AIDSWEEKLY Plus, Monday, 23 June 1997
Daniel J. DeNoon, Senior Editor
A major U.S. pharmaceutical company has promised a full- scale effort to develop an HIV vaccine.
The promise came from R. Gordon Douglas, president of Merck Vaccines, Merck & Co. Inc., in a briefing on AIDS vaccines delivered to the Congressional Task Force on International HIV/AIDS.
Merck has licensed naked DNA technology from Vical Inc., San Diego, California, for use in developing vaccines for HIV and six other pathogens (hepatitis B, hepatitis C, herpes simplex, human papilloma virus, influenza, and tuberculosis).
"Merck has already invested thousands of research hours and millions of dollars toward the discovery, development, and production of new medicines and vaccines for the treatment and prevention of HIV and will continue to devote the resources necessary to develop an HIV vaccine to curb the epidemic worldwide," Douglas told the Congressional committee. "We are well positioned in the science and technology of vaccine research and development and HIV virology to achieve this goal."
The Merck DNA vaccine for HIV is currently in preclinical development and "is nowhere near human trials," according to a company spokesperson.
Another naked DNA vaccine, under development by Apollon Inc., Malvern, Pennsylvania, entered a Phase I clinical trial in 1996. This study enrolled subjects with asymptomatic HIV infection and relatively high T-cell counts.
A previous HIV vaccine developed in the late 1980s by Merck in collaboration with Repligen Inc., Cambridge, Massachusetts, employed HIV envelope subunits as antigens. This approach was abandoned when it failed to elicit antibodies capable of neutralizing primary HIV isolates.
In contrast, Merck has high hopes for the naked DNA approach.
"Although our HIV vaccine research is still in the preclinical stage, we have - in anticipation of fast-track development once we have an HIV vaccine clinical candidate - engaged the full range of support from Merck to plan our development program, including teams from basic research, assay development, process development, formulation, animal safety assessment, regulatory, quality assurance, clinical research, and manufacturing," Douglas said. "We are committed to pursue an HIV vaccine with as much vigor and passion as that which drove the discovery and development of our HIV protease inhibitor, Crixivan."
While noting that an HIV vaccine is of great importance to developing nations, Douglas listed a number of "barriers" to supplying vaccines and medicines to these areas:
* Inadequate protection of intellectual property. Douglas particularly noted that many nations fail to comply with the Trade-Related Intellectual Property Sections of the General Agreement on Tariffs and Trade (GATT) agreement.
* Government price and profit controls. Such controls "limit research incentives and the revenues needed to invest in high- risk development programs," Douglas said. Moreover, the Merck vaccine president suggested that price controls lead to black marketeering and to parallel trade in patented medicines (in which wholesalers buy drugs in price-controlled markets and sell them in free markets, keeping the price difference for themselves).
* Lack of quality assurance in misdirected efforts to cut costs.
* Lack of resources for poor nations to purchase drugs and vaccines "that necessarily cost more than older vaccines."
* Inadequate data on HIV epidemiology. Douglas called for more studies on disease occurrence, rate of new infections, clade incidence, and identification of clinical trial sites with known epidemiology.
* Lack of health-system infrastructures to support rigorous vaccine and treatment regimens.
Douglas called on agencies such as the World Health Organization and the World Bank "to assure that once an HIV vaccine is available, the distribution and health-care systems are in place to effectively deliver the vaccine to populations at risk." - by Daniel J. DeNoon, Senior Editor
970623
AW970606
Copyright © 1997 - Charles Henderson, Publisher. All rights Reserved. Permission to reproduce granted to AEGIS by Charles W. Henderson. Authorization to reproduce for personal use granted granted by C. W. Henderson, Publisher, provided that the fee of US$4.50 per copy, per page is paid directly to the Copyright Clearance Center, 27 Congress Street, Salem, Massachusetts 01970, USA.
Published by Charles Henderson, Publisher. Editorial & Publishing Office: P.O. Box 5528, Atlanta, GA 30307-0528 / Telephone: (800) 633-4931; Subscription Office: P.O. Box 830409, Birmingham, AL 35283-0409 / FAX: (205) 995-1588 http://www.newsfile.com
AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, iMetrikus, Inc., the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 1997. 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 ©1990, 2000. AEGiS & the Sisters of Saint Elizabeth of Hungary. 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 ÆGIS, or the party credited as the provider of the content.