Today, President Obama announced the United States will continue to act aggressively to stop the global spread of the pandemic 2009-H1N1 influenza virus and is prepared to make 10 percent of its H1N1 vaccine supply available to other countries through the World Health Organization (WHO). In recognition that diseases know no borders and that the health of the American people is inseparable from the health of people around the world, the United States is taking this action in concert with Australia, Brazil, France, Italy, New Zealand, Norway, Switzerland, and the United Kingdom. The United States will make the H1N1 vaccine available to the WHO on a rolling basis as vaccine supplies become available, in order to assist countries that will not otherwise have direct access to the vaccine.

This week, the Food and Drug Administration officially licensed the 2009-H1N1 influenza vaccine. Last week, the Department of Health and Human Services and the National Institutes of Health announced that one dose of the vaccine – instead of two doses – will be effective in developing immunity in most adults, and HHS Secretary Sebelius announced the vaccine would be available in the coming weeks, earlier than originally anticipated. We remain confident that the United States will have sufficient doses of the vaccine to ensure that every American who wants a vaccine is able to receive one. We continue to recommend that early priority at home and abroad should be given to pregnant women, health care workers, individuals caring for infants less than 6 months of age, and other high-risk populations.

There is broad international recognition that the 2009-H1N1 pandemic presents a global health risk. Millions of people around the world have been affected, thousands have died and the virus continues to spread across international borders. The United States recognizes that just as this challenge transcends borders, so must our response. We invite other nations to join in this urgent global health effort. Working together, we can ensure that this vaccine limits the spread of the disease, reduces the burden on health care systems, reduces the risk of an even more virulent strain emerging and, most importantly, saves lives—in the United States and around the world.

Kathleen G. Sebelius at the WHA

Press Briefing with Kathleen G. Sebelius
U.S. Secretary of Health and Human Services

and

Dr. Richard Besser
Acting Director
U.S. Centers for Disease Control

Tuesday, May 19, 2009
Geneva

SECRETARY SEBELIUS: Good morning, everyone. I’m pleased to be here this morning at my first opportunity to meet here at the World Health Assembly as a representative of the United States of America. I’m now four weeks into my new position as Secretary of Health and Human Services and am delighted to have the chance to have an introduction to our world partners and see in person Dr. Margaret Chan who’s been not only been a great leader for WHO but a frequent collaborator during my early weeks on the job.

With me today are Dr. Josh Sharfstein who is the Principal Deputy Commissioner of the Food and Drug Administration. Yesterday in the United States Senate the new Commissioner of FDA, Dr. Peggy Hamburg, was confirmed but we’re delighted to have Josh with us today. Mary Wakefield, who’s our Administrator for Health Resources and Services Administration, HRSA, dealing with a lot of our health capacity and health disparities in the United States. And Dr. Richard Besser is to my right. Dr. Besser is the Acting Director of the Centers for Disease Control and has been leading our effort on response to the H1N1 virus.

Let me just make a few opening comments and then we’d be pleased to take questions from you.

As I say, it’s been an active four weeks on the job. I didn’t expect to come in necessarily with an international pre-pandemic situation, but it has been not only a great opportunity to learn about what is our capacity in the United States and the preparation that we’ve had underway in states throughout the country that I participated in as governor, making sure that we were ready for a health crisis, I’ve now been able to not only see acted out in the United States but around the world. The issues of collaboration, cooperation, communication and readiness are brought home by dealing with H1N1.

I had a great opportunity in the brief time I’ve been here to not only meet with our strategic partners and allies, Canada and Mexico, who we’ve been working very very closely with on H1N1 in terms of our border issues and our initial cooperation, but the partners in the Global Health Security Initiative, but also met with ministers representing every region in the world, knowing how a potential pandemic situation really is a world strategy. I had the opportunity for the first time to meet Dr. Chan, although Dr. Chan and I have been phone pals over the last four weeks, very frequent communication, a lot of interaction and a lot of cooperation with the World Health Organization. What this has brought home is disease knows no borders, that we are really connected to one another in this global world. But as was said yesterday, for the first time I think a demonstration that there is a strategy now worldwide for not only prevention and preparation but how to deal and manage with this issue going forward. A lot of it involves communication and cooperation.

We’ve also had an opportunity to present the President’s new Global Health Initiative. As you know, President Obama has committed a $63 billion investment over the next six years, not only continuing and increasing the efforts on HIV/AIDS under the PEPFAR Initiative, but a real focus on maternal and child health issues which a number of countries have underway. An effort to look at some of the previous neglected tropical diseases which are impinging on world health issues. And a real commitment to be part of the global strategy and global community to reduce health disparities around the world.

So this has been a great opportunity for me to become acquainted with some of the leaders, world health issues in other parts of the world, and I see it as a great first step in new partnerships moving forward, and have been very pleased to be here.

With that, we would be happy to respond to the questions you may have.

QUESTION: Ms. Secretary, I was wondering you could elaborate a little bit your views on what was triggered by the UK Secretary of Health yesterday on the need for more flexibility in going to phase six.

And I have a small technical question for the CDC Acting Director. The concerns flagged by the Chinese Minister of a possibility of H5N1 and AH1N1 mixing together to get a new mutation. How concerned are you about that? Thank you.

SECRETARY SEBELIUS: I’ll try to deal with the issue of the phases on the flu issue. As you know, there’s been a lot of discussion. We are now at level five as pronounced by Dr. Chan before we arrived here, and much discussion in the last 24 hours about when and if to go to level six.

I think there seems to be a broad consensus that having some flexibility in this situation with the World Health Organization, looking at what level six does and doesn’t mean in terms of triggering response is appropriate at this stage. What we’ve tried to do in the United States and I think certainly our neighbors in North America have also adopted this strategy but we’re sharing it around the world, is to take an aggressive approach within our country to talk about issues of personal responsibility, what people should be doing to prevent the spread of this disease which includes hand washing on a frequent basis, staying home. If you are sick, keeping your children home if they are ill. Don’t get on an airplane if you have flu-like symptoms because what we know is that the virus spreads very easily.

So what we’ve told people in America at least is that we are preparing and are ready as if this were phase six, that that doesn’t trigger any additional activity. I think what Dr. Chan has talked about is right now the situation seems to lend itself at level five to the kind of dialogue that we’re having here, and I think there will be discussions about when and if it’s appropriate to declare a level six pandemic. But that’s what the World Health Organization is authorized to do. I think the steps that she’s taken and the openness and transparency of this discussion and the collaborative nature of the discussions that are taking place are exactly what’s required in this situation.

Dr. Besser might answer the specifics about the science.

DR. BESSER: Thank you, Madame Secretary.

The question that you raised is a very important one. In some circles we hear concerns that this has been an over-reaction, that the virus is less severe than we had initially thought and that it’s no different than seasonal flu.

As we go forward there are a lot of important questions. One question is, what if this virus changes? What if it picks up factors that make it more severe? So the question about H5N1 and the H1N1 virus reassorting is really part of the broader question and points to the issue that we really need to be vigilant. We need to track this virus as it spreads around the world. We need to do the studies to determine whether there’s any change in that virus because that will help guide the steps that we take around the globe to minimize the impact on people’s health.

QUESTION: I’ve been rapped on my knuckles for using the “P” word as it’s called now. So I’m wondering whether going to phase six might not indeed trigger some kind of mass hysteria because people do not understand the subtleties of the language that you are using.

Also I was wondering, has the United States been doing everything it can, or are there weaknesses that you need to address?

Finally, it seems as if the developing countries are going to come into play perhaps in a very serious manner when the swine flu hits the southern hemisphere. What preparations are you planning to do as a leader to get these countries the support that they need?

SECRETARY SEBELIUS: Those are three good questions.

I think what we’ve tried to do in the United States at least is talk about the fact that the term pandemic is more about geography than severity. Getting that word out I think is very important, so we’re relying on a lot of you in this room to help do that. That it is not an indication necessarily of the lethality of the disease, it’s about how many regions in the world the disease is confirmed.

But there’s no question that having that conversation across the globe is important so people understand what it is that’s happening. As Dr. Besser said, at least at this point the flu is presenting itself as relatively mild. We’re cautiously optimistic that at this phase that’s what looks to be how it’s being presented. But what happens in flu season, again to your second question, will be informed greatly by what happens in the southern hemisphere as flu season combines with this H1N1 virus showing up.

What we know about seasonal flu is at least in the United States we have millions of people affected every year. Over 200,000 hospitalizations and 36,000 people die every year from seasonal flu. So even mild flu has a lot of deaths associated with it, and that’s when people have fairly good access to health treatment and have not a lot of underlying health conditions.

What happens with the kind of flu outbreak in the developing nations where in refugee camps or where there is not access to sanitation and clean water or the underlying health conditions are already in very difficult shape could be quite severe.

So we will learn a lot from the southern hemisphere. There will be a lot of intense not only analysis of what’s happening, but there’s so much uncertainty right now about what H1N1 actually will do, whether it will mutate, how it will present itself, what kind of impact it has, and what population is most affected.

We know now that it appears as if a younger generation than seasonal flu is being impacted and affected in Mexico and the United States. Whether or not that continues to present itself that way or whether it shifts into a different age group again will inform if and when there’s a vaccine, who should be vaccinated. What are the appropriate age groups?

But there’s no question that continuing to watch the southern hemisphere very closely, to send scientists there to figure out what’s going on. There’s a discussion underway about stockpiles of anti-virals that have been distributed by the World Health Organization. Certainly the United States is a partner in making sure that both anti-viral treatment and when and if there is a vaccine available the vaccine availability and distribution is certainly something that we have a responsibility for not only in our own country to keep Americans safe and secure, but we feel a responsibility as a good partner around the globe.

QUESTION: I have two questions. First of all on Saturday night after two years of negotiations the agreement of sharing viruses and other materials failed, basically. It’s not going to be continued during this week at least. The idea is that it goes on during the year, but during this week countries would not negotiate. That’s at least what we understand. And developing countries do claim that it was the U.S. position that avoided the agreement to be concluded. Can you explain your position on this agreement and why is it that developing countries are at least accusing you of avoiding the agreement to be signed?

Secondly Japan and in the UK, there is also not only the mild issue of the virus but also political and economic considerations. Yesterday we had the Minister of Health of Mexico saying very clearly that the political and economic impact of calling pandemic would be big. Do you think there is a politicization of the issue at the moment?

SECRETARY SEBELIUS: I’ll try to address the second question first and then maybe turn to Dr. Besser in terms of the virus agreement.

The issue of I think the impact of aggressive steps to control and contain the virus is certainly a balancing issue and one that again we’ve seen in the United States. I think there’s no question that the Health Minister of Mexico took some courageous steps to contain this new virus in Mexico, basically shutting down a lot of the operations in Mexico City. That had an economic impact, a negative economic impact. But I think he deserves not only some credit for that courage but also the encouragement moving forward that as those decisions are weighed, we need to take into account the impact of not only the economy, but on the health of individuals in our own countries and around the world.

The United States very aggressively dealt with the situation in our country, initially closing schools and recommending that we have a fairly aggressive approach to trying to contain the virus. When it then became clear it was presenting in a less lethal form than initially appeared, that guidance changed. But I think as we watch this develop and as we learn more about the virus, there will be a balance between what are the health impacts, how can we best control and contain the outbreak, and what the balance of the health impact is.

Again in the United States, there’s a health impact to closing schools. If parents can’t go to work and don’t have access to affordable child care, there’s an impact to that. Are the kids in safe and secure — if the kids stay home from school and turn around and go to the mall, it’s not necessarily a wise strategy.

So whether that’s called politics or common sense, I think you have to balance what it is that we’re advising people to do and then what they’re to do with that advice.

So my guess is that will continue. And sharing strategies with one another, what we think is effective. We did not feel that closing the border was an effective strategy, although that was certainly an issue raised in the United States, why not close the border with Mexico, why not close the border? Once the disease presented itself within our borders, we knew that was not an effective health strategy and had huge economic consequences with millions of dollars in commerce, in workers traveling across that border every day.

So I think weighing the cost effectiveness of the strategy given will be something that individual leaders will do with safety and security being foremost.

Dr. Besser, if you’d like to try the virus issue.

DR. BESSER: We feel for the global community to be able to respond quickly and effectively to any emerging infection there has to be transparency and sharing of information. Our approach throughout this has been one of sharing information about the virus, sharing strains. We immediately posted on GENBANK the genomics around the virus and are working to develop vaccine seed strains to share with manufacturers around the world.

We’ve been sharing diagnostic kits and so far have sent kits to 237 labs in 107 countries.

This has been our approach. It’s been the approach that Mexico and Canada have taken. We feel it’s one of the reasons that we’ve been able to learn so much so quickly, it’s that open sharing of information.

QUESTION: But the agreement?

DR. BESSER: I don’t want to comment on the proceedings of the committee, but the approach to open sharing of viruses is really critical to the health community being able to respond to new threats.

QUESTION: Madame Secretary from the first day that it was announced on the 25th of April in the news conference in Washington and you said now even that the U.S. is always ahead of the WHO in dealing with this situation, so if it’s four, it’s five in the U.S.; if it’s five in the world, it’s six in the U.S..

So what if in the coming days it is declared six? What would be the implications of such a move? Do you favor travel restrictions, travel advisories? Will you start immediately producing the vaccine?

SECRETARY SEBELIUS: I think that, again, the work on the vaccine is very much underway and we are at the steps of testing the various strains to see which is the most appropriate to become a vaccine potential or whether we’ll need several. We are sharing that information with labs around the world, as Dr. Besser said. And frankly, we’re trying to accelerate the production of seasonal flu vaccines so that the production capacity is available to turn to an H1N1 vaccine production should that be required and necessary.

But the Food and Drug Administration is working very closely with NIH on the science and the safety of a new vaccine production. So the steps are being aggressively pursued.

There are people who say why don’t you make the vaccine right now? Because we don’t know enough. We don’t know enough about the strain, we don’t know enough about how the flu will present itself to know even what exactly is going to be needed. So this time is very important.

I think the conversations about what is the world approach to everything from travel advisories to safety steps is part of the conversation that Dr. Chan is engaging the global community and having right now. Some of that is I think a step by step situation that depending on the presentation of the disease and where it has appeared and what is the strategy, individual health ministers, heads of countries will have those conversations about their own border strategies, about their own situations.

We have determined in the United States, since we know that we have over 5,000 cases already presented. We know that’s an underestimate of the cases because now we’re looking at not individual case counts but where the disease is presenting, that we have a situation where we’re trying to do some containment. Again, in the United States at least, the most effective strategy right now are steps that people can take very easily. Washing your hands, using alcohol-based sanitizer, staying home if there are flu-like symptoms. We know that the anti-virals, Tamiflu and others, are effective in treatment. So we’ve pushed those stockpiles out to states around the country and they are available.

So we are taking steps at least to try and contain and monitor, but I think that conversation will continue as we see the outbreak in regions around the world that have not yet experienced this flu, in the southern hemisphere as that goes forward. Again, I think that’s what Dr. Chan is really trying to coordinate. What is the worldwide strategy, and how can we best not only communicate but collaborate with one another?

QUESTION: Several countries have said that they’ve placed advanced orders for a pandemic flu vaccine. Has the United States done this? Are you convinced that the U.S. has the manufacturing capacity to produce enough vaccine for its population if necessary?

SECRETARY SEBELIUS: Can you repeat the first part of that about the borders? I’m sorry, I couldn’t –

QUESTION: Have you placed any advanced orders for –

SECRETARY SEBELIUS: Oh, advanced orders. I’m sorry. I thought I heard you say borders.

No. At this point we have not placed orders for vaccine and as you know, the capacity for manufacturing is international. There are companies in various parts of the world that have the capacity to make vaccine. What I think we know is that that capacity has limitations and certainly the discussion moving forward has to involve how that capacity, if and when a vaccine is necessary, is distributed, and what is the appropriate not only protocol for who gets vaccinated, who is the most vulnerable population, in what order; but how then we deal in the developed countries with developing countries who also may have need for not only the anti-virals but the vaccine. But those discussions are very much underway.

We are having discussions in the United States about steps we would need to take to look at our population. Critical health care personnel kind of being at the front line and then who else. But I think anybody would tell you there’s still so much uncertainty about this virus, and that it is really premature for us to even make a determination of how many people would appropriately be vaccinated, in what order? How many doses would be required, at what point? All of those I think discussions are still very much underway.

Thank you all very much.

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Kathleen G. Sebelius at the WHA

Plenary Session Remarks
By Kathleen G. Sebelius
U.S. Secretary of Health and Human Services

Geneva, May 18, 2009

Mr. President, Madam Director-General, fellow delegates:

It is my honor to represent the United States of America and address the World Health Assembly and I want you to know that the United States is here to work with you and we are here to listen.

President Obama and I know that this is a unique moment in our history, a moment where we must unite to improve the health of all our nations. We are committed to partnering with you to advance the cause of social justice, to expand access to health care and reduce health disparities. And we know that working together, we can achieve the goals that we all share.

I want to begin my remarks today with an update on the H1N1 flu virus and a few words of gratitude.

Several weeks after this outbreak began, we are cautiously optimistic that this virus might be less severe than was first feared, based on initial reports from our close neighbor, Mexico. While this is good news, we are continuing to act aggressively and appropriately to help mitigate the consequences of the outbreak and protect public health.

Today, I would like to outline a few of those actions.

The United States has distributed millions of treatment courses of antiviral drugs across the United States and Mexico that help save lives.

U.S. government agencies are working together in an unprecedented way to develop a vaccine and ensure that production of seasonal flu vaccine continues.

We know that there are things that everyone can do to reduce the risk of infection and have conducted a massive public campaign to inform Americans and help stop the spread of this virus.

In times of crisis, clear, concise, accurate information is essential and our government has used traditional media and new methods of the internet to spread information that can help limit the spread of the virus.

As in the past, we have worked closely with the World Health Organization and the international community, evaluating the threat the new flu virus poses, sharing information about the spread of the disease within our borders, and coordinating our response. Our WHO Collaborating Center for Influenza in the United States has developed and is in the process of distributing kits that will allow the new virus to be rapidly detected to over 130 countries. In addition, the sequence of the new virus has been shared with our international partners and with industry so that we can be better prepared across the globe.

The United States’ Centers for Disease Control and Prevention, a WHO Collaboration Center, is testing specimens from other countries that have not been sub-typed in their home country.

And our Emergency Operation center is hosting liaisons from the Pan-American Health Organization (PAHO), the European Centre for Disease Prevention and Control (ECDC), the China CDC and the Public Health Agency of Canada so we can better coordinate our response.

There is more work to be done – work that we must do together – but we have much to be proud of. Viruses know no borders and the success we have achieved to date would not have been possible without an unprecedented level of international preparation and cooperation.

So on behalf of President Obama and the American people, I want to thank you all for your leadership, cooperation and tireless efforts to help protect public health.

And let me also offer a special word of thanks to Director-GeneralDr. MargaretChan whose strong leadership ensured the world responded quickly and appropriately to this outbreak.

We recognize that the United States has an important role to play both in the response to this outbreak and in our shared work to improve the health of our people and our nations. Together, we have made progress. The President’s Emergency Plan for AIDS Relief and the United States’ work to fight malaria and tuberculosis have saved over a million lives in countries around the world.
But today alone, 26,000 children will die from poverty and preventable diseases. HIV/AIDS infection rates remain unacceptable – both in the United States and in countries across the globe – and the AIDS pandemic has a woman’s face. Diseases that we know how to treat take the lives of millions every year.
We can and must do more.

President Obama is committed to ushering in a new era in global health, an era that no longer tackles disease and illness in isolation.

Instead, our world demands a new, integrated approach to public health – one that seeks to understand and target the many factors that that can threaten the lives and livelihoods of all our citizens.

The President has requested $63 billion over six years to support a holistic approach. This approach will work to fight previously neglected tropical diseases.

And it will focus on women and families. We know that every minute of every day, a woman dies from complications related to pregnancy or childbirth. President Obama’s agenda will help improve maternal and child health, and support a full range of family planning reproductive health services for women.

This new initiative will expand our efforts to fight AIDS, malaria and tuberculosis and will build on what we know works.

But it will also use new resources to make smart, cost-effective investments in programs that make whole communities healthier. It will emphasize disease prevention and seek out strategies that do not battle one disease, but rather, battle the conditions that allow diseases to thrive. And we believe this initiative is compatible with the implementation of the International Health Regulations, which we continue to support.

As we implement this new initiative, we will seek your advice and expertise. We will not operate in isolation or ignore the good work that so many of your countries have done. Instead, international partnerships, cooperation and consultation will be the hallmarks of this new initiative.

We know that we must all work together to tackle the challenges we face and we are pleased that Chinese Taipei is seated as an Observer at this World Health Assembly. This action helps to fill a gap that had existed in the global health network.

We welcome Chinese Taipei’s presence and participation in this Assembly and hope experts from Taiwan will be able to participate consistently and meaningfully in technical meetings of the WHO, for the benefit of global public health.

Together, all our nations will build on the good work that is saving lives in nations around the world. We will tackle decades-old challenges that continue to plague our planet. And we will implement the new comprehensive strategy to improve global health.

We know the United States alone cannot take on every challenge. In a world with a seemingly infinite number of challenges, we have limited resources. But let me make it clear, President Obama will not shy away from the opportunity to lead and collaborate as we work together to protect the health and safety of communities across the globe.

So I want to thank you for your warm welcome and I look forward to meeting and speaking with all of you in the days ahead.

Thank you very much.

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United States Trade Representative Ron Kirk, Canadian Minister of International Trade and Minister for the Asia Pacific Gateway Stockwell Day, and Mexican Secretary of the Economy Gerardo Ruiz Mateos today issued the following statement calling for an end to unscientific bans on pork imports from their respective countries due to the fears of the H1N1 flu virus, noting the large and negative economic impact of such bans. More than a dozen countries worldwide have sought to ban pork imports from H1N1-affected nations:

“We would like to express our concern for the victims of the current outbreak of H1N1 human influenza. Our governments remain committed to doing everything possible to bring the outbreak under control.

“We are also concerned that some trading partners are imposing restrictions on trade in swine, pork and other meat products from North America that are without scientific justification and inconsistent with their international obligations. These unjustified restrictions will likely result in serious trade disruptions without cause and result in significant economic damage.

“On May 2, the World Health Organization [WHO], the World Organization for Animal Health [OIE], the Food and Agriculture Organization [FAO] and the World Trade Organization issued a statement saying that ‘there is no evidence that the virus is transmitted by food. There is currently therefore no justification in the OIE Terrestrial Animal Health Standards Code for the imposition of trade measures on the importation of pigs or their products.’ They stressed that ‘pork and pork products, handled in accordance with good hygienic practices recommended by the WHO, FAO, Codex Alimentarius Commission and the OIE, will not be a source of infection.’

“In view of the above, we urge our trading partners to remove these restrictions on our products immediately. We will continue to follow this situation closely, and will take any steps to prevent the enforcement of unjustified measures against our exports, as appropriate.”

(end text)

Office of Public Affairs
U.S. Mission to the United Nations – Geneva
For Release: May 4, 2009
On May 4-5, Dr. Esther Brimmer will make her first visit to Geneva since assuming her position as U.S. Assistant Secretary of State for International Organizations. During her visit, Dr. Brimmer will meet with Geneva-based United Nations agencies and International Organizations, as well as diplomatic counterparts and staff of the U.S. Mission.

Dr. Esther Brimmer was nominated by President Barack Obama to the position of Assistant Secretary of State for International Organizations Affairs on March 11, 2009, and was confirmed to that position by the United States Senate on April 2, 2009. In her role as Assistant Secretary, Dr. Brimmer leads the Bureau of International Organization Affairs, which strives to advance U.S. interests through international organizations in areas including human rights, peacekeeping, food security, humanitarian relief, and climate change.

Dr. Brimmer’s visit to Geneva will transpire less than a month after taking up her post, and underscores the Administration’s commitment to multilateral engagement and appreciation of the essential role played by Geneva-based institutions on a wide range of critical global issues.

Dr. Brimmer’s introductory meetings will include calls on counterparts at the World Health Organization (WHO), the U.N. High Commissioner for Refugees (UNHCR), the U.N.’s Office of the High Commissioner for Human Rights (UNOHCHR), the International Labor Organization (ILO), the World Meteorological Organization (WMO), the International Telecommunication Union (ITU) and the U.N. Conference on Trade and Development (UNCTAD).

In keeping with the Obama Administration’s commitment to engagement with other nations on issues of shared concern, in March the United States announced its intent to run for a seat on the UN Human Rights Council (HRC). During her Geneva visit, Dr. Brimmer will discuss the U.S. candidacy in her meetings with multilateral partners.

As part of its candidacy, the U.S. has published its Human Rights Commitments and Pledges.

Biography of Dr. Esther Brimmer

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For more information visit the CDC webpage

http://www.cdc.gov/swineflu/