Public Health and Medical Services.45 While public health and medical
activities may comprise the bulk of the federal response to a pandemic, other ESF
authorities may be involved to sustain infrastructure affected by absenteeism or
supply chain disruptions, requiring the coordination of other federal departments.
43 HHS anticipates that its efforts to establish adequate domestic surge capacity for flu
vaccine production will continue through 2013. See Testimony of Gerald W. Parker,
Principal Deputy Assistant Secretary, Office of the Assistant Secretary for Preparedness and
Response, HHS, hearing on “Pandemic Flu: Progress Made and Challenges Ahead,” before
the U.S. Senate Committee on Appropriations, Subcommittee on Labor, Health and Humanthst
Services, Education and Related Agencies, 110 Cong., 1 Sess., Jan. 24, 2007.
44 See DHS, National Response Plan, Dec. 2004, hereafter called the NRP, at
[http://www.dhs.gov/xprepresp/committees/editorial_0566.shtm], and CRS Report
RL32803, The National Preparedness System: Issues in the 109th Congress, by Keith Bea.
45 For more information on ESF-8, see CRS Report RL33579, The Public Health and
Medical Response to Disasters: Federal Authority and Funding, by Sarah A. Lister.
The National Strategy notes the federal departments designated as the lead for
various aspects of a pandemic response: HHS for the medical response, the U.S.
Department of Agriculture (USDA) for the veterinary response, the Department of
State for international activities, and DHS for overall domestic incident management.
In addition, DHS is responsible for coordinating the preparedness of privately owned
critical infrastructures such as banking and telecommunications.
While pandemic influenza scenarios have been used to exercise specific
elements of response, such as distribution of stockpiled medications, there has been
no national exercise to test a multi-sector, multi-jurisdictional response. As a
condition of receipt of $350 million in FY2006 supplemental appropriations,
Congress called on states to conduct pandemic flu exercises that would “enable
public health and law enforcement officials to establish procedures and locations for
quarantine, surge capacity, diagnostics, and communication.”46 The funds, awarded
by CDC, are to be used by states to test three aspects of response: control of
community gatherings (e.g., school closings); medical surge capacity; and mass
vaccination / mass prophylaxis.47 While no doubt useful, these exercises will be
carried out state-by-state, retaining a health-sector focus. The only national multi-
sector pandemic exercise to date has been a table-top simulation conducted by
members of the Cabinet.48
Emergency Declarations and Federal Assistance
In the United States, public health authority rests principally with the states as
an exercise of their police powers.49 States play a leading role in preparing for and
responding to public health threats, with HHS (primarily CDC) providing support
through funding, training, technical assistance, advanced laboratory support, data
analysis and other activities. The Public Health Service Act grants the Secretary of
HHS the authority to declare a situation a public health emergency, which triggers
an expansion of certain federal authorities.50 Though states already have considerable
power in responding to public health events, most can also declare public health
emergencies and expand their powers further. In an influenza pandemic, response
measures such as quarantine or prohibitions against administration of vaccine to non-
46 H.Rept. 109-359, to accompany H.R. 2863, Department of Defense, Emergency
Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic
Influenza Act, 2006, p. 523.
47 CDC, “Pandemic Influenza Guidance Supplement: Phase 2,” guidance for FY2006 funds,
July 10, 2006, at [http://www.bt.cdc.gov/planning/coopagreement/].
48 White House, “Press Gaggle after Avian Flu Tabletop Exercise with Homeland Security
Advisor Fran Townsend, Secretary of Health and Human Services Michael Leavitt, and
Secretary of Homeland Security Michael Chertoff,” transcript, Dec. 10, 2005, at
[ ht t p: / / www.whi t e house.gov/ news/ r el eases/ 2005/ 12/ 20051210-2.ht ml .]
49 The term police powers derives from the 10th Amendment to the Constitution, which
reserves to the states those rights and powers not delegated to the United States.
Historically these have been interpreted to include authority over public health and safety.
50 For more information, see CRS Report RL33579, The Public Health and Medical
Response to Disasters: Federal Authority and Funding, by Sarah A. Lister.
priority individuals would likely be carried out, at least initially, by state rather than
An influenza pandemic may disrupt services beyond the health sector. Each of
the pandemic influenza plans listed earlier is written with the premise that the NRP
could be triggered by a flu pandemic, thereby guiding a coordinated federal response
to problems within the health sector and other affected sectors through routine, non-
emergency, federal assistance mechanisms.52 According to the Implementation Plan,
the Secretary of Homeland Security may declare a pandemic an Incident of National
Significance, triggering the NRP, early in the event, perhaps while foreign countries
were affected, but before the disease had reached the United States.53
States may require additional federal assistance to maintain essential services
during an influenza pandemic. Typically, such assistance is triggered by presidential
emergency or disaster declarations pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act (the Stafford Act).54 Disaster assistance authorized
by the Stafford Act includes the provision of emergency funds and supplies to
stricken households, as well as aid in clearing and rebuilding damaged infrastructure.
While a virus would not cause infrastructure damage directly, certain sectors may
nonetheless be affected as a result of widespread absenteeism or supply chain
disruptions. For example, water treatment facilities may be damaged, or may have
to be shut down, if they are not adequately maintained, or if replacement parts are
unavailable. Sectors that depend heavily on continuous computer support (e.g.,
banking) may be disrupted by absenteeism.
51 For a discussion of the exercise of federal and state authorities in response to the shortage
of influenza vaccine in 2004, see CRS Report RL32655, Influenza Vaccine Shortages and
Implications, by Sarah A. Lister and Erin D. Williams. See also CRS Reports: RL33201,
Federal and State Quarantine and Isolation Authority, by Kathleen S. Swendiman and
Jennifer K. Elsea; RL33609, Quarantine and Isolation: Selected Legal Issues Relating to
Employment, by Nancy Lee Jones and Jon O. Shimabukuro; RS22219, The Americans with
Disabilities Act (ADA) Coverage of Contagious Diseases, by Nancy Lee Jones; and
RS21414, Mandatory Vaccinations: Precedent and Current Laws, by Kathleen S.
52 In addition, the NRP Biological Incident Annex notes that “Actions described in this
annex take place with or without a presidential Stafford Act declaration or a public health
emergency declaration” by the Secretary of HHS. See NRP, Biological Incident Annex, p.
BIO-1. While this annex addresses intentional bioterrorism events, it also addresses
naturally occurring biological threats, and explicitly mentions pandemic influenza. In
contrast, the NRP Catastrophic Incident Annex does not explicitly mention pandemic
influenza. While this annex is designed to address disasters with “extraordinary levels of
mass casualties” such as could occur with a pandemic, it is also explicitly focused on
“no-notice or short-notice incidents of catastrophic magnitude,” a definition that would not
likely apply to an influenza pandemic. See NRP, Catastrophic Incident Annex, p. CAT-1,
and DHS, Notice of Change to the National Response Plan, May 25, 2006, pp. 9-10, at
53 Implementation Plan, p. 37.
54 See CRS Report RL33053, Federal Stafford Act Disaster Assistance: Presidential
Declarations, Eligible Activities, and Funding, by Keith Bea.
It is unclear whether Stafford Act major disaster assistance could be provided
in response to a pandemic. Emergency declarations pursuant to the Stafford Act were
made in response to West Nile virus in 2000, so there is precedent for a presidential
emergency declaration, (providing a lower level of federal assistance) in response to
an infectious disease threat. The matter of presidential authority to declare a major
disaster (providing a higher level of federal assistance) in response to an infectious
disease threat generally, and a flu pandemic specifically, is less clear. In the past,
FEMA has, in the context of the national TOPOFF exercises, interpreted biological
disasters as ineligible for major disaster assistance pursuant to the Stafford Act.55
However, the Administration view is that the President’s authority to declare a major
disaster pursuant to the Stafford Act could be applied to an influenza pandemic.56
Limited Surveillance and Testing Capability
The CDC coordinates domestic surveillance for seasonal flu in humans.57
Monitoring for pandemic flu is integrated into these existing systems. Key challenges
in the rapid detection of novel flu viruses in humans are the vagueness of flu
symptoms, which can be seen with many other diseases, and the difficulty in
distinguishing specific flu strains of interest from the background of other strains
commonly in circulation.
The routine CDC system for domestic flu surveillance has seven reporting
components: (1) more than 120 laboratories; (2) more than 1,000 sentinel healthcare
providers; (3) death records from 122 cities; (4) reports from health departments in
the states, territories, New York City and the District of Columbia; (5) influenza-
associated deaths in children; (6) Emerging Infections Program sites in 10 states; and
(7) laboratory-confirmed hospitalizations for influenza in young children in three
sentinel counties.58 Reporting to these systems at CDC by state and local health
departments and healthcare providers is voluntary. Information is gathered and
analyzed weekly during the winter flu season.
CDC has issued recommendations to public health and medical professionals
for the investigation of possible human cases of avian or pandemic flu in individuals
who have a history of recent travel to a region affected by H5N1 avian flu, and who
55 See DHS, Office of the Inspector General, A Review of the Top Officials 3 Exercise,
Office of Inspections and Special Reviews, OIG-06-07, November 2005, p. 30, at
[http://www.dhs.gov/xoig/rpts/mgmt/editorial_0334.shtm]. The anthrax attack in 2001also
did not result in a Stafford Act declaration.
56 Implementation Plan, Appendix C, “Authorities and References,” p. 212.
57 Another key activity is the enhanced monitoring of avian flu in birds. The H5N1 strain
of concern has not yet been detected in humans or birds in the United States. For more
information on domestic monitoring in birds, see CRS Report RL33795, Avian Influenza in
Poultry and Wild Birds, by Jim Monke and M. Lynne Corn.
58 CDC, “Overview of Influenza Surveillance in the United States,” June 26, 2006, at
[http://www.cdc.gov/ flu/weekly/pdf/flu-s urveillance-overvi ew.pdf].
exhibit symptoms of severe respiratory disease.59 Between February 2003 and May
Investigations showed no evidence of H5N1 virus infections.60
There is not, at this time, a rapid point-of-care (bedside) test that healthcare
workers or epidemiologists can use to screen a person for H5N1 flu, or any other
specific strain of influenza. CDC recommends the use of commercial flu screening
tests for initial patient evaluation. The agency cautions that commercially available
screening tests cannot reliably distinguish H5N1 flu from other influenza A strains;
therefore, specimens that test positive on screening should be followed up with
specimens sent to the state’s public health laboratory to determine which flu strain
is involved. At this time, public health labs in all 50 states have the capability to test
for H5N1 influenza, though there is a lag time in shipping the samples, and in test
turnaround.61 The Implementation Plan calls on HHS, in coordination with DOD,
VA and DHS, to support the private-sector development of reliable, rapid, point-of-
care diagnostic tests for specific flu strains. CDC awarded contracts for this purpose
to four companies in December 2006.62
Isolation and Quarantine
Isolation and quarantine have been used for hundreds of years to prevent the
spread of communicable diseases. Both methods restrict the movement of those
affected, but they differ depending on whether an individual has been exposed to a
disease (quarantine), or is actually infected (isolation). Persons in isolation may be
significantly ill, so isolation often occurs in a healthcare setting. Persons under
quarantine are, by definition, not ill from the disease in question, though they may
have other health conditions that complicate the quarantine process.
In the United States, quarantine authority is generally based in state rather than
federal law.63 The federal government has the responsibility to prevent the
introduction, transmission, and spread of communicable diseases from foreign
59 CDC, “Health Updates on Avian Influenza,” June 7, 2006, and previous, at [http://www.
cdc.gov/ flu/avian/professional/updates.htm] .
60 J. R. Ortiz, et al., “No Evidence of Avian Influenza A (H5N1) among Returning U.S.
Travelers,” Emerging Infectious Diseases, vol. 13(2), Feb. 2007, at [http://www.cdc.gov/
EID/content/ 13/2/294.htm] .
61 An H5N1 influenza diagnostic test, developed by CDC, was approved by the Food and
Drug Administration (FDA) and delivered to laboratories in the national Laboratory
Response Network, which includes public health labs in all 50 states, many federal labs, and
others, in February 2006. See [http://www.bt.cdc.gov/lrn/].
62 CDC, “CDC Awards $11.4 Million to Develop New Rapid Diagnostic Tests for Avian
Influenza,” press release, Dec. 4, 2006.
63 For more information, see CRS Report RL33201, Federal and State Quarantine and
Isolation Authority, by Kathleen S. Swendiman and Jennifer K. Elsea. See also: CRS
Reports RL33609, Quarantine and Isolation: Selected Legal Issues Relating to
Employment, by Nancy Lee Jones and Jon O. Shimabukuro; and RS22219, The Americans
with Disabilities Act (ADA) Coverage of Contagious Diseases, by Nancy Lee Jones.
countries, and the authority to impose quarantine on incoming travelers suspected to
be infected with or exposed to certain diseases on a list of quarantinable
communicable diseases. Diseases are listed by an executive order of the President,
in consultation with the Secretary of HHS. On April 1, 2005, President Bush added
to the list “influenza caused by novel or re-emergent influenza viruses that are
causing, or have the potential to cause, a pandemic.”64 Federal quarantine is carried
out by CDC’s Division of Global Migration and Quarantine, which operates
quarantine stations at major ports, and also works closely with states to carry out
quarantine activities.65 CDC has noted that having pandemic influenza on the list
assures the agency of this option for disease control, should it be felt to be
On October 4, 2005, in response to a question at a press conference, President
Bush suggested the use of the military to enforce quarantines during a flu pandemic.66
The comment prompted questions on two issues: the role of quarantine in controlling
pandemic flu, and the role of the military in responding to domestic disasters.
While isolation and quarantine were crucial in the worldwide response to SARS,
these methods are less likely to be successful in controlling influenza. Influenza has
a shorter incubation period than SARS, and is often contagious in the absence of
symptoms or before symptoms appear, making it difficult to identify persons who
should be quarantined.67
There has been considerable interest in recent years in studying or predicting the
effects of a variety of so-called “non-pharmaceutical interventions” (NPI), including
isolation and quarantine, on the potential spread of pandemic flu.68 The
Implementation Plan discusses CDC’s readiness to implement quarantines for
incoming travelers, and strategies for school closures and other “social distancing”
64 See Executive Order: “Amendment to E.O. 13295 Relating to Certain Influenza Viruses
and Quarantinable Communicable Diseases,” Apr. 1, 2005, at [http://www.whitehouse.gov/
news/releases/2005/04/20050401-6.html]; and CDC, “Questions and Answers on the
Executive Order Adding Potentially Pandemic Influenza Viruses to the List of
Quarantinable Diseases,” Apr. 11, 2005, at [http://www.cdc.gov/ncidod/dq/qa_influenza_
65 See CDC Division of Global Migration and Quarantine home page at [http://www.cdc.
gov/ ncidod/dq/index.htm] .
66 Press conference with President George Bush, Federal News Service transcript, Oct. 4,
67 Christophe Fraser, et al., “Factors that Make an Infectious Disease Outbreak
Controllable,” Proceedings of the National Academy of Sciences, vol. 101(16), pp.
68 See, for example: the Models of Infectious Disease Agent Study (MIDAS), funded by the
National Institutes of Health, at [http://www.nigms.nih.gov/Initiatives/MIDAS/]; and studies
of the effectiveness of measures applied during the 1918 flu pandemic, conducted by Dr.
Howard Markel with funding from the Defense Threat Reduction Agency, presented to the
Institute of Medicine, workshop on “Ethical and Legal Considerations in Mitigating
Pandemic Disease,” Sept. 19, 2006, at [http://www.iom.edu/CMS/3783/3924/35857/
measures that may be used by local governments to slow disease spread. The Plan
also notes the need for continued study of the potential impacts, both good and bad,
of various approaches. The Plan makes specific reference to the practice of
geographic quarantine (also known as cordon sanitaire), the “isolation, by force if
necessary, of localities with documented disease transmission from localities still free
of infection,”69 saying, “The implementation of conventional geographic quarantine
imposes significant opportunity costs and may result in the diversion of significant
resources and assets that might be used to better effect supporting less draconian
disease containment measures.”70 In February 2007, CDC released a planning guide
for the graded use of NPI — including school closures, liberal work leave policies,
and teleworking strategies — matched to pandemic severity.71 The guide does not
propose the use of compulsory isolation or quarantine measures, recommending that
such actions be voluntary.
Following the terror attacks of 2001, DOD activated a new combatant
command, Northern Command or NORTHCOM, to, among other functions, provide
military assistance to civil authorities in response to terrorist attacks.72 The NRP also
articulates this role for the military in response to terrorist attacks, major disasters,
and other emergencies.73 There has, however, long been a prohibition against the use
of federal military personnel for domestic law enforcement, except in extraordinary
circumstances.74 There were no instances in the 20th century in which federal troops
were used to enforce a domestic quarantine for any disease, though there are earlier
ex am pl es. 75
Medical Surge Capacity
An influenza pandemic of even limited magnitude has the potential to disrupt
the normal workings of the healthcare system in a variety of ways. These may
include deferral of elective medical procedures; diversion of patients away from
overwhelmed hospital emergency departments and tertiary care facilities; protective
quarantines of susceptible populations such as residents of long-term care facilities;
and hoarding, theft or black-marketeering of scarce resources such as vaccines or
69 Implementation Plan, p. 108.
70 Ibid, p. 109.
71 CDC, “Interim Pre-pandemic Planning Guidance: Community Strategy for Pandemic
Influenza Mitigation in the United States — Early Targeted Layered Use of
Non-Pharmaceutical Interventions,” Feb. 2007, at [http://www.pandemicflu.gov/].
72 CRS Report RS21322, Homeland Security: Evolving Roles and Missions for United States
Northern Command, by Steve Bowman and James Crowhurst.
73 NRP, “Defense Support of Civil Authorities,” pp. 41 ff.
74 CRS Report RS22266 , The Use of Federal Troops for Disaster Assistance: Legal Issues,
by Jennifer K. Elsea.
75 Information provided by Dr. Dale Smith, medical historian, Uniformed Services
University of the Health Sciences, Bethesda, Maryland, Oct. 13, 2005.
Several additional factors complicate the healthcare burden posed by pandemic
flu. First, it is thought that a pandemic would spread across the United States in a
compressed timeframe similar to seasonal flu, that is, over a six- to eight-week
period. Second, while it is desirable that affected patients be kept in isolation,
domestic isolation capacity is limited. Third, the healthcare workforce is likely to be
affected by pandemic flu. Even if they are protected directly by limited vaccines or
antiviral drugs, their family members may be affected and require additional care at
home. Fourth, supplies of healthcare consumables such as gloves, masks and
antibiotics would be stressed by a surge in global demand.76 Even a mild flu
pandemic would likely place a significant and near-simultaneous strain on the
nation’s healthcare system.
Rationing Scarce Resources
The WHO recommends that countries identify priority groups for vaccination
and antiviral drugs, as these measures become available, and recommends that
countries make these decisions before a pandemic occurs. The National Vaccine
Advisory Committee (NVAC, which reports to the director of the National Vaccine
Program in HHS) and the Advisory Committee on Immunization Practices (ACIP,
which reports to the HHS Secretary and CDC) met in joint session in July 2005 to
report to HHS Secretary Leavitt their recommendations for prioritizing vaccine and
antiviral drugs for the U.S. civilian population during a pandemic.77 The two
committees put forth unanimous recommendations for prioritizing pandemic flu
vaccine. Their recommendations were incorporated into the HHS Pandemic Plan,
and are displayed in Table 2.
Healthcare workers with direct patient contact and those involved in making the
vaccine were given top priority by the committees. Next were those at highest risk
of serious complications from flu. During seasonal flu, and during the 1957 and
1968 pandemics, those at highest risk were the very old, the very young, and
individuals with certain serious chronic diseases. The committees noted that during
a pandemic other groups may be shown to be at higher risk, and that tiers could be
redefined according to the specific epidemiologic findings. For example, during the
1918 pandemic, healthy young people were found to be at increased risk of death
when they became infected. According to the committees’ estimates, more than 60%
of the U.S. population, including most children, would not fall into any of the
designated priority groups.
76 See CRS Report RS22453, Avian Flu Pandemic: Potential Impact of Trade Disruptions,
by Danielle Langton.
77 Charles M. Helms, NVAC Chairman, letter to HHS Acting Assistant Secretary for Health
Cristina V. Beato, on NVAC recommendations regarding priority use of vaccine and
antiviral drugs during an influenza pandemic, Aug. 10, 2005, at [http://www.hhs.gov/
Table 2. NVAC and ACIP Recommendations
for Pandemic Vaccine Priority Groups
(persons in thousands)
Group and TierGrouptotalCumulativetotal
Healthcare workers with direct patient contact9,0009,000
Vaccine and antivirals manufacturing personnel409,040
1BHighest risk of serious flu complications25,84034,880
1CPregnant women, immunocompromised individuals,and household contacts of infants 10,70045,580
1DKey government leaders and responders15145,731
2ARest of high risk individuals59,100104,831
2BMost critical infrastructure and public healthemergency responders8,500113,331
3Other key government health decision makers,mortuary services personnel500113,831
4Healthy 2- to 64-year-olds not in other groups179,260293,091
The proposed scheme comports with a tradition in public health practice to
prioritize the most vulnerable, in this case those most vulnerable to severe
complications from flu. Such a strategy does not necessarily save the most lives,
though. To accomplish that when resources are scarce, resources would be given to
those most likely to survive or to have better outcomes as a result, to the extent that
one could determine who those people were. Conversely, treatment would be
withheld from those who were unlikely to benefit, so that others may. The HHS
proposal has prompted considerable debate about strategies for withholding resources
during a pandemic, and shown that rationing schemes to optimize one goal (e.g.,
equity and fairness) may conflict with schemes to optimize another (e.g., slowing
disease transmission). These are ethically complex decisions with which the civilian
medical community has little experience.78
Although HHS included recommendations for vaccine priorities in its pandemic
plan, these recommendations may change. On December 14, 2006, HHS published
a request for information (RFI) in the Federal Register asking for “input on pandemic
influenza vaccine prioritization considerations from all interested and affected
78 For further discussion, see CRS Report RL33381, The Americans with Disabilities Act
(ADA): Allocation of Scarce Medical Resources During a Pandemic, by Nancy Lee Jones,
and the section on Strategies for Rationing in CRS Report RL32655, Influenza Vaccine
Shortages and Implications, by Sarah A. Lister and Erin D. Williams.
parties....”79 The Implementation Plan requires HHS, in coordination with DHS, to
make priority recommendations for access to pre-pandemic and pandemic influenza
vaccines. The recommendations are to reflect the pandemic response goals that were
described in the National Strategy,80 as well as maintaining national security. A
federal interagency working group has been established to recommend priority
groups, and the RFI will provide information for the working group. The working
group’s draft guidance and recommendations will be published in the Federal
Register for comment. HHS noted that it was particularly interested in responses to
several questions concerning priorities for vaccines, including, “How can fairness,
equity, efficiency and related principles be reflected in the determination of priority
groupings for receipt of pre-pandemic or pandemic vaccine?” The initial deadline for
responses to HHS was January 18, 2007; it was subsequently extended to February
Influenza Vaccine Supply and Use
Overview. Vaccination is considered the best preventive measure for influenza.
But, because of continuous changes in the genes of flu viruses, vaccines must be
“matched” to specific strains to provide good protection. Flu vaccine is currently
produced in chicken eggs, using a time-consuming process with a six-month lead
time. Since a vaccine could not be mass produced against a pandemic flu strain until
that strain emerged, planning assumes that a matched flu vaccine would not be
available for initial global pandemic control. Health officials are working to increase
the speed of flu vaccine production, to increase global flu vaccine production
capacity, to develop and create limited stockpiles of prototype vaccines for H5N1 and
other novel flu strains, and to develop “universal” flu vaccines that don’t require
strain matching for effectiveness.
On November 1, 2005, the Administration requested $7.1 billion in emergency
funding for pandemic preparedness. Congress provided FY2006 emergency
supplemental appropriations of $3.8 billion in December 2005, of which $3.3 billion
was provided to HHS. A second FY2006 supplemental appropriation in June 2006
provided HHS with an additional $2.3 billion.82 The bulk of this funding has gone
to support flu vaccine related activities. The Administration has established two
primary vaccine goals: (1) establishment and maintenance of stockpiles of pre-
pandemic vaccine adequate to immunize 20 million persons against influenza strains
79 71 Federal Register 75252, Dec. 14, 2006.
80 These goals are: (1) stopping, slowing or otherwise limiting the spread of a pandemic to
the United States; (2) limiting the domestic spread of a pandemic, and mitigating disease,
suffering and death; and (3) sustaining infrastructure and mitigating impact to the economy
and the functioning of society. National Strategy, p. 2.
81 See HHS, “Request for Information (RFI): Guidance for Prioritization of Pre-pandemic
and Pandemic Influenza Vaccine,” at [http://aspe.hhs.gov/PIV/RFI/]; and CRS Report
RL33381, The Americans with Disabilities Act (ADA): Allocation of Scarce Medical
Resources During a Pandemic, by Nancy Lee Jones.
82 See CRS Report RS22576, Pandemic Influenza: Appropriations for Public Health
Preparedness and Response, by Sarah A. Lister.
that present a pandemic threat; and (2) expansion of domestic influenza vaccine
manufacturing surge capacity for the production of pandemic vaccines for the entire
domestic population within six months of a pandemic declaration.83
Limited Vaccine Production Capacity. In 2005, there was worldwide
capacity to produce at most 300 million doses of injectable trivalent flu vaccine, the84
annual vaccine that contains three different strains of influenza. Only one (sanofi
pasteur85) of nine manufacturers was located in the United States. WHO reports that86
in 2006, worldwide capacity had expanded to 400 million doses. Though
production capacity can, in theory, be tripled by converting to single-strain
production for a pandemic vaccine, two doses (vs. the single dose given each year)
may be required to afford protection, because there is no prior immunity to be
“boosted.” Furthermore, in initial trials of an H5N1 prototype vaccine, immunity
was produced only by very high doses of viral antigen, which means that more
capacity would be needed to make a given number of doses.
One means to increase domestic vaccine production capacity is to expand
manufacturing infrastructure. In July 2006, HHS issued a solicitation for proposals
to retrofit existing domestic manufacturing facilities to enable the emergency
production of pandemic vaccine. HHS plans to award these contracts in February
2007. HHS plans to issue a request for proposals later in 2007 to assist in building
new domestic manufacturing plants to produce of seasonal and pandemic influenza
vaccines using new cell-based technologies, which may have several advantages over
Vaccine Research and Development. In addition to expanding bricks-
and-mortar vaccine capacity, HHS has also used emergency supplemental
appropriations to award contracts for research on improved methods of flu vaccine
production. Research efforts, generally overseen by the NIH, include cell-based
(rather than egg-based) production, recombinant and DNA vaccines, and so-called
“antigen-sparing” approaches to boost the immune response to lower doses of virus.
NIH also supports intramural and extramural research to enhance understanding of
the basic nature of human immunity to influenza, and efforts to develop a universal
vaccine that would provide durable immunity against diverse flu strains, eliminating
83 Implementation Plan,” p. 9.
84 David S. Fedson, “Preparing for Pandemic Vaccination: An International Policy Agenda
for Vaccine Development,” Journal of Public Health Policy, Vol. 26, pp. 4-29, 2005,
(hereafter called Fedson article), at [http://www.palgrave-journals.com/jphp/fedson.pdf].
85 The company does not use capital letters in its name.
86 WHO, “WHO Reports Some Promising Results on Avian Influenza Vaccines,” press
release, Feb. 16, 2007, at [http://www.who.int/mediacentre/news/notes/2007/np07/en/
87 See testimony of Gerald W. Parker, Principal Deputy Assistant Secretary, Office of the
Assistant Secretary for Preparedness and Response, HHS, hearing on “Pandemic Flu:
Progress Made and Challenges Ahead,” before the U.S. Senate Committee on
Appropriations, Subcommittee on Labor, Health and Human Services, Education andthst
Related Agencies, 110 Cong., 1 Sess., Jan. 24, 2007.
the need for annual vaccination and protecting against pandemic flu strains that have
yet to emerge.88
Global Vaccine Availability. Some have been critical of the U.S. approach
to pandemic flu vaccine development, which sets the goal of universal vaccine
availability for Americans, but does not address the provision of vaccine to other89
countries. In early February 2007, officials in Indonesia announced that they would
no longer provide WHO with samples of H5N1 avian flu affecting their country,
samples that are used by manufacturers to develop pandemic vaccines that would not
likely be available to developing countries during a pandemic. On February 16,
Indonesian officials and the WHO jointly announced an agreement whereby
Indonesia would resume sending avian flu virus samples to the WHO as soon as it90
is guaranteed access to affordable vaccines against the disease. The episode
foreshadows the types of international tensions that may arise during a pandemic.91
Regulatory Issues. From a regulatory standpoint, the Food and Drug
Administration (FDA) considers that a pandemic flu vaccine produced using
currently-approved processes would merely represent a strain change (as with
seasonal flu vaccine), not a new product.92 This would allow for a streamlined
approval process in which a licensed manufacturer would submit additional
information as a supplement to its current product license. The agency considers that
virus derived by reverse genetics or grown using cell culture methods does not pose
additional regulatory obstacles.93 Prototype human vaccines ideally should undergo
clinical trials to establish efficacy, dosage and scheduling protocols. The FDA
88 Ibid. See, also, testimony of Anthony S. Fauci, Director, National Institute of Allergy and
Infectious Diseases, National Institutes of Health, HHS, hearing on “Pandemic Flu: Progress
Made and Challenges Ahead,” before the U.S. Senate Committee on Appropriations,
Subcommittee on Labor, Health and Human Services, Education and Related Agencies,
110th Cong., 1st Sess., Jan. 24, 2007; and CBO, “A Potential Influenza Pandemic: An
Update on Possible Macroeconomic Effects and Policy Issues,” p. 1, May 22, 2006, revised
July 27, 2006.
89 See, for example, the Fedson article.
90 Donald G. McNeil Jr., “Indonesia and WHO in Accord on Flu Virus,” The International
Herald Tribune, Feb. 19, 2007.
91 See “Global Solidarity Needed in Preparing for Pandemic Influenza,” The Lancet,
editorial, vol. 369, p. 532, Feb. 17, 2007; and WHO, “WHO Reports Some Promising
Results on Avian Influenza Vaccines,” press release, Feb. 16, 2007, at [http://www.who.int/
mediacentre/news /notes/2007/np07/en/index.html ].
92 Presentation of Jesse L. Goodman, Director, FDA Center for Biologics Evaluation and
Research, “Meeting the Challenge of Pandemic Vaccine Preparedness: An FDA
Perspective,” at the Institute of Medicine Symposium on Pandemic Influenza Research, Apr.
“FDA Aims to Approve New Flu Treatments in Weeks,” Dow Jones News Service, Nov.
93 Reverse genetics is a technique to modify viruses so they can be grown more easily for
vaccine production. Cell culture is a streamlined method of growing large amounts of virus.
Both techniques are explained in greater detail in CRS Report RL32655, Influenza Vaccine
Shortages and Implications, by Sarah A Lister and Erin D. Williams.
recommends that these trials be carried out before a pandemic occurs, to the extent
The HHS final plan notes that if a pandemic were to spread swiftly, pandemic
vaccine may be pressed into service before standard safety and efficacy tests could
be completed. Such unlicensed vaccine could be used under FDA’s Investigational
New Drug (IND) provisions. These include strict inventory control, record keeping,
and informed consent requirements, which would pose an additional challenge for
public health officials during a vaccination campaign.
Congress provided an additional mechanism, permitting the use of unapproved
drugs and vaccines in an emergency, in the Project BioShield Act of 2004 (P.L. 108-
276). This Emergency Use Authorization (EUA) permits the use of unapproved
products during a declared public health emergency when alternatives are not
available.94 In early 2005, when FDA issued an EUA for an anthrax vaccine for the
military, the agency noted that the statute is self-executing, and that implementing
regulations were not required.95
Intellectual Property Issues. To produce a vaccine against H5N1 or
another pandemic flu strain, scientists start with a virus in circulation, and modify it
for mass production. Flu virus for vaccine is grown in fertilized chicken eggs. Avian
flu strains must first be weakened, or attenuated, or they would kill the chicken
embryos, making it impossible to produce vaccine. Traditionally, flu viruses were
attenuated using a cumbersome trial-and-error gene-swapping process. In developing
prototype H5N1 vaccines, the virus was attenuated using a process called reverse
genetics (RG). RG is a more efficient and reliable means of genetic modification,
which removes unwanted genes and substitutes others.
RG is a patented invention. One of the patent holders, Medimmune, Inc., has
waived compensation for production of prototype pandemic flu vaccines and clinical
trials, saying that it had:
notified the World Health Organization in December 2003 that it would grant
free access to its intellectual property to government organizations and
companies developing pandemic influenza vaccines gratis for public health
purposes. In addition, MedImmune, Inc., has given similar notification to NIH
and (other officials) in the United States, and the National Institute for Biological
Standards and Control (NIBSC) in the United Kingdom. For corporate
manufacturers considering the commercial sale of pandemic influenza vaccines
produced by reverse genetics, MedImmune, Inc., has sent out letters to all such
94 FDA, “Emergency Use Authorization of Medical Products,” draft guidance, not for
implementation, June 2005, at [http://www.fda.gov/oc/bioterrorism/emergency_use.html].
This emergency us e authority is somewhat broader than the Secretary’s authority to declare
a public health emergency. For more information, see the Appendix, “Federal Public Health
Emergency Authorities,” in CRS Report RL33579, The Public Health and Medical
Response to Disasters: Federal Authority and Funding, by Sarah A. Lister.
95 FDA, “Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of
Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack With
Anthrax; Availability,” 70 Federal Register 5452, Feb. 2, 2005.
manufacturers offering licenses to its intellectual property under reasonable96
In the United States, the federal government may use patented processes without
consent, as long as the patent holder is appropriately compensated.97 The situation
is more complicated in other countries with vaccine plants (mainly in Europe), and
would require that certain agreements among RG patent holders and governments be
ironed out before mass production could begin.
Vaccine Tracking and Distribution. The sudden shortage of seasonal flu
vaccine in the United States for the 2004-2005 season offered an unplanned exercise
for pandemic preparedness, highlighting the implications of limited production
capacity for vaccines and antiviral drugs, and the absence of a coordinated national
system for their distribution.
In December 2006, Congress passed P.L. 109-417, the Pandemic and All-
Hazards Preparedness Act. The act authorizes the Secretary of HHS, with the
voluntary cooperation of manufacturers, wholesalers, and distributors, to track the
initial distribution of federally purchased flu vaccine during a pandemic. The act also
requires the Secretary to improve the effective distribution of seasonal flu vaccine,
by promoting communication between state, local, and tribal public health officials
and those manufacturers, wholesalers, and distributors who agree to participate in the
tracking program. Vaccine distribution information submitted to the Secretary shall
remain confidential in accordance with the exception to the Freedom of Information
Act (FOIA) governing trade secrets and commercial or financial information, and be
subject to the privacy regulations promulgated under the Health Insurance Portability
and Accountability Act of 1996 (P.L. 104-191).
Antiviral Drug Supply and Use
Since pandemic flu vaccine would be unavailable in the early stages of a
pandemic, governments and private parties have been interested in drugs that could
treat or prevent serious illness from flu. Because influenza is a virus, antibiotics,
which treat bacterial infections, are not effective in treating the direct effects of flu.
Two types of antiviral drugs have been developed to treat flu: adamantanes and
neuraminidase inhibitors (NIs).98 Though both types are used to treat serious
infections of seasonal influenza, the H5N1 flu strain has been shown to be resistant
to adamantanes. Hence, planning efforts for a possible H5N1 pandemic have focused
on NIs. Two NIs are available, and both are licensed by the FDA: oseltamivir
(Tamiflu®) and zanamivir (Relenza®). The drugs can be used either for treatment
96 See Statement from Medimmune, Inc., regarding reverse genetics technology, in “Reverse
Genetics, Intellectual Property, and Influenza Vaccination,” Institute of Medicine, The
Threat of Pandemic Influenza: Are We Ready? Workshop Summary, p. 192 ff., Nov. 2004,
97 See CRS Report RL32051: Innovation and Intellectual Property Issues in Homeland
Security, by John R. Thomas. This authority is based in existing law and does not require
an emergency declaration or other special circumstance.
98 See CDC, antivirals for influenza, at [http://www.cdc.gov/flu/professionals/treatment/].
when someone is severely ill with flu, or for prevention in those at risk of severe
illness. When used for prevention, also called prophylaxis, the drug must be given
for weeks (rather than the five-day treatment regime), as long the flu virus is in
circulation. This has implications for stockpiling, and for the potential development
of viral resistance to the drugs.
WHO has recommended that countries create stockpiles of NIs to prepare for
a pandemic. Initially, the availability and cost of Tamiflu, a patented drug, were of
concern to government officials seeking to acquire the drug in large amounts for their
citizens. The patent holder, the Swiss pharmaceutical company Roche, Inc., has
since signed agreements to manufacture the drug with more than 15 external
contractors in 10 different countries.99 Several countries have stockpiled enough
Tamiflu to treat one-fifth or more of their populations.
The federal government has established two primary goals for stockpiling
existing antiviral medications: (1) establishment and maintenance of stockpiles
adequate to treat 75 million persons (one-fourth of the population), divided between
federal and state stockpiles; and (2) establishment and maintenance of a federal
stockpile of 6 million treatment courses reserved for domestic containment efforts.100
States were expected to procure 31 million of the 75 million treatment courses, for
which HHS would reimburse 25% of the cost. Some public health officials and
Members of Congress protested the 75% state matching requirement.101 In an
October 2006 survey of state health officials, 29 reported that they had not yet
identified and put in place state funds to purchase antiviral drugs, though all but 10
of them reported that they planned, ultimately, to purchase the full amount allotted
to them under the federal subsidy program.102
Priority groups for antiviral drugs are laid out in the HHS Pandemic Plan,
beginning with treatment for those who are admitted to hospitals with severe illness
from flu. Priority categories are otherwise fairly similar to those for vaccine (See
Table 2.), encompassing certain groups of high risk individuals as well as healthcare
workers and other responders.
In June 2005, it was reported that farmers in China were using the flu antiviral
drug amantadine (an adamantane) to treat poultry flocks to prevent avian flu, and that
this may have caused the H5N1 strain to become resistant to the drug.103 Health
99 See CRS Report RL33159, Influenza Antiviral Drugs and Patent Law Issues, by Brian T.
100 National Strategy, p. 9.
101 See Gardiner Harris, “Administration’s Flu Plan Gets Mixed Reception in Congress,” The
New York Times, Nov. 3, 2005.
102 Association of State and Territorial Health Officials, (ASTHO), “ASTHO Survey of State
and Territorial Pandemic Influenza Antiviral Purchase and Stockpiling,” Oct. 2006, at
[http://www.astho.org/pubs/AntiviralSurvey121806.pdf]. Respondents included officials
from all 50 states, the District of Columbia, and three territories.
103 See, for example, Fu Jing, “Misuse of Antiviral on Poultry Must Stop,” China Daily, June
officials in China and elsewhere denounced the practice. Tamiflu, the more widely
available of the two NIs, is generally effective against H5N1 flu, but resistance to the
drug has been documented in strains of seasonal flu that circle the globe each year,
and in at least four cases of H5N1 avian flu in humans. Scientists caution that
resistance to Tamiflu could become a problem if the drug were pressed into service
during an influenza pandemic, especially if it were used for prolonged periods for
prophylaxis.104 In March 2006, the FDA issued an order prohibiting the extra-label
use, in poultry, of all approved human anti-influenza drugs, to help prevent the
emergence of resistance, preserving the effectiveness of these drugs for treating or
preventing influenza infections in humans.105
Public health officials have cautioned against an over-reliance on antiviral drugs
in pandemic planning. There would likely be limited availability, and drug resistance
could emerge as a serious problem. Also, it has not been clearly shown that
treatment with Tamiflu, for example, would actually improve survival rates in
clinical settings during a potential H5N1 pandemic.106 Nonetheless, given that the
best pandemic response tool — vaccine — will be largely unavailable in the early
going, governments can offer antiviral drug stockpiling as a tangible effort to protect
Liability and Compensation for Pandemic Countermeasures
Status of Current Planning Efforts. Certain vaccines are covered under
the National Vaccine Injury Compensation Program (VICP). Under VICP, an excise
tax applied to vaccine sales pays for a public compensation fund. Congress enacted
the program in 1986 as a no-fault alternative to the tort system for resolving personal
injury claims resulting from adverse reactions to selected childhood vaccines (i.e.,
those that CDC has recommended be routinely administered to children.) Individuals
of any age alleging injury from any covered vaccine must seek compensation through107
the program first, though they may decline a proposed award and then sue in court.
In the American Jobs Creation Act of 2004 (P.L.108-357), Congress added trivalent
flu vaccine — the annual vaccine that contains three flu strains — to the Vaccine
Injury Table, a list of vaccines covered under VICP. Since the law explicitly covered
trivalent vaccine, monovalent (or single-strain) pandemic vaccines would not be
covered under this mechanism.
104 Q. Mai Le, “Avian Flu: Isolation of Drug-resistant H5N1 Virus,” Nature 437, 1108 Oct,
20, 2005; and Luciana L. Borio and John G. Bartlett, “Isolation of H5N1 Influenza Virus
Resistant to Oseltamivir,” Clinician’s Biosecurity Network Weekly Bulletin, Oct. 18, 2005.
105 71 Federal Register 14374-14377, Mar. 22, 2006.
106 In addition, Tamiflu may, in some people, cause adverse effects that would require that
it be discontinued. See CDC, “Antiviral Medications for Influenza,” at [http://www.cdc.gov/
107 For more information, see the National Vaccine Injury Compensation Program Home
Page at [http://www.hrsa.gov/vaccinecompensation/].
In December 2005, Congress passed P.L. 109-148, the Department of Defense,
Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of
Mexico, and Pandemic Influenza Act, 2006. Division C of the act limits liability
with respect to countermeasures (including vaccine) for pandemic flu and other
public health emergencies. Specifically, upon a declaration by the Secretary of HHS
of a public health emergency, or the credible risk of such emergency, the act would,
with respect to a “covered countermeasure,” eliminate liability (except in the case of
willful misconduct) for the United States, and for manufacturers, distributors,
program planners, persons who prescribe, administer or dispense the countermeasure,
and employees of any of the above.
On February 1, 2007, HHS Secretary Leavitt made a declaration of emergency
pursuant to P.L. 109-148, saying he had “determined there is a credible risk that the
spread of avian influenza viruses and resulting disease could in the future constitute
a public health emergency,” triggering liability protections solely for “pandemic
countermeasure influenza A (H5N1) vaccine....”108 The declaration is effective from
December 1, 2006 through February 28, 2010.
P.L. 109-148 also called for the establishment in the Treasury of the “Covered
Countermeasure Process Fund” to provide compensation to eligible individuals for
covered injuries (i.e., serious physical injury or death) directly caused by the
administration or use of a covered countermeasure during a declared public health
emergency, depending upon an appropriation to the fund. The act does not establish
appropriations authority for the fund, however.109
The Implementation Plan tasked HHS with developing a protocol and decision
tools for medical countermeasures, to implement the act’s liability protections and
compensation mechanism. HHS published its protocol and decision tool in December
Smallpox Vaccine Injury Compensation. During implementation of the
smallpox vaccination program in 2003, Congress grappled with waiving liability in
order to protect the manufacturer, public officials, health providers and others who
would make, recommend and deliver the product, while assuring that those who
suffered adverse events resulting from the vaccine could be appropriately
compensated.111 The smallpox vaccine used for the 2003 campaign carries an
unusually high risk of adverse events, and most scientists do not believe that a
pandemic flu vaccine would carry a comparable risk.
108 72 Federal Register 4710-4711, Feb. 1, 2007.
109 For more information, see CRS Report RS22327, Pandemic Flu and Medical Biodefense
Countermeasure Liability Limitation, by Henry Cohen.
110 HHS, “Public Readiness and Emergency Preparedness Act (PREP Act) for Pandemic
Influenza Medical Countermeasures Utilization Protocol & Decision Tools,” Dec. 4, 2006,
111 See CRS Report RL31960, Smallpox Vaccine Injury Compensation, by Susan Thaul.
The 1976 Swine Flu Affair. A 1976 vaccination campaign that was intended
to protect Americans from the threat of a swine flu pandemic in 1976 is often referred112
to as a debacle. In January 1976, a novel influenza strain (“swine flu”) emerged
in New Jersey. In March, the Ford Administration announced a campaign to
vaccinate the U.S. population by December. On August 18, Congress passed P.L.
94-380, the National Swine Flu Immunization Program of 1976. Among other
provisions, the law shielded manufacturers, distributors, and public or private
organizations that would administer the vaccine, from claims of injury or death that
might result, and established that all such claims would be asserted directly against
the United States. More than 40 million civilians were vaccinated against swine flu
between October 1 and December 16. The campaign was suspended at that time due
to several cases of Guillain-Barré syndrome, a potentially serious neurological
condition causing paralysis and sometimes death, suspected to have been caused by
the vaccine. Meanwhile, a flu pandemic never emerged. The worrisome virus from
New Jersey never led to a global pandemic, or even to localized outbreaks. The
federal government ultimately paid out $93 million to individuals injured by the113
Analysts have commented that delays in indemnifying manufacturers threatened
the availability of swine flu vaccine in 1976, while delays in providing for injury
compensation compromised voluntary participation in the civilian smallpox vaccine
campaign in 2003. A successful emergency vaccination campaign may depend on
resolving both policy concerns expediently.
Influenza as a Weapon
In the late 1990s, Congress authorized the Select Agent program to track the
movement of certain bacteria and viruses that could potentially be used as biological
weapons.114 The program, which is administered by CDC and the U.S. Department
of Agriculture, was expanded in statute following the anthrax attacks of 2001. An
interagency working group determines which pathogens to place on the list of Select
Agents. Once an organism is listed, those individuals and facilities working with it
must be registered, undergo background investigations, and follow various guidelines
in facility maintenance and management, shipping, recordkeeping and other
practices. The list does not include common human strains of influenza, though it
does include highly pathogenic strains of avian influenza, i.e., strains which are
shown to cause disease in commercial poultry. As such, H5N1 influenza is a listed
pathogen. When scientists from the CDC and the Armed Forces Institute of
112 Sources for this section are: Richard E. Neustadt and Harvey V. Fineberg, The Swine Flu
Affair, a report to the Secretary of Health, Education and Welfare, June, 1978; and HHS
Draft Pandemic Influenza Preparedness and Response Plan, Annex 11: “Lessons Learned
from the 1976 Swine Influenza Program,” Aug. 2004.
113 U.S. Department of Justice, Civil Division, Torts Branch, “Swine Flu Statistics,” Jan. 3,
1991. Overall, 4,179 claims were filed under the act. Not all claims were resolved
administratively, and 1,604 claimants proceeded to file suit.
114 For more information, see the CDC Select Agent program page at [http://www.
cdc.gov/od/sap] and CRS Report RL31719, An Overview of the U.S. Public Health System
in the Context of Emergency Preparedness, by Sarah A. Lister.
Pathology recently re-created the 1918 pandemic flu virus, since it was a human
influenza virus, it was not on the Select Agent list. It was subsequently added by
HHS Secretary Leavitt on October 20, 2005.115 Other flu strains that typically affect
humans (rather than birds) remain unregulated at this time.
When asked about the possibility that influenza viruses could be used
deliberately as biological weapons, CDC Director Julie Gerberding replied, “... we
recognize that influenza has some of the important characteristics of an excellent
threat agent. It’s easily transmissible, it’s relatively easy to produce and it’s very easy
to modify or engineer. So it does have characteristics that if a person was intent on
modifying ..., it is not beyond our imagination to consider that beyond our
preparedness efforts.”116 Dr. Gerberding also noted the natural behavior of the virus,
which constantly shuffles its genes to produce new combinations, saying that “mother
nature herself is a very effective terrorist.”
If H5N1 avian flu were to cause a human pandemic, it would be reasonable to
assume it was a natural event. Nonetheless, since influenza viruses are amenable to
intentional manipulation, the Implementation Plan states that in the event of a
pandemic, “The Federal Bureau of Investigation (FBI) will closely monitor events
through coordination with the [CDC] and take appropriate action in the event that it
is suspected that there was deliberate human intervention in the spread of the
115 CDC, “Possession, Use, and Transfer of Select Agents and Toxins - Reconstructed
Replication Competent Forms of the 1918 Pandemic Influenza Virus Containing Any
Portion of the Coding Regions of All Eight Gene Segments,” 70 Federal Register 61047,
Oct. 20, 2005.
116 Testimony of CDC Director Julie Gerberding before the House Committee on Homeland
Security, Subcommittee on Prevention of Nuclear and Biological Attacks, hearing onthst
“National Biodefense Strategy,” July 28, 2005, 109 Congress, 1 Sess.
117 Implementation Plan, p. 156.