HIV Vaccines - Accelerating the Development of Preventive HIV Vaccines for the World: Summary Report and Recommendations of an International Meeting

Executive Summary
The epidemic of HIV-1 continues to spread throughout the world despite current prevention
efforts. Between 1993 and 2000 the World Health Organization projects that at least 26 million
people will become infected with HIV-1 - an average of 10,000 people a day over the 7-year
period. While a substantial increase in the financial and human resources available for prevention
activities would reduce the number of new infections, there is a growing realization that the
current range of prevention activities will not be able to halt the epidemic. Other measures are
urgently required. The development of safe and effective preventive HIV-1 vaccines would
dramatically improve the prospects for controlling the HIV epidemic provided they be made
accessible to those at greatest risk of infection.
Meeting participants acknowledged the unprecedented effort that has been made by the scientific
community to understand the biology and pathogenesis of HIV since its discovery as the etiologic
agent of AIDS in 1984. In addition, there has been considerable interest shown by national and
international public and private sector institutions in the development of HIV vaccines. These
ongoing efforts, while constrained by budgetary and human resource limitations, have lead to
major advances in scientific knowledge, and there are now encouraging signs that the
development of a preventive HIV vaccine may be possible. A number of obstacles, however,
hinder product development, and make it unlikely that a vaccine appropriate for use throughout
the world will be developed and made available in a timely fashion unless remedial actions are
taken. In 1993 over US$ 1.5 billion was spent worldwide on HIV prevention and over US$ 5 billion
on HIV-related health care. Yet, in the same year less than US$ 160 million was invested
worldwide by the public and private sectors in HIV vaccine research and development. This was
considered insufficient given the current and rising health, humanitarian, social, and economic
costs of the HIV epidemic. The investment of additional resources was viewed as potentially
making a significant difference, especially if targeted at the critical gaps in current development
efforts.
The national research agencies of the developed countries have been playing a key role in
vaccine research. Product development activities, however, have been left almost exclusively to
the pharmaceutical and biotechnology companies. In the current environment the incentives for
industry to invest substantially in the development of a preventive HIV vaccine are limited - there
are a number of other products with more attractive investment prospects. To overcome this
market failure and ensure more active industry participation, positive steps will need to be taken.
The dominance of the national research agencies of the developed countries and the
pharmaceutical and biotechnology companies in HIV vaccine research and development has
meant that current efforts are directed almost exclusively towards vaccine products catering to the
needs of the developed world. This emphasis raises cause for concern about the ultimate
provision of an HIV vaccine to those in greatest need - over 90% of new infections are occurring
in the developing world. For example, the industry investment in product development has, in
general, been targeted at those vaccine approaches that are perceived as the safest, and has
been based upon the sub-types of HIV-1 found in developed countries. Approaches that have
technical characteristics that may make them better suited for use in developing countries are not
being pursued aggressively. The rationale is that proving efficacy of a vaccine is the priority,
following which other products will be developed in a sequential fashion. Given the many
scientific uncertainties remaining, participants at the Bellagio meeting concluded that the
development and testing of multiple empirical approaches in a parallel fashion, rather than