June 25, 2003
CHICAGO (AP) -- Heart muscle inflammation should be
added to the list of serious but uncommon side effects
linked to smallpox shots, a U.S. military study found.
The study details 18 cases of probable
myopericarditis out of 230,734 military personnel
vaccinated between December 2002 and mid-March. The rate
is more than triple the expected rate in nonvaccinated
people and translates to at least 78 cases per million
people.
Updated figures show 37 cases out of 450,293 military
people vaccinated through May 28, a similar rate.
All patients recovered and are being evaluated to see
whether there are any lasting effects on the heart.
The other known side effects from smallpox shots may
include soreness at the injection site, fever and muscle
aches. Less common but more serious reactions include a
widespread skin rash, and -- rarely -- encephalitis, an
inflammation of the brain. Government data show only one
civilian and one military case of encephalitis were
reported through May.
A federal advisory panel last week recommended
against expanding the civilian smallpox program to
millions of emergency workers because of concerns about
heart inflammation. The panel cited at least 18
suspected cases among some 37,000 civilian health care
workers vaccinated so far.
The military study appears in Wednesday's Journal of
the American Medical Association.
It is one of several published in JAMA detailing
otherwise generally positive results from the military
and civilian smallpox immunization programs.
The studies found that serious side effects are
uncommon; one suggests they are rare even in some people
with immune system problems.
"The really important news is that it is possible to
conduct a mass smallpox vaccination in a safe and
effective manner," said Dr. William Winkenwerder Jr.,
assistant secretary of defense for health affairs.
A JAMA editorial says the studies help alleviate
concerns that surfaced when the government began
smallpox programs for the military and some health care
workers as part of terrorism preparedness efforts.
Routine smallpox immunization in the United States ended
in 1972.
Some experts had worried that the current U.S.
population might be more vulnerable to side effects from
the vaccine than people before 1972 because of increases
in immune-compromising conditions such as AIDS.
"The observation that this smallpox vaccine can be
administered safely in a 21st century population with a
very low adverse-event rate is a critically important
piece of new information," Drs. Anthony Fauci and Mary
Wright of the National Institute of Allergy and
Infectious Diseases said in the editorial.
The overall rate of side effects in the military was
largely below the rates reported before 1972, one of the
studies found.
Myopericarditis causes inflammation of the heart
muscle and the fibrous tissue that envelops the heart.
The ailment probably occurred during smallpox
vaccination in the 1960s, too, but was underrecognized
because diagnostic technology was less sophisticated,
military officials say.
Eight other heart-related events occurred shortly
after vaccination in the military program, including
four heart attacks, one of them fatal.
While military doctors think those were not related
to the vaccine, the risk prompted government officials
to recommend against giving the shots to people with
heart conditions or strong risks of heart disease.
Copyright 2003 The Associated Press. All rights
reserved.