Friday, 25 October Conference Call on AIDS Vaccine

Comments by Seth Berkley, M.D. Page 4
President's Advisory Council on HIV and AIDS Research Subcommittee
Conference Call, October 25, 1996
Vaccines are needed here as much as they are in Africa, but neither the private nor the public
sector is stepping up to this challenge. Yet the scientific community is now convinced that an
AIDS vaccine is possible. What is needed is to put HIV vaccine development back on the
priority agendas of the public sector research institutions, pharmaceutical companies and the
general population and particularly important, to assure that any such development effort be
made towards developing a vaccine that can be used in areas where the epidemic is spreading
most rapidly. This is a global problem and the response is best done globally. Unlike other
problems that Americans have tackled in alone, we need to work with others. The initiative is
particularly interested in developing countries, because that is where 90% of the infections
currently occur; because that is where the epidemic is spreading the most rapidly and therefore,
would provide good sites for vaccine testing; because there are no drugs available and, therefore,
the need for vaccines is greatest and finally, because there is no organization with developing
vaccines for these countries on its agenda.
The International AIDS Vaccine Initiative (IAVI) has three main strategies: Advocacy for
vaccine development, and a push-pull strategy. The push strategy calls for a directed scientific
program to fill in the gaps in vaccine development and assure that a range of vaccine approaches
are moving forward. The pull strategy is for a program to create a more enabling environment
for vaccine development.
IAVI will be run like a virtual company and do no research itself, but contract with those best
able to move vaccine development forward (usually industry). Viruses respect no borders and
even for the U.S., it seems pragmatic to create vaccines appropriate for all strains of the virus.
Furthermore, it also makes eminent sense to test vaccines where the epidemic is spreading most
rapidly, often in countries with non-U.S. subtype strains.
More importantly, vaccine development is an applied science. It needs to be done through a
directed research effort which is goal oriented with clear benchmarks. Vaccines cannot be
efficiently made by researcher originated mechanisms. They need to be developed by an
experienced vaccinology team that will, step by step, solve the problems it encounters during the
development effort. The team will require the use of a good manufacturing practice facility for
vaccine lot production, another reason to work closely with industry. Vaccines will need to be
tested in humans. We do not, nor will we necessarily ever, have clear correlates of immunity or
a perfect animal model. We need to learn as much as we can in the imperfect test systems we
now have and then speedily move the products into human testing.
Where are we now?
We incorporated the Initiative earlier this year, and recruited an excellent scientific director,
Peggy Johnston who you all met. We have consulted broadly with the HIV scientific
community, and with the HIV activist community here and abroad. We have had consultations
with scientists, vaccine developers and companies from around the world. We are in regular
dialog members of industry. We have set up a scientific review committee composed of some of

the best of the world's scientists. Just as the epidemic does not respect borders, we feel we
should search for the world's best in our quest for a solution to this problem.