Smallpox vaccination Hazard
Articles in this HTML page:
Hazards Contact Vaccinia
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ProMED-mail posts, [which in turn may cite original sources]
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SMALLPOX VACCINATION HAZARDS (03)
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
(while Jenner was still alive), the problem of keeping live stocks of
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),
"One solution to the problem was to keep the vaccine 'alive' by
transferring it from one human recipient to the next, a practice known
the arm-to-arm technique. First, an individual was vaccinated, and as
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
local orphanage to serve as the source of smallpox vaccine for all
more than a week old. From then on, the orphanage continuously
the vaccine from one child to another for more than ninety-two years
The author goes on to note the hazards of the arm-to-arm method: It
"contaminate the vaccine with dangerous pathogens, resulting in
spread of hepatitis or syphilis. In 1861, for example, 41 Italian
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.
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
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
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
The researchers, led by Dr. John Neff, a former researcher with the
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
The majority of such cases -- a few of which resulted in death --
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
to people with a history of eczema even though they had no active skin
Age distribution of those U.S. cases shows young people are more
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,
to the study.
Most cases happened in the home, with many victims getting the virus
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.
risk needs to be kept in perspective." But they do admit that in this
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.
vaccinated, this group could spread the virus for up to 19 days. Even
who have had a smallpox shot in the past could shed more of the virus
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
in the past 30 years, according to the researchers.
Today there are more people with weak immune systems. The authors
that's likely due to the spread of HIV and wider use of drugs to
the immune system for cancer patients and organ transplant recipients,
example. "Contact vaccinia in this population could be especially
the authors write.
Preparation and a carefully crafted vaccine policy is key to keeping
contact vaccinia under control should mass smallpox vaccinations become
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.
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
Some additional background references:
1: Contact spread of vaccinia from a National Guard
MMWR Morb Mortal Wkly Rep. 1985 Apr 5;34(13):182-3.
2: Smallpox vaccination and contact spread of vaccinia virus. Bull Pan
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,
R, Quillien MC, Chastel C. [Accidental localized vaccinia. A report of
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
6: Grosfeld JC, van Ramshorst AG. Eczema vaccinatum. Report of four
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
8: Lane JM, Millar JD, Neff JM. Smallpox and smallpox vaccination
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.
SMALLPOX VACCINATION STRATEGIES - USA (07)
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
available for consultation at any hour in case of bad reactions to
vaccine, which may be given soon to a half-million hospital workers.
The network would be part of the most comprehensive system ever to
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
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.
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,
when, said Dr. Gina Mootrey, another official at the centers, in
the monitoring plan to a panel advising the government on smallpox
On Wednesday, the advisory panel recommended offering the immunization
an estimated half-million emergency room and other hospital workers
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
risk of developing a severe and potentially fatal illness known as
The panel also recommended not giving smallpox vaccine to anyone who
family or household member with either skin condition because the virus
the vaccine could be transmitted to them.
The panel's chairman, Dr. John F. Modlin of Dartmouth Medical School,
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
are trying to become pregnant, should also not be given the vaccine, the
Modern knowledge about the safety of the vaccine is limited because the
government stopped standard use of smallpox vaccine in 1972 as the
was being eradicated from the world.
Earlier this year, researchers reported that 36.4 percent of volunteers
a study missed school, work, or recreation or had difficulty sleeping
receiving a dose of the smallpox vaccine that was used before smallpox
declared eradicated in 1980.
Individuals with severe reactions might be treated with either of 2
One is vaccinia immune globulin, a drug that is derived from the blood
individuals who have been immunized against smallpox, and is now in
supply. The government owns the only stores.
The other is cidofovir, a drug that experts hope might be effective
vaccinia, the virus in the vaccine that protects against smallpox.
Cidofovir must be injected, is dangerous, and its only approved use is
a different virus.
Another reason for instituting the monitoring system is to maintain
credibility and public confidence, Dr. Mootrey said. Last year during
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
to start discussions with state and territorial health officials on
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
go right and that is a reason to go slowly at first."
Under the monitoring system, each hospital worker will be given a
identification number at the time of vaccination.
The recipients will also receive a telephone hotline number to report
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
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.
turn, about 30 percent of this group will need referrals for more
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
California Kaiser Permanente hospital, Stanford University, and
About 100 recipients are expected to need treatment with vaccinia
globulin, cidofovir, or both.
The disease centers plan to conduct a telephone survey involving 15 000
20 000 vaccine recipients on the tenth and twenty-first days after
[Byline: Lawrence K. Altman]
"Smallpox Vaccination Would Require Close Monitoring"
Reuters Health Information Services (www.reutershealth.com)
(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
should keep the vaccination site covered until the scab separates, but
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
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
A key issue the guidelines addressed was preventing the transmission of
vaccinia virus, the virus used in the vaccine, from healthcare workers
have been vaccinated to those that have not. Vaccinia virus is related
the smallpox virus, but much less dangerous. The virus generally poses
risk to healthy individuals but could be a problem for certain
including those with weakened immune systems.
Between two to six unvaccinated people might contract the virus for
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,
"at least a single layer of impermeable acoustic dressing," until the
However, the committee recommended against the need for healthcare
to be placed on leave after receiving smallpox vaccination unless they
develop symptoms from the vaccination or do not adhere to infection
"Very close contact required for transmission of vaccinia to household
contacts is unlikely to occur in the healthcare setting," Modlin
during the briefing.
ACIP also recommends that healthcare workers with eczema, a type of
allergic skin rash called atopic dermatitis, or other skin conditions
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
risky are included, the vaccine may be contraindicated for up to 10% to
Pregnant healthcare workers, those with HIV/AIDS or other
individuals should not receive the vaccine, but neither routine
testing nor mandatory HIV/AIDS testing is recommended. Female
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.
Orenstein, director of CDC's National Immunization Program, told Reuters
Health that the same kinds of contraindications considered for those
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 (www.nytimes.com) (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
eradication of the disease). There has been much discussion re: the
changed environment (HIV/AIDS, increased population with eczema and
dermatitis, increased people on immunosuppressant medication,
etc.) since vaccination was stopped, with an awareness of an increase in
the numbers of persons at high risk of complications following receipt
As a note, it is interesting that Dr. Modlin gives a range of 7-17
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
of the envelope estimates proposed by Dr. Kemper et al Expected Adverse
Events in a Mass Smallpox Vaccination Campaign Effective Clinical
March/April 2002 [URL below], they estimated that 25 percent of the
population would be excluded from vaccination because of high risk or
possibility of coming in contact with a high-risk individual.
While the plan does address the issue of vaccination of healthcare
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
were born after smallpox vaccination was discontinued (and hence will be
primary vaccinees) combined with today's larger pool of high risk
(with either acquired via infection or have iatrogenically acquired
immunosuppression) may be very risky. In the article by Neff JM, Lane
Fulginiti VA, Henderson DA. Transmission of Vaccinia Virus JAMA 16 Oct
288 /15 (discussed in ProMED-mail posting Smallpox vaccine hazards (02)
20021015.5559) there is mention that "most contacts were in the home,
few patients apparently acquired vaccinia from a recently vaccinated
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
care workers (especially those receiving a primary vaccination) from
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
not know how many HIV infected persons were vaccinated before the
stopped using the vaccine, the prevalence of HIV infection was much
in 1984 than it is today. This last finding raises concerns re:
vaccination of healthcare workers without requiring HIV testing prior to
The above plan as stated will hopefully provide a better data base on
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
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
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
SMALLPOX VACCINE RESULTS ARE IN
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.
AND THIS WAS A POPULATION OF EXTREMELY HEALTHY VOLUNTEERS. YOUNG ADULTS WHO SHOULD
BE AT THE VERY PEAK OF LIFE, WITH THEIR IMMUNE DEFENSES FULLY INTACT.
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
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.
Smallpox shots cause worry
Experts startled by array of side effects
By Ceci Connolly
THE WASHINGTON POST
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
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
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
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
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
RON PAUL'S TEXAS STRAIGHT TALK - A Weekly Column
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."
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.
Dr. Jeffrey S. Sartin, MD
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.