Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
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San Francisco Examiner, Tuesday, March 16, 1999
Eric Rosenberg, Examiner Washington Bureau
Burke made progress but knew he needed the financial backing and laboratory firepower of a pharmaceutical manufacturer in order to succeed.
"I went to all the major companies that were involved in AIDS work at the time," said Burke, now director of the university's Center for Immunization Research. "I couldn't get anybody interested, and I was shocked."
Burke's experience highlights the fact that, with a few exceptions, the pharmaceutical industry has been reluctant to commit resources toward such a goal, despite worldwide demand for a vaccine to protect against a disease that afflicts 35 million people and infects 16,000 more people daily.
Instead, according to the Pharmaceutical Research and Manufacturers of America, a trade organization that represents prescription drug makers, companies are sinking research dollars into 101 new treatments for people infected with HIV.
These include new classes of antiviral drugs to suppress HIV once a person is infected, medications to fight AIDS-related diseases such as Kaposi's sarcoma and drugs to fend off opportunistic infections that attack when the immune system is suppressed by the virus.
Although President Clinton has made development of an AIDS vaccine a top priority, and Congress has budgeted nearly $200 million this year alone for the effort, companies are investing in only 12 experimental vaccine proposals.
Nearly 20 years after the disease erupted, only one AIDS vaccine has received Food and Drug Administration approval for widespread human testing. That vaccine is under development by VaxGen, a small, 52-employee biotechnology firm in South San Francisco.
Five major manufacturers
More than 90 percent of the world's vaccines against other diseases are produced by five companies: Merck & Co., of Whitehouse Station, N.J.; SmithKline Beecham and Wyeth-Lederle of Philadelphia; Pasteur Merieux Connaught of Swiftwater, Pa.; and Chiron Corp. of Emeryville.
All are involved to varying degrees in AIDS vaccine research. For example, SmithKline Beecham has only a small AIDS vaccine effort under way. "At this point, it's not one of the major efforts in our vaccine programs," said Richard Koenig, a SmithKline spokesman.
Pasteur, on the other hand, has aggressively pursued an experimental vaccine that is nearing government approval for a large-scale human study.
Other companies started but then curtailed AIDS vaccine programs. They include Bristol-Myers Squibb, British Biotech and Immuno AG.
Nothing else in the works
Dr. Donald Francis, president of VaxGen and a former AIDS specialist at the federal Centers for Disease Control and Prevention, said that if VaxGen and Pasteur failed, "There's nothing five years behind us. That's it in the AIDS vaccine field."
Lagging science and drug economics are the two considerations underlying the modest corporate interest in AIDS vaccines.
Scientists have made strides unlocking the mysteries of how the virus operates after it infects a person. While the knowledge has been key to making new drugs that slow or halt the disease's deadly progression, it doesn't point to the discovery of a vaccine that would render a healthy person immune to HIV.
Dr. Peggy Johnston, assistant director for AIDS vaccines at the National Institute for Allergy and Infectious Diseases, said company officials worried that not enough was known about how HIV worked to warrant a large vaccine investment.
"There are enormous challenges that AIDS presents that are unparalleled compared with other viruses," said Johnston.
For example, HIV is proving more resilient than other viruses. Vaccines typically fend off disease by stimulating the body's production of antibodies, which in turn destroy an invading virus. However, HIV appears to defend itself with a kind of sugar-based shield to fend off antibodies.
Another problem is that different strains of HIV exist in the West, Africa and Asia. So a vaccine to protect against the North American variety might not work against other strains.
The economics of vaccines also are daunting.
The average vaccine costs about $100 million to develop, but because the scientific understanding of HIV is murky, a company could commit the resources and more than a decade of work and still fail to invent a vaccine.
Lousy investment
Even assuming that a company could develop an AIDS vaccine effective against all strains, it still might add up to be a poor investment.
In order to make a profit on vaccines, which are typically priced in the $1 to $5 per shot range, a drug maker must sell millions of inoculations. While industrialized countries could easily afford the price, much of the developing world, which is the largest potential market for an AIDS vaccine, would have difficulty.
The profitability issue is fueling a proposal by the International AIDS Vaccine Initiative (IAVI), an advocacy group based in New York, which is pressing wealthy nations to create a $1 billion AIDS vaccine purchase fund for the Third World, effectively assuring profit to a successful manufacturer.
"We think the fund would provide a very strong incentive for industry," said Victor Zonana, a vice president at IAVI. "The companies would know that in addition to their markets in industrialized countries, they would have a guaranteed paying market in developing countries."
Pharmaceutical executives believe that even with such a fund in place, a vaccine won't be as profitable as AIDS therapeutic drugs, which are taken for a patient's lifetime as opposed to only a few times, as are vaccines.
Francis, the president of VaxGen, is fairly confident that if his company's vaccine works, the firm will turn a profit. "It won't be great profit," he said. "You can bet that."
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