IAVI Highlights Gaps in Current AIDS Vaccine Development Efforts,
Calls on G-8 Nations to Create Vaccine Purchase and Development Funds

FOR IMMEDIATE RELEASE Contact: Victor Zonana
May 15, 1998 212-655-0201


NEW YORK --International AIDS Vaccine Initiative president Dr. Seth Berkley issued the following statement to mark the first anniversary of President Clinton's May 18, 1997 call to develop an AIDS vaccine within a decade:

*We commend President Clinton for his leadership in highlighting the need to accelerate the development of an AIDS vaccine, and we applaud the Administration and Congress for increasing HIV vaccine research spending.

*We also salute the AIDS Vaccine Advocacy Coalition for its thoughtful critique of vaccine research efforts at the U.S. National Institutes of Health. Like AVAC, we believe that the President can do more in order to achieve our common goal of an AIDS vaccine by 2007. Specifically:

*We believe that efforts to develop an AIDS vaccine must be globalized, with true partnerships created between industrialized and developing nations.

*We believe that the current emphasis on basic science be must matched by an increased commitment to applied research and product development.

*We believe that governments and international organizations must create an environment that fully engages the private sector.

*President Clinton*s continued political leadership will be crucial in each of these areas,* Dr. Berkley said.

Globalizing the effort: President Clinton deserves credit for helping to persuade the leaders of the eight largest industrialized nations to declare last June in Denver that the development of an AIDS vaccine is *an urgent public health imperative.*

With over 90% of new infections occurring in developing nations, a successful vaccine must protect against virus strains present in both industrialized and developing nations. In addition, a successful vaccine must be practical to use in developing nations; that is, it must be inexpensive to manufacture, easy to administer, and stable under field conditions.

*Now, it is time for the G-8 leaders to make their commitment concrete,* Dr. Berkley said. *President Clinton should mark the first anniversary of his call by championing the creation of an international AIDS Vaccine Development Fund to support industrial development of vaccines for testing in developing countries.* Such a fund could be capitalized at $2 million per G-8 nation for the first two years, rising to $5 million to $10 million for the next five years.

Industrialized nations should also begin to take steps, now, to ensure that once preventive AIDS vaccines are developed, they will be rapidly accessible throughout the developing world. To this end, Dr. Berkley said, *President Clinton should urge the creation of an international Vaccine Purchase Fund. The Purchase Fund would be guaranteed by lines of credit, perhaps through the World Bank, and would only be made available once a vaccine was successfully developed. This would allow for the creation of a large Vaccine Purchase Fund -- say, $1 billion to $1.5 billion -- with little or no current outlay.*

Broadening the Scientific Effort: Vaccine development is an applied science. It must be done through a directed effort that is goal-oriented and has clear benchmarks.

While we applaud the NIH*s stepped up commitment to basic and targeted research, the President should direct that a parallel push be made in two critical areas: preclinical development and manufacturing; and clinical and field-testing in humans.

It is unacceptable that 17 years into the epidemic, not a single vaccine candidate has been put into wide scale efficacy trials, even though 25 candidates have been shown to be safe and most have demonstrated some degree of immunogenicity. *We urgently need answers on which potential vaccines work and which do not. In our view, the only failed trials are those that fail to provide any useful scientific information. We believe multiple, concurrent efficacy trials around the world will be necessary to achieve our goal,* Dr. Berkley said.

Incentives for the Private Sector: The pharmaceutical and biotechnology industries play a key role in vaccine development and must be given more incentives in order to fully engage them in the search for a vaccine. As Gordon Douglas, president of Merck Vaccines told a Congressional Task Force last year, *It is generally recognized that much of the technical expertise and infrastructure required for HIV vaccine development is present only in industry.*

The Vaccine Purchase Fund outlined above has the additional virtue of assuring commercial vaccine companies a viable market in developing countries, and President Clinton should take the lead in advocating its creation to his G-8 partners. *By encouraging industrial investment in vaccine development, the Vaccine Purchase Fund will help to mobilize private capital and allow market forces to work,* Dr. Berkley said.

The President should also direct the Administration to explore and rapidly address liability and other issues that keep many of the world*s vaccine giants on the sidelines or limited in their approaches. He should also use his bully pulpit to encourage all who might make a contribution to join this global effort.

The International AIDS Vaccine Initiative is a global initiative dedicated to quickening the pace of HIV vaccine research and development, so that a vaccine suitable for use throughout the world can become reality.
The Initiative focuses on three major areas of activity: education and advocacy; accelerating scientific progress; and fostering a more supportive environment for vaccine development.

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Note to Reporters, Editors and Producers: IAVI next month will issue its Scientific Blueprint for HIV Vaccine Development detailing steps needed to accelerate the development of an AIDS vaccine.

Dr. Berkley is located in New York City and is available to comment on the first anniversary of President Clinton*s call for an AIDS vaccine. Contact Victor Zonana or Dr. Berkley directly at 212-655-0201.

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