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The Smallpox Vaccination Plan: Challenges and Next
Steps
Bill Number: Oversight Hearing
Hearing Date: January 30, 2003
Witness:
Julie L. Gerberding, MD, MPH, Director
Centers for Disease Control & Prevention
Atlanta, GA
Testimony:
Good morning, Mr. Chairman and members of the Committee.
I am Dr. Julie Gerberding, Director of the Centers
for Disease Control and Prevention (CDC) and Administrator
of the Agency for Toxic Substances and Disease Registry
(ATSDR).
Thank you for the opportunity to testify today about
the efforts underway to assure the nation is prepared
in the event of an attack using smallpox virus as
a weapon.
THE DISEASE
Smallpox is a serious, contagious, and sometimes
fatal infectious disease. There is no specific treatment
for smallpox disease. Prevention strategies involve
vaccination of exposed or potentially exposed individuals.
Smallpox outbreaks have occurred from time to time
for thousands of years, but the disease was eradicated
after a successful worldwide vaccination program.
The last case of smallpox in the United States was
in 1949. The last naturally occurring case in the
world was in Somalia in 1977.
Regardless of the mode, magnitude or duration of any
terrorist attack, smallpox would be expected to spread
from person to person following its introduction.
Much is known about the natural transmission of smallpox.
Generally, direct and fairly prolonged face-to-face
contact is required to spread smallpox from one person
to another. Smallpox also can be spread through direct
contact with infected bodily fluids or contaminated
objects, such as bedding or clothing. Rarely, smallpox
has been spread by virus carried in the air in enclosed
settings, such as buildings, buses, and trains. Humans
are the only natural hosts of variola, the virus that
causes smallpox. Smallpox is not known to be transmitted
by insects or animals.
THE VACCINE
The smallpox vaccine is the only way to prevent smallpox.
The vaccine is made from a virus called vaccinia,
which is another “pox”-type virus related
to smallpox virus. The vaccine helps the body develop
immunity to smallpox. It was successfully used to
eradicate smallpox from the human population. We have
had a lot of experience with the smallpox vaccine
and know it is very effective: it was used to eradicate
smallpox from the world. It is safe in most people,
but in some people it is associated with life-threatening
adverse events. This risk of serious adverse events
has made it more difficult to find the right balance
between preparedness and not placing people at risk
unnecessarily.
Routine vaccination of the American public against
smallpox stopped in 1972 after the disease was eliminated
in the United States. Vaccination was stopped because
the risk of the vaccine was felt to outweigh the risk
from the disease.
Until recently, the U.S. government provided the
smallpox vaccine only to a few hundred scientists
and medical professionals annually who work with smallpox
and similar viruses in a research setting.
The stockpiling of smallpox vaccine was an important
priority before September 11, 2001, and smallpox vaccine
was already in production at that time. The events
of the fall of 2001 heightened concern that terrorists
may have access to the virus and attempt to use it
against the American public. In response to these
events, the Department of Health and Human Services
(HHS) increased its order for vaccine, accelerated
production, and began working to develop a detailed
plan for the public health response to an outbreak
of smallpox. The United States currently has sufficient
quantities of the vaccine for every single person
in the country in an emergency situation.
SMALLPOX RESPONSE PLANNING
A single report of a smallpox case in the United
States will require an aggressive outbreak control
effort to contain spread of the disease. In partnership
with State and Local Health authorities, DHHS/CDC
is in the process of establishing a smallpox preparedness
and response program that:
• Enhances community awareness and clinician
expertise about smallpox disease and smallpox vaccination
through education and training;
• Performs disease surveillance and laboratory
analysis to rapidly detect a single case of smallpox
and any subsequent cases;
• Implements public health interventions, based
on careful consideration of epidemiology and mode
of transmission of smallpox, in the safest possible
manner;
• Provides vaccination and follow-up service,
on a voluntary basis, immediately to those individuals
who respond to a smallpox emergency (including, but
not limited to, those who will treat the victims,
provide security, vaccinate the population, and perform
disease case investigations), then, based on knowledge
gained, expand the program to include those responders
who would be occupationally at risk during a smallpox
outbreak;
• Provides for the capability to rapidly vaccinate
a greater number of responders or the entire population
should a case occur or threat levels of a possible
smallpox terrorist attack increase.
• Response to an Attack
States need to be prepared to rapidly implement aggressive
smallpox containment activities, including the ability
to vaccinate their entire populations. On October
28, 2002, CDC issued post-event smallpox planning
guidance to the 50 states; the District of Columbia;
the commonwealths of Puerto Rico and the Northern
Marianas Islands; American Samoa; Guam; the U.S. Virgin
Islands; the republics of Palau and the Marshall Islands;
the Federated States of Micronesia; and the nation's
three largest municipalities (New York, Chicago and
Los Angeles County). To date, all 62 jurisdictions
have developed plans that are undergoing review by
CDC.
In addition, we are also working collaboratively
with other nations (Canada, France, Germany, Italy,
Japan, Mexico, and the U.K.) in the Global Health
Security Action Group (GHSAG) to provide a coordinated
and collaborative response to a bioterror event. In
particular, we are working closely with Canada and
Mexico, as a smallpox outbreak in either could necessitate
a rapid response in the U.S.
INCREASING PREPAREDNESS PRIOR TO AN ATTACK
• President’s Plan
On December 13, 2002, President Bush announced a plan
to better protect the American people against the
threat of smallpox attacks by hostile groups or governments.
This announcement is a vital step in ensuring that
we are prepared to respond to a single reported case
of smallpox. The President’s decision will provide
the public health and emergency response system with
a cadre of vaccinated individuals who would respond
in the event of outbreak of smallpox. The President’s
announcement identified the need for the public health
system to provide smallpox vaccine to the following:
• Smallpox Response Teams
HHS has been working with state and local governments
to form volunteer state and local Smallpox Response
Teams that can provide critical services to their
fellow Americans in the event of a smallpox attack.
To ensure that Smallpox Response Teams can mobilize
immediately in an emergency, health care workers and
other critical personnel are being asked to volunteer
to receive the smallpox vaccine. Pre-attack vaccination
of Smallpox Response Teams will allow them, in the
event of a smallpox attack, to immediately administer
the vaccine to others and care for victims. In the
initial phase of vaccination, vaccine will be offered
to core members of public health and health care response
teams. Then vaccination will expand to include health
care workers and others who may be first responders.
• Department of Defense and State Department
Personnel
The President also announced that the Department of
Defense (DOD) will vaccinate certain military and
civilian personnel who are or may be deployed in high
threat areas. Some United States personnel assigned
to certain overseas embassies will also be offered
vaccination.
• Members of the General Public
The federal government is not recommending that members
of the general public be vaccinated at this time.
The government has no information that a smallpox
attack is imminent, and there are significant side
effects and risks associated with the vaccine. HHS
is in the process of establishing an orderly process
to make unlicensed vaccine available to those adult
members of the general public without medical contraindications
who want to be vaccinated either in 2003, with an
unlicensed vaccine, or in 2004, with a licensed vaccine.
A member of the general public may also be eligible
to volunteer for an on-going clinical trial for next
generation vaccines.
IMPLEMENTATION OF SMALLPOX PREPAREDNESS PLANS
On November 22, 2002, CDC asked states how they intend
to vaccinate individuals most likely to respond to
a smallpox attack. CDC requested pre-attack plans
that contain information on the number of people comprising
each Smallpox Response Team, information on where
vaccines would be administered, the number of health
care facilities identified to participate, and the
number of clinics needed to support this effort. States
were also asked to address vaccine logistics and security,
vaccine safety monitoring, training and education,
data management, and communications in their plans.
• Status of State Pre-Attack Vaccination Plans
States have worked diligently to develop plans to
vaccinate and have begun implementing them. My oral
testimony will address the current status of their
implementation.
The plans indicate that approximately 450,000 public
health and healthcare personnel may be offered the
smallpox vaccine. Vaccination is voluntary and eligible
individuals will make their own decisions as to whether
or not to receive the vaccine. There are no negative
ramifications employment ramifications for anyone
who chooses not to be vaccinated. About 1,500 clinics
around the nation will be set up to deliver the vaccine
to those who choose to receive it. In addition, state
health officials have identified over 3,300 health
care facilities that will participate in the program.
DISTRIBUTING VACCINE TO THE STATES
The National Pharmaceutical Stockpile (NPS) Program
ensures the availability and rapid deployment of life-saving
pharmaceuticals, antidotes, other medical supplies,
and equipment necessary to counter the effects of
nerve agents, biological pathogens, and chemical agents.
The NPS Program stands ready for immediate deployment
to any U.S. location in the event of a terrorist attack
using a biological toxin, chemical or radiological
agent directed against a civilian population at the
request of the locality.
The week of January 20, 2003, CDC delivered kits
with enough vaccine and needles for 21,600 public
health and healthcare workers to Connecticut, Nebraska,
Vermont and Los Angeles County. As of January 22,
2003, 20 states (including 1 county) requested nearly
100,000 doses of vaccine. These were the first shipment
of vaccine to state and local governments under the
President's plan to protect the American people from
an intentional release of the smallpox virus. Under
the program, smallpox vaccine is being offered to
those most likely to respond to a potential outbreak
of the disease. Each state notifies CDC when it is
ready to receive its shipment of smallpox vaccine
to begin pre-event vaccination of public health and
healthcare workers. Once CDC receives a request for
smallpox vaccine from a state, the order is forwarded
to the National Pharmaceutical Stockpile for processing
and shipment. CDC is providing smallpox handling instructions,
cold chain management guidance, and all appropriate
documentation. CDC will deliver Dryvax? smallpox vaccine,
packaged and shipped in increments as small as one
vial (100 doses). CDC will validate all delivery information
prior to shipment and will release vaccine after validation
of temperature monitoring information.
TRAINING AND EDUCATION
Because smallpox vaccine has not been used routinely
in the United States since the
early 1970s, many of today’s healthcare providers
are not familiar with the disease, the vaccine, or
the vaccine’s potential side effects. This makes
training of those administering and those receiving
the vaccine necessary to ensure that this program
is implemented as safely as possible. Anyone considering
vaccination must receive information on conditions
that are contraindications to vaccination (e.g., certain
skin conditions, compromised immune systems, pregnancy,
allergies to components of the vaccine, or household
contacts with a condition listed above). CDC has held
19 training and education sessions on smallpox that
reached an estimated 800,000 clinicians, members of
the public health workforce, and members of the general
population. Training has been conducted in classrooms,
via satellite, over the Internet, through videotaped
sessions and CD-ROM, and over the telephone. Thirty
different training products, in a wide variety of
media formats, currently are available.
• Training for Response Team Members
Training and education for Smallpox Response Team
members will be critical. In order to prepare for
their participation in a smallpox response effort,
all Smallpox Response Team vaccination candidates
will be asked to watch a video distributed by CDC
and will receive a packet of information describing
the purpose of the national smallpox preparedness
program. The response team members will receive general
information about smallpox disease and the vaccine,
including pre- and post-vaccination worksheets to
provide instructions for anticipating and monitoring
any potential side effects, as well as fact sheets
on various methods of treatment for side effects resulting
from vaccination. Prior to vaccination, each vaccine
recipient will be required to fill out a patient medical
history and consent form to confirm the absence of
contraindications and to confirm the patient’s
consent in receiving the vaccine.
• Training for Clinicians
Clinicians must be able to detect the first symptoms
of a potential case of smallpox. During vaccination
of response team members, clinicians will be an important
resource for volunteers who are making a decision
about whether or not they want to accept the smallpox
vaccine. CDC has an ongoing initiative to educate
clinicians about smallpox, done in conjunction with
experts from a variety of medical professional organizations,
including the Infectious Disease Society of America,
the American Academy of Dermatology, the American
College of Emergency Medicine (within a consortium
of other emergency clinician organizations), and several
primary care organizations. We are planning to help
these organizations repackage information from CDC,
and distribute it to their constituents in the format
most appropriate for their members. In addition, CDC
has established ongoing communication with 66 professional
organizations that represent front-line clinicians
to determine the smallpox training and education needs
of their members. Within the next month, CDC is planning
a national mail-out of critical clinician information
to the nation’s hospital and clinical community
through each state’s licensing board. In addition,
we anticipate hundreds of thousands of clinicians
will participate in CDC’s upcoming Public Health
Training Network program on “Clinical Management
of Adverse Events Following Smallpox Vaccination:
A National Training Initiative” scheduled for
February 4, 2003. To supplement this extensive campaign
to educate clinicians, CDC is also utilizing its normal
means of getting information to clinicians, including
the Health Alert Network, the secure Epi-X program,
and the Morbidity and Mortality Weekly Report (MMWR).
CDC has also contracted to establish a 24-hour-a-day,
7-day-a-week hotline for clinicians to call with questions
about smallpox vaccinations.
• Training for Laboratorians
CDC is providing smallpox training for laboratorians,
including detailed instructions on the differentiation
of smallpox from other rashes. On January 29, 2003,
CDC will broadcast nationally a training program entitled,
“Smallpox and Vaccinia Laboratory Testing: A
National Training Initiative.” The program presents
detailed information, specific to those who perform
testing and those who use laboratory services, such
as physicians, nurses, epidemiologists, and state
medical officers. They will also be given specific
information on the laboratory role in diagnosing adverse
events associated with smallpox vaccination. In addition,
CDC has developed “Agents of Bioterrorism: A
Guide for Clinical Laboratories,” which includes
information for clinical laboratorians about handling
specimens suspected of containing smallpox. This guide
will be distributed to the state public health laboratories
within the next two weeks. The state public health
laboratories can customize the guide with state-specific
information and deliver it to the clinical laboratories
in their area.
• Education for the Public and the Media
CDC has, and will continue to use, weekly (and as
warranted) media briefings, media advisories, access
to smallpox vaccine experts, and public information
materials to create awareness of the smallpox vaccination
recommendations, the purpose of the recommendations,
and the risks associated with smallpox vaccine. In
addition, CDC is using its website to provide easy
access to a wide range of smallpox education materials,
including materials designed specifically to meet
the needs of different audiences—such as members
of the public, health care providers, people for whom
smallpox vaccination is recommended, and state and
local health departments. We have been, and will continue
to work with, state and local health departments and
other partners to help ensure our messages and materials
are visible and readily available. CDC also operates
a 24-hour-a-day, 7-day-a-week public information hotline
that is accessible in English and Spanish.
PREVENTING, DIAGNOSING, TREATING, AND MONITORING
ADVERSE EVENTS
Ensuring that we can implement this program as safely
as possible has been central to our planning. The
first part of this effort is to carefully educate
and screen those considering vaccination. We have
had a great deal of experience with this vaccine and
have information on who is at risk of serious adverse
events (e.g., those who have certain skin conditions,
have compromised immune systems, are pregnant, have
allergies to components of the vaccine, or have a
member of their household with a condition listed
above). Second, we will, with state and local health
departments and the healthcare community, ensure that
we diagnose, manage, and treat adverse events promptly
and correctly. Third, we will very carefully monitor
adverse events to ensure that we know of any unexpected
patterns or types of adverse events on a real-time
basis and can quickly modify the program to decrease
the risk of adverse events if necessary. Included
in this effort is education about what to expect after
vaccination, when to be concerned about an adverse
event, and where to go for help.
The Smallpox Vaccine Adverse Events Monitoring and
Response System will monitor the occurrence of clinically
significant, especially serious, adverse events (AEs).
It will also serve to identify any unexpected adverse
events. This process will help to build state capacity
for assessment of adverse events.
• Diagnosing and Treating Adverse Events
CDC will provide technical assistance to state health
departments, including screening to identify and exclude
persons with contraindications and help in implementing
proper clinical procedures. There will be a designated
telephone hotline for state health departments. CDC
will monitor state tracking of clinically significant
AEs. CDC will also inform states of any adverse event
reports transmitted directly to CDC.
Efforts are underway to work with healthcare providers
to assure they are educated about the smallpox vaccination
program and smallpox vaccine AEs. This includes recognizing
possible AEs and managing and treating any AEs among
their patients. Standard algorithms are under development
to assist physicians in proper identification and
treatment of these patients.
Vaccinia Immune Globulin (VIG) is a product used
to treat certain serious adverse reactions caused
by smallpox vaccine. Sufficient quantities of VIG
are available now to treat all anticipated adverse
events resulting from the current vaccination program.
New VIG is being produced and delivered to the National
Pharmaceutical Stockpile for distribution, if needed,
as the vaccination program expands. An effort is underway
to produce new lots that will meet the standards for
intravenous immune globulin. Cidofovir is a drug used
to treat viral infections in persons with HIV/AIDS.
It may be helpful in treating vaccinia reactions in
cases where VIG does not work.
The state will inform CDC of VIG and/or Cidofovir
requests. A CDC clinical team will then assess the
request with the state and treating physician. CDC
Drug Services and the National Pharmaceutical Stockpile
will coordinate release of VIG and Cidofovir. The
treating physician will then designated as a co-investigator
on the Investigational New Drug (IND) protocol.
• Reporting
CDC is working with the states to develop an active
surveillance system to detect serious adverse events
following smallpox vaccine. CDC intends to implement
recommendations that all health care workers have
their vaccination sites monitored in the hospital
daily, which will contribute information on serious
illnesses that occur in all vaccinees. In addition,
CDC will use the Vaccine Adverse Event Reporting System
(VAERS), a national surveillance system administered
by CDC and the Food and Drug Administration (FDA),
to monitor smallpox AEs. The data collected through
VAERS will be analyzed to identify any new or rare
vaccine side effects, increases in rates of known
side effects, associations with specific vaccine lots,
or patient risk factors.
• Post-vaccination Surveillance
Post-vaccination surveillance will be conducted for
people receiving the smallpox vaccine. This surveillance
will assist in determining the rates of common AEs,
assessing impact on time lost from work, and evaluating
vaccinee satisfaction with the immunization program.
This will be done by telephone survey 10 and 21 days
post-vaccination.
• Data and Safety Monitoring Board
CDC has established a Data and Safety Monitoring Board
to provide advice to the CDC and program managers
on selected aspects of pre-event smallpox vaccination
program implementation.
The committee will review reported adverse events
to determine whether rates of serious events are within
expected limits; whether recommendations for screening
out persons with contraindications are being properly
observed; whether adverse events following vaccination
are causally or only coincidentally linked to vaccination;
and whether the adverse events experienced necessitate
a substantial change in the way the program is run.
IOM COMMITTEE
Through the Institute of Medicine’s (IOM) Committee
on Smallpox Vaccination Program Implementation, the
IOM is providing advice to the CDC and program managers
on selected aspects of pre-event smallpox vaccination
program implementation. The IOM Committee released
its first report on January 17, 2003.
The committee is making recommendations to CDC and
state and local vaccine program managers to improve:
CDC guidance designed to identify potential vaccine
recipients at high risk of vaccine adverse events
and complications; CDC measures to ensure the early
recognition, evaluation, and appropriate treatment
of adverse events and complications of smallpox vaccination;
CDC plans for collecting and analyzing data on vaccine
immunogenicity, adverse events, complications, and
vaccine coverage; the informed consent process for
vaccine recipients; professional education and training
materials; communication plans for public health and
medical professionals and the public; state smallpox
vaccination implementation plans; and the achievement
of overall goals of the smallpox vaccination program
(e.g., vaccine coverage rate, equity of access, adverse
reaction rates, etc.).
CONCLUSION
Assuring the nation is prepared in the event of an
attack by a hostile group or government is one of
the highest priorities for the administration. HHS
and CDC are dedicated to assisting the states in increasing
smallpox preparedness. We greatly appreciate all the
work the states and local jurisdictions have done
to develop plans and begin to implement them. We look
forward to continuing to support states’ efforts
to protect the American people.
Thank you for the opportunity to testify before you
today on this important public health issue. I would
be happy to answer any of your questions.
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