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The Smallpox Vaccination Plan: Challenges and Next
Steps
Bill Number: Oversight Hearing
Hearing Date: January 30, 2003
Witness:
Martha Baker, R.N., Co-Chair
Service Employees International Union (SEIU) Nursing
Alliance
Washington, DC
Testimony:
Good morning Committee Chairman Gregg, Ranking Member
Kennedy and other Members of the Senate HELP Committee.
My name is Martha Baker. I have been a registered
nurse for 23 years. I work in the Trauma Intensive
Care Unit of Jackson Memorial Hospital in Miami, Florida,
and I’m a national leader of the 1.5 million
member Service Employees International Union, the
largest health care union in the country. I am also
president of SEIU Local 1991 and co-chair of the SEIU
Nurse Alliance, which is made up of 110,000 nurses
across the country. In addition to nurses, our union
represents doctors, laboratory technicians, EMTs,
orderlies, dietary workers, laundry workers, environmental
services workers, and other occupations within the
health care sector. Many of these employees work in
occupations that would likely be defined as “first
responders” in the event of a smallpox attack.
As a trauma nurse, I deal with emergencies every
day and work on the frontlines of medicine, providing
every patient that comes through the door with the
best care possible. If a smallpox outbreak occurred,
I’d want to do no less for someone suffering
from that terrible disease. That’s why –
if there is a bioterrorism threat – it makes
sense that health workers should take steps now so
we’re ready to respond. Unfortunately, problems
with the Bush Administration’s smallpox vaccination
plan are making a lot of nurses like me hesitant to
roll up our sleeves and put the health of our patients,
our loved ones, and ourselves on the line.
Dr. Fauci and Dr. Gerberding have already discussed
the scientific details of this vaccine. Suffice it
to say, everyone agrees that this is a very dangerous
human vaccine. When the vaccine was routinely being
administered up until 1972, for every 1 million vaccinated,
1,000 people suffered serious side effects, 14-52
people suffered life-threatening complications and
one or two died.
The question we face today is whether our elected
leaders in Washington could be doing more to make
sure the vaccine program is safe and effective. The
prestigious Institute of Medicine says better safeguards
are needed. The American Public Health Association
has called for compensation for vaccine victims, liability
protection, and adequate resources to safely implement
the plan.
Many hospitals across the country are speaking with
their feet. The USA Today reported last week that
more than 80 hospitals have decided to opt out of
the program. The majority of states have not yet ordered
the vaccine. And in Connecticut, only four doctors
showed up to get vaccines after nurses’ concerns
about the plan went unanswered.
I’d like to talk about the issues workers and
management at my hospital faced when we tried to figure
out how to safely implement this plan.
First, everyone wanted to be sure we weren’t
doing anything to put our patients at risk.
Jackson Memorial is one of the largest public hospital
in the country. On any given day, we care for hundreds
of patients. Some are pregnant women, newborn infants,
and children. Many of them are battling cancer or
are HIV positive. If I or anyone in my household has
these conditions, the Centers for Disease Control
and Prevention says I shouldn’t take the vaccine.
So how can we be sure our patients are 100 percent
safe in the care of nurses, doctors, or other caregivers
who get vaccinated? In June, the Advisory Committee
on Immunization Practices (ACIP) recommended against
direct patient care for about three weeks. In October,
the same panel said patient care is safe. While the
medical experts debate the issue, the nurses I work
with just want to know – Am I going to infect
someone in my care?
Nurses, doctors, and management at our hospital decided
that any volunteer who could accidentally expose vulnerable
patients to the virus in the vaccine should be put
on administrative leave until they were no longer
shedding the live virus in the vaccine.
In our hospital – as in just about every hospital
across the country – understaffing is a constant
issue. Too few nurses are already under pressure to
provide quality care to patients who are sicker than
ever before. Recent studies suggest that the smallpox
vaccine will make up to 1 in 3 nurses too sick to
work for a few days – and those are just the
people with normal reactions.
Staff at our hospital will be vaccinated in stages,
so we don’t create a staffing crisis that compromises
care. And if workers at our hospital get sick for
a few days as a result of the vaccine, management
has agreed to treat it as an on-the-job injury so
they won’t face any loss of income.
Next, we thought about our own health and the health
of our families.
The Washington Post reported last week on a survey
that showed how little nurses know about smallpox
and the vaccine. I can tell you from my own experience
that it’s true. So we knew we had to make sure
everyone is provided with good information by holding
training sessions on work time so they can make an
informed decision. We’re also going to closely
monitor people who are vaccinated and make that information
is available as we go along so other workers can benefit
from our experience. The lack of proper surveillance
and reporting is a critical missing piece of President
Bush’s vaccination plan. It would be a shame
if the 10 million “first responders” who
are set to get vaccinated after health care workers
don’t have access to the knowledge we gain during
the first phase of this plan. This is why we support
the Institute of Medicine recommendations for “active”
monitoring of those vaccinated, and not the “passive”
monitoring CDC currently recommends.
Many health workers being asked to volunteer for
this vaccine are women who have children at home,
are pregnant, or could be pregnant. Latex allergies
and other skin disorders are more common among health
care workers. And certainly advanced treatments mean
many people, including nurses and other health workers,
are living with cancer, HIV, or other disorders that
put them at a higher risk of adverse reactions from
the smallpox vaccine.
Our hospital is providing free and confidential testing
for any volunteers who want to be sure they aren’t
pregnant or infected with HIV before they volunteer
for this vaccine. Our service men and women in the
military who are candidates for the vaccine are being
offered such protection, but as of yet, the federal
government has not agreed to pay for such tests for
civilian health worker volunteers. Spending a relatively
small amount on preventative testing can reduce the
cost of any compensation fund, as adverse effects
are less likely if people at high risk are identified
and screened out. Not everyone will need testing,
but there must be mandatory screening with free voluntary
testing where such follow-up is indicated. Not only
must testing be confidential, but smallpox responders
must be protected against any discrimination or retaliation
on the job if they refuse to be vaccinated.
Most nurses are used to vaccinations. We see how
sick people get at this time of year and counsel our
patients about getting their flu shots. Health care
workers fought for access to the Hepatitis B vaccine.
So in a way, getting another vaccination is all in
a day’s work. And since the average age of nurses
is 47, many of us got a smallpox vaccine when we were
children.
But there’s a reason why our country stopped
vaccinating children against smallpox. The risks outweighed
the benefits. People were getting sick and a few were
dying from the vaccine. A doctor I work with had one
of the life-threatening reactions to the vaccine that
everyone is talking about – she got encephalitis
when she was vaccinated as a child.
The situation is potentially much more precarious
today. Back in 1972, few people lived with weakened
immune systems, and less than 5 percent had eczema;
both groups that are now considered high risk and
should not be exposed to the vaccine. Today, it is
estimated that between 30 million and 50 million Americans
fit a high-risk category. This includes people who
are receiving chemotherapy, have had organ transplants,
are pregnant or are planning to become pregnant, have
allergies to some antibiotics or latex, are taking
high doses of steroids, have, or have ever had eczema
(now estimated at up to 22 percent of the population),
or are infected with the AIDS virus.
The risks of this vaccine are real. Health care workers
around the country are asking: What if me or one of
my patients or one of my children is one of the unlucky
few who gets sick?
Unfortunately, there is no good answer to that question.
This is why careful screening and free, confidential
testing – as well as active, on-going medical
surveillance of vaccine volunteers and their patients,
co-workers, and household members – is essential.
Health care workers and those close to them must have
immediate access to free medical treatment if needed.
If serious reactions occur, countermeasures must be
in place to perhaps prevent a life threatening response,
including the immediate availability of Vaccinia Immune
Globulin (VIG).
The Homeland Security Act protects the drug companies
who produced the vaccine and the hospitals who administer
it from liability. If workers, their patients, or
their family members get sick as a result of the vaccine,
they’ll be lucky if they receive a “get
well” card from our elected leaders. I think
we can do better than that – and I hope you
do, too.
Nurses at my hospital had a voice in how our smallpox
vaccination plan will be implemented because we have
a union. But most health care workers aren’t
so lucky. Without action by Congress, the safety of
this plan for workers and our patients will depend
a lot on where you live and which hospital you work
in.
Even our hospital hasn’t been able to answer
the question of what will happen if one of us, or
one of our patients, or someone we live with gets
really sick from this vaccine. At Jackson Memorial
we are fortunate since our employer has agreed to
pay for up to seven days of administrative leave for
those of us who have less severe reactions.
But what happens after that is an unknown. Where can
health care workers or others suffering injury or
illness from the vaccine or exposure to the vaccine
turn to for coverage of medical care and lost wages.
State and federal workers’ compensation programs
do not provide an adequate safety net. We have already
heard that some state workers’ compensation
programs won’t cover us and others won’t
do enough. Some workers’ compensation programs
may not cover the claims of workers who have adverse
reactions because they have voluntarily agreed to
be vaccinated. Some state workers’ compensation
laws do not require coverage for all workers. Since
workers’ compensation only applies to injuries
that are work-related, it won’t provide any
protection for patients or family members who could
be at risk.
Even where applicable, workers will not be fully
compensated. Most workers’ compensation programs
replace only two-thirds of workers’ earnings.
There are also limits on the maximum weekly benefits,
which means that more highly paid health care workers
cannot receive anything approaching adequate replacement
of their lost income. In addition, there are caps
on medical care, posing a particular problem for workers
who suffer a severe side effect. Clearly, for most
civilian responders and others who become ill from
exposure to the vaccine, the workers’ compensation
program will not be there for us.
So where do we turn for coverage of our medical costs
and lost wages if we become ill from the vaccine –
either directly or indirectly? Since health care and
emergency workers are being asked to step forward
to help protect our nation against a possible smallpox
attack, we believe the federal government has a responsibility
to make sure that no one vaccinated or harmed as a
result of the vaccinia virus has to worry about paying
for medical treatment or recovering lost wages. In
the case of more severe adverse reactions, there must
be a fair compensation program that is easily accessible,
recognizes the no-fault likelihood of injury, and
covers the cost of medical care and lost income.
If smallpox is a threat, then we need to prepare
for it in a way that doesn’t make the problem
worse. It has been SEIU’s view that the national
smallpox program should not proceed until all necessary
protections and safeguards are in place. But now that
vaccinations have started, Congress urgently needs
to pass and fund legislation that closes the gaps
in the Administration’s smallpox plan that could
put everyone at risk.
The Need for Federal Legislation
This is why SEIU and other unions representing health
care and emergency workers have developed a legislative
proposal that speaks to the safeguards that we believe
must be in place in order to carry out a successful,
safe smallpox responder program. I have attached the
full proposal, but briefly we believe a safe, effective
smallpox program must include the following:
• Sufficient federal funding to allow all states
through state and local public health agencies, in
cooperation with hospitals and other health care entities,
to have the needed resources to carry out and coordinate
all aspects of a comprehensive smallpox program. States
should not have to siphon funds now being used to
strengthen state and local public health infrastructure
to fund the smallpox program. States must ensure there
are the following:
1. Mandatory education that is available prior to
vaccination for all potential smallpox responders,
their household members, and co-workers who may be
exposed to the vaccinia virus.
2. Mandatory Medical Screening and voluntary testing
program that provides free and confidential screening
and testing for pregnancy, HIV, and other conditions
that could put volunteers at high risk of side effects.
Workers who choose not to receive the vaccine should
not face discrimination or retaliation on the job.
3. Medical Surveillance and Treatment of volunteers,
patients, co-workers, and household members for any
adverse effects of the vaccine. Treatment must be
available at no cost to those suffering adverse reactions
to the vaccine as well as protections to ensure no
lost wages or benefits if they are required to take
time off from work. A federal compensation program
must available for those suffering from more serious
adverse reactions. For those responders or others
who have no health insurance, there must be some provision,
such as temporary Medicaid coverage, to ensure that
treatment costs are covered. In addition, the Institute
of Medicine has recommended a much stronger system
of reporting adverse reactions tot he vaccine.
• Compliance with the Needlestick Safety and
Prevention Act of 2000. Only the safest and most effective
bifurcated needles should be used to administer the
smallpox vaccine. A sheathed bifurcated needle is
available for the smallpox vaccine. We urge that the
FDA expeditiously expand their current license for
safer bifurcated needles so that they can be used
as part of this national smallpox program and included
as part of vaccine kit.
• A National Smallpox Vaccine Injury Compensation
Program. This program would cover costs for medical
care, lost wages, and pain and suffering for those
who face more severe reactions to the vaccine or as
a result of exposure to the vaccinia virus. We already
have a model for this in the childhood vaccine injury
compensation act, which is a no-fault, easily accessible
compensation program.
Conclusion
SEIU, along with the other health care unions, are
very pleased that Chairman Gregg, Majority Leader
Frist and Senator Kennedy have agreed to work together
in crafting legislation that we believe will meet
many of these points raised above. We look forward
to working with you to assure our nation’s smallpox
program includes the protections that health care
workers, emergency workers, patients, and household
members need and deserve. Given that smallpox vaccinations
have already begun, we hope that you will move quickly
to introduce legislation and to appropriate the necessary
funds to make it a reality. On behalf of SEIU, we
are grateful for this opportunity to express the concerns
of frontline health care responders.
Thank you.
OUTLINE FOR SMALLPOX LEGISLATION
The following are the critical elements that must
be included in any federal legislation related to
the implementation of a National Smallpox Vaccination
Program for all potential smallpox responders (includes
the anticipated 10 million civilian health care workers
and first responders) and their household contacts,
co-workers, patients, and the general public who by
reason of contact could contract the vaccinia virus
or other illnesses resulting from the smallpox vaccine.
Since this is a program for national defense, there
must be a comparable range of protections and services
provided to the civilian smallpox volunteers as are
being provided to military personnel and defense contractors
through the Department of Defense smallpox program.
I. Urgency for legislation to protect potential Smallpox
Responders. With the civilian smallpox responder program
expected to begin January 24, it is imperative that
emergency legislation be passed and signed into law
prior to the start date that would provide for a Smallpox
Responder Protection Program in accordance with the
elements listed below and that sufficient appropriations
are also approved to carry out a comprehensive program.
Any legislation must include new funding to states
to provide for education, screening, medical surveillance,
and treatment; protection against discrimination in
the workplace; requirement to use safer needles; and
compensation due to adverse reactions and inability
to work.
II. Education, Screening, and Medical Surveillance
Program
The legislation shall include new funding to the
states to establish state programs with the requirements
listed below. States are responsible for ensuring
that all these requirements are carried out.
• Mandatory Education
Prior to the initiation of a vaccination program,
a mandatory education program on the smallpox vaccine
for all potential smallpox responders, their household
contacts, and co-workers who may be exposed to the
vaccinia virus.
1. The mandatory education program for smallpox responders
shall be similar in format to the requirements for
education under the OSHA Bloodborne Pathogens Standard
(OSHA 1910.1030(g)(2)).
2. The mandatory education must explain verbally and
in writing the screening and medical surveillance
program; the risks for those smallpox responders vaccinated,
their household contacts, patients, and co-workers;
coverage for lost wages and benefits and on-going
medical care for those injured by the vaccine directly
or as a result of contact with someone who received
the vaccine; the injury compensation program, and
the right to refuse the vaccine without being discriminated
against at work.
3. All written information must be available in easy
to read form and distributed to all smallpox responders,
as well as household contacts, co-workers, and patients
potentially exposed to the vaccinia virus through
those who were vaccinated. Where appropriate, multilingual
materials should be developed. This information should
also be available on a website established by the
state or through the CDC that is the central source
for all information available to the public on the
National Smallpox Vaccine Program.
4. Employers shall be responsible for ensuring that
all potential smallpox responders and their co-workers
receive the mandatory education program.
5. This program shall be available free of cost and
shall be available on work time.
• Medical Screening
Provide free and confidential medical screening
1. Confidential medical screening must be available
to everyone volunteering for the vaccine to determine
if there are any health risks for the smallpox responder
or their household contacts that would eliminate or
delay the smallpox responder as a candidate for vaccination.
Any test results and information collected during
medical screening must be considered protected health
information and not available to employers.
2. Medical screening shall include appropriate medical
examination and testing.
3. Any willing smallpox responder must agree to confidential
medical screening prior to vaccination.
4. Medical screening shall be free and done on work
time.
• Medical Surveillance and Treatment
Provide on-going medical surveillance and treatment.
1. For the first four weeks following the vaccination,
there must be on-going monitoring for all those who
were vaccinated to determine if there are any adverse
reactions that require immediate medical treatment.
Medical surveillance will be done by the agency or
facility that vaccinated the first responders. However,
it is the responsibility of the state public health
agency to ensure that adequate medical surveillance
is carried out in accordance with the CDC guidelines
for active surveillance and follow-up.
2. Immediate evaluation and required medical treatment
shall be provided to anyone who appears to have an
adverse reaction to the vaccine, including co-workers
and household contacts of the vaccinated smallpox
responder. The agencies or facilities designated by
the state to carry out the smallpox vaccination program
are responsible for ensuring that anyone who has an
adverse reaction shall receive immediate evaluation
and treatment, if needed.
3. Those vaccinated, affected co-workers and household
contacts shall receive all medical surveillance and
treatment free of cost and without any loss of wages
or benefits. All costs related to surveillance and
treatment and lost wages and benefits shall be borne
by the federal government as provided under Sections
III and IV.
4. Adequate protection for those vaccinated will be
provided to minimize accidental transmission of the
vaccinia virus to co-workers, patients, household
contacts, and the public.
5. Those responsible for medical surveillance shall
make a determination when a worker should be removed
from regular work in order to protect patients and
co-workers as a result of an adverse reaction to the
vaccine. Workers relieved of work for this reason
shall not suffer any loss in wages or benefits.
6. The federal government must ensure that there are
adequate supplies of the vaccinia immune globulin
(VIG) available through the state public health agencies
to assist in treatment of adverse reactions. Anyone
injured by the lack of available VIG must be able
to sue the federal government under the Smallpox Vaccine
Injury Compensation law.
7. Similar to DoD’s Vaccine Adverse Reporting
System, the federal agency responsible for administering
the National Smallpox Vaccine program shall establish
a uniform reporting system for adverse responses to
the smallpox vaccine so the public can fully evaluate
the risks of the vaccine. (CDC has issued in its smallpox
guidelines a requirement for states for filing Vaccine
Adverse Event Reporting System (VAERS) Reports.)
• Protection Against Discrimination
Protect all smallpox responders from job discrimination
or retaliation for refusal to be vaccinated.
1. There must be no discrimination in the workplace
based on an individual’s decision whether or
not to participate in the smallpox vaccination program.
2. An appeal process must be available if a worker
is discriminated against for refusal to be vaccinated.
Antidiscrimination protections afforded workers shall
be similar to those provided employees under Section
211, 42USC 5851(b)(1)(Energy Reorganization Act) and
administered by DOL subject to 29CFR Part 24 –
Procedures for the Handling of Discrimination Complaints
under Federal Protection Statutes. Employees will
also be afforded the right to sue employers who violate
the prohibition against discrimination.
• Each workplace where smallpox responders
are present must ensure that systems are in place
to protect vulnerable patients from being exposed
to smallpox responders who have had the vaccine, and
to inform patients of the safeguards that have been
put into place.
• Administer the vaccine with safer needles.
Only the safest and most efficacious bifurcated needles
meeting OSHA’s Bloodborne Pathogens Standard
may be used to administer the smallpox vaccine. Sheathed
needles are now available for the smallpox vaccine.
Before the commencement of the vaccine program, the
FDA must issue the license for use of the sheathed
bifurcated needles for the smallpox vaccine. The 50
million needles the government shipped to health care
facilities with the vaccine do not comply with the
Needlestick Safety and Prevention Act of 2000 designed
to protect health care workers and patients from accidental
needlesticks. To the extent available in the marketplace,
the use of safer needles shall be implemented either
by direct purchase by CDC or reimbursement through
CDC. States must ensure that the vaccine is administered
with safer devices in all public and private workplaces.
• Full funding to state public health agencies
to enable every state to develop and carry out the
required education, screening, medical surveillance,
and treatment programs. Such funds should be new monies
available as an emergency appropriation to the states.
States should not have to siphon funds now being used
to strengthen state and local public health infrastructure
to fund the smallpox program.
III. Provision of free medical treatment for smallpox
responders, for household contacts, co-workers, patients,
and others who are injured as a result of contact
with someone who received the vaccine.
For those without insurance or whose insurance would
not cover treatment of adverse reactions to smallpox
as an exclusion or because of high deductible.
Options:
• Require the state departments of health through
the designated smallpox agencies, facilities, or providers
to provide medical treatment. The state grant program
must include sufficient monies to enable the public
health departments to provide the direct medical care,
reimburse providers for care, or contract for such
care.
• At state option, extend Medicaid coverage
temporarily to smallpox responders who become ill
as a result of their own participation in the National
Smallpox Vaccination Program or develop symptoms after
coming in contact with an individual who has participated
in the program. (Modeled after the coverage provided
to people who have been diagnosed with breast and
cervical cancer through the CDC early detection program.)
IV. Leave Rights for Smallpox Responders
Experts say approximately 1 in 3 people who are vaccinated
will feel too sick to work or to provide proper patient
care for one or more days.
• All vaccinated smallpox responders, affected
co-workers and household contacts who are not well
enough to work must have up to 4 days of leave without
loss of wages or benefits. Employers may seek reimbursement
for wages and benefits paid to these workers.
• In the interest of public safety, employers
shall make a determination if a smallpox responder
who has an adverse response to the vaccine shall be
placed on leave or transferred to another position.
The responder shall not suffer any loss of wages,
leave or benefits.
• Any health care facility or other employer
that decides that vaccinated smallpox responders should
be transferred or placed on leave to protect vulnerable
patients must ensure that the individual does not
lose wages, accumulated leave or other benefits.
V. National Smallpox Vaccine Injury Compensation
Program
• Notwithstanding Section 304 of the Homeland
Security Act, a national vaccine injury compensation
program must be established providing compensation
to any smallpox responders injured as a result of
receiving the vaccine. It must also provide compensation
to persons who are injured as a result of coming into
contact with a person who has been vaccinated. For
adverse reactions that are recognized consequences
of the vaccine, the right to recover shall be on a
no fault basis, similar to the Injury Table used for
the Childhood Vaccine Injury Compensation system.
This means that if one of these conditions occurs
there is no requirement to prove that the vaccine
or the manner of administration caused the injury.
(Presumption of statutory dependency.)
• Coverage under the compensation system is
designed for the less routine consequences or adverse
reactions to the vaccine including but not limited
to: autoinocculation to other sites, generalized vaccinia,
eczema vaccinatum, progressive vaccinia, post-vaccination
encephalitis, blindness, vaccinia necrosum or death.
• System must have a mechanism for proving causation
for other consequences. Like the CVIC system, this
allows for any adverse consequences that may not be
listed on the injury table to be proved as having
been caused by the vaccine or administration.
• System must be simple to access: filing forms
with one agency and receiving quick response.
• Compensation must include provision for medical
costs, pain and suffering, lost wages and a fair system
for determining damages. Caps acceptable but must
be fair. There should be provision for recovery of
wages and benefits by anyone injured even if the condition
is reversible and the individual can be expected to
return to work. In order to ensure that the individual
volunteer does not bear the brunt of direct hardships,
there needs to be a requirement for employers to continue
wages and benefits while the individual is off work
with a right for the employer to subrogate and receive
reimbursement from the compensation fund. In the case
of catastrophic permanent injury or death, there has
to be a system for determining payment of lost wages
and pain and suffering. In either case the compensation
fund must pay or reimburse for all medical costs.
• Administrative system for determining damages
must be relatively speedy and simple. CVIC system
is a good model.
• Trust Fund must be established that is funded
directly by Appropriations. Since the vaccine has
been purchased and is being distributed at expense
of the federal government a vaccine surcharge system
cannot be used.
VI. Liability Protection
Section 304(c)(7)(B) of the Homeland Security Act
of 2002 must be amended to clarify that a vaccinated
person who transmits vaccinia accidentally is a “covered
person” and immune from liability for injury
caused by transmission of vaccinia.
Prepared by the AFL-CIO, American Federation of State
and County Municipal Employees (AFSCME), the American
Federation of Teachers (AFT) and the Service Employees
International Union (SEIU).
January 8, 2002
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