Testimony
Statement by
Julie L. Gerberding, M.D., M.P.H.
Director
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services
on
Influenza Preparedness
before
The Subcommittee on Labor/HHS/Education and Related Agencies
Appropriations Subcommittee
United States House of Representatives
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April 12, 2005
Mr. Chairman and members of the Subcommittee, I am pleased
to be here today to discuss the work of the Centers for Disease
Control and Prevention (CDC) in the control of influenza: first, by
promoting protection against annual outbreaks of influenza, and
second, by implementing necessary steps to prepare for the next
influenza pandemic.� Each year, influenza causes an average of
36,000 deaths in the United States, mostly among the elderly, and
over 200,000 hospitalizations. In addition, a global outbreak, or
“pandemic” influenza, which has occurred three times
during the past century, could have the potential to kill tens of
millions of people worldwide.� These issues are closely linked,
and� comprehensive preparedness for annual influenza outbreaks is
the basis of an effective response to pandemic influenza.� By
fortifying the system that supports our efforts in both of these
areas, CDC can have a great impact on America’s health and
national security.��
Today’s testimony will address CDC’s response to the
vaccine shortage experienced during the 2004 annual influenza
season and our plans for next year.�� We also provide some
background related to annual outbreaks, pandemics, and avian
influenza and discuss four primary areas that CDC and the public
health system are addressing to ensure that we have the capacity to
effectively detect and respond. These four areas are: enhancing our
surveillance capacity; increasing vaccine and antiviral supply;
increasing vaccination coverage; and strengthening state-based
pandemic preparedness planning.
CDC response to 2004 vaccine shortage and plans for next
year
As you are aware, Chiron Corporation notified HHS on October 5,
2004 that none of its influenza vaccine would be available for
distribution in the United States for the 2004-2005 influenza
season.� This effectively reduced the anticipated vaccine supply by
nearly half– more than 100 million doses had been expected;
Chiron was expected to produce 46-48 million doses.� Despite the
challenges presented by the loss of Chiron’s vaccine, CDC
immediately responded by changing recommendations to focus vaccine
efforts and then began monitoring. State specific flu vaccination
data�for adults and children were rapidly collected�and reported on
an ongoing basis from November 2004 through February 2005.�
CDC’s Behavior Risk Factor Surveillance System reported that
62.7 percent of Americans 65 years of age and older reported being
vaccinated for influenza between September 2004 and January 2005.�
This coverage is comparable to the percentage of older Americans
vaccinated in previous years without supply shortages.� So, many
at-risk older Americans were vaccinated as a result of effective
work of state and local health departments and the cooperation of
younger, healthier Americans who ‘stepped aside’ for
the older and more vulnerable populations allowing us to maximize
the utility of the vaccine we had available.� In addition, through
January of 2005, 48.4 percent of young children (between 6
and 23 months of age) were vaccinated. � This marked the highest
ever vaccination coverage rate in response to a first-time
recommendation of a new vaccine for children. �
CDC is now planning for the 2005-2006 influenza season.� We
anticipate continued challenges in meeting the nation’s
vaccine supply needs.� CDC has identified several scenarios
regarding vaccine supply, including possible production shortfalls
among current influenza vaccine manufacturers for the U.S. market
and/or the entry of new vaccine manufacturers into the U.S.
market.� We have worked with the Advisory Committee on Immunization
Practices (ACIP) to refine prioritization plans should there be
another critical vaccine shortage and we have developed possible
influenza vaccine supply scenarios that range from worst-case to
best-case situations.� These scenarios form the basis for CDC
planning efforts.� In collaboration with the Food and Drug
Administration and the National Vaccine Program Office, CDC is
meeting with U.S.-licensed and other vaccine manufacturers to
discuss plans for the next season, including production and
distribution plans and establishing advance vaccine purchase
guarantees.
Background:� Annual Outbreaks, Pandemics, and Avian
Influenza
Complex changes occur in strains of influenza circulating each
year.� To ensure that the annual influenza vaccine contains strains
that most closely match those currently circulating each year,
disease-causing strains are collected from across the globe using
current surveillance systems. On the basis of these data, advisory
groups at the World Health Organization (WHO) and in the United
States recommend the strains to be included in each year’s
vaccine.� The technical data and expertise that CDC provides are
vital to this process.� Global surveillance needs to be enhanced to
improve data available for the annual vaccine strain selection
process and to provide as early a warning as possible when a new
strain emerges. There are no guaranteed scientific methods to
predict which strain will lead to a pandemic, so constant vigilance
is critical.
In order for an influenza virus, such as the avian influenza H5N1
strain, to potentially cause a pandemic, it must meet three major
criteria: (1) possess a new surface protein to which there is
little or no pre-existing immunity in the human population; (2)
have the ability for sustained transmission from person to person;
and (3) be able to cause illness in humans.� Fortunately, the
present avian influenza H5N1 strain in Southeast Asia does not yet
have the capability of sustained person-to-person transmission,
although chicken-to-human transmission has occurred, and in at
least two clusters, limited person-to-person transmission has been
identified.
Ongoing reports of outbreaks of H5N1 influenza outbreaks in poultry
populations indicate that the virus now exists in Southeast Asia.�
It has also caused illnesses and deaths in humans.� Between January
28, 2004 and March 31, 2005, WHO has confirmed 74 confirmed
human cases of avian influenza in Southeast Asia, including 49
deaths.� New cases are reported almost weekly.� CDC is closely
monitoring this situation in collaboration with WHO.�
Influenza Surveillance
Surveillance is and must be the foundation for all influenza
prevention and control activities.� Early-warning surveillance
activities are being expanded to help detect the next pandemic.�
Public health professionals are monitoring ongoing changes in the
H5N1 strain of avian flu for mutations that may cause increased
human infections, as well as monitoring for other viruses with
pandemic potential.� These actions are paramount in developing
prototype vaccine candidates as quickly as possible.����
Global Surveillance
Because a pandemic strain can arise anywhere and at any time,
expanded global surveillance capacity is needed.� The outbreaks of
avian influenza in Southeast Asia have highlighted gaps in disease
surveillance globally that now are being addressed to improve our
ability to prepare for an influenza pandemic.� DHHS has made
significant contributions and progress in the past year to enhance
surveillance in Southeast Asia.� CDC’s Global Disease
Detection Initiative supports the strengthening of our capacity to
respond to pandemic influenza.� Funding from this resource has been
used around the world to increase the number of international
public health sites that have the capacity to conduct disease
identification and intervention activities, provide critical public
health expertise to countries in need, train international
collaborators to recognize and respond to influenza and other
disease threats, and improve communications capabilities.� In FY
2004 CDC allocated $2.5 million of our global disease detection
funds for avian influenza surveillance.� Such activities expand
geographic coverage and develop an adequate capacity to conduct
effective surveillance.� CDC will continue to support the expansion
of international surveillance networks and the closing of gaps in
information, infrastructure,�laboratory and surveillance technology
in key areas of the world through the Global Disease Detection
program and other international programs at CDC.
Countries affected by avian influenza and their neighbors need
increased training and transfer of technology to allow rapid
identification and analysis of influenza viruses.� Strengthening
the capacity of these countries to conduct influenza surveillance
allows them to share influenza virus isolates through the WHO
surveillance network.� These efforts, in turn, increase our ability
to detect new variants earlier, make more informed vaccine
decisions for annual influenza, and build an early warning system
for new virus strains that may cause a pandemic.� With the
ever-present threat of a new pandemic strain, we need to know what
is happening in the barnyards of Southeast Asia, as well as
elsewhere throughout the world.� Year-round, CDC’s worldwide
surveillance for new strains of influenza prepares us for next
year’s epidemic and for the next pandemic.
Domestic Surveillance
In the past year, CDC has also considerably improved domestic
surveillance, adding two new major components to our surveillance
system.� We have worked with the Council for State and Territorial
Epidemiologists to make pediatric deaths due to influenza a
nationally notifiable disease.� In addition, we have implemented
hospital-based surveillance for influenza in children at selected
sites and issued interim guidelines to states and hospitals to
enhance surveillance for potential cases of people infected by
avian influenza.� CDC also set up special laboratory training
courses for identification of avian influenza using rapid molecular
techniques.� So far, health professionals from 31 states have been
trained, and we plan to train staff from the remaining states in
the coming months.
Vaccine and Antiviral Supply and Vaccination Coverage
The best strategy for influenza prevention and control both during
annual outbreaks and during a pandemic is vaccination. To fully
implement this strategy, we need an ample supply of vaccine, robust
demand, and effective vaccination coverage. Antiviral medications
are a second line of defense.
The vaccine manufacturing system in the United States is fragile.�
Currently, there are only three influenza vaccine manufacturers
producing vaccines for the US market, and only one of those
manufacturers produces its vaccine entirely in the United States.�
During an influenza pandemic, the presence of US-based
manufacturing facilities would be critically important because
vaccine produced in other countries may not be available to the US
market.� CDC has developed several strategies to address potential
vaccine shortages.� Some strategies support enhanced vaccine
production, while others work to ensure vaccine is distributed to
populations with the greatest need.�
For the first time, we have created stockpiles of both influenza
vaccine and antiviral medications.� DHHS initially budgeted $40
million in FY 2004 to develop a strategic reserve of influenza
vaccine licensed for use during the 2004-2005 influenza season
through the Vaccines for Children program, and has budgeted another
$40 million in new money in FY 2005 to develop a strategic reserve
of influenza vaccine licensed for use during the 2005-2006
influenza season.
In the event of a pandemic, there would be limited time to test,
produce, and administer vaccine. CDC estimates that it would take
several months for the first dose of pandemic vaccine to be ready
and longer to manufacture enough to vaccinate the entire U.S.
population.� In FY 2004 DHHS invested $13 million in the
development and production of two million doses of H5N1 vaccine to
prepare our nation for a potential influenza H5N1 pandemic.
One of the greatest challenges in vaccine planning is the
year-to-year unpredictability of public demand for influenza
vaccine, which makes manufacturers reluctant to produce large
amounts of the vaccine.� Increased and stable public demand for
influenza vaccine on a yearly basis would allow companies to have a
predictable market and provide them with incentive to increase
production.� There is an emerging consensus that it is desirable to
expand vaccine coverage recommendations to include people beyond
high priority groups for whom routine vaccination is already
recommended. Research is under way to determine how broad the
recommendations for influenza vaccination should be.� Meanwhile,
CDC is developing strategies to increase demand for, and access to,
influenza vaccine for persons who are currently recommended to be
vaccinated.�
The President’s Budget Request for FY 2006 includes
provisions to help protect against annual shortages of influenza
vaccine in the US.� The request includes an additional $40 million
in new money for purchasing influenza vaccine for the Vaccines for
Children Program stockpile. The FY 2006 request also includes
increases for the Immunization Grant Program (Section 317).� The
first initiative calls for an increase of $30 million to allow CDC
to enter into sales guarantee contracts with manufacturers to
ensure the creation of more vaccine for upcoming influenza seasons
by expanding the production of bulk monovalent (single strain)
influenza vaccine. The second increase in the FY 2006 request is
$20 million to ensure that states have access to additional
influenza vaccine. The investment will increase influenza
vaccination coverage for children to reduce the burden of annual
influenza and further improve the infrastructure for an influenza
pandemic.
The request also includes a proposed change in the law for VFC to
allow underinsured children to receive VFC vaccine at approximately
7,000 state and local public health clinics.� Thus, access points
will be expanded for underinsured children beyond rural health
centers and federally qualified health centers.
State-based Pandemic Influenza Preparedness Planning
States have a major role in the event of a pandemic and are
preparing for it by developing pandemic influenza plans or revising
existing plans to be stronger and more effective. The key elements
of these plans include surveillance, vaccination, antiviral drug
use, community containment measures, communications, response of
the health care system, and ability to maintain essential public
services.� CDC is developing detailed guidance and materials,
including information on who should be included in priority groups
for both vaccine and antiviral distribution, to assist states in
creating these plans.
Containment Measures
If a pandemic strain starts circulating in the United States,
isolation precautions for persons who are ill and quarantine for
healthy but exposed persons may be considered as part of state
actions that may be needed to limit the spread of pandemic
influenza, particularly before a vaccine becomes available.�
Measures such as these would require a multi-level, multifaceted,
staged process and would involve tribal, � state, and
federal authorities.� Steps such as evaluating all ill travelers
arriving from affected areas, adding pandemic influenza to the list
of quarantinable diseases by Presidential Executive Order, and
implementing a series of travel notices to minimize outbreaks
extending to wider geographic areas may be needed.� CDC is
preparing for this potential need by expanding the number and
capacity of its quarantine stations at major ports of entry into
the United States.� As with any quarantine, such activities need to
be undertaken judiciously to minimize adverse impacts on civil
liberties.�
Collaboration with other Agencies
CDC has created extensive partnerships with other DHHS agencies,
other federal agencies, provider groups, non-profit organizations,
and state and local health departments to enhance pandemic and
annual influenza planning and to improve the balance between
vaccine supply and demand.� CDC is collaborating with the National
Institutes of Health, the National Vaccine Program Office, the Food
and Drug Administration, the Health Resources Services
Administration, the Centers for Medicare and Medicaid Services, and
others involved with the DHHS Draft Pandemic Influenza Response and
Preparedness Plan to address critical decisions and actions needed
at the federal and state levels.� CDC welcomes the opportunity to
work more extensively with other DHHS agencies and agencies
throughout the government on these important issues.
Last Revised: April 13, 2005
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