Friday, 25 October Conference Call on AIDS Vaccine

Comments by Seth Berkley, M.D. Page 2
President's Advisory Council on HIV and AIDS Research Subcommittee
Conference Call, October 25, 1996
can make. There are now dozens of drugs in the pipeline and there is much progress. But is the
solution now at hand? These drugs are complicated to take, and if taken incorrectly, will likely
lead to antimicrobial resistance. More importantly, they cost $15-20,000 per year per person in
addition to the substantial health care and monitoring costs. This translates to a cost of $300-400
billion per year globally if we were to make these drugs available to all those infected. And let
me remind you that drug therapy is forever and will continue to be compounded by costs of those
newly infected. The developing world has almost no access to any of these drugs. Will the
world make these resources available? Can they make them available? The South African
Minister of Health recently said: It is here that we are seeing a new form of apartheid, between
those who have access to treatment and benefit from a concentration of efforts on improving
their disease outcomes and the vast majority of the those who have no access to treatment and
care.
At the end of the day, a vaccine is our only hope of controlling the epidemic on a global basis.
Furthermore, I contend, that a vaccine is possible:
First, it is critical to acknowledge the scientific effort that has been made to date. There has been
an unprecedented effort to study the Human Immunodeficiency Virus. More scientific advances
have been made in understanding this organism in the last decade than in understanding probably
any organism in history.
There are still some key scientific issues that remain and I do not want to underestimate the
hurdles that still need to be overcome if we are to succeed. But there is now good evidence that
there can be immunologic protection against HIV and that a vaccine is possible.
Yet, despite having a flurry of early activity in vaccine development, it is an effort that is
currently in severe trouble. In 1984, when the viral origin of this disease was first recognized,
there was only one drug licensed to treat viral diseases. Since the time of Jenner (the discoverer
of Smallpox vaccine 200 years ago) virtually all viral infectious viral diseases were prevented
using vaccines. There were over 20 vaccines licensed for use in humans with scores more for
use in the veterinary market. The public health community immediately understood that a
vaccine was the most cost effective and logical way to approach this epidemic.
What happened? It turned out that this virus was biologically more difficult than other agents,
that there was not a perfect animal model, and that there were no surrogate markers of
protection. In addition, paradoxically, although the biotechnology revolution brought new and
exciting tools to bear on the problem, vaccine development up to that point had always been an
empirical science. HIV is the first disease where we have felt, perhaps with hubris, that we
could design all aspects of the vaccine prior to testing in humans. This is an untested hypothesis.
Let me give you a counter example: We still do not understand the correlates of protection for
pertussis (whooping cough) nor do we have an animal model, yet we have a whole family of

effective vaccines. The same holds true for a whole host of other infectious agents. Yet, the call
from the basic science HIV community has been we need more basic science before we can