ederal
officials said yesterday that they might now have access to much more
smallpox vaccine than had been thought, a finding that many said changed
their options in responding to a terrorist attack with smallpox.
The 15.4 million doses in a government stockpile can be diluted with
confidence fivefold without losing potency. In addition, a drug company,
Aventis Pasteur, said it had more than
85 million doses of vaccine, which has been stored, frozen, for decades.
An official of the company said in an interview that tests showed that
the vaccine was still effective. Other tests are under way to see if it
too can be stretched to cover more people. [Page A19.]
The existence of the Aventis stockpile was reported yesterday in The
Washington Post.
Most health officials are not advocating resumption of mass
vaccination against smallpox, because the vaccine itself can kill and
cause injuries, including brain damage. But the disclosure that vaccine
supplies are more abundant than had been thought is likely to reignite
the debate about how the government should prepare for what most
consider the remote possibility of a terrorist attack involving
smallpox.
Richard J. Markham, chief executive for the American operations of
Aventis Pharma, the parent company of Aventis Pasteur, said in an
interview yesterday that the company had told the Department of Health
and Human Services about its vaccine stockpile years ago but that the
government had shown little interest until after the terrorist attacks
last fall. Federal officials, who spoke on condition of anonymity, said
the government began negotiations with the company about the stockpile
in October but did not disclose its existence because of national
security concerns, legal issues and questions about whether the vaccine
was effective.
In a news conference conducted by telephone yesterday, Tommy G.
Thompson, the secretary of the Department of Health and Human Services,
deflected questions about the Aventis vaccine and the negotiations with
the company. Mr. Thompson said he would provide more information today,
but added, "We expect this to turn out to be more good news."
Routine vaccination against smallpox, a highly infectious viral
disease that killed about a third of those who contracted it, was
abandoned in the United States in 1972 and the disease was declared
eradicated from the world in 1980. The only two official stocks of the
virus are held by Russia and the United States. But many experts on
terrorism say it is possible that stocks of the virus may exist in other
hands.
Because much of the world's population has not been vaccinated
against the disease and because the immunity from vaccination is
believed to wane, the release of the smallpox virus could be
catastrophic.
The Centers for Disease Control and Prevention announced months ago
that if an outbreak occurred it would isolate infected people and
vaccinate those who had come in contact with them. This tactic, ring
vaccination, was used by the centers and the World Health Organization
to eradicate the disease. The smallpox vaccine is expected to protect
people if it is given in the first four days after they are exposed to
the virus.
But some medical experts call for a national dialogue on the best way
to prepare for a possible smallpox outbreak that was spread by
terrorists.
In an editorial in a forthcoming issue of The New England Journal of
Medicine, made public yesterday, Dr. Anthony Fauci, the director of the
National Institute of Allergy and Infectious Diseases, said there was
"considerable skepticism" about the C.D.C.'s plan, despite what he
called the soundness of its approach and its success in the past.
"I would like to hear it debated," Dr. Fauci said in an interview,
perhaps in Congressional hearings or even in televised town meetings.
"A decision about what your approach is going to be should be done in
a way that the American public can understand why those decisions are
going to be made," he said.
"You want to have that kind of discussion in the absence of the
horror that accompanies an ongoing attack," Dr. Fauci said.
In the same issue of the medical journal, which released the articles
early citing the widespread interest in smallpox, Dr. William J.
Bicknell of Boston University School of Public Health, criticized the
ring vaccination approach, saying it is based on optimistic assumptions
about how fast the virus would spread and how the public would respond.
"An epidemic is highly likely to outrun the vaccinators," Dr.
Bicknell wrote. "Effective enforcement of quarantine is also difficult.
Official reassurances followed by further uncontrolled outbreaks could
provoke panic, flouting of authority and even the breakdown of medical
and public health services."
But even critics of the disease control agency's plan are not
necessarily advocating a return to mass vaccinations. The chances of a
smallpox attack are generally deemed to be low, and the vaccine can have
severe, even lethal, side effects.
While these reactions are rare — one to two out of every million
people vaccinated die and a few hundred out of every million have severe
reactions, a number that is high enough to cause health experts to
question the wisdom of mass vaccinations.
"If there were absolutely no toxicity whatsoever to the smallpox
vaccine, there would be very little debate," Dr. Fauci said at a news
conference on yesterday. "We could eliminate the threat of a smallpox
bioterrorism attack."
Writing for the April 25 issue of The New England Journal of
Medicine, Dr. Fauci, Dr. Jeffrey M. Drazen, the journal's editor, and
Dr. Bicknell urge the public to consider agonizing choices: Voluntarily
immunize everyone with a vaccine that could kill about 200 Americans,
leave some alive but brain damaged, and disfigure others with deep and
permanent scars. Or save the vaccine for an attack and use ring
vaccination and assume it would contain the epidemic.
Some experts, like Dr. Jonathan B. Tucker, author of "Scourge: The
Once and Future threat of Smallpox" (Atlantic Monthly Press, 2001), said
they would like to see more information on how real the bioterrorist
threat was.
Dr. John Modlin, who heads a committee of experts that advises the
disease control agency on immunization, said the group was considering
who should have access to the vaccine and expected to discuss the issue
and possibly make recommendations at a meeting in June.
Dr. Modlin said he expected that his group would not recommend
vaccinating everyone because the vaccine was so risky. The most
difficult question, he said, was deciding if some people should be
offered the vaccine because they would help in an emergency.
"In some parts of the country state and local health officials feel
strongly that their first responders should be immunized," Dr. Modlin
said. "At the federal level, officials want to keep those numbers
small."
It would be difficult to identify those who should be vaccinated, he
said, adding: "The more we immunize, the more we increase the likelihood
of adverse events. If we immunize tens or hundreds of thousands there
will be serious adverse events, possibly even deaths. The question is
whether that is good public health policy." The C.D.C. usually accepts
the committee's recommendations but in this case, Dr. Modlin said, the
final decision might be made by Mr. Thompson or President Bush.
Dr. Jeffrey Hunker, a national security expert who is dean of the
Heinz School of Public Policy and Management at Carnegie Mellon
University, said he did not envy the person who had to make the final
decision about the smallpox vaccine.
"It may in fact be our best choice to vaccinate everybody, but the
fact is that you are literally going to have poster children who are
dying from the vaccination," Dr. Hunter said. "This presents one of the
most difficult public policy choices anyone is ever going to have to
face."