AIDS Vaccine Panel Discussion [Minutes]

7-APR-97 PACHA AIDS VACCINE PANEL DISCUSSION - p. 15

would provide long-term sterile immunity, while an acceptable vaccine might prevent
viral burdens of less than 1,000 viral particles per mL in the blood. This is just one of a
myriad of possible endpoints.
Definition of the market size has been cited in the background document as a
barrier in terms of incentive to industry. At Merck we believe that the development of
an effective vaccine against HIV is important for human health and are working hard to
achieve this goal. We also believe that there will be a market for such a vaccine. An
indication from governmental bodies at appropriate times on their strategy for
utilization of such a vaccine, of course, is very helpful.
It goes without saying that the entire scientific foundation of HIV vaccine
development in terms of pathogenesis, molecular biology and virology, animal models,
immunology, and many other issues is dependent on government- and foundationsponsored research. The earlier stages of vaccine development can be performed with
pilot materials made in what we call current GMP pilot plants, which are located either
in industry or in government. But I'd like to make the point that the earlier industry
becomes involved in these projects, the more likely that a transferrable process yielding
similar results will be developed, because ultimately the vaccine has to be
manufactured.
In my experience working both in government and industry, certain aspects of
vaccine development, however, are best done by industry because of their experience,
personnel, infrastructure, organization, and the flexibility to assign teams to solve
technical problems as they occur. I'll give you some examples. Development of
reproducible and scalable processes for manufacturing, along with validated assays
required to measure appropriate properties of the vaccine, design of factories,
engineering demonstrations, and production of final consistency lots are all processes
which are fraught with pitfalls that require experience, facilities, and large numbers of
dedicated staff.
Clinical trials, on the other hand, governmental agencies have experience in the
design and execution of pivotal efficacy trials for licensure, as does industry, which is
necessarily obsessed with licensure and all of its requirements and pitfalls.
I've been asked to comment on a possible target date for vaccine development,
and I agree with the previous speakers. I think it's almost impossible to predict what
that would be. Since we don't know whether we need to or how to induce broadly
cross-reacting antibody, it makes it a tough guess. But 7 to 10 years is not completely
out of the ball park.
I've been asked to comment on the cost, and also I find this extremely difficult
to estimate, because I'm not sure how long it will take, and I'm not sure how broad the