Smallpox vaccine side effects catch doctors by surprise

By Ceci Connolly / The Washington Post
http://www.detnews.com/2002/health/0212/05/health-28078.htm
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 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 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 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 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 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, ãCan 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 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
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 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 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, 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."