HHS H1N1 Press Conference 4-29-09

29 de abril de 2009
11:00 a.m. EST

HHS Secretary, Kathleen Sebelius

Dr. Joshua Sharfstein, Acting FDA Commissioner

Dr. Anthony Fauci, Director, NIAID/NIH

Dr. Jesse Goodman, Director, Center for Biologics Evaluation and Research (CBER), FDA

Dr. Bruce Gellin, Director, National Vaccine Policy Program Office, HHS
Dr. Richard Besser, Acting CDC Director via satellite
RADM William Craig Vanderwagen, Assistant Secretary for Preparedness and Response,
US Department of Health and Human Services (HHS),
Robin Robinson, Ph.D., director of the Biomedical Advanced Research Development Authority (BARDA), HHS Office of the Assistant Secretary for Preparedness and Response.

KATHLEEN SEBELIUS, HEALTH AND HUMAN SERVICES SECRETARY : 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 underway 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, the 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 work places. They have the resources and the tools they need to respond to the outbreak.

In addition, all of 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 Web site for parents and families.

HHS is working closely with state and local health departments and others to insure 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 Web site.

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 with influenza, 200,000

Americans on average are hospitalized every year, and tens of thousands die from influenza and complications.

But 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 insuring 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 insure that the vaccine is safe and effective for use.

As a vaccine manufacturing is underway, 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’re 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 daycare, 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, and to provide some additional update on the outbreak.

DR. RICH BESSER, ACTING DIRECTOR, CDC: Thank you very much, Madam Secretary. I hope you can hear me there in Washington.

SEBELIUS: We can hear you.

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 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 specter of infections.

We have been seeing a situation in Mexico and the United States that has appeared somewhat different. We’ve 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 in a broader spectrum, and that is 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. We’ll remind you that these numbers change quickly. We update the CDC Web site with case counts every day at 11:00 a.m., and those are the numbers we use for reporting over the next 24-hour cycle.

We are 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 81 years. We are seeing that 64 percent are under age 18. There have been five hospitalization 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 tri-national 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 materials 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 developed this guidance in conjunction with our partners. The guidance for pregnant women and H1N1 is on the way. We are also posting guidance for clinicians caring for children. We have antiviral recommendations for patients in close contact, and we have 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 investigation 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 issue’s come up as to why we don’t close the border, and we’ve learned a lot from previous outbreaks, and we’ve learned a lot about how to best use our resources in the – 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 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 effect 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 communities 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 do 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.

JOSH SHARFSTEIN, ACTING FDA COMMISSIONER: 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 take a special moment to welcome Secretary Sebelius and just say how happy we are that you’re here.

FDA is working as part of the 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, international 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 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 patient effective vaccine for this disease. There is a tremendous amount of work all the way from the lab to anticipating to licensure, going on in 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 approves two emergency use authorizations or prepared for my approval, two authorizations for antiviral medications which were assigned early Monday morning to make antiviral drugs available and permit the strategic stockpile to go for Tamiflu. This included authorization for use under age one.

There is an – and I should say that team is also actively engaged in all of 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 work very closely with CDC, but – in approving another emergency use authorization to permit the distribution. There are tests 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 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’s 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 assembled (ph) 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 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 the other activities that will be important.

Gracias.

BESSER: I’d like to ask Dr. Fauci from the National Institute of Health to talk a bit more about some of the vaccine development efforts underway.

DR. TONY FAUCI, NATIONAL INSTITUTE OF HEALTH: Thank you, Dr. Besser. I’ll be quite brief.

I just want to summarize that the NIH, as traditionally been the case, is the research, both basic and clinical limb, of the HHS team that you’ve heard from and will continue to hear from in this approach towards this new virus.

What is going on now is a question often asked regarding vaccines and what are we doing. As you know and have heard through the media that the strain of the vaccine has been isolated by the CDC. That will be made into what we call a reference strain for the purpose of developing vaccines.

A reference strain is then put into what we call a seed virus for growth to determine the best conditions to grow it in order to make enough for a vaccine.

Right now that process has already started. The virus reference strains have been distributed to the appropriate people and will continue to be distributed to those who would utilize it.

At the NIH, our purpose and our function, which we’ve already geared up for, is to do the clinical trials on the pilot lots that will emerge from the production through our pharmaceutical company partners. Those trials will take a period of months. They will probably begin within a couple of months, and the purpose of those trials is to determine the safety, the immunogenicity, which means does it induce a response that you would predict would be protective, and importantly, what is the proper dose.

So again, we’re part of the team that is in the process, that has already been launched, a pre-planned process of developing a vaccine for this problem that we have right now, and this again is going to be a stepwise process that we will continually update you with.

Thank you very much.

UNIDENTIFIED PARTICIPANT: Thanks, Dr. Fauci.

The Secretary has to run up to the Hill for a meeting, but has time for a few questions.

SEBELIUS: And if they’re tough, I’m going to defer to Dr. Besser.

Sí.

UNIDENTIFIED PARTICIPANT: Hi, Madam Secretary. (INAUDIBLE) indicated concerns about community transmission in regards to the cases in New York City, and so I’m wondering with that concern, aside from school closures, are there steps that are under consideration?

SEBELIUS: Well, currently I think, as Dr. Besser said, the situation is being evaluated on an ongoing basis. As you know the way response works, it starts at the local level, and in the discussions with local partners, I think, the CDC has recommended first of all that schools close when an infected student has been identified.

More aggressive steps have been considered by some school districts, and I think that is currently under discussion, but as you know there then is a large ripple effect. What happens to the parents, where do those children go, do you close the daycare center if a younger sibling is there, so I think closing a broader affected area is always being actively monitored and under discussion, and right now there are some affected districts that have taken broader steps, closing a series of schools, but the CDC recommendation currently is if an infected student is identified, close that school, and contain the illness at that level.

I talked to Dr. Chan this morning, the Director of the World Health Organization. There is again daily conversation about this, not only across the U.S. government agencies but I would suggest around the world, and those collaborations will continue, and this is a situation that is evolving and updated on a regular basis.

Yes, sir.

UNIDENTIFIED PARTICIPANT: Was the – can I ask you a couple of questions about the toddler this morning? Do you know whether or not the baby or the toddler was being treated with antivirals, and if so, is that cause for any concern that they may not be as effective as people think?

SEBELIUS: I’m going to ask Dr. Besser to answer that question.

BESSER: (INAUDIBLE) Whenever we have a case of confirmed H1N1 disease, we’re going to look at the specifics on when did the illness start, what type of treatment was received, how long did it take between illness onset and treatment, and the Texas State Department of Health is actively investigating this case, and I would refer you to them for those details.

But I do want to caution you that there’s very little you will glean from one case. It’s looking at these cases together where patterns start to emerge that will help us improve and refine treatment guidelines and continue to evaluate our control strategies.

SEBELIUS: One more question (INAUDIBLE) and then Dr. Besser (INAUDIBLE)

UNIDENTIFIED PARTICIPANT: (INAUDIBLE)

UNIDENTIFIED PARTICIPANT: (INAUDIBLE) with “Congressional Quarterly.” I just wondered in light of what is going to be I am sure growing public interest in Tamiflu, could you clarify what that drug can and can’t do and under what circumstances people you know would seek to use it?

SEBELIUS: Well, again, I would like to refer to the scientists and to – and the doctors to answer this question, so Dr. Besser, maybe you could answer the question about how effective the antiviral is and what people can expect, and thank you all very much. I’m going to turn over to Dr. Besser.

BESSER: Thank you very much, Madam Secretary.

We know that this virus that’s circulating is susceptible, can be treated by Oseltamivir, which is Tamiflu, and Zanamivir, which is Relenza, and that’s good news, and we have treatment guidance up on our Web site, and we’ve distributed to the clinical community so that they know how to use those drugs across patient populations.

There are other circumstances in which we’re recommending that antiviral treatment be used. Close contacts in the family who have underlying medical conditions that would put them at a greater risk of severe influenza, that’s a group that – for whom drugs are recommended.

And so as we learn more, as we learn more about severity and transmission, we’ll continue to update our treatment guidelines, and again, one of the reasons we have pushed forward with distributing the first 25 percent of the antiviral to the states is so that they have those drugs on hand should additional treatment be required.

Next question?

UNIDENTIFIED PARTICIPANT: Yes.

JARED (ph) (INAUDIBLE), DOW JONES: Hi, Jared (ph) (INAUDIBLE) from Dow Jones. What does the federal government do in the case, where, somebody comes over on a plane from Mexico …

UNIDENTIFIED PARTICIPANT: Right.

JARED (ph): … and they come here and they – turns out they do have the swine – they do have swine flu, what do you do for the rest of the other passengers who, maybe, aren’t ill on the plane?

TONY (ph): Well, we’re calling it the 2009 H1N1 flu, now. That’s the name for it. But having said that Rich (ph), why don’t you …

RICH (ph): Yes, thanks Tony (ph). We know from previous experience the importance of, yes, investigating and controlling outbreaks that could occur on airliners. This is something that happens all the time.

We have a quarantine system in this country. And one of the big functions of that is so that when there’s an identified illness, on a plane, either an illness that’s identified in flight or one that’s identified after a plane has landed, we use this system to identify who was on the plane and to take appropriate measures.

In the setting where we have a confirmed case of someone who was symptomatic on an airliner, we would work to notify those individuals, so that they would understand that there had been exposure and appropriate measures could be taken. Those measures would depend on the individual and their underlying medical condition. And whether we thought there had been an exposure that put them at risk.

TONY (ph): Thank you, Rich (ph).

UNIDENTIFIED PARTICIPANT: Next question.

TONY (ph): Next question, yes, right back there.

ANDREA BRUCE (ph), PBS NEWS: Good morning, Andrea Bruce (ph), PBS News. Two questions; one, of the – maybe this is for Dr. (Shar’s) team first and then for you, second.

TONY (ph): Yes, sure.

BRUCE (ph): Of the 50 million or so doses of antiviral, which were on the stockpile, which were released with the order on Monday, can you update on us how many have actually been shipped and to which states?

And secondarily, I know that it’s hard to give an exact timeline …

TONY (ph): Sure.

BRUCE (ph): … for vaccine production but we’ve heard and been speaking broadly, a couple of months, could you give us a better sense of where you are on, on the timeline and give me …

TONY (ph): Sure, Dr. Bresser (ph) will be because CDC’s responsibility for the strategic national stockpile; Rich (ph).

RICH (ph): Yes, thanks Tony (ph). Well, the stockpile is moving. As of this morning, New York City and New York State and Indiana had received their full allotment. There’s a number of states that have received partial allotments and by May 3rd, they all will have received their allotments.

You know this is a very forward-leaning move and so, there are no states that are having any shortages of these drugs, within the medical community.

TONY (ph): OK, next question; yes.

UNIDENTIFIED PARTICIPANT: Could you just remind us why we’re concerned about this; 36,000 deaths a year from flu. You’ve only got 150 or so, in Mexico, at this point. No deaths in the United States. Isn’t it possible that you’re simply looking where you have not looked before and that this goes on …

TONY (ph): Sure.

UNIDENTIFIED PARTICIPANT: … sort of all the time.

TONY (ph): Right.

UNIDENTIFIED PARTICIPANT: Why the concern?

TONY (ph): Yes.

UNIDENTIFIED PARTICIPANT: And then a final question about the distribution of the Tamiflu stockpile. Some states had not bought their allotments before …

TONY (ph): Right.

UNIDENTIFIED PARTICIPANT: … Florida; Texas.

TONY (ph): Right.

UNIDENTIFIED PARTICIPANT: Is that causing any problems, the fact that some states had not stepped up …

TONY (ph): Sure. I’ll answer quickly and then, I’ll hand it over to, Rich (ph). This is a virus that is, what we call a pre-pandemic. And it has pandemic potential, which means it’s a virus that we’ve never seen before.

There’s no background immunity, in the population. And it is spreading from human-to-human, which – all of which has the potential for a pandemic. So, the question you asked is a reasonable question, why is this not something that we’ve seen before?

The fact is, we have not seen this before, with this particular virus. So, it really is something different. Rich (ph), you want to pick up on that?

RICH (ph): Yes, thanks very much. You know at the start of an outbreak, you don’t know what the course is going to look like. You don’t know if this is a virus that’s going to fizzle out, in a couple weeks or one that is going to become more-or-less a virulent in the diseases it causes.

Because of that we’ve been undertaking, as a global community and as a national community, intensive planning in the event that we do enter a pandemic. And we’re using those plans and we’re asking people at the state and local level, whether they be governmental or business or community or faith-based, to look at the planning that they’ve undertaken and move forward. So that if this were to develop into something more severe, they would know what they would need to do.

If we could see into the future, it would be absolutely wonderful because then we could tailor all of our responses, specifically, to what would be occurring. But that’s not the case and that’s why we’re being aggressive and forward-leaning. And we’re going to continue to adapt our strategy and approach based on what we’ve learned.

Now, regarding the stockpile question; yes, different states have decided – had decided to purchase variable amounts of anti-virus, for many different reasons. Some, their budgets just would not allow for additional purchases. Others, took a different strategy in terms of thinking about how they would want to control a future pandemic.

But every state has a proportional share of the strategic national stockpile and that contains approximately 50 million treatment courses. So, we have a large supply of antivirals to distribute in the country, to help support the treatment of patients who may be sick.

TONY (ph): Just to underscore, again, part of your question, this is, as we know, influenzas traditionally and historically are unpredictable. And as Rich (ph) said, we don’t know – this is a dynamic situation where its going, so when you have an unpredictable virus that is a virus that we’ve not seen before that underscores the kinds of caution and preparatory issues that we’re dealing with; next question.

JENNIFER LUBELT (ph), MODERN HEALTHCARE MAGAZINE: Jennifer Lubelt (ph), Modern Healthcare Magazine; if this is such a concern, why aren’t you doing more to close the borders to Mexico; restricting air travel, if Mexico is such a hot bed? And another question I had is, there was a scare in the 1970’s regarding this virus, why hasn’t a vaccine ever been developed on it?

TONY (ph): OK, I’ll hand over to, Rich (ph), the issue with the borders but with regard to the 1970’s, you’re referring to the 1976 so-called swine flu. That was a completely different virus than the virus we’re dealing with right now. Completely different in the sense that the genes are different and it doesn’t have any relationship.

The designation of H1N1 is the same. It was called the swine flu but from a viral standpoint in spreading, it’s quite, quite different. Rich (ph), do you want to do the travel?

RICH (ph): Thanks. We are undertaking a number of efforts, at the border. As I mentioned earlier, the Customs and Border Patrol are looking for individuals who appear sick and are referring them to public health professionals for evaluation.

We’re handing out information sheets to individuals, as they cross the border, so that they know what the signs and symptoms of H1N1 disease are. And they know what they should do if they become ill.

We also know from many, many years of experience, in terms of controlling infectious diseases, especially, infections such as influenza, which are quite contagious that intensive efforts at border entry and exit screening, are not an effective mechanism for preventing introduction of an infectious disease. Our overarching global strategy and one that we would’ve implemented had bird flu, for instance, started in a faraway place, would be to try and send a team to control that or quench it or knock it out where it was first starting.

And at the same time, implement some border control to delay, maybe, by a matter of a couple weeks, the introduction into our own borders. We never had any sense that we would be able to prevent, fully, a new infectious agent from entering once it left its closely contained area. But the idea was, maybe, we could delay its entry, within the border.

We’re faced with a situation here, in which, at the time of detection – this was not detected in a faraway place. This virus was detected in San Diego. And the ability to identify it in Mexico was based on a lot of the preparedness work that was going on here, as part of our pandemic preparedness efforts, to develop new points of care testing.

And they identified, in San Diego, a new novel virus that was sent to CDC. And that was identified as the – a new H1N1 virus. We shared that as we always do with the international community. And the Canadians identified that as the strain that was causing an outbreak in Mexico.

And so, increasing efforts at the border; putting major efforts in terms of entry and exit screening or trying to close the border, would use up major resources that could be applied at things we know work. And that is one of our overarching principles. We – there are thousands of things you could do.

We want to do the things that we think are going to have the greatest impact on controlling and slowing this and decreasing the impact on people’s health.

TONY (ph): Thank you, Rich (ph). You had your hand up young lady, yes.

UNIDENTIFIED PARTICIPANT: Hi, thank you. I just wanted to follow-up on an earlier question. I was not clear as to whether it’s known; whether the child that died was taking antiviral treatments.

TONY (ph): Is that known?

RICH (ph): I need to refer you to the Texas State Department of Health. We don’t like to comment on individual patients and their courses and their history. And so, I would refer you to them.

They are doing the investigation in terms of when this child became sick; when this child received treatment and the course there. And so, I think they are discussing this in a press conference or in other manners.

TONY (ph): Yes, also, to underscore the point that was made earlier, you’ve got be careful and I urge the press, to take a single patient and whether or they not got a drug and whether or not they did well or not, its such a complicated situation you would not want to make any conclusions about the efficacy of a drug, in order – just basis of one patient.

UNIDENTIFIED PARTICIPANT: And then, could I just clarify, quickly, on the distribution of the stockpile, when we say that New York City and New York State have received their entire allocation, we’re talking about the 25 percent of their – is that correct?

RICH (ph): That’s correct.

TONY (ph): Jessie (ph); go.

JESSIE (ph): Yes, I just want to comment that the anti-influenza drugs, they are effective. They can reduce the severity of illness and its complications but that’s very proportionate to their early use. Some people can become too sick for them to be really effective and they’re not absolutely. So that’s a very, very important message.

TONY (ph): Right; yes.

UNIDENTIFIED PARTICIPANT: A follow-up on another question, I’m not sure you answered it. When can we see a vaccine ready? I mean what sort of timeline?

You talked about various timelines but when – what’s the end date for …

TONY (ph): You know this is a process of decision making that will go on about the types of tracks that we’re going to do. So, when you talk about when will there be vaccine, there will be vaccine in pilot lots within a period of a few months.

That will be determined whether or not we have the right dose or whether or not it induces the immune response that we feel is appropriate; whether or its not safe. A lot of things happen on the way to that that will dictate whether it grows well; whether we’re going to have X-amount versus 10X amounts. So, those are the kinds of things that really are an iterative ongoing process.

But actual vaccine to be able to test in people, not distributed and again, I want to underscore the importance of people understanding the difference of making a vaccine that we have available for a decision point, of what we will do with it versus, I think, the underlying point that you’re making, when is it going to be for people? There’s a big difference between having it ready and distributing it. We’re just talking about the process, now, of gearing up to get the doses ready.

RICH (ph): Dr. Pattea (ph), I’d like to see if Dr. Gellin, would like to add anything about that process and timeline.

GELLON (ph): Thank you, Rich (ph). I think that Tony (ph) said it well. I mean we’re – its going now as fast as it can go and (INAUDIBLE) work its way through from the laboratory into the manufacturers. And then the clinical testing will go long before then.

We’re hopeful that by early fall we could, potentially, have something available but as Tony (ph) said that decision about what to do with it, is separate from having it. So, I think, the bottom line here, is that you – in the same way that Rich (ph) has mentioned the importance of being forward-leaning; to be prepared; its really the same thing with the vaccine preparation because if you wanted to use a vaccine, you have to have it. Thanks, Rich (ph).

UNIDENTIFIED PARTICIPANT: By early fall, you’re hopeful that you’ll have a vaccine ready but not one that necessarily can be used.

TONY (ph): There will certainly – well, what we’re talking about when you hear people talk about early fall, there will be doses likely then. How many and what we’ll do with them are an issue, the decision making with it (ph), how it relates, for example, to the seasonal flu vaccine distribution and manufacturing, is an important issue. All of these decisions will be made on the basis of the dynamic situation, as it evolves right now.

RICH (ph): Dr. Gellon (ph), would you like to add anything about that?

GELLON (ph): No. No, I don’t think so, thanks.

TONY (ph): Yes.

UNIDENTIFIED PARTICIPANT: Thanks. I wondered if I could follow-up on the effectiveness of the antivirals. Given the – given how new this virus apparently is, how do you know that in fact, these antivirals are effective in …

PATTEA (ph): Its an excellent question and you want to distinguish between effective in someone who is sick and you give it to them because that varies on when you get it to them. I mean if someone comes in, in the early phase traditionally and we’re not even talking about this particular virus, with something like Tamiflu or Relenza, the earlier you get the treatment, the better.

When you talk about how we are saying that something is sensitive to a particular drug, its based on an in vitro-type of testing, the, in the test tube determination of whether or not this particular virus would respond, in the sense, of being suppressed by the drug. So, when we say that something is sensitive to Tamiflu or sensitive to Relenza, we’re talking about the in vitro determination.

You can have a drug that is sensitive – a virus that’s sensitive to a drug and it really has a number of other complicating factors about when you get to the patient. How ill is the patient? Is it used as prophylaxis or is it used as therapy? And is it used as early a therapy or not?

So, all we can say right now is that on the basis of those in vitro determinations, it’s sensitive.

RICH (ph): Dr. Pattea (ph), let me add on there. One of the areas that’s being looked at, in Mexico and that is a critically important question, is the effectiveness of treatment and the effectiveness of when treatment was introduced.

And so that really pushes on the importance of the studies that are going on in Mexico. That’s where they’ve seen the most cases. That’s where they’ve had the most experience with treatment. And so, looking to see what can we learn from that about this virus and the impact of treatment will be essential to modifying and refining our guidance here.

TONY (ph): Yes; go.

UNIDENTIFIED PARTICIPANT: (INAUDIBLE).

TONY (ph): So, one more and then we’ll take the gentleman behind you.

UNIDENTIFIED PARTICIPANT: Just a quick follow-up.

TONY (ph): Yes.

UNIDENTIFIED PARTICIPANT: Do you, at this point then, have any estimates of the number of patients, either in Mexico; in this country or elsewhere, in the world, where patients have actually been treated with either of the antivirals?

TONY (ph): I’ll refer that to Dr. Bresser (ph); Rich (ph).

RICH (ph): Yes, thanks Tony . No, we don’t have information to share on that. We have teams in Mexico who are reviewing charts; who are doing interviews, to try and glean as much information from that as they can.

We’re also collecting clinical information here, in the United States. You know this is a dynamic situation that’s rapidly changing. When we talked yesterday, we were talking about 60 some odd cases. Two days before that we were at 20.

And with each of these cases, we’re trying to learn as much as we can. The initial cases in this country, the vast majority had not received treatment because they had illness that was not very severe. And they were identified as parts of groups or clusters or part of the surveillance process itself.

So, we will continue to look at that and try and determine what is the treatment effectiveness of this drug, with this virus.

TONY (ph): OK. Thanks, Rich (ph). We have one last question – one last and then, one up there; yes, please. You got it.

UNIDENTIFIED PARTICIPANT: Thank you. This question is for Dr. Bresser (ph). I know you had spoke to this before but has the government, at all yet, had to use its quarantine powers and if so, where?

RICH (ph): You know the – when we talk about quarantine, we talk about isolating or putting aside individuals who may have been exposed to a disease. What we are recommending here, in this situation, is what we would call, voluntary isolation.

So, you have an individual who’s sick with the flu. We tell them to go home. Stay home for, at least, seven days or one day passed the end of your symptoms.

We are also suggesting that people consider, what we call, voluntary quarantine. In that situation, family members who’ve been exposed, we want them to decrease the amount of contact they have with others in the community not because they’re definitely sick but in an abundance of caution, to try and reduce the likelihood that they would spread infection, if they were sick.

We have not implemented any more aggressive quarantine powers and we wouldn’t envision doing so. It has very little role in the control of an infectious disease like influenza.

TONY (ph): Thank you, Rich (ph); the last question, young lady; yes.

UNIDENTIFIED PARTICIPANT: I think that the normal American when they get flu-like symptoms, they kind of go home but they don’t necessarily go to the doctor. At what point should Americans feel like they need to actually go to the doctor and be identified as someone who may have swine flu or H1N1 and what should they do?

TONY (ph): Yes, right. So, there are guidelines on the CDC Web site for that so, Rich (ph), you want to summarize that?

RICH (ph): Yes, thanks, Tony (ph). I would refer people to the Web site. If you are an individual who has flu-like symptoms, so fever, aches, respiratory symptoms; maybe, some nausea or diarrhea and you have an underlying medical condition, you should, definitely, contact your doctor. And see whether you should be evaluated and treated.

If you have milder symptoms, I would say, before going into your doctor’s office or going to an emergency room, give a call and see. If you’ve had contact with someone who has been diagnosed with this H1N1 virus or if you’ve traveled to Mexico, you should definitely give your doctor a call, let them know and let them know how best they want to manage you and your illness.

This is a relationship between the healthcare provider and the patient. And we’re providing some guidance here but it needs to be individualized based on the age of the patient; the severity of the symptoms and any other underlying health conditions that may be in place.

TONY (ph): Thank you very much, Rich (ph) and on behalf of the team, I want to thank you all for your attention and your thoughtful questions. Thank you very much.

FIN