United States Government Accountability Office

GAO Testimony 

Before the Committee on Government

Reform, House of Representatives

INFLUENZA PANDEMIC

Challenges in Preparedness 

and Response 

Statement of Marcia Crosse 

Director, Health Care

For Release on Delivery 

Expected at 10:00 a.m. EDT 

Thursday, June 30, 2005 

 

GAO-05-863T
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

June 30, 2005

INFLUENZA PANDEMIC

Challenges in Preparedness and

Highlights of GAO-05-863T, a testimony Response 

before the Committee on Government

Reform, House of Representatives 

Shortages of influenza vaccine in

the 2004–05 and previous influenza 

seasons and mounting concern 

about recent avian influenza 

activity in Asia have raised concern

about the nation’s preparedness to

deal with a worldwide influenza 

epidemic, or influenza pandemic.

Although the extent of such a 

pandemic cannot be predicted, 

according to the Centers for

Disease Control and Prevention

(CDC), an agency within the 

Department of Health and Human 

Services (HHS), it has been

estimated that in the absence of

any control measures such as 

vaccination or antiviral drugs, a 

“medium-level” influenza pandemic 

could kill up to 207,000 people in

the United States, affect from 15 to

35 percent of the U.S. population, 

and generate associated costs 

ranging from $71 billion to $167 

billion in the United States. 

GAO was asked to discuss the

challenges the nation faces in

responding to the threat of an

influenza pandemic, including the 

lessons learned from previous 

annual influenza seasons that can

be applied to its preparedness and 

overall ability to respond to a

pandemic. This testimony is based 

on GAO reports and testimony

issued since 2000 on influenza 

vaccine supply, pandemic planning, 

emergency preparedness, and

emerging infectious diseases and

on current work examining the 

influenza vaccine shortage in the 

United States for the 2004–05

influenza season. 

The nation faces multiple challenges to prepare for and respond to an

influenza pandemic. First, key questions about the federal role in purchasing 

and distributing vaccines during a pandemic remain, and clear guidance on 

potential priority groups is lacking in HHS’s current draft of its pandemic

preparedness plan. For example, the draft plan does not establish the actions 

the federal government would take to purchase or distribute vaccine during 

an influenza pandemic. In addition, as was highlighted in the nation’s recent 

experience responding to the unexpected influenza vaccine shortage for the 

2004–05 influenza season, clear communication of the nation’s response plan

will be a major challenge. During the 2004–05 influenza season, state health 

officials reported that mixed messages created confusion. For example, CDC 

advised vaccination for persons aged 65 and older, and at the same time a 

state advised vaccination for persons aged 50 and older. Further challenges

include ensuring an adequate and timely supply of influenza vaccine and 

antiviral drugs, which can help prevent or mitigate the number of influenzarelated deaths. Particularly given the length of time needed to produce 

vaccines, influenza vaccine may be unavailable or in short supply and might 

not be widely available during the initial states of a pandemic. Finally, the 

lack of sufficient hospital and health care workforce capacity to respond to 

an infectious disease outbreak may also affect response efforts during an 

influenza pandemic. Public health officials we spoke with said that a largescale outbreak, such as an influenza pandemic, could strain the available 

capacity of hospitals by requiring entire hospital sections, along with their 

staff, to be used as isolation facilities.

www.gao.gov/cgi-bin/getrpt?GAO-05-863T.

To view the full product, including the scope 

and methodology, click on the link above.

For more information, contact Marcia Crosse

at (202) 512-7119.
Mr. Chairman and Members of the Committee: 

I am pleased to be here today as you discuss the nation’s preparedness to 

respond to a worldwide influenza epidemic—known as a pandemic.1

Shortages of influenza vaccine in the 2004–05 and previous annual 

influenza seasons, as well as mounting concern about recent avian 

influenza activity in Asia, have raised concern about the nation’s 

preparedness to deal with a pandemic. Pandemic influenza, which arises

periodically but unpredictably from a major genetic change in the 

influenza virus, can lead to worldwide disease and death.2

 Although the 

extent of the next pandemic cannot be predicted, modeling studies suggest

that its effect in the United States could be severe. According to the 

Centers for Disease Control and Prevention (CDC), it has been estimated 

that in the absence of any control measures such as vaccination and drugs,

a “medium-level” influenza pandemic in the United States could kill 89,000 

to 207,000 people, affect from 15 to 35 percent of the U.S. population, and 

generate associated costs ranging from $71 billion to $167 billion. In the 

event of a pandemic, the nation will likely experience a vaccine shortage. 

The nation’s experience responding to the unexpected shortage of annual

influenza vaccine during the 2004–05 influenza season—in which public 

health officials sought to match available vaccine supply with demand—

underscores the challenges that federal, state, and local entities would 

need to meet in the event of a pandemic. In addition, our recent work has 

highlighted other challenges in responding to pandemic influenza. 

You asked us to provide our perspective on the nation’s preparedness for 

responding to an influenza pandemic, including the lessons learned from

previous annual influenza seasons that would be applicable to pandemic 

preparedness. In this testimony, I will discuss challenges we identified 

related to (1) planning for the purchase and distribution of influenza 

vaccine, including defining priority groups to be vaccinated; 

(2) communicating information about the situation and the response plan 

clearly and effectively among health officials, providers, and the public; 

 1

An influenza pandemic is defined by the emergence of a novel influenza virus, to which 

much or all of the population is susceptible, that is readily transmitted person to person, 

and causes outbreaks in multiple countries. 

2

Influenza pandemics can have successive “waves” of disease and last for up to 3 years.

Three pandemics occurred in the 20th century: the “Spanish influenza” of 1918, which 

killed about 500,000 people in the United States; the “Asian influenza” of 1957, which killed 

about 70,000 people in the United States; and the “Hong Kong influenza” of 1968, which 

killed about 34,000 people in the United States. 

Page 1 GAO-05-863T
(3) ensuring an adequate supply of vaccine and antiviral drugs; and 

(4) addressing hospital and workforce capacity to respond to large-scale 

outbreaks of infectious disease, including pandemic influenza. 

My testimony today is based on reports and testimony on influenza 

vaccine supply, pandemic planning, emergency preparedness, and 

emerging infectious diseases that we have issued since October 20003

 and 

on a review in progress for this committee on actions taken and lessons 

learned at federal, state, and local levels to ensure that high-risk 

individuals had access to vaccine during the 2004–05 influenza vaccine 

shortage. Our prior work includes analysis of information provided by and 

interviews with officials in the Department of Health and Human Services

(HHS), specifically from CDC, the Food and Drug Administration (FDA), 

and the National Vaccine Program Office. We also interviewed public 

health department officials, vaccine manufacturers, and vaccine 

distributors; surveyed physician group practices; and reviewed HHS’s

August 2004 draft Pandem c nf uenza Preparedness and Response P an. 

Since March 2005 we have reviewed documents and interviewed officials 

from HHS, CDC, and the National Vaccine Program Office; national

organizations, including the Association of State and Territorial Health 

Officials; organizations that conduct mass immunization clinics; a major 

vaccine manufacturer; and a large purchaser of influenza vaccine. We also 

conducted site visits at a judgmental sample of states and localities.

i I l l

 

4

 We 

conducted our work in accordance with generally accepted government 

auditing standards. CDC and the National Vaccine Program Office

provided comments on the facts contained in this statement, and we made 

changes as appropriate. 

In summary, the nation faces multiple challenges to prepare for and 

respond to an influenza pandemic. First, key questions remain about the 

federal role in purchasing and distributing vaccines during a pandemic, 

and clear guidance on potential priority groups is lacking in HHS’s current 

draft of its pandemic preparedness plan. In addition, as highlighted by the 

nation’s recent experience responding to the unexpected influenza vaccine 

3

See “Related GAO Products” at the end of this testimony for a list of our earlier work

related to infectious diseases, influenza vaccine supply, and pandemic planning. 

4

The states included California, Florida, Maine, Minnesota, and Washington, and the

localities included San Diego and San Francisco, California; Miami–Dade County, Florida; 

Portland, Maine; Stearns County, Minnesota; and Seattle–King County, Washington. We

selected these states and localities on the basis of geography, population size, and state

vaccination success rates.

Page 2 GAO-05-863T
shortage for the 2004–05 influenza season, clear communication of the 

nation’s response plan will be a major challenge. Further challenges

include ensuring an adequate and timely supply of influenza vaccine and 

antiviral drugs, which can help prevent or mitigate the number of

influenza-related deaths. Finally, the lack of sufficient hospital and health

care workforce capacity to respond to an infectious disease outbreak may

also affect response efforts during an influenza pandemic. 

Influenza is more severe than some other viral respiratory infections, such

as the common cold. Most people who contract influenza recover 

completely in 1 to 2 weeks, but some develop serious and potentially lifethreatening medical complications, such as pneumonia. People aged 65

and older, people of any age with chronic medical conditions, children 

younger than 2 years, and pregnant women are generally more likely than 

others to develop severe complications from influenza. 

Background 

Vaccination is the primary method for preventing influenza and its more

severe complications. Produced in a complex process that involves 

growing viruses in millions of fertilized chicken eggs, influenza vaccine is 

administered annually to provide protection against particular influenza 

strains expected to be prevalent that year. Experience has shown that

vaccine production generally takes 6 or more months after a virus strain 

has been identified; vaccines for certain influenza strains have been 

difficult to mass-produce. After vaccination, it takes about 2 weeks for the 

body to produce the antibodies that protect against infection. According to

CDC recommendations, the optimal time for vaccination is October 

through November, because the annual influenza season typically does not

peak until January or February. Thus, in most years vaccination in 

December or later can still be beneficial. 

At present, two vaccine types are recommended for protection against

influenza in the United States: an inactivated virus vaccine injected into 

muscle and a live virus vaccine administered as a nasal spray. The 

injectable vaccine—which represents the large majority of influenza 

vaccine administered in this country—can be used to immunize healthy 

individuals and those at highest risk for complications, including those 

with chronic illness and those aged 65 and older, but the nasal spray 

vaccine is currently approved for use only among healthy individuals aged 

5 to 49 years who are not pregnant. Vaccine manufacture and purchase 

Page 3 GAO-05-863T
take place largely within the private sector: for the 2004–05 influenza 

season, two companies (one producing the injectable vaccine and one 

producing the nasal spray) manufactured vaccine for the U.S. market.

5

Although vaccination is the primary strategy for protecting individuals 

who are at greatest risk of serious complications and death from influenza, 

antiviral drugs can also contribute to the treatment and prevention of

influenza. Four antiviral drugs have been approved for treatment. If taken

within 2 days after symptoms begin, these drugs can reduce symptoms and

make someone with influenza less contagious to others. Three of the four

antiviral drugs are also approved for prevention; according to CDC, they

are about 70 to 90 percent effective for preventing illness in healthy adults. 

HHS has primary responsibility for coordinating the nation’s response to

public health emergencies. As part of its mission, the department has a 

role in the planning needed to prepare for and respond to an influenza 

pandemic. One action the department has taken is to develop a draft

national pandemic influenza plan, titled Pandem c In uenza Preparedness 

and Response P an, which was released in August 2004 for a 60-day 

comment period. Within HHS, CDC is the principal agency for protecting 

the nation’s health and safety. CDC’s activities include efforts to prevent 

and control diseases and to respond to public health emergencies. CDC 

and its Advisory Committee on Immunization Practices (ACIP)

recommend which population groups should be targeted for vaccination 

each year and, when vaccine supply allows, recommends that any person

who wishes to decrease his or her risk of influenza-like illness be

vaccinated. FDA, another HHS agency, also plays a role in preparing for 

the annual influenza season and for a potential pandemic. FDA is

responsible for ensuring that new vaccines and drugs are safe and 

effective. The agency also regulates and licenses vaccines and antiviral 

agents.

i fl

l

 

6

HHS has limited authority to control vaccine production and distribution 

directly; influenza vaccine supply and marketing are largely in the hands of 

5

HHS also located and purchased about 1.5 million doses of vaccine from manufacturers

not licensed in the United States. Although this vaccine could be made available to be 

administered under special protocols, according to HHS officials, none of the vaccine was

used in the 2004–05 influenza season. 

6

In addition, FDA develops influenza reference strains and reagents and makes them

available to manufacturers for vaccine development and evaluation. 

Page 4 GAO-05-863T
the private sector.7

 Although the Public Health Service Act authorizes the 

Secretary of HHS to “take such action as may be appropriate” to respond 

to a public health emergency, as determined and declared by the 

Secretary, it is not clear whether or to what extent the Secretary could 

directly influence the manufacture or distribution of influenza vaccine to

respond to an influenza pandemic.8

 The appropriateness of the Secretary’s 

response would depend on the nature of the public health emergency, for 

example on the available evidence relating to a pandemic. According to a 

senior HHS official involved in HHS emergency preparedness activities, 

manufacturers of vaccine for the U.S. market have agreed in principle to 

switch to production of pandemic influenza vaccine should the need arise 

and proper compensation and indemnification be provided; therefore, he 

said, it would probably be unnecessary for the federal government to 

nationalize vaccine production, although the federal government has the 

legal authority to do so if circumstances warrant it. 

For the 2004–05 influenza season, CDC estimated as late as September 

2004 that about 100 million doses of vaccine would be available for the

U.S. market.

9

 CDC and ACIP recommended vaccination for about 

185 million people, including roughly 85 million people at high risk for 

complications.10 On October 5, 2004, however, one manufacturer 

announced that it could not provide its expected production of 

46–48 million doses—roughly half of the U.S. supply of expected vaccine.11

 7

Under the Federal Food, Drug, and Cosmetic Act, FDA ensures compliance with good

manufacturing practice. FDA has limited authority to prohibit the resale of prescription 

drugs, including influenza vaccine, that have been purchased by health care entities such as

public or private hospitals. This authority would not extend to resale of the vaccine for

emergency medical reasons. The term “health care entity” does not include wholesale

distributors.

8

According to the act, to declare a public health emergency, the Secretary must determine 

that (1) a disease or disorder presents a public health emergency or (2) a public health

emergency, including significant outbreaks of infectious disease or bioterrorist attacks,

otherwise exists. Public Health Service Act § 319 (current version at 42 U.S.C. § 247d).

9

See Centers for Disease Control and Prevention, “Supplemental Recommendations about 

Timing of Influenza Vaccination, 2004–05 Season,” Morbidity and Mortality Weekly Report, 

vol. 53, no. 37 (2004): 878–879.

10Not everyone in target populations receives a vaccination each year. See Centers for

Disease Control and Prevention, “Prevention and Control of Influenza Recommendations of 

the Advisory Committee on Immunization Practices (ACIP),” Morbidity and Mortality

Weekly Report, vol. 53, no. RR-06 (2004): 1–40. 

11The license for this manufacturer, with production facilities in Liverpool, England, was

temporarily suspended by British regulatory authorities.

Page 5 GAO-05-863T
Because a large proportion of vaccine produced by the other major 

manufacturer of injectable vaccine had already been shipped before

October 5, 2004, about 25 million doses of injectable vaccine for high-risk 

individuals and others, and about 1 million doses of the nasal spray 

vaccine for healthy people, were available after the announcement to be 

distributed to Americans who wanted an influenza vaccination. 

Preparing for and responding to an influenza pandemic differ in several 

respects from preparing for and responding to a typical influenza season. 

For example, past influenza pandemics have affected healthy young adults

who are not typically at high risk for complications associated with

influenza, and a pandemic could result in an overwhelming burden of ill

persons requiring hospitalization or outpatient medical care. In addition, 

the demand for vaccine may be greater in a pandemic. 

Challenges remain in planning for purchase and distribution of vaccine 

and defining priority groups in the event of a pandemic. HHS has not 

finalized planning for an influenza pandemic, leaving unanswered 

questions about the nation’s ability to prepare for and respond to such an 

outbreak. For the past 5 years, we have been urging HHS to complete its 

pandemic influenza plan. The document remains in draft form, although 

federal officials said in June 2005 that an update of the plan is being 

completed and is expected to be available in summer 2005. Key questions 

about the federal role in purchasing and distributing vaccines during a 

pandemic remain, and clear guidance on potential groups that would likely

have priority for vaccination is lacking in the current draft plan. 

Planning for Purchase 

and Distribution of 

Vaccine and Defining 

Priority Groups

One challenge is that the draft pandemic plan does not establish the 

actions the federal government would take to purchase or distribute 

vaccine during an influenza pandemic. Rather, it describes options for 

vaccine purchase and distribution, which include public-sector purchase

of all pandemic influenza vaccine; a mixed public-private system where

public-sector supply may be targeted to specific priority groups; and 

maintenance of the current largely private system. The draft plan does not 

specifically recommend any of these options. According to the draft plan, 

the federal government’s role may change over the course of a pandemic, 

with greater federal involvement early, when vaccine is in short supply. 

Noting that several uncertainties make planning vaccination strategies 

difficult, the draft plan states that national, state, and local planning needs 

to address possible contingencies, so that appropriate strategies are in 

place for whichever situation arises. 

Page 6 GAO-05-863T
If public-sector vaccine purchase is an option, establishing the funding 

sources, authority, or processes to do so quickly may be needed. During 

the 2004–05 shortage, some state health officials reported problems with 

states’ ability, with regard to both funding and the administrative process, 

to purchase influenza vaccine. For example, during the effort to 

redistribute vaccine to locations of greatest need, the state of Minnesota 

tried to sell its available vaccine to other states seeking additional vaccine 

for their high-risk populations. According to federal and state health

officials, however, certain states lacked the funding or authority under 

state law to purchase the vaccine when Minnesota offered it. In response 

to problems encountered during the 2004–05 shortage, the Association of 

Immunization Managers proposed in 2005 that federal funds be set aside 

for emergency purchase of vaccine by public health agencies and that cost

not be a barrier in acquiring vaccine to distribute to the public.12

Although an influenza pandemic may differ from an annual influenza 

season, experience during the 2004–05 shortage illustrates the importance

of having a distribution plan in place ahead of time to prevent delays when 

timing is critical: 

• Collaborating with stakeholders to create a workable distribution

plan is time consuming. After the October 5, 2004, announcement of the 

sharp reduction in influenza vaccine supply, CDC began working with the 

sole remaining manufacturer of injectable vaccine on plans to distribute 

this manufacturer’s remaining supply to providers across the country. The 

plan had two phases and benefited from voluntary compliance by the

manufacturer to share proprietary information to help identify geographic

areas of greatest need for vaccine. The first phase, which began in October 

2004, filled or partially filled orders from certain provider types, including 

state and local public health departments and long-term care facilities. The 

second phase, which began in November 2004, used a formula to 

apportion the remaining doses across the states according to each state’s 

estimated percentage of the national unmet need. States could then 

allocate doses from their apportionment to providers and facilities, which 

would purchase the vaccine through a participating distributor. The state 

ordering process under the second phase continued through mid-January.

Health officials in several states commented on the late availability of this

vaccine; officials in one state, for example, remarked that the phase two 

vaccine was “too much, too late.” 

 12The Association of Immunization Managers is an organization that represents 64 state, 

territorial, and urban-area immunization programs funded by CDC. 

Page 7 GAO-05-863T
• Identifying priority groups in local populations also takes time. 

Federal, state, and local officials need to have information on the 

population of the priority groups and the locations where they can be 

vaccinated to know how, where, and to whom to distribute vaccine in the 

event of an influenza pandemic. During the 2004–05 influenza season, 

federal officials developed a distribution plan to allocate a limited amount

of vaccine, but the states also had to determine how much vaccine was 

needed and where to distribute it within their own borders. For example, 

state health officials in Florida did not know exactly how many high-risk 

individuals needed vaccination, so they surveyed long-term care facilities 

and private providers to estimate the amount of vaccine needed to cover 

high-risk populations. It took nearly a month for state officials to compile 

the results of the surveys, to decide how many doses needed to be 

distributed to local areas, and to receive and ship vaccine to the counties. 

• Distributing the vaccine to a state or locality is not the same as 

administering the vaccine to an individual. Once vaccine has been 

distributed to a state or local agency, individuals living in those areas still 

need to be vaccinated. Vaccinating a large number of people is 

challenging, particularly when demand exceeds available supply. For 

example, during the 2004–05 influenza season, many places giving 

vaccinations right after the shortage was announced were overwhelmed 

with individuals wanting to be vaccinated. Certain local public health

departments in California, including the Santa Clara County Public Health

Department, provided chairs and extra water for people waiting in long 

lines outdoors in warm weather. Fear of a more virulent pandemic 

influenza strain could exacerbate such scenarios. A number of states

reported that they did not have the capacity to immunize large numbers of 

people and partnered with other organizations to increase their capacity. 

For example, in 2004–05, according to state health officials in Florida,

county health departments, including those in Orange and Broward 

Counties, worked with a national home health organization to immunize 

high-risk individuals by holding mass immunization clinics and setting up

clinics in providers’ offices to help administer available vaccine quickly. 

Other locations, including the local health department in Portland, Maine, 

held lotteries for available vaccine; according to local health officials, 

however, administrative time was required to arrange and publicize the 

lottery. 

HHS’s draft pandemic plan does not define priority groups for vaccination,

although the plan states that HHS is developing an initial list of suggested 

priority groups and soliciting public comment on the list. The draft plan 

instructs the states to define priority groups for early vaccination and 

indicates that as information about virus severity becomes available, 

Page 8 GAO-05-863T
recommendations will be formulated at the national level. According to 

the plan, setting priorities will be iterative, tied to vaccine availability and 

the pandemic’s progression. Without agreed-upon identification of

potential priority groups in advance, however, problems can arise. During 

the 2004–05 season, for example, CDC and ACIP acted quickly on 

October 5, 2004, to narrow the priority groups for available vaccine, giving

the narrowed groups equal importance.13 In some places, however, there 

was not enough available vaccine to cover everyone in these narrowed 

priority groups, so states set their own priorities among these groups. 

Maine, for example, excluded health care workers from the state’s early 

priority groups because state officials estimated that there was not enough 

vaccine to cover everyone in CDC and ACIP’s priority groups. 

Another challenge in responding to a pandemic will be to clearly 

communicate information about the situation and the nation’s response 

plans to public health officials, providers, and the public. Experience 

during the 2004–05 vaccine shortage illustrates the critical role 

communication plays when information about vaccine supply is unclear.14

• Communicating a consistent message and clearly explaining any 

apparent inconsistencies. In a pandemic, clear communication on who 

should be vaccinated will be important, particularly if the priority

population differs from those targeted for annual influenza vaccination, or 

if the priority groups in one area of the country differ from those in others. 

During the 2004–05 influenza season, health officials in Minnesota 

reported that some confusion resulted when the state determined that

Communicating 

Information about the 

Situation and

Response Plan Clearly 

and Effectively 

 13On October 5, 2004, CDC, in coordination with ACIP, issued interim recommendations for 

influenza vaccination during the 2004–05 season that took precedence over earlier

recommendations. The season’s priority groups for vaccination with injectable influenza 

vaccine were considered to be of equal importance. They included all children aged 6–23

months, adults aged 65 years and older, persons aged 2–64 years with underlying chronic 

medical conditions, all women who would be pregnant during the influenza season,

residents of nursing homes and long-term care facilities, children aged 6 months–18 years

on chronic aspirin therapy, health care workers involved in direct patient care, and out-ofhome caregivers and household contacts of children younger than 6 months. See Centers

for Disease Control and Prevention, “Interim Influenza Vaccination Recommendations,

2004–05 Influenza Season,” Morbidity and Mortality Weekly Report, vol. 53, no. 39 (2004): 

923–924. 

14According to CDC officials, as part of preparations for the 2005–06 influenza season, the 

agency is preparing communication strategies with appropriate messages to respond to the 

fluctuations in supply and demand anticipated throughout the season. CDC has developed 

the communication plan but has not released the plan, as it is in the clearance process.

Page 9 GAO-05-863T
vaccine was sufficient to meet demand among the state’s narrower priority 

groups and made vaccine available to other groups, such as healthy 

individuals aged 50–64 years, earlier than recommended by CDC. Health 

officials in California reported a similar situation. State health officials 

pointed out that in mid-December, local radio stations in California were 

running two public service announcements—one from CDC advising those 

65 and older to be vaccinated and one from the California Department of

Health Services advising those 50 and older to be vaccinated. State

officials emphasized that these mixed messages created confusion. 

• Communicating information from a primary source. Having a primary 

and timely source of information will be important in a pandemic. In the 

2004–05 influenza season, individuals seeking vaccine could have found 

themselves in a communication loop that provided no answers. For 

example, CDC advised people seeking influenza vaccine to contact their 

local public health department; in some cases however, individuals calling 

the local public health department would be told to call their primary care 

provider, and when they called their primary care provider, they would be 

told to call their local public health department. This lack of a reliable 

source of information led to confusion and possibly to high-risk 

individuals’ giving up and not receiving the protection of an annual

influenza vaccination.15

• Recognizing that different communication mechanisms are 

important and require resources. Another challenge in communicating 

plans in the event of a pandemic will be to ensure that the communication 

mechanisms used reach all affected populations. During the 2004–05 

influenza season, public health officials reported the importance of 

different methods of communication. For example, officials from the 

Seattle–King County Public Health Department in Washington State 

reported that it was important to have a hotline as well as information 

posted on a Web site, because some seniors calling Seattle–King County’s 

hotline reported that they did not have access to the Internet. According to

state and local health officials, however, maintaining these communication 

mechanisms took time and strained personnel resources. In Minnesota, for

example, to supplement state employees, the state health department

 15According to data collected during December 1–11, 2004, on self-reported vaccination

during September 1 through November 30, 2004, among adults in priority groups who had 

not yet received influenza vaccine, about 23 percent reported that they attempted to obtain

vaccination but could not. See Centers for Disease Control and Prevention, “Estimated 

Influenza Vaccination Coverage among Adults and Children—United States, 

September 1–November 30, 2004,” Morbidity and Mortality Weekly Report, vol. 53, no. 49

(2004): 1147–1150. 

Page 10 GAO-05-863T
asked public health nursing students to volunteer to staff the state’s 

influenza vaccine hotline.

• Educating health care providers and the public about all available 

vaccines. For the 2004–05 season, approximately 3 million doses of nasal 

spray vaccine were ultimately available for vaccinating healthy individuals 

aged 5–49 years who were not pregnant, including some individuals (such 

as health care workers in this age group and household contacts of 

children younger than 6 months) in the priority groups defined by CDC 

and ACIP, yet some of these individuals were reluctant to use this vaccine 

because they feared that the live virus in the nasal spray could be 

transmitted to others. State health officials in Maine, for example, reported 

that the state purchased about 1,500 doses of the nasal spray vaccine for 

their emergency medical service personnel and health care workers, yet

administered only 500 doses. 

Challenges in ensuring an adequate and timely supply of influenza vaccine 

and antiviral drugs—which can help prevent or mitigate the number of

influenza-related deaths until an pandemic influenza vaccine becomes

available—may be exacerbated during an influenza pandemic. Particularly

given the time needed to produce vaccines, influenza vaccine may be 

unavailable or in short supply and may not be widely available during the 

initial stages of a pandemic. According to CDC, maintaining an abundant

annual influenza vaccine supply is critically important for protecting the 

public’s health and improving our preparedness for an influenza pandemic. 

The shortages of influenza vaccine in 2004–05 and previous seasons have

highlighted the fragility of the influenza vaccine market and the need for 

its expansion and stabilization. 

In its budget request for fiscal year 2006, CDC reports that it plans to take 

steps to ensure an expanded influenza vaccine supply. The agency’s fiscal 

year 2006 budget request includes $30 million for CDC to enter into

guaranteed-purchase contracts with vaccine manufacturers to ensure the 

production of bulk monovalent influenza vaccine. If supplies fall short,

this bulk product can be turned into a finished trivalent influenza vaccine 

product for annual distribution.16 If supplies are sufficient, the bulk

vaccine can be held until the following year’s influenza season and 

developed into finished vaccines if the bulk products maintain their 

Ensuring Supply of 

Influenza Vaccine and

Antiviral Drugs

 16Monovalent influenza vaccine protects against a single strain of influenza; trivalent 

influenza vaccine protects against three strains of influenza. 

Page 11 GAO-05-863T
potency and the circulating strains remain the same. According to CDC, 

this guarantee will help expand the influenza market by providing an 

incentive to manufacturers to expand capacity and possibly encourage 

additional manufacturers to enter the market. In addition, CDC’s fiscal

year 2006 budget request includes an increase of $20 million to support 

influenza vaccine purchase activities.17

In the event of a pandemic, before a vaccine is available or during a period 

of limited vaccine supply, use of antiviral drugs could have a significant 

effect. Antiviral drugs can be used against all strains of pandemic influenza

and, because they can be manufactured and stored before they are needed,

could be available both to prevent illness and, if administered within 

48 hours after symptoms begin, to treat it. Like vaccine, antiviral drugs 

take several months to produce from raw materials, and according to one 

antiviral drug manufacturer, the lead time needed to scale up production 

capacity and build stockpiles may make it difficult to meet any large-scale, 

unanticipated demand immediately. HHS’ National Vaccine Program Office

also reported that in a pandemic, the manufacturing capacity and supply 

of antiviral drugs is likely to be less than the global demand. For these 

reasons, the National Vaccine Program Office reported that analysis is 

under way to determine optimal strategies for antiviral drug use when 

supplies are suboptimal; the office also noted that antiviral drugs have

been included in the national stockpile. HHS has purchased more than 

7 million doses of antiviral drugs for the national stockpile. 

Nevertheless, this stockpile is limited, and it is unclear how much will be

available in the event of a pandemic, given existing production capacity. 

Moreover, some influenza virus strains can become resistant to one or 

more of the four approved influenza antiviral drugs, and thus the drugs 

may not always work. For example, the avian influenza virus strain (H5N1)

identified in human patients in Asia in 2004 and 2005 has been resistant to 

two of four existing antiviral drugs.

 17The $20 million increase is for CDC’s Immunization Grant Program that provides vaccines

for children, adolescents, and adults who present primarily at local health departments but

are not eligible for CDC’s Vaccines for Children program.

Page 12 GAO-05-863T
The lack of sufficient hospital and workforce capacity is another challenge 

that may affect response efforts during an influenza pandemic. The lack of

sufficient capacity could be more severe during an influenza pandemic 

compared with other natural disasters, such as a tornado or hurricane, or

with an intentional release of a bioterrorist agent because it is likely that a 

pandemic would result in widespread and sustained effects. Public health

officials we spoke with said that a large-scale outbreak, such as an 

influenza pandemic, could strain the available capacity of hospitals by 

requiring entire hospital sections, along with their staff, to be used as 

isolation facilities. In addition, most states lack surge capacity—the ability 

to respond to the large influx of patients that occurs during a public health

emergency. For example, few states reported having the capacity to

evaluate, diagnose, and treat 500 or more patients involved in a single 

incident. In addition, few states reported having the capacity to rapidly 

establish clinics to immunize or treat large numbers of patients. Moreover, 

shortages in the health care workforce could occur during an influenza 

pandemic because higher disease rates could result in high rates of 

absenteeism among workers who are likely to be at increased risk of

exposure and illness or who may need to care for ill family members. 

Important challenges remain in the nation’s preparedness and response 

should an influenza pandemic occur in the United States. As we learned in

the 2004–05 influenza season, when vaccine supply, relative to demand, is

limited, planning and effective communication are critical to ensure timely

delivery of vaccine to those who need it. HHS’s current draft plan lacks 

some key information for planning our nation’s response to a pandemic. It

is important for the federal government and the states to work through

critical issues—such as how vaccine will be purchased, distributed, and 

administered; which population groups are likely to have priority for 

vaccination; what communication strategies are most effective; and how

to address issues related to vaccine and antiviral supply and hospital and 

workforce capacity—before we are in a time of crisis. Although HHS 

contends that agency flexibility is needed during a pandemic, until key 

federal decisions are made, public health officials at all levels may find it

difficult to plan for an influenza pandemic, and the timeliness and 

adequacy of response efforts may be compromised. 

Mr. Chairman, this concludes my prepared statement. I would be happy to

respond to any questions you or other Members of the Committee may 

have at this time. 

Hospital and 

Workforce Capacity 

to Respond to LargeScale Infectious

Disease Outbreaks

Concluding

Observations 

Page 13 GAO-05-863T
Page 14 GAO-05-863T

GAO Contact and Staff Acknowledgments 

For further information about this testimony, please contact Marcia

Crosse at (202) 512-7119. Jennifer Major, Nick Larson, Gay Hee Lee, Kim 

Yamane, George Bogart, and Ellen W. Chu made key contributions to this

statement. 
Page 15 GAO-05-863T

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Related GAO Products 

n luenza Pandemic: Challenges Rema n in Preparedness. GAO-05-760T. 

Washington, D.C.: May 26, 2005. 

Flu Vaccine: Recent Supply Shortages Underscore Ongoing Challenges. 

GAO-05-177T. Washington, D.C.: November 18, 2004. 

Emerg ng Infec ious Diseases: Rev ew of S ate and Federal Disease 

Surveillance Effor s. GAO-04-877. Washington, D.C.: September 30, 2004. 

n ect ous Disease Preparedness: Federal Chal enges in Responding to

Influenza Outbreaks. GAO-04-1100T. Washington, D.C.: September 28, 

2004. 

Emerg ng Infec ious Diseases: Asian SARS Outbreak Challenged 

n ernational and Nat onal Responses. GAO-04-564. Washington, D.C.: 

April 28, 2004. 

Publ c Hea th Preparedness: Response Capac y mproving, bu Much 

Remains to Be Accomp shed. GAO-04-458T. Washington, D.C.: February

12, 2004. 

Infectious Diseases: Gaps Remain in Survei ance Capabil ies o State and 

Local Agenc es. GAO-03-1176T. Washington, D.C.: September 24, 2003. 

Severe Acute Respira ory Syndrome: Estab ished Infectious D sease 

Control Measures Helped Contain Spread, but a Large-Scale Resurgence 

May Pose Challenges. GAO-03-1058T. Washington, D.C.: July 30, 2003. 

SARS Outbreak: Improvemen s to Pub c Health Capacity Are Needed for

Responding o Bio errorism and Emerg ng Infect ous Diseases. GAO-03-

769T. Washington, D.C.: May 7, 2003. 

Infectious Disease Outbreaks: Bioterrorism Preparedness Efforts Have 

mproved Pub c Heal h Response Capac ty, but Gaps Rema n. GAO-03-

654T. Washington, D.C.: April 9, 2003. 

Bioterrorism: Preparedness Var ed across Sta e and Local Jurisdictions. 

GAO-03-373. Washington, D.C.: April 7, 2003. 

Global Heal h: Chal enges in Improving Infectious Disease Surve ance 

Systems. GAO-01-722. Washington, D.C.: August 31, 2001. 
Flu Vaccine: Steps Are Needed to Better Prepare for Possible Future 

Shortages. GAO-01-786T. Washington, D.C.: May 30, 2001. 

Flu Vacc ne: Supply Prob ems Heigh en Need o Ensure Access for High

Risk People. 

i l t t -

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GAO-01-624. Washington, D.C.: May 15, 2001. 

n luenza Pandemic: P an Needed for Federal and State Response. GAO01-4. Washington, D.C.: October 27, 2000. 

West Nile Virus Outbreak: Lessons for Pub ic Heal h Preparedness. 

GAO/HEHS-00-180. Washington, D.C.: September 11, 2000. 

Global Health: Framework for Infectious Disease Surveillance. 

GAO/NSIAD-00-205R. Washington, D.C.: July 20, 2000. 

(290479) Page 16 GAO-05-863T
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