posted 07-10-2002 09:17 PM               

Volunteers Undergo Vaccine Trials

ASSOCIATED PRESS

SAN FRANCISCO- With the jab of a needle, volunteers are being injected with a smallpox vaccine as part of government-sponsored experiments that come amid heightened fear of biological terrorism.

About 330 volunteers will be inoculated with diluted doses of the vaccine over the next two weeks at four sites across the nation.

On Monday, the Oakland Medical Center began vaccinating 50 volunteers. Researchers will test two vaccines. One, known as Dryvax, was made 20 years ago and consists of 15 million doses.

The other is more than 70 million doses that Aventis Pasteur Inc. donated to the government, which now must determine whether the vaccines are still useable.

For decades, Aventis' doses sat nearly unnoticed in a walk-in freezer at a remote mountainside lab in Pennsylvania.

The firm thought the contents of their freezer were so worthless they were planning to destroy the stockpile.

Then came Sept. 11 and the ensuing anthrax attacks. Suddenly the nation's available supply of vaccine for smallpox, a disease that had been declared eradicated worldwide in 1980, was deemed crucial.

"In the past year, I think we've all become more aware of the possibility of a bioterrorist attack in the United States," said Steve Black, co-director of the Vaccine Research Center at Oakland Medical Center. "I hope we never need to use this vaccine again, but it's important to make certain that if we do it will be available and it will work," Black said. "If we can show that this vaccine stock is still effective, it will go a long way toward making a dose of smallpox vaccine available for everyone in the U.S."

Volunteers have already begun receiving the vaccine at Vanderbilt University in Nashville, Tenn., and the University of Iowa. Baylor College of Medicine, in Houston, also is enrolling volunteers.

Results are expected by mid-August. The tests are part of a $12.6 million National Institutes of Health grant awarded last year to Vanderbilt, which is overseeing the experiment and will enroll about 90 volunteers of its own.

Federal officials at the Centers for Disease Control and Prevention now are considering vaccinating as many as 500,000 health care workers and emergency personnel who would be first to see any smallpox cases. Because the vaccine carries significant risks - including death - officials do not want to resume mass vaccinations.

Bioterrorism experts consider the possibility of a smallpox attack one of the most frightening, albeit unlikely, threats because one infected patient could infect many others. Health workers will inject the vaccine, the area will be bandaged and the area will be checked.

Subsequent blood tests will determine whether the test subjects develop the antibodies needed to fight off the disease.

Two studies released in March by The New England Journal of Medicine found that out of the 700 previously unvaccinated young adults who received some of the Dryvax vaccine, one-third had pain bad enough to miss school, work or other activities after being inoculated. While no one in the study fell seriously ill, some experienced fever, headache, nausea, muscle aches, lesions and swelling.
http://www.lasvegassun.com/sunbin/stories/thrive/2002/jul/09/070903481.html

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July 08, 2002

Feds Prepare for Smallpox Quarantine

ASSOCIATED PRESSATLANTA- Federal health officials are quietly making plans for quarantining Americans who might be exposed to a highly contagious smallpox patient, addressing sensitive questions of how to hold people, possibly against their will, in case of a bioterror attack.

The planning, still in draft form, addresses complex logistical and policy questions, including where people would be kept while waiting for officials to confirm a smallpox case and, if necessary, administer vaccinations.

"It's not pretty to think through these type of doomsday scenarios, but it's important to start to put yourself there and imagine things unfolding if you want to anticipate how to react," said Dr. Marty Cetron, a quarantine expert at the Centers for Disease Control and Prevention.

Within the next few weeks, the plan will be circulated among top federal officials and others involved in the preparation, said Cetron, who co-chairs a CDC working group on the issue.

The group began with this scenario: Officials get word that an international flight is headed for the United States with a smallpox-infected passenger aboard.

The case would be fairly easy because the people would be in one place and health officials wouldn't have to track them down.

Still, if the passengers weren't held for treatment, CDC experts estimate that a plane filled with 500 people including one with smallpox could result in dozens - maybe hundreds - of sick people, including passengers on the plane who got sick and the people they would infect.

The vaccine is only effective within four days of someone being exposed to smallpox, so if people leave the scene it would be difficult to find them in time.

Under the plan, officials would stress that people would be better off staying in quarantine because that's where the vaccine and other medications would be available.

That's a big change from past centuries, when people in quarantine were written off, Cetron said. "All the goodies will be delivered inside the box," he said. "It's a fundamental difference to spend as much, if not more attention, on monitoring and preserving the health on the people inside the box."

Once planning is complete for this scenario, the CDC group plans to tackle more complicated situations, such as a smallpox patient in a sports stadium or an infected person wandering through an airport.

Smallpox was declared eradicated in 1980, but samples of the deadly virus still exist in both the United States and Russia. Bioterrorism experts consider the possibility of a smallpox attack one of the most frightening, albeit unlikely, threats because one infected patient could infect many others.

Routine immunizations against smallpox in the United States ended in 1972, meaning many Americans have no protection against the disease.

Federal officials are now considering vaccinating as many as 500,000 health care workers and emergency personnel who would be first to see any smallpox case.

But because the vaccine carries significant risks, including death, officials do not want to resume mass vaccinations - a point President Bush made Monday.

"I worry about calling for a national vaccination program and that it could cause a loss of life," Bush said at a White House news conference.

Rather, the plan is to vaccinate others only if they are exposed to the virus, or exposed to someone who is exposed. Another alternative - one endorsed Monday in a study in the Proceedings of the National Academy of Sciences - would be mass vaccinating all Americans if a smallpox case emerged.

The authors of that study predicted significantly fewer people would die using a mass vaccination strategy.

The airliner scenario is not entirely fictitious. In December, a flight from Taiwan bound for Newark, N.J., was delayed for about four hours in Seattle after an anonymous tipster told U.S. Customs Service agents that a passenger had smallpox. It turned out to be a hoax, but the situation provided a real-life example of how people on the plane reacted.

"People got really scared because they sat there on a plane for two hours without any idea what was going on," said Kristy Lillibridge, an epidemiologist who is part of the CDC working group.

The draft CDC plan calls for taking the airplane to a hangar or another facility where passengers can get off without going into the airport, she said. The suspicious passenger would be isolated from the others, but everyone would be kept in quarantine while officials did tests to determine if the passenger was in fact infected with smallpox.

Still unresolved: how long to keep people if a smallpox exposure is confirmed. Options include one to two days, or long enough to give the shots; seven days, long enough to see if the vaccination worked; or 17 days, when no one would be contagious anymore. "It is such a sensitive topic. Those kinds of decisions, to actually use a quarantine, will be made at very high levels," Cetron said.