IAVI Report Vo. 5, no. 2

there were discussions about vaccines and we defended the
need for a profitable industry. Without that, you will destroy
investment in vaccine R&D.
The Kerry-Pelosi bill, which was introduced in the U.S.
Congress, would provide a tax credit for investment in
vaccines. (See article, page 11.] What are your thoughts
on this type of incentive?
There must be incentives if industry is to continue investing in
vaccines, particularly vaccines for developing countries.
Industry has the know-how to develop these vaccines, so you
need to give them incentives. The Kerry-Pelosi bill is a good
start and we hope the bill passes in this legislative session. But
some companies will not benefit from these credits because of
their global structure.
Would a vaccine purchase fund be useful?
Absolutely. You have to help industry invest in research and
development (known as "Push mechanisms) and also create
mechanisms to guarantee the purchase of vaccines ("Pull"
mechanisms). If you don't have both, it will not work. With
the hepatitis B vaccine, there is a sufficient market in
industrialized countries. But with malaria and HIV vaccines,
the market in the U.S. and Europe, initially, will not be big
enough to justify the research expenses.
Can you give us an overview of
SB Bio's vaccine program? We now believe t
We built this company on the
hepatitis franchise - vaccines for enough along
Hepatitis A and B. After that, we candidate HIVv
decided to go with a combination
hepatitis vaccine. We are also trials by the
developing new combination
vaccines.
Other areas of research include vaccines for human
papilloma virus [some HPV viruses cause cervical cancer] and
meningitis. We are already in clinical studies with these and
hope to reach the market in the coming years. And we're
working on vaccines to prevent chlamydia, CMV and other
diseases, but these are more long-term projects.
How is the malaria vaccine program coming?
We've been working in malaria for about seventeen years. Our
collaboration with the U.S. Army's Walter Reed Army Institute
of Research (WRAIR) has been excellent and has enabled us to
continue our research. It is a very complex area but we've
generated interesting results in challenge experiments and in
clinical trials in Gambia. Does it mean that we have the final
vaccine? We have to test that.
What we need now is continued support for the clinical
development of this product. We are discussing how to get the
support we need to conduct these studies.
And we're considering what to do to ensure supply if the
vaccine is effective. We are now at the stage where we must
decide whether to invest significant funds in production
facilities. This is a critical area where government programs
can make a huge difference.

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As a company executive who is responsible to
shareholders, how do you decide on the level of
resources to invest in a malaria vaccine?
I'm responsible for guaranteeing a return on investment to the
shareholders. So when you take a program like HIV or malaria
vaccine development, it's difficult to decide what to do. If we
do not have public help, it will be very difficult.
Our association with Walter Reed is a very good example of
collaboration between public and private sectors. We are
taking knowledge we have in vaccines and adjuvants and
working with WRAIR to try to develop a vaccine.
The HIV vaccine program has more or less the same
problem. We have not made a lot of noise about this program,
although we have been working on HIV since 1987. Why?
Because we needed to establish that it was scientifically
feasible to develop a vaccine. And this is not demonstrated by
simply moving a product into clinical studies. We needed
reasonable pre-clinical data to justify this step.
We now believe that the science is far enough along to
begin clinical trials and have a candidate vaccine that we
would like to take into the clinic by the end of the year. So, in
both malaria and HIV, we have made progress. But we are still
a way off.
Is there money to be made from
a malaria or HIV vaccine?
It's a very difficult question. If no
t the science is far mechanism is created to purchase
try to move a the vaccine, I think it will be very,
very difficult to build a market. For
cine into human example, with malaria, we had
initially thought there would be a
d of the year good market for the travel sector
from industrialized countries. People
could take the shot before they
traveled to certain regions. But today we don't believe that a
product can meet the challenge. So the market will be in
developing countries.
With HIV, I think the first demonstration of efficacy will be
in developing countries. And then people will look at whether
we can we use it in the Europe and the U.S., where the need is
totally different. But traditionally, vaccines do not become
available in developing countries until 15-20 years after their
introduction. So we all need to act quickly and set up
mechanisms for purchasing these vaccines. This will require a
major paradigm shift.
What mechanisms do we need to stimulate investment in
developing vaccines for developing countries?
First, the public sector needs to continue to fund basic
research, as well as clinical development conducted by
industry. Second, you need to help fund capital investment,
because we'll need to build plants to manufacture the vaccines.
You can't make manufacturing decisions too late in the
process; otherwise, you will delay availability of the vaccine.
This is a critically important issue.
Third, we need a 10-15 year program that provides funds
for purchasing the vaccine, so industry is not forced to

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