Panel
Leery of Mass Smallpox Doses
Major Risks Outweigh Benefits of Immunizing the
General Public, Experts Say
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By David Brown
Washington Post Staff Writer
Friday, October 18, 2002; Page A02
ATLANTA, Oct. 17 -- Among members of the main scientific committee that
provides advice to the federal government on the use of vaccines, there is
little or no support for the idea of making smallpox vaccine available to
the general public.
While the Advisory Committee on Immunization Practices (ACIP) did not
formally consider that issue in its two-day meeting here, general discussion
and interviews with most of its members found overwhelming opposition to
making the smallpox vaccine available to the general public.
The vaccine has not been widely available in 30 years. Smallpox was
eradicated in 1978, although the virus that causes it exists in several
laboratory freezers -- and possibly in the hands of terrorist groups or
hostile nations.
Two weeks ago, three top Health and Human Services Department officials
said they favored eventually making the vaccine available to citizens who
want it.
But, concerned about the vaccine's risks, many committee members said
they would recommend against that.
"I think it's a mistake," said Paul A. Offit, chief of infectious
diseases at the Children's Hospital of Philadelphia and one of 13 appointed
members of the committee, most of them academic physicians. "I think we
don't help the public if we say, 'You can be immunized. It's up to you.' "
"My personal view . . . is that that is not the appropriate thing at this
time," said John F. Modlin, a professor at Dartmouth Medical School and the
committee's chairman.
"I don't think that we're ready for that," said Myron J. Levin, a vaccine
specialist at the University of Colorado School of Medicine. "Do they know
something that I don't know?"
Although posed rhetorically, Levin's question is the crucial one. If the
answer is "yes" and the "something" that policymakers know is that a rogue
nation indisputably possesses smallpox virus, then widespread immunization
becomes much more attractive, many committee members said.
The panel endorsed a plan at this meeting that would lead to the
vaccination of as many as 500,000 health care workers in thousands of U.S.
hospitals who would care for any victims in an outbreak. It rejected, at
least for the moment, the proposal to vaccinate 7 million to 10 million
people, mostly health care workers and emergency "first responders."
Smallpox vaccine consists of a weakened form of a live microbe called
vaccinia, which is related to smallpox virus and stimulates immunity to it.
In about one-third of recipients the vaccine causes an inflamed arm and
fever. In people with compromised immune systems (such as those undergoing
cancer chemotherapy) it occasionally causes life-threatening, whole body
infections.
Even the more limited plan will require putting in place an elaborate
system to screen out people who may be hurt by the smallpox vaccine, collect
data on side effects, rapidly identify severe complications, and distribute
the two drugs (cidofovir and vaccinia immune globulin) used to treat them.
Many ACIP members said the government would do well to gain experience from
a limited program before considering wider use of the vaccine -- assuming
that a smallpox attack is not imminent.
Donald A. Henderson, the former head of the global smallpox eradication
campaign and now the Bush administration's main adviser on smallpox matters,
told the committee that the risk of the disease's reappearance is no
different now from what it was when the panel last met, in June.
"The risk as appraised is a small one. It is not zero, and that is the
worrisome piece," Henderson said.
The list of legal and logistical problems facing even a limited vaccine
campaign is long. A big one is liability for damages.
Persons or entities that might face lawsuits include the drug companies
that produce the vaccine; the federal government, which will own all of it;
state health departments, which will oversee its distribution; hospitals
that employ the health care workers who volunteer to get it; manufacturers
of the bandages designed to limit the spread of vaccinia virus from a
person's arm; doctors and nurses who provide advice to vaccine recipients,
who will be instructed to call a national hotline if they have side effects;
and the recipients themselves, a few of whom may inadvertently transmit the
virus to other people who subsequently suffer complications.
The committee was instructed to ignore this issue in reaching its
judgments. But it could not entirely avoid thinking about it.
"We have been assured by people in DHHS that they realize this is a very
important issue. They are dealing with these . . . issues. Nobody has given
us any details," Dixie E. Snider, Jr., an associate director of the Centers
for Disease Control and Prevention and the committee's secretary, said in
response to a question.
If a smallpox vaccination campaign runs into unexpected problems, the
damage could be more than just monetary, numerous members observed.
Government credibility and confidence in the medical system could also be
eroded.
"If we were to have, say, 10 deaths, I am concerned not only that it
would impugn the smallpox program but all the immunization and vaccination
programs," Levin said. "They are really the flower of medical science in
this country and the whole thing could be affected."
If citizens suffer complications from smallpox vaccine even after
choosing to take it, "trust me, they'll blame us," said Bonnie M. Word, a
committee member and pediatrician in private practice in New Jersey.
"They'll blame the government."
© 2002 The Washington Post Company
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