Press Briefing by Jim Wilkinson, Deputy Assistant to the President and Deputy National Security Advisor for Communications , Barry Bennett, Deputy of Communications, G8 Summit Planning Organization, and Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health

International Media Center

Savannah, Georgia

8:05 A.M. EDT

MR. BENNETT: My name is Barry Bennett, I'm the Communications Director for the summit. I would like to go over today's schedule as we know it.

At 9:15 a.m., the U.S.-French bilateral meeting. At 9:30 a.m., leaders of Senegal and Ghana arrive at Hunter Army Airfield. At 10:00 a.m., the leaders of Uganda, Nigeria, and South Africa arrive at Hunter Army Airfield. At 10:00 a.m., we're also expecting a readout from the U.S.-France bilateral meeting.

At 10:15 a.m., the wrap-up G8 plenary session begins. At 11:55 a.m., there is a photo opportunity with the African leaders, immediately followed by the outreach luncheon with the African leaders. The African leaders will hold a press conference on Sea Island, video-conferenced back into this very room at 2:45 p.m.

At 4:00 p.m., President Bush will address the press in Briefing Room C. Also at 4:00 p.m., the Russian President will have his final press conference, but it will be to tape, down in Sea Island. So we won't see that, unfortunately.

Q: That will be beamed into this building somewhat later?

MR. BENNETT: At this point, there's no plans to do that. We're trying to work that out. They're taping it for their own press. I think it just happens to be -- that's when everything is done and they want to get it done and get out of Dodge.

At 4:45 p.m. Prime Minister Blair will have his press conference. That will be from Sea Island. That's beamed back here into the -- but not into this room, but into the main hall, real time.

At 5:00 p.m. President Chirac will hold his final press conference in this room. Also at 5:00 p.m. Chancellor Schroeder will have his final press conference in Room B, on the corner here. Also at 5:00 p.m., Berlusconi will have his, at 5:00 p.m. down there, beamed back into the main hall.

Q: -- that's Sea Island?

MR. BENNETT: That's Sea Island, beamed back into the main hall. There will be transcripts of all this, and the schedule will come out here in about five minutes.

At 7:30 p.m. the Japanese will hold their final press conference in this very room. That should wrap up at 8:15 p.m., and we're out of here.

A couple housekeeping notes. Food service continues through lunch. And we've hit our 55,000 doughnut quota -- (laughter) -- 220 million calories. Many people should plan on walking home, including myself. But thank you all for being so cooperative and letting us pull this off. I'd like to have Jim talk about the policy developments of the day.

MR. WILKINSON: Good morning, everyone. I brought a special guest, in Dr. Fauci, to get a little new news on the summit that he'll make shortly. I would echo Barry's comments on Krispy Kreme doughnuts. I'm glad Andre Sittof, who came this morning with his very own bag, has learned this part of American culture.

It's been quite a successful summit, a summit of policy accomplishments and achievements. Before Dr. Fauci comes up and makes his comments on a new achievement you don't know about yet, I want to just recap yesterday and the accomplishments of the first day.

As you know, the G8 leaders met to advance freedom by strengthening international cooperation to make the world safer and better. Yesterday President Bush and the G8 pledged united support for the Iraqi people and the new interim government, including support for elections, reconstruction and debt reduction. Very historic meeting yesterday between President Bush and President Ghazi. They also launched a historic partnership with the broader Middle East to support democratic, social and economic reforms.

They took new action on the proliferation of weapons of mass destruction, including expanding the Proliferation Security Initiative, strengthening the International Atomic Energy Agency, and refraining from new transfers of uranium enrichment and reprocessing technology. It strengthens the global counterterrorism cooperation that we've seen among the nations, with a special focus on the security of international travel.

They adopted an action plan focused on applying the power of entrepreneurship to the eradication of poverty by facilitating global remittances, micro-finance funding and access to financing for housing and clean water. And they encouraged increased action to promote global economic growth by directing trade ministers to put the WTO's Doha global trade negotiations back on track for successful conclusion.

But already, just in the first days of the summit, it's been a summit of accomplishments.

Before I turn it over to Dr. Fauci, I was just asked a special request at our staff meeting this morning. Barry Bennett extolled all of us to say thank you to the volunteers. Lots of these local citizens and others have come here to make your lives easier -- to serve you food and drive you around and give you access and help serve you. And I would just ask that we follow Barry Bennett's instruction that if, today, if you see these local folks, just say "thank you" because they really have done a great job for you and for the summit and for these leaders -- a lot of long hours. They're all volunteers, they don't get paid. As a matter of fact, this is costing them more than they would ever get out of it. So just thank them today if you see them, because they really want to help you.

Doctor?

DR. FAUCI: Thank you very much, Jim. I'm going to brief you very -- in some few short words, and I'll be happy to entertain any questions after, about the initiatives that are going to be made public today in the arena of health. The first one, which is really the new, brand-new deliverable is what is being referred to as the global HIV vaccine enterprise.

Just as a word or two of background, as you know, over the last few years, dating from the beginning of President Bush's administration, he had asked several of us -- Secretary Thompson of the Department of Health and Human Services and myself -- to develop ways that he might evaluate of how we can attack the global HIV problem.

It started off a couple of years ago, in the spring of 2002, when he sent Secretary Thompson and I to Africa to scope out the situation with regard to the feasibility of treating people with HIV infection, knowing that the whole area of HIV is going to be treatment, care and prevention. We've reported back to him, and on the basis of that, he established that program that I think some of you are familiar with, the $500 million prevention of mother-to-child transmission initiative, which was a $500 million initiative. But immediately upon deciding upon that and announcing it, he wanted to go even further in developing a more global treatment and care program, which over the next several months, working rather intensively with White House staff, we put together what is now known as the President's emergency plan for AIDS relief -- the $15 billion program that, over five years, is going to treat 2 million people in 14 countries in sub-Saharan Africa and the Caribbean, and prevent 7 million infections, and care for 10 million people.

But as a next step -- and that's what this is all about -- is what can we do about the development of a vaccine, which is a very problematic issue because of the scientific gaps, as well as the logistic gaps. A group of scientists, in the summer of '03, put together a broad proposal in a paper that was published in Science Magazine in June of 2003, calling for the need for a global HIV enterprise, which a virtual consortium -- not an organization with a head and with pooled money, but an agreement to form an alliance among the interested stakeholders, be they individual scientists, government or what have you, to agree upon the philosophy that we will develop a strategic plan that would provide coordination, collaboration, and sharing of information, as well as closing the gaps. And from that time, where the first meeting following that paper took place in Northern Virginia, in Airlie House, outside of Washington, and the beginnings of the strategic plan began to come to fruition -- at that point, we brought this to the attention of the President, who said this may be the way we can have that in-road into developing an HIV vaccine globally.

So we put together -- and the President proposed this to the G8, and the G8 has endorsed this, this global HIV enterprise, which, as I remember, to emphasize, it's a virtual consortium based on a strategic plan so that when other nations, G8 and other nations, decide they want to align their own resources or put new resources into vaccine development, there will be a strategic plan framework with which they can synergize with the other nations.

The United States, already with regard to resources, some of you may know, in '03, has dedicated in spending $488 million, the United States government, on HIV vaccine. And this is in '04 -- in '05 -- that was '04 -- in '05, it's going to be $533 million. So it's not a question of dumping a lot more money into it, it's a question of solving these issues, of bringing it in a global enterprise.

The six major components of this strategic plan are: Encouraging the development of HIV vaccine development centers, such as the center that we have on the NIH campus in Bethesda, which is a model and a prototype of the entire comprehensive approach towards the scientific aspects of HIV. The other is to stimulate increased, dedicated vaccine manufacturing capacity, because the vaccine manufacturing capability in the world is somewhat fragile in that not a lot of companies have these that are able to do beyond what the vaccines already have. To standardize the laboratory and clinical parameter, so that if you do a trial in sub-Saharan Africa and one in the United States and one in the U.K., that the laboratory data that we collect and the clinical information is interchangeable, as opposed to individual silos. The next is to develop an integrated clinical trials system. We already have an extensive one worldwide -- the Brits and the French also have a pretty good one -- is to integrate them. And then, to have what we call, maximizing the agreement among regulatory authorities so that if a trial is done in the UK or in South America, those data can be used for an approval of a vaccine in Japan -- to bring a global aspect to it. And finally, to embrace the engagement of scientists from developing countries.

This proposal has been endorsed, and as the new announcement associated with this, is that to get the ball rolling in these six major components of the strategic plan, the President is proposing spending $15 million in '05 for a virtual center. Now, a virtual center is a center where you have sort of money that glues people together, be it in a medical center, or what have you. And then the '06 money that would be the continuation of that will be decided according to the standard of budgetary process that we go through each year.

But the funding of that initial virtual center will come through the peer review mechanism. This has been agreed upon, and we're going to have the strategic plan individuals, which is a global array of individuals, report within the next several months to the United States as the G8 presidency this year, and then each year, starting with the UK next year and beyond, each year, there will be a reporting of the progress of the strategic plan.

So this is an exciting new initiative, and, I think, rounds out the approach that we have regarding prevention, care, and, in this case now, treatment, and now, finally, with vaccines.

So I'd be happy to answer any questions about that.

Q: Does that result, the $15 million, does that ultimately result in a building somewhere, or is it just to lay the groundwork --

DR. FAUCI: No. It's a very good point. In the original strategic plan, which we are working on right now, the scientists, there's two types of centers. There's a physical building, including a critical mass of scientists in that building, which is what we have at the NIH in Bethesda, Maryland. But there also is what we call virtual centers, and this is not an unusual concept.

For example, you take a medical center in City X, and you have multiple different people in different departments working on things that relate to a subject. It could be cancer, it could be heart disease. In this case, it would be an AIDS vaccine. And what you do when you have a virtual center is that you put the money in -- and this start-up cost of $15 million will be to bring the people together, to be able to synergize, essentially intellectually link, as opposed to necessarily in the same building.

So the first shot at this, to encourage other countries to form these global centers anywhere in the world, what the President is proposing is that in '05 we're going to put start-up money for a virtual center. It will be peer-reviewed in the usual way, likely in some medical center, likely in the United States. And then following up on that, in '06, the amount of money it will take to what the yearly costs are. And that will be decided, as we develop our '06 budget.

Q: So just so I understand, this batch of money, $15 million, goes to an unspecified medical center at an unspecified site, likely in the United States?

DR. FAUCI: Right.

Q: Has any other country put up money here at G8?

DR. FAUCI: Not right now, because they were just met with the agreement of this. This was just put upon them, as the sherpas got together and worked this out. And now the concept of the enterprise has been agreed upon and endorsed by the G8, and we fully expect and hope that there will be interest in joining and embracing this strategic plan, so that if a company -- a country comes in, they could pick any one, two, three or four or whatever of the six major components of the enterprise, and say, we decide that we would like to get involved in contributing to this.

Each individual country will own their own resources. This is not pooling of resources. It's getting individual entities to agree upon the commitment that they will work in a synergistic, collaborative way towards an HIV vaccine.

Q: I think from our previous conversation, you led me to understand the $15 million is not necessarily part of the $533 million of next year?

DR. FAUCI: Not necessarily, no. It will be '05 money. It's being worked out now whether it's going to be part of the $533 million or additional add-on. And then the '06 will be the normal budget process that we go through.

Q: Who will own the patent on the vaccine when it's developed?

DR. FAUCI: Again, it will be the same issues that exist now. For example, if company A or scientist B, or whomever, is the one that actually makes that discovery, that patent is owned by the person that makes the discovery. So the only thing that the enterprise is really different and I think innovative, is that when you work on something, the broad direction is an agreed upon strategic plan. So the individual countries who put money in, that will be their money. They will not put money in a pool that somebody else is going to decide what to do with it, so long as they agree that this will be within the framework of that strategic plan.

Q: For those of us who aren't science reporters, can you bring us up to speed on where the science is right now on a vaccine?

DR. FAUCI: Yes, and that's the reason why the President took such an interest in this, because although a considerable amount of progress has been made, I think I can say, as a scientist, that this is one of the most difficult scientific problems that we face. And the reason being, is that if you think of all the diseases that we deal with that are fatal diseases -- small pox, polio, measles, and others -- there is always a way where the body's immune system, most of the time, can ultimately handle that microbe. I mean, for example, only 15 percent to 30 percent of people who get small pox actually die. The other 80 to 85 percent of them do really quite well and recover. The same thing with polio, it's greater than 90 percent.

With HIV, there isn't a single documented example of the 60 -plus million people who have been infected with HIV who actually have spontaneously eradicated the virus from their body, which tells us that the body has a lot of trouble handling the HIV virus, which means that there are a lot of scientific problems that we need to solve before we're going to get a vaccine. And the only way we're going to do that is if everybody, globally, who is working on it, work on it in a synergistic way, which is, I think, the beauty of this particular proposal.

Q: One more question related to that. Where are your negotiations with Congress on the $533 million, and the $15 million? How is that proposal --

DR. FAUCI: That's money that's already there. The $15 billion commitment over five years is a commitment that the President, with the agreement the Congress has made, that we're going to spend $15 million on the President's emergency plan for AIDS relief, what we refer to as PEPFAR. That program is now underway. Ambassador Randall Tobias is the AIDS Coordinator. And already, in February 23rd, 24th the rollout took place, and from that time, already, there have been $342 million disbursed to sub-Saharan Africa and the Carribean. And the money is now being spent.

And it's a yearly issue. At the end of five years, there will be $15 billion. There's some slight misunderstanding about, is it going to be $3 billion a year? Unlikely. It will probably rev up, so that in some years, there will be more than $3 billion, and then in the early years there will be less. But at the end of the five year period, we will have spent $15 billion, $10 billion of which is new money, $1 billion of which will go to the Global Fund in $200 million installments over five years. And the rest will be bilateral.

Q: A question about -- well, two questions, actually. Will commercial pharmaceutical companies be precluded from --

DR. FAUCI: No, absolutely not.

Q: And if so, what if they come up with a vaccine before this consortium comes up with a vaccine? What does that mean for the consortium?

DR. FAUCI: The name of the game is developing a vaccine. We couldn't care less who comes up with it, we just want to make sure we get a vaccine. So if part of this plan, someone yells, " Eureka, I have it," then that's wonderful, we will have accomplished our goal. The goal is not to have the enterprise concept do it. The goal is to have the enterprise help us get to the goal of getting a vaccine. The most -- the best thing in the world that could happen is that if some company, a year from now, says we have a vaccine, then we don't need an enterprise. That would be wonderful.

Q: well, what happens to the centers if they are already developed and somebody comes with a vaccine? Do you go elsewhere to another disease?

DR. FAUCI: Yes, well, that's exactly -- well, very good point. We have this vaccine research center that we have on the campus that's the center that my -- that I direct, as the Director of the Institute. That center is there, and it was originally developed for HIV. But as biodefense became another important priority within the United States government, we now have that center also involved, very successfully, in developing of second, third generation small pox vaccines, ebola vaccines are coming out of that, West Nile virus vaccines. So if you have a center that's involved in a particular direction, and you solve that problem, you still have intellectual capital and physical capacity that can easily be diverted to other important diseases.

Q: Two questions for you. The first not directly on the AIDS initiative. Do you have a list of how many people have followed the President's call to get vaccinated for small pox?

DR. FAUCI: It's about 40,000 people, total. And that's not counting military, which is about 400,000. But that's part of the obligation of getting their vaccinations. I'm talking about the civilian population. It's about 40,000.

Q: And mostly first responders --

DR. FAUCI: They're mostly people who are on first responder teams, people in designated -- many of the hospitals in the public health clinics and the medical centers have designated smallpox response teams, so if someone comes to the ER and looks like they have smallpox, they bring those people in -- that group is, as well as some of the other first responders.

Q: And the AIDS -- you seem to be talking about, among the measures you're taking, homogenization of research standards --

DR. FAUCI: No, no. Homogenization of laboratory data. So, for example, if I do a trial in the east coast of the United States, and I'm measuring a particular laboratory parameter, and I've designed the clinical trial to measure viral load and immune parameters, et cetera, and then somebody does a trial in England or in sub-Saharan Africa, and they do different parameters, or they measure in a different way, it's very difficult to compare results and learn what you want to do better for the next trial. Because, as I've mentioned to some of you, I doubt very seriously if an HIV vaccine is going to be a home run first shot at the plate.

What will happen is that there will be a trial, it will be partially successful -- in the United States, one in U.K., one in Japan. The data will be looked at, and say, now we know from this that the next trial, we're going to do it a little bit differently. But if the three different groups are measuring different things, you have no way of pooling that data and getting, yet again, ahead of the game. So when we say, standardization, we want to make sure that we're all measuring the same thing.

Q: I don't mean to be dense, but I have enough trouble with political science. (Laughter.) Why is that different from the existing system of publishing a paper in a scientific journal, having peer reviews? How is that different from the current system at the NIH?

DR. FAUCI: How was what different?

Q: Proposing sharing centers, the homogenization of standards or parameters? Why is that different from the current system?

DR. FAUCI: All -- because right now, I can do a trial with HIV and measure -- and I'm going to use words that you don't understand, but just bear with me, they're just concept -- I'm going to measure this type of immune cell and I'm going to measure the viral load by this way. I publish it in a scientific journal; anybody can read it. The next person does it, and he measures another parameter, and another way of looking at the virus, and he publishes -- or she publishes. So now you have two papers in the literature, good science. However, when you say, can we look at this and say, we can learn that this phenomenon exists because they both looked at the same thing -- it's like it's a great study, but we're looking at different things.

So what we're saying is that when we agree on the strategic plan, let's agree that if you do a trial here and you do a trial there, we're going to at least use the same laboratory parameters to measure. Because if you don't do that, you can't compare the results with this trial versus the results with that trial. So we want all of the trials to be comparably evaluateable. That's really the issue.

Q: Isn't there a danger, though, of possibly being in lock-step and slowing development?

DR. FAUCI: How's that?

Q: If you're all going along the same path? If you all agree --

DR. FAUCI: No -- again, don't confuse a strategic plan, which is an overarching way of filling in the gaps. So, for example, most investigators will say you're looking at one thing, and there's this very important gap here that might be -- if you knew what the answer to that gap is, you could then jump-start even more in the direction. If you don't have a strategic plan, you never know where the gaps are, because everybody is working on their own individual thing. So it's not going to impede individual creativity, but it's going to put out a blueprint, so that at least you know what gaps are not filled. So it's not going to be telling people what to do, it's going to provide a framework, so that everybody is looking, at least, at what everybody else is doing.

Q: Nobody would have to be getting a little bit lazy and saying, oh, they'll figure it out, we'll just go along with them? See what I'm saying?

DR. FAUCI: Well, yes, but the only trouble is, that's exactly what's going on right now. That's the problem.

Q: One more. NIH scientists have reporting requirements to make public research developed -- I think it's quarterly. Will this also have reporting requirements? In other words, will this center -- here's what we're doing, here's what we know, here's where we're going?

DR. FAUCI: We do that all the time. In fact, we now -- be it biodefense or AIDS, we have, at the NIH -- and remember, the U.S. federal government, in the form of the NIH and the CDC, is already doing about 75 to 80 percent of all of the action, globally. But what we do is that we regularly have conferences where we bring in our grantees and talk about what we're doing and sharing data. What the enterprise will do, that will make that global, as opposed to just here.

Q: So, in fact, you are extending NIH reporting standards abroad?

DR. FAUCI: I don't know what you -- I don't want to make that statement, because it may get misconstrued. What do you mean, we're extending NIH reporting standards?

Q: -- as I understand it, NIH scientists have to report and to make public the status of their research, what they've found --

DR. FAUCI: But most everybody does that anyway. In fairness to the Europeans and the Japanese, they do that, also. I don't see that as an issue. The European science is excellent, Asian science, Russia -- it's all excellent science, and they all do the same thing, they report it openly.

Q: Sir, this year, the G8, my understanding is, for the first time, included the biodefense to their preparedness program. What is the biggest threat, in your opinion, in terms of --

DR. FAUCI: There are multiple threats, you never can totally predict. But we have what's called the Category A agents, which include small pox, anthrax, botulism toxin, tularemia plague, and the hemorrhagic viruses, such as ebola. Clearly, anthrax is still very much on top because of the ease of being able to make it, and its extraordinary ability to be disseminated.

Q: The U.S. government is prepared to slot $15 million for 2005. What will be the expectations for other G8 nations?

DR. FAUCI: Well, we would hope that -- two things -- that the nations that have not put substantial resources into vaccine development and wish to do so will do so within the framework of this strategic plan, and those that are already doing it will align those resources so that they would put -- so we're hoping that this will generate interest and resources.

Q: -- of the eight G8 nations, Russia has a really dangerous spreading of HIV/AIDS -- so what do you think will be the specific contributions that the Russians will make?

DR. FAUCI: Well, remember, Russia has some extraordinarily good scientists, excellent scientists, particularly in the arena of microbiology and infectious diseases. So we would hope that Russia, as one of the G8 nations, will, in fact, embrace this -- which they have already, I mean, the G8 has embraced it -- but that there will be more resources that go into that. This may be a catalyst to get more resources that are put in by the government of Russia to the vaccine research endeavor.

Q: Could I get you to finish just one sentence. You said -- and I'm paraphrasing -- nations that haven't put significant money into this will do so, and that the framework -- those that are putting significant money in will align their resources --

DR. FAUCI: In other words, if there are countries that do have a significant investment in vaccine, that they will, as they continue to invest in vaccine research, will align it in accordance with what the strategic plan is. So instead of going a different directions, we'll say, you know what we're going to do? We're going to agree that the money that we're spending now, we're going to pay more attention to what the strategic plan is.

Q: Does that mean you're going to ask them to spend more?

DR. FAUCI: You know, I wouldn't want to put in the position of saying that we, as a nation, are telling other people they should be spending more, but the obvious sequitur of that is that we have a serious problem here, we've agreed upon a principle at the G8; yes, we would like other countries to invest more money, absolutely.

MR. BENNETT: Again, I'd like to thank every member of the press who's here. They've been great to work with. I'd like to thank my staff who spent almost a year putting this together. They've done a phenomenal job. And I'd like to tell my wife, I'm coming home soon. Thanks. (Laughter.)

Q: Are you going to tell us about any of the other agreements that are coming out today, or is it just AIDS today?

MR. BENNETT: We'll pump out the paper like we did yesterday.

Q: I never got any paper.

MR. BENNETT: The emails should have been flowing. So if your email box isn't --

Q: Why does it take so long to get the announcements out, and will there be a final leader statement today?

MR. BENNETT: There will be transcripts of all the leaders, and there will be a final G8 statement.

Q: No, the joint statement.

MR. BENNETT: I believe there will be. I haven't talked to a sherpa this morning.

Q: -- something called the chairman's summary, or something?

MR. BENNETT: I don't know if we'll have an actually summit readout.

END 8:39 A.M. EDT