Influenza Pandemic
Applying Lessons Learned from the 2004-05 Influenza Vaccine Shortage Gao ID: GAO-06-221T November 4, 2005Concern has been rising about the nation's preparedness to respond to vaccine shortages that could occur in future annual influenza seasons or during an influenza pandemic--a global influenza outbreak. Although the timing or extent of a future influenza pandemic cannot be predicted, studies suggest that its effect in the United States could be severe, and shortages of vaccine could occur. For the 2004-05 annual influenza season, the nation lost about half its expected influenza vaccine supply when one of two major manufacturers announced in October 2004 that it would not release any vaccine. GAO examined federal, state, and local actions taken in response to the shortage, including lessons learned. The nation's experience during the unexpected 2004-05 vaccine shortfall offers insights into some of the challenges that government entities will face in a pandemic. GAO was asked to provide a statement on lessons learned from the 2004-05 vaccine shortage and their relevance to planning and preparing for similar situations in the future, including an influenza pandemic. This statement is based on a GAO report, Influenza Vaccine: Shortages in 2004-05 Season Underscore Need for Better Preparation (GAO-05-984), and on previous GAO reports and testimonies about influenza vaccine supply and pandemic preparedness.
A number of lessons emerged from federal, state, and local responses to the 2004-05 influenza vaccine shortage that carry implications for handling future vaccine shortages in either an annual influenza season or an influenza pandemic. First, limited contingency planning slows response. At the start of the 2004-05 influenza season, when the supply shortfall became apparent, the nation lacked a contingency plan specifically to address severe shortages. The absence of such a plan led to delays and uncertainties on the part of state and local public health entities on how best to ensure access to vaccine by individuals at high risk of severe influenza-related complications. Second, streamlined mechanisms to expedite vaccine availability are key to an effective response. During the 2004-05 shortage, for example, federal purchases of vaccine licensed for use in other countries but not the United States were not completed in time to meet peak demand. Some states' experience also highlighted the importance of mechanisms to transfer available vaccine quickly and easily from one state to another. Third, effective response requires clear and consistent communication. Consistency among federal, state, and local communications is critical for averting confusion. State and local health officials also emphasized the value of updated information when responding to changing circumstances, using diverse media to reach diverse audiences, and educating providers and the public about prevention alternatives. Over the past 5 years, GAO has urged the Department of Health and Human Services (HHS) to complete its plan to prepare for and respond to an influenza pandemic. GAO has reported on the importance of planning to address critical issues such as how vaccine will be purchased and distributed; how population groups will be given priority for vaccination; and how federal resources should be deployed before the nation faces a pandemic. On November 2, 2005, HHS released its pandemic influenza plan. GAO did not have the opportunity to review the plan before issuing this statement to determine the extent to which the plan addresses these critical issues.
GAO-06-221T, Influenza Pandemic: Applying Lessons Learned from the 2004-05 Influenza Vaccine Shortage
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Testimony:
Before the Committee on Government Reform, House of Representatives:
United States Government Accountability Office:
GAO:
For Release on Delivery:
Expected at 10:00 a.m. EST:
Friday, November 4, 2005:
Influenza Pandemic:
Applying Lessons Learned from the 2004-05 Influenza Vaccine Shortage:
Statement for the Record by Marcia Crosse:
Director, Health Care:
GAO-06-221T:
GAO Highlights:
Highlights of GAO-06-221T, a statement for the record for the Committee
on Government Reform, House of Representatives:
Why GAO Did This Study:
Concern has been rising about the nation‘s preparedness to respond to
vaccine shortages that could occur in future annual influenza seasons
or during an influenza pandemic”a global influenza outbreak. Although
the timing or extent of a future influenza pandemic cannot be
predicted, studies suggest that its effect in the United States could
be severe, and shortages of vaccine could occur. For the 2004–05 annual
influenza season, the nation lost about half its expected influenza
vaccine supply when one of two major manufacturers announced in October
2004 that it would not release any vaccine. GAO examined federal,
state, and local actions taken in response to the shortage, including
lessons learned. The nation‘s experience during the unexpected 2004–05
vaccine shortfall offers insights into some of the challenges that
government entities will face in a pandemic.
GAO was asked to provide a statement on lessons learned from the
2004–05 vaccine shortage and their relevance to planning and preparing
for similar situations in the future, including an influenza pandemic.
This statement is based on a GAO report, Influenza Vaccine: Shortages
in 2004–05 Season Underscore Need for Better Preparation (GAO-05-984),
and on previous GAO reports and testimonies about influenza vaccine
supply and pandemic preparedness.
What GAO Found:
A number of lessons emerged from federal, state, and local responses to
the 2004–05 influenza vaccine shortage that carry implications for
handling future vaccine shortages in either an annual influenza season
or an influenza pandemic.
* First, limited contingency planning slows response. At the start of
the 2004–05 influenza season, when the supply shortfall became
apparent, the nation lacked a contingency plan specifically to address
severe shortages. The absence of such a plan led to delays and
uncertainties on the part of state and local public health entities on
how best to ensure access to vaccine by individuals at high risk of
severe influenza-related complications.
* Second, streamlined mechanisms to expedite vaccine availability are
key to an effective response. During the 2004–05 shortage, for example,
federal purchases of vaccine licensed for use in other countries but
not the United States were not completed in time to meet peak demand.
Some states‘ experience also highlighted the importance of mechanisms
to transfer available vaccine quickly and easily from one state to
another.
* Third, effective response requires clear and consistent
communication. Consistency among federal, state, and local
communications is critical for averting confusion. State and local
health officials also emphasized the value of updated information when
responding to changing circumstances, using diverse media to reach
diverse audiences, and educating providers and the public about
prevention alternatives.
Over the past 5 years, GAO has urged the Department of Health and Human
Services (HHS) to complete its plan to prepare for and respond to an
influenza pandemic. GAO has reported on the importance of planning to
address critical issues such as how vaccine will be purchased and
distributed; how population groups will be given priority for
vaccination; and how federal resources should be deployed before the
nation faces a pandemic. On November 2, 2005, HHS released its pandemic
influenza plan. GAO did not have the opportunity to review the plan
before issuing this statement to determine the extent to which the plan
addresses these critical issues.
www.gao.gov/cgi-bin/getrpt?GAO-06-221T.
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 or crossem@gao.gov.
[End of section]
Mr. Chairman and Members of the Committee:
I am pleased to have the opportunity to provide information on our
recent review of the 2004-05 influenza vaccine shortage, with lessons
to consider as the nation improves its ability to respond to an
influenza pandemic (a global influenza outbreak resulting from a major
genetic change in the influenza virus).[Footnote 1] Concern about the
nation's preparedness to respond to an influenza pandemic has been
growing for some time, in part because of the increase in the number of
identified human cases of avian influenza in Asia.[Footnote 2] Studies
suggest that a pandemic's effects in the United States could be severe,
and shortages of vaccine could occur. The nation's experience
responding to the shortage of annual influenza vaccine for the 2004-05
influenza season--in which the nation faced an unexpected loss of
nearly half its projected vaccine supply--offers insight into the some
of the challenges that federal, state, and local entities will face if
a pandemic occurs.
My statement includes findings from our recent report on last winter's
influenza vaccine shortage and discusses lessons learned from that
experience that could help prepare the nation to respond to future
vaccine shortages in either an annual influenza season or an influenza
pandemic.[Footnote 3] My statement also draws from several GAO reports
and testimonies on influenza vaccine supply, pandemic planning, and
emergency preparedness for emerging infectious diseases that we have
issued since October 2000.[Footnote 4] This body of work includes
interviews with officials in the Department of Health and Human
Services (HHS), such as officials from the Centers for Disease Control
and Prevention (CDC) and the National Vaccine Program Office. For the
report on the 2004-05 influenza vaccine shortage, we conducted site
visits at a sample of states and localities.[Footnote 5] We also
interviewed officials from public health departments and a major
influenza vaccine manufacturer; national organizations, including the
Association of State and Territorial Health Officials and the
Association of Immunization Managers; organizations that conduct mass
immunization clinics; and a large purchaser of influenza vaccine. We
conducted all of our work in accordance with generally accepted
government auditing standards.
In summary, a number of lessons emerged from federal, state, and local
responses to the 2004-05 influenza vaccine shortage that carry
implications for handling future vaccine shortages in either an annual
influenza season or an influenza pandemic. First, limited contingency
planning slows response. At the start of the 2004-05 influenza season,
when the nation unexpectedly lost roughly half its projected influenza
vaccine supply, the nation lacked a contingency plan specifically for a
severe vaccine shortage. The absence of such a plan led to delays and
uncertainties on the part of state and local public health entities on
how best to ensure access to vaccine by individuals at high risk of
severe influenza-related complications. Since 2000, we have encouraged
the development of a plan to address critical issues that could arise
in an influenza pandemic. Second, streamlined mechanisms to expedite
vaccine availability are key to an effective response. During the 2004-
05 shortage, for example, federal purchases of vaccine licensed for use
in other countries but not the United States were not completed in time
to meet peak demand. Some states' experience also highlighted the
importance of mechanisms to transfer available vaccine quickly and
easily from one state to another. Third, effective response requires
clear and consistent communication. Consistency among federal, state,
and local communications is critical for averting confusion. State and
local health officials also emphasized the value of updated information
when responding to changing circumstances, using diverse media to reach
diverse audiences, and educating providers and the public about
prevention alternatives.
Background:
Influenza is more severe than some viral respiratory infections, such
as the common cold. During an annual influenza season, most people who
contract influenza recover completely in 1 to 2 weeks, but some develop
serious and potentially life-threatening medical complications, such as
pneumonia. People aged 65 years 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. In an average year in the United States,
more than 36,000 individuals die and more than 200,000 are hospitalized
from influenza and related complications.
Pandemic influenza differs from annual influenza in several ways.
According to the World Health Organization, pandemic influenza spreads
to all parts of the world very quickly, usually in less than a year,
and can sicken more than a quarter of the global population, including
young, healthy individuals. Although health experts cannot predict with
certainty which strain of influenza virus will be involved in the next
pandemic, they warn that the avian influenza virus identified in the
human cases in Asia, known as H5N1, could lead to a pandemic if it
acquires the genetic ability, so far absent, to spread quickly from
person to person.
Vaccination is the primary method for preventing influenza and its
complications. Produced in a complex process that involves growing
viruses in millions of fertilized chicken eggs, influenza vaccine is
administered each year to protect 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 for the annual influenza
season, it takes about 2 weeks for the body to produce the antibodies
that protect against infection. According to CDC recommendations, the
optimal time for annual vaccination is October through November.
Because the annual influenza season typically does not peak until
January or February, however, 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 both
healthy individuals and individuals at highest risk for severe
complications, including those with chronic illness and those aged 65
years and older. The nasal spray vaccine, in contrast, is currently
approved for use only among healthy individuals aged 5 to 49 years who
are not pregnant. For the 2003-04 influenza season, two manufacturers-
-one with production facilities in the United States (sanofi
pasteur[Footnote 6]) and one with production facilities in the United
Kingdom (Chiron)--produced about 83 million doses of injectable
vaccine, which represented about 96 percent of the U.S. vaccine supply.
A third U.S. manufacturer (MedImmune) produced the nasal spray
vaccine.[Footnote 7] For the 2004-05 influenza season, CDC and its
Advisory Committee on Immunization Practices (ACIP) initially
recommended vaccination for about 188 million people in designated
priority groups, including roughly 85 million people at high risk for
severe complications.[Footnote 8] On October 5, 2004, however, Chiron
announced that it could not provide its expected production of 46-48
million doses--about half the expected U.S. influenza vaccine supply.
Although vaccination is the primary strategy for protecting individuals
who are at greatest risk of severe complications and death from
influenza, antiviral drugs can also help to treat infection. If taken
within 2 days of a person's becoming ill, these drugs can ease symptoms
and reduce contagion. In the event of a pandemic, such drugs could
lower the number of deaths until a pandemic influenza vaccine became
available. Four antiviral drugs have been approved by the Food and Drug
Administration (FDA) for treatment of influenza: amantadine,
rimantadine, oseltamivir, and zanamivir.[Footnote 9]
HHS has primary responsibility for coordinating the nation's response
to public health emergencies. Within HHS, CDC is one of the agencies
that protect 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 ACIP recommend which population groups should be
targeted for vaccination each year and, when vaccine supply allows,
recommend that any person who wishes to decrease his or her risk of
influenza be vaccinated.[Footnote 10] In addition, the National Vaccine
Program Office is responsible for coordinating and ensuring
collaboration among the many federal agencies involved in vaccine and
immunization activities; the office also issued a draft national
pandemic influenza preparedness plan in August 2004.[Footnote 11]
Preparing for and responding to an influenza pandemic differ in several
respects from preparing for and responding to an annual influenza
season. For example, past influenza pandemics have affected healthy
young adults who are not typically at high risk for severe influenza-
related complications, so the groups given priority for early
vaccination may differ from those given priority in an annual influenza
season. In addition, according to CDC, a vaccine probably would not be
available in the early stages of a pandemic. Shortages of vaccine would
therefore be likely during a pandemic, potentially creating a situation
more challenging than a shortage of vaccine for an annual influenza
season.
Limited Contingency Planning Slows Response:
One lesson learned from the 2004-05 season that is relevant to a future
vaccine shortage in either an annual influenza season or a pandemic is
the importance of planning before a shortage occurs. At the time the
influenza vaccine shortage became apparent, the nation lacked a
contingency plan specifically designed to respond to a severe vaccine
shortage. The absence of such a plan led to delays and uncertainty on
the part of many state and local entities on how best to ensure access
to vaccine during the shortage by individuals at high risk of severe
complications and others in priority groups. Faced with the
unanticipated shortfall, CDC redefined the priority groups it had
recommended for vaccination[Footnote 12] and asked sanofi pasteur, the
remaining manufacturer of injectable vaccine, to suspend distribution
until the agency completed its assessment of the shortage's extent and
developed a plan to distribute the manufacturer's remaining vaccine to
providers serving individuals in the priority groups. Developing and
implementing this distribution plan took time and led to delays in
response and some confusion at state and local levels.
Our work showed that several areas of planning are particularly
important for enhancing preparedness before a similar situation occurs
in the future, including defining the responsibilities of federal,
state, and local officials; using emergency preparedness plans and
emergency health directives; and facilitating the distribution and
administration of vaccine.
* Clearly defining responsibilities of federal, state, and local
officials can minimize confusion. During the 2004-05 vaccine shortage,
even though CDC worked with states and localities to coordinate roles
and responsibilities, problems occurred. For example, CDC worked with
national professional associations to survey long-term-care providers
throughout the country to determine if seniors had adequate access to
vaccine. Maine and other states, however, also surveyed their long-
term-care providers to make the same determination. This duplication of
effort expended additional resources, burdened some long-term-care
providers in the states, and created confusion.[Footnote 13]
* Emergency preparedness plans help coordinate local response. State
and local health officials in several locations we visited reported
that using existing emergency plans or incident command centers (the
organizational systems set up specifically to handle the response to
emergency situations) helped coordinate effective local responses to
the vaccine shortage. For example, public health officials from Seattle-
King County said that using the county's incident command system played
a vital role in coordinating an effective and timely local response and
in communicating a clear message to the public and providers. In
addition, according to public health officials, emergency public health
directives helped ensure access to vaccine by supporting providers in
enforcing the CDC recommendations and in helping to prevent price
gouging in certain states.
* Partnerships between the public and private sectors can facilitate
distribution and administration of vaccine. In San Diego County,
California, for example, local health officials worked with a coalition
of partners in public health, private businesses, and nonprofit groups
throughout the county. Other mechanisms facilitated administering the
limited supply of influenza vaccine to those in high-risk or other
priority groups. In Stearns County, Minnesota, for example, public
health officials worked with private providers to implement a system of
vaccination by appointment. Rather than standing in long lines for
vaccination, individuals with appointments went to a clinic during a
given time slot.
Although an influenza pandemic may differ in some ways from an annual
influenza season, experience during the 2004-05 shortage illustrated
the importance of having contingency plans in place ahead of time to
prevent delays when timing is critical. Some health officials indicated
that, as a result of the experience with the influenza vaccine
shortage, they were revising state and local preparedness plans or
modifying command center protocols to prepare for future emergencies.
For example, experiences during the 2004-05 influenza season led Maine
state officials to recognize the need to speed completion of their
pandemic influenza preparedness plan.
Over the past 5 years, we have reported on the importance of planning
to address critical issues such as how vaccine will be purchased and
distributed; how population groups will be given priority for
vaccination; and how federal resources should be deployed before the
nation faces a pandemic. We have also urged HHS to complete its
pandemic preparedness and response plan, which the department released
in draft form in August 2004. This draft plan described options for
vaccine purchase and distribution and provided planning guidance to
state and local health departments. As we testified earlier, however,
the draft plan lacked clear guidance on potential priority groups for
vaccination in a pandemic, and key questions remained about the federal
role in purchasing and distributing vaccine.[Footnote 14] The
experience in 2004-05 also highlighted the importance of finalizing
such planning details. On November 2, 2005, HHS released its pandemic
influenza plan. We did not, however, have an opportunity to review the
plan before issuing this statement to determine whether the plan
addresses these critical issues.
Streamlined Mechanisms for Expediting Vaccine Availability Are Key to
Effective Response:
A second lesson from the experience of the 2004-05 vaccine shortage
that is relevant to future vaccine shortages in either an annual
influenza season or a pandemic is the importance of streamlined
mechanisms to make vaccine available in an expedited manner. For
example, HHS began efforts to purchase foreign vaccine that was
licensed for use in other countries but not the United States shortly
after learning in October 2004 that Chiron would not supply any
vaccine. The purchase, however, took several months to complete, and so
vaccine was not available to meet the fall 2004 demand; by the end of
the season, this vaccine had not been used. In addition, recipients of
this foreign vaccine could have been required to sign a consent form
and follow up with a health care worker after vaccination--steps that,
according to health officials we interviewed in several states, would
be too cumbersome to administer.
Some states' experience during the 2004-05 vaccine shortage also
highlighted the importance of mechanisms to transfer available vaccine
quickly and easily from one state to another; the lack of mechanisms to
do so delayed redistribution to some states. During the 2004-05
shortage, some state health officials reported problems with their
ability to purchase vaccine, both in paying for vaccine and in
administering the transfer process. Minnesota, for example, tried to
sell its available vaccine to other states seeking additional vaccine
for their priority populations. According to federal and state health
officials, however, certain states lacked the funding or flexibility
under state law to purchase the vaccine when Minnesota offered it. As
we have previously testified, establishing the funding sources,
authority, or processes for quick public-sector purchases may be needed
as part of pandemic preparedness.[Footnote 15]
Recognizing the need for mechanisms to make vaccine available in a
timely manner in the event of a pandemic, HHS has taken some action to
address the fragility of the current influenza vaccine market. In its
budget request for fiscal year 2006, CDC requested $30 million to enter
into guaranteed-purchase contracts with vaccine manufacturers to help
ensure vaccine supply. According to the agency, maintaining an abundant
supply of annual influenza vaccine is critically important for
improving the nation's preparedness for an influenza pandemic. HHS is
also taking steps toward developing a supply of vaccine to protect
against avian influenza strains that could be involved in a
pandemic.[Footnote 16]
Effective Response Requires Clear and Consistent Communication:
Experience during the 2004-05 shortage also illustrated the critical
role communication plays when demand for vaccine exceeds supply and
information about future vaccine availability is uncertain, as could
happen in a future annual influenza season or a pandemic. During the
2004-05 shortage, CDC communicated regularly through a variety of media
as the situation evolved. State and local officials, however,
identified several communication lessons for future seasons or if an
influenza pandemic occurred:
* Consistency among federal, state, and local communications is
critical for averting confusion. State health officials reported
several cases where inconsistent messages created confusion. Health
officials in California, for example, reported that local radio
stations in the state were running two public service announcements
simultaneously--one from CDC advising those aged 65 years and older to
be vaccinated, and one from the state advising those aged 50 years and
older to be vaccinated.
* Disseminating clear, updated information is especially important when
responding to changing circumstances. Beginning in October 2004, CDC
asked individuals who were not in a high-risk group or another priority
group to forgo or defer vaccination; this message, however, did not
include instructions to check back with their providers later in the
season, when more vaccine had become available. According to CDC, an
estimated 17.5 million individuals specifically deferred vaccination to
save vaccine for those in priority groups;[Footnote 17] local health
officials said that many did not return when vaccine became available.
* Using diverse media helps reach diverse audiences. During the 2004-05
influenza season, public health officials emphasized the value of a
variety of communication methods--such as telephone hotlines, Web
sites, and bilingual radio advertisements--to reach as many individuals
as possible and to increase the effectiveness of local efforts to raise
vaccination rates. In Seattle-King County, Washington, for example,
health department officials reported that a telephone hotline was
important because some seniors did not have Internet access. Public
health officials in Miami-Dade County, Florida, said that bilingual
radio advertisements promoting influenza vaccine for those in priority
groups helped increase the effectiveness of local efforts to raise
vaccination rates.
* Education can alert providers and the public to prevention
alternatives. In the 2004-05 shortage, some of the nasal spray vaccine
for healthy individuals went unused, in part because of fears that the
vaccine was too new and untested or that the live virus in the nasal
spray could be transmitted to others.[Footnote 18] Further, public
health officials we interviewed said that education about all available
forms of prevention, including the use of antiviral medications and
good hygiene practices, can help reduce the spread of influenza.
Concluding Observations:
Experience during the 2004-05 influenza vaccine shortage highlights the
need to prepare the nation for handling future shortages in either an
annual influenza season or an influenza pandemic. In particular, that
season's shortage emphasized the vital need for early planning,
mechanisms to make vaccine available, and effective communication to
ensure available vaccine is targeted to those who need it most. As our
work over the past 5 years has noted, it is important for federal,
state, and local governments to develop and communicate plans regarding
critical issues--such as how vaccine will be purchased and distributed,
which population groups are likely to have priority for vaccination,
and what communication strategies are most effective--before we face
another shortage of annual influenza vaccine or, worse, an influenza
pandemic.
GAO Contact and Staff Acknowledgments:
For further information about this statement, please contact Marcia
Crosse at (202) 512-7119 or crossem@gao.gov. Kim Yamane, Assistant
Director; George Bogart; Ellen W. Chu; Nicholas Larson; Jennifer Major;
and Terry Saiki made key contributions to this statement.
[End of section]
Related GAO Products:
Influenza Vaccine: Shortages in 2004-05 Season Underscore Need for
Better Preparation. GAO-05-984. Washington, D.C. September 30, 2005.
Influenza Pandemic: Challenges in Preparedness and Response. GAO-05-
863T. Washington, D.C. June 30, 2005.
Influenza Pandemic: Challenges Remain in Preparedness. GAO-05-760T.
Washington, D.C. May 26, 2005.
Flu Vaccine: Recent Supply Shortages Underscore Ongoing Challenges. GAO-
05-177T. Washington, D.C. November 18, 2004.
Infectious Disease Preparedness: Federal Challenges in Responding to
Influenza Outbreaks. GAO-04-1100T. Washington, D.C. September 28, 2004.
Public Health Preparedness: Response Capacity Improving, but Much
Remains to Be Accomplished. GAO-04-458T. Washington, D.C. February 12,
2004.
Flu Vaccine: Steps Are Needed to Better Prepare for Possible Future
Shortages. GAO-01-786T. Washington, D.C. May 30, 2001.
Flu Vaccine: Supply Problems Heighten Need to Ensure Access for High-
Risk People. GAO-01-624. Washington, D.C. May 15, 2001.
Influenza Pandemic: Plan Needed for Federal and State Response. GAO-01-
4. Washington, D.C. October 27, 2000.
FOOTNOTES
[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. Among the most notorious 20th-century outbreaks was
the "Spanish influenza" of 1918, which is estimated to have killed
500,000 or more people in the United States and 40-50 million people
worldwide.
[2] Since December 2003, 122 confirmed avian influenza cases in humans
have been reported to the World Health Organization (WHO); these cases
have occurred in four countries, and about half the victims died. See
World Health Organization, "Cumulative Number of Confirmed Human Cases
of Avian Influenza A/(H5N1) Reported to WHO,"
http://www.who.int/csr/disease/avian_influenza/country/cases_table_2005_
11_01/en/index.html, downloaded Nov.1, 2005. Avian influenza has also
been confirmed in birds in Europe.
[3] GAO, Influenza Vaccine: Shortages in 2004-05 Season Underscore Need
for Better Preparation, GAO-05-984 (Washington, D.C. Sept. 30, 2005).
[4] See "Related GAO Products" at the end of this testimony.
[5] The states were California, Florida, Maine, Minnesota, and
Washington, and the localities were 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.
[6] The company spells its name without capital letters.
[7] Another injectable influenza vaccine for adults, produced by
GlaxoSmithKline Biologicals, based in Belgium, was approved and
licensed by FDA on August 31, 2005, for the U.S. market. The company
expects to produce about 8 million doses for the 2005-06 influenza
season.
[8] Not everyone in target populations receives a vaccination each
year. For example, CDC reported that in 2003 an estimated 66 percent of
people aged 65 years and older received an influenza vaccination. 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. 54, no.
RR-8 (2004), 1-40.
[9] According to CDC, the H5N1 avian influenza virus is resistant to
amantadine and rimantadine, commonly used for influenza; oseltamivir
and zanamivir would probably work to treat influenza caused by the H5N1
virus, but additional studies are still needed to prove their
effectiveness.
[10] In addition, FDA plays a role in preparing for annual influenza
seasons and a potential pandemic in approving and regulating use of
vaccines and drugs, including antiviral medications. FDA also develops
influenza reference strains and reagents and makes them available to
manufacturers for vaccine development and evaluation.
[11] Department of Health and Human Services, National Vaccine Program
Office, Draft Pandemic Influenza Preparedness and Response Plan
(Washington, D.C. August 2004).
[12] These revised recommendations decreased the number of people in
groups recommended for vaccination by about half, from about 188
million to about 98 million. 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.
[13] After the 2004-05 influenza season, CDC reviewed its response to
the vaccine shortage and took a number of steps, including issuing
interim guidelines in August 2005 to assist in responding to possible
future shortages.
[14] See GAO, Influenza Pandemic: Challenges in Preparedness and
Response, GAO-05-863T (Washington, D.C. June 30, 2005).
[15] GAO-05-863T.
[16] In addition, HHS has also taken steps to stockpile antiviral
drugs, which could be beneficial in the event of a pandemic, before a
vaccine specific for the responsible virus strain is available or
during a period of limited vaccine supply. By December 2004, HHS had
purchased and stockpiled enough of two antiviral medications
(rimantadine and oseltamivir) to treat more than 7 million people, and
the department recently announced intentions to buy enough antiviral
drugs to treat 20 million people. Like vaccine, however, antiviral
drugs take several months to produce from raw materials, and HHS's
National Vaccine Program Office has reported that in a pandemic, the
manufacturing capacity and supply of antiviral drugs are likely to be
less than global demand.
[17] See Centers for Disease Control and Prevention, "Estimated
Influenza Vaccination Coverage among Adults and Children--United
States, September 1, 2004-January 31, 2005," Morbidity and Mortality
Weekly Report, vol. 54, no. 12 (2005), 304-307.
[18] The nasal spray vaccine was recommended for 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.
