Transcript of Press Briefing

U.S. Department of Health and Human Services
Pandemic Influenza Plan
Wednesday, November 2, 2005

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OPERATOR: Now I will turn the meeting over to Ms. Christina Pearson, Deputy Assistant Secretary for Public Affairs. Ma'am, you may begin.

MS. PEARSON: Hello. Thank you to everyone for joining us today on the conference call. We are here today to answer your questions about the HHS Pandemic Influenza Pan that was released this morning. You should have received materials. They were e-mailed to you. But if you did not, please, you can access all of them at www.pandemicflu.gov. Before we begin, I just want to tell you who we have here today with us. We have Secretary Mike Leavitt. We have Dr. Julie Gerberding of the CDC, Dr. Tony Fauci of NIAID, Dr. Bruce Gellin of the National Vaccine Policy Office. We have Deputy Secretary Alex Azar and Dr. William Raub of the Emergency Preparedness Office here at HHS.

So, Mr. Secretary?

SECRETARY LEAVITT: Thank you and good morning. Our purpose is to speak of pandemics and our National Pandemic Plan.

Just a word about pandemics themselves. Pandemics happen. In the last 300 years of recorded history, 10 have been noted and recorded, three in the last 100 years. Those periods of viruses mount massive pandemic assaults that have made masses ill and millions have been caused to die. They happened before and they'll happen again.

They occur when a virus achieves a form of transmissibility between people. When that occurs anywhere, there is risk everywhere. Good leadership right now is creating an atmosphere of information without inflaming, inspiring preparation without panic. Currently scientists are concerned about the H5N1 virus. It is and remains primarily an animal and bird diseases. However, there is uncertainty about its future. Scientists worry that it is following a pattern that could in fact achieve human to human transmission. If it isn't the H5N1 virus, it will be another virus, because pandemics in fact do occur.

Yesterday the President laid out a broad national strategy. It called on Congress to appropriate on an emergency basis $7.1 billion. Today I would like to go to a step closer in granularity and discuss the HHS portion of this plan. It is essentially the Public Health and Medical Response portion of the plan. I will describe the plan in six logical steps through which a pandemic would likely flow.

The first step I'll refer to as international surveillance. Pandemics have been compared to forest fires. If you think of the world as a vast forest ready for--or susceptible to fire, it only takes a spark to start a forest fire. With a pandemic it only takes a spark to create a pandemic. The spark can come anywhere in the world. As with a forest fire, if you are there when it happens, you can contain the damage. If it's allowed to burn over a period of time, it can become uncontainable very quickly.

In order to have surveillance a network is needed throughout the world, a new in the context of pandemics would mean labs, epidemic investigators, rapid response teams. We hope to have American experts on the ground in areas of particular importance. It will include joint containment plans that we formulate with other nations in the event that containment someplace in the world is possible.

The second portion of the plan I'll reference is domestic surveillance. Once again this means having adequately developed networks of laboratories, medical training for local providers. It means good communication networks so that if the virus occurs and begins to sustain human-to-human transmission in the United States, we know it and we know the parameters of it.

The third portion I will refer to is vaccines. We view vaccines to be the foundation of this plan. The good news is we have a vaccine that's been developed by the National Institute of Health. The bad news is we lack capacity to manufacture a vaccine in sufficient volumes and in the timeframes necessary.

The plan lays out two overriding objectives. One is the development of a 20 million course stockpile of vaccines that would be directed at the current strain. It's very possible that the strain--and likely that the strain would have changed, but it would in fact still produce some level of immune response and would be the best opportunity we have to inoculate early responders and others that would need protection.

The second overriding objective is to provide the capacity to produce in a six-month period 300 million courses of an appropriate vaccine developed from whatever the strain is that has caused the pandemic.

Our efforts will focus on three basic areas.

The first is expanding existing egg-based production. The second would be developing new cell technology, cell-based production technology that would allow vaccines to be produced in new and innovative ways. And the third is adjuvant technology or dose-sparing technology, which allows us to use a vaccine in ways that make it more efficient.

A primary tenet of our effort on vaccines is to assure that all of these are produced domestically.

The fourth category I'll refer to as anti-virals. I wish to emphasize here that anti-virals are an important part of a comprehensive plan, but to focus on any one anti-viral is misplaced. There are uncertainties that anti-virals of any specific origin--there is no certainty that they will be effective and there's no capacity to change the anti-virals to match the virus, and as viruses mutate, they may, in fact, change in a way that would cause the anti-viral to not be effective. There are distribution dilemmas.

I want to emphasize, however, that they are part of the plan, because they're an important part of a comprehensive plan. We will--we have vendor representations that they can deliver as part of our stockpiling effort 20 million courses by the fourth quarter of 2006, and up to 81 million courses by the summer of 2007. We view the anti-virals to be an important asset that will be deployed locally.

You'll see in the plan also $400 million for the development of new and better anti-virals.

The fifth portion of the plan deals with communication; that is to say the need for clear, well-informed information that can be disseminated from authoritative sources at the time a pandemic occurs.

The fifth--rather the sixth is the state and local preparation. This is a critical part of the plan. A pandemic is unique to all other natural disasters. We have recently been through hurricanes, and as large as those events were, they were constrained geographically. A pandemic is not. It's quite likely that a pandemic would be occurring in as many as a thousand or more different locations around the country, and many beyond that in the world. A pandemic is not constrained by time. Most natural disasters happen in the course of a day or two or three. A pandemic will stretch on for a year or more.

So the need for local management in a pandemic is evident; and, therefore, state and local preparation is a very important part of this plan. The President has directed that we move with dispatch to begin working with state and local governments to assure their level of preparation.

This morning we--the President put forward a budget that we are now dealing with Congress on. I would like to just close with one comment.

There is no certainty that the H5N1 virus will mutate into a trans--human-to-human transmissible disease. It's possible that some could say if it doesn't, was this an overreaction? And it may be those who say did we cry wolf? The reality is that if the H5N1 virus does not trigger a pandemic flu, there will be another virus at a later time, and we will have accomplished five important things with this plan.

First, we'll have cell-based technology that will allow us the capacity to produce vaccines in sufficient size and within the constraints of time.

Second, we will have made substantial progress in expanding our annual flu capacity. Each year, we lose as many as 36,000 people from the annual flu, and we struggle to balance our need for domestic flu vaccine. This plan takes that off the table as a problem.

Third, we will have better state and local preparedness for any medical emergency. And fourth, we'll have an international network of disease surveillance that will serve this country and others. And last, we'll have peace of mind of knowing we're ready.

With that, we'll now go to the question portion of the conference.

OPERATOR: Thank you, sir. If you would like to ask a question, please press Star 1 on your touchtone phone. We will announce you prior to asking your question. To withdraw your question, please press Star 2. Once again, to ask your question, please press Star 1. One moment for the first question.

Our first question is from Deidra Henderson from the Boston Globe. You may ask your question.

QUESTIONER: Good morning. Thank you very much for doing this. My question has to do with an issue that's of interest to the drug industry. The President said yesterday that he'll ask Congress for liability protection to help encourage more domestic vaccine production. It's not clear how extensive that liability shell would be. Would it apply solely to therapies developed for pandemic preparedness or would drugs already on sale also be eligible?

SECRETARY LEAVITT: It would apply only to pandemic-related vaccines and medications.

QUESTIONER: Thank you.

OPERATOR: The next question comes from Todd Zwillich of WebMD. You may ask your question.

QUESTIONER: His. Thanks. Two quick questions. Mr. Secretary, this morning in the hearing, of course, Senator Harkin expressed some concern about this 75/25 dynamic in terms of having States pay for antiviral. You seemed to correct him at one point by telling him that actually the Federal Government pays for the majority under the plan of antivirals. Can you help us understand the difference between those two things?

SECRETARY LEAVITT: Yes. We've identified 44 million doses that will be paid 100 percent by the Federal Government. 6 million doses will be paid for by the Federal Government entirely for the purpose of being able to deploy on a spot basis where they might be needed. And then the 31 million doses will be--the Federal Government will assist the States in meeting their responsibility for public health by sharing the cost.

QUESTIONER: 75/25 approximately in most cases?

SECRETARY LEAVITT: Well, on that 31 million.

QUESTIONER: On that 31 million, okay. And the second question is, can you describe or can someone describe what the plan says about potential transportation restrictions, either domestically or internationally in the event that a pandemic is identified?

SECRETARY LEAVITT: I indicated to you that this is dealing with the public health and the medical portion. Those details will be developed as we go forward with the Department of Homeland Security and the Department of Transportation.

QUESTIONER: They haven't been developed yet?

SECRETARY LEAVITT: Not in their entirety.

QUESTIONER: Okay.

OPERATOR: Jeremy Mineer of the Chicago Tribune, you may ask your question.

QUESTIONER: So I guess following up on that, thanks very much. So this does not include things like economic impact, how to recover from the inability to ship food supplies where they're needed, kind of keep commerce in place. I think there's been a little bit of initial criticism that it didn't address some of those questions.

SECRETARY LEAVITT: It's important to recognize what this plan is and what it is not. The President laid out a broad national strategy, and we are now releasing the medical and public health portion of what will be a national plan. The national plan also needs to include integrated plans from other departments of the Federal Government, but also integrated plans with State and local governments and other private interests. This is a network that--this needs to be a network approach to pandemic protection.

QUESTIONER: One more thing for Tony Fauci, and [unintelligible]. You said that it's perhaps not likely that this would happen this year. I've never quite understood what the basis for that, saying that is. I mean are there things, properties of this virus, adaptations it would need that make you say that?

SECRETARY LEAVITT: Dr. Fauci?

DR. FAUCI: Yeah. When you talk about a percentage probability of something happening, first of all, when you're dealing with influenza of any type, particularly a pandemic flu, we don't know, it's uncertain. So you can't say anything definitively. If you look at probabilities, just on the laws of probability, it is unlikely that something is going to happen. In other words, is there a greater than 50 percent chance that this is going to happen in the next couple of months? I would say as a public health person and an infectious disease person that that would be unlikely.

But in the same breath as I say that, I would say that I am prepared for it happening tomorrow, and I would not be surprised if it did. But if you just go up to 30,000 feet and talk about general probabilities it is not a probable issue that it would happen.

But again, please make sure that when you hear us say that, that does not take away from the fact that we are assuming the worst case scenario.

SECRETARY LEAVITT: This is Secretary Leavitt. As I have probed this question with scientists and epidemiologists, a comparison is often drawn to the virus responsible for the 1918 pandemic. While there are genetic and symptomatic similarities, we know nothing about what happened in the 10 years prior to 1918, and so it's very difficult for us to go beyond what Dr. Fauci has said.

QUESTIONER: Good. Thanks very much.

OPERATOR: Jeff Nesmith of Cox Newspapers, you may ask your question.

QUESTIONER: Thank you. I have a two-part question. One part's for Dr. Gellin and one is for Dr. Gerberding. Dr. Gellin, you have a PDF, I mean an RFP or some similar thing on the street for a common or cell-based pandemic flu vaccine, which I think closed in June. I was wondering, have any contracts been issued, and if not, when do you think they might be?

And the question for Dr. Gerberding is about the same for her request for proposal for a monovalent vaccine, I guess using eggs. I don't know if that was the Chiron thing I read about or if that's still pending. Can I get some kind of status on where those two actions are now?

DR. GELLIN: This is Dr. Gellin. I'll go first. It's an RFP, request for proposal, and in fact, this is the second series of RFPs that we put out. We put out one a year ago to do the same thing, to begin to accelerate the development of cell-culture based influenza vaccines with the goal of having a vaccine that could be licensed in the United States and building facilities in the United States. And we made one such award a year ago, and that project is off and running.

In the spring we put out an RFP to begin to build on that, and those are still being evaluated, and so therefore I'm limited in what I can say about that, given the procurement process. But needless to say, that we went ahead with that because of our concern about increasing capacity and moving towards cell-based production.

QUESTIONER: Before Dr. Gerberding answers, Dr. Gellin, a year ago, what was that? Was that to Sanofi Pasteur?

DR. GELLIN: That was to Sanofi Pasteur. I believe it was a $97 million five-year contract, again, and we're pleased with the progress that they've been making towards that goal.

QUESTIONER: Okay, thank you.

Dr. Gerberding?

DR. GERBERDING: When you're talking about monovalent, what that's about is purchasing vaccine in bulk before it separated into the vials that contained three different strains of the virus, so as an extra insurance policy we put out an opportunity for manufacturers to prepare bulk vaccine to augment our seasonal vaccine supply. This doesn't have anything to do with pandemic vaccine. This just has to do with an insurance policy. In case we ran short of the regular seasonal vaccine, we could late in the season convert that bulk into vials of vaccine if we need it for an especially severe fly season.

Also in some cases, that monovalent vaccine possibly could be used for the following year if we had the exact same need for that strain in the subsequent year.

QUESTIONER: Thank you, ma'am.

OPERATOR: The next question comes from Maggie Fox of Reuters. You may ask your question.

QUESTIONER: Thank you. I want to ask first of all, you talked about a vendor.

MS. PEARSON: Maggie, could you speak up a little bit? We unfortunately have a very bad connection and can't really hear you.

QUESTIONER: Sure, sorry about that.

Secretary Leavitt, you talked about a vendor making representations that they could get us 20 million doses or courses of antiviral by 2006. That seems a bit faster than we thought before, and I've heard some hints that maybe Roche has made some deals or something.

And I'd also like to ask a little bit more about the details of what's being done to encourage vaccine makers to accelerate what they do, some of the things Dr. Fauci and Dr. Gerberding, that we've been talking about for years. Do we have any details on how this money is going to be spent to encourage them?

SECRETARY LEAVITT: I'll ask Dr. Gellin to talk some, or Dr. Raub, about the vendor representations on delivery, and then I'll go from there.

DR. RAUB: We've talked to the companies that make neuraminidase inhibitors. GSK makes Relenza and Roche makes Tamiflu. Part of the discussions have to do with their investments in their own capacity. As you probably know, they began last year to build some U.S.-based capacity that's now coming on line, and I think that's going to be a source of some of this capacity.

But at the same time, given our interest in more quantities of antivirals as well as other countries, they are beginning to make those investments in capacity and have told us that they would be able to deliver the 25 percent number, the 81 million treatment courses that the Secretary mentioned, by mid-2007 based on their new capacity.

SECRETARY LEAVITT: With respect to vaccines, let me just generally outline our approach without going into any specifics because of proprietary interests.

As indicated earlier on the call, we have engaged in an RFP earlier this year. That RFP revealed a number of promising technologies that in our judgment warrant further development. There will be an expectation that vaccine manufacturers come to the table with capital and intellectual property. We will then evaluate those assets and be prepared to bring assets of our own to stimulate their development. There will undoubtedly be investments made in research and development of a number of different technologies.

After a first round, we will reevaluate to see which continue to show the best promise and we'll continue to fund those and eliminate those that are not. We will manage the procurement toward producing an outcome with several different manufacturers who have the capacity to deliver vaccines.

There will be a serious of principles that we'll be using to evaluate them. Among those principles are, first, that production must be domestic. We're interested in developing production capacity that's inside the confines of the United States. Second, producers that develop the lowest-cost, highest-quality. The third will be a need for flexibility in capacity to be able to move capacity from one technology to another based on the promise. And fourth, we have an ongoing interest as I stated earlier in having a continuous benefit in the annual flu.

Somehow we'll need to keep this new production well deployed or warm, and we see that as being a very important public health benefit. I also indicated we'd be investing in three general categories. One will be cell based, the second will be expansion of our egg-based production, and the third will be in the area of adjuvants.

I'll invite Dr. Raub and Dr. Fauci to add to that answer.

DR. FAUCI: Yes. Thank you, Mr. Secretary. There are several of the components that the Secretary had been discussing with the pharmaceutical manufacturers of vaccines. Some of them require issues that can be handled without financial investment, some of the issues regarding liability and regulatory cooperation and collaboration. But there are those that fall under the category of shared risks, and the Secretary very nicely outlined virtually all of them.

There's a shared risk for a company to make a move from their standard operational procedures be they in eggs or any other way to make a transition, for example, to cell based or to try and retrofit or upgrade their manufacturing plants to meet the needs and the demands that we are facing now with what we need to supply for a pandemic flu. All of these things, we don't expect the risk will be taken entirely by the pharmaceutical company, and investments in that shared risk are part of the package that we're talking about.

MS. PEARSON: I think we're ready for the next question.

OPERATOR: John Wilkerson of FDA Week. You may ask your question.

QUESTIONER: Would FDA be willing to use European data to approve cell-based manufacturing facilities in order to speed that technology? I ask this question because apparently Roche is applying for a cell-based flu vaccine in Europe but has yet to do so here.

DR. FAUCI: The FDA has manifested a willingness to look at any and all data. Obviously, when you do clinical studies there are certain guidelines that need to be followed in order to ascertain and to confirm that the data was collected in a way that it's actually usable within the framework of our own regulatory structure. But on many occasions the FDA has made it very clear that they are open to looking at and examining data from any source provided it's collected in an appropriate manner.

MR. WILKERSON: Does FDA have criteria for approving a cell-based vaccine?

DR. FAUCI: They don't have predetermined criteria that is up front and listed in a menu fashion. They do require GNP in all of their production facilities. So I think one of the things that comes up is that if you're going to be collecting data on a product that was made, it is not only the integrity of the clinical trial that they would examine, but importantly they'd have to examine the facility within which the product was made, its consistency, it's lot to lot variability. All of those things are very important, as you know, in the approval process.

SECRETARY LEAVITT: This is Mike Levitt again. I just want to build on your question and the previous question and make clear that in our meetings with pharmaceutical companies, three things have become clear. One is the need for liability relief. The second is some level of certainty that there will be a buyer for a product. And third is regulatory streamlining so as to meet our time frames.

MR. WILKERSON: Thank you.

OPERATOR: Our next question comes from Erin Sykes [ph] of NBC News. You may ask your question.

MS. SYKES: Hi. Good morning. I was just--a very quick question. Just wondering. Getting back to the basics, the plan is going to be implemented for people in the population to get the vaccine as quickly as they can, but what kind of plan is in place just for communications concerns as far as now people are going to the doctor's office thinking that they have bird flu already.

What kind of plans are in place to clarify the differences between avian flu and bird flu and why this plan is in place now? And if there is a pandemic, are we going to see similar distribution tactics, cheering our elderly people and children below 24 months going to be getting the vaccine first?

SECRETARY LEAVITT: I'm going to ask Dr. Gerberding to comment on this, but let me make a couple of things clear. One we need to make a distinction between the annual flu and pandemic or avian flu.

We're talking today about the development of capacity to develop a vaccine, not a plan to give vaccine to 300 million Americans. We're talking about the capacity to make it.

We anticipate if a pandemic develops, that we will have the ability to get the--identify the strain and convert it into a vaccine, but we don't have the capacity to make it. So we're only talking about the capacity, not a plan to give vaccine to people.

Dr. Gerberding, do you have any further comment on that?

DR. GERBERDING: I think you made the appropriate distinction. We have seasonal flu here now. We have a vaccine for it. Our challenge is to get people vaccinated because we know that's the best way to fight the flu, and we're encouraging everyone to get their seasonal flu vaccine.

Pandemic is still something that's a potential, but not actualized, and what we're doing with the President's proposal is creating the capacity to make that vaccine, but we hope we never have to use it. We just need to be able to make it and use it if we need it.

OPERATOR: Our next question comes from Tony Pugh of Knight Ridder Newspapers. You may ask your question.

MR. PUGH: Thank you. Secretary Leavitt, I wanted to ask you about a previous comment you made regarding the state flu preparedness plans that have come into CDC. You had said earlier that, for the most part, they were not adequate and that they would have to be revised. I'm wondering if you could describe a little bit what some of the general shortcomings are, and what some of the revisions you think are necessary to bring them in line with the new plan.

And my second question has to do with some of the requirements that the HHS plan makes on local health departments. It calls on them to do a lot of surveillance, a lot of reporting, a lot more work in the event of a pandemic. And many of the groups that represent those health departments say that they are strapped for money, and that the President's budget calls for cutting $130 million from those very departments.

I'm wondering if you could describe what the Administration is proposing to do to help those departments with this increased load that they would have in the event of a pandemic?

SECRETARY LEAVITT: I'll deal with the second part. I'll ask Dr. Raub to talk about the state plans.

With respect to the planning, for the last two years, through a series of cooperative agreements dealing with public health emergency preparedness, we've had a specific provision in there to encourage planning for pandemic influenza. And as you indicate, the states have addressed that.

Almost to a state, the major uncertainties they have had to this point are ones that we're now addressing, namely will there be vaccine? How much will be available? Where will it come? What about anti-viral drugs?

So for many of them, certain elements they have not been able to wrap up planning without some of the federal government's position being defined better, and that's what we're addressing now.

On the other hand, many things they can and should address with respect to social distancing, as it's called, movement restrictions, other practices that could involve closing schools or discouraging public gatherings--things that would help to contain or at least slow the progress of an infection--we find the plans uneven in that area. Some have addressed it quite thoroughly; others have more work to do. In the coming weeks and months, we will be working with the state and local officials with a view not only to getting more specificity, building on a body of guidance that is in the HHS document now being issued, a series of 11 supplements that provided considerable detail on tactical information that will be valuable to the states, but also working towards some common features, some interoperability, such that there can be smooth interactions on the plans within states, between states, and between states and the federal government.

MR. RAUB: Okay. With respect to the second part, let me just emphasize that public health is and should remain a state and local function and that these are very important. The important reason for that is that every community is different and requires a different approach.

The role of the national government is to assist them in meeting that obligation, and we will continue to do that. This plan provides many different circumstances where that's the case. As you mentioned surveillance, we are working with the states to develop what we call biosents, where we're funding in large measure the development of a system to gather real-time data.

With respect to communication, we're providing communication equipment and--communication assistance--laboratory both equipment and training. We are assisting in the procurement of anti-virals, as I indicated earlier.

The $130 million that you referenced was not reduced. It was just redirected into a different category.

MR. PUGH: Thank you.

OPERATOR: Our next question comes from Nellie Bristol of the Lancet. Please ask your question.

MS. BRISTOL: Hi. Thank you. Do you have any estimates on how long it will take until we have domestic production of the number of vaccines needed to meet the six-month goal?

SECRETARY LEAVITT: Dr. Gellin will respond.

DR. GELLIN: Well, I think that you'll want to go back and talk a little bit about the technologies.

Clearly, as we've been discussing, the vaccines are currently made in eggs. In the near-term, that's the multiplier, to be able to expand the number of influenza vaccines that can be manufactured in eggs.

At the same time, essentially on a parallel track--and we hope a fast moving parallel track--is bringing in the cell culture technology. There are a number of different companies that have already begun to work on this, and they're at different stages in development. And we're optimistic that they could start being--we could have licensed vaccines within the next four or five years.

DR. FAUCI: Just one added point on that. I'm sorry. This is Dr. Fauci. Another point on that that would impact this entire process of the time frame has to do with another issue that's going on in parallel, as Dr. Gellin said, and that is the studies with adjuvants. We have some studies that are now available, not on H5N1, but on H9N2, which indicate that adjuvants can actually successfully expand your capability.

In January of '06, we will begin with Chiron, as well with Sanofi Pasteur, adjuvant studies on the H5N1, and we will probably have some data on that as we get into the late spring and early summer, which can inform us I think very importantly as to what the dosage that we originally projected for and how we can truncate that regarding the quantity of antigen, as well as the time frame.

So all of that is going to factor into the time frame of when we'll start having doses available.

SECRETARY LEAVITT: I'm going to ask Dr. Fauci to describe for some of you who may not follow this as closely as others how the dosage is arrived at and why that's important, and then describe the role of adjuvants in that calculation.

DR. FAUCI: Thank you, Mr. Secretary. This is Tony Fauci again. The standard dose that you give each year is 15 micrograms without adjuvant for the seasonal influenza. You require a relatively small dose because there is a fundamentally primed population. Many of the people who get vaccinated have either been exposed to influenza before, and even though it isn't with the same virus, there's enough similarity that you get what we call cross-priming.

SECRETARY LEAVITT: Why don't you describe what an adjuvant is and how that works.

DR. FAUCI: An adjuvant is a substance that amplifies, expands and heightens the immune response to any protein or other substance that you give simultaneously with an antigen. So if you were to give the influenza killed virus to an individual, they would make a response that's at a certain level. If you give it together with an adjuvant, almost invariably you would have a greater degree of response, the height of the response, but also the breadth of the response. There is some indication that the degree of cross-reactivity among similar strains is enhanced significantly when you give it with this adjuvant or this expanding compound.

SECRETARY LEAVITT: For the nonscientists on the phone, think of it as Hamburger Helper for vaccines.

[Laughter.]

DR. FAUCI: Very well, Mr. Secretary. That's true.

The situation as you know with the original data that was made public this summer was that in order to get to the dose response curve that would predict protection for the H5N1 with Sanofi Pasteur required 90 micrograms followed in 4 weeks by 90 micrograms without adjuvant. We anticipate and hope, and again only the clinical study will prove it, that if you give adjuvant in your dose response curve you may be able to get to that critical point of a predictive immunity with a much lesser dose than the 90 plus 90. If in fact that occurs, that would impact the time table that you questioned about.

MS. PEARSON: Operator, this will be our last question.

OPERATOR: Thank you. One moment. Mr. John Wellerman [ph] of Bloomberg News, you may ask your question.

MR. WELLERMAN: Actually, I have two questions. First of all, I wanted to find out why the estimates of deaths from the pandemic increased so much. I believe last year studies said that it might be 200,000 people killed by pandemic. This iteration says 1.9 million.

And I also had a question about whether you think a wider flu vaccine, annual recommendations might keep production capacity warm for a pandemic.

SECRETARY LEAVITT: I'll ask Dr. Gellin to answer the estimates and I'll ask Dr. Gerberding to talk about the annual flu benefit of keeping this production warm.

DR. GELLIN: Actually in the plan that you'll read we actually provide two estimates and one of them is based on the 1957-1958 pandemic which in looking back over pandemics was relatively mild. The difference in pandemics is the virus itself, and particularly in how much disease it may cause, not necessarily in terms of how transmissible it may be.

We felt that it would be important that we have a worst-case scenario to make sure that our planning efforts were measured against that. So we also have the model of the 1918 pandemic, and that's what leads to these higher numbers.

We don't know what the H5N1 virus will do, we don't know what any virus will do, but we felt that we would be best suited to have our preparations based on that worst case which is in modern memory is 1918.

SECRETARY LEAVITT: Dr. Gerberding?

DR. GERBERDING: Yes. With respect to the overall impact of seasonal vaccine and keeping the factories warm, so to speak, for a long period of time we've been expanding the list of indications for use of seasonal influenza vaccine. We're taken a science-based approach. So when the data are available to indicate that there's benefit to a group of people, then our advisory committees have recommended expanding vaccines.

Of course, in theory we would like to expand the indications for influenza because the manufacturers will make more flu vaccine if we use more flu vaccine, and this is a very good way for us to develop a more robust manufacturing capacity over time. But the investments that we could make in augmenting the production and capability for pandemic flu under this proposed initiative would also help us have a much more robust manufacturing capability for seasonal flu, and that's one of the advantages that the Secretary mentioned in his opening remarks that while we're focusing on pandemic flu, the investments we're making are going to pay off for overall preparedness in many other beneficial ways.

DR. FAUCI: Yes, and if you talk to the manufacturers themselves apropos of what Julie said, that if you were to give them a proposal and say why don't we just build a bunch of factories that are just there ready to go and having the personnel ready to work on it but we don't use until we get a pandemic situation? And the answer to that is that you just can't do that. You have to have those skilled people working on a yearly basis around the seasonal flu to keep them to be able to be skilled enough to make it happen, and the best way to do that is to put them to work on making seasonal flu and increasing the number of people that we have available to get flu. So it really is part of keeping the intellectual and skilled capacity warm as opposed to just keeping them in reserve.

SECRETARY LEAVITT: This is Mike Leavitt. Let me just sum up, once again saying that a virus is a networked enemy and if it is approached, to borrow a computer analogy, with a mainframe response, we will not succeed. A networked enemy will overcome a mainframe response. We have to have a network of response and that means a network internationally, a network in terms of all federal agencies, a network in terms of the way the federal government interacts with the state and local governments, and the way we interact with the private sector.

What you have seen today is the medical and public health component of that network, and much will be added to this as time goes forward.

MS. PEARSON: With that we're going to conclude today's phone call. I appreciate everyone joining us. Before we hang up I just want to remind you of a few things. First of all, if you have any media inquiries you can always reach us through the HHS Press Office, that's (202) 690-6343. And if you are looking for the HHS Pandemic Influenza Plan and other information, we have a website that was launched yesterday by the President. That is www.pandemicflu.gov. I would point you in that direction. The HHS plan is up there as well as press releases, speeches, fact sheets and other materials from many sources.

So with that, thank you very much for joining us today, and we'll be talking to you soon.

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