SMALLPOX
AND FORCED VACCINATION:
WHAT EVERY AMERICAN NEEDS TO KNOW
Part 2
...continued
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 ten years.20
The CDC recommends that lab and medical personnel at high risk of
being exposed to vaccinia viruses be revaccinated every ten 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 five to seven 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 one
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 one 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 one in 81,000 to one 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 one 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 five 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 ten-state survey revealed that transmission
of vaccinia virus infection occurred in 27 per million total vaccinations
(one 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 one in 1,890 first time
vaccinations.20
Fever: According to the CDC, approximately 70 percent of
children experience temperatures under 100 F. for four to 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 five 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
continued...
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here for part 3 of 4 including, "EDITORIAL:
Vaccinating America at Gunpoint"
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