IAFF Guidance on Smallpox Vaccinations
The following is a reprint of the recommendations from the International Association of Fire Fighters.
Some editorial changes have been made, not affecting the information
provided in the original document. Additional information
can be found on the IAFF website,
www.iaff.org or by contacting the IAFF at:
International Association of Fire Fighters
1750 New York Avenue, NW
Washington, DC 20006
202.737.8484
202.737.8418 (Fax)
Introduction
The government of the United States believes that there is a threat of a
possible biological attack on our civilians utilizing the smallpox virus.
Smallpox has significant health effects, including death, for those exposed.
There is no treatment for smallpox and the only effective way of preventing
the disease is vaccination. However, there are also serious complications
and contraindications associated with smallpox vaccination.
The decision whether to receive the smallpox vaccine is a personal one
for IAFF members and other first responders. The goal of this document,
prepared by the IAFF, is to provide every IAFF member with the best possible
information on smallpox vaccination so each fire fighter and other first
responder can make an informed and educated decision based on his or her
individual circumstances.
Besides insuring that the employer has adopted a comprehensive vaccination
program, each IAFF member must thoroughly review the pros and cons of
smallpox vaccination outlined in this document. It is your health and, in
some cases, your life at stake – and no one can make that decision but you.
Why Smallpox and the Vaccination Can Be Dangerous
Smallpox is an acute, contagious disease that can be fatal in up to 30% of
those who contract it. Survivors are usually scarred and in rare cases may
be blinded. The virus is usually spread from person to person through close
contact.
The smallpox vaccine has known complications and known side effects. Most
people will experience mild reactions that include a sore arm, fever, and
body aches. It has been reported that 1 out of 3 vaccinated individuals will
miss time from work, school, or recreational activities. It has been
estimated that for every million people vaccinated, 15 will have
life-threatening reactions, and one or two deaths will occur.
In addition, there are individuals who are at high-risk for complications
from the vaccine and should not be part of the vaccination program. Persons
with conditions such as suppressed immune systems (either through disease or
treatment); with eczema or atopic dermatitis; acute, chronic or exfoliative
skin conditions; or that have a moderate or severe short-term illness should
decline the vaccine. In addition, those that are pregnant, plan to become
pregnant within one month, or are breast feeding; that are allergic to the
vaccine or any of its ingredients; or have a history of chronic use of
steroids are also at significant risk for complications.
However, fire fighters, emergency medical personnel and other first
responders that are exposed to smallpox should get the vaccination, since
the risk of smallpox outweighs the complications associated with the
vaccine.
The IAFF will continuously update this information as more data is generated
and as conditions change.
Factors You Must Consider
- Do you reside in an area that is at a perceived risk for a terrorist
attack?
- Do you understand that there is no treatment for smallpox?
- Have you studied the adverse impacts of smallpox vaccination outlined in
this document?
- Do you have any health conditions, as outlined in this document, which may
adversely affect your reaction to the vaccine?
- Do your household contacts or co-workers have any health conditions, as
outlined in this document, which may adversely affect them if you are
vaccinated?
- Has your decision been thoroughly discussed and reviewed with your family?
- Has your employer adopted a comprehensive vaccination program, including
training and medical monitoring, as recommended by the IAFF?
- Has your employer addressed the issue of compensation and leave for
individuals that experience adverse reactions from the vaccine?
- Are you, your family, and your employer prepared to deal with any adverse
reaction that may result from receiving the vaccination?
Comprehensive Smallpox Vaccination Program
The IAFF believes that before any vaccination program is initiated by the
employers of our membership, each of the IAFF-endorsed provisions detailed
below must be fully implemented.
The IAFF advises all of its members not to proceed with smallpox
vaccinations if your employer fails to agree to this comprehensive smallpox
vaccination program, which has been derived from and is consistent with
recommendations from the Department of Health and Human Services (HHS), the
Centers for Disease and Prevention (CDC), the Department of Defense (DOD)
and the Advisory Committee on Immunization Practices (ACIP).
The IAFF recommends that:
Smallpox vaccinations shall be made available, at no cost, by their employer
to all fire fighters and emergency medical personnel and such vaccinations
shall be provided while the employee is on duty.
Fire fighters or emergency medical personnel shall be entitled to decline
the smallpox vaccine. Any employee who declines to receive the vaccine shall
not be subject to discrimination at work. If an employee declines to receive
the vaccination, he/she must sign a waiver. The waiver shall include the
following language (language is consistent with waiver language promulgated
by U.S. OSHA for hepatitis B vaccination and Section 4(b)(4) of the OSHA
Act):
“I understand that due to my occupation, I may be at risk of being exposed
to and acquiring smallpox. I have been given the opportunity to be
vaccinated with smallpox vaccine, at no charge to myself. However, I decline
the smallpox vaccine at this time. I understand the by declining this
vaccine, I continue to be at risk of acquiring smallpox, a serious disease.
If in the future I want to be vaccinated with the smallpox vaccine, I can
receive the vaccination at no charge to me. My statement of declination of
smallpox vaccination is not intended to supersede or in any manner affect
any workers’ compensation law or to enlarge or diminish or affect in any
other manner to common law or statutory rights, duties, or liabilities of
employers and employees under any law with respect to injuries, diseases, or
death of employees arising out of, or in the course of, employment. I also
understand that I will not be discriminated against by my employers if I
decline to be vaccinated.”
If an employee initially declines vaccination but decides later to get
vaccinated, the employer shall make the vaccine available at no cost. If at
some point the U.S. Public Health Service recommends that people who have
had the vaccination should be revaccinated, they shall be made available to
all employees at no cost.
Training for First Responders
Prior to vaccination employees shall receive training, which shall be
provided at no cost during working hours to all fire fighters and emergency
medical personnel. The training must include at a minimum:
- General explanations of the epidemiology and symptoms of smallpox;
- Specific information on how smallpox is transmitted, including modes of
delivery as a weapon;
- Actions and procedures to be followed in the event of exposure;
- The employer's exposure control plan and how the employees can obtain a
copy;
- Information on how to recognize tasks that may involve exposures to
smallpox;
- Up-to-date information on the vaccinia (smallpox) vaccine;
- The method of vaccination and the spectrum of normal and adverse vaccination
reactions, including the benefits, the risks and the fact that it is
provided at no cost to the employee;
- Risks to non-vaccinated family members and fellow employees;
- Specific information on vaccination-site care;
- Copies and explanation of all CDC and DOD protocols on the subject of
smallpox;
- A description of the post-exposure evaluation;
- The methods (and limitations of those methods) that may prevent exposures
to smallpox, including personal protective clothing and equipment (PPE),
work practices and decontamination;
- The selection of appropriate PPE; and
- The proper use, location, removal, handling, decontamination and disposal
of PPE.
Medical Monitoring
It is essential to medically screen vaccine recipients, their family and
fire station contacts for contraindications before vaccination to prevent
serious complications. While the standard of practice for all immunizations
requires medical screening, smallpox vaccination is unique in that there is
a need to screen for risks among family/household contacts and employee
contacts in the fire station.
Prior to vaccination the employer shall provide medical screening to
ensure the vaccine is not contraindicated for medical reasons. Such reasons
shall be:
Weakened immune system (Note: cancer treatment, an organ transplant, HIV,
or medications to treat autoimmune disorders and other illnesses can weaken
the immune system).
Any fire service member who is concerned that they could have HIV
infection may request and the employer shall provide confidential HIV
testing. The confidential results shall be reported to the potential
vaccinee before vaccination, and the results of the test and the fact that
the test was requested shall remain confidential and not recorded in the
medial file.
HIV testing is recommended for anyone who has a history of risk factors
for HIV infection or is not sure of his or HIV-infection status. Anyone who
is concerned that they may be HIV-infected should request confidential
screening prior to smallpox vaccination.
Any fire service member who has a weakened immune system due to medical
treatment (i.e. cancer drug or radiation) or chronic steroid use.
Employees with eczema or atopic dermatitis should not get the vaccine
even if the condition is not currently active, mild or experienced as a
child;
Acute, chronic or exfoliative skin conditions such as burns, chickenpox,
shingles, impetigo, herpes, severe or uncontrolled acne or psoriasis.
Employees with any of these conditions should not get the vaccine until the
condition has resolved or a physician affirms it is under maximal control.
However, employees with contraindicated skin conditions who received
smallpox vaccine earlier in life may be revaccinated after medical
consultation for individual risk-benefit decision making;
Pregnancy or plans to become pregnant within one month of vaccination.
Vaccine shall not be provided during pregnancy nor shall it be provided to
employees who live in a household with a pregnant individual; and
Women of childbearing potential shall be provided with
screening/questioning for pregnancy before receiving immunizations. Any
woman who is uncertain about pregnancy status shall be medically tested for
pregnancy before immunization. Vaccination shall be deferred for pregnant
women at least until resumption of full duties following pregnancy, or later
as postpartum care may require, or while they are currently breastfeeding.
In addition, individuals should not get the smallpox vaccine if they:
- Are allergic to the vaccine or any of its ingredients.
- Have a moderate or severe short-term illness. These people should wait
until they are completely recovered to get the vaccine.
- Have a history of chronic use of steroids.
Employees who have any of the above conditions, or live with someone who
does, should NOT get the smallpox vaccine unless they have been directly
exposed to the smallpox virus.
If directly exposed to the smallpox virus, fire fighters and EMS
personnel who were not vaccinated should get the vaccine immediately,
regardless of their health status. If exposed, the risk of smallpox
outweighs the complications associated with the vaccination. After an
exposure, any non-vaccinated employee must be quarantined until vaccinated
and medically released.
Vaccinations
The vaccine shall only be made available after the employee has received
the required training and after the employee has been medically evaluated.
Vaccinations are to be given by or under the supervision of a licensed
physician or other health care professional according to the recommendations
of the U.S. Public Health Service. The employer shall ensure that health
care professionals used for vaccinating their employees remain alert to
modifications in clinical recommendations as the smallpox vaccination
program progresses. The employer shall implement a quality assurance program
to assess vaccination technique of vaccinators.
The vaccination is usually provided at the deltoid muscle of the
non-dominant arm, avoiding any skin conditions, tattoos or skin folds. The
vaccination consists of three (3) punctures with a bifurcated needle for
individuals who were never vaccinated or fifteen (15) punctures for those
who have been previously vaccinated or for vaccination retakes.
An assessment of vaccine take is required for all vaccines. The employer
shall ensure that medical personnel trained in vaccination evaluation
inspect the vaccination site of all vaccinees at six (6) to eight (8) days
after vaccination administration. All employees shall be instructed to
report if they do not develop a characteristic smallpox vaccination
reaction.
If a characteristic vaccination reaction does not manifest within six (6)
to eight (8) days after smallpox vaccination, the employee shall be provided
with revaccination. Such revaccination shall only be repeated once. For
those individuals who do not respond to vaccination with a visible skin
lesion, referral for immunologic evaluation is required.
Adverse Reactions
Any individual who experiences any adverse reaction from the smallpox
vaccine shall be provided with immediate medical and follow-up care at no
cost to the employee.
Any fire fighter or emergency medical personnel who has an adverse
reaction to the smallpox vaccine and is unable to perform his/her duties
shall be entitled to receive occupational disability benefits as provided by
the employer for on-duty injuries/illnesses for the duration of the
disability. Any leave of absence associated with an adverse reaction shall
be immediately classified and treated as a line-of-duty injury. All medical
costs associated with the vaccination and adverse reaction treatment shall
be borne by the employer.
The IAFF will continue with legislative effects that will provide a fair
compensation system – like the federal Vaccine Injury Compensation Fund – to
assist our members and their families who may be injured from receiving the
vaccine or coming into contact with someone who received it. Vaccine
manufacturers and those who administer it have been offered immunity from
liability through recent Homeland Security legislation.
If an employee experiences any adverse reaction to the vaccine, the
employer shall immediately file a Vaccine Adverse Event Reporting System (VAERS)
form. Additional information on filing a VAER report can be found at the
following CDC/FDA Web site:
www.vaers.org.
Vaccination-Site Care
The virus used in the vaccination (vaccinia) can be cultured from the
site of the vaccination beginning at the time of development of a papule
(two to five days after vaccination) and until the vaccination scab
separates from the skin. During this entire period, the employee must care
for the site to prevent spread of this virus to another area of the body or
to another person through inadvertent contact.
Site care will also assist in preventing any secondary infection.
High-risk individuals may be especially vulnerable to virus shedding and
scab particles from a vaccinated employee during the post-vaccination
healing period.
Hand washing is the most important measure to prevent inadvertent contact
spread from vaccination sites. Hands must be washed after any touching of
the vaccination site area with soap and water or when unavailable with an
alcohol-based waterless antiseptic solution.
The employer shall evaluate and direct any fire or EMS activities
(including emergency response and training) that may subject employees’
vaccination sites to undue pressure (may burst a pustule), rubbing or
prolonged immersion in water (may cause tissue breakdown or secondary
infection). Many fire or EMS activities, including donning and doffing heavy
protective clothing, donning and doffing SCBA, carrying heavy objects (hose
or high-rise packs), and leaning against walls while using hose lines at a
fire may lead to injury of the vaccination site.
The employer must defer any non-emergency activities, including training,
that may complicate vaccine site care and cleanliness. Any vaccination site
injury must be reported, immediately evaluated, and if necessary treated by
medical personnel. General vaccination site care recommends leaving the site
unbandaged. However, for fire and EMS personnel, bandaging may be more
appropriate to help reduce spread and accidental infection.
Prior to initiating a small-pox vaccination program, fire departments
must develop plans for: site-care stations; personnel to monitor employees’
vaccination sites; procedures and training to promote effective bandaging;
procedures and training for scrupulous hand washing hygiene; and
bio-hazardous waste procedures for disposal of contaminated bandages and
dressing, as well as laundering decontamination procedures for clothing
(bleach shall not be used for protective clothing), towels, sheets or other
cloth materials that have had contact with the site.
The employer must provide employees with occlusive (wound-sealing)
dressings, such as semi-permeable polyurethane dressings (e.g. Opsite® or
Tega Derm®). Be aware that occlusive dressings, including non-permeable
(hard) or semi-permeable (i.e. polyurethane) coverings, allow for the
accumulation of viral contaminated exudate, which requires extra care when
removed to prevent viral contamination. Also fluid can accumulate under such
dressings, which may increase the maceration of the vaccination site.
Occlusive dressings require the vaccination site to first be covered with
dry gauze and then applying dressing over the gauze.
Fire fighters are involved in arduous work in wet environments. If the
employee becomes wet from their environment or from perspiration, any
clothing, bandage, and/or dressing must be removed as soon as practical and
replaced with clean clothing and dressings.
The IAFF and our medical advisors will be investigating alternative
vaccine administration sites (i.e. lower medial or lateral thigh) for fire
fighters and EMS personnel.
Family, Patient and Co-worker Contacts
The employer is required to develop procedures to minimize contact of
newly vaccinated employees with unvaccinated employees and the public.
For employees who have risk factors and accordingly have not been
vaccinated, the employer shall ensure that they are physically separated and
exempt from activities that pose the likelihood of contact with recently
vaccinated employees and potentially infectious materials. Employees with
contraindications to vaccination shall not share or use common sleeping
space, linens, towels, protective clothing (e.g. protective clothing) and
equipment (SCBA, etc.) with employees who have been vaccinated.
The employer must make provisions for pregnant fire fighters and
emergency medical personnel to ensure they are not exposed to vaccinated
employees.
The employer must make provisions for immuno-compromised fire fighters
and emergency medical personnel to ensure they are not exposed to vaccinated
employees.
The employer must ensure that non-vaccinated fire fighters and emergency
medical personnel with eczema, atopic dermatitis, or acute, chronic or
exfoliative skin conditions are not exposed to vaccinated employees.
The employers shall formally educate employees through procedures and
training, of the risks of close physical contact with family members,
including those who may have risk factors and infants less than one year
old. Employees must be instructed that, while off-duty, vaccination site
care (including bandaging and wearing of long sleeved shirts) must continue.
The employer shall also inform employees that blood donations must be
deferred until the scab spontaneously separates from the vaccination site or
if the scab is otherwise removed, blood must not be donated for at least two
months after the date of vaccination. Any employee who had any vaccine
complication must defer donation of blood until fourteen (14) days after
complications have been completely resolved.
Recordkeeping
The employer is required to maintain records according to the following
schedule:
Medical records (including the employee's name, social security number,
smallpox vaccination status, all examinations and evaluations, healthcare
professionals' written opinions, and information provided to the healthcare
professionals) for the duration of employment, plus at least 30 years; and
Training records for three (3) years from the date on which the training
occurred. Medical records are confidential and may not be disclosed or
reported without the employee's written consent. Medical records are to be
available to employees and to anyone having written consent of the employees
upon request. Training records are available to the employee or employee
representative upon request.
Background Information
Fire Fighters/EMS Personnel and Smallpox
Smallpox is a serious, contagious, and sometimes fatal infectious
disease. There is no specific treatment for smallpox, and the only
prevention is vaccination. Smallpox can cause a severe rash covering the
whole body that can leave permanent scars, high fever, severe headache or
backache, dizziness, severe abdominal pain and delirium.
Smallpox kills about three out of 10 people infected. The incubation
period is seven to 17 days, yet the infected individual would not be
contagious until the appearance of a rapidly spreading rash. If the infected
individual survives, contagion lasts until the very noticeable scabs from
smallpox pustules have completely healed, which usually takes three weeks.
Smallpox is usually spread by contact with infected persons. 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.
Historically, indirect spread was less common. Rarely was smallpox spread
by virus carried in the air in enclosed settings such as buildings, buses,
and trains. Smallpox is not known to be transmitted by insects or animals.
However, the deliberate release of smallpox as a weapon of mass destruction
is now regarded as a possibility, and the United States is taking
precautions to deal with this potential terrorism threat.
In the United States, routine vaccination against smallpox ended around
1972. In May 1980, the World Health Organization declared the global
eradication of smallpox as a naturally occurring disease and recommended
that all countries cease vaccination. Military smallpox vaccination programs
continued longer. In 1984, routine military vaccinations were limited to
recruits entering basic training. This practice was discontinued in 1990.
In the wake of the terrorist attacks of September 11, 2001 and the
subsequent anthrax letter attacks, the U.S. government reassessed the threat
of a smallpox attack. The resumption of a smallpox vaccination program is
intended to ensure that the first responders, including fire fighters and
emergency medical personnel, can achieve its missions in case smallpox is
used as a biological weapon.
On Friday, Dec. 13, 2002, President George W. Bush announced that
smallpox vaccinations are to be provided for the military as well as medical
professionals, emergency responders and response teams that will be the
first on the scene at a biological attack. The President recognized that
first responders – our Nation’s fire fighters and emergency medical
personnel – are first on the scene and will assist in the treatment of
civilians in a crisis. To do this job effectively, the President declared
that fire fighters and emergency medical personnel should be protected
against the disease.
The President’s program includes a three-phase implementation plan. Phase
One vaccinations would be provided to public health staff and key health
care workers at local hospitals who might be called upon to treat and manage
initial smallpox cases. Fire and emergency medical personnel with the
potential for exposure will be included in Phase Two of the vaccination
program. Phase Three will involve immunizations to the public; but, the
details of this phase are not yet available.
The smallpox vaccine helps the body develop immunity to smallpox. The
vaccine is made from a virus called vaccinia, which is a “pox”-type virus
related to smallpox. The smallpox vaccine contains the “live” vaccinia
virus-not dead viruses like many other vaccines. For that reason, the
vaccination site must be cared for carefully to prevent the virus from
spreading.
Historically, the vaccine has been effective in preventing smallpox
infection in 95% of those vaccinated. In addition, the vaccine was proven to
prevent or substantially lessen infection when given within a few days of
exposure.
The smallpox vaccine is not given as a shot with a hypodermic needle. The
vaccine is given using a bifurcated (two-pronged) needle that is dipped into
the vaccine solution. When removed, the needle retains a droplet of the
vaccine. The needle is used to prick the skin a number of times in a few
seconds, usually in the upper arm. The pricking is not deep, but it will
cause a sore spot and one or two droplets of blood to form.
If the vaccination is successful, a red and itchy bump develops at the
vaccine site in three or four days. In the first week, the bump becomes a
large blister, fills with pus, and begins to drain. During the second week,
the blister begins to dry up and a scab forms. The scab falls off in the
third week, leaving a small scar.
Vaccine Complications
For about three weeks, the vaccination is highly contagious and can cause
infection in the person who received the vaccine or other people in close
contact. Fever is common after the vaccination. Generalized rashes and
secondary pyogenic (pus-producing) infections at the site of the vaccine may
also occur. Inadvertent vaccination at other sites is the most frequent
complication, which usually results from autoinoculation of the vaccinia
virus which was transferred from the vaccine site. The most common sites are
the eyes face eyelids, nose, mouth, genitalia and rectum. Accidental
infection (autoinoculation) of the eye may lead to blindness. Again,
prevention includes vaccine site management and hand hygiene.
Generalized vaccinia among persons without any underlying illness may
occur. It is characterized by a rash, which is usually self-limited and
usually requires no therapy, except among individuals whose conditions
appear toxic or those that have a serious underlying illness.
More serious complications that may follow vaccination include
inflammation of the brain (encephalitis) and spinal column
(encephalomyelitis) which is characterized by an influx of cells,
dysfunction of the brain associated with confusion and decreased mental
capacity (encephalopathy), systemic (total body) vaccinia infection
(progressive vaccinia) and extensive scaling of the skin on which vaccinia
infection is superimposed (eczema vaccinatum). These complications, which
are rare, may result in severe disability, permanent neurological sequelae
and/or death. Death most often results from post vaccination encephalitis or
progressive vaccinia. Approximately 1 death per million primary vaccinations
and 1 death per 4 million revaccinations have occurred after smallpox
vaccinations. Deaths have also been reported in unvaccinated contacts of
individuals who have been vaccinated.
In revaccinated individuals, the risks of complications have been low.
Most complications have occurred in patients with underlying diseases or who
have received therapy which impairs the immunologic system or those who have
not received the vaccine in many years.
Individuals at risk for experiencing increased side affects from the
vaccine are those who have skin conditions such as eczema and/or atopic
dermatitis, have weakened immune systems such as transplant patients, are
HIV-positive or chemotherapy patients, are pregnant or plan to become
pregnant within a month, have known severe reaction to the smallpox vaccine
from the past and those with a history of chronic steroid use. Anyone who
falls into these categories or who lives with individuals in these
categories should not receive the vaccine, unless exposed to smallpox.
Accordingly, formal training and medical screening of potential vaccine
recipients is essential to ensure that those at risk do not receive the
vaccine.
There are two treatments that may help people who have certain serious
reactions to the smallpox vaccine. These are: Vaccinia Immune Globulin (VIG)
and Cidofovir. Patients receiving these drugs would need to stay in the
hospital for observation and possible additional treatment, as the VIG and
Cidofovir may cause a number of side effects as well. CDC will review
summary reports of adverse events and will investigate all individual
reports of serious events.
The federal government has also directed the states to work with
hospitals to set up systems to diagnose, manage, and treat people who
experience adverse reactions from the vaccine. This will include rapid
access to the primary treatment for most serious adverse events.
The IAFF and our medical advisors will continue to review the progress
and any additional problems with the vaccination program as it is
implemented in the United States and abroad.
The IAFF is consulting with the Department of Health and Human Services (HHS)
and the Centers for Disease Control and Prevention (CDC) so our membership
is protected and prepared to protect the nation in the event of a smallpox
outbreak. Further updates on this important issue will be posted on
www.iaff.org.
|
