The Search For A Vaccine

NEWSWEEK: How did the International AIDS Vaccine Initiative get started?

Seth Berkley: The conceptual work for IAVI began in 1993-94, when I was still at the Rockefeller Foundation. We launched it officially in 1996, with one person and $100,000. We now have 30 full-time people and another 20 part-time. Our operating budget this year is $24 million. We've raised about $230 million, and our goal is to have $550 million by 2007. This is a unique organization in that we fully intend to go out of business. There's no attempt to build an endowment, no attempt to build a long-term career structure. The idea is to solve a problem.

I gather that of the $20 billion the world spends on AIDS each year, only $350 million goes into vaccine research.

That's probably high. Of the $350 million nominally spent on HIV vaccines, only about $50 million to $70 million goes into product development, and only $20 million is spent directly on the developing world.

How fast is the science advancing? Are today's vaccine candidates markedly more promising than last year's?

Are we getting better study results all the time? Absolutely. What has changed most, though, is not the science but people's attitude. As scientists get better results, people become more confident and more willing to invest seriously in this, more willing to take the risk.

What are the signs of progress?

When we started, the NIH [National Institutes of Health] was spending $75 million on vaccine work, and they're now up to $250 million. Next year it's going up to $400 million. So their rate of growth is good on research. We're trying to make sure that translates into an increase in products. We're not smarter than NIH, but we're less encumbered. I don't have a committee making sure that women are represented in trials. I don't have to follow the competitive procurement rules. I don't have to publish in the Federal Register. I don't have to worry about what proportion of my contracts are going to minority-owned businesses. I understand why the government does these things, but this is a global emergency.

Don't many experts believe it's premature to focus on product development until you know more about immunity and the best ways to achieve it?

Sure, that's still a huge issue. But there's middle ground. Somebody may say they don't think a particular vaccine is good enough. But look what happens when you turn the question around. Suppose you have a vaccine that triggers a cellular immune response in 50 percent of people. Should we find out whether that response is protective against HIV? Absolutely.

What do you say when treatment advocates accuse you of turning your back on people who are already infected?

I do question whether it's realistic to think we can blanket the poorest parts of the world with antiretroviral drugs. We're talking about populations that don't even have drinking water. I've worked in 31 African countries. I know the challenges of delivering health care in that environment. The thing that really makes people mad is not our message but the amount of attention and funding that IAVI has gotten. I'm not trying to take money away from anyone, I just want to make sure that this mission succeeds.

How would you rate the U.S. government's response to global health issues?

The United States is at the bottom of the barrel. That's a disgrace. We now spend 0.1 percent of GNP on international aid. Ireland will soon be at .7 percent, and Norway is at .7 percent. We Americans are incredibly focused on ourselves. People don't even have passports. We think we're the center of the universe.

Why has the pharmaceutical industry been so reluctant to pursue an AIDS vaccine?

I think the private sector has had good reasons for staying away from it. HIV is a difficult target because it varies so much from one place to another. It's not enough to have a vaccine that works well against one strain of the virus. And testing a vaccine is vastly harder than testing a drug. You have to follow huge numbers of healthy people for long periods to get the first clue that you're making any difference. Then you look at the market. The populations most in need of a vaccine can't afford to pay for it. So chances are, you'll be forced into giving the vaccine away once you develop it.

What's your strategy for getting around these obstacles?

Since we can't go into human trials with high confidence of a payoff, we need to test a lot of different approaches at the same time. We hope that by supporting companies that have promising candidates to study, we can get 8 to 12 vaccines moving forward at once. Everyone agrees the world should get the best minds focused on the problem and devote the resources needed to solve it. But when you get down to individual countries, individual companies, individual scientists, the calculus changes. We need to get back to that global mindset.

Is this something the World Health Organization should be tackling?

The WHO can't sit down behind closed doors to work with manufacturers. There are all kinds of restrictions on how people in public agencies interact with the private sector. And the WHO has to respond to public sentiment in member states. Everyone's agitating right now to get drugs out to the hardest-hit countries. That's important-people are dying and we need to do that. But have you heard any noise like this about vaccines?

What about other public health agencies?

The NIH is showing more interest in vaccine development, but that's not its traditional mandate. NIH is the premier biomedical research institution in the world. What it does so well is basic science. Which receptors are important? Which genes are important? Which molecules have therapeutic potential? Product development is not the skill set NIH has. NIH has a tradition of working through academic institutions. It's geared toward peer-reviewed publication, not industrial production.

How can IAVI change the political climate?

You need somebody working on the public policy agenda who doesn't have conflicts of interest. Suppose a company comes up tomorrow with a vaccine that works. They go to the government and say, "We want you to create a fund to buy our vaccine." It looks like they're just seeking a handout. Or suppose they announce a tiered pricing scheme. People will assume that they're price-gouging in rich countries, not that they're trying to make their vaccine affordable in poor ones. We [IAVI] can go out there as independent advocates and say, "Look, we're not here to maximize a company's profits. We're trying to stop a plague."

What's your plan for getting the private sector involved?

If all the systems we've advocated are in place, we'll have a set of effective vaccine candidates. We'll have regulatory harmony so that once the vaccine is approved in one or two countries you don't have to start over every time you want to sell it someplace else. We'll have a purchase fund that can buy the vaccine for the very poorest populations. And we'll have a political climate in which it's OK for companies to sell the same product at different prices in rich and poor countries.

How critical is a purchase fund to all of this?

If you can present a company with a list of countries that have agreed they'll collectively put up $3 billion to buy a vaccine, with certain qualities once it's ready, that's a pretty strong incentive. Everything you can do to add incentives is for the better, because speed is essential to solving this problem. Even if we came up with an effective vaccine today, it would take us at least five years to get it out to people.

You've advocated crunching the development-and-approval process from 20 years down to 10. Wouldn't that make it harder to guarantee safety and efficacy?

That depends on how high you set the bar. If you're South Africa and 24 percent of your population is infected, what level of risk are you willing to tolerate in a vaccine? A lot more than you are in a country where 0.1 percent of the population is infected and where infected people have access to expensive triple-drug cocktails. If the United States wants to say we'll only use something that's been found completely harmless, that's fine. But that shouldn't keep vaccine makers from exporting a product that other countries are ready to approve.

What do you most love about your job from day to day?

I love engaging people in this issue. That jazzes me up. The most discouraging thing is the politics-coming up against so many people saying, "Not in my shop," or "Not on my budget," or worrying that our work is going to interfere with theirs. The other thing that's hard is confronting the public apathy on this issue. This is like looking at botched abortions or mass starvation. I don't understand why there isn't more outrage, more determination to do something.

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