The 2009 Influenza Pandemic: An Overview
Sarah A. Lister
Specialist in Public Health and Epidemiology
C. Stephen Redhead
Specialist in Health Policy
June 12, 2009
Congressional Research Service
7-5700
www.crs.gov
R40554
CRS Report for Congress
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repared for Members and Committees of Congress
The 2009 Influenza Pandemic: An Overview
Summary
On April 29, 2009, in response to the global spread of a new strain of influenza, the World Health
Organization (WHO) raised its influenza (“flu”) pandemic alert level to Phase 5, one level below
declaring that a global influenza pandemic was underway. On June 11, as the virus continued to
spread on several continents, WHO declared the outbreak to be an influenza pandemic (Phase 6).
WHO’s pandemic declaration is based on the geographic spread of the virus, not on a worsening
of the severity of the illnesses it causes.
Officials now believe the outbreak of the new flu strain began in Mexico in March 2009, or
perhaps earlier. The novel “H1N1 swine flu” was first identified in California in late April. Health
officials quickly linked the new virus to many of the illnesses in Mexico. Since then, cases have
been reported around the world. As of June 11, 2009, almost 29,000 cases were reported in 74
countries, on all continents but Antarctica. Most of the reported cases are in Mexico, the United
States, and Canada. However, increasing numbers of cases are now reported in Argentina, Chile,
Australia, and other countries in the Southern Hemisphere, as their winter approaches and flu
transmission becomes more efficient. Health officials note that reported cases likely represent
only a fraction of actual infections. For example, a U.S. official commented in May that there
may actually have been upwards of 100,000 cases thus far in the United States.
Investigations to date suggest that human infections with the new flu strain are usually mild,
although severe illnesses and deaths have been reported. This pattern is similar to the behavior of
seasonal flu, which circulates the globe each year. It is also consistent with the likelihood of
substantial underreporting, as noted above. Health officials continue to monitor the situation,
saying that the efficiency of viral transmission and the severity of illness could change.
When the outbreak began in late April, U.S. federal agencies adopted a pandemic response
posture under the overall coordination of the Secretary of Homeland Security. Among other
things, officials have released antiviral drugs from the national stockpile, and launched efforts to
develop and manufacture a vaccine. The Obama Administration has requested about $9 billion in
emergency supplemental appropriations and contingent budget transfer authorities to address the
threat. House and Senate appropriators have included pandemic flu funding in pending FY2009
supplemental appropriations. Congressional committees in both chambers have convened
hearings to assess the situation.
This report first provides a synopsis of key events, actions taken, and authorities invoked by
WHO, the U.S. federal government, and state and local governments. It then discusses the WHO
process to determine the phase of a flu pandemic, and selected actions taken by the Departments
of Homeland Security and Health and Human Services, and by state and local authorities. Next, it
lists congressional hearings held to date, and provides information about appropriations and
funding for pandemic flu activities. Finally, it summarizes U.S. government pandemic flu
planning documents and lists sources for additional information about the situation as it unfolds.
This report will be continually updated to reflect unfolding events.
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The 2009 Influenza Pandemic: An Overview
Contents
Synopsis ..................................................................................................................................... 1
Key Official Actions by WHO..................................................................................................... 4
Determination of Influenza Pandemic Phase.......................................................................... 4
International Health Regulations ........................................................................................... 6
Travel Guidance.................................................................................................................... 7
Food Safety Guidance ........................................................................................................... 7
Key U.S. Government Actions ....................................................................................................7
Department of Homeland Security (DHS) ............................................................................. 7
Leadership Designation................................................................................................... 7
Customs and Border Protection (CBP) Activities............................................................. 8
Department of Health and Human Services (HHS) ................................................................ 8
Determination of a Public Health Emergency .................................................................. 8
FDA: Emergency Use Authorizations.............................................................................. 9
CDC: Travel Notices ....................................................................................................... 9
CDC: Disease Surveillance ............................................................................................. 9
Vaccine Development and Use ...................................................................................... 11
Naming the Virus Strain ...................................................................................................... 13
Key State and Local Actions................................................................................................ 14
School Closures ............................................................................................................ 14
Congressional Hearings............................................................................................................. 16
Senate ................................................................................................................................. 16
House ................................................................................................................................. 16
Appropriations and Funding...................................................................................................... 17
Public Health Emergency Funding Mechanisms .................................................................. 17
Emergency Supplemental Appropriations for FY2009 ......................................................... 18
Prior Funding for Pandemic Flu Preparedness ..................................................................... 20
U.S. Pandemic Influenza Preparedness Documents ................................................................... 21
Key Information Sources........................................................................................................... 23
CRS Reports and Experts .................................................................................................... 23
World Health Organization (WHO) Information.................................................................. 24
U.S. Federal Government Information................................................................................. 25
Additional Information........................................................................................................ 25
Figures
Figure 1. WHO Influenza Pandemic Phases................................................................................. 6
Figure 2. Proposed Timeline for H1N1 Vaccine Development, Manufacturing, and
Possible Distribution and Administration................................................................................ 12
Tables
Table 1. WHO Influenza Pandemic Phases .................................................................................. 5
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Table 2. HHS Funding for Pandemic Influenza, FY2004-FY2010.............................................. 21
Contacts
Author Contact Information ...................................................................................................... 26
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The 2009 Influenza Pandemic: An Overview
Synopsis
On April 29, 2009, in response to the global spread of a new “H1N1” strain of influenza, the
World Health Organization (WHO) raised its influenza (“flu”) pandemic alert level to Phase 5,
one level below declaring that a global influenza pandemic was underway. On June 11, as the
virus continued to spread on several continents, WHO declared the outbreak to be an influenza
pandemic (Phase 6). WHO’s pandemic declaration is based on the geographic spread of the virus,
not on a worsening of the severity of illnesses it causes.
Officials now believe the outbreak of the new flu strain began in Mexico in March 2009, or
perhaps earlier. The novel “H1N1 swine flu” was first identified in California in late April. Health
officials quickly linked the new virus to many of the illnesses in Mexico. Since then, cases have
been reported around the world. As of June 11, 2009, almost 29,000 cases were reported in 74
countries, on all continents but Antarctica. Most of the reported cases are in Mexico, the United
States, and Canada. However, increasing numbers of cases are now reported in Argentina, Chile,
Australia, and other countries in the Southern Hemisphere, as their winter approaches and flu
transmission becomes more efficient. Health officials note that reported cases likely represent
only a fraction of actual infections. For example, a U.S. official commented in May that there
may actually have been upwards of 100,000 cases thus far in the United States.
2009 Influenza Pandemic Status
International: World Health Organization (WHO): Outbreak Status as of June 11, 2009
(http://www.who.int/csr/disease/swineflu/en/index.html)
• WHO declared an influenza pandemic (Phase 6) on June 11, 2009.
• WHO reports almost 29,000 cases in 74 countries around the world, including 144 deaths. Most of the reported
deaths occurred in Mexico.
• WHO advises no restriction of regular travel or closure of borders; however, sick individuals are advised to
delay travel. No infection risk from consumption of well-cooked pork products.
United States Centers for Disease Control and Prevention (CDC), Food and Drug Administration
(FDA): Outbreak Status as of June 5, 2009 (http://www.cdc.gov/h1n1flu; http://www.fda.gov/h1n1flu)
• CDC reports a total of 13,217 cases in al 50 states, DC, and PR, including 27 deaths. Officials say that reported
cases most likely underestimate the actual number of infections.
• The Acting Health and Human Services Secretary declared a public health emergency on April 26.
• CDC has released to states 11 million treatment courses of the antiviral drugs Tamiflu and Relenza, and sent an
additional 400,000 courses to Mexico.
• FDA has issued Emergency Use Authorizations for certain unapproved uses of Tamiflu and Relenza, and for use
of an unapproved diagnostic test for the new H1N1 strain.
• CDC has issued mitigation guidance for the general public; specific guidance for clinicians and laboratories, and
regarding pregnant women and other groups; and recommendations for affected schools and communities. CDC
rescinded a prior recommendation against non-essential travel to Mexico.
• Federal government and manufacturers are developing a vaccine against the new H1N1 strain.
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The 2009 Influenza Pandemic: An Overview
The new flu strain responsible for the outbreak is an apparent reassortment of several existing
strains of influenza A subtype H1N1 virus, including strains typically found in pigs, birds, and
humans (see box below). The U.S. Centers for Disease Control and Prevention (CDC) reports that
the symptoms and transmission of the novel H1N1 flu from person to person are much like that of
seasonal flu. Laboratory testing of the new strain indicates that the antiviral drugs oseltamivir
(Tamiflu) and zanamivir (Relenza) are expected, in most cases, to be effective in treating illnesses
that result from this new strain.
In response to the situation, Janet Napolitano, Secretary of the Department of Homeland Security
(DHS), has assumed the role of Principal Federal Official, coordinating federal response efforts.
Charles E. Johnson, then the Acting Secretary of Health and Human Services (HHS), declared a
public health emergency. Among other things, this allowed the Food and Drug Administration
(FDA) to issue Emergency Use Authorizations (EUAs), permitting certain unapproved uses of
Tamiflu and Relenza (such as in very young children), as well as the use of an unapproved
diagnostic test for the new flu strain, and unapproved uses of some types of protective facemasks.
CDC has released stocks of Tamiflu and Relenza, respiratory protection devices, and other
medical supplies, from the Strategic National Stockpile (SNS), to help states respond to the
outbreak. CDC reports that it has released to state health officials 11 million of the 50 million
treatment courses of Tamiflu and Relenza stockpiled in the SNS, and purchased additional
courses to replenish the stockpile. CDC also has activated its Emergency Operations Centers to
coordinate the agency’s response to the outbreak, and sent 400,000 treatment courses of antiviral
drugs to Mexico. CDC’s initial advice to travelers to postpone all non-essential travel to Mexico
has been rescinded, and travelers are now urged to take appropriate precautions while traveling.
According to DHS, U.S. border control agents are visually inspecting incoming travelers from
Mexico, and referring those who appear to be sick to CDC quarantine stations or local health
officials. Administration officials have resisted calls to implement more aggressive measures such
as closing the U.S.-Mexico border, noting that the new flu strain is already in the United States
and that the focus of mitigation strategies is on where U.S. illnesses are being reported, and on
patients’ families and their surrounding communities.
In the United States, many affected communities implemented school closures when students
were found to be infected with the new H1N1 flu strain. Those decisions, made by local officials,
were based on an initial CDC recommendation that communities with confirmed H1N1 flu cases
consider closing schools for up to 14 days, depending on the extent and severity of illness. CDC
revised its initial guidance as it became clear that the virus was circulating widely in affected
communities and that illnesses caused by the new strain were generally mild. It now recommends
against routine school closures when small number of students are infected, arguing that such
closures do little to reduce the spread of a virus that is already in circulation while placing a
considerable burden on the affected community. CDC’s actions and those of local education
authorities illustrate the challenges facing government officials as they attempt to make evidence-
based decisions about community mitigation interventions in a constantly changing environment.
Health officials note that as the new flu strain spreads and the number of reported cases grows,
precise case counts are less meaningful for purposes of disease control. The CDC has begun
tracking illnesses at the population (rather than individual) level using its multi-layered
surveillance system for seasonal flu, which tracks hospitalizations, outpatient medical visits, and
other measures. One CDC official commented that reported cases of H1N1 flu probably represent
only a fraction of actual cases, saying that early findings from the seasonal flu surveillance
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The 2009 Influenza Pandemic: An Overview
systems suggest that the actual number of cases in the United States thus far may be upwards of
100,000.1
The U.S. response to the current situation triggers a slate of pandemic flu plans that were
developed, beginning around 2004, to address concerns about the global spread of another novel
flu strain, the H5N1 avian flu. In FY2006 supplemental appropriations, Congress provided $6.1
billion for pandemic planning across several departments and agencies.2 These earlier efforts, and
others aimed at preparedness for bioterrorism and emerging infections in general, have generally
streamlined the response to the new H1N1 flu.
Influenza Defined
Influenza (“flu”) is a respiratory illness that can be transmitted from person to person. Flu viruses are of two main
genetic types: Influenza A and B. Influenza A strains are further identified by two important surface proteins that are
responsible for virulence: hemagglutinin (H) and neuraminidase (N).
Seasonal flu circulates each year in the winter in each hemisphere. The dominant flu strains in global circulation
change from year to year, but most people have some immunity; infection can be fatal. CDC estimates that there are
about 36,000 deaths from seasonal flu each year, on average. Vaccines are made each year based on predictions of the
strains that are most likely to circulate in the upcoming flu season.
Avian flu (“bird flu”) is caused by viruses that occur naturally among wild birds, and that may also affect domestic
poultry. In 1997 a new H5N1 strain of avian flu emerged in Asia, and has since caused millions of deaths among
domestic poultry, and hundreds of deaths in humans. Health officials have been concerned that this strain could cause
a human pandemic, and governments around the world have carried out a number of preparedness activities,
including vaccine development and stockpiling, and planning for continuity of services.
Swine flu occurs naturally and may cause outbreaks among wild and domestic swine. People do not normally get
swine flu, but each year CDC identifies a few isolated cases of human flu that are caused by flu strains typical y
associated with swine.
Pandemic flu is caused when a novel strain of human flu (i.e., one that spreads from person to person) emerges and
causes a global outbreak, or pandemic, of serious illness. Because there is little natural immunity, the disease is often
more severe than is typical of seasonal flu.
(Adapted from HHS, “Flu Terms Defined,” http://www.pandemicflu.gov. For more information about pandemic flu,
see “Understanding Pandemic Influenza” in CRS Report RL33145, Pandemic Influenza: Domestic Preparedness Efforts.)
To address the threat, the Obama Administration has requested more than $4 billion in emergency
supplemental appropriations, and has asked for budget transfer authorities to mobilize additional
amounts. Funds were also requested in regular FY2010 appropriations. House and Senate
appropriators have included pandemic flu funding in pending FY2009 supplemental
appropriations legislation. Congressional committees in both chambers have convened hearings
to assess the situation.
Efforts to prepare for a possible mass vaccination campaign are underway, including development
of and clinical trials on a prototype vaccine, and limited mass production of pilot lots. Federal
officials note that a decision to actually administer vaccine broadly across the population would
be made separately, based on circumstances in the future.
1 Comments of Dr. Dan Jernigan, deputy director of CDC’s influenza division, “CDC Telebriefing on Investigation of
Human Cases of H1N1 Flu,” transcript, May 15, 2009, http://www.cdc.gov/media/.
2 CRS Report RS22576, Pandemic Influenza: Appropriations for Public Health Preparedness and Response, by Sarah
A. Lister.
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This report describes the WHO process to determine the phase of a threatened or emerging flu
pandemic and touches on several related issues. It then provides additional information about
selected actions taken by the Departments of Homeland Security (DHS) and Health and Human
Services (HHS), and by state and local authorities; lists congressional hearings held to date; and
provides information about appropriations and funding for pandemic flu activities. Finally, the
report summarizes U.S. government pandemic flu planning documents and lists sources for
additional information about the situation as it unfolds. All dates refer to 2009 unless otherwise
specified. This report will be continually updated to reflect unfolding events.
Key Official Actions by WHO
Determination of Influenza Pandemic Phase
The World Health Organization is the coordinating authority for health within the United Nations
system. It is responsible for providing leadership, guiding a research agenda, setting norms and
standards, articulating evidence-based policy options, providing technical support to countries,
and monitoring and assessing health trends. WHO does not have enforcement powers.
An influenza pandemic occurs when a novel flu strain emerges and spreads across the globe,
causing human illnesses. For that to happen, the virus must have the following features: it must be
genetically novel so that there is a lack of preexisting immunity; it must be pathogenic (i.e.,
capable of causing illness in humans); and it must be easily transmitted from person to person.
WHO, in consultation with experts in member countries, monitors the spread of influenza among
human populations, and has developed a scale to monitor pandemic risk. It consists of five “pre-
pandemic” phases with increasing incidence of animal and then human illness and transmission,
and a sixth phase that represents a full-blown human pandemic, with sustained viral transmission
and outbreaks in most or all regions of the world. Historically, flu pandemics have occurred in
multiple waves before subsiding. Table 1 describes WHO’s phases of a flu pandemic.
As a result of the rapid spread of the new flu strain, WHO raised the pandemic alert level from
Phase 3, where it had been for several years because of the threat of H5N1 avian flu, to Phase 4
on April 27, and then to Phase 5 on April 29.3 Phase 3 meant that a novel flu strain was causing
sporadic small clusters of human illness, but was not sufficiently transmissible to sustain
community-level outbreaks. Phase 4, by contrast, signaled that human-to-human transmission of
the new H1N1 virus was sufficient to sustain community-level outbreaks. According to WHO,
raising the alert level to Phase 5 meant that there was sustained community-level transmission in
two or more countries within one WHO region, and that a pandemic could be imminent. The
pandemic phases are depicted in graphical form in Figure 1. The figure displays Phases 5 and 6
together, signifying that Phase 5 is a call for concerted global pandemic response efforts.4
3 WHO, “Influenza A(H1N1),” http://www.who.int/csr/disease/swineflu/en/index.html.
4 WHO, and its regional office for the Americas, the Pan American Health Organization (PAHO), have also developed
interactive maps to track the locations of cases of the new H1N1 flu strain. WHO maps are updated and linked from
daily situation updates at http://www.who.int/csr/disease/swineflu/en/index.html; see, also, PAHO, “Laboratory
Confirmed Human Cases of Influenza A/H1N1,” http://ais.paho.org/flu/sm/en/atlas.html.
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The 2009 Influenza Pandemic: An Overview
On June 11, WHO raised the level to Phase 6, declaring that an influenza pandemic, caused by the
new H1N1 strain, was underway.5 According to WHO Director General Dr. Margaret Chan:
Spread in several countries can no longer be traced to clearly-defined chains of human-to-
human transmission. Further spread is considered inevitable.... The world is now at the start
of the 2009 influenza pandemic. We are in the earliest days of the pandemic. The virus is
spreading under a close and careful watch. No previous pandemic has been detected so early
or watched so closely, in real-time, right at the very beginning. The world can now reap the
benefits of investments, over the last five years, in pandemic preparedness.6
Table 1. WHO Influenza Pandemic Phases
(current alert level is highlighted)
Phase Description
Phase 1
No animal influenza virus circulating among animals has been reported to cause infection in
humans.
Phase 2
An animal influenza virus circulating in domesticated or wild animals is known to have caused
infection in humans and is therefore considered a specific potential pandemic threat.
Phase 3
An animal or human-animal influenza reassortanta virus has caused sporadic cases of smal clusters
of disease in people, but has not resulted in human-to-human transmission sufficient to sustain
community-level outbreaks.
Phase 4
Human-to-human transmission of an animal or human-animal influenza reassortant a virus able to
sustain community-level outbreaks has been verified.
Phase 5
The same identified virus has caused sustained community-level outbreaks in two or more
countries in one WHO region.b
Phase 6
An influenza pandemic. In addition to the criteria defined in Phase 5, the same virus has caused
sustained community-level outbreaks in at least one other country in another WHO region.b
Post-peak
Levels of pandemic influenza in most countries with adequate surveillance have dropped below
Period
peak levels.
Possible New
Level of pandemic influenza activity in most countries with adequate surveillance rising again.
Wave
Post-pandemic
Levels of influenza activity have returned to the levels seen for seasonal influenza in most
Period
countries with adequate surveillance.
Source: Adapted from WHO, Pandemic Influenza Preparedness and Response: A WHO Guidance Document, April
2009, Table 1, p. 13, http://www.who.int/csr/disease/influenza/pipguidance2009/en/index.html.
a. A reassortant virus results from a genetic reassortment process in which genes from animal and human
influenza viruses mix together to create a new strain.
b. WHO governs through six regional offices that do not strictly correspond with the world’s continents. The
WHO regions are the African Region; the Region of the Americas; the South-East Asia Region; the
European Region; the Eastern Mediterranean Region; and the Western Pacific Region. See “WHO–Its
People and Offices,” http://www.who.int/about/structure/en/index.html.
For several years, WHO urged governments, corporations, and other interests to develop
pandemic influenza preparedness and response plans. Generally these plans are staged according
5 WHO, “World Now at the Start of 2009 Influenza Pandemic” (Statement of Dr. Margaret Chan), press release, June
12, 2009, http://www.who.int/csr/disease/swineflu/en/index.html.
6 Ibid.
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to WHO pandemic phases. WHO has noted that under the current definitions, pandemic phases
do not reflect the severity of illness, but rather the global extent of sustained community-level
outbreaks. Some members of the public, however, have come to think of any flu pandemic as a
catastrophic incident on the scale of the one that occurred in 1918, or that many have feared
might result from the deadly H5N1 avian flu if it became transmissible among humans. Some
have argued that the definition of a pandemic should be rewritten to take severity into account,
and that a Phase 6 pandemic designation for the current H1N1 flu situation could trigger over-
reactions that were more disruptive than the disease.7
Figure 1. WHO Influenza Pandemic Phases
Source: WHO, Pandemic Influenza Preparedness and Response: A WHO Guidance Document, April 2009, Figure 3,
p. 31, http://www.who.int/csr/disease/influenza/pipguidance2009/en/index.html.
International Health Regulations
In 2005, the World Health Assembly adopted a revision of the International Health Regulations
(IHR), giving a new mandate to WHO and member states to increase their respective roles and
responsibilities for the protection of international public health. The IHR(2005) require signatory
nations (which include the United States) to notify WHO of all events that may constitute a
“Public Health Emergency of International Concern,” and to provide information regarding such
events. The IHR(2005) also include provisions regarding designated national points of contact,
definitions of core public health capacities, disease control measures such as quarantine and
border controls, and others. The IHR(2005) require WHO to recommend, and signatories to use,
control measures that are no more restrictive than necessary to achieve the desired level of health
protection.8
7 See, for example, Robert Roos, “WHO Drawing Closer to Declaring a Pandemic,” CIDRAP News (Center for
Infectious Disease Research and Policy), June 2, 2009, http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/
index.html.
8 For more information, see CRS Report R40560, The 2009 Influenza A(H1N1) Outbreak: Selected Legal Issues,
coordinated by Kathleen S. Swendiman and Nancy Lee Jones.
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On April 25, 2009, upon the advice of the Emergency Committee called under the rules of the
IHR(2005), the WHO Director-General declared the global threat of H1N1 flu a Public Health
Emergency of International Concern. This designation calls upon signatories to provide timely
and transparent notification of events to WHO, to collaborate with other countries in disease
reporting and control, and to adopt effective risk communication strategies to reduce the potential
for international disease spread and the likelihood of unilateral imposition of trade or travel
restrictions by other countries.9
Travel Guidance
A number of governments have instituted enhanced passenger screening practices at their borders,
and policymakers have debated more extensive prohibitions against the entry of travelers from
countries or areas affected by the outbreak. The WHO has consistently advised against movement
restrictions as a means to control influenza, citing a lack of evidence of their effectiveness,
coupled with their potentially harmful effects on public confidence, local economies, and trade.10
Food Safety Guidance
WHO has published a joint statement with Food and Agriculture Organization of the United
Nations (FAO), the World Organization for Animal Health (known by its French acronym, OIE),
and the World Trade Organization (WTO), saying:
In light of the spread of influenza A(H1N1), and the rising concerns about the possibility of
this virus being found in pigs and the safety of pork and pork products, we stress that pork
and pork products, handled in accordance with good hygienic practices recommended by the
WHO, FAO, Codex Alimentarius Commission and the OIE, will not be a source of infection.
To date there is no evidence that the virus is transmitted by food. There is currently therefore
no justification in the OIE Terrestrial Animal Health Standards Code for the imposition of
trade measures on the importation of pigs or their products.11
Key U.S. Government Actions
Department of Homeland Security (DHS)
Leadership Designation
On April 27, Janet Napolitano, Secretary of the Department of Homeland Security (DHS), stated
in a press briefing that she was serving as the coordinator of the federal response to the flu
9 WHO, International Health Regulations, http://www.who.int/ihr/en/.
10 WHO, No Rationale for Travel Restrictions, May 1, 2009, http://www.who.int/csr/disease/swineflu/guidance/
public_health/travel_advice/en/index.html.
11 Joint FAO, OIE, WHO and WTO Statement on A(H1N1) virus, May 2, 2009, http://www.wto.org/english/news_e/
news09_e/jt_stat_02may09_e.htm. See, also, CRS Report R40575, Potential Farm Sector Effects of 2009 H1N1
“Swine Flu”: Questions and Answers , by Renée Johnson.
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outbreak, having assumed the role of Principal Federal Official (PFO).12 According to the
National Response Framework (NRF), which guides a coordinated federal response to disasters
and emergencies in general, the Secretary of Homeland Security leads federal incident response.13
Customs and Border Protection (CBP) Activities
Customs and Border Protection (CBP), in DHS, is reportedly monitoring incoming travelers at
ports of entry (typically a visual inspection for possible symptoms), providing information about
disease control measures, and referring symptomatic persons to a CDC quarantine station14 or a
local public health official for evaluation. According to CBP, “at this time all U.S. ports of entry
are open and operating as normal with officers using risk based border screening.”15
Administration officials resisted calls to implement more aggressive measures such as closing the
U.S.-Mexico border. They commented that such a measure could be highly disruptive and not
necessarily effective at controlling the spread of disease, and argued instead that the new flu
strain is already in the United States, and that the focus of mitigation strategies is on where U.S.
illnesses are being reported, and on patients’ families and their surrounding communities.16 WHO
and CDC officials have commented that scientific evidence does not support closure of a border
to travelers as an effective means of controlling the spread of influenza.17
Department of Health and Human Services (HHS)
Determination of a Public Health Emergency
On April 26, Charles E. Johnson, then the Acting HHS Secretary, who is responsible for
coordinating the public health and medical response to the flu outbreak, declared a public health
emergency pursuant to Section 319 of the Public Health Service Act.18 Among other things, this
authority enables FDA to implement an authority in the Federal Food, Drug, and Cosmetic Act—
the so-called Emergency Use Authorization (discussed below)—allowing for the use of
unapproved medical treatments and tests, under specified conditions, if needed during an
incident.
12 Department of Homeland Security, Remarks by Secretary Napolitano at Media Briefing on H1N1 Flu Outbreak,
April 27, 2009, http://www.dhs.gov/ynews/.
13 CRS Report RL34758, The National Response Framework: Overview and Possible Issues for Congress, by Bruce R.
Lindsay. The PFO position has been controversial, however, because it may conflict with the role of the Federal
Coordinating Officer (FCO), a leadership position established in the Robert T. Stafford Disaster Relief and Emergency
Assistance Act (the Stafford Act).
14 CDC, Quarantine Stations, http://www.cdc.gov/ncidod/dq/quarantine_stations.htm.
15 U.S. Customs and Border Protection, CBP Monitors H1N1 Flu Outbreak; All Ports Operating Routinely, April 30,
2009, http://www.cbp.gov/xp/cgov/newsroom/alerts/flu/.
16 See also “Closing the Border” in CRS Report R40560, The 2009 Influenza A(H1N1) Outbreak: Selected Legal
Issues, coordinated by Kathleen S. Swendiman and Nancy Lee Jones.
17 Donald G. McNeil, “Containing Flu Is Not Feasible, Specialists Say,” The New York Times, April 29, 2009. See also
WHO, No Rationale for Travel Restrictions, May 1, 2009, http://www.who.int/csr/disease/swineflu/guidance/
public_health/travel_advice/en/index.html.
18 HHS, “HHS Declares Public Health Emergency for Swine Flu,” press release, April 26, 2009, http://www.hhs.gov/
news. More information about this authority is available in CRS Report RL33579, The Public Health and Medical
Response to Disasters: Federal Authority and Funding, by Sarah A. Lister, and CRS Report R40560, The 2009
Influenza A(H1N1) Outbreak: Selected Legal Issues, coordinated by Kathleen S. Swendiman and Nancy Lee Jones.
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FDA: Emergency Use Authorizations
If an emerging public health threat is identified for which no licensed or approved product exists,
the Federal Food, Drug and Cosmetic Act authorizes the FDA Commissioner to issue an
Emergency Use Authorization (EUA) so that unapproved but potentially helpful countermeasures
can be used to protect the public health.19 On April 27, pursuant to authority provided by the prior
public health emergency determination, FDA issued EUAs to allow emergency use of (1)
oseltamivir (Tamiflu) and zanamivir (Relenza) for the treatment and prophylaxis of influenza; (2)
disposable respirators for use by the general public; and (3) an unapproved diagnostic test for the
new flu strain.20
CDC: Travel Notices
On April 27, CDC issued a Travel Health Warning, its highest advisory level, recommending that
U.S. travelers avoid all nonessential travel to Mexico.21 (The agency had issued a Travel Health
Precaution, the next lower advisory level, on April 25.) On April 28, the Department of State
issued a travel alert to U.S. citizens of the health risks of travel to Mexico due to the flu outbreak,
noting the CDC’s Travel Health Warning of the previous day.22 On May 15, CDC downgraded the
Travel Health Warning for Mexico, returning to the precaution level, and the Department of State
lifted its travel alert. Travelers to Mexico are advised to be alert regarding local conditions,
practice good hygiene, and consult with their physicians regarding any health conditions that
could put them at higher risk of illness.23 Each of these advisories regarding travelers leaving the
United States is voluntary.
CDC: Disease Surveillance
Because illnesses with the novel H1N1 flu have generally been mild, health officials
acknowledge that the disease may be substantially underreported. It is likely that for every
infection that results in a health care encounter and a confirmed laboratory test, there are many
mild infections for which victims don’t seek care, and silent infections in which individuals may
be infectious to others in the absence of symptoms. Health officials in many U.S. states and cities
have stopped running confirmatory tests on every suspected case of H1N1 influenza, feeling that
better use of epidemiology and laboratory resources can be made by monitoring disease spread to
new areas, rather than repeatedly confirming its presence in an affected area.24
19 Food and Drug Administration, Guidance: Emergency Use Authorization of Medical Products, July 2007,
http://www.fda.gov/oc/guidance/emergencyuse.html.
20 Information is available at CDC, “Swine Flu: Emergency Use Authorization (EUA) of Medical Products and
Devices,” http://www.cdc.gov/swineflu/eua/, and FDA, “2009 H1N1 (Swine) Flu Virus,” http://www.fda.gov/
NewsEvents/PublicHealthFocus/ucm150305.htm.
21 CDC, “Travel Health Warning: Travel Warning: Swine Influenza and Severe Cases of Respiratory Illness in
Mexico–Avoid Nonessential Travel to Mexico,” April 27, 2009.
22 U.S. Department of State, Bureau of Consular Affairs, “Travel Alert: Mexico - 2009-H1N1 Influenza,” April 28,
2009.
23 CDC, “Travel Health Precaution: Travel Health Warning for Novel H1N1 Flu in Mexico Removed,” May 15, 2009,
http://wwwn.cdc.gov/travel/content/travel-health-precaution/novel-h1n1-flu-mexico.aspx; and U.S. Department of
State, Bureau of Consular Affairs, “Travel Alert: Mexico - 2009-H1N1 Influenza,” May 15, 2009,
http://travel.state.gov/travel/cis_pa_tw/pa/pa_3028.html.
24 This approach should not affect medical care. Clinicians are advised to provide care, including treatment with
(continued...)
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To get a clearer picture of the magnitude and spread of disease in the United States, CDC has
begun tracking the H1N1 outbreak using its multi-layered surveillance system for seasonal flu.25
The system showed that during the week ending May 30, 2009, there were higher levels of flu-
like illness than is normal for this time of year, that flu activity had decreased in comparison to
the previous few weeks, and that approximately 82% of all flu viruses reported to CDC that week
were the new H1N1 strain.
To track seasonal flu, CDC collects, compiles, and analyzes information from various sources
year round, and publishes a weekly report from October through mid-May. The surveillance
system is a collaboration between CDC and state and local health departments, public health and
private clinical laboratories, vital statistics offices, health care providers, clinics, and emergency
departments. Information is collected from several different data sources, as follows:
• Viral Surveillance: About 80 U.S. WHO Collaborating Laboratories and 70 National
Respiratory and Enteric Virus Surveillance System (NREVSS) laboratories across the
country report the number of respiratory specimens tested and the number positive
for flu virus. All state public health laboratories participate as WHO collaborating
laboratories, along with some county public health laboratories and some large
medical centers. Most NREVSS participants are hospital laboratories.
• Outpatient Illness Surveillance: Information on patient visits to health care providers
for influenza-like illness (ILI) is collected through the U.S. Outpatient Influenza-like
Illness Surveillance Network (ILINet).
• Mortality Surveillance: Rapid tracking of influenza-associated deaths is done through
two systems: (1) The 122 Cities Mortality Reporting System. Each week, the vital
statistics offices of 122 cities report the total number of death certificates received
and the number of those for which pneumonia or influenza was listed as the
underlying or contributing cause of death; (2) Surveillance for Influenza-associated
Pediatric Mortality. Influenza-associated deaths in children is a nationally notifiable
condition. Laboratory-confirmed influenza-associated deaths in children are reported
through the National Notifiable Disease Surveillance System.26
• Hospitalization Surveillance: Two systems monitor hospitalizations with laboratory
confirmed flu infections: (1) The Emerging Infections Program (EIP) Influenza
Project conducts surveillance for laboratory-confirmed influenza-related
hospitalizations in children and adults in 60 counties covering 12 metropolitan areas
of 10 states.27 (2) The New Vaccine Surveillance Network (NVSN) provides
(...continued)
antiviral drugs, based on the severity of a patient’s symptoms, the presence of conditions that would place a patient at
greater risk of severe infection, and other clinical considerations. It is not necessary that H1N1 flu be confirmed in
order for appropriate treatment to be provided.
25 Information in this section is drawn from CDC, “Novel Influenza A (H1N1) – Congressional Update,” Issue #13,
May 13, 2009; and CDC, “FluView: A Weekly Influenza Surveillance Report Prepared by the Influenza Division,”
http://www.cdc.gov/flu/weekly/.
26 For more information, see CDC, “National Notifiable Diseases Surveillance System,” http://www.cdc.gov/ncphi/
disss/nndss/nndsshis.htm.
27 San Francisco CA, Denver CO, New Haven CT, Atlanta GA, Baltimore MD, Minneapolis/St. Paul MN,
Albuquerque NM, Las Cruces, NM, Albany NY, Rochester NY, Portland OR, and Nashville TN.
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The 2009 Influenza Pandemic: An Overview
estimates of laboratory-confirmed flu hospitalization rates for young children in three
counties: Hamilton County, OH; Davidson County, TN; and Monroe County, NY.
• Summary of the Geographic Spread of Influenza: State health departments report the
estimated level of spread of flu activity in their states each week through the state and
territorial epidemiologists’ reports.
Vaccine Development and Use
Vaccination is considered the best preventive measure against influenza. But, because of
continuous changes in the genes of flu viruses, vaccines must be “matched” to strains in
circulation to provoke good immunity. Vaccine is currently produced through a time-consuming
process, using chicken eggs, with a lead time of four months or more. Since a vaccine cannot be
produced for a flu pandemic until that strain emerges, a matched vaccine would not be available
for initial global pandemic response.28 Recent U.S. pandemic planning efforts have focused on (1)
expanding domestic capacity to mass-produce flu vaccine in the near term; (2) developing
approaches to speed up and “stretch” existing production capacity, such as through the use of
adjuvants, vaccine additives that boost the immune response so that a lower virus dose is
effective; and (3) developing better approaches for flu vaccine production in the future. Although
recent progress has been made to improve domestic production capacity, a vaccine for the current
H1N1 pandemic will still be made using the egg-based process, with its significant lag time.
U.S. efforts to make a vaccine against H1N1 pandemic flu are underway. Federal officials have
said that there are three key decision points in developing and using vaccines in response to a flu
pandemic: (1) to develop prototype or “seed strain” viruses with the proper characteristics to
produce a safe and effective vaccine, to develop a prototype vaccine(s), and to conduct clinical
trials on the prototype(s); (2) to purchase and mass-produce large amounts of a promising
vaccine; and (3) to administer the vaccine widely, that is, to conduct a mass-vaccination
campaign. These decision points are presented, in a timeline of the U.S. pandemic flu vaccine
strategy, in Figure 2. Each of these decision points is distinct. The first step has begun, and the
second is partly underway. Officials note that it is important to begin production of a pandemic
vaccine at this time, but that a decision to administer the vaccine, once it were available, would be
made separately, based on conditions at the time.29
Figure 2 also shows that there may be a second wave of transmission of H1N1 flu in the United
States in the fall, which could occur between peaks of seasonal and pandemic flu activity in the
Southern Hemisphere (i.e., during summer in the United States), and seasonal flu activity in the
Northern Hemisphere (i.e., during our upcoming winter). The figure illustrates the three types of
activities corresponding to the decision points noted earlier: (1) vaccine development; (2) vaccine
manufacturing; and (3) vaccine distribution and administration. Each type of activity involves
several distinct steps, some of which must be carried out sequentially, and others of which could
be carried out simultaneously. The figure also shows the overlap between the production of
seasonal flu vaccine for the Northern Hemisphere, and production of a vaccine against the
pandemic strain.
28 For more information about flu vaccine development and manufacturing, see Congressional Budget Office, U.S.
Policy Regarding Pandemic-Influenza Vaccines, September 2008, https://www.cbo.gov/ftpdocs/95xx/doc9573/09-15-
PandemicFlu.pdf.
29 See, for example, transcript of CDC media briefing, comments of Dr. Anne Schuchat, June 11, 2009,
http://www.cdc.gov/media/.
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Figure 2. Proposed Timeline for H1N1 Vaccine Development, Manufacturing, and Possible Distribution and Administration
Source: Adapted by CRS from background material provided for a meeting of the National Biodefense Science Board (administered by HHS) regarding the U.S. 2009
H1N1 vaccine strategy, May 22, 2009, http://www.hhs.gov/aspr/conferences/nbsb/090522-nbsb-meeting.html.
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The 2009 Influenza Pandemic: An Overview
On May 22, HHS Secretary Kathleen Sebelius announced that approximately $1 billion in
existing funds were to be used for clinical trials on H1N1 prototype vaccines, to be conducted
over the summer, and for commercial-scale production of two potential vaccine ingredients for
the pre-pandemic influenza stockpile.30 Also in May 2009, HHS issued new orders on existing
contracts with several flu vaccine manufacturers to produce a bulk supply of vaccine antigen and
adjuvant and to produce pilot (also called investigational) lots of a 2009 H1N1 vaccine. Most of
this would be stored in bulk, and a small amount would be prepared as vaccine for use in clinical
studies to evaluate vaccine safety and the dosage required for a protective effect. This research is
to include studies with adjuvant to determine its safety and the effect it would have on the
immune system’s response.31 These efforts are led by the HHS Biomedical Advanced Research
and Development Authority (BARDA), in coordination with FDA, CDC, and other HHS
agencies.
If federal officials decide to request and purchase enough vaccine against H1N1 flu to support a
mass vaccination campaign, sufficient doses32 would not be available until the fall of 2009,
because of the timing and capacity limitations discussed earlier. Financing for this purchase
would also have to be established. President Obama has requested substantial funding and budget
transfer authority in pending FY2009 supplemental appropriations, which could support this
objective. (See the section “Emergency Supplemental Appropriations for FY2009”.)
If federal officials also decide to launch a mass vaccination campaign, several key decisions
would have to be made. It is not yet clear whether such a campaign would use the private-sector
distribution mechanism that delivers seasonal flu vaccine each year, or the public sector
mechanism that CDC, state, and local officials have practiced to distribute countermeasures from
the Strategic National Stockpile. This key decision would affect several others, including how to
prioritize vaccine (which would become available in phases) to those most in need,33 and how to
track who has received the vaccine, and any adverse events that occur in those who receive it.
Naming the Virus Strain
When news of the outbreak of a new flu strain emerged, WHO, CDC, and others referred to the
virus as H1N1 “swine influenza” or “swine-origin influenza.” This is based on the presumed
evolutionary origin of the strain from strains that circulate in swine, since it contains genetic
material typically found in North American and Eurasian swine flu strains. There has been no
30 HHS, “HHS Takes Additional Steps Toward Development of Vaccine for the Novel Influenza A (H1N1),” press
release, May 22, 2009, http://www.hhs.gov/news/.
31 HHS, Biomedical Advanced Research and Development Authority (BARDA), “HHS 2009 H1N1 Vaccine
Development Activities,” https://www.medicalcountermeasures.gov/BARDA/MCM/panflu/factsheet.aspx, and “2009-
H1N1 Influenza Vaccine Development Next Steps: Questions and Answers,”
https://www.medicalcountermeasures.gov/BARDA/MCM/panflu/nextsteps.aspx.
32 Presuming that two doses of vaccine per person would be needed to provoke good immunity, approximately 600
million doses would be needed for a universal vaccination campaign in the United States.
33 If necessary, CDC would provide guidance based on the epidemiology of infections at the time. Currently, people
with underlying chronic health conditions appear to be at greater risk from severe illness from H1N1 flu, and the
elderly appear to be at lower risk than is typically seen with seasonal flu. These patterns could change as the pandemic
progresses. For information about possible approaches to the prioritization of vaccine, see CRS Report RL33381, The
Americans with Disabilities Act (ADA): Allocation of Scarce Medical Resources During a Pandemic, by Nancy Lee
Jones; and “Rationing Scarce Resources” in CRS Report RL33145, Pandemic Influenza: Domestic Preparedness
Efforts, by Sarah A. Lister.
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evidence to date that pigs are involved in the transmission of this virus to humans, however.
There have been concerns that the term “swine flu” has had unwarranted economic and trade
implications for swine and pork products, among other concerns.34 Others have raised concerns
that because of religious practices that call for the avoidance of swine and pork products by some
persons of Jewish or Muslim faiths, disease control measures may be compromised in these
groups if illness is perceived as a social stigma. On April 29, 2009, officials from HHS, DHS, and
other federal agencies referred to the virus as “2009 H1N1.”35 On April 30, 2009, WHO began
referring to the new strain as influenza A(H1N1).
On May 2, the Canadian Food Inspection Agency reported finding the H1N1 outbreak strain in a
swine herd in Alberta, the first time the strain has been identified in swine. Preliminary
investigation suggests that the herd was exposed to the virus from a Canadian worker who had
recently returned from Mexico and had been exhibiting flu-like symptoms when he worked in
proximity to the swine.36
Key State and Local Actions
School Closures37
When the H1N1 outbreak first began in the United States, many affected communities closed
schools when students were found to be infected with the new flu strain. Legal authority to close
schools rests with state or local officials and is highly variable among the states. A CDC-
requested study found that school closure is legally possible in most jurisdictions during both
routine and emergency situations.38 The study also indicated that state authority for closure may
be vested at various levels of government and in different departments, generally the state or local
education agencies or state or local departments of health.
In keeping with its obligation to provide public health assistance to states, on May 1, CDC, in
consultation with the U.S. Department of Education, issued guidance with respect to school
closures during the outbreak, recommending that “affected communities with laboratory-
confirmed cases of influenza A H1N1 consider adopting school dismissal and childcare closure
measures, including closing for up to 14 days depending on the extent and severity of illness.”39
34 CRS Report R40575, Potential Farm Sector Effects of 2009 H1N1 “Swine Flu”: Questions and Answers , by Renée
Johnson.
35 See, for example, HHS, “Secretary of Health and Human Services Kathleen Sebelius Holds News Conference on
Swine Flu,” transcript, comments of Anthony Fauci, Director of the National Institute of Allergy and Infectious
Diseases, National Institutes of Health, April 29, 2009.
36 Canadian Food Inspection Agency, “An Alberta Swine Herd Investigated for H1N1 Flu Virus,” press release, May
2, 2009, http://www.inspection.gc.ca/english/anima/disemala/swigri/swigrie.shtml.
37 For more information, see “School Closures” in CRS Report R40560, The 2009 Influenza A(H1N1) Outbreak:
Selected Legal Issues, coordinated by Kathleen S. Swendiman and Nancy Lee Jones, and CDC, “Guidance for Child
Care Programs, Schools, Colleges and Universities,” http://www.cdc.gov/h1n1flu/guidance/.
38 James G. Hodge, Jr., Dhrubajyoti Bhattacharya, and Jennifer Gray, “Legal Preparedness for School Closures in
Response to Pandemic Influenza and Other Emergencies,” http://www.pandemicflu.gov/plan/school/
schoolclosures.pdf.
39 CDC, “Change in CDC’s School and Childcare Closure Guidance,” press release, May 5, 2009, http://www.cdc.gov/
media/. See, also, U.S. Department of Education, “H1N1 Flu Information,” http://www.ed.gov/admins/lead/safety/
emergencyplan/pandemic/index.html.
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The guidance for this particular outbreak was derived from earlier broad guidance for pandemic
planners, issued by CDC in 2007.40
School closures are challenging for all parties involved. Among other things, parents must find
alternate arrangements for care of their children, educators must adopt alternate means of
delivering their services, and children’s education may be compromised. On May 5, CDC
officials reissued their guidance regarding school closures. Noting that the disease appeared to be
widespread and generally mild, CDC said that under the circumstances, widespread school
closures may be more burdensome than beneficial to affected communities. The revised guidance
recommended against closures based on individual cases of H1N1 flu. It recommended instead
that emphasis be placed on keeping sick students and employees home, and that closings be
considered if the burdens of infection and absenteeism were substantial.41
Early in the H1N1 outbreak, officials in some school districts were criticized for being too
aggressive, sometimes closing schools in entire districts for isolated cases in individual schools.
Since then, New York City has continued to struggle with H1N1 outbreaks in schools, prompting
“some parents, school staff and teachers’ union officials [to wonder] whether the city was moving
too slowly to close schools with high absenteeism.”42 CDC’s actions and those of local education
authorities illustrate the challenges facing government officials as they attempt to make evidence-
based decisions about community mitigation interventions in a constantly changing environment.
As with CDC guidance in general, recommendations regarding school closure are intended to be
weighed by local officials in light of local circumstances. In the original guidance, as quoted
above, CDC recommended that state and local officials “consider adopting school dismissal and
childcare closure measures, including closing for up to 14 days depending on the extent and
severity of illness.”43 Although this language placed considerable discretion in local hands, local
officials may initially have been reluctant to scale back from immediate 14-day closures when the
virus was detected. In addition to initial uncertainty about the outbreak’s severity, there may also
have been uncertainty about local decision-making protocols. In an assessment of state pandemic
flu preparedness conducted by HHS and DHS in 2007 through 2008, planning for student
dismissal and school closure was found to be a weakness among the states. More than half of
them were graded as having either “many major gaps” or “inadequate preparedness” for this
planning task.44 The H1N1 outbreak will inform efforts by CDC, the Department of Education,
and state and local officials to study “lessons learned” and refine their plans for future incidents.
40 CDC, Interim Pre-pandemic Planning Guidance: Community Strategy for Pandemic Influenza Mitigation in the
United States - Early Targeted Layered use of Non-Pharmaceutical Interventions, Appendix 6, Pandemic Influenza
Community Mitigation Interim Planning Guide for Elementary and Secondary Schools, February 2007, pp. 87-91,
http://www.pandemicflu.gov/plan/community/index.html.
41 CDC, “Update on School (K–12) and Child Care Programs: Interim CDC Guidance in Response to Human
Infections with the Novel Influenza A (H1N1) Virus,” May 5, 2009 (continually updated), http://www.cdc.gov/h1n1flu/
K12_dismissal.htm.
42 Anemona Hartocollis and Javier C. Hernandez, “Fears of Swine Flu Close Three More Schools,” The New York
Times, May 15, 2009.
43 CDC, “Change in CDC’s School and Childcare Closure Guidance,” press release, May 5, 2009, http://www.cdc.gov/
media/.
44 HHS and DHS, Assessment of States’ Operating Plans to Combat Pandemic Influenza: Report to Homeland Security
Council, “Operating Objective B.4–Enhance State Plans to Enable Community Mitigation through Student Dismissal
and School Closure,” January 2009, pp. 25-26, http://www.pandemicflu.gov/plan/states/state_assessment.html.
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Congressional Hearings
Congressional committees in both chambers have convened or planned hearings to assess the
emergence of the new strain of H1N1 influenza. Hearings are listed below.
Senate
Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related
Agencies, The Public Health Response to the Swine Flu Epidemic, April 28, 2009.
Committee on Health, Education, Labor, and Pensions, The Swine Flu Epidemic: The Public
Health and Medical Response, April 29, 2009.
Committee on Homeland Security and Governmental Affairs, Swine Flu: Coordinating the
Federal Response, April 29, 2009.
Appropriations Agriculture, Rural Development, and FDA Subcommittee, Hearing to Discuss the
2009 H1N1 Virus, May 7, 2009.
Homeland Security and Governmental Affairs, Subcommittee on State, Local and Private Sector
Preparedness and Integration, Pandemic Flu: Closing the Gaps, June 3, 2009.
Homeland Security and Governmental Affairs, Subcommittee on Oversight of Government
Management, the Federal Workforce and the District of Columbia, Pandemic Flu Preparedness
and the Federal Workforce, June 16, 2009.
House
Committee on Energy and Commerce, Subcommittee on Health, Swine Flu Outbreak and the
U.S. Federal Response, April 30, 2009.
Foreign Affairs Committee, Subcommittee on Africa and Global Health, Global Health
Emergencies Hit Home: The Swine Flu Outbreak, May 6, 2009.
Committee on Education and Labor, Ensuring Preparedness Against the Flu Virus at School and
Work, May 7, 2009.
Committee on Oversight and Government Reform, Subcommittee on the Federal Workforce,
Postal Service, and the District of Columbia, Protecting the Protectors: An Assessment of Front-
Line Federal Workers in Response to the H1N1 Flu, May 14, 2009.
Committee on Oversight and Government Reform, State and Local Pandemic Preparedness, May
20, 2009.
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Appropriations and Funding
Public Health Emergency Funding Mechanisms
For the response to a public health incident the HHS Secretary may, under certain conditions, use
two designated emergency funds, discussed below. Neither has received a prior appropriation,
however, so the Secretary is not currently able to use these funding mechanisms for the response
to the H1N1 flu outbreak.
The first mechanism is a no-year “Public Health Emergency Fund,” which becomes available to
the HHS Secretary upon the determination of a public health emergency pursuant to Section 319
of the Public Health Service Act. This authority was invoked with respect to the H1N1 flu
outbreak on April 26. (See the earlier section “Determination of a Public Health Emergency.”)45
The other mechanism is the “Covered Countermeasure Process Fund,” which would be used to
provide compensation to individuals for serious physical injuries or deaths from the use of
medical countermeasures, as identified in a declaration issued by the HHS Secretary.46 A
declaration was issued for the use of the antiviral drugs Tamiflu and Relenza for a possible
pandemic flu virus in October 2008.47 If funds were available, compensation could be provided
for serious physical injuries or deaths resulting from the use of these drugs in this situation,
including for unapproved uses pursuant to the Emergency Use Authorization discussed earlier.
(See “FDA: Emergency Use Authorizations.”) On May 7, the Administration released its FY2010
budget request, which included $5 million for the fund.48 On May 14, the House passed H.R.
2346, the Supplemental Appropriations Act, 2009, which would provide $1.85 billion in
supplemental appropriations to HHS for the response to the H1N1 outbreak and pandemic flu
preparedness in general, and would allow some of the monies to be used for the Covered
Countermeasure Process Fund. The version of H.R. 2346 passed by the Senate on May 21 would
provide $900 million to HHS for pandemic preparedness, but does not specifically mention the
Covered Countermeasure Process Fund.49
45 For more information, see “Federal Funding to Support an ESF-8 Response,” in CRS Report RL33579, The Public
Health and Medical Response to Disasters: Federal Authority and Funding, by Sarah A. Lister.
46 CRS Report RS22327, Pandemic Flu and Medical Biodefense Countermeasure Liability Limitation, by Henry Cohen
and Vanessa K. Burrows. The compensation program is administered by the Health Resources and Services
Administration (HRSA) in HHS.
47 HHS, “Declaration Under the Public Readiness and Emergency Preparedness Act” (notice regarding use of Tamiflu
and Relenza), 73 Federal Register 61861-61864, October 17, 2008.
48 HHS, Health Resources and Services Administration, “Justification of Estimates for Congressional Committees,
FY2010,” pp. 352-357, http://www.hrsa.gov/about/budgetjustification/.
49 Information on the FY2009 supplemental appropriation is tracked in CRS Report R40531, FY2009 Spring
Supplemental Appropriations for Overseas Contingency Operations, coordinated by Stephen Daggett and Susan B.
Epstein.
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Emergency Supplemental Appropriations for FY200950
On April 27, Representative Obey, the Chairman of the House Appropriations Committee, and
Senator Harkin, the Chairman of the Senate Labor, Health and Human Services, Education, and
Related Agencies Appropriations Subcommittee, both suggested that Congress might add funds to
the pending FY2009 defense supplemental appropriations request to respond to the H1N1 flu
outbreak. On April 30, President Obama sent a letter to House Speaker Nancy Pelosi formally
requesting $1.5 billion for this purpose.
On May 14, the House passed H.R. 2346, the Supplemental Appropriations Act, 2009, which
would provide more than $2 billion for the current outbreak and pandemic preparedness, $550
million above the request. The bill would provide the following amounts, with instructions:51
• $1.85 billion to HHS for the Public Health and Social Services Emergency Fund,
including no less than $200 million to CDC for a number of specified activities, and
no less than $350 million to upgrade state and local public health capacity for
responding to the outbreak.
• Of the $1.3 billion to HHS that is not specifically designated, funds may be
transferred to other HHS accounts and to other federal agencies, pursuant to certain
notification requirements. These funds may also be used for purchases for the
Strategic National Stockpile, and for construction or renovation of privately owned
vaccine production facilities. Funds may also be provided to the Covered
Countermeasure Process Fund, discussed above.
• $200 million to the President for the Global Health and Child Survival account, to
support global efforts to control the spread of the outbreak.
On May 14, the Senate Committee on Appropriations marked up and reported S. 1054, the
Supplemental Appropriations Act, 2009, which would provide $1.5 billion for influenza activities,
the amount requested by the Administration.52 The committee recommended the funding for a
new account under the Executive Office of the President, as requested. On May 21, the Senate
passed an amended version of H.R. 2346, including the flu provisions in S. 1054, as follows:
• $900 million to HHS for the Public Health and Social Services Emergency Fund, for
allocation by the Secretary for pandemic preparedness and response activities
including vaccine development, purchase of antivirals and medical equipment,
diagnostic and vaccine delivery equipment, antiviral research, and support for state
and local preparedness; and an additional $50 million to the FDA for activities
including vaccine and antiviral development, manufacturer assistance, approval
reviews, and safety activities, including blood and consumer protection response.
• $190 million to DHS for activities including planning and coordination, and
purchasing personal protective equipment and antivirals for DHS personnel and state
and local responders.
50 Information in this section is tracked in greater detail in CRS Report R40531, FY2009 Spring Supplemental
Appropriations for Overseas Contingency Operations, coordinated by Stephen Daggett and Susan B. Epstein.
51 H.Rept. 111-105, pp. 38-40 and 53-54.
52 S.Rept. 111-20, pp. 58-60.
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• $100 million to the Secretary of Agriculture for activities including animal health
surveillance and disease investigation, and impacts resulting from misinformation
about flu transmission.
• $110 million for the Department of Veterans Affairs (VA), Veterans Health
Administration, for activities including purchasing protective equipment for high-risk
populations and occupations, expanding its antiviral stockpile, and improving
information technology capabilities.
• $150 million to the President for Global Health and Child Survival account, to
facilitate information sharing, limit the spread of the virus, reduce mortality and the
social and economic impacts, and respond to emergency needs in affected countries.
On June 2, while the House and Senate bills were in conference, President Obama sent another
request to Speaker Pelosi, requesting the higher amount of $2.05 billion provided in the House-
passed bill, along with additional funding and transfer authorities, to address the current H1N1 flu
outbreak and prepare for a possible pandemic.53 The new request sought an additional $2.0 billion
in appropriations, and transfer authorities that could potentially mobilize more than $6 billion in
additional funding, all to be used only if the President were to determine that the additional
resources were “required to address critical needs related to emerging influenza viruses.... ”54
The magnitude of funds that could be mobilized under the requested transfer authorities suggests
that the Administration may be looking for a means to purchase a large number of vaccines
against the H1N1 virus. Funds currently available to HHS could support vaccine development
and modest procurements, but would not be adequate for procurements and related activities
sufficient to support a mass-vaccination campaign, if one were needed. GAO has noted that the
National Strategy for Pandemic Influenza: Implementation Plan (2006), which lays out 324
action items for federal agencies to prepare for and respond to a flu pandemic, contains no
discussion of the possible costs of these actions, or how they would be financed.55 There has not
been a Stafford Act declaration for the current flu outbreak, so disaster relief funds administered
by the Federal Emergency Management Agency (FEMA) are not available for response efforts.
Many relevant activities, such as vaccine purchase, would probably not be eligible for the use of
these funds, even if they were available.56
53 Executive Office of the President, Office of Management and Budget, Estimate #5, 111th Cong., 1st Sess.,
June 2, 2009, http://www.whitehouse.gov/omb/assets/budget_amendments/supplemental_06_02_09.pdf.
54 Ibid.
55 U.S. Government Accountability Office, Influenza Pandemic: Continued Focus on the Nation’s Planning and
Preparedness Efforts Remains Essential, GAO-09-760T, June 3, 2009, pp. 10-11, http://www.gao.gov. See also
Homeland Security Council, National Strategy for Pandemic Influenza: Implementation Plan, May 2006,
http://www.pandemicflu.gov/plan/federal/pandemic-influenza-implementation.pdf.
56 The Robert T. Stafford Disaster Relief and Emergency Assistance Act (the Stafford Act) authorizes assistance to
federal, state, and local governments, and private non-profit entities, upon a Presidential declaration of emergency or
disaster. See “Federal Statutory Authorities for Disaster Response” and “Federal Funding to Support an ESF-8
Response,” in CRS Report RL33579, The Public Health and Medical Response to Disasters: Federal Authority and
Funding, by Sarah A. Lister. See also CRS Report RL34724, Would an Influenza Pandemic Qualify as a Major
Disaster Under the Stafford Act?, by Edward C. Liu.
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Prior Funding for Pandemic Flu Preparedness
In the fall of 2005, in the aftermath of Hurricane Katrina, and as H5N1 avian flu was spreading
across several continents, Congress provided $6.1 billion in FY2006 supplemental appropriations
for pandemic planning across several federal departments and agencies.57 Since then, annual
funding has been provided to CDC, FDA, and for other activities in HHS to continue work on
vaccine development, stockpiling of countermeasures, and assistance to states. In total, from
FY2004 through FY2009, HHS has received almost $7 billion for pandemic flu preparedness.58
(See Table 2.) The U.S. Departments of Agriculture and the Interior have also received annual
funding to monitor avian flu in domestic poultry and wild birds, respectively. The U.S. Agency
for International Development (USAID) has received funds to assist other countries in managing
avian flu transmission to humans, and preparing for a possible pandemic.59
In addition to amounts it specifically appropriates, Congress is also interested in how agencies
budget for influenza within their existing activities. However, defining such amounts is difficult,
for two reasons. First, for about 15 years, domestic public health capacity for infectious disease
control has moved away from “categorical” funding and programs (i.e., one disease at a time),
and toward the development of flexible capacity that can adapt to new, unanticipated threats.
These flexible surveillance systems, laboratory networks, communications platforms, and other
capabilities, can pivot rapidly to address new threats. But because pandemic planning efforts are
tightly woven into the fabric of these flexible capabilities, it is not easy to tease out threads that
describe the nation’s investment solely for pandemic flu preparedness. Any attempt to do so
requires making judgments about what is “in” and “out” of scope that are somewhat arbitrary.
Second, for similar reasons, it can be difficult to tease apart investments made for pandemic flu,
versus seasonal flu, versus avian or swine flu, versus investments in drug and vaccine
development in general. Because different agencies use different methods and assumptions to
account for their influenza spending, these amounts are not necessarily comparable between
agencies, and caution is advised in adding such amounts together as if they were comparable.
HHS has tracked its pandemic influenza funding for the past several fiscal years, using
comparable criteria from year to year. These amounts are presented in the department’s annual
budget requests, in sections designated for pandemic influenza, and are presented in Table 2.
57 CRS Report RS22576, Pandemic Influenza: Appropriations for Public Health Preparedness and Response, by Sarah
A. Lister.
58 This amount is exclusive of any funds that may be provided in pending FY2009 supplemental appropriations.
59 Information can be found in CRS Reports on the applicable appropriations bills, at http://apps.crs.gov/cli/
level_2.aspx?PRDS_CLI_ITEM_ID=73, and: CRS Report R40239, Centers for Disease Control and Prevention
Global Health Programs: FY2004-FY2009, by Tiaji Salaam-Blyther.
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Table 2. HHS Funding for Pandemic Influenza, FY2004-FY2010
(dollars in millions, rounded)
FY2009
Agency/Activity FY2004
FY2005
FY2006
FY2010
a FY2007 FY2008 FY2009b
supp.
req.
req.c
OS and/or PHSSEF
50
99
5,152
0
75
585
0
354
CDC
0 0 400 70 155 156 0 156
FDA
0 0 20 33 35 39 0 39
NIH
0 0 18 35 34 35 0 35
Executive Office of
the President
0 0 0 0 0 0
4,050 0
TOTAL,
Program Level
50 99
5,590d 138 299 815
4,050 584
Source: Compiled by Congressional Research Service from HHS annual “Budget in Brief” documents at
http://www.hhs.gov/asrt/ob/docbudget/, unless otherwise noted below.
Notes: OS is Office of the HHS Secretary. PHSSEF is Public Health and Social Services Emergency Fund, an
account administered by the Secretary, which Congress has typical y used to provide one-time funding for non-
routine activities. NIH is the National Institutes of Health.
a. Appropriated in P.L. 109-148, the Department of Defense, Emergency Supplemental Appropriations to
Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act, 2006, and P.L. 109-234, the
Emergency Supplemental Appropriations Act for Defense, the Global War on Terror, and Hurricane
Recovery, 2006. Funds are available until expended.
b. Appropriated in P.L. 111-8, the Omnibus Appropriations Act, 2009. Pandemic flu funding was not included
in P.L. 111-5, the American Recovery and Reinvestment Act of 2009 (ARRA), or other supplemental
appropriations for FY2009.
c. Amount requested includes $2.05 billion as recommended by the House, and an additional contingent $2
billion, to be used if needed. The President also requested the authority to mobilize several billion more
dollars, if needed, through specified transfers. Executive Office of the President, Office of Management and
Budget, Estimate #5, 111th Cong., 1st Sess., June 2, 2009, http://www.whitehouse.gov/omb/assets/
budget_amendments/supplemental_06_02_09.pdf. For information on congressional actions, see CRS
Report R40531, FY2009 Spring Supplemental Appropriations for Overseas Contingency Operations, coordinated
by Stephen Daggett and Susan B. Epstein.
d. Total does not include $30 million in supplemental funding to HHS that was transferred to the U.S. Agency
for International Development (USAID).
U.S. Pandemic Influenza Preparedness Documents
In the George W. Bush Administration, pandemic flu preparedness efforts were coordinated by
the Homeland Security Council.60 Numerous federal and other documents that are specific to
preparedness and response for a flu pandemic have been published. Selected documents are listed
below. These plans are intended to address a pandemic caused by any so-designated flu strain, but
60 Incident preparedness and response are different functions. At each level of government, they involve different
leadership roles, legal authorities, organizational structures, and funding mechanisms. Generally, during an incident,
certain conditions must be met before a jurisdiction can implement response activities, or access funds reserved for that
purpose. With respect to the current H1N1 flu outbreak, the U.S. federal government has commenced pandemic flu
response activities, under the overall coordination of the Secretary of Homeland Security.
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they were written when there was significant global concern about H5N1 avian flu. To date, that
flu strain has behaved quite differently from the current H1N1 outbreak strain. In particular, the
H5N1 strain has not shown the ability to transmit efficiently from person to person, but human
infections that result directly from contact with infected poultry have generally been very severe,
and there has been a high fatality rate.61
Unless otherwise noted, the U.S. pandemic flu plans below can be found on a government-wide
pandemic flu website managed by HHS.62
• The National Strategy for Pandemic Influenza, November 2005, published by the
Homeland Security Council, outlines general responsibilities of individuals, industry,
state and local governments, and the federal government in preparing for and
responding to a pandemic.
• National Strategy for Pandemic Influenza, Implementation Plan, May 2006,
published by the Homeland Security Council, assigns more than 300 preparedness
and response tasks to departments and agencies across the federal government;
includes measures of progress and timelines for implementation; provides initial
guidance for state, local, and tribal entities, businesses, schools and universities,
communities, and non-governmental organizations on the development of
institutional plans; provides initial preparedness guidance for individuals and
families. One- and two-year implementation status reports have also been published.
• The HHS Pandemic Influenza Plan, November 2005, provides guidance to national,
state and local policy makers and health departments, outlining key roles and
responsibilities during a pandemic and specifying preparedness needs and
opportunities. This plan emphasizes specific preparedness efforts in the public health
and health care sectors.
• The HHS Pandemic Influenza Implementation Plan, Part I, November 2006,
discusses department-wide activities: disease surveillance; public health
interventions; medical response; vaccines, antiviral drugs, diagnostic tests, and
personal protective equipment (PPE); communications; and state and local
preparedness.
• Interim Pre-pandemic Planning Guidance: Community Strategy for Pandemic
Influenza Mitigation in the United States–Early Targeted Layered use of Non-
Pharmaceutical Interventions, February 2007, published by CDC, guidance for
“social distancing” strategies to reduce contact between people, with respect to:
closing schools; canceling public gatherings; planning for liberal work leave policies;
teleworking strategies; voluntary isolation of cases; and voluntary quarantine of
household contacts.
• Department of Defense Implementation Plan for Pandemic Influenza, August 2006,
provides policy and guidance for the following priorities: (1) force health protection
and readiness; (2) the continuity of essential functions and services; (3) Defense
61 For more information about H5N1 avian flu and related public health concerns, see WHO, Avian influenza,
http://www.who.int/csr/disease/avian_influenza/en/index.html; WHO, Confirmed Human Cases of Avian Influenza A(H
5N1), http://www.who.int/csr/disease/avian_influenza/country/en/; and CRS Report RL33145, Pandemic Influenza:
Domestic Preparedness Efforts, by Sarah A. Lister (archived).
62 See http://www.pandemicflu.gov/plan/federal/index.html.
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support to civil authorities (i.e., federal, state, and local governments); (4) effective
communications; and (5) support to international partners.
• VA Pandemic Influenza Plan, March 2006, provides policy and instructions for
Department of Veterans Affairs (VA) in protecting its staff and the veterans it serves,
maintaining operations, cooperating with other organizations, and communicating
with stakeholders.
• Pandemic Influenza Preparedness, Response, and Recovery Guide for Critical
Infrastructure and Key Resources, published by DHS, September 2006, 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).
• State pandemic plans: All states were required to develop and submit specific plans
for pandemic flu preparedness, as a requirement of grants provided by HHS.63
Key Information Sources
CRS Reports and Experts
2009 H1N1 “Swine Flu”: CRS Experts: http://www.crs.gov/experts/WE04022.shtml
Current CRS Reports on public health and emergency preparedness in general:
http://apps.crs.gov/cli/cli.aspx?PRDS_CLI_ITEM_ID=3276&from=3&fromId=13
Current CRS Reports on specific aspects of the pandemic influenza threat:
• CRS Report R40560, The 2009 Influenza A(H1N1) Outbreak: Selected Legal Issues,
coordinated by Kathleen S. Swendiman and Nancy Lee Jones.
• CRS Report R40531, FY2009 Spring Supplemental Appropriations for Overseas
Contingency Operations, coordinated by Stephen Daggett and Susan B. Epstein.
• CRS Report R40575, Potential Farm Sector Effects of 2009 H1N1 “Swine Flu”:
Questions and Answers , by Renée Johnson.
• CRS Report R40588, The 2009 Influenza A(H1N1) “Swine Flu” Outbreak: U.S.
Responses to Global Human Cases, by Tiaji Salaam-Blyther.
• CRS Report R40619, The Role of the Department of Defense During A Flu
Pandemic, by Lawrence Kapp and Don J. Jansen.
• CRS Report RL32724, Mexico-U.S. Relations: Issues for Congress, by Mark P.
Sullivan and June S. Beittel.
63 For more information, see HHS, Assessment of States’ Operating Plans to Combat Pandemic Influenza: Report to
Homeland Security Council, January 2009, at http://www.pandemicflu.gov/plan/states/index.html, and CRS Report
RL34190, Pandemic Influenza: An Analysis of State Preparedness and Response Plans, by Sarah A. Lister and Holly
Stockdale.
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The 2009 Influenza Pandemic: An Overview
• CRS Report RL34724, Would an Influenza Pandemic Qualify as a Major Disaster
Under the Stafford Act? by Edward C. Liu.
• CRS Report RL33381, The Americans with Disabilities Act (ADA): Allocation of
Scarce Medical Resources During a Pandemic, by Nancy Lee Jones.
• CRS Report RS22327, Pandemic Flu and Medical Biodefense Countermeasure
Liability Limitation, by Henry Cohen and Vanessa K. Burrows.
• CRS Report RS21507, Project BioShield: Purposes and Authorities, by Frank
Gottron.
• CRS Report RL33609, Quarantine and Isolation: Selected Legal Issues Relating to
Employment, by Nancy Lee Jones and Jon O. Shimabukuro.
• CRS Report RL31873, Banking and Financial Infrastructure Continuity: Pandemic
Flu, Terrorism, and Other Challenges, by N. Eric Weiss.
• CRS Report RS22264, Federal Employees: Human Resources Management
Flexibilities in Emergency Situations, by Barbara L. Schwemle.
Archived CRS Reports on the threat of pandemic influenza: These products generally discuss
concerns about a possible human flu pandemic resulting from H5N1 avian influenza, and
enhanced federal preparedness efforts during 2005 through 2007.
• CRS Report RL33145, Pandemic Influenza: Domestic Preparedness Efforts, by
Sarah A. Lister.
• CRS Report RL33219, U.S. and International Responses to the Global Spread of
Avian Flu: Issues for Congress, by Tiaji Salaam-Blyther.
• CRS Report RS22576, Pandemic Influenza: Appropriations for Public Health
Preparedness and Response, by Sarah A. Lister.
World Health Organization (WHO) Information
• Information about the current H1N1 swine flu situation: http://www.who.int/csr/
disease/swineflu/en/index.html
• Pandemic Influenza Preparedness and Response: A WHO Guidance Document,
(April 2009): http://www.who.int/csr/disease/influenza/pipguidance2009/en/
index.html
• Current phase of flu pandemic alert: http://www.who.int/csr/disease/avian_influenza/
phase/en/index.html
• WHO, interactive world maps of reported cases are updated and linked from daily
situation updates at http://www.who.int/csr/disease/swineflu/en/index.html
• Pan American Health Organization (PAHO), a regional office of the WHO, H1N1 flu
page: http://new.paho.org/hq/index.php?option=com_content&task=blogcategory&
id=805&Itemid=569
• PAHO, interactive map of reported cases in the Americas: http://ais.paho.org/flu/sm/
en/atlas.html
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• International Health Regulations (2005): http://www.who.int/topics/
international_health_regulations/en/
U.S. Federal Government Information
• DHS, “Department Response to H1N1 (Swine) Flu,” with links to information in
other federal departments and agencies: http://www.dhs.gov/xprepresp/programs/
swine-flu.shtm
• CDC, H1N1 (swine flu) page: http://www.cdc.gov/h1n1flu/
• CDC Public Health Law Program, 2009 H1N1 Flu Legal Preparedness,
http://www2a.cdc.gov/phlp/H1N1flu.asp
• FDA, 2009 H1N1 (Swine) Flu Virus, http://www.fda.gov/NewsEvents/
PublicHealthFocus/ucm150305.htm
• Department of Defense Pandemic Influenza Watchboard: http://fhp.osd.mil/
aiWatchboard/
• Pandemic flu planning information: http://www.pandemicflu.gov/ (Note: much of
this information is in the context of planning for the H5N1 avian flu threat.)
• HHS Pandemic Planning Updates, addressing monitoring and surveillance, vaccines,
antiviral medications, state and local preparedness, and communications, through
January 2009: http://www.pandemicflu.gov/plan/federal/index.html#hhs (Note: much
of this information is in the context of planning for the H5N1 avian flu threat.)
Additional Information
• Mexico, Ministry of Health (in Spanish): http://portal.salud.gob.mx/
• Canada: Public Health Agency of Canada: http://www.phac-aspc.gc.ca/alert-alerte/
swine_200904-eng.php; Canadian Food Inspection Agency:
http://www.inspection.gc.ca/english/toce.shtml
• Security and Prosperity Partnership of North America, North American Plan for
Avian and Pandemic Influenza, August 2007, http://www.spp-psp.gc.ca/eic/site/spp-
psp.nsf/vwapj/pandemic-influenza.pdf/$FILE/pandemic-influenza.pdf
• Center for Infectious Disease Research and Policy (CIDRAP), at the University of
Minnesota, frequent updates, including scientific and technical information,
http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/index.html
• Centers for Law and the Public’s Health: A Collaborative at Johns Hopkins and
Georgetown Universities, H1N1 (Swine Flu) Legal Preparedness and Response page:
includes updates of “U.S. Federal, State, or Local Declarations of Emergency or
Public Health Emergency,” http://www.publichealthlaw.net/Projects/swinefluphl.php
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Author Contact Information
Sarah A. Lister
C. Stephen Redhead
Specialist in Public Health and Epidemiology
Specialist in Health Policy
slister@crs.loc.gov, 7-7320
credhead@crs.loc.gov, 7-2261
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