Subject: The H1n1 Strain Of Swine Flu
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(Note: This was fed in progress. Dr. Besser appears via video teleconference from Atlanta, Georgia.)
SEC. SEBELIUS: (In progress) -- President Obama for the opportunity to serve in this important office, and I want to join the president in sending my condolences to the families in the United States and Mexico who are mourning the loss of loved ones today.
And we know that many individuals are suffering from the 2009 H1N1 flu virus, and more cases are being identified every day. We're determined to fight this outbreak and do everything we can to protect the health of every American.
It's my honor to take a leadership position in this very important department, but I want to assure everyone that the efforts on this influenza outbreak have been under way not only within the agency but across the government for some time.
Last night I arrived in Washington and immediately after my swearing-in met with officials from the White House to discuss the national response to the flu outbreak. CDC and the entire department have been doing incredible work to respond to this outbreak, and I want to thank not only those individuals behind me but Dr. Rich Besser, who is visiting by video and doing his great job in Atlanta, for their efforts.
So I've asked the leadership team to be here today and discuss what's going on to respond to the outbreak. And with me are acting FDA Commissioner Josh Sharfstein and Dr. Jesse Goodman, who is the acting chief scientist at the FDA; the director of HHS National Vaccine Program, Dr. Bruce Gellin; the acting assistant secretary for Preparedness and Response, Dr. Craig Vanderwagen; the director of the Biomedical Advanced Research Development Authority, Dr. Robin Robinson; the director of the National Institute of Allergy and Infectious Diseases from NIH, Dr. Tony Fauci; and Rich Besser, who is the acting director of the Centers for Disease Control, who is with us by video from Atlanta.
Now all of these individuals and their agencies have been working with our colleagues across government to implement the necessary steps to reduce illness, minimize the disruption in our communities, schools and workplaces. They have the resources and the tools they need to respond to the outbreak.
In addition, all the agencies in the Department of Health and Human Services have been working aggressively to notify the public about steps people can take to protect themselves and limit the spread of the virus. Information is available at www.cdc.gov, www.cdc.gov, and HHS offices have distributed Web-based tools to state and community groups, our partners, that provide links to resources and information regarding the 2009 H1N1 virus.
Later today we'll be posting additional information and guidance on the website for parents and families.
HHS is working closely with state and local health departments and others to ensure that any Americans who are infected with the flu virus receive the treatment they need. Antiviral treatment guidance that doctors and clinicians can use has been developed and posted on the CDC website.
The federal government has nearly 50 million treatment courses of the antiviral drugs Tamiflu and Relenza in the strategic national stockpile. The government has already begun shipping the medications and other personal supplies from the stockpile to states.
States with confirmed cases are a priority as the resources are distributed.
I want to make it clear: These drugs are effective in treating patients who have acquired the 2009 H1N1 flu virus. However, the flu is always serious. We know that each year millions of Americans are affected (sic) with influenza; 200,000 Americans, on average, are hospitalized every year; and tens of thousands die from influenza and complications.
While we still don't know what this virus will do, we expect to see more cases, more hospitalizations. And unfortunately, we're likely to see additional deaths from the outbreak.
Currently, the FDA and Centers for Disease Control and Prevention are developing virus reference strains, the information regarding a virus that's necessary to develop a vaccine. And today, there are a series of steps that HHS is taking in that vaccine development. We've begun the process, we're in full gear, and the process is more speedy than it's ever been before.
We're committed to ensuring that these vaccines are safe. HHS and the Food and Drug Administration will monitor the manufacturing of a potential vaccine and conduct strict oversight to ensure that the vaccine is safe and effective for use. As the vaccine manufacturing is under way, the NIH will also conduct clinical trials to make sure that the best dosage and formulation of the vaccine is available.
The work done by NIH and FDA are critical, and it will help to make sure that this process is conducted in the most effective manner possible. We'll be working quickly, but safety is and will remain our top priority. Strict oversight measures will be in place as we work to manufacture an important vaccine.
In the interim, there are things every American can do. And while they seem relatively simple, they are incredibly effective. Wash your hands, often. Wash your hands. Cover your mouth and nose when coughing or sneezing. And don't go to work or school if you feel ill. Don't send your child to day-care, don't send your child to school, if you have flu-like symptoms. That will help contain the spread of this disease.
I'd like to call on, now, Dr. Rich Besser from -- the acting director of CDC, to provide some additional update on the outbreak.
DR. BESSER: Thank you very much, Madame Secretary. I hope you can hear me there in Washington.
SEC. SEBELIUS: We can hear you.
DR. BESSER: The situation continues to be one of much uncertainty. It's a situation that's changing very quickly. And our approach continues to be aggressive steps to try and minimize the impact on people's health.
What I'd like to do is provide a situational update. This morning, we confirmed the first death, of a child in the United States, from H1N1 infection, a 23-month-old in Texas. This is quite sad news. As a parent, as a pediatrician, I -- I am moved by this. And my heart goes out to the family in Texas who is dealing with this situation.
As we've been discussing over the past week, influenza is a quite serious disease, and one in which we expect to see a spectrum of infections. We have been seeing a situation in Mexico and the United States that has appeared somewhat different. We have been hearing reports of quite severe infection coming out of Mexico, and initially seeing much less severe disease in this country. As we continue to look for cases, we expect to see more cases and a broader spectrum. And that is what we are -- what we are seeing.
We know from annual flu, from seasonal flu, that on average in the United States 36,000 individuals die. And so putting it into perspective, this is a serious virus. It's a serious outbreak that we're dealing with. And we're taking aggressive measures.
Let me tell you where we are in terms of our case counts and our updates, but remind you that these numbers change quickly. We update the CDC website with case counts every day at 11 a.m., and those are the numbers we use for reporting over the next 24-hour cycle. We're reporting 91 confirmed cases in the United States, in 10 states. This is an increase from yesterday's report of five states. We have cases reported from New York, with 51; Texas, with 16; California, with 14; Massachusetts, with two; Michigan, two; Arizona, with one; Nevada, with one; Indiana, with one; Kansas, with two; and Ohio, with one. But again, these numbers are almost out of date by the time I say them, given the activities going on around the country to look for cases and to investigate them.
We're seeing a broader age range among cases. The median age is 22 years, with a range of 8 to 81 years. We are seeing that 64 percent are under age 18. There have been five hospitalizations so far, including the child who died. But we have a number of suspect cases that have been hospitalized, and we expect that number will go up.
The most recent onset for a case was April 24th. We don't know enough at this point to say more about transmission, but we are aggressively looking at transmission both here and abroad.
We continue to participate on teams here, in several states, and as part of the trinational effort in Mexico to try and understand the situation going on there. We're working closely with the World Health Organization and the Pan American Health Organization on these investigations.
We are working around the clock on our deployment of material to support state and local efforts. At this point there's no state that is anywhere near running into trouble in terms of their supplies of antivirals or their ability to take care of patients, but with our forward-moving approach, trying to be aggressive, we are distributing 25 percent of the stockpile supplies that are allocated for each state to those states now. And some of the states have received them, and all of the states will receive them by May 3rd.
We continue to issue guidance, and we develop this guidance in conjunction with our partners. The guidance for pregnant women and H1N1 is on the Web. We are also posting guidance for clinicians caring for children. We have antiviral recommendations for patients in close contacts, and we've posted guidance for airline crews in identifying potentially sick passengers.
When I finish my comments, we'll be hearing an update on some of the work going on at the Food and Drug Administration to support the investigations and support control of this outbreak, and then we'll be hearing an update on the vaccine work that is going on across the department.
I wanted to comment on issues around travel. There is a travel warning in place for Mexico, and what we have recommended is that non- essential travel to Mexico be postponed. The borders remain open, and we've increased our surveillance. So the Customs and Border Patrol officials are actively looking for individuals who may be sick. They are handing out the CDC travel health advisory notices so that individuals know what the symptoms are of H1N1 disease and when they should see their doctor. Individuals who are identified as sick are referred to public-health professionals for further evaluation.
The issues come up as to why we don't close the borders. And we've learned a lot from previous outbreaks and we've learned a lot about how to best use our resources in controlling outbreaks, putting those resources in areas that we know will be effective.
What we've learned from SARS most recently, and in particular the experience of the WHO director-general in Hong Kong, is that the intensive efforts to implement increased border screening, on end- entry-and-exit, was not an effective way of identifying cases or preventing transmission.
And so we will continue to put our efforts into those things that we believe will have the greatest impact, on reducing the impact of this outbreak on our population and populations around the world.
We are recommending multiple actions. As the secretary was just saying, there is so much that people can do, in terms of planning, in the event that schools are closed in their communities, in terms of preventing person-to-person transmission of infections.
And if people put their efforts in that direction and take that responsibility, we will continue to take our responsibility in helping prepare and mitigate, reduce the impact of this in their communities.
What are we in? We call this a pre-pandemic period. We are investigating an outbreak of a new strain of influenza. What you call this matters much less than what we do about it. And we are being aggressive in our efforts.
No single action will control this. But the combination of actions that are being taken, across the country at the state, federal and local level, will be effective at decreasing the impact of this event. But as we continue to look for cases, we expect to see more severity. And unfortunately I would anticipate that we will see additional deaths.
I want to reiterate that all of our guidance that we put up is interim. As we learn more, we will change. As the situation changes, we will adapt and we will respond accordingly.
At this point, I'd like to turn the podium over to Dr. Josh Sharfstein at the FDA, so he can talk about the tremendous efforts going on there, to respond to this outbreak.
JOSHUA SHARFSTEIN, M.D. (Food and Drug Administration, Department of Health and Human Services): Thank you very much, Dr. Besser. And on behalf of everyone at the FDA, I want to thank you and the CDC for the tremendous work you're doing and the collaboration that we've had.
And I also want to just take a special moment to welcome Secretary Sebelius and to say how happy we are that you're here.
FDA is working as part of a team led by HHS, in close coordination with other public-health agencies. I've asked Dr. Jesse Goodman, who is the FDA's acting chief scientist and a national expert in infectious disease and in flu vaccine manufacturing and licensing, to coordinate and lead FDA's efforts on the H1N1 flu virus.
We have shifted from our ordinary approach, within FDA, to an incident management structure that includes seven specific teams.
All of the FDA's centers are engaged in this effort. And what I'm going to do is just briefly mention what these seven teams are that are now working on the virus.
The first -- and these are in no particular order -- we have a vaccine team, and the goal of the vaccine team is to facilitate the availability of a safe and effective vaccine for this disease. There is a tremendous amount of work, all the way from the lab to anticipating to licensure, going on at FDA, working in collaboration with CDC and NIH in developing the actual reference strain of the virus that will be used for a vaccine, as well as thinking through how the potency of the vaccine will be tested, what the clinical trials will look like and ultimately what the application for approval will look like.
We have an antiviral team. This is the team that approved two emergency-use authorizations -- or prepared for my approval two authorizations for antiviral medications, which were signed early Monday morning, to make antiviral drugs available and permit the strategic stockpile to go, for Tamiflu; this included authorization for use under age 1. There is an in -- and I should say, that team is also actively engaging all the manufacturers of products that could be effective against this virus so that we could be ready, and clinicians could have access to treatments that we believe are promising.
There is an in vitro diagnostics team, which is responsible for the lab tests to identify the flu. And we worked very closely with CDC that -- in approving another emergency-use authorization to permit the distribution of their test for this virus around the country. And that also happened early Monday morning.
We have a personal protective equipment team that approved -- that handled the emergency-use authorization on N95 masks, which have a use in accordance with the CDC guidance. And they are also working with manufacturers of other personal protective equipment on their supply to make sure that it's available when we need it.
There is a blood team that is thinking in advance of any implications for the blood supply.
We have a shortage team that is working to facilitate the availability of antiviral drugs in coordination with the department, in talking to manufacturers about their production capacity and what they will be able to do.
And finally, we have established a consumer-protection team to start thinking about the fact that there may be treatments that may be marketed to people that potentially are dangerous and fraudulent.
And we want to keep that activity to a minimum.
So across all these areas, FDA has been literally working around the clock in coordination with the other agencies. And we believe that the structure that we've set up is going to be flexible enough to see these current efforts through, as well as engage in all of the other activities that will be important.
DR. BESSER: I'd like to ask Dr. Fauci from the National Institutes of Health to talk a bit more about some of the vaccine development efforts under way.
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