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Several articles on this web page have been taken from ProMED-mail posts, [which in turn may cite original sources]
ProMED-mail is a program of the International Society for Infectious Diseases

Other sources are marked as Non-ProMED


Date: Wed, 16 Oct 2002 09:27:19 EDT

Regarding the claim in the previous posting (reference below) that:
Vaccinated people can transmit vaccinia virus

An interesting historical note is that during the early days of vaccination (while Jenner was still alive), the problem of keeping live stocks of the vaccine was solved by transferring the vaccine from one recipient to the next. As explained by Jonathan B. Tucker in his book "Scourge: The Once and Future threat of Smallpox" (New York: Atlantic Monthly Press, 2001), p. 29:

"One solution to the problem was to keep the vaccine 'alive' by transferring it from one human recipient to the next, a practice known as the arm-to-arm technique. First, an individual was vaccinated, and as soon as the cowpox pustule had appeared on his or her arm, matter from the lesion was then used to vaccinate other recipients. In 1801 in St. Petersburg, Russia, for example, a recently vaccinated girl was sent to a local orphanage to serve as the source of smallpox vaccine for all children more than a week old. From then on, the orphanage continuously transferred the vaccine from one child to another for more than ninety-two years (1801-93)."

The author goes on to note the hazards of the arm-to-arm method: It could "contaminate the vaccine with dangerous pathogens, resulting in inadvertent spread of hepatitis or syphilis. In 1861, for example, 41 Italian children who had been vaccinated by arm-to-arm transfer acquired syphilis from a child with an undiagnosed case of the disease." (p. 33)

Ed Regis, Ph.D.
College Fellow
McDaniel College
Westminster, Maryland 21157

Source: CNN Online 15 Oct 2002 Posted: 6:34 PM EDT (2234 GMT)

Vaccinated people can transmit vaccinia virus
New research on smallpox vaccinations
- -------------------
Experts poring over data from past widespread smallpox vaccinations conclude the live virus used in the vaccine may result in cases of
contact vaccinia --
the spreading of the vaccinia virus from someone recently vaccinated to someone who has not had the shot.

Vaccinia, a less virulent relative of smallpox, is the live virus used in smallpox vaccinations. People with skin disorders like eczema can spread the virus across their own skin and potentially infect others who aren't vaccinated. The vaccinia virus may cause a rash, fever, and head or body aches.

The researchers, led by Dr. John Neff, a former researcher with the Center for Disease Control and Prevention's Smallpox Eradication Program, discussed what they found in a commentary in this week's Journal of the American Medical Association released today.

Their research focused on mass vaccinations in the United States, United Kingdom, and Sweden from 1947 to 1968. Overall, in the U.S. studies, the rate of contact vaccinia was in the range of 2 to 6 per 100 000 vaccinations.

The majority of such cases -- a few of which resulted in death -- occurred in children with eczema, a skin disorder characterized by itchy red skin and even blisters in severe cases. The disease was more likely to be spread to people with a history of eczema even though they had no active skin lesions.

Age distribution of those U.S. cases shows young people are more vulnerable to contact vaccinia:

Younger than 1 year:      25 cases
One to 4 years of age:   113 cases
Five to 19 years of age:  40 cases
Twenty years or older:    44 cases
That translates to 62 percent of the cases occurring in children 5 years old or younger and almost 20 percent in those 20 years or older, according to the study.

Most cases happened in the home, with many victims getting the virus from vaccinated family members or playmates. In rare cases, transmission occurred from a vaccinated nurse to a patient.

"The risk (of contact vaccinia) is not large," the researchers write.
"This risk needs to be kept in perspective." But they do admit that in this day and age we're more susceptible than past generations. Why?

Since widespread smallpox vaccinations stopped in 1972, almost everyone born since then has no immunity to vaccinia, according to the authors. If vaccinated, this group could spread the virus for up to 19 days. Even those who have had a smallpox shot in the past could shed more of the virus and for a longer period of time depending on how long it's been since their last vaccination and how many shots they've had in all. In short, most people born before 1972 have had only one smallpox shot and they would probably react as if they've never had one at all.

Eczema, also called atopic dermatitis, is more prevalent today. In the United States, rates have increased from 3 to 6 percent to 6 to 22 percent in the past 30 years, according to the researchers.

Today there are more people with weak immune systems. The authors theorize that's likely due to the spread of HIV and wider use of drugs to suppress the immune system for cancer patients and organ transplant recipients, for example. "Contact vaccinia in this population could be especially serious," the authors write.

Preparation and a carefully crafted vaccine policy is key to keeping contact vaccinia under control should mass smallpox vaccinations become a reality, according to the commentary.

They recommend public health officials carefully screen for those with a history of eczema and compromised immune systems. The public should be informed about how contact vaccinia is spread and how to avoid it. Finally, a surveillance system needs to be in place to document and track adverse reactions to the vaccine.

[Byline: Gina Hill]

Article source reference:
Neff JM, Lane JM, Fulginiti VA, Henderson DA.
Transmission of Vaccinia Virus JAMA 16 Oct 2002 288 /15.

The data presented in the above newswire are from different studies that were used as part of this review. Readers are referred to the actual article for a more detailed discussion of the epidemiology of contact vaccinia during the 50's, 60's, and 70's.

The authors are very prudent in adding the comment about the increased numbers of people in today's environment with weakened immune systems.

Some additional background references:

1: Contact spread of vaccinia from a National Guard vaccinee--Wisconsin. MMWR Morb Mortal Wkly Rep. 1985 Apr 5;34(13):182-3.

2: Smallpox vaccination and contact spread of vaccinia virus. Bull Pan Am Health Organ. 1985;19(4):400-1.

3: Contact spread of vaccinia from a recently vaccinated Marine--Louisiana. MMWR Morb Mortal Wkly Rep. 1984 Jan 27;33(3):37-8.

4: Lejeune B, Coroller A, Labouche F, Le Fur JM, Colin J, Dorval JC, Masse R, Quillien MC, Chastel C. [Accidental localized vaccinia. A report of six recent cases (author's transl)] Sem Hop. 1982 Jan 21;58(3):148-52.

5: Chaudhuri AK, Cassie R, Douglas WS. Contact vaccinia from recently vaccinated British soldiers. Br Med J (Clin Res Ed). 1981 May 30;282(6278):1797.

6: Grosfeld JC, van Ramshorst AG. Eczema vaccinatum. Report of four cases by contact-infection. Treatment with methiasazone (Marboran). Dermatologica. 1970;141(1):1-10.

7: Goldstein JA, Neff JM, Lane JM, Koplan JP. Smallpox vaccination reactions, prophylaxis, and therapy of complications. Pediatrics. 1975 Mar;55(3):342-7.

8: Lane JM, Millar JD, Neff JM. Smallpox and smallpox vaccination policy. Annu Rev Med. 1971;22:251-72.

9: Mellin H, Neff JM, Garber H, Lane JM. Complications of smallpox vaccination, Maryland 1968. Johns Hopkins Med J. 1970 Mar;126(3):160-8.


Source: NY Times 18 Oct 2002 [edited]

Close Monitoring Is Planned for Smallpox Vaccinations
- -------------------------

Federal health officials said today that a network of experts would be made available for consultation at any hour in case of bad reactions to smallpox vaccine, which may be given soon to a half-million hospital workers.

The network would be part of the most comprehensive system ever to monitor the safety of a vaccine, officials of the federal Centers for Disease Control and Prevention here said.

It would also be the first formal program in which doctors treating a patient with a vaccination complication could immediately consult with designated experts at selected medical centers around the country. Such consultations have been done informally, with the disease centers relying on reports from doctors that were not collected in a standard way.

"We are responding to criticism that we have not had comprehensive, standard clinical evaluations" of adverse reactions to vaccines, Dr. Walter Orenstein, an official at the disease centers, said.

The monitoring system will help determine the frequency of complications caused by the smallpox vaccine, the riskiest of all vaccines.

The network will also be used to determine who will get the scarce and dangerous drugs needed to treat complications of the smallpox vaccine, and when, said Dr. Gina Mootrey, another official at the centers, in announcing the monitoring plan to a panel advising the government on smallpox vaccinations.

On Wednesday, the advisory panel recommended offering the immunization to an estimated half-million emergency room and other hospital workers because of the possibility of a bioterrorist attack.

Today, the panel recommended that anyone with either of 2 common skin conditions -- eczema and atopic dermatitis -- not receive a smallpox vaccination. The exclusion also applies to anyone who has had either condition in the past, even a mild case. Such individuals are at increased risk of developing a severe and potentially fatal illness known as eczema vaccinatum.

The panel also recommended not giving smallpox vaccine to anyone who has a family or household member with either skin condition because the virus in the vaccine could be transmitted to them.

The panel's chairman, Dr. John F. Modlin of Dartmouth Medical School, said the criteria might exclude an estimated 7 percent to 17 percent of Americans from receiving the vaccine.

Individuals infected by the AIDS virus and women who are pregnant, or who are trying to become pregnant, should also not be given the vaccine, the panel said.

Modern knowledge about the safety of the vaccine is limited because the government stopped standard use of smallpox vaccine in 1972 as the disease was being eradicated from the world.

Earlier this year, researchers reported that 36.4 percent of volunteers in a study missed school, work, or recreation or had difficulty sleeping after receiving a dose of the smallpox vaccine that was used before smallpox was declared eradicated in 1980.

Individuals with severe reactions might be treated with either of 2 drugs. One is vaccinia immune globulin, a drug that is derived from the blood of individuals who have been immunized against smallpox, and is now in short supply. The government owns the only stores.

The other is cidofovir, a drug that experts hope might be effective against vaccinia, the virus in the vaccine that protects against smallpox. Cidofovir must be injected, is dangerous, and its only approved use is for a different virus.

Another reason for instituting the monitoring system is to maintain credibility and public confidence, Dr. Mootrey said. Last year during the anthrax attacks, the centers were widely criticized for failing to communicate pertinent information about anthrax in a timely manner to health officials, doctors and the public.

The monitoring system will require extensive cooperation from state and local health departments and hospitals to resolve a number of issues, including liability for the health professionals involved. The centers plan to start discussions with state and territorial health officials on Friday. Most experts at the meeting were cautiously optimistic about the plan.

Dr. Guthrie S. Birkhead, an official of the New York State Health Department, called the plan comprehensive but underscored the need for health officials and hospitals to immediately talk through the issues.

Dr. Kent Sepkowitz, an infectious disease expert at Memorial Sloan-Kettering Cancer Center in Manhattan, complimented the center for developing "a good system," but added that "it will take months for it to go right and that is a reason to go slowly at first."

Under the monitoring system, each hospital worker will be given a personal identification number at the time of vaccination.

The recipients will also receive a telephone hotline number to report any possible adverse effect like fever, a spreading rash or altered mental status caused by encephalitis.

An estimated 35 percent, or 175 000, of the recipients are expected to call the hotline, where the staff will provide advice and refer those needing immediate care to their doctors.

Of these, about 17 500 are expected to need care from a designated local specialist in dermatology, allergy, neurology, and infectious diseases. In turn, about 30 percent of this group will need referrals for more extensive consultation with experts at designated hospitals around the country.

The experts are at Columbia-New York Presbyterian Hospital in Manhattan, Boston University, Johns Hopkins, the University of Maryland, the Northern California Kaiser Permanente hospital, Stanford University, and Vanderbilt University.

About 100 recipients are expected to need treatment with vaccinia immune globulin, cidofovir, or both.

The disease centers plan to conduct a telephone survey involving 15 000 to 20 000 vaccine recipients on the tenth and twenty-first days after vaccination.

[Byline: Lawrence K. Altman]

"Smallpox Vaccination Would Require Close Monitoring"

Reuters Health Information Services (
(10/15/02); McKinney, Merritt [Not from Pro-MED-mail]

A panel of smallpox experts has suggested that the widespread use of the smallpox vaccine--which contains vaccinia, a live virus related to smallpox--may lead to many more cases of vaccine-related side effects, which can include brain damage and death, particularly among those people with compromised immune systems and infants. In a report published in the October 16th issue of the Journal of American Medical Association, experts including Dr John M. Neff, of the Children's Hospital and Regional Medical Center in Seattle, Wash., say a tightly controlled and limited vaccination program that includes comprehensive screening and education to exclude those people who are at risk of dangerous side effects, as well as people in contact with high-risk individuals, may result in only a fractional number of serious exposures. However, Neff adds, the program currently undergoing review by the government is far too extensive a plan to contain the exposure and risks--particularly since immunization stopped in 1972, making anyone under 30 years old and newly vaccinated a risk to others for weeks afterward. The makeup of today's population is different too, Neff observed, citing the prevalence of HIV, more organ-transplants, and other illnesses that can compromise immune systems.

Source: ABC news / Reuters 18 Oct 2002 [edited]

Spread of Vaccinia

ATLANTA (Reuters Health) - Healthcare workers who receive smallpox vaccine should keep the vaccination site covered until the scab separates, but they can care for patients immediately after vaccination, federal health officials announced Thursday.

Earlier this week, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) recommended that over 500,000 healthcare workers--those most likely to treat patients in the event of a smallpox outbreak--should be vaccinated against smallpox.

In a telephone media briefing, Dr. John Modlin, chair of the ACIP, summarized several specific recommendations made on the vaccination of healthcare workers.

A key issue the guidelines addressed was preventing the transmission of vaccinia virus, the virus used in the vaccine, from healthcare workers who have been vaccinated to those that have not. Vaccinia virus is related to the smallpox virus, but much less dangerous. The virus generally poses no risk to healthy individuals but could be a problem for certain individuals, including those with weakened immune systems.

Between two to six unvaccinated people might contract the virus for every 100,000 people immunized, according to a report in The Journal of the American Medical Association Tuesday [see ProMED-mail posting Smallpox vaccine hazards (02) 20021015.5559 - Mod.MPP]

ACIP is recommending that healthcare workers involved in direct patient care cover the vaccination site with absorbent material, such as gauze, and "at least a single layer of impermeable acoustic dressing," until the scab separates.

However, the committee recommended against the need for healthcare workers to be placed on leave after receiving smallpox vaccination unless they develop symptoms from the vaccination or do not adhere to infection control precau

"Very close contact required for transmission of vaccinia to household contacts is unlikely to occur in the healthcare setting," Modlin stressed during the briefing.

ACIP also recommends that healthcare workers with eczema, a type of allergic skin rash called atopic dermatitis, or other skin conditions avoid receiving the smallpox vaccine.

According to Modlin, about 2% to 5% of adults have eczema or atopic dermatitis, although when other skin conditions that could make the vaccine risky are included, the vaccine may be contraindicated for up to 10% to 20% of people.

Pregnant healthcare workers, those with HIV/AIDS or other immunocompromised individuals should not receive the vaccine, but neither routine pregnancy testing nor mandatory HIV/AIDS testing is recommended. Female healthcare workers should be counseled not to become pregnant for 4 weeks after vaccination and HIV testing should be offered, they suggest.

Smallpox vaccine may be administered at the same time as any inactivated vaccine or live vaccine, with the exception of varicella (chickenpox), according to ACIP.

Regarding the risk to household contacts of healthcare workers, Dr. Walter Orenstein, director of CDC's National Immunization Program, told Reuters

Health that the same kinds of contraindications considered for those being vaccinated should be applied.

"So, for example, if a healthcare worker has a child in the home with eczema, then that worker should not be vaccinated," Orenstein said.

Modlin pointed out that "for the most part...organizations representing emergency room physicians, nursing staff and others have been very supportive of the process and have participated and, more or less, agree with the ACIP's actions."

According to Orenstein, the order in which healthcare workers will be vaccinated is still being worked out.

[by: Emma Hitt, PhD]

More: Spread of Vaccinia

"Big Question About Smallpox: What if . . . ?"
New York Times ( (10/15/02) P. F6; Grady, Denise
[Non Pro-MED-mail source]

Dr. William Schaffner, chairman of the preventive medicine department at Vanderbilt University, has spent much of this year worrying about the fact that the site of a smallpox vaccination can shed live virus and infect others who might be exposed to it. Schaffner is one of the infectious disease experts currently advising the government as it considers the first wave of inoculations of about 500,000 soldiers, along with selected health care workers, against a possible smallpox bioterrorist attack. The government has suggested that once the vaccine is approved for mass use, it should be offered to the public. The greatest concern, says Schaffner, is that vaccinated people pose a risk to others who are particularly vulnerable to the vaccine itself, like pregnant women, infants, people with autoimmune disorders, cancer, or new organ recipients, and those with a history of eczema or other skin conditions. He notes that the program will establish a transmissible infection, and people other than the volunteers could easily acquire the infection from accidental exposure, though studies from the 1960s indicate that transmission rates in this manner were low. Schaffner points out that 40 years ago, when the vaccine was in routine use, HIV was unknown, organ transplants were rare, and rates of eczema were very much lower than they are today. Special vaccine bandages are being tested to determine whether their usage will reduce the chance of transmission. A secondary concern, says Schaffner, is time lost from work by at least 30 percent of health care workers and other first line defenders resulting from their reactions, or the side effects of receiving the vaccine for the first time.

[ProMED-mail has been covering the debates and discussions related to a resumption of vaccination with smallpox vaccine in the USA. All of the information currently available on the risks of the smallpox vaccine are based on data collected 30 or more years ago, when smallpox vaccinations were routine in the USA and elsewhere (prior to the declaration of global eradication of the disease). There has been much discussion re: the changed environment (HIV/AIDS, increased population with eczema and atopic dermatitis, increased people on immunosuppressant medication, transplants, etc.) since vaccination was stopped, with an awareness of an increase in the numbers of persons at high risk of complications following receipt of the vaccine.

As a note, it is interesting that Dr. Modlin gives a range of 7-17 percent of the population that would have to self exclude from vaccination by virtue of their own risk or risk of a close contact. Remembering the back of the envelope estimates proposed by Dr. Kemper et al Expected Adverse Events in a Mass Smallpox Vaccination Campaign Effective Clinical Practice, March/April 2002 [URL below], they estimated that 25 percent of the population would be excluded from vaccination because of high risk or the possibility of coming in contact with a high-risk individual.

While the plan does address the issue of vaccination of healthcare workers involved in active patient care, with requirements for an occlusive impermeable dressing until the scab separates, one can't help but remain concerned that the combination of a large pool of health care workers who were born after smallpox vaccination was discontinued (and hence will be primary vaccinees) combined with today's larger pool of high risk patients (with either acquired via infection or have iatrogenically acquired immunosuppression) may be very risky. In the article by Neff JM, Lane JM, Fulginiti VA, Henderson DA. Transmission of Vaccinia Virus JAMA 16 Oct 2002 288 /15 (discussed in ProMED-mail posting Smallpox vaccine hazards (02) 20021015.5559) there is mention that "most contacts were in the home, but a few patients apparently acquired vaccinia from a recently vaccinated nurse in the hospital". They also mention that while there were no reports of progressive vaccinia in contacts of vaccinees, these data came from the 1960s when there were fewer immunosuppressed persons. Given today's environment, there may be a real need to exclude recently vaccinated health care workers (especially those receiving a primary vaccination) from active patient care.

In the article by Neff JM et al, there was mention of a case of disseminated vaccinia that occurred in an apparently healthy military recruit (in 1984) who was later diagnosed as having HIV/AIDS. While we do not know how many HIV infected persons were vaccinated before the military stopped using the vaccine, the prevalence of HIV infection was much lower in 1984 than it is today. This last finding raises concerns re: vaccination of healthcare workers without requiring HIV testing prior to vaccination.

The above plan as stated will hopefully provide a better data base on the risks associated with smallpox vaccination in the current environment. Through active and passive surveillance, more data should become available on the actual risks associated with the vaccine, with the ultimate outcome being recommendations based on real rather than hypothesized data. What this plan does not discuss is how the liability issues will be handled. Yes, there will be individuals with serious complications from receipt of the vaccine, or from contact with a recent vaccine recipient. And in today's heightened litigious environment, who will shoulder the burden of the liabilities for the medical and other costs associated with these serious reactions?

Smallpox Vaccine Results are IN

This article is from Jon Rappoport's Stratiawire publication,

By investigative journalist Jon Rappoport
Monday, December 09, 2002
DECEMBER 9. The first returns are in on the smallpox vaccine. A recent multi-center US government clinical trial on 200 "young adults" has been completed.

MSNBC reports. The volunteers who got the shot were VERY healthy to begin with. One researcher, Kathy Edwards, called them the "crème de la crème."

Okay? So get this. "Yet when she [Edwards] inoculated them with smallpox vaccine, arms swelled, temperatures spiked and panic spread [at Baylor University]. It was the same at clinics in Iowa, Tennessee, and California."

Stats: After the shot, one-third of the volunteers missed at least a day of work or school. 75 out of 200 experienced high fever. "Several were put on antibiotics because physicians worried that their blisters signaled a bacterial infection."


And look, smallpox is a VIRUS, and antibiotics DON'T WORK against viruses. So, in essence, the researchers were inferring that the vaccine SUPPRESSED THE IMMUNE SYSTEMS of the volunteers---thus allowing bacterial infections to bloom suddenly---OR the vaccine was contaminated with bacteria to begin with.

Researcher Edwards, who headed up the study, said, "I can read all day about it [the adverse effects of the vaccine], but seeing it is quite impressive. The reactions we saw were really quite remarkable."

When a researcher makes a comment like this, you know some very bad things are happening.


Of course, this story didn't get much play in the press. But the handwriting is on the wall. Anyone can see what'll happen if they start shooting up people by the millions with the vaccine. For example, people who don't qualify as severely immune suppressed by any obvious assessment, but still do, in fact, have reduced immune capacity---AND THAT IS A WHOLE LOT OF PEOPLE.---these folks will be AT GREAT RISK from the vaccine.

This government study is KEY. Because later on, they will try to cover up the devastating effects of the vaccine. They will lie, distort, omit. But right now, here it is. Out in the open. The results, for all to see.

Let me tell you something. The CDC WANTED to release the results of this study. They wanted to go on the record now, before the stuff really hits the fan. They are very frightened of being nailed for killing people with the vaccine.

More, Smallpox Vaccine Results are IN
Smallpox shots cause worry
Experts startled by array of side effects
By Ceci Connolly

Dec. 5 — As physical specimens, the Baylor University students were fit and healthy, the "crème de la crème," in the words of researcher Kathy Edwards. Yet when she inoculated them with smallpox vaccine, arms swelled, temperatures spiked and panic spread.

IT WAS the same at clinics in Iowa, Tennessee and California. Of 200 young adults who received the vaccine as part of a recent government study, one-third missed at least one day of work or school, 75 had high fevers, and several were put on antibiotics because physicians worried that their blisters signaled a bacterial infection.

Even for experts such as Edwards, the Vanderbilt University physician overseeing the study, the side effects were startling. "I can read all day about it, but seeing it is quite impressive," she said. "The reactions we saw were really quite remarkable."

President Bush is poised to announce plans, perhaps as early as this week, to resume vaccinating Americans against smallpox as part of a massive push to protect the nation from a biological assault. As he weighs the decision, researchers are becoming reacquainted with the unpleasant — often severe — complications of the vaccine.

The experiences in a half-dozen clinical trials offer an early look at what military personnel, hospital workers and other emergency workers will likely encounter if Bush adopts the recommendations of his top health advisers to vaccinate as many as 11 million people in the coming months. What is disconcerting, say the people participating in the clinical trials, is that when it comes to smallpox vaccination, what had once been considered ordinary is rather extraordinary by today's standards.

"I just wanted to go to bed for a day or two there," said Alison Francis, a New York University graduate student who received the vaccine. Francis, 24, said she felt tired and achy after getting her shot. Her arm was heavy, warm to the touch and terribly itchy. "I thought, 'Can you just chop off my arm?' "

Participating in the study was part patriotism and part selfishness, she said. "Now I'm protected."

Once among the deadliest scourges on earth, smallpox was declared eradicated worldwide in 1981. But growing hostilities with Iraqi President Saddam Hussein, Osama bin Laden and others have renewed fears that the virus could be used as a potent, stealthy weapon. Vaccination is surefire protection against the disease, but it is risky. For every 1 million vaccinated, between 15 and 52 people will suffer life-threatening consequences such as brain inflammation, and one or two will die, according to historical data. Pregnant women, babies, people with eczema or weakened immune systems should not receive the vaccine.

Federal health officials have proposed resuming vaccination in stages, beginning with as many as 500,000 hospital workers most likely to see an initial case. Later, as many as 10 million police, fire and medical personnel would be offered the vaccine. The Pentagon hopes to vaccinate 500,000 soldiers.

Over the past year, federal researchers have been testing the 40-year-old vaccine for its safety and potency. None of the 1,500 volunteers has died or been seriously injured by the vaccine. But even the most mundane cases can be disturbing to doctors and patients unaccustomed to the live virus used in the vaccine and its side effects.

Unlike most modern vaccines, the smallpox vaccine is administered by 15 quick pricks that "establish an infection in your skin," said Julie Gerberding, director of the Centers for Disease Control and Prevention in Atlanta. "There is the immediate discomfort of getting poked in the arm and a range of annoying reactions."

Within three to four days, a red itchy bump develops, followed by a larger blister filled with pus. In the second week, the blister dries and turns into a scab that usually falls off in the third week. During the three weeks, many people experience flu-like symptoms " aches, fever, lethargy " and terrible itchiness.

"You can't scratch it; it's all bandaged up; all I could do was smack it," said Meg Gifford, a University of Maryland junior who participated in one study. For a weekend, she was "pretty miserable," suffering from a slight fever, an arm that was hot to the touch and swollen lymph nodes in her armpit.

At the University of Rochester Medical Center, researcher John Treanor saw a wide range of reactions, from a small rash to swelling the size of a grapefruit. About 5 percent of the 170 participants had rashes that spread to other parts of the body. It took time and experience, he said, for the team to get comfortable with the natural course of the vaccine.

"The reactions we are seeing are totally out of line with today's vaccine experience and absolutely in line with historical experience," said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. "In the 30 years since we had routine vaccination, the public's tolerance level has gone way down."

Maryland researchers have begun a second trial revaccinating older adults to see how much immunity stays in the system. Early indications are that people who have been previously inoculated do not suffer as many severe side effects. "I had a small red mark and that was about it," said Edward Dudley, 33.

Very few of today's physicians have administered the vaccine or treated its side effects. Even at the CDC, where health experts work with an array of germs, smallpox vaccinations were briefly halted when 10 people had serious enough reactions to begin antibiotics, said Walter Orenstein, director of the CDC's National Immunization Program.

"The clinic physician couldn't decide if this was a normal, primary exuberant take or a bacterial infection," he said. He added that, in fact, the swollen, itchy, red arms were routine.

As a first-year medical student 33 years ago, Orenstein was so alarmed by the fever, swollen glands and red streak up his arm after he was vaccinated that he went to the emergency room for antibiotics. "I respect this vaccine," he said.

If Bush moves forward with vaccination, Edwards warns doctors to expect the array of unsightly, unfamiliar complications that will come.

"You are going to have to be prepared to see these individuals and to see really bad takes," she told state health officers. "You'll wonder if they are bacterial infections; in some cases the rash will move up the arm and onto the chest. The vaccinee requires a lot of TLC."

© 2002 The Washington Post Company


Government Vaccines- Bad Policy, Bad Medicine

"Simply put, it is not ethical to give a medicine that will kill and maim persons for no demonstrable benefit. Assuaging fears about vulnerability to a potential disease is not a benefit any physician should accept."
Dr. Jeffrey S. Sartin, MD

A controversy over vaccines, specifically the smallpox vaccine, is brewing in Washington. The administration is considering ordering mass inoculations for more than one million military personnel and civilian medical workers, ostensibly to thwart a smallpox outbreak before it occurs. Yet dangerous side-effects from the vaccine- ranging from mild flu symptoms to gangrene, encephalitis, and even death- cause many to question the wisdom and need for such inoculations.

As a medical doctor, I believe mandated smallpox vaccines are bad medicine. The available vaccine poses significant risks, even though the more serious complications affect only a statistically small number of people. As with any medical treatment, these risks must always be balanced against the perceived benefit. Remember, not a single case of smallpox has been reported, despite the near-hysteria that characterized recent news reports. Even if some individuals became infected, smallpox spreads only with very close contact. Those in the surrounding community could then decide to accept vaccines based on a much more tangible risk.

As a legislator, I believe mandated smallpox vaccines are very bad policy. The point is not that smallpox vaccines are necessarily a bad idea, but rather that intimately personal medical decisions should not be made by government. The real issue is individual medical choice. No single person, including the President of the United States, should ever be given the power to make a medical decision for potentially millions of Americans. Freedom over one's physical person is the most basic freedom of all, and people in a free society should be sovereign over their own bodies. When we give government the power to make medical decisions for us, we in essence accept that the state owns our bodies.

The possibility that the federal government could order vaccines is real. Provisions buried in the 500-page homeland security bill give federal health bureaucrats virtually unchecked power to declare health emergencies. Specifically, it gives the Secretary of the Department of Health and Human Services- in my view one of the worst of all federal agencies- power to declare actual or potential bioterrorist emergencies; to administer forced "countermeasures," including vaccines, to individuals or whole groups; and to extend the emergency declaration indefinitely. These provisions mirror those found in the Model Emergency Health Powers Act, a troubling proposal that was rejected by most state legislatures last year. That Act would have given state governors broad powers to suspend civil liberties and declare health emergencies. Yet now we're giving virtually the same power to the Secretary of HHS. Equally troubling is the immunity from civil suit granted to vaccine manufacturers in the homeland security bill, which potentially could leave individuals who get sick from a bad batch of vaccines without legal recourse.

Politics and medicine don't mix. It is simply not the business of government at any level to decide whether you choose to accept a smallpox vaccine or any other medical treatment. Yet decades of federal intervention in health care, including the impact of third-party HMOs created by federal legislation, have weakened the doctor-patient relationship. A free market system would allow doctors and patients to make their own decisions about smallpox inoculations, without the federal government hoarding, mandating, nor prohibiting the vaccine. Instead, we're moving quickly toward the day when government controls not only what vaccines patients receive, but what kind of health care they receive at all.