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THE VACCINE REACTION
“When
it happens to you or your child, the risks are 100%”
Published by the National Vaccine
Information Center
Barbara Loe Fisher, Editor
SMALLPOX
AND FORCED VACCINATION:
WHAT
EVERY AMERICAN NEEDS TO KNOW
-
Barbara Loe Fisher
The
terrorist attacks on New York City and Washington, D.C. on September 11, 2001
and the subsequent threats of biological warfare against US citizens have
prompted calls by public health officials to prepare for mass vaccination
campaigns for anthrax and smallpox.1,2 National vaccination programs
targeting civilians, including children, are being proposed in model state
legislation that would give public health officials the power to use the state
militia to enforce vaccination during state-declared health emergencies.3,4
While it is critical for the US to have a sound, workable plan to respond to an
act of bioterrorism, as well as enough safe and effective vaccines stockpiled
for every American who wants to use them, there are legitimate concerns about a
plan which forces citizens to use vaccines without their voluntary, informed
consent.
All
mass vaccination campaigns result in casualties because every vaccine, like
every drug, carries an inherent risk of injury or death.5,6,7,8,9
Some individuals are genetically or biologically more vulnerable to vaccine
reactions than others,10 but there are few reliable biomarkers to
predict who they are5,6,7,8,9 which is why legally protecting the
informed consent rights of all citizens becomes a moral imperative. The human
right to be fully informed about all known and unknown risks, as well as
benefits, of any medical intervention and make a voluntary decision about
whether to take the risk, has been the centerpiece of bioethics ever since the
Nuremberg Code was adopted after World War II 11 and the doctrine of
informed consent was introduced into U.S. case law in 1957.12
In
evaluating the potential risk of a bioterrorism attack with real, as well as
unpredictable, risks of exposing large numbers of children and adults to a
prophylactic mass vaccination program for smallpox, some health officials have
already concluded that the risks of mass vaccination outweigh the theoretical
benefits.13,14,15 However, even in the event of a proven biological
weapons assault and smallpox outbreak, sacrifice of the informed consent ethic
would result in state-forced vaccine-induced injury and death of a biologically
vulnerable minority in service to the majority, posing serious constitutional
and moral questions.
Although there have been suggestions that federal vaccine testing regulations should be curtailed in an effort to get a national supply of smallpox vaccine produced quickly,16,17 no mass vaccination campaign should be initiated without sound scientific evidence proving the vaccines to be used are safe and effective in protecting against an organism that may be used in a bioterrorism attack. This is particularly important if the organism, such as the smallpox virus, may have been genetically engineered to be vaccine and treatment resistant.18 Untested vaccines have the potential to give the illusion of safety and efficacy to the public when, in fact, they may cause far greater harm and be far less effective than predicted.
The old live vaccinia virus vaccine for smallpox was never tested for safety or efficacy in controlled trials prior to mandates19,20 and it may have caused more reactions, injuries and deaths than any vaccine ever used by humans on a mass basis. Those recently vaccinated become infected with vaccinia virus and can transmit the virus to others, leading to injury and death for some.13,20,21,22,23,24,25 Unless the old vaccine for smallpox or a newly formulated vaccine is fully tested for safety and efficacy before being released for public use, legally and ethically the vaccine would have to be considered experimental and the mandated use of it a state-enforced national scientific experiment. Public
Health Different Today: Scientific evaluation of the mass use of
any new vaccine must be viewed in context with the other vaccines Americans are
getting today and in consideration of the general health of different segments
of our population. The most significant difference between the health of the
U.S. population today compared to 1971, when routine vaccination for smallpox
was halted in America, is that the numbers of Americans suffering with
autoimmune and neurological disorders has increased significantly.21,26,27
In
the past three decades, the numbers of children and young adults with asthma,
learning disabilities and attention deficit hyperactivity disorder (ADHD) have
doubled; diabetes has tripled; and autism has increased 200 to 600 percent in
nearly every state.29,30, 31,32,33,34,35,36,37,38 Live vaccinia virus
vaccine for smallpox, for example, would be given to children already receiving
37 doses of 11 other live virus and killed bacterial vaccines, including
diphtheria, pertussis, tetanus (DTaP), polio, measles, mumps, rubella (MMR),
haemophilus influenzae B, hepatitis B, chicken pox, and pneumococcal vaccines.39
In 1971, most American children were only receiving DPT, polio, measles and
rubella vaccines.40
In addition, today there are many more adults suffering with HIV, lupus,41 herpes42 and other diseases affecting the immune system. Without appropriate safety studies evaluating the risks of an old or a new vaccine in the real world of today, there is no reliable way to predict the potential negative impact on the health of children and adults, especially on the tens of millions of Americans already suffering with chronic autoimmune and neurological disorders.
BIOLOGICAL WARFARE
Biological
warfare is not a new phenomenon. History is full of examples of warring factions
trying to weaken each other’s troops or civilian populations by making them
sick. From the ancient Greeks and Romans, who polluted the water supplies of
their enemies with dead animals, to warriors in medieval times who catapulted
corpses of people infected with bubonic plague into the castles of their
enemies, to European conquerors who came to the New World and used smallpox
contaminated blankets to kill native Indians with no natural immunity to
smallpox, there is a long history of man using disease as a weapon. 43
Modern
biological weapons using lethal microorganisms were developed in the 1930’s by
Japanese scientists, including aerosolized anthrax that was designed to be used
in a specially designed fragmentation bomb. US and British scientists developed
biological weapons during World War II using anthrax, botulinum toxin,
encephalitis virus, staph enterotoxin and other deadly organisms.
Even though the US has had biological weapons capability, the US has
never used biological weapons on any nation and, since the Biological Weapons
Convention in 1972, has supported a worldwide ban on development and use of
biological weapons.
There
is evidence, however, that other nations have not stopped making biological
weapons and that the Soviet Union, in particular, may have weaponized smallpox
virus after 1972 in large quantities and that some of the virus may have been
supplied to other countries such as Iraq, North Korea and China. There are still
outstanding questions about whether Soviet scientists succeeded in making the
smallpox virus a more lethal weapon by genetically engineering it so that any
vaccine or drug would be ineffective. 1,18
SMALLPOX DISEASE
Smallpox
is a highly contagious, serious disease caused by the variola virus, a double
stranded DNA virus which belongs to the genus orthopoxvirus that includes
cowpox, monkeypox, and vaccinia. Poxviruses
primarily affect the skin and cause disease in both humans (smallpox) and
animals (swinepox, camelpox, sheeppox, goatpox, fowlpox).19
History:
The first recorded cases of smallpox were in Asia in the first century
A.D. but there is evidence the disease was present in China, India and Africa
before that time. Smallpox was rarely seen in Europe until the Crusades, when
Crusaders invaded the Holy Land during the Middle Ages and brought the disease
back home with them. The Americas
did not see smallpox until the Spanish invaders brought the disease to native
Indian populations, who had no experience with the virus at all, which resulted
in high mortality and significant destruction of tribes. In 18th
century England, smallpox caused one in 10 deaths and was the leading cause of
death in children.43,46
After
worldwide mass vaccination campaigns in the 20th century, in 1979 the
World Health Organization declared wild smallpox virus eradicated from the
earth. The only remaining smallpox virus at that time was reported to exist in
secure labs in the Soviet Union and the United States. However, since then,
there have been reports that Soviet scientists developed the capacity to produce
large quantities of the virus modified to survive delivery by missile warhead
and that some of these stocks were supplied to countries hostile to the US.47
In addition, there is the possibility that the smallpox virus has been
genetically or otherwise biologically altered to make it an even more lethal
bioterrorism weapon, which may limit the effectiveness of the vaccinia virus
vaccine used to prevent smallpox in the past.18,48
Viability As A Bioterrorist Weapon:
Variola is a relatively stable virus in the natural environment and may retain
its infectivity for as long as 24 to 48 hours if it is aerosolized and not
exposed to sunlight or ultraviolet light. 49 There are several
delivery routes that have been discussed if smallpox were to be used as a
bioterrorist weapon to cause large numbers of infections in a population:
release of the virus into a building, subway or airplane ventilation system or
an area-wide drop of the virus by a plane or missile. Each of these theoretical
scenarios requires that the terrorists: (1) have succeeded in obtaining the
smallpox virus from one of the official laboratory storage facilities in the US
or Russia or from a country which has secretly obtained the virus; (2) have the
technical expertise and laboratory facilities to culture and maintain the
viability of the virus; (3) have the ability to transport the virus in liquid or
powder form without destroying its effectiveness; (4) have the technology to
deliver it to large numbers of susceptible people. 45,50
Some
have hypothesized that several “volunteer” infected carriers could silently
transmit the disease,18 perhaps in large cities during the first week
of the contagious period before the characteristic smallpox lesions appeared on
their faces and limbs. Theoretically, this could happen although it would not be
as effective as delivery of the organism to large numbers of people in a wide
area. Still, even one person carrying smallpox could cause others to become
infected who, in turn, could infect others. Reportedly, in 1970 a single
smallpox infected man returning to Germany from Pakistan caused the direct or
indirect infection of 19 others in a German hospital.51 In 1970,
virtually everyone in Europe and the U.S. had been vaccinated against smallpox.
Variola
Virus: The variola
virus which causes smallpox is an orthopoxvirus and has not been documented to
infect animals or insects. Cowpox, monkey pox and vaccinia are the three other
orthopoxviruses and all three of these viruses can cause disease in both animals
and humans.49
Two Kinds of Smallpox: There are two kinds of smallpox: variola minor and
variola major. Variola minor causes a milder case of the disease resulting in a
case-fatality ratio of less than one percent. Variola major is much more serious
with a case fatality of between 20 and 30 percent. The variola virus causing
both variations of smallpox are biologically and immunologically
indistinguishable from each other in the laboratory and a mild case of variola
major can look like a case of variola minor. Endemic variola major was
eradicated from the US in 1926 and variola minor disappeared from the US in the
1940’s.19,22
Infection and Contagion: According to the Working Group on Civilian Biodefense,
“Historically, the rapidity of smallpox contagion was generally slower than
for such diseases as measles and chickenpox. Patients spread smallpox primarily
to household members and friends; large outbreaks in schools, for example, were
uncommon.”49
Face-to-face
contact with an infected person is usually required to transmit smallpox, which
is spread from one person to another through nasal secretions and saliva by
coughing and sneezing.52 A
person usually becomes infected by inhaling the virus, which enters the
respiratory tract and multiplies there and in the spleen, bone marrow and lymph
nodes. The liver, spleen and lymph nodes can become enlarged.19,49
Coming
into direct contact with the secretions from open smallpox skin lesions can also
spread the disease. Secretions from smallpox lesions can contaminate clothing,
bedding, or other materials, which have been used by an infected person, so
disinfection of articles used by an infected person is necessary. Hot water
containing hypochlorite bleach and quaternary ammonia has been used to
decontaminate clothing, bedding and cleaning surfaces possibly exposed to the
virus and formaldehyde has been used to fumigate contaminated areas.52
No Contagion for One or Two Weeks: A
person with smallpox is infectious from a day before the rash appears (about 10
to 14 days after infection) until all lesions have healed and the scabs have
fallen off. In the incubation period of the disease during the two weeks prior
to the appearance of a fever and flu-like symptoms, there is no evidence that
the smallpox virus sheds and can be transmitted to others and the person looks
and feels healthy. Only after the
fever and flu-like symptoms begin and then disappear before the outbreak of a
rash, will the person be highly contagious and able to infect others through the
release of virus in the mouth, throat and respiratory tract. The large amounts
of virus shed from the skin lesions can be infectious but are not as infectious
as the virus released by the respiratory tract.49.52
Although
persons suffering from variola major, the more severe smallpox, are visibly sick
and often bedridden even before the outbreak of the rash, those who have variola
minor, the milder smallpox, may not know they are sick until the rash and
lesions erupt. Therefore, unsuspecting carriers of a less severe form of
smallpox could spread the disease more easily during the early part of the
contagious period.
There
are estimates that one infected person may transmit the disease to between 5 and
10 other persons in populations with no natural or vaccine-induced immunity.52
Those persons can, in turn, infect 5 to 10 others and that is how an epidemic
can begin.
Incubation and Symptoms: The incubation period of smallpox from the time of
infection to the time that symptoms begin to appear is about 12 to 14 days at
which time the person develops a fever of 102 to 106 F., extreme fatigue, severe
headache and back pain, and, occasionally, abdominal pain and vomiting. After 3
or 4 days the fever goes down and the patient may appear to recover but then a
rash appears on the face and forearms and spreads to the trunk, legs, and,
sometimes, appears on the palms and soles of the feet.20,22,49,52
On
the third or fourth day after the rash appears, hard lumps (papules) form under
the skin. These papules swell and turn into vesicles (sacs under the skin filled
with fluid) that eventually turn into pustules (open skin lesions containing
clear, then cloudy fluid filled with pus). A fever often accompanies the rash
and formation of papules and vesicles. The pustules, which can resemble chicken
pox lesions but are much deeper in the skin, also develop and ulcerate in the
mucous membranes of the nose, mouth and throat and release large amounts of
virus into the mouth and throat. 20,22,49,52
The
deep ulcerative skin lesions eventually form crusts and scabs that usually fall
off within three weeks after the beginning of the illness. The patient can be
left with small scars or deep pits in the skin if the sebaceous glands of the
skin are destroyed.20,22,49,52
Rare Types of Smallpox: A
milder illness may occur both in those who have been vaccinated and those who
have not been vaccinated, including cases that include a rash but no eruption of
any lesions (variola sine eruptione). But in another rare form of smallpox,
known as malignant smallpox, the disease remains in the rash stage and pustular
lesions do not erupt. Malignant smallpox is almost always fatal, as is another
rare form of smallpox, known as hemorrhagic smallpox. A person with hemorrhagic
smallpox develops fever, bone marrow depression, a drop in platelets (thrombocytopenia)
and uncontrollable bleeding into the skin and mucous membranes leading to death.22,49
Complications and Mortality: The
smallpox lesions can become infected, leading to bacterial superinfections
usually caused by staphylococcus aureus. Other complications include
conjunctivitis (inflammation of the membrane covering the eyeball); bacterial
pneumonia; viral arthritis; sepsis (blood infection); encephalomyelitis
(inflammation of the brain) and osteomyelitis (inflammation of the bone).
Permanent damage can include blindness, brain damage, and severe facial and body
scarring. In the past, smallpox killed between one percent and 30 percent of
those infected, depending upon whether the person had variola minor or variola
major, and mortality was highest in infants and the elderly.19,22,46,49
Misdiagnosis Can Occur: Before smallpox was eradicated in 1977, doctors
sometimes confused chicken pox with smallpox. During the first two to three days
of the rash, it is almost impossible to distinguish between the two diseases.
The main symptomatic difference between the two is that smallpox lesions are all
in the same stage of development while chickenpox lesions can be in various
stages of development on different parts of the body. Also, the smallpox rash
primarily affects the face and limbs of the body and the chickenpox rash is
primarily on the trunk of the body and almost never affects the palms of the
hand or soles of the feet like smallpox. Lab tests can distinguish between a
herpes group infection (chicken pox) and a poxvirus infection (smallpox).19,22,52
Other
diseases that can mimic smallpox are eczema vaccinatum, eczema herpeticum,
rickettsialpox, drug reactions, contact dermatitis, and erythema multiforme
(inflammation of the skin and mucous membranes). Meningococcemia, typhus and
hemorrhagic fevers can also be mistaken for the more severe fulminant,
hemorrhagic smallpox.22
Human monkeypox, which occurs in Africa, is difficult to distinguish from smallpox.
Also, sometimes disseminated vaccinia virus infection (from the vaccine) can be
confused with smallpox.19
Definitive Lab Diagnosis:
Lab detection of smallpox can occur within a few hours but definitive
identification requires growth of the virus in cell culture or on the
chorioallantoic egg membrane and characterization of strains by use of biologic
assays, such as polymerase chain reaction (PCR) techniques.22,49
Treatment for Smallpox Limited: Vaccinia virus vaccine given up to four days after exposure
to the virus reportedly can provide protection or lessen the severity of
smallpox.49 Antibiotics will not cure smallpox because it is a viral,
not a bacterial, infection. There are a number of anti-viral medications being
investigated, such as cidofovir, but there is no drug currently on the market
licensed as a specific treatment for smallpox.52
Like
with chicken pox, preventing bacterial infection of the skin lesions is
important. Sterile sheets, clothing and other sterile procedures can help reduce
complicating bacterial skin infections. Antibiotics to treat secondary
infections are given by injection or orally as topical antibiotics are not used.
Antihistamines may reduce itching and scratching of the lesions and help prevent
their spread to other parts of the body, such as the eyes.22,52
LIVE VACCINIA VIRUS (SMALLPOX) VACCINE
Early History of Smallpox Prevention:
The idea of deliberately exposing a healthy person to biological matter from
smallpox lesions of an infected person in order to confer immunity dates back to
China several centuries B.C., when Chinese doctors dried and ground up the
crusts of smallpox scabs and used tubes to blow the material into the noses of
healthy persons. In Africa, Asia Minor and parts of Europe, people swallowed
smallpox scabs or had doctors scratch smallpox lymph into their skin (variolation).46
In
17th and 18th century England and America, it was common
practice to scrape smallpox pus from lesions of a person infected with smallpox
and then scrape it onto the skin of healthy children and adults in the hope of
causing a mild, rather than a severe, form of smallpox. This process became
known as variolation. Although smallpox variolation worked for some, it left one
in 300 dead and others with severe enough smallpox that they were permanently
scarred or blinded from the intervention. Many others were unknowingly infected
with syphilis, tuberculosis and hepatitis because the biological matter from
smallpox lesions was taken from persons also suffering from those serious
diseases. Variolation also contributed to the spread of smallpox throughout
populations.46
Jenner
Uses Cowpox Virus: In 1796, British physician Edward Jenner
observed that milkmaids who contracted the generally mild cowpox never came down
with the more severe smallpox. (Cowpox is a disease of the teats and udders of
cows and when cowpox infects humans it causes low-grade fever, lymph node
swelling, and superficial lesions that are much milder than smallpox and heal
without scarring. Sometimes cowpox can cause encephalitis and, in persons with a
history of eczema, there is a risk of serious infection).22
Jenner
experimented on an eight year old boy. He infected him with cowpox by scraping
pus from lesions of a child infected with cowpox onto the skin of the boy.
Later, Jenner twice challenged the boy’s immunity to smallpox by
scraping pus from the lesions of a person with smallpox onto the boy’s skin.
The boy never came down with smallpox and Jenner widely promoted his discovery
and advocated cowpox inoculation as a prevention for smallpox.46
Vaccinia Virus Emerges:
Eventually,
Jenner’s method for preventing smallpox was modified and standardized for mass
production by the pharmaceutical industry. Apparently, as Jenner refined the
cowpox inoculation process, a new virus called vaccinia
evolved. To this day, it is unknown
exactly how the vaccinia virus came into being but theories are that it is a
weakened form of the smallpox or cowpox virus or, more likely, a hybrid of the
two viruses.19,47,53,54 Jenner’s smallpox prevention method became
known as “vaccination” and was endorsed by government health officials in
Europe and America in the 19th and 20th centuries.
Vaccinia Virus Vaccine Never Tested: The
currently licensed vaccine for smallpox contains live vaccinia virus, a double
stranded virus with a broad host range. According
to Harrison’s
Principles of Internal Medicine (1994), “Vaccinia virus never underwent controlled trials to
establish safety and efficacy before licensing. Nevertheless, the vaccine was
highly effective, despite considerable adverse effects.”19
There
are now multiple strains of vaccinia virus with varying degrees of virulence for
humans and animals. Scientists working on new vaccines for diseases, such as
HIV, have created recombinant vaccinia viruses from several strains of vaccinia
virus.19,20,53
Wyeth Vaccine From 1970’s Used Calves: When
vaccinia virus was used to make smallpox vaccine in the past, it was prepared
from the vesicle fluid taken from live calves deliberately infected with
vaccinia virus. After the calves were slaughtered, the pustules were scraped to
recover fluid and the scrapings were freeze dried. This is how the approximately
15.4 million doses of smallpox vaccine currently stockpiled in the US was
manufactured by Wyeth Laboratories in the 1970’s.21,47
Wyeth
used calf vesicle fluid containing a seed virus derived from a New York City
Board of Health strain of vaccinia virus.20 This stockpiled vaccine,
known as Dryvax, contains trace amounts of polymyxcin B sulfate, streptomycin
sulfate, chlortetracycline hydrochloride and neomycin sulfate, as well as
glycerin (50%) and phenol (.25%).55 Phenol is an extremely poisonous
compound obtained by distillation of coal tar and used as an antimicrobial.
Ingestion or absorption of phenol through the skin can cause colic, weakness,
collapse and local irritation and corrosion.56
Stockpiles Have Deteriorated:
Reportedly,
Dryvax stockpiles have been stored in glass tubes in the form of freeze dried
crystals that would be mixed with a liquid diluent just before vaccination using
a bifurcated needle that allows droplets of the vaccine to be scratched onto the
skin. In 1999 the CDC discovered that some of the U.S. Dryvax smallpox vaccine
stockpiles had badly deteriorated: rubber stoppers on the glass storage tubes
had decayed and vacuum pressure had been lost while the liquid diluent had
changed color and there were only one million bifurcated needles to administer
more than 15 million doses.57
Old
Vaccine Now Being Tested in Volunteers: However, in response to
the fear generated after September 11 that smallpox virus stored in the Soviet
Union may have fallen into the hands of terrorists in other countries, some of
these old stocks of vaccinia virus vaccine are being diluted to one in ten or
one in five and given to volunteers at the University of Maryland, St. Louis
University, University of Rochester School of Medicine and Baylor College of
Medicine to test its effectiveness.14,15,58 The goal is to increase
the numbers of doses of old vaccinia virus vaccine currently available in order
to buy time for new vaccine production.
New Vaccines To Use Different Cell Tissues:
According
to the Working Group on Civilian Biodefense, “The traditional method for
producing vaccines on the scarified flank of a calf is no longer acceptable
because the product inevitably contains some microbial contaminants, however
stringent the purification measures.”49 New vaccinia virus vaccines
reportedly will not use vaccinia virus cultured from calf vesicle fluid but will
be grown in laboratories using other cell tissues such as human fibroblasts
(from fetal connective tissue cells).21
In
the June 22, 2001 MMWR, the CDC confirms that previous methods of vaccine
production using calves are no longer being used and that vaccinia virus for new
production of smallpox vaccine must be grown using a Food and Drug
Administration approved cell culture substrate.
The CDC indicates that new cell-culture vaccinia virus vaccine will be
evaluated for safety and efficacy by direct comparison with Dryvax using
appropriate animal models, serologic and cell-mediated immunity methods and
cutaneous indicators of successful vaccination.20
Antibody Level for Protection Unknown: Live
vaccinia virus vaccine produces neutralizing antibodies that are genus specific
and cross-protective for orthopoxviruses
(monkeypox, cowpox, variola). According to the CDC, the efficacy of vaccinia vaccine to
prevent smallpox has never been measured precisely during controlled trials and
the level of antibody required for protection against smallpox infection is
unknown. The level of antibody required for protection against
vaccinia virus infection is also unknown. However, more than 95 percent of
first-time vaccinees are reported to experience neutralizing or hemagglutination
inhibition antibody.20
Duration of Immunity Estimates Vary: According
to the CDC, the live vaccinia virus vaccine is protective for five to 10 years.20
The CDC recommends that lab and medical personnel at high risk of being exposed
to vaccinia viruses be revaccinated every 10 years.24 However,
analysis of a 1902-1903 smallpox outbreak in Liverpool, England as well as a
study conducted at the University of Massachusetts Medical Center and published
in a 1996 article in the Journal
of Virology suggests that
varying degrees of immunity from vaccinia virus vaccination may persist for up
to 50 years.59,60 If true, then the oldest half of the US population,
which was vaccinated before 1970, may have some remaining immunity to the
smallpox virus.
Vaccinia Virus Vaccination Procedure: The
method of vaccinia virus vaccination is to withdraw reconstituted vaccine from
the vial with a sterile bifurcated (forked) needle, then release a droplet of
vaccine onto the skin over the deltoid muscle in the upper arm; then repeatedly
press (15 times) the forked needle into the superficial layer of skin covered
with vaccine hard enough to draw traces of blood. A loose, porous bandage or
gauze held with tape is then applied to help prevent the person from touching
the vaccination site and transferring the live virus to other parts of the body
or to other persons.20,52
Two
to five days after inoculation, a red papule (lump) at the site should appear.
On day five or six, the papule should swell and fill with fluid (turn into a
vesicle). Between days seven and 11, the vesicle should turn into a pustule
(become an open, pus-filled lesion). About two weeks after vaccination, the
pustule dries and develops a crust that falls off by the end of the third week
and leaves the characteristic smallpox scar on the skin.22
If
a person is already partially immune to smallpox (either through previous
experience with the disease or vaccination), there may be an accelerated process
that includes a papule that appears within 3 days, vesiculates in 5 to 7 days,
and heals with little scarring. If only a papule develops without vesiculation
and without leaving some kind of scar, it is considered a failed vaccination and
many times the person is revaccinated in an attempt to get a “Jennerian
vesicle” that is considered proof of successful vaccination.22
VACCINIA
VACCINE REACTION RATE VERY HIGH
The
live vaccinia virus vaccine to prevent smallpox may be the most highly reactive
vaccine that has ever been used in humans.
As with most vaccines, when complications occurred with the vaccinia
virus vaccine, they were quite similar to the complications of the disease they
were designed to prevent.
According
to the World Health Organization “existing vaccines have proven efficacy but
also have a high incidence of adverse side-effects. The risk of adverse events
is sufficiently high that vaccination is not warranted if there is no or little
real risk of exposure. Vaccine administration is warranted in individuals
exposed to the virus or facing a real risk of exposure. A safer vaccinia-based
vaccine, produced in cell culture is expected to become available shortly. There
is also interest in developing monoclonal antivariola antibody for passive
immunization of exposed and infected individuals, which could also be safely
administered to persons infected with HIV.”52
Potential 70,000 Severe Reactions Requiring VIG:
According to the Working Group on Civilian Biodefense “It has been estimated
that if 1 million persons were vaccinated [with live vaccinia virus vaccine], as
many as 250 persons would experience adverse reactions of a type that would
require administration of VIG [vaccinia immune globulin].”49
Using
these vaccine risk estimates would yield a serious vaccine reaction rate of 1 in
4,000 persons. This would mean that out of 280 million Americans who receive the
vaccinia virus vaccine there could be approximately 70,000 persons who would
experience reactions severe enough to require VIG.
VIG
is ineffective in treating postvaccinal encephalitis.20 Estimates are
that postvaccinal encephalitis following live vaccinia vaccine occurs in between
1 in 81,000 to 1 in 345,000 persons receiving their first smallpox vaccination,20,22
which would add thousands of cases of postvaccinal encephalitis in the initial
mass vaccination of all Americans, for whom VIG treatment is not beneficial.
Potential Neurological Reactions in the Young: One
1992 study by the State Research Institute of Standardization and Control of
Medical Biologics in Russia reported a neurological complication rate of 1 in
3,200 persons aged five years and older who received a first live vaccinia virus
vaccination.61 Approximately 120 million Americans are between the
ages of 5 and 35 according to the US 2000 census. If all those Americans were
first-time vaccinees, approximately 37,500 of them could suffer a neurological
reaction.
Re-Introducing Vaccinia Virus A Risk:
The vaccinia virus vaccine has not been used on a mass basis in the U.S.
since the early 1970’s so the virus is not circulating in our population and
no one under age 30 has had any experience with it.
Because live vaccinia virus vaccine can cause vaccinia viral infection
in the vaccine recipient or in a close contact of the recently vaccinated
person, those who get vaccinated will be exposing themselves and others to the
vaccinia virus and potential complications.
The CDC reports that one 10-state survey revealed
that transmission of vaccinia virus infection occurred in 27 per million total
vaccinations (1 in 37,000 vaccinations) and 44 percent of those contact cases
occurred among children. Approximately 60 percent of contact transmissions in
the survey resulted in the inadvertent inoculation of otherwise healthy persons.
About 30 percent of the eczema vaccinatum cases were a result of contact
transmission.20,62
Common Vaccinia Virus Vaccine Reactions:
Fever, fatigue and irritability are common, especially in children, during the
vesicular and pustular stages and swollen lymph glands may persist for months
after vaccinia virus vaccination.22
Inadvertent
inoculation at other body sites: According to the CDC: “Inadvertent
inoculation at other sites is the most frequent complication of vaccinia
vaccination and accounts for approximately half of all complications of primary
vaccination and revaccination.” Autoinoculation occurs when the recently
vaccinated person touches or scratches the lesion at the vaccination site and
transfers the live vaccinia virus to other parts of the body, such as the face,
eyelid, nose, mouth, genitalia and rectum, and more lesions form. Most lesions
heal without therapy but vaccinia immunoglobulin (VIG) can be used when the eye
is involved, unless there is inflammation of the cornea (because VIG can
increase corneal scarring). The CDC estimates inadvertent inoculation occurs in
1 in 1,890 first time vaccinations.20
Fever:
According to the CDC, approximately 70 percent of children experience
temperatures under 100 F. for 4-14 days after the first vaccination and 15-20
percent will experience temperatures under 102 F. After revaccination, 35
percent of children experience temperatures under 100 F. and 5 percent
experience temperatures under 102 F. Fever is less common in adults. 20
Rashes
and Hives: A raised rash (erythema) or hives (urticaria) can occur
approximately 10 days after a first vaccination, which usually does not involve
a fever and resolves within two to four days. Sometimes erythema and urticaria
can be confused with generalized vaccinia. 20
More Severe Reactions:
Moderate and severe immune and neurological complications of live vaccinia
vaccination occur more than ten times more often among first-time vaccinees than
among those who are revaccinated and are more frequent among infants. 20
Well known serious complications of live vaccinia virus vaccination include
progressive vaccinia, postvaccinal encephalomyelitis; eczema vaccinatum; and
generalized vaccinia, and reaction rates for these serious vaccine complications
vary.
Progressive Vaccinia (vaccinia gangrenosa, vaccinia necrosum):
When the live vaccinia virus continues to grow in the body and healing of the
primary vaccinal lesion caused by smallpox vaccination does not occur, there can
be a slowly progressive destruction of large areas of skin (necrosis),
subcutaneous tissue, viscera (internal organs) and bone. Progressive vaccinia
almost always occurs in persons with a severe immune deficiency caused by
cancer, radiation or chemotherapy, and AIDS or other serious immune system
disorders such as lupus. Those who develop progressive vaccinia almost always
die within six months.19,20,22,49
In
the past, it was estimated that this reaction occurred in 1 in 1 million to 1.6
in 1 million vaccinations with a case fatality ratio of almost 90 percent.20,22,53
However, this severe reaction to live vaccinia virus vaccine will most likely
occur more often today if mass smallpox vaccination campaigns are introduced in
populations with a high incidence of undiagnosed HIV/AIDS or other immune system
deficiencies.
Postvaccinal
Encephalitis/Encephalomyelitis:
Inflammation of the brain can develop two to 25 days after vaccination.22
It occurs most frequently in children under age one or two years and in older
children and adults receiving their first smallpox vaccination.20,53,61
Symptoms can appear suddenly and include fever, vomiting, drowsiness,
restlessness, confusion, convulsions, hemiplegia (partial paralysis), aphasia
(loss of speech), loss of consciousness and coma. Recovery is often incomplete,
with residual brain damage and paralysis, which occurs most frequently in
children under two years old.53
Death rates following post vaccinal encephalitis range from 25 percent to
50 percent of patients, usually within a week of onset.20,53
Conservative estimates of frequency range from 1 in 345,00022 to 1 in
81,000 persons receiving their first-vaccination.20
Eczema
Vaccinatum:
This reaction is seen in persons with a history of eczema or other types of
chronic skin conditions like contact dermatitis. The person develops high fever,
swollen lymph nodes and widespread inflammation and appearance of lesions on
areas of skin previously affected by eczema that can spread to areas of healthy
skin. Especially severe cases can occur when persons, who have active eczema or
a history of eczema, come in contact with those recently vaccinated with live
vaccinia virus.20,22 The CDC states “Eczema vaccinatum might be
more severe among contacts than among vaccinated persons.”20
Eczema
vaccinatum can be mild and self limited but also can be severe and fatal.
Estimates of frequency ranges from 1 in 100,00019 to 1 in about
26,000 first time vaccinations.20
Generalized
Vaccinia:
This reaction involves a vesicular rash similar to but milder than smallpox that
can be localized around the vaccination site or cover the body and can occur
among healthy persons without underlying illness. It is most serious in those
who have underlying immunosuppressive illness. The CDC estimates that 241.5
cases of generalized vaccinia per 1 million first time vaccinations occurs
(about 1 in 4,100 vaccinations).20
Death:
Death from vaccinia vaccination is most often the result of postvaccinal
encephalitis or progressive vaccinia. Death has been estimated to occur in 1 in
1 million vaccinated persons.22
Other
Serious Vaccinia Vaccine Reaction Reports: There are a number of other serious vaccinia
vaccine reactions reported in the medical literature, including progressive or
generalized vaccinia in persons with genital herpes,63,64,65 HIV,66
and active acne;67 development of skin cancer;68
basal
cell carcinoma in a smallpox vaccination scar;69 discoid lupus
erythematosus in a smallpox vaccination scar;70 diabetes;71
thrombocytopenia purpura;72 cardiac complications leading to heart
damage;73,74 clubfoot in babies whose mother’s were vaccinated in
the first trimester;75 and chromosomal breakage and changes in
children after revaccination.76,77
VIG Treatment and Prevention of Vaccine
Complications: Treatment for and prevention of vaccinia
complications is limited. Vaccine Immune Globulin (VIG), which is composed of
preformed antibody to vaccinia virus taken from the blood of persons who have
already been vaccinated with vaccinia virus, has been used in cases of
autoinoculation of the eye, progressive vaccinia, eczema vaccinatum and
generalized vaccinia. VIG is of no use in cases of postvaccinal encephalitis.20
VIG
has also been used to try to prevent serious vaccine reactions by giving persons
with contraindications (such as immune suppression) VIG before vaccination.20,49.
Although VIG has been useful in treating some cases of vaccinia vaccine
reactions, there is no assurance that VIG will either prevent or modify the
course of every serious reaction.
The
stockpiled supply of old VIG reportedly has deteriorated over the years and is
limited.26,57 There is not enough VIG to treat the number of serious
vaccine reactions that are estimated would occur if all of the 15.4 million
doses of stockpiled Dryvax vaccine were used.14,20,26,49 The blood
from volunteers in current Dryvax trials using diluted old vaccine may be able
to be utilized to make more VIG.14,15,58
Contraindications:
According to Harrison’s
Principles of Internal Medicine,
contraindications to vaccinia virus vaccine include: B or T cell immune system
disorders, eczema, pregnancy, disorders of the central nervous system, neoplasms
of the reticuloendothelial system, and use of immunosuppressive drugs.19
The
CDC now lists the following contraindications in the absence of an emergency
(actual exposure to smallpox):20
·
Persons who experience anaphylactic reactions to
polymyxin B sulfate, streptomycin sulfate, chlortetracycline hydrochloride and
neomycin sulfate should not be vaccinated with Dryvax;
·
Persons with eczema or other skin conditions:
“Vaccinia vaccine should not be administered to persons with eczema of any
degree, those with a past history of eczema, those whose household contacts have
active eczema, or whose household contacts have a history of eczema. Persons
with other acute, chronic or exfoliative skin conditions (e.g., atopic
dermatitis, burns, impetigo or varicella zoster) might also be at higher risk
for eczema vaccinatum and should not be vaccinated until the condition
resolves.”
·
Persons Infected with HIV;
·
Persons with immunosuppression (leukemia, lymphoma,
generalized malignancy, solid organ transplantation, cellular or humoral
immunity disorders, therapy with akylating agents, antimetabolites, radiation or
high-dose corticosteroid therapy);
·
Infants and Children under age 18;
·
Pregnant Women: “Vaccinia virus has been reported
to cause fetal infection on rare occasions, almost always after primary
vaccination of the mother. Cases have been reported as recently as 1978. When
fetal vaccinia does occur, it usually results in stillbirth or death of the
infant soon after delivery.”
Other
contraindication considerations : Although the CDC does not list herpes
infection as a contraindication in non-emergencies, the case reports of
progressive vaccinia in persons with herpes suggest that use of the vaccinia
virus vaccine today may result in many more cases of progressive vaccinia than
in the past. Herpes infection, like HIV, is more widespread today than it was
prior to the early 1970’s, when routine vaccinia virus vaccination was
discontinued.
CDC
Eliminates Absolute Contraindications In Emergency: The CDC
states that:
“No absolute contraindications exist regarding vaccination of a person
with a high-risk exposure to smallpox.
Persons at greatest risk for experiencing serious vaccination complications are
also at greatest risk for death from smallpox. If a relative contraindication to
vaccination exists, the risk for experiencing serious vaccination complications
must be weighed against the risk for experiencing a potentially fatal smallpox
infection. When
the level of exposure risk is undetermined, the decision to vaccinate should be
made after prudent assessment by the clinician and the patient of the potential
risks versus the benefits of smallpox [vaccinia virus] vaccination.”
Other
Considerations: Whether a person dies from a disease or a vaccine, a death
is a death and one cause of death is no more important than another when
individual human life is valued. Because there are no genetic or other
biomarkers to definitively predict ahead of time who will be harmed by
vaccination, there must be strict adherence to the informed consent ethic,
especially during times of emergencies when all contraindications are officially
suspended. To do any less, places public health officials and anyone, who forces
vaccination on a person without that person’s informed consent, in the role of
judge and executioner of the genetically and biologically vulnerable.
Preventing Contact Transmission of Vaccinia
Virus: Care must be taken to prevent spread of the vaccine
virus from the vaccination lesion site to other areas of the body or to another
person. Use of gauze or porous bandages (to allow air to dry the site lesion) is
advised with bandages changed every 1 to 2 days. No salves or ointments should
be placed on the vaccination lesion. The most important action for preventing vaccinia virus
transmission is frequent hand washing with soap and water or disinfecting agents
after contact with the vaccination site. Disposal of bandages that have covered
the site in sealed plastic bags and decontaminating clothing or materials that
have contact with the site by laundering in hot water with bleach is also
important.20,52
Recombinant Vaccinia Virus Vaccine Transmission:
Scientists are using vaccinia virus as a vehicle for creating new vaccines.
Genes from herpes simplex virus, hepatitis B virus, HIV and malaria reportedly
have been inserted into the vaccinia genome.19 In the 1970’s and
1980’s, as researchers began experimenting with genetically engineering
different strains of vaccinia viruses to contain and express foreign DNA to
induce protection against infectious agents such as HIV, there were reports of
laboratory-acquired infections with vaccinia or recombinant viruses.20,24
In
1991 the CDC’s Advisory Committee on Immunization Practices (ACIP) advised
that health care workers, who were exposed to volunteers in new vaccine trials
using genetically engineered vaccinia virus, be vaccinated with vaccinia virus
vaccine. The CDC recommendations stated that::
“With
the initiation of human trials of recombinant vaccines, physicians, nurses and
other health-care personnel who provide clinical care to recipients of these
vaccines could be exposed to both vaccinia and recombinant viruses. The exposure
could occur from contact with dressings contaminated with the virus or through
exposure to the vaccine. The risk of transmission of recombinant viruses to
exposed health care workers is unknown…however, because of the potential for
transmission of vaccinia or recombinant vaccinia viruses to such persons, the
ACIP suggests that health care personnel who have direct contact with
contaminated dressings or other infectious material from volunteers in clinical
studies be considered for vaccination.”24
Health
Secretary Orders 300 Million Doses of Vaccine:
One month after the September 11 terrorist attacks on the
World Trade Center and the Pentagon, DHHS Secretary Tommy Thompson called on
industry and government to produce and stockpile 300 million doses of vaccinia
virus vaccine by the end of 2002. He said that all Americans should know they
“have their name on a vaccine shot in our inventory.” Cost estimates range
from $500 million to nearly $2 billion.1,15,78
In order to be able to accomplish this goal, some in industry are calling
for cutting the number of participants in vaccine trials and bypassing standard
safety and efficacy requirements to quickly create a stockpile of vaccine.16,17,25
Industry
Asks for Immunity From Lawsuits: Drug companies competing for the
multi-million dollar contract to produce enough vaccinia virus vaccine to
vaccinate every American are asking Congress to pass legislation shifting all
liability for vaccine injuries and deaths to the government (American taxpayer).
Already, there are bills being drafted in Congress to create a federal
fund to compensate victims of bioterrorism vaccines, such as vaccinia virus
vaccine.79
New Office of Preparedness Created: DHHS
Secretary Thompson has appointed D.A. Henderson, founding director of the Center
for Civilian Biodefense Studies at Johns Hopkins University and architect of the
worldwide smallpox eradication effort, as well as Philip Russell, a retired Army
major general specializing in vaccine development, to head a new Office of
Preparedness that will expand new vaccine programs and develop strategies to
respond to public health emergencies. Dr. Henderson has been quoted as saying
his top priority is to improve the “communications system” that will allow
the medical community and government to mount a coordinated response.80
Emergency Plan Will Militarize Public Health System:
The Working Group on Civilian Biodefense has stated “The
discovery of a single suspected case of smallpox must be treated as an
international health emergency.”49 Although
it is very important to have a well crafted bioterrorism emergency response plan
in place, along with enough vaccine for everyone who wants to use it, it is
difficult to envision the necessity for giving public health officials the kind
of sweeping police powers now being advocated by the Centers for Disease Control
(CDC).
With
funding and direction provided from the CDC, a lawyer at the Georgetown
University Center for Law and the Public’s Health, Lawrence Gostin, has
created model state legislation that will allow public health officials to
mobilize and use “all or any part of the organized militia” to isolate,
quarantine and force vaccination and medical treatment on American citizens in
states where a Governor has called a “state of emergency” for 30 days or
more. (Go to www.publichealthlaw.net to read
the law).
Public
health officials would be given the power to “coordinate all matters
pertaining to the public health emergency,” including the right to seize
private property such as “communications devices, carriers, real estate,
fuels, food, clothing and health care facilities” and take control of “the
use, sale, dispensing, distribution and transportation of food, fuel, clothing
and other commodities, alcoholic beverages, firearms, explosives and
combustibles” as well as take control of roads and public areas.
If
passed by the states, the law would give unprecedented police powers to public
health officials and those they designate to charge citizens with misdemeanors
and imprison them if they refuse to comply with vaccination, medical treatment
or isolation orders without being able to go to court first. Those who
participate in enforcing the law would not be held liable for any injury, death
or loss of property which resulted.
In
the preface to this model state legislation, Gostin justified the law he wrote
for the CDC by referring to the 1905 Supreme Court decision Jacobsen v Massachusetts,
which upheld the right of US states to pass mandatory vaccination laws. Gostin,
who is a longtime forced vaccination proponent, will be working with the
National Governors Association, National Conference of State Legislatures,
Association of State and Territorial Health Officials, National Association of
City and County Health Officers, and National Association of Attorneys General
to get this legislation passed in every state. It has already been introduced in
Massachusetts.
Jacobsen v Massachusetts Revisited: How
did we get to this point in America, where public health officials would presume
to appropriate the kind of police power they are now saying they should be
given? It all goes back to a man name Jacobsen who, in 1905, sued the state of
Massachusetts for requiring him and his son to get a second vaccinia virus
(smallpox) vaccination or pay a $5 fine. Jacobsen refused to get revaccinated or
pay the fine, saying that he and his son had had a bad reaction to a previous
vaccination for smallpox and were afraid they would be injured or die from a
second one. Jacobsen maintained that forcing him to be revaccinated was “an
assault upon his person” and violated his constitutional rights.
In
its majority opinion in Jacobsen
v Massachusetts, 197 U.S. 11(1905), the Supreme Court rejected the
evidence Jacobsen presented to show that the vaccine can cause injury and death
and that doctors cannot distinguish between those who will be harmed and those
who will not be harmed. The Court concluded, “The matured opinions of medical
men everywhere, and the experience of mankind, as all must know, negative the
suggestion that it is not possible in any case to determine whether vaccination
is safe.”
Doctors Cannot Predict Who Will Be Harmed: The
fact the Supreme Court at the turn of the 20th century did not have
accurate medical information upon which to base their precedent-setting decision
is unfortunate. It has been proven in the succeeding 96 years, most recently in
the US Court of Claims in Washington, D.C. where nearly two billion dollars has
been awarded to families whose children have been killed or been injured by
mandated childhood vaccines, that often doctors cannot predict ahead of time
which individuals will react to vaccines and die or be left with mental
retardation, medication-resistant seizure disorders, paralysis, learning
disabilities, ADHD, autism, chronic arthritis, or other immune and brain
dysfunction.6
Cruel and Inhuman To The Last Degree: This
is a critical point in measuring the consequences of assigning police powers to
public health officials for the purpose of enforcing vaccination, particularly
in cases where parents suspect their children are at increased risk for reacting
to vaccines - even though government health officials, anxious to achieve a 100
percent vaccination rate, disagree. In their opinion, the 1905 Supreme Court
justices acknowledged that vaccination must not be forced on a person whose
physical condition would make vaccination “cruel and inhuman to the last
degree. We are not to be understood as holding that the statute was intended to
be applied in such a case or, if it was so intended, that the judiciary would
not be competent to interfere and protect the health and life of the individual
concerned.”
Therefore,
when interpreting Jacobsen v Massachusetts in 2002, it is important to remember
that, although the Court agreed that states may enact “such reasonable
regulations established directly by legislative enactment as will protect the
public health and the public safety,” the
Supreme Court made it clear that mandatory vaccination laws
must not be applied unreasonably so as to result in harm to individuals.
In other words, the state does not have the right to command that an individual
sacrifice his or her life in the name of the public health.
Utilitarianism
Was in Fashion: What,
then, did the 1905 Supreme Court mean when it went on to declare that “it was
the duty of the constituted authorities primarily to keep in view the welfare,
comfort and safety of the many, and not permit the interests of the many to be
subordinated to the wishes or convenience of the few?” The “wishes or
convenience” of the few certainly does not translate into the ”lives” of
the few, but still, the historical context in which this declaration was made is
very important.
In 1905, the political doctrine known as “utilitarianism” was a popular philosophical tenet, which judged the rightness or wrongness of an action by its consequences and held that an action that is moral or ethical results in the greatest happiness for the greatest numbers of people. With its emphasis on num
