Aventis to Donate
Smallpox Vaccine
With Sudden Increase in Supply, U.S. Is
Reevaluating Inoculation Policy
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By Ceci Connolly
Washington Post Staff Writer
Saturday, March 30, 2002; Page A02
Vaccine-maker Aventis Pasteur announced yesterday it will donate about 85
million doses of 40-year-old smallpox vaccine to the federal government, as
top administration officials reassessed whether to develop a mass
inoculation plan for the United States.
After five months of secret negotiations, the French vaccine-maker and
the Department of Health and Human Services confirmed that the company is
giving its stores of vaccine to the government at no charge, dramatically
increasing the nation's supply at a time of mounting anxiety over a
biological attack.
"This is just a huge insurance policy," said HHS Secretary Tommy G.
Thompson. By year's end, America will have at least 286 million doses of
vaccine, he said. Aides said later that figure could be as high as 711
million doses, depending on how well the Aventis vaccine can be diluted.
In the wake of the Sept. 11 hijackings and the anthrax attacks last fall,
federal leaders have been rushing to buttress the nation's biodefenses.
Although they stress that the likelihood of a smallpox attack remains low,
the highly contagious nature of the often fatal disease makes it a grave
threat.
Current policy calls for stockpiling smallpox vaccine and tapping that
reserve only if an outbreak occurs. Once a case was confirmed in a
community, public health officials would descend there, isolating the
patient and vaccinating in "rings," beginning with people closest to the
exposure.
But facing growing public pressure -- and with the much larger supply of
vaccine suddenly available -- the Bush administration is reevaluating that
position.
Vice President Cheney, Homeland Security Director Tom Ridge and Pentagon
officials have been "developing protocols" for who should be inoculated
when, Thompson said. A task force at the Centers for Disease Control and
Prevention will convene a conference in early May to consider the issue and
make recommendations.
Smallpox inoculation was routine in this country until the mid-1970s,
when the deadly disease was eradicated here. Some health experts are
reluctant to reinstitute a vaccination program because the vaccine can cause
dangerous, potentially fatal side effects in relatively rare instances. If
the entire nation were vaccinated, scientists estimated, up to 400 people
would die from the vaccine's side effects.
D.A. Henderson, a Baltimore physician who led the smallpox eradication
effort and now runs the federal Office of Public Health Preparedness, said
that because the vaccine is effective within four days of exposure and
because the current threat of a smallpox attack is low, the risks of
vaccination may outweigh the benefits.
And because the shot leaves a scab, the live virus from which the vaccine
is made can be transmitted from one person to another, posing particular
risk to people with weak immune systems. "This isn't just a personal choice,
it's a societal choice," Henderson said.
Many physicians, emergency response personnel and citizens argue that a
crisis would be the worst time to implement a complicated, massive
vaccination program.
"An epidemic is highly likely to outrun the vaccinators," William
Bicknell, a physician at Boston University School of Public Health, wrote in
an article released this week by the New England Journal of Medicine.
Although he has known about the Aventis stockpile for months, Thompson
only acknowledged it this week, after its existence was reported by The
Washington Post. Thompson said the vaccine was kept secret until officials
could determine whether it was still good, which tests have indicated is the
case. "There was no sense heightening expectations of the American people"
if the vaccine did not pass muster, he said.
Some in the federal government have known about the stocks for years,
said Richard Markham, chief executive officer of Aventis Pharma. "The
vaccine was never lost," Markham said. "It's just that it was unimportant
until last fall."
The vaccine had been stored frozen in two-liter bottles in a warehouse at
the company's U.S. subsidiary in Swiftwater, Pa. Over the past two decades,
Aventis officials have periodically considered destroying the vaccine and
regularly consulted with the government on that question. When the anthrax
attacks occurred, Aventis called again.
Soon thereafter, the vaccine was transferred to vials and moved to a
secure location. One source in Pennsylvania said a military convoy escorted
the material to the Tobyhanna Army Depot near the Pocono Mountains.
The Aventis vaccine is similar to 15.4 million doses of a smallpox
vaccine known as Dryvax, produced by Wyeth Pharmaceuticals, that are already
in the government's possession. Both vaccines were grown from the same seed
stock, and both were made using calf skins.
On Thursday, federal researchers announced that the Dryvax vaccine can be
safely diluted fivefold, meaning those stocks could be used to vaccinate
many more people. Yesterday, Thompson and Henderson predicted that the
Aventis vaccine will be equally potent.
"All indications are it is as safe and effective as the 15.4 million
doses we have now," Thompson said. Over the next six to eight weeks, the
National Institutes of Health will conduct clinical trials on the Aventis
vaccine and then perform dilution tests. Aventis, which is still finalizing
the agreement, estimates that its vaccine is worth $150 million.
HHS also recently signed agreements with Acambis Inc. and Baxter
International Inc. to buy by the end of this year a total of 209 million
doses of a newer vaccine that is grown on tissue cell culture.
© 2002 The Washington Post Compa
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