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Part 2


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


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


Click here for part 3 of 4 including, "EDITORIAL: Vaccinating America at Gunpoint"