[Memorandum to Presidential Advisory Council on AIDS Research Committee Members from Margaret I. Johnston]

Recommendation; The Administration should take three actions. First, the Administration should
direct NIH, HtIS to double its AIDS vaccine efforts over the next 1-2 years by shifting AIDS
dollars being spent on non-AIDS research into this important area. The AIDS vaccine programs
should remain focused within the NIAID, which has already identified unfunded opporunities in
AIDS vaccine R&D. Second, NIAID should be given a clear mandate to undertakc a directed,
empiric vaccine development program. as well as expand more fundamental research on AIDS
vaccines. Third, the Administration should establish a coordinating committee whose rote is to
facilitate communication between the agencies and showcase accomplishments, but not attempt to
micromanage agency research. Committee membership should be extended to representatives of
the private sector and non-government organizations that support research on HV/AIDS vaccines,
to help facilitate private-public parmerships, and provide a continuing outside perspective.
3. Objective: The Administration should become an active participant in the international effort to
identify a safe and effective vaccine.
Background: Almost all clinical vaccine research supported by the NfIH remains focused on the
subtype of HI V found in the U.S. Insufficient attention has been paid to development of more
traditional vaccine designs and products suitable for testing in high risk individuals in developing
countries, where the need for a vaccine is unarguably greatest, where the acceptable risk:benefit
ratio is high relative to developed countries, and where information on vaccine efficacy might
inexpensively and quickly be obtained. This critical gap in vaccine R&D efforts has arisen in large
part from the reliance on the private sector to develop products for clinical testing. The private
sector contributes expertise in advancing vaccine concepts into clinical trials and assuring their
progression toward the market place. Unfortunately, interest in preventive vaccines by the
pharmaceutical and biotechnology companies has fallen. with few companies maintaining
substantial programs. Venture capital views HIV/AIDS vaccine development as too long term and
with too little potential to warrant investment Companies that remain in the field remain focused
on strategies and subtypes for developed countries.
The paucity of innovative products suitable for phase I testing has not only hindered vaccine
development per sc, but, in my opinion, has also hindered the ability of researchers to conduct
more fundamental research on the human immune responses to HIV antigens and innovative
presentation methods.
The International AIDS Vaccine Initiative (IAVI) is a global initiative with the singular mission of
accelerating development of a safe and effective HIV/AIDS vaccine for use throughout the world.
The first priority of IAVI is to launch a directed vaccine research and development program to
carry out promising, gap-filling research that is currently under-explored, that is not being pursued
by others, and that takes the needs of developing countries into account (additional information
concerning the formation of IAVI and its goals is attached).
Recommendations: The President or Vice President should make a public statement in support
of internaional efforts to accelerate development of HIVIAIDS vaccines suitable for the world, in
general, and the International AIDS Vaccine Initiative, specifically. Acknowledgment of the
Rockefeller Foundation and the International AIDS Vaccine Initiative by Dr. Shalala in her
meeting with philanthropic leaders on April 1 would help reinforce the commitment of the
Administration to intemational AIDS vaccine development efforts. The Administration should join
with The Rockefeller Foundation, UNAIDS and other organizations to help assure the success of
MA V!, without diverting resources from other critical areas of HIV/AIDS research, by providing
direct funding in fiscal year 1997 ($16 million).
Interim Secretarist * cie The Rockefeller Foundation * 42 Fifth Av'ente * New York, NY 10018-Z'02 * UA
phone [phone] * fax [phone]