July 7, 2000

A Call for Fair Access to Future AIDS Vaccine

 

New York Times- July 7, 2000

         

By LAWRENCE K. ALTMAN

 

DURBAN, South Africa, July 6

 

Though a vaccine to prevent AIDS is years away, steps should be taken now to enable a vaccine to be distributed widely in           the third world as soon as it becomes available, a leading group in the vaccine effort said here today.

 

As the 13th International AIDS Conference prepared to open here on Sunday, the International AIDS Vaccine Initiative, a research consortium supported by government and private grants, issued a blueprint to provide simultaneous access to an AIDS vaccine in rich and poor countries.

 

The public and private sectors need to learn new ways of doing business, the research group said in recommending sweeping changes in the way vaccines are produced, licensed, priced, bought and distributed.

 

 The group argued that economics alone fails to fully explain the long delays that often ensue before vaccines become available in developing countries, and urged steps to harmonize the hodgepodge of national regulations and international guidelines that govern vaccine approval and use. The blueprint also calls for creation of an international group to monitor and assess experimental vaccines.

 

"It is not too soon to plan for an AIDS vaccine because failure to act promptly would repeat the tragedy of the widespread lack of availability to anti-H.I.V. drugs," said Dr. Seth Berkley, the president of the Vaccine Initiative, which collaborates with Unaids, the United Nations' joint program on AIDS.

 

The United Nations has concluded that AIDS threatens to severely damage the economies of sub-Saharan countries like South Africa, Zimbabwe, Zambia, Botswana and Swaziland where H.I.V., the virus that causes AIDS, has infected at least 20 percent of adults.

 

Most health officials believe a vaccine would be the most effective weapon in stopping the epidemic. However, the most severely affected countries would be the least able to afford a vaccine, just as they cannot pay for anti-H.I.V. drugs that are helping extend the lives of many infected people in developed countries. Also, many developing countries do not have the network of health systems needed to deliver a vaccine.

 

Rarely, if ever, have health officials introduced vaccines into developed and developing countries simultaneously. Vaccine manufacturers usually limit their initial production capacity for markets in developed countries. Only with time and after production capacity increases do prices fall to a level that poor countries can afford.

 

Thus, a delay of about 15 years has usually occurred between the time when vaccines for infections like hepatitis B were widely introduced into developed and developing countries. The first hepatitis B vaccine was developed in the early 1980's.

 

The United States and other developed countries quickly organized systems to deliver polio vaccines in the 1950's. But it took decades to conduct similar programs in countries with less effective health care systems and polio was eradicated from the Western Hemisphere only in the 1990's. The World Health Organization's goal of eradicating polio in the rest of the world by 2000 has been set back a few years.

 

The delay in introducing vaccines to the third world is "a colossal public health failure" that should not be repeated with AIDS, Dr. Berkley said. He also said that with more than five million new H.I.V. infections occurring each year, a delay of five years in delivering an AIDS vaccine could cost 20 million or more lives.

 

Scientists are challenged in developing an AIDS vaccine largely because of the virus's ability to mutate. Two years ago, the pipeline for AIDS vaccines was nearly empty. But today, the Vaccine Initiative said, there are promising products in early development, although there is still no plan to get any to the most affected communities in the world.

 

In 1985, Margaret Heckler, then Secretary of Health and Human Services, promised an AIDS vaccine within a year. In the intervening years, however, only 3 of 25 vaccines that have been injected into humans have advanced to the second stage of the three-stage testing system. Two are still in the second stage. One is known as an Alvac canary pox vaccine and is made by Aventis Pasteur of France. A second combines the Alvac vaccine and one prepared from a molecular component of the surface of H.I.V., known as gp120.

 

A vaccine made by VaxGen of Brisbane, Calif., is the only one to reach the third stage. VaxGen's product is being tested in the United States and Thailand, and findings are not expected until at least 2002.

 

New techniques are needed to estimate demand for an AIDS vaccine in developing countries and to assure sufficient production capacity because it takes five years to design, build and bring to full capacity facilities to produce vaccines.

 

An AIDS vaccine would be unlike most immunizations because it would be accompanied by counseling to promote safe sex practices and reduce risky behavior. Moreover, in the developed world, an unknown number of people might decline an AIDS vaccine out of concern that it might produce side effects that would not appear until years after the immunization. Also, some may shun an AIDS vaccine because it would make the standard H.I.V. blood test for a recipient positive. Additional tests would then be needed to document that the blood findings were from an AIDS vaccine, not from infection with the virus.

 

In the third world, there seems to be less concern about side effects because of the epidemic's severity.

 

Even if coordination with the World Health Organization's existing international vaccine programs produces maximum use of a vaccine for AIDS, the Vaccine Initiative said, new delivery systems will be needed to reach adolescents and adults at high risk of infection. And the work to create delivery systems could cost more than the vaccine itself.

 

The Vaccine Initiative urged the World Trade Organization and the major industrialized nations to create a tiered pricing structure to help poor countries pay what they can afford and allow companies to obtain a satisfactory return on investment.

 

The research group cited support for the blueprint from Sean Lance, chairman and chief executive officer of Chiron, a biotechnology company in Emeryville, Calif., that seeks to develop an AIDS vaccine.

 

Although Chiron collaborates with researchers in South Africa and has distribution agreements for other products with South Africa, the company has vastly reduced its representation at the AIDS conference because of concerns of personal safety in Durban, a spokeswoman for Chiron said. Mr. Lance, a native South African, is not attending.