With Sudden Increase in Supply, U.S. Is Reevaluating Inoculation Policy
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