Smallpox vaccine side effects
catch doctors by surprise
by Ceci Connolly, Washington Post, December 5, 2002
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As physical specimens, the Baylor University students were fit
and healthy, the "creme de la creme," in the words of
researcher Kathy Edwards. Yet when she inoculated them with
smallpox vaccine, arms swelled, temperatures spiked and panic
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 people had high fevers and several were put
on antibiotics because physicians worried that their blisters
signaled a serious 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
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 itself.
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 up to
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
"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, ăCan you just chop off
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 Iraq, Osama bin Laden and other terrorists 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 excema or weakened immune systems should not
receive the vaccine.
Federal health officials have proposed resuming vaccination in
stages, beginning with up to 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 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 have 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 literally "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
"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 one 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 practicing physicians have administered
the vaccine or treated its side effects. Even at the CDC,
where health experts work daily 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 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,
explaining that, in fact, the swollen, itchy, red arms were
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, as expected, 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."