Wall Street Journal - March 29, 2002
Sarah Lueck, Staff Reporter of The Wall Street Journal

Officials from Aventis Pasteur, a unit of France's Aventis Co., confirmed they had a found 85 million doses of smallpox vaccine in a freezer at the company's Pennsylvania plant. On top of that discovery, researchers announced Thursday that the 15.4 million doses of smallpox vaccine the U.S. has on hand can be diluted and yet remain effective, increasing them to 74 million doses.

Health and Human Services officials are moving rapidly toward their goal of having enough vaccine available to protect every man, woman and child in the U.S. The Aventis vaccine that was found is still being tested for effectiveness, but HHS officials said initial results have been positive and they are viewing it as an "insurance policy" if there were an attack by terrorists. The company and the government are in contract negotiations.

Richard Markham, chief executive of Aventis Pasteur's parent, Aventis Pharma, said the company contacted officials at the Centers for Disease Control and Prevention and the Food and Drug Administration in the 1990s about the stores of smallpox vaccine they discovered in a freezer at the company's Swiftwater, Pa., plant. The doses, stored in 60 two-liter bottles and now transferred to smaller vials and stored in a secret location, probably date back to the 1950s, when the U.S. was still routinely vaccinating the population.

In the 1990s, Aventis was discussing with the federal agencies, which are part of HHS, whether to destroy the smallpox vaccine doses and how to do so, Mr. Markham said. In October, after the anthrax attacks raised concerns about preparedness for bioterrorism, Aventis reminded FDA about the doses, Mr. Markham said. They didn't want to go public with the doses they had until they had been tested for effectiveness, he said.

Friday, HHS and company officials plan to release more details about the discovery, which was reported in the Washington Post.

In the dilution study, which was funded by the National Institutes of Health and appears in the April 25 issue of the New England Journal of Medicine, 600 volunteers received varying strengths of vaccine: undiluted, a one-fifth dilution and a one-tenth dilution. The diluted doses had the same effectiveness as the undiluted vaccine, but researchers are more confident of the one-fifth dilution.

"We are extremely pleased with the results of this study," HHS Secretary Tommy Thompson said.

Officials say the risk of a smallpox attack is very low. But as the stockpile has grown, health officials, emergency workers and the general public have begun to wonder whether they should be able to choose to be protected before an attack occurs.

Current federal policy calls for "ring vaccination" in the event of a smallpox outbreak, in which those exposed to the deadly virus would be isolated and vaccinated, with vaccine then being given to their closest contacts and later to that group's contacts. The smallpox vaccine can offer protection to someone already exposed to the disease, for as long as four days later.

Some health experts question whether ring vaccination would be sufficient in a large-scale outbreak. In an editorial appearing in the April 25 issue of the New England Journal of Medicine, Bill Bicknell of the Boston University School of Public Health argues that vaccination of the U.S. population would be an important deterrent to terrorists. He suggests that when the vaccine supply is sufficient, emergency personnel and health workers that would deal with an attack should be vaccinated and monitored for adverse reactions. Then, the government should allow members of the public to volunteer to receive it, he said.

Federal officials say they are trying to balance the possible threat of a smallpox outbreak with the very real risks of the vaccine itself, which is made from live vaccinia virus. The vaccine can cause severe illness, including a vaccinia infection or encephalitis, and would be fatal to an estimated one to two people out of every million vaccinated.

Even if they aren't vaccinated, people with suppressed immune systems, such as from HIV or organ transplants, could be in danger of contracting vaccinia infections merely from contact with vaccinated individuals. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said policy makers need to keep an open mind about the country's smallpox vaccination strategy. He suggested town meetings to inform the public about the issue and congressional hearings.

"People are asking why aren't we vaccinating first-responders, vaccinating people on demand," Dr. Fauci said. "I'm not contradicting the CDC policy of ring vaccination. But there needs to be an open, transparent discussion about it."

HHS officials, as well as those in the Office of Homeland Security, already have begun discussing whether to give preoutbreak vaccinations; who should get them; and how such an operation could be carried out. A working group of government and nongovernment experts plans to discuss the issue.

-- Marilyn Chase in San Francisco contributed to this article.

Write to Sarah Lueck at sarah.lueck@wsj.com

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