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Weekly 2009 H1N1 Flu Media Briefing

October 23, 2009, 1p.m.

Operator: Yes.  Thank you, sir.  I will turn it over to you in a moment.  Welcome and thank you for standing by.  At this time I would like to remind parties that your lines are on a listen-only mode until question and answer session at which time you may press star 1 ask a question.  The call is being recorded.  If you have objections, disconnect at this time.  I will hand the meeting over to Glen Nowak.  You may begin. 

Glen Nowak: Thank you for being here and for calling in today for today's briefing on the H1N1 situation in the country.  Today, Dr. Thomas Frieden, Director of CDC,will be talking about where things stand with respect to influenza disease, influenza vaccine and what we know going forward.  I will turn the podium over to Dr. Frieden, director of the CDC. 

Thomas Frieden: Good afternoon, everyone.  We are now in a period where the vaccine availability is increasing steadily but far too slowly.  It's frustrating to all of us.  We wish there were more vaccine available.  We need to remember that the enemy here is a virus.  Pandemic influenza is very challenging to deal with.  The tools that we have available are not as modern as we would like or as rapid, and all of us can be part of an effective response.  Manufacturers are working hard to get as much vaccine out safely as possible.  The vaccine strains of the virus grow and that's how we develop vaccine. Even if you yell at them, they don't grow faster.  At the government we are doing everything we can to get vaccine out as soon as it becomes available.  Shipping is overnight.  We're distributing to literally tens of thousands of doctors, hospitals, health centers throughout the country.  The health care providers -- health care providers can do quite a bit with vaccinating as soon as vaccine becomes available.  There is now a significant amount of vaccine available.  And I will go through that more in a minute.  And also ensuring prompt treatment of people with underlying conditions or severe illness.  H1N1 influenza remains overwhelmingly susceptible to Tamiflu, so people who are severely ill or have underlying conditions who get sick can rapidly be treated.  Community groups and schools can do a lot to reduce the risk both of spread and of disruption of learning and work.  And the public can do a lot by staying home when you're sick, covering your cough and sneeze and washing your hands often.  Also, if you have an underlying condition or you're severely ill with flu, see your provider right away.  And, of course, as vaccine becomes available, get vaccinated. 

Now, in terms of the virus, where are we today?  We continue to have widespread activity of H1N1 influenza.  46 states are reporting widespread activity.  We have had up until now many millions of cases of pandemic influenza in the U.S. And the numbers continue to increase.  This remains largely a young person's disease, but we are seeing it increasingly affect young adults as well as children. As happens with flu each year it generally begins in kids and then we see it later in young adults.  We are still not seeing significant numbers of cases in the elderly, and that is a characteristic of this virus which has not changed since spring.  We are not seeing any greater severity of this particular virus than we did in the spring and it's comparable generally to that of seasonal influenza.  Again, we're not seeing significant increases in resistance, nor are we seeing big changes in the genetic nature of the virus that would make it less susceptible to vaccine.  We're seeing an increasing number of schools closing because of the virus and we would just remind school administrators and others of the CDC guidance that indicates that schools should be closed when administratively it becomes difficult or impossible for the school to continue operating or if there are a large number of kids who have serious underlying conditions such as muscular dystrophy that would put them at greater risk for serious complications of the flu.  It is a local decision whether or not to close.  We provide guidance and have worked closely with the education department on that.

As of now, we have seen, since the beginning of the pandemic in April and May, more than a thousand deaths from pandemic influenza and more than 20,000 hospitalizations in this country.  We expect that influenza will occur in waves.  We can't predict how high, how far or how long the wave will go or when the next will come.  We are now in the second wave of pandemic influenza.  Whether this will continue through the fall into winter, whether it will go away and come back in the winter.  In the traditional flu season which would peak usually in December, January, February, only time will tell.  Various estimates are possible and we look carefully at this.  What we are committed to doing, as we’ve been doing from day one, is to provide all of the information that's available to us to you as soon as we are confident in it.  What we have learned more in the last couple of weeks is that not only is the virus unpredictable, but vaccine production is much less predictable than we wish.  We are nowhere near where we thought we'd be by now.  We are not near where the vaccine manufacturers predicted we would be.  We share the frustration of people who have waited on line or called a number or checked a website and haven't been able to find a place to get vaccinated.  As public health professionals, vaccination is our strongest tool.  Not having enough of it is enormously frustrating to all of us.  The enemy here, again, is the virus.  The technology we are using, although it's tried and true, is not well suited for pandemics.  Our planning anticipated a six to nine-month period between emergence of a new virus and availability of vaccine against that virus.  The six-month clock will be up really at the end of October.  By that time we will have some vaccine, but not as much as we would like.  As you recall, we had an ethical choice a few weeks ago where we had some vaccine available and we knew that getting out some vaccine, not enough for everyone who wants it, would be a challenging situation and would be frustrating for many.  The alternative would be to let it stock up until we have enough for larger proportions of people who wanted to get it.  Doing that would have meant it would be waiting in warehouses when people who want to get vaccinated could get vaccinated and could be protected. 

As of this Wednesday, there were 14.1 million doses available to the states for ordering.  11.3 million had been shipped, so there are now more than 11 million doses in the community in various places.  As of today, there are 16.1 million doses available for shipping.  If you look on a week-to-week basis, we had a big increase in the past week in the amount that had been shipped out to the community.  An increase of about 5.4 million doses between last Wednesday and this Wednesday.  So there is steady progress getting vaccine out.  There is a lot of vaccine out there and we have been working hard to ship it overnight, to work with states and localities so that they can hit the ground running and so try to make it as easy as possible.  One of the things we are hearing anecdotally, a lot of the initial vaccine is in the form of the mist, the nasal spray.  This is a vaccine that is available in many places.  It's only recommended for use in people who are healthy and between the ages of 2 and 49.  It's available both seasonal mist and H1N1 mist is available this year.  I received seasonal flu vaccine a couple weeks ago using the mist.  There is every reason to believe it will be as effective as the shot.  It's one less needle, so kids may like that.  There is no risk to health care workers if they get the mist for their patients.  There are some misconceptions about this.  It's a weakened virus that's been adapted in the laboratory not to grow at the usual human temperature, so it's something that's not a risk to patients if you as a health care worker get this vaccine.  On the flip side of the frustration is the fact that there is a lot of interest in this vaccine and we are glad to see that.  We wish it didn't take so long to produce and there have been efforts going back many years to develop more rapid methods of producing vaccine.  More than $2 billion has been spent by the Department of Health and Human Services trying to develop newer methods of vaccine production.  This is a high priority, but it's not easy.  And we will not go out with a new vaccine until we are completely confident of its safety.  Even if we had a new vaccine now I'm not sure we would use it in the midst of a pandemic which has a similar seasonality to seasonal flu.  Within the coming weeks, we will see an increase in the amount of vaccine available.  As that happens, we are hoping to see that continued strong interest in getting vaccinated.  Vaccine is our best protection against the flu and as supply increases, we need to be ready on the part of health care workers, on the part of the public health departments throughout the country and on the part of people who want to get vaccinated to find the vaccine and get it. 

I want to say a few words about seasonal flu vaccine.  More than 85 million doses have been distributed and, just to remind you, seasonal flu vaccine is distributed by the manufacturers.  It does not go through the public system.  We provide about 10% of the overall seasonal vaccine.  We don't have as much awareness of where it is and where the shortages are.  We heard a number of reports of shortages and seasonal vaccine availability.  These were surprising to us until we got back, earlier this week, new data about the uptake of seasonal flu vaccination which has been unprecedented.  By our estimates, over 60 million people have already been vaccinated already for seasonal influenza.  That is way more way sooner than in any prior year.  That's strong uptake and we hope that trend continues.  Before taking questions I would just summarize that flu brings significant challenges and pandemic influenza, even more serious and challenging issues that the vaccine technology we have today is not well suited to making a vaccine in time for the first wave or even early into the second wave of the pandemic.  The vaccine is arriving too late for many but still when we have lots of disease around.  So 16 million doses isn't what we would have wanted by this time.  It isn't what had been predicted by this time, but it's also a significant number and we hope to see vaccine doses that are available used promptly.  In the next few weeks, we do anticipate that we will have significantly more vaccine available, and we recognize that this is very challenging for state and local health departments, which have to allocate the vaccine and try to do that equitably but also reach the highest risk populations, the populations for which it can do the most benefit.  Thank you all for your interest, and we'll be happy to take some questions.  We'll start in the room. 

Mike Stobbe: Thanks.  Mike Stobbe from the A.P. Doctor, first, you just said the vaccine is coming too late for many.  Do you mean it's coming too late – do you mean, they'd rather it be here sooner or do you mean, as a medical issue, it's coming to late to benefit them? 

Thomas Frieden: If people have already had H1N1 influenza then the vaccine is not going to help.  On the other hand, many people who think they have had H1N1 influenza have had a cold or another virus, not H1N1.  So we do recommend that everyone get the H1N1 vaccination if they are in a priority group when it becomes available. 

Mike Stobbe: And my follow-up, I'm sorry.  Who has been getting the shot?  Do you have information of the doses that have gone out already?  Is it mainly health care workers? 

Thomas Frieden: Most -- we have very preliminary information on who's getting vaccinations and most have been children.  Large numbers of children have been vaccinated.  By next week at this time we'll have a bit more information on at least the age groups of the different groups getting vaccinated. 

Diana David: Thank you.  Diana Davis from WSB Atlanta.  Do you have information on the percentage of vaccine in the pipeline or that's being shipped out as we speak, injectable versus the nasal spray? 

Thomas Frieden: It has been about half and half.  More than half is the injectable now, but significant proportion is the nasal spray.  Frankly, in past years nasal spray has gone unused, so we think it is an effective vaccine, particularly useful for health care workers and for children, healthy, between the ages of 2 and 49.  Shall we go to the phone?  First from the phone, then we'll come back to the room. 

Operator: First question is from Miriam Falco, CNN.  Your line is open.

Miriam Falco: I know you have discussed this before, but if you wouldn't mind discussing it again.  Can you tell us how many pregnant women have died and why it's so important that pregnant women get the flu shot?  We're hearing that women looking for the thimerisol-free injectable vaccine are having trouble finding it.  Do you have any information on that, too? 

Thomas Frieden: Pregnancy is a risk factor for influenza each year.  It's also a risk factor for serious illness and death from H1N1 influenza.  About six times more likely to die from H1N1 influenza if you're pregnant.  So women who are pregnant are a high priority for the vaccine.  There is no evidence that thimerisol increases the risk of problems but we would like to have thimerisol-free vaccine for those who want it.  The challenge is that it is used for multi dose vials and multidose, you may have more of that product.  So finding thimerisol-free vaccine for those who want it may be a challenge.  Next question? 

Operator: The next is from Helen Branswell, Canadian Press.  Your line is open.

Helen Branswell: Thank you very much.  In terms of the slowness of the production process at this point, I know vaccine manufacturers have had problems with yield.  I was noticing today that the European medicine agency is suggesting that people use two doses, even in adults.  I'm wondering if you're having an indication whether that's having an impact on how quickly the United States can get vaccine from suppliers in Europe. 

Thomas Frieden: I didn't hear your question.  You said the indication is that -- are using -- something about doses? 

Helen Branswell: I'm sorry.  The European medicines agency, the E.M.E.A. Today said that it's sticking with a two-dose regime for adults with H1N1 vaccine.  I'm wondering if that is going to have a knock-on effect on the American supply, if countries in Europe are using two doses for each person whether you are anticipating that means your supplies from Europe will be later than currently anticipated. 

Thomas Frieden: The data we have seen is very encouraging for a single dose for everyone 10 and above.  So I would think that that would be the general recommendation.  Our supplies are already preordered and it's a question of when they get delivered.  I don't think that would be a consideration.  Are there other questions in the room before we go back to the phone? 

Reporter: If young children get their first vaccine in one form, say, a shot.  And then three to four weeks later they get a shot, can they mix the two types? 

Thomas Frieden: We think that's probably going to be fine.  Back to the phone? 

Operator: The next question is from Elizabeth Weise, USA Today.  Your line is open.

Elizabeth Weise: Thank you very much for taking my call.  I'm wondering when do you think that we'll have robust supplies of vaccine available such that you can just, you know, be looking for it in your local Walgreens and pretty much anyone who wants one will be able to get it? 

Thomas Frieden: Well, we have had difficulties with the projections that we have had so far.  What we can say now is that certainly there are 16.1 million doses available for ordering, that there are more than 11 million doses already in the community and that the numbers will continue to increase.  We think supply will become much more widespread within the next several weeks.  But giving an exact date given how far off some of the projections have been from what we have now, I would prefer to just take it one day at a time, one week at a time.  We're committed to doing everything we can to get the vaccine out as soon as it becomes available to work with states and localities to get it used as soon as it's out and to make the information available for people so that within the limitations of supply we can make it as convenient and accessible to people as possible. 

Mike Stobbe: Mike from the A.P. Could you put this into context?  46 states widespread.  Is this as much illness as we see from flu as we ever do at the height of any season?  My second question was, you talked about the seasonal vaccine availability in 60 million doses already out there.  It's supposed to be 114 million at the end of the season.  Is that going to be enough, do you think? 

Thomas Frieden: 46 states having widespread transmission is the peak of flu season.  To be basically in the peak of flu season in October is extremely unusual.  It is, though, a very different pattern and the fact that we're having a young person's flu now doesn't mean we're not going to have an older person's flu later on in the year.  It's good that the seasonal flu vaccine is out.  There are 85 million doses out already of which at least 60 million appear to have been used already.  Another 30 million will be coming in in the coming months.  We have never used all of the seasonal flu vaccine.  So manufacturers have always been frustrated that they produce it and then they have from a few to tens of millions of doses unused in past years.  So the fact that we have high uptake is very encouraging.  With the technology we have now, we can't turn on a dime and make more flu vaccine available as the utilization goes up.  We hope there will be enough seasonal flu vaccine for everyone who wants to have it.  We are confident that there will be eventually enough H1N1 vaccine for everyone who wants to be vaccinated, but probably or certainly not for everyone as soon as they would like to be vaccinated.  On the phone? 

Operator: Next is Maggie Fox from Reuters.  Your line is open. 

Maggie Fox: Dr. Frieden, I was intrigued by something you said about if there was a new vaccine available now I'm not sure we'd use it unless there is a pandemic with similar severity to seasonal flu.  Can you tell us what you mean by that? 

Thomas Frieden: I said it a little differently.  It's a hypothetical comment, but basically if we had a new vaccine technology we might not want to roll it out in a pandemic.  We are using a tried and true technology.  If we had a new technology and we had a strain of pandemic influenza that not only was widespread but was causing severe illness in a larger proportion of people than seasonal flu which H1N1 is not so far, then we might want to use a newer vaccine technology because the risk to benefit ratio would be different.  So the point was simply that we don't have a new technology.  We are using a tried and true technology.  We need to try to find new technologies and ultimately we would like those to be used for the seasonal flu vaccine each year.  On the phone? 

Operator: Next is from Donald McNeil, New York Times.  Your line is open.

Donald McNeil: Hi, doctor.  So we are still getting calls from women who complain that their pediatricians are against giving the swine flu or the H1N1 flu shot or OB/GYNs against giving it to them as pregnant women because they mistrust the shot.  What do you, as head of CDC, say to the women and the doctors? 

Thomas Frieden: I can understand the hesitancy and reluctance to take a vaccine that appears to be new and different.  All we can do is provide the facts.  The facts are that this is the same manufacturing process, the same manufacturers, the same factories, the same safeguards as the seasonal flu vaccine that has been used for more than 100 million doses each year for many years and which has an excellent safety record.  If we had had this pandemic earlier, we would most likely have included H1N1 influenza as part of the regular seasonal flu vaccine.  So there is every reason to be confident in the safety of seasonal flu vaccination and there is no reason to think that the H1N1 vaccine would be any less safe.  Next question from the phone? 

Operator: The next is from Tom Maugh, L.A. Times. Your line is open.

Tom Maugh: Can you please expand on the information that came out yesterday that one out of every five kids had the swine flu during the first couple weeks of October? 

Thomas Frieden: I'm glad you asked me that.  I think maybe it got a bit misinterpreted.  The data was that one in five kids had some sort of a flu-like illness according to a telephone survey.  That is very different from saying they had H1N1 influenza and a much smaller proportion -- and we don't know how much smaller -- would have had H1N1 influenza.  We have seen in certain communities with lots of H1N1 influenza that the peak attack rate can be as high as one in five of children at the peak of activity.  I don't think that's what those data show.  That data simply show that kids get a lot of infections.  So cover your cough and sneeze and wash your hands.  Next question from the phones? 

Operator:  Jonathan Serrie, Fox News.  Your line is open.

Jonathan Serrie: Thanks for taking my call.  During the initial weeks of the H1N1 vaccine and certainly during the testing, no significant side effects were found beyond the occasional sore arm you would expect with the seasonal flu vaccine.  Just want to confirm that that's still the case and if you could say what's being done to track the long-term safety of the vaccine. 

Thomas Frieden: Thank you.  Vaccine safety is something we take extremely seriously.  We have several tracking systems in place to monitor any potential adverse effect from the vaccination.  We also have specific programs to look at women who have had influenza and were treated with medications or not to see if there were long-term problems.  One of the things we are looking at very closely is the risk of Guillain-Barré syndrome. And some background information is very important for people to understand.  Guillain-Barré syndrome is a rare but serious condition that's generally self-limited.  It can, in exceptional cases, be severe or even fatal.  So it's something we take very seriously.  Guillain-Barré syndrome occurs as part of the normal course of events, even when there is no vaccination going on at a rate of about 20 people per day every day of the year in the U.S.  With a little more actually in the winter months, I believe.  And that is one of the reasons why we need to anticipate that there will be some people who get vaccinated and develop Guillain-Barré syndrome.  Many of them, perhaps all of them, would have developed Guillain-Barré syndrome even without vaccinations.  So we look at all of the reports.  We encourage people to report.  We assess every report and ultimately it's a question of looking at the numbers and saying, are the numbers we are seeing, are they higher than numbers that would have happened by chance, without a vaccination program?  We have time for one or two more questions.  Any more questions in the room? 

Diana Davis: As the winter starts and we get into what's usually the traditional seasonal flu season, sit going to matter for clinicians to know if they are dealing with H1N1 or seasonal flu?  A physician asked me that the other day. 

Thomas Frieden: We track on a community basis what strands are spreading.  So for an individual clinician, it's not necessary to send samples for testing to determine what type.  We have monitoring systems in place throughout the country so we can see if it remains H1N1 and it's overwhelmingly H1N1 now.  As the winter progresses, that may change.  The bottom line doesn't really change that the most important thing to do is if you've got the flu, most people aren't going to need testing, aren't going to need treatment.  If you have an underlying condition or if you are severely ill with difficulty breathing, important to get care promptly and vaccination as soon as that becomes available.  Last question from the phone. 

Operator: The last question is Pat Weschler from Bloomberg.  Your line is open.


Pat Weschler: Good afternoon.  I was calling because Bloomberg today reported that U.S. officials only heard last week that at least three suppliers would be having significant shortfalls and that the reason for this was manufacturing problems.  We also heard that you're not going to be able to make the 195 million dose level you suggested for the end of the year.  Which companies are having manufacturing problems and also what are the manufacturing problems and have they been remedied at this point? 

Thomas Frieden: What we are seeing are manufacturing delays.  This is not unusual for influenza.  Often in influenza season it's a chicken and egg process.  It doesn't move as quickly or as efficiently as we'd like and it's not as predictable as we wiykd kuje.  As it happens, the flu mist has been growing well.  So the virus that has been growing to make the flu mist has grown well.  We have seen a steady supply of the nasal mist.  Each different supplier has its own challenges, but we have to recognize again that the enemy here is the virus and the vaccine technology we have gets antiquated, but we have confidence in its safety and we have confidence that ultimately there will be enough vaccine for everybody who wants to be vaccinated to get vaccinated.  Thank you very much. 

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