Next flu pandemic: What to do until the vaccine arrives?

Next flu pandemic: What to do until the vaccine arrives? Scientists call for more study of routine preventive measures during annual flu season.

November 10, 2006 -- Experts believe the world is overdue for influenza pandemic. However, unless effective action against pandemic flu is taken now, we are in "dire straits," according to a paper published in the November 10 issue of Science. The articled titled, "Next Flu Pandemic: What to Do Until the Vaccine Arrives?," calls for research during the regular season flu season to better understand the effectiveness of non-pharmaceutical interventions such as social distancing, hand washing, face masks, and the like.

"These are ironically similar to the measures used in 1918 to combat the greatest of all known influenza pandemics, but there's a lot we don't know about what may very well be our best defenses," says lead author Stephen Morse, PhD, associate professor of Clinical Epidemiology in the Department of Epidemiology at Columbia University's Mailman School of Public Health. According to Dr. Morse, unfortunately, there are no readily accessible compendia of best practices or even comprehensive databases of community epidemiologic data, which might help to design the most effective interventions. "As the weather turns cold and the regular flu season is upon us, there is an opportunity to prepare and move ahead with community studies and clinical trials in humans."

How influenza is transmitted, from person to person, whether by large droplets or by fine particles, may seem to be a specialist issue, observes Dr. Morse, but "it has a direct bearing on how far apart people should position themselves to prevent infection and on whether inexpensive face masks might be useful."

Dr. Morse's coauthors are Richard L. Garwin, PhD, IBM Research Laboratories and Paula J. Olsiewski, PhD, of the Alfred P. Sloan Foundation. This spring, the authors organized a workshop on personal and workplace protective measures for pandemic influenza held at the Mailman School of Public Health and funded by the Alfred P. Sloan Foundation.

"There are many basic things we don't know about how influenza is transmitted," said Dr. Garwin of IBM. "For example, it appears that a relatively low number of people catch the flu from another person. Breaking the transmission chain with non-pharmacological measures has proved challenging, but the prize is enormous."

Often also neglected, according to the authors, are protective measures that fall between individual protection and the whole population -- "the excluded middle"-- such as buildings, facilities and smaller areas such as work places and homes. Examples might include improved air-handling systems, room-size fans, portable air-filtration systems, or physical barriers such as room dividers and doors.

"We should systematically address knowledge gaps now during upcoming flu seasons rather than wait to empirically test measures ad hoc when the next pandemic is upon us," says Dr. Morse. ###

Contact: Stephanie Berger sb2247@columbia.edu 212-305-4372 Columbia University's Mailman School of Public Health

Technorati Tags: 1918 Pandemic and Influenza Virus or CDC and Pandemic and Avian influenza or Bird Flu and H5N1 or adenovirus and recombinant or vaccines and Epidemiology

White House Press Briefing Pandemic Influenza (VIDEO)

Technorati Tags: President Bush and White House or Scott McClellan and Fran Townsend, or 1918 Pandemic and Influenza Virus or CDC and Pandemic and Avian influenza or Bird Flu and H5N1 or adenovirus and recombinant or vaccines and Journal of Virology or Pandemic Influenza

Press Briefing by Scott McClellan and Homeland Security Advisor Fran Townsend, FULL STREAMING VIDEO, James S. Brady Briefing Room, 12:35 P.M. EDT. Fact Sheet: Advancing the Nation's Preparedness for Pandemic Influenza and In Focus: Pandemic Flu

MR. McCLELLAN: All right, good afternoon, everyone. You should have our copies of the implementation plan for the pandemic influenza, and I've got our Homeland Security Advisor with me today, Fran Townsend, to give you an overview of that and then take your questions on it.

And with that, I'll just turn it over to Fran.

MS. TOWNSEND: Ladies and gentlemen, thank you. As you know, we -- the President has had us release today our implementation plan that relies on the national strategy for a pandemic influenza. The strategy was initially released in November of last year. And we assembled an interagency team led, on the Homeland Security Council side, by myself and Dr. Rajeev Venkayya, known to many of you.

The team really assembled the best and brightest of health professionals throughout the interagency community, and we benefit from their expertise in the context of this report.

I should make clear, from the outset, that we do not know whether the bird virus that we are seeing overseas will ever become human -- a human virus. And we cannot predict whether a human virus will lead to a pandemic. Moreover,

there is no way to predict how severe a pandemic would be. In the plan, we describe a wide spectrum of severity, and we are candid that we should understand and prepare the worst-case scenario.

This brings us to the next stage of our planning efforts. I have the privilege of releasing and describing to you the implementation plan that is relying on the strategy, as I've mentioned. As you know, the strategy was accompanied by a budget request the President transmitted to Congress for $7.1 billion to support his strategy. Shortly after we released it, as I mentioned, we assembled an interagency team of health professionals and experts. The plan that they wrote, the plan that we have assembled, is a road map that the U.S. government will follow to translate the principles of the President's strategy into tangible actions by all federal departments and agencies.

The plan outlines how the federal government will invest the $7.1 billion that was requested from Congress, including $3.8 billion that has already been appropriated. This is not the beginning of our investment in pandemic preparedness. We have invested already over $6 billion in public health and medical infrastructure since 2001. Many of those investments are directly relevant to pandemic preparedness. The plan is a comprehensive one divided into chapters addressing major considerations raised by a pandemic influenza: protecting human health, protecting animal health, international considerations, border and transportation security, public safety and security considerations, and then planning for considerations of institutional organizations. Each chapter describes the relevant considerations, roles and responsibilities of federal and non-federal entities, the specific actions the departments and agencies will take to address the pandemic threat, and expectations of our non-federal partners in this effort.

The plan contains over 300 specific actions for federal departments and agencies, because we think it is important to be able to measure and demonstrate the effectiveness of our efforts. Every one of the federal actions included in the plan included a measure of performance and a time line for implementation of that action.

Given the size of the document, it is worth highlighting some of the priorities that we have identified, including advanced international capacity for early warning and response, limiting the arrival and spread of the pandemic to the United States, providing clear guidance to all stakeholders, and accelerating the development of countermeasures.

We recognize that it is unusual for the government to provide this amount of detail about its plans, but we think it is essential to demonstrate to the rest of the world, our international partners, state and local governments, business, families, individuals, just how seriously we take this threat.

The implementation plan devotes a full chapter to the United States government's response to a pandemic, and describes in detail the actions we will undertake at each stage before, during and after a pandemic. It describes the policy decisions that we will confront and make throughout the response, recognizing that many of these decisions cannot be undertaken until we know the characteristics of the actual pandemic virus, if and when one emerges.

Finally, in Appendix A, we have offered practical advice to schools, elementary and university; business; private sector; families and individuals for them to consider in their preparations.

While the federal government has many responsibilities here, we cannot forget that a pandemic occurs because of the spread of the virus from one person to another. This means that individual actions are perhaps the most important element of our preparedness and response activities. We depend on everyone outside of the government to take this as seriously as we do, and to put systems in place to reduce the transmission of infection, and to put plans in place that will mitigate the impact of a pandemic on human health and the functioning of our communities. We also believe that our partners outside of government will complement our approach, the approach that we are taking to pandemic preparedness.

In addition to describing the actions we are taking, we provide a great deal of detail in the rationale behind our approach and our framework for future decision making.

I'd like to take a moment to describe what the plan does not cover. It is important that -- to point out that there are things in the implementation -- that the implementation plan does not answer, and it is not intended to do so. For instance, it does not answer all the questions about vaccine and antiviral medication prioritization. We are actively discussing those issues across the government and incorporating the scientific epidemiologic and modeling data that is being developed in real time.

Another example is the specific interventions that we will undertake at our borders and ports of entry to slow the entry of disease. We recognize that we cannot make these decisions in a vacuum, and must consult with our international partners to ensure that we adopt a consistent approach.

It was impossible to capture in a plan of this type the full spectrum of planning that we have asked every department and agency to undertake. Those details are captured in department and agency specific plans which were completed in draft form on March 31st. And I would encourage you, to the extent you have questions about specific department or agency implementation plans, to direct your questions to them.

The President has given clear direction to departments that their plans must show, first, how they are going to protect their employees and create a safe work environment; second, how they will identify and ensure continuity of operations at times of significant and sustained absenteeism; third, how they will support the overall federal response to a pandemic and undertake actions contained in the plan; and fourth, how they will communicate pandemic preparedness and response guidance to their stakeholders -- public, private, state, and local governments.

The administration takes this threat seriously. And therefore, the actions contained within this plan -- we take the actions contained in this plan seriously, which is the reason that we have assigned performance measures and aggressive time frames. No one should leave with the impression that this work is only beginning today. Many of these actions began weeks or months ago. In some cases, we have already made -- seen remarkable performance and results despite laying out very aggressive measures for action.

For instance, one of the actions in the plan is to expand the Medical Reserve Corps, a community-based program of volunteer health and medical providers, by 20 percent. That meant from 350 to 420 chapters in 2006. That objective was placed in the draft plan early in 2006, and the Medical Reserve Corps has already achieved it.

You will see additional concrete examples of progress in the coming weeks, including advancement in our vaccine efforts, which represent the foundation of our pandemic preparedness; translation of the recent modeling efforts to strategies for states and localities to protect their citizens during a pandemic; additional pandemic preparedness guidance for businesses, critical infrastructure providers, families, and individuals; expansion of a new office at the Department of State, the Avian Influenza Action Group, an interagency body that can rapidly gather information and deploy cross-government personnel, material and other capabilities to assess and respond to any international situation of concern.

These are just a few examples of the additional progress you can expect to see. We intend to track the implementation of action contained in this plan through the Homeland Security Council. And at the end of Chapter Two, you will find additional examples of actions we have already undertaken. This will be a dynamic process. We intend to update and revise the implementation plan on a regular basis as our preparedness, the state of technology, and our understanding of the threat evolves.

Congress has appropriated the first $3.8 billion of the $7.1 billion requested and necessary to support these efforts. We will work with Congress to secure the remainder of the necessary funds, including $2.3 billion in fiscal year '07 and an additional $1 billion in fiscal year '08, to achieve the objectives in international health surveillance and containment efforts, medical stockpiles, the domestic capacity to produce emergency supplies of pandemic vaccine and antiviral medications, and preparedness at all levels of government.

As you can see, we have taken an unprecedented level of activity to address this threat. But let me say a few words about the threat. First of all, a human pandemic has not begun, and we cannot say whether or not a pandemic will begin. Right now, it is relatively difficult for the current bird influenza virus to infect humans. Despite a widespread outbreak, the virus has only infected 205 people, and killed 113 of those infected. However, it is possible that if the virus undergoes genetic changes, it could signal the start of a human pandemic.

Given the pattern of history, which suggests that bird flu viruses played a role in pandemics over the past century, we cannot ignore the possibility that this virus could evolve into one that infects and is transmitted to humans. At present, scientists believe that there is a risk, that the virus is more likely to be acquired and be transmitted between human in areas where there is widespread outbreaks of virus and birds, and significant contact between infected animals and humans. These are the current circumstances in many parts of Asia, Africa and Europe.

If this develops into a circumstance where there is efficient human-to human transmission, we will take immediate action to prevent or to slow the spread of the infection, including entry and exit screening, restrictions on movement across borders, and consider the rapid deployment of antiviral medications in coordination with our international partners.

The key elements of an international response effort include, first, agreed epidemiological triggers for international response and containment, the rapid transparent reporting and sharing of samples, rapid response teams, stockpiles of countermeasures and logistical support for an international response.

Minimizing the opportunities for the virus to mutate, and helping other nations to prepare should a pandemic virus emerge is a global responsibility, and is also the first line of defense for the United States. The U.S. has pledged $334 million to strengthen preparedness, response and containment abroad. We are working bilaterally with nations and also helping to improve the capacity of the World Health Organization and other international partners to lead the international response efforts.

To highlight the importance of this issue to international governments, in September of 2005, at the U.N. General Assembly, the President launched the International Partnership on Avian and Pandemic Influenza to heighten awareness of the threat and to work to establish resources that will help prevent, detect, and limit the spread of animal and human pandemic influenza within and between national borders.

We will have to act fast to see if evidence that the virus is evolving into one that presents a greater danger to humans -- in other words, we cannot afford to be complacent. But rest assured, our investment now, regardless of whether there is a human pandemic based on the current avian flu, will serve to strengthen and better protect the American people not only from pandemic flu, but from bioterror and other public health emergencies.

While the human pandemic threat is unpredictable, the spread of influenza in birds is predictable. Nearly 20 countries have identified the virus in their bird populations since the start of February of this year. In addition, in 2006, the virus has been identified on two new continents -- Europe and Africa. It is possible, in fact likely, that the virus will appear in our wild bird population this year. As we speak, scientists are examining birds that have migrated to the U.S. from Asia and Europe to gain early warning of its arrival.

It is critically important for me to point out that the arrival of avian flu in our wild bird population will not necessarily represent a risk to our domestic poultry population. The poultry industry has excellent biosecurity practices in place that limit or nearly eliminate the likelihood of contact between poultry, wild poultry -- between domestic poultry and wild bird populations. The industry is also constantly on the lookout for any new infections in their bird populations, whether an avian influenza virus or something else. And when they find something -- and this has happened several times in the past with different viruses -- they take swift action to eradicate the infection.

Even if the avian flu virus were to make its way to our domestic poultry population, we can say with confidence that the risk to human health is exceedingly low, as long as people follow the usual practice of thoroughly cooking poultry before eating it.

Secretaries Johanns and Leavitt have spent a lot of time explaining what it means to have the virus here in birds, and the limited risk that poses to human health. It is a message worth repeating. We are not in the midst of a human pandemic, but we cannot predict when one will happen. This is why it is important for everyone to prepare. If the H5N1 avian bird flu virus appears in birds, it will not signify the start of a human pandemic, and will not necessarily represent a threat to our domestic poultry population. No matter what happens, properly cooked poultry kills the virus and eliminates the risk to human health.

I hope that I've been able to provide you sort of with an overview and some insight into our thinking, and the effort that went into drafting the report. And I look forward to taking your questions.

Q There's already some criticism that you're putting out a lot of steps that you already knew that you needed to take to prevent the spread and to prepare. Can you respond to the criticism of that, and why more of these 300 steps that are outlined have not been completed already?

MS. TOWNSEND: Many of them are underway and great progress has already been made. Additional steps have to be taken. And for that reason, we set very specific guidelines and targets, objectives. I think it's a misnomer to say that we haven't been planning before this. You're sort of in a no-win. If we didn't put out a plan, that would have been the criticism. The fact is, we have a responsibility to the American people, as well as to state and local governments, to provide them with our expertise, our insight, our advice on how best to prepare, and then to work with them in advance of a crisis to ensure that we understand what they expect and will need from us, and to help them to minimize and mitigate against the spread of the disease.

Q Stockpile status -- how many doses have been manufactured, and who are the lead manufacturers? And where does that stand right now? And how much more is needed?

MS. TOWNSEND: I would say to you that there is no question, we do not have enough in the stockpile for every American. And the fact is, the President, concerned about that, met with manufactures late last year to encourage them to return stockpile and production capacity to the United States.

There are a number of reasons for that -- liability, legal liability in the vaccine industry chief among them. The fact is that the plan incentivizes both the R&D technology that is moving from egg-based to cell-based technology to produce vaccine, and sort of working with the vaccine production manufacturers.

This is a serious, long-term issue. But you should also recognize that one of the reasons you don't have the vaccine is you can't produce it until you actually know the genetic makeup of the virus that is the basis of the pandemic. For example, Secretary Leavitt, as you know, came out and said, based on the current bird flu, we began vaccine production. That's mutated again and we're beginning a second stage of vaccine production, based on more recent developments evolving in the virus itself. We'll have to continue to do that, and that takes time.

Q How many doses do you have on the second stage of what's thought to be the virus -- on dosage, how many millions do we have?

MS. TOWNSEND: I don't have the number off the top of my head. I'd refer you to HHS, Secretary Leavitt, who is responsible for that.

Q Fran, thank you. Can you tell us a little bit, walk us through the chain of command? As we saw with Hurricane Katrina, you can have a plan, but if it's not implemented and there's not coordination, it might not work. As I understand it, the Health and Human Services Secretary would be the point person. But what's the chain of command, direct access to the President? What's the role of Secretary Chertoff, what's your role, U.S. military, Secretary Rumsfeld? How are you going to coordinate that within the government in a crisis?

MS. TOWNSEND: Okay, so is this one question or several? Okay. All right, let me start from the top down, because that's the easiest way to do this. The "who's in charge" -- I mean, essentially what you're asking me, Ed, is who's in charge. And the answer is, in a national crisis, the President of the United States is in charge. I am the President's staff, as are the rest of us here, and we will support the President in that.

Let's talk about operationally what happens. You remember from the Katrina report -- what we talked about in the Katrina report was, we ought to look to the people with the expertise to give us the best options for solutions to national problems. So in the case of a public health crisis, obviously, the President is going to rely, in terms of public health advice, on the Secretary of HHS.

That said, the Secretary of DHS, Secretary Chertoff, as the Homeland Security Secretary, has statutory authority and responsibility to coordinate an incident of national significance across the federal government. There's no question, if there were a severe pandemic, there would be activities and actions required by the federal government across not just in Health and Human Services, but across the federal government. And it would be Secretary Chertoff, who would be the President's incident manager to ensure the coordination across the federal government to support the response to a public health emergency.

Q Madam, what advice do you have for the travelers overseas? Let's say if I'm traveling to Asia, which country you think you should warn me not to travel? Or how this disease one can bring from overseas?

MS. TOWNSEND: I want to be careful not to panic people. I think it's really important that we talk about -- based on facts and what we know. Obviously, the United States government has, based on science, created a planning assumption, a worst-case scenario. And that's our responsibility, to assume the worst knowing that anything short of that we will, then, be well prepared for.

We haven't seen a human-to-human transmission of the disease -- efficient human-to-human transmission. So what we know of the facts is, this is a bird virus now. The human infections are -- have been tied directly to exposure to infected birds in particular countries. And so that's -- and countries have been very transparent with the findings of infections in birds, and people. What I would say to you is, there's not a reason to panic now, but to be aware. And in Appendix A, as I mentioned, we talk about particular planning considerations that people should consider whether they're individuals, families, or organizations.

Q When the virus does arrive on the continent, what would you say to hunters? Are there any plans to restrict or ban duck hunting?

MS. TOWNSEND: I will tell you that in terms of the wild bird population, the Department of Interior, working with USDA and Secretary Johanns, have an extensive planning effort, also surveillance and detection, early warning. We expect, based on migration routes -- we look to Alaska and then down on through the continent in that path -- and we work with state and local officials who obviously have the greatest role in setting hunting requirements, licensing and restrictions.

Again, we have to understand the role of the federal government. In the federalist form of government, we give advice, we give guidance, we provide special capabilities, but we have to work with state and local authorities in terms of planning and preparedness and the actions that they will take to mitigate impact.

Q So you're going to tell the states to ban -- again, the duck example because it's a popular bird -- would you tell the states, then, to ban or restrict duck hunting?

MS. TOWNSEND: Is that possible? Yes, it's possible we could give that advice. But again, I'm reluctant to engage in hypotheticals -- what if it's a duck -- because I think it has very much to do with how pathogenic is it, how contagious is it, what are the particular qualities of the virus that appears, if it appears.

Q This is the worst-case scenario, and you say you don't want Americans to panic. But can you give us a general idea -- you've seen some of the headlines today: chaos ensues -- can you give us a general idea how you think this country would look if there's a severe outbreak, and what would happen?

MS. TOWNSEND: I think it's important to distinguish this from a terrorist attack or a natural disaster. I refer to those as a kinetic event. It happens, and it's sudden, and it's pervasive. In the case of the Gulf Coast, it was 93,000 square miles affected at one time. That is not the scenario you will face with a pandemic. It will not be a single moment in time event. It will unfold slowly, over days, weeks, months. It will not be in all places at the same time.

There's good news to that. It allows us to take mitigation measures both at the federal, state and local level, at the community and individual level, that can have a direct impact on how many people get sick, and how badly it affects the economy. And so that's the good news. And that's why you want to plan for the worst, knowing very well that that -- if it's not the worst-case scenario, we will have less of an impact on this country.

You are likely to see it arrive overseas first, which gives us opportunities at least in an hour period to consider measures at the border. And you wouldn't just take measures at a border. You would have a layered approach. You would consider screening measures at points of departure. We're working on education measures in flight, and then upon arrival. Those measures will be for a set period of time. There's only a set period of time that that's likely to help, because once you begin to see efficient human transmission in the United States, those sort of measures at the border become less important. And what you want to ensure is that communities are prepared to start taking measures right away.

Q In terms of chaos, in terms of what happens in this country if there is a severe outbreak here? You talk about the borders and trying to stop it, but I think the report says, once it was overseas it would probably be here within two months. So what happens -- assure Americans that there won't be chaos.

MS. TOWNSEND: And that's right. I mean, I think it's -- look, we deal with the science of this. I'm talking to scientists and doctors. We don't see -- the worst-case scenario that we anticipate in the report, it's not that we see it likely to happen; we think it's the worst case. Do I think that's going to result in chaos? No. And that's the whole purpose and whole point of doing a national planning effort.

Secretary Leavitt, for example, called in at the end of last year public health officials from around the country and talked to them about the importance of planning. He then has been on a 50-state tour to talk to them, to go to their states and talk to them about continuing efforts. We're working with them to strengthen their plans. The whole purpose of planning and preparation is to mitigate the uncertainty, to take the fear out of it so there's not chaos.

Q But some of it -- you have 40 percent of the workforce out in the most severe outbreak. You've got guidelines for people to stay three feet apart, which seems unworkable in areas of work -- I mean, how can it not be chaos with the economy --

MS. TOWNSEND: Good planning and preparation will avoid it being chaotic. It just will. And the answer is, we're communicating not only with government officials at the state and local level, but it's the whole purpose in communicating directly with the American people about steps they can take.

Q Speaking of good planning, you all have yet to spend even half of the amount of money that's been appropriated for this year. People have criticized the government for getting in line very slowly to get the antivirals from Roche. You haven't spent the money on expanding vaccine capacity. Why has it taken so long to spend the money that you already have in hand? And also, some in Congress said that you didn't even come up with the most recent supplemental request, that they had to sort of push the administration to come up with this newest $3.3 billion request. So why has the administration, according to a lot of people, been so slow even to spend the money that you already have?

MS. TOWNSEND: Of the $3.7 or .8 billion that is in the -- was in the emergency supplemental, we've already obligation $1.8 billion of that. The rest of the money will be obligated before the end of the fiscal year.

And you'll be not surprised, I suppose, to hear me say that the administration needed no push from anyone to begin this pandemic preparedness. As I said at the beginning of the press briefing, our efforts, in terms of strengthening public health and preparedness, including for pandemic, go back to 2001 and include over $6 billion. So it's hardly that we've been slow. There is an effort. There is a -- there has been a diminution of vaccine production capability in this country, and it's not something that you can do overnight. It does take planning; it does take obligating funds, and having the funds so that you can obligate them.

I can assure you, as you go through the details of the plan, you will see in fairly specific detail how we plan to spend the $7.1 billion.

Q Back to the drug manufacturers, you mentioned the legal liability issue. What needs to happen in order for the drug makers to start racking up the vaccine?

MS. TOWNSEND: Well, part of it is reestablishing, if you will, strengthening vaccine production capability in this country, as it was mentioned by one of our colleagues. Some of that is now overseas. Secretary Leavitt has spent a good deal of time talking privately with the manufacturers. I'd leave to him to what extent he wants to discuss those discussions publicly. But the President has made very clear litigation reform and liability reform is high on the agenda, not least of all because of its impact -- the impact of liability litigation has had on the vaccine industry.

Q So do they need a waiver out of legislation -- is that what you're saying?

MS. TOWNSEND: These are ongoing talks between the Secretary of HHS, the Department of Justice, and the vaccine manufacturers.

Q Yes, later in the report, it calls on limiting non-essential domestic travel. Could you define what that means for us and tell us who will decide what domestic travel is?

MS. TOWNSEND: Well, the reference to domestic travel is travel inside the borders of the United States, and -- not that I ever seem to get to take one, but imagine your average summer vacation. It would be limiting non-essential travel that you don't have to take inside the United States.

These are recommendations you'll see, as I mentioned, in Appendix A. We make all sorts of similar type recommendations to individuals to consider, in terms of limiting their exposure to the potential virus.

Q -- to the mall, I mean, going to see friends? Would it be local? And who would enforce it?

MS. TOWNSEND: It's not a question of enforcing it. Some of this -- it's hard to legislate common sense. Some of this is, if we were facing a real threat of a human pandemic inside the United States, some of our advice is to communities, to state and local governments, but some of it is to your average American. I have two small children, and if I thought that there was the risk of -- the spread of a pandemic, and that they would more at risk at the mall, I wouldn't be going to the mall if I didn't need to be there. And I imagine that as you talk to parents and people in their communities throughout the country, they feel the same way.

Q You touched briefly a couple of times on the potential for border restrictions. Can you elaborate on what that would mean, since we're told that a total shutdown of some borders would be impractical, in terms of stopping the spread.

MS. TOWNSEND: Not only impractical -- ineffective. We don't expect that shutting -- a tight shutdown of the borders would actually stop it from arriving here. So worse than impractical, it's ineffective. And of course, there are second- and third-order consequences in terms of our economy, given that we spend -- that there's trillions of dollars in international trade.

When you look at border restrictions, there's a period of time very early on in a potential pandemic where they may be effective not in stopping the arrival of the virus, but in buying us time, and slowing the spread of the pandemic to allow communities, frankly, and individuals to get better prepared if they haven't already.

And so we look at things like departure screening, on plane screening, and arrivals screening. We have done -- we have continued to do planning -- Department of Health and Human Services, as well as DHS -- for medical stations at some international airports. That plan is ongoing so that we could ramp it up quickly if there was an indication of the virus overseas.

Yes, sir.

Q Yes, after World War II, we had a hospital system here under Hill-Burton where we made an estimate of how many hospital beds you need per population. Now we've long gone away from that system, and hospitals have been working on a more for-profit motive. But given the fact of a dangerous pandemic, wouldn't it be necessary to again look at this situation to make sure that especially in the rural regions -- it may hit in the rural regions, not in the big city -- there are hospital facilities available to be able to take care of that, otherwise, you'll have to move people from -- over long distances, thus increasing the dangerous threat of pandemic. Have you looked at this, and have you drawn any conclusions with regard to that in your report? Or do you intend to?

MS. TOWNSEND: I wouldn't say -- I don't think that there are conclusions drawn in the report directly related to that. I'd have to -- I may be wrong. I don't think so. But what I would say to you is, this goes directly to our planning with state and local officials.

You know, I'm fond of saying, having been a local myself earlier in my career, rarely will the solution itself to the practical problem faced in a community come from inside the beltway, come from Washington. The answer is, what we can do is give advice and guidance, the kinds of planning assumptions that they ought to look at, their capacity and how to increase the capacity and how to increase the capacity to meet local need.

And that's the sort of advice and guidance we're giving. We're working with state and local officials through Secretary Leavitt, and we will continue to do as part of the planning effort.

Q Can you give a concrete recommendation? I mean, you should know from a central point of view where there are gaps and where there are potential problems and be able to inform the local authorities of that and maybe provide some assistance --

MS. TOWNSEND: Absolutely --

Q -- just advice, saying --

MS. TOWNSEND: No, to the extent that we identify vulnerabilities or gaps, we are absolutely sharing those with state and local officials and working with them in terms of closing those gaps.

Q Can I follow on that? Here in Washington and in other cities, there are communities that are overrun with Canadian Geese. In Rockville, where the Institute of Health is, they had to a million crows and rookeries in the trees. Are those areas at increased risk? If we're sure that the bird flu will come to this country, shouldn't we be culling our birds at this time as a preventative act?

MS. TOWNSEND: You know, I wouldn't -- I don't really see that we need to do that as a preventive act now, prior to the arrival. I don't know what good that would do. The fact is, we look at migration routes. We've done this sort of very much based, rationally based on the science of it, put in surveillance and early warning, if you will, capability. And the poultry -- both poultry -- domestic poultry and wild bird populations, we have experience with this. This wouldn't be the first time we had this sort of problem with a virus in poultry. Particularly the domestic poultry industry is well aware of how to eradicate disease and infection in their population and has a lot of experience at doing it very effectively.

In the back.

Q Getting back to the domestic travel question. Can you provide a little detail about the set of circumstances that would have to arise where these travel restrictions, domestic travel restrictions might be imposed and how that might work?

MS. TOWNSEND: You know, the reason that we don't address that specifically in the report is because it's -- a lot of this has got to do with -- we've laid out what we think the issues are where we'll confront and the order in which we will -- we are most likely to confront them. But it's difficult to answer that in the hypothetical. It will depend on where it's from and how contagious the disease is. Do we see a localized outbreak or do we see it spread across states widely across the country? It's just -- it's near impossible for me to answer that hypothetically.

Q And on that, if I could. What triggers the implementation of the plan? Is it the first transmission from human-to-human? What is it that starts the process?

MS. TOWNSEND: What you'll see, as part of the graphic I think that was provided in the pre-briefing package, we have -- WHO divides the pandemic roll out into six phases. We have used WHO's six-stage planning process in terms of the outbreak of a pandemic. We have broken that into subcategories, and we very specifically tied actions to stages in the pandemic. And I'd encourage you to look in the sheet.

This graphic in particular lays out both the WHO stages of a pandemic and then maps that against our subcategories and how we will behave in the event of a pandemic outbreak.

Q I'd like to follow on his question about your advice to local communities. HHS has made it clear, repeatedly, that they consider the best planning to be at the local community hospitals, the state and local public health departments. But those departments and the hospitals, almost to the department and the hospital, have said, thanks for your advice, we appreciate it; we do not have -- do not have the resources to buy the ventilators, to buy the surge capacity, to buy all of the extra things that we're being told -- and the antivirals -- that we're being told that we need. Hospitals were here in Washington a couple of weeks ago -- Hopkins, Stanford, top hospitals in the country -- each one of them, all together, said the advice is great, there's no way for us to pay for it on our margins.

So that being the case, what is the advice for those hospitals, those public health communities to actually prepare?

MS. TOWNSEND: Well, just as you have a personal budget, I have a personal budget, the federal government has a budget, so do state and local communities. And it's a matter of setting priorities. We believe that this should be a priority for resource allocation and for planning, for policy implementation and planning. We believe those hospitals -- it's more that they need to do than simply buying things, whether it's antivirals and vaccine or ventilators, that's all very important, don't misunderstand me. But there are policies and procedures they need to put in place, in terms of essential personnel -- policies for absenteeism, how they will staff emergency rooms -- and all that planning needs to be done now while they look at the resource implications and plan for those, as well.

Q May I follow on the phases? In the dark old days, there was quarantine for people with leprosy, polio, tuberculosis. Do you envision a quarantine aspect to any of those phases?

MS. TOWNSEND: There is certainly recommendations here that there should be what the medical community calls social distancing -- that is, communities to take steps, both at the individual level and the community level, to decrease the number of public gatherings; the potential for school closings. And we do tie those sorts of recommendations to various stages in pandemic implementation.

MR. McCLELLAN: Let's do two more, and then Fran's going to need to leave.

MS. TOWNSEND: Let's get to people who haven't gone.

Q What fraction of the vaccine, the antiviral stockpile, whatever its size, is the administration prepared to send overseas for containment of an outbreak outside the United States?

MS. TOWNSEND: I don't remember the number off the top -- I don't remember the number off the top of my head. In fact, what we've done is made commitments based on dollar commitments, and I don't remember, standing here, what it is. We can get that -- we can get that for you, though.

But what we've said is, the President has said, both at the U.N., and he's continued to raise individually and bilaterally meetings with heads of state, the importance of this. And this is not just -- the international commitment is just that. All countries have to understand that it's in the international community's interest to contribute to the stockpiles, but this is not solely a U.S. burden. We will be good international partners, and we will contribute, but every country needs to contribute.

Yes, ma'am, last one.

Q Thank you. How soon are you going to let the general public know what you're doing and what's going on, because a lot of the people are very afraid, they don't know -- there's going to be another New Orleans hurricane problem, or are you going to do it via television, radio, or how?

MS. TOWNSEND: Part of the -- you'll see as part of the detailed planning process, we talk about risk communications, and talking to the American people. Secretary Leavitt and Secretary Johanns have already done that. They have both met with all the major networks. We have tried to communicate not only with the media but with the American people and state and local communities.

We will be transparent. And that's why I said the planning and implementation process will be a dynamic one. We will update it. We have a website, pandemicflu.gov, where people can get additional information as we continue to update implementation and planning efforts.

Thanks, everybody.

MR. McCLELLAN: Are there other questions?

Q Can you distinguish between this plan and the HHS plan? When we write about this, how -- we all wrote stories last fall when HHS's plan came out, it was the flu plan; now we're going to write another story that says, the flu plan came out. What's the difference between the two?

MS. TOWNSEND: Well, as I said -- think of it this way: there's the strategy, this is the implementation plan for the strategy, and then each of the departments and agencies has their implementation plan. HHS has a large role and responsibility in this, and so they, too, have a very detailed plan for their department and agency.

Thank you.

MR. McCLELLAN: All right, are there any other questions? We've got a congressional meeting starting here pretty quick.

Q A quick one on that, can I just ask you --

MR. McCLELLAN: On?

Q -- on the pandemic, just broadly speaking, the criticism from Democrats today has been --

MR. McCLELLAN: Well, I mean, we had Fran here to talk about the preparedness plan. But go ahead.

Q But just in general, they're saying that -- like, when Fran was asked about chaos, she said with proper planning and coordination, there won't be chaos. What Democrats are saying this morning and this afternoon is that with Katrina, there was planning, but it wasn't implemented. And how can you assure the American people that you can prevent --

MR. McCLELLAN: Well, I think the United States has been leading the way in working with our international partners to prepare for a possible pandemic. And that's why we are moving ahead with the implementation plan. We outlined the strategy back in November. And we have also been moving forward on getting the necessary funding in place to make sure we have the resources to address this possible outbreak.

Are there other questions -- we've got a congressional meeting coming up -- on different topics?

Steve, go ahead.

Q What are you hearing about the possibility that Senate Democrats will filibuster some of your judicial nominees, like Brett Kavanaugh?

MR. McCLELLAN: Well, my expectation is that Brett Kavanaugh's hearing -- I'm sorry, vote in committee is going to go forward this week. He is someone who is exceptionally well qualified. He is someone who will apply the law in a fair and impartial manner. And I think that there are some Democrats that want to resort to some of the past old tricks. They are simply playing politics with judicial nominations.

And there was a bipartisan agreement that was reached to move forward on the nominees. We hope that Democrats are not going to break that good bipartisan process that was set up to move forward, because each nominee deserves a fair up or down vote. And Brett Kavanaugh is someone who has been praised by people on both sides of the political spectrum who know him, he is someone who is well qualified to serve on the D.C. Circuit Court of Appeals, and has good, diverse experience, not only from appearing before the courts, but also from his experience here as a senior aide to the President of the United States.

Q Scott, Vicente Fox's plan on -- this Friday I think it is -- to sign into a law a bill that essentially legalizes all type of narcotic drugs in his country, and concerns about the possible availability of those to the United States to people there. Any reaction from the White House on that?

MR. McCLELLAN: Well, I think that the State Department and our Office of National Drug Control Policy have been talking with Mexican officials about this. I don't want to jump ahead of where it is. The State Department has previously talked about our views on the situation and our concerns.

Connie, go ahead.

Q Thank you. Iran now says it's close to the 5 percent mark on enriching uranium, which is enough for electricity, but not nearly enough for weapons. Would the U.S., would the allies accept have Iran having electricity in nuclear energy, and not weapons --

MR. McCLELLAN: Well, we've talked about that previously. This isn't about whether or not they should have the right to civilian nuclear power, this is about the regime's defiance of the international community and failure to live up to its obligations. And that's why it's important to have an objective guarantee in place for a civilian nuclear program. It's a regime that has defied the international community and hid its activities for some two decades.

And that's why the Europeans were working to negotiate in good faith with the regime so that they could realize peaceful civilian nuclear power. And Russia even came forward with a proposal, which we expressed support for. And it would provide guarantees.

But what the regime needs to do is return to a suspension of its uranium enrichment and reprocessing activities, and come back and negotiate in good faith. Now they have shown that they are continuing to defy the international community, they're continuing to isolate themselves from the rest of the world. That's why we are moving forward with our partners in the Security Council and our friends and allies elsewhere to address this in a diplomatic way and to continue to keep the pressure on the regime to change its behavior. We are looking at moving forward on a Chapter 7 resolution at the Security Council, which would compel action by the regime.

And that's where we are at this point. And we're involved in ongoing discussions. There have been discussions going on in Paris, there will be some additional discussions next week in New York. This evening the President will be welcoming Chancellor Merkel of Germany here to the White House, and this is a topic that they will be talking about. We all have a shared concern about the regime developing nuclear weapons under the cover of a civilian program.

Q On the EU summit in Vienna that the President is going to Austria, can that be seen as a part of the effort of the administration to get the EU into a kind of "coalition of the willing" against Iran?

MR. McCLELLAN: Well, we are already moving forward on a number of fronts with our friends and allies at the United Nations Security Council. This is a concern that the regime has with the international community. The international community is concerned about their continued defiance, and the international community is united in our goal to prevent the regime from developing a nuclear weapons know how or nuclear weapons. And that's why we are continuing to move forward on the diplomatic front. We're taking it a step at a time, but we think it's time for the Security Council to act and move forward on a resolution under Chapter 7 that would compel action by the regime. And this is something we'll continue to discuss with our friends in Europe and elsewhere.

Let me keep going. Sarah, go ahead.

Q Can I follow up? Can you give some details about the trip to Vienna? Is the President going to overnight in Vienna; how long --

MR. McCLELLAN: Well, we put out a statement earlier today, I made some remarks earlier today. That's where it is at this point, and we'll update you as we get closer to that trip on additional activities that might take place. But he looks forward to going to participate in the U.S.-EU summit in Vienna.

Q Thank you. Puerto Rico is broke, out of money. Schools are closed and most of the government is shut down. Does the President plan to ask Congress for more money, for money to bail out Puerto Rico and again make it solvent?

MR. McCLELLAN: I'll be glad to take your question and take a look into it.

Go ahead.

Q There are numerous reports about low-intensity operations ongoing in Iran from three different places -- PKK going over the border into Iraq, the MEK southern border of Iraq into Iran, and also certain operations from Balochistan involving also the Pakistanis. Does the U.S. have a policy, given also reports which I know you won't comment on, on possible special forces operations in Iran? Does U.S. policy, based on the notion that an enemy of our enemy is our friend, consider changing its policy towards the PKK or --

MR. McCLELLAN: Our policies haven't changed on those organizations. They remain the same. And you're bringing up organizations that we view as terrorist organizations.

Q We would never cooperate with them, in terms of --

MR. McCLELLAN: Our policy hasn't changed.

Q Scott.

MR. McCLELLAN: Goyal.

Q Question on U.S.-India nuclear agreement, civilian nuclear agreement. All over the United States, Indian-American leaders are here in town for the last two days and have been going into meeting after meeting. And this morning, they had a meeting at the White House, and Mr. Karl Rove, among others, spoke to the group. And also yesterday on the Capitol Hill, Senator John Kerry was speaking --

MR. McCLELLAN: Let's get to your question. I'm sorry to rush you, but we got a congressional meeting --

Q My question is that --

MR. McCLELLAN: -- that I think you all would prefer I be in so I can provide you information on that.

Q My question is that, what message you think President has for this group on this agreement, and also --

MR. McCLELLAN: Same message he said previously, and we want Congress to move forward on the agreement.

Q Thank you.

MR. McCLELLAN: All right --

Q Can you just -- on Medicare, the GAO report saying the 1-800 number is not really working?

MR. McCLELLAN: Well, first of all, let me point out that this report that you are referring to was a snapshot of one aspect of all efforts being used to communicate and sign seniors up for the new Medicare prescription drug benefit. It was a snapshot that was taken three months ago, in the January and early February time frame. And the Centers for Medicare and Medicaid Services has continued to take steps to make improvements to their communications tool. But there are a lot of communications tools. There's a website. There is outreach going on across the country, and enrollment sessions -- the 1-800-MEDICARE line, as well.

But the Centers for Medicare and Medicaid Services also has an ongoing monitoring program which takes a random sample of the calls coming in to make sure that they are being answered accurately. And they have found that 93 percent of the time, those calls from people wanting to sign up are being answered accurately. And Secretary Leavitt also said that -- I think this was earlier today -- that most of the calls currently being -- are being answered in two to three minutes.

Now, this brings up a very good point. I think all of us -- both at the government and within the media -- have a responsibility to help educate seniors so that they know what is available for them. They have many more options now that are available so that they can choose the health care that best meets their individual needs and so that they can get access to prescription drug coverage that they have not had access to previously.

A typical senior is saving 50 percent or more on their savings. Surveys by groups like the AARP show that eight out of ten beneficiaries say they are satisfied with the new prescription drug benefit.

So I think you have to look at all those aspects, and we need to make sure that seniors continue to get good information about what is available so that they can sign up. The enrollment period ends May 15th, and that's why we're continuing to make a push to encourage seniors to take a look. There are now a number of options available to you so that you can get better quality of care and save a significant amount of money on your prescription drug benefits. And I think that's important to get across to seniors across America.

The goal has already been exceeded in terms of what we expected for this year. But we're pleased that seniors are happy with the coverage that they are getting, by and large. And where they're not, we'll continue to work with them to improve.

Q Thank you.

MR. McCLELLAN: Thank you.

END 1:26 P.M. EDT, For Immediate Release, Office of the Press Secretary, May 3, 2006

RELATED: Sunday, January 29, 2006 Vaccine provides 100 percent protection against avian flu virus in animal study, Tuesday, November 01, 2005 President Outlines Pandemic Influenza Preparations and Response, Thursday, October 27, 2005 HHS Buys Vaccine Preparations For Potential Influenza Pandemic. Sunday, October 16, 2005 FLU VIRUS REPORTED TO RESIST DRUG ENVISIONED FOR PANDEMIC . Sunday, October 09, 2005 Researchers Reconstruct 1918 Pandemic Influenza Virus . Tuesday, August 09, 2005 Bird Flu Cases Increase . Sunday, August 07, 2005 universal flu vaccine . Tuesday, April 05, 2005 Avian Influenza in Asia . Sunday, March 27, 2005 Experimental Avian Flu Vaccine

Vaccine provides 100 percent protection against avian flu virus in animal study

PITTSBURGH, Jan. 26 – University of Pittsburgh researchers announced they have genetically engineered an avian flu vaccine from the critical components of the deadly H5N1 virus that completely protected mice and chickens from infection.

Avian flu has devastated bird populations in Southeast Asia and Europe and so far has killed more than 80 people.

Because this vaccine contains a live virus, it may be more immune-activating than avian flu vaccines prepared by traditional methods, say the researchers. Furthermore, because it is grown in cells, it can be produced much more quickly than traditional vaccines, making it an extremely attractive candidate for preventing the spread of the virus in domestic livestock populations and, potentially, in humans, according to the study, published in the Feb 15 issue of the Journal of Virology and made available early online.

"The results of this animal trial are very promising, not only because our vaccine completely protected animals that otherwise would have died, but also because we found that one form of the vaccine stimulates several lines of immunity against H5N1," said Andrea Gambotto, M.D., assistant professor in the departments of surgery and molecular genetics and biochemistry, University of Pittsburgh School of Medicine, and lead author of the study.

Dr. Gambotto and his colleagues constructed the vaccine by genetically engineering a common cold virus, called adenovirus, to express either all or parts of an avian influenza protein called hemagglutinin (HA) on its surface. Found on the surface of all influenza viruses, HA allows the virus to attach to the cell that is being infected and is, therefore, critical to the influenza virus' ability to cause illness and death.

Since the late 1990s, a number of outbreaks of the avian influenza H5N1 in poultry have occurred in Cambodia, China, Indonesia, Japan, Laos, South Korea, Thailand and Vietnam. Outbreaks recently have been reported in Turkey and Romania. To date, H5N1 has caused the most large-scale and widespread bird deaths in known history--an estimated 150 to 200 million birds have either died in the outbreaks or been killed as part of infection control actions in the last eight years.

The H5N1 virus does not usually infect humans. However, in 1997, the first case of spread from a bird to a human occurred in Hong Kong during an outbreak of bird flu in poultry. The virus caused severe respiratory illness in 18 people, six of whom died. Since that time, more than 170 cases of known H5N1 infection have occurred among humans worldwide, approximately half of whom died.

Based on the published sequence of the Vietnam strain of the H5N1 avian influenza virus, members of the University of Pittsburgh Vector Core Facility, led by Wentao Gao, Ph.D., research instructor in the School of Medicine's department of surgery, constructed several adenovirus "vectors"--viruses that have been modified to serve as a vector, or delivery vehicle, for foreign genes or DNA--containing either the full genetic sequence of the HA protein or sequences for only parts, or subunits, of HA. They also constructed a vector containing sequences for a portion of the HA protein from the H5N1 Hong Kong strain.

Collaborating with investigators Xiuhua Lu, Ph.D., Doan C. Nguyen, M.D., Yumi Matsuoka, Ph.D., Ruben O. Donis, Ph.D., and Jaquelin M. Katz, Ph.D., of the Influenza Branch of the Centers for Disease Control and Prevention, Dr. Gambotto's team tested the ability of their slightly different vaccines to protect mice from infection by wild-type H5N1 by comparing its performance to an adenovirus vector containing no H5N1 genes, or an "empty vector." The investigators then observed the H5NI-exposed mice for any signs of illness, including weight loss and death, and also checked their blood for anti-viral antibodies and other markers of H5N1-specific immunity.

All of the mice immunized with the empty vector vaccine experienced substantial weight loss beginning about three days after exposure to wild-type H5N1, and all were dead within six to nine days of avian flu exposure. In sharp contrast, most of the mice immunized with the adenovirus containing either the whole or part of the HA protein showed only mild and short-lived weight loss and survived H5N1 infection.

When the investigators looked for evidence of a specific immune response to H5N1, they found similar results. Although they were able to isolate high levels of infectious H5N1 from multiple organs in the mice vaccinated with the empty vector, and to various degrees in animals vaccinated with the vectors containing the HA subunits, they isolated only very small amounts of H5N1 from the mice immunized with the full-length HA vaccine three days after infection. Six days after infection, they could not detect any infectious H5N1 in the organs of mice immunized with the full-length HA vaccine.

Moreover, when they looked at the cellular immune response to vaccination, they found that all of the animals immunized with full-length HA or the subunit vaccines developed strong cellular immune responses. However, only the full-length HA-immunized mice developed strong T-cell responses to both of the HA subunits. According to Simon Barratt-Boyes, B.V.Sc., Ph.D., associate professor, department of infectious diseases and microbiology, University of Pittsburgh Graduate School of Public Health, and one of the co-authors of the study, the ability of this particular recombinant vaccine--a vaccine carrying only the important immune-stimulating proteins--to induce both antibody- and T cell-directed immunity is extremely encouraging.

"This means that this recombinant vaccine can stimulate several lines of defense against the H5N1 virus, giving it greater therapeutic value. More importantly, it suggests that even if H5N1 mutates, the vaccine is still likely to be effective against it. How effective, we are not sure," Dr. Barratt-Boyes cautioned. "We won't know until that occurs."

Based on the superior degree of protection that they found in mice vaccinated with full-length HA vaccine, Dr. Gambotto's group, working with David E. Swayne, D.V.M., Ph.D., at the U.S. Department of Agriculture, tested its effectiveness in chickens, which have almost a 100 percent mortality rate to H5N1 exposure. In all, the researchers inoculated four groups of chickens either through their noses (intranasally) or with subcutaneous injections of either the HA-containing vaccine or the empty vector vaccine. The chickens were then challenged with a dose of whole H5N1 virus 10,000 times greater than the dose given to the mice and significantly greater than the dose farm chickens are likely to be exposed to during a natural outbreak.

Interestingly, all of the chickens that were immunized subcutaneously survived exposure to H5N1, developed strong HA-specific antibody responses and showed no clinical signs of disease. In contrast, half of the chickens immunized intranasally died and half survived. All of the chickens immunized with the empty vector (intranasally and subcutaneously) died within two days of H5N1 exposure. The researchers are still not yet sure why the subcutaneous delivery is more effective than the intranasal delivery of the vaccine, but they suggested it may be because the adenovirus vector they used has limited infectivity via the nose and respiratory tract.

Dr. Gambotto and his colleagues suggest that rather than replacing traditional inactivated influenza vaccines, their adenovirus-based vaccine could be a critically important complement to them. Because it appears to be so successful in immunizing chickens against H5N1, widespread inoculation of susceptible poultry populations could provide a significant barrier to the spread of the virus via that route in this country and other countries that have so far been spared from avian flu. Also, if there were a disruption in the traditional vaccine production pipeline, a recombinant vaccine could be an attractive alternative for human immunization as well, they said.

Indeed, according to Dr. Gambotto, there are several major advantages to this type of vaccine development approach over traditional approaches. Flu vaccines currently are prepared in fertilized chicken eggs, a process developed more than 50 years ago that requires millions of fertilized eggs that would be in short supply if a pandemic--a widespread, global outbreak--were to occur. The recombinant vaccine approach grows the vaccine in cell cultures, which are unlimited in supply. Another major advantage of this approach is its speed.

"It takes a little over a month for us to develop a recombinant vector vaccine compared to a minimum of several months via traditional methods," he explained. "This capacity will be particularly invaluable if the virus begins to mutate rapidly, a phenomenon that often limits the ability of traditional vaccines to contain outbreaks of mutant strains." Dr. Gambotto added that his group is planning a small clinical trial of the vaccine in humans in the very near future.

###

The research was supported by internal University of Pittsburgh funds. Others involved in this study include Paul D. Robins, Ph.D. and Angela Montecalvo, Ph.D., University of Pittsburgh School of Medicine; and Adam C. Soloff, B.S., University of Pittsburgh Graduate School of Public Health.

Contact: Jim Swyers / Lisa Rossi SwyersJP@upmc.edu / RossiL@upmc.edu 412-647-3555 (phone) 412-624-3184 (fax) University of Pittsburgh Medical Center

more at 1918 Pandemic and Influenza Virus or CDC and Pandemic and Avian influenza or Bird Flu and H5N1 or adenovirus and recombinant or vaccines and Journal of Virology

RELATED: Tuesday, November 01, 2005 President Outlines Pandemic Influenza Preparations and Response, Thursday, October 27, 2005 HHS Buys Vaccine Preparations For Potential Influenza Pandemic. Sunday, October 16, 2005 FLU VIRUS REPORTED TO RESIST DRUG ENVISIONED FOR PANDEMIC . Sunday, October 09, 2005 Researchers Reconstruct 1918 Pandemic Influenza Virus . Tuesday, August 09, 2005 Bird Flu Cases Increase . Sunday, August 07, 2005 universal flu vaccine . Tuesday, April 05, 2005 Avian Influenza in Asia . Sunday, March 27, 2005 Experimental Avian Flu Vaccine

President Outlines Pandemic Influenza Preparations and Response

President Outlines Pandemic Influenza Preparations and Response, William Natcher Center, National Naval Medical Center, Bethesda, Maryland, 10:04 A.M. EST

President George W. Bush delivers his remarks regarding his National Strategy for Pandemic Influenza Preparedness and Response Tuesday, Nov. 1, 2005. "Today, I am announcing key elements of that strategy.

Our strategy is designed to meet three critical goals: First, we must detect outbreaks that occur anywhere in the world; second, we must protect the American people by stockpiling vaccines and antiviral drugs, and improve our ability to rapidly produce new vaccines against a pandemic strain; and, third, we must be ready to respond at the federal, state and local levels in the event that a pandemic reaches our shores," said President Bush. White House photo by Paul Morse.

THE PRESIDENT: Thank you all. Michael, thank you very much for your introduction. And thanks for the warm reception here at the National Institute of Health. It's good to be back here again.

For more than a century, the NIH has been at the forefront of this country's efforts to prevent, detect and treat disease, and I appreciate the good work you're doing here. This is an important facility, an important complex, and the people who work here are really important to the security of this nation. The scientists who have been supported by the folks who work here have developed and improved vaccines for meningitis and whooping cough and measles and mumps and rubella and chickenpox, and other infectious diseases. Because of the revolutionary advances in medicine pioneered with the help of the NIH, Americans no longer fear these dreaded diseases -- many lives have been saved.

At this moment, the men and women of the NIH are working to protect the American people from another danger -- the risk of avian and pandemic influenza. Today, I have come to talk about our nation's efforts to address this vital issue to the health and the safety of all Americans. I'm here to discuss our strategy to prevent and protect the American people from a possible outbreak.

I appreciate members of my Cabinet who are here. More importantly, I appreciate the hard work you've done on this issue. Secretary Rice, Secretary Johanns, Secretary Mineta, Secretary Nicholson, Secretary Chertoff. I appreciate the fact that Dr. J.W. Lee, Director-General of the World Health Organization has joined us. Dr. Lee, thank you for being here.

I want to recognize Dr. David Nabarro, the Senior United Nations System Coordinator for Avian and Human Influenza. Thanks for being here. This is -- you're about to hear me talk about an international scope of response and detection necessary to protect not only our own people, but people around the world. And the fact that these two gentlemen are here is an important signal.

I want to thank Dr. Elias Zerhouni, he's the Director of the NIH; doing a fine job. I want to thank Julie Gerberding, who's the Director of the Centers for Disease Control and Prevention. I appreciate Dr. Rich Carmona, U.S. Surgeon General. Dr. Tony Fauci, Director of the National Institute of Allergy and Infectious Diseases. I want to thank Dr. Bruce Gellin, Director of the National Vaccine Program Office. I want to thank Dr. Andy von Eschenbach, who is the Acting Director of the FDA and the Director of the National Cancer Institute.

I appreciate all the members of the health care community who have joined us today. I want to thank state and local officials who are here. I particularly want to thank Senators Specter and Kennedy for coming, as well as Congressmen Linder, Burgess and Price. I appreciate you all taking time to be here.

Most Americans are familiar with the influenza or the "flu" as a respiratory illness that makes hundreds of thousands of people sick every year. This fall as the flu season approaches, millions of our fellow citizens are once again visiting their doctors for their annual flu shot. I had mine. For most, it's just simply a precautionary measure to avoid the fever or a sore throat or muscle aches that come with the flu. Seasonal flu is extremely dangerous for some -- people whose immune systems have been weakened by age or illness. But it is not usually life-threatening for most healthy people.

Pandemic flu is another matter. Pandemic flu occurs when a new strain of influenza emerges that can be transmitted easily from person to person -- and for which there is little or no natural immunity. Unlike seasonal flu, most people have not built up resistance to it. And unlike seasonal flu, it can kill those who are young and the healthy as well as those who are frail and sick.

At this moment, there is no pandemic influenza in the United States or the world. But if history is our guide, there is reason to be concerned. In the last century, our country and the world have been hit by three influenza pandemics -- and viruses from birds contributed to all of them. The first, which struck in 1918, killed over half-a-million Americans and more than 20 million people across the globe. One-third of the U.S. population was infected, and life expectancy in our country was reduced by 13 years. The 1918 pandemic was followed by pandemics in 1957 and 1968 which killed tens of thousands of Americans, and millions across the world.

Three years ago, the world had a preview of the disruption an influenza pandemic can cause, when a previously unknown virus called SARS appeared in rural China. When an infected doctor carried the virus out of China, it spread to Vietnam and Singapore and Canada within a month. Before long, the SARS virus had spread to nearly 30 countries on six continents. It infected more than 8,000 people and killed nearly 800. One elderly woman brought the virus from Hong Kong to Toronto, where it quickly spread to her son and then to others. Eventually, four others arrived with the virus and hundreds of Canadians fell ill with SARS, and dozens died.

By one estimate, the SARS outbreak cost the Asian-Pacific region about $40 billion. The airline industry was hit particularly hard, with air travel to Asia dropping 45 percent in the year after the outbreak. All this was caused by a limited outbreak of a virus that infected thousands and lasted about six months. A global influenza pandemic that infects millions and lasts from one to three years could be far worse.

Scientists and doctors cannot tell us where or when the next pandemic will strike, or how severe it will be, but most agree: at some point, we are likely to face another pandemic. And the scientific community is increasingly concerned by a new influenza virus known as H5N1 -- or avian flu -- that is now spreading through bird populations across Asia, and has recently reached Europe.

This new strain of influenza has infected domesticated birds like ducks and chickens, as well as long-range migratory birds. In 1997, the first recorded outbreak among people took place in Hong Kong, when 18 people became infected and six died from the disease. Public health officials in the region took aggressive action and successfully contained the spread of the virus. Avian flu struck again in late 2003, and has infected over 120 people in Thailand, Cambodia, Vietnam and Indonesia, and killed more than 60 -- that's a fatality rate of about 50 percent.

At this point, we do not have evidence that a pandemic is imminent. Most of the people in Southeast Asia who got sick were handling infected birds. And while the avian flu virus has spread from Asia to Europe, there are no reports of infected birds, animals, or people in the United States. Even if the virus does eventually appear on our shores in birds, that does not mean people in our country will be infected. Avian flu is still primarily an animal disease. And as of now, unless people come into direct, sustained contact with infected birds, it is unlikely they will come down with avian flu.

While avian flu has not yet acquired the ability to spread easily from human to human, there is still cause for vigilance. The virus has developed some characteristics needed to cause a pandemic: It has demonstrated the ability to infect human beings, and it has produced a fatal illness in humans. If the virus were to develop the capacity for sustained human-to-human transmission, it could spread quickly across the globe.

Our country has been given fair warning of this danger to our homeland -- and time to prepare. It's my responsibility as President to take measures now to protect the American people from the possibility that human-to-human transmission may occur. So several months ago, I directed all relevant departments and agencies in the federal government to take steps to address the threat of avian and pandemic flu. Since that time, my administration has developed a comprehensive national strategy, with concrete measures we can take to prepare for an influenza pandemic.

Today, I am announcing key elements of that strategy. Our strategy is designed to meet three critical goals: First, we must detect outbreaks that occur anywhere in the world; second, we must protect the American people by stockpiling vaccines and antiviral drugs, and improve our ability to rapidly produce new vaccines against a pandemic strain; and, third, we must be ready to respond at the federal, state and local levels in the event that a pandemic reaches our shores.

To meet these three goals, our strategy will require the combined efforts of government officials in public health, medical, veterinary and law enforcement communities and the private sector. It will require the active participation of the American people. And it will require the immediate attention of the United States Congress so we can have the resources in place to begin implementing this strategy right away.

The first part of our strategy is to detect outbreaks before they spread across the world. In the fight against avian and pandemic flu, early detection is our first line of defense. A pandemic is a lot like a forest fire: if caught early, it might be extinguished with limited damage; if allowed to smolder undetected, it can grow to an inferno that spreads quickly beyond our ability to control it. So we're taking immediate steps to ensure early warning of an avian or pandemic flu outbreak among animals or humans anywhere in the world.

In September at the United Nations, I announced a new International Partnership on Avian and Pandemic Influenza -- a global network of surveillance and preparedness that will help us to detect and respond quickly to any outbreaks of disease. The partnership requires participating countries that face an outbreak to immediately share information and provide samples to the World Health Organization. By requiring transparency, we can respond more rapidly to dangerous outbreaks.

Since we announced this global initiative, the response from across the world has been very positive. Already, 88 countries and nine international organizations have joined the effort. Senior officials from participating governments recently convened the partnership's first meeting here in Washington.

Together, we're working to control and monitor avian flu in Asia, and to ensure that all nations have structures in place to recognize and report outbreaks before they spread beyond human control. I've requested $251 million from Congress to help our foreign partners train local medical personnel, expand their surveillance and testing capacity, draw up preparedness plans, and take other vital actions to detect and contain outbreaks.

A flu pandemic would have global consequences, so no nation can afford to ignore this threat, and every nation has responsibilities to detect and stop its spread.

Here in the United States, we're doing our part. To strengthen domestic surveillance, my administration is launching the National Bio-surveillance Initiative. This initiative will help us rapidly detect, quantify and respond to outbreaks of disease in humans and animals, and deliver information quickly to state, and local, and national and international public health officials. By creating systems that provide continuous situational awareness, we're more likely to be able to stop, slow, or limit the spread of the pandemic and save American lives.

The second part of our strategy is to protect the American people by stockpiling vaccines and antiviral drugs, and accelerating development of new vaccine technologies. One of the challenges presented by a pandemic is that scientists need a sample of the new strain before they can produce a vaccine against it. This means it is difficult to produce a pandemic vaccine before the pandemic actually appears -- and so there may not be a vaccine capable of fully immunizing our citizens from the new influenza virus during the first several months of a pandemic.

To help protect our citizens during these early months when a fully effective vaccine would not be available, we're taking a number of immediate steps. Researchers here at the NIH have developed a vaccine based on the current strain of the avian flu virus; the vaccine is already in clinical trials. And I am asking that the Congress fund $1.2 billion for the Department of Health and Human Services to purchase enough doses of this vaccine from manufacturers to vaccinate 20 million people.

This vaccine would not be a perfect match to pandemic flu because the pandemic strain would probably differ somewhat from the avian flu virus it grew from. But a vaccine against the current avian flu virus would likely offer some protection against a pandemic strain, and possibly save many lives in the first critical months of an outbreak.

We're also increasing stockpiles of antiviral drugs such as Tamiflu and Relenza. Antiviral drugs cannot prevent people from contracting the flu. It can -- but they can reduce the severity of the illness when taken within 48 hours of getting sick. So in addition to vaccines, which are the foundation of our pandemic response, I am asking Congress for a billion dollars to stockpile additional antiviral medications, so that we have enough on hand to help treat first responders and those on the front lines, as well as populations most at risk in the first stages of a pandemic.

To protect the greatest possible number of Americans during a pandemic, the cornerstone of our strategy is to develop new technologies that will allow us to produce new vaccines rapidly. If a pandemic strikes our country -- if a pandemic strikes, our country must have a surge capacity in place that will allow us to bring a new vaccine online quickly and manufacture enough to immunize every American against the pandemic strain.

I recently met with leaders of the vaccine industry. They assured me that they will work with the federal government to expand the vaccine industry, so that our country is better prepared for any pandemic. Today, the NIH is working with vaccine makers to develop new cell-culture techniques that will help us bring a pandemic flu vaccine to the American people faster in the event of an outbreak. Right now, most vaccines are still produced with 1950's technology using chicken eggs that are infected with the influenza virus and then used to develop and produce vaccines. In the event of a pandemic, this antiquated process would take many, many months to produce a vaccine, and it would not allow us to produce enough vaccine for every American in time.

Since American lives depend on rapid advances in vaccine production technology, we must fund a crash program to help our best scientists bring the next generation of technology online rapidly. I'm asking Congress for $2.8 billion to accelerate development of cell-culture technology. By bringing cell-culture technology from the research laboratory into the production line, we should be able to produce enough vaccine for every American within six months of the start of a pandemic.

I'm also asking Congress to remove one of the greatest obstacles to domestic vaccine production: the growing burden of litigation. In the past three decades, the number of vaccine manufacturers in America has plummeted, as the industry has been flooded with lawsuits. Today, there is only one manufacturer in the United States that can produce influenza vaccine. That leaves our nation vulnerable in the event of a pandemic. We must increase the number of vaccine manufacturers in our country, and improve our domestic production capacity. So Congress must pass liability protection for the makers of life-saving vaccines.

By making wise investments in technology and breaking down barriers to vaccine production, we're working toward a clear goal: In the event of a pandemic, we must have enough vaccine for every American.

The third part of our strategy is to ensure that we are ready to respond to a pandemic outbreak. A pandemic is unlike other natural disasters; outbreaks can happen simultaneously in hundreds, or even thousands, of locations at the same time. And unlike storms or floods, which strike in an instant and then recede, a pandemic can continue spreading destruction in repeated waves that can last for a year or more.

To respond to a pandemic, we must have emergency plans in place in all 50 states and every local community. We must ensure that all levels of government are ready to act to contain an outbreak. We must be able to deliver vaccines and other treatments to frontline responders and at-risk populations.

So my administration is working with public health officials in the medical community to develop -- to develop effective pandemic emergency plans. We're working at the federal level. We're looking at ways and options to coordinate our response with state and local leaders. I've asked Mike Leavitt -- Secretary Leavitt -- to bring together state and local public health officials from across the nation to discuss their plans for a pandemic, and to help them improve pandemic planning at the community level. I'm asking Congress to provide $583 million for pandemic preparedness, including $100 million to help states complete and exercise their pandemic plans now, before a pandemic strikes.

If an influenza pandemic strikes, every nation, every state in this Union, and every community in these states, must be ready.

To respond to a pandemic, we need medical personnel and adequate supplies of equipment. In a pandemic, everything from syringes to hospital beds, respirators, masks and protective equipment would be in short supply. So the federal government is stockpiling critical supplies in locations across America as part of the Strategic National Stockpile. The Department of Health and Human Services is helping states create rosters of medical personnel who are willing to help alleviate local shortfalls during a pandemic. And every federal department involved in health care is expanding plans to ensure that all federal medical facilities, personnel, and response capabilities are available to support local communities in the event of a pandemic crisis.

To respond to a pandemic, the American people need to have information to protect themselves and others. In a pandemic, an infection carried by one person can be transmitted to many other people, and so every American must take personal responsibility for stopping the spread of the virus. To provide Americans with more information about pandemics, we're launching a new website, pandemicflu.gov. That ought to be easy for people to remember: pandemicflu.gov. The website will keep our citizens informed about the preparations underway, steps they can take now to prepare for a pandemic, and what every American can do to decrease their risk of contracting and spreading the disease in the event of an outbreak.

To respond to a pandemic, members of the international community will continue to work together. An influenza pandemic would be an event with global consequences, and therefore we're continuing to meet to develop a global response. We've called nations together in the past, and will continue to call nations together to work with public health experts to better coordinate our efforts to deal with a disaster.

Now, all the steps I've outlined today require immediate resources. Because a pandemic could strike at any time, we can't waste time in preparing. So to meet all our goals, I'm requesting a total of $7.1 billion in emergency funding from the United States Congress. By making critical investments today, we'll strengthen our ability to safeguard the American people in the awful event of a devastating global pandemic, and at the same time will bring our nation's public health and medical infrastructure more squarely in the 21st century.

The steps I have outlined will also help our nation in other critical ways. By perfecting cell-based technologies now, we will be able to produce vaccines for a range of illnesses and save countless lives. By strengthening our domestic vaccine industry, we can help ensure that our nation will never again have a shortage of vaccine for seasonal -- seasonal flu. And by putting in place and exercising pandemic emergency plans across the nation, we can help our nation prepare for other dangers -- such as a terrorist attack using chemical or biological weapons.

Leaders at every level of government have a responsibility to confront dangers before they appear, and engage the American people on the best course of action. It is vital that our nation discuss and address the threat of pandemic flu now. There is no pandemic flu in our country or in the world at this time -- but if we wait for a pandemic to appear, it will be too late to prepare, and one day many lives could be needlessly lost because we failed to act today.

By preparing now, we can give our citizens some peace of mind knowing that our nation is ready to act at the first sign of danger, and that we have the plans in place to prevent and, if necessary, withstand an influenza pandemic.

Thank you for coming today to let me outline my strategy. Thank the United States Congress for considering this measure. May God bless you all. (Applause.)

END 10:30 A.M. EST, For Immediate Release, Office of the Press Secretary, November 1, 2005

RELATED: Thursday, October 27, 2005 HHS Buys Vaccine Preparations For Potential Influenza Pandemic. Sunday, October 16, 2005 FLU VIRUS REPORTED TO RESIST DRUG ENVISIONED FOR PANDEMIC . Sunday, October 09, 2005 Researchers Reconstruct 1918 Pandemic Influenza Virus . Tuesday, August 09, 2005 Bird Flu Cases Increase . Sunday, August 07, 2005 universal flu vaccine . Tuesday, April 05, 2005 Avian Influenza in Asia . Sunday, March 27, 2005 Experimental Avian Flu Vaccine

more at 1918 Pandemic and Influenza Virus or CDC and Pandemic and Avian influenza or Bird Flu and H5N1 or Tamiflu and oseltamivir or President Bush and National Institute of Health