Barbara Loe Fisher, Editor

In this time of great sadness, fear and confusion, Americans have a choice to make: either we defend the individual freedoms our forefathers fought and died to give us, or we sacrifice those freedoms and let the terrorists win. What we choose to do will define who we are as a nation for many years to come.

- Barbara Loe Fisher

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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

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