Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: THURSDAY, November 25, 1993 TAG: 9311260039
SECTION: NATL/INTL PAGE: A-27 EDITION: HOLIDAY
SOURCE: Newsday
DATELINE: LENGTH: Medium
The potential vaccines had seemed to work against special strains of the AIDS virus cultivated in the laboratory. But in recent tests, all but one of the vaccines failed to stimulate immune responses against real-life strains of the virus. The exception, a vaccine developed by United Biomedical Inc. of Hauppauge, N.Y., has been shown to work in only one person so far, with promising but incomplete results in two others.
"Only the UBI people have reported that result," said Dani Bolognesi, director of the Center for AIDS Research at Duke University Medical Center. "That needs to be confirmed." Bolognesi said his center will now test UBI's vaccine.
"It makes sense to pause," said Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, in explaining his agency's decision not to begin large-scale tests now. "My first responsibility is to the health of the American people."
Fauci said his agency and the vaccine manufacturers will determine whether the fault lies with the testing technology or with the vaccines themselves.
"A lot of labs are trying to sort this out, but until we have the data we can't say," said Bolognesi, whose research center will test all government-sponsored experimental AIDS vaccines. "I'm very encouraged by the number of people attacking this problem. We'll work hard to determine if this is a snag that can be unraveled so that we can get back on course."
To that end, government and company scientists will confer and come up with plans to retest the vaccines and the assays, the measures used to assess their effectiveness.
The agency has said it will reconsider the testing situation this spring, when it has more data. But the delay has upset the dwindling group of U.S. vaccine makers, who wanted to start big, government-sponsored tests early in 1994.
"To delay the start of those trials after we have major commitments would be viewed as a major disincentive for the company," said Genentech's AIDS vaccine chief Jack Obijeski. Such statements make researchers fear that companies will curtail or even abandon expensive AIDS vaccine research and development.
The big South San Francisco biotech company already has pumped about $100 million into AIDS vaccine development, Obijeski said, and has more than 200,000 doses of its genetically engineered AIDS vaccine ready to go. Obijeski said numerous other projects could offer Genentech better returns with fewer potential liability problems than the AIDS vaccine.
"You can't wait forever for the lab people to find out everything," Obijeski said, "because 5,000 more people worldwide become infected with the AIDS virus every day."
In these tests, thousands of noninfected volunteers from high-risk groups would be vaccinated. Researchers would test their immune responses and would wait to see, over time, whether they were less likely to get infected than a similar group that got no vaccine. The tests would be sponsored by NIAID, which runs the federal vaccine-research effort.
by CNB