Wall Street Journal - June 1, 1984
Michael Waldholz, Staff Reporter of The Wall Street Journal

Scientists at Merck & Co. said the vaccine, for use against a type of hepatitis, proved completely safe in a study of 37 healthy adults, all Merck employees who volunteered for the test. The report of the study, published in today's Journal of the American Medical Association, said the vaccine produced antibodies against hepatitis B in the test subjects' blood, an indication the vaccine would protect against the illness.

The new vaccine is the first of what is expected to be a host of vaccines produced through biotechnology. Vaccines against herpes, malaria, gonorrhea and other illnesses are currently being researched.

A vaccine against hepatitis B already exists, but it is produced from the blood of hepatitis B carriers and is difficult, expensive and potentially dangerous to make. That vaccine, also developed by Merck and marketed under the name Heptavax-B since 1982, has run into resistance from potential users because of its high cost and the fear that the donors' blood might be contaminated. The new vaccine, which Merck hopes to have generally available in two-to-three years, is expected to overcome many problems associated with its Heptavax-B product. The company still must conduct tests to ensure that the vaccine protects those most at risk of getting the illness.

"This is an important hurdle for the vaccine. We believe it will prove to be the vaccine of choice against hepatitis B," said Edward M. Scolnick, senior vice president of Merck's Merck Sharp & Dohme Research Laboratories and principal researcher of the study.

Today is the second day in a row Merck's vaccine researchers made news. A research team reported earlier that a vaccine against chicken pox had been tested successfully. The company's common stock closed at $85.375, up $1.875, in composite trading yesterday on the New York Stock Exchange.

Hepatitis B can be transmitted through blood transfusions, hypodermic needles, or sexually and is common among homosexual males, health care workers, and some Third World populations. Symptoms of the disease vary from flu-like illness to liver failure. It is believed to cause liver cancer among some Third World victims.

Merck is the first out of the gate in a race among a number of companies to produce a less-expensive and more easily produced hepatitis B vaccine. Biogen, a Dutch-American biotechnology concern with U. S. headquarters in Boston, also is deep into research on a similar vaccine made through genetic engineering. Last year Biogen announced that its vaccine was effective in chimpanzees. A spokesman for the company said it has licensed a major pharmaceutical company to conduct human tests on the vaccine, expected to begin sometime this year. Biogen declined to name the drug company.

In April, researchers at the New York Blood Center and California Institute of Technology jointly reported the production of a vaccine produced through a completely different synthetic technique. This vaccine is composed of chemicals that make up a small part of the antigen, or molecule that stimulates the body to produce antibodies against hepatitis B. In April, the scientists said they successfully produced the chemicals in a way expected to be less costly than those used in genetic engineering.

That synthetic vaccine is expected to be tested soon on animals, but is some years away from human usage.

Both the genetically engineered and synthetic versions will solve a major roadblock to widespread use of a hepatitis B vaccine. Merck's Heptavax-B is produced from the blood of hepatitis B carriers, many of whom are homosexuals. Many potential recipients of Heptavax-B worry that the vaccine might contain the agent suspected of causing acquired immune deficiency syndrome, or AIDS, even though Merck has argued strongly that its purification process eliminates any such problem.

The new vaccines would also avoid the production difficulties associated with Heptavax-B, the making of which involves the handling of blood containing live hepatitis virus.

Merck's Heptavax-B is also expensive, costing about $100 for a three-shot dosage. Many hospitals and health institutions say the price is too high for widespread innoculation. Because of this, only 400,000 people have received the vaccine, far fewer than Merck first expected.

Researchers also are seeking a hepatitis B vaccine that, if inexpensive enough, could be distributed widely among Third World nations. Some suggest that such a vaccine should cost as little as $1 a shot. Officials at Merck said they weren't sure how much the new vaccine might cost, or whether it would be less expensive than Heptavax-B.

Merck's new vaccine was produced from material first developed by Chiron Corp., a small biotechnology company based in Emeryville, Calif. Merck paid for the research under which Chiron developed the vaccine and is negotiating a licensing arrangement with Chiron.

Cetus Corp. of Emeryville, Calif., has already brought to market a vaccine for use in animals that was developed through genetic engineering. The vaccine is licensed to the Norden Laboratories unit of SmithKline Beckman Corp. and prevents a fatal diarrheal disease of newborn pigs. It is believed to be the first recombinant vaccine to make it to market, a Cetus spokeswoman said.
840601
WJ840601

Copyright © 1984 - The Wall Street Journal. Reproduction of this article (other than one copy for personal reference) must be cleared through the WSJ Permissions Desk.

Always watch for outdated information. This article first appeared in 1984. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 1984. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .