October 16, 2009
NOTE: This is a rough, unedited transcript and transcription errors may appear.
Glen Nowak: Thank you and thank you for joining us this after our update regarding H1N1 flu. Today's update will give you an update on respect to the H1N1 illness, flu activity in the United States as well as where things stand with respect to the vaccine. Today's briefing be will be provided by Dr. Anne Schuchat. I will turn the podium to Dr. Schuchat.
Anne Schuchat: Good afternoon, everyone. Influenza is widespread in the country and illness, hospitalizations and deaths continue to increase. 41 states are now identifying widespread disease from influenza, that's up from 37 last week. The other states are all seeing either regional or local activity. It's unprecedented for this time of year to have the whole country seeing such high levels of activity. The influenza-like illness that we track with our ILInet sentinel provider system is showing higher levels of illness than we saw last week. Again, these are unprecedented levels of illness. The national average is about 6.1% of doctors visits, for purposes of influenza-like illness that's very high at any time particularly in October. We also track mortality around the country. Through something called the pneumonia and influenza mortality survey with 122 cities. And for the first week this fall, we're seeing that the amount of influenza and pneumonia mortality is above the epidemic threshold. All of these things may suggest it's a very busy and difficult flu season and we are seeing very high levels of activity around the country. We are also having updates on the pediatric deaths. Unfortunately those are going up as well. There are now a total of 86 children under 18 who died from this H1N1 influenza virus, the 2009 H1N1 influenza virus. We had 11 more influenza pediatric deaths reported in week 40, which is the week that ends October 10. Ten of those are confirmed to be due to the new strain, the 2009 H1N1 strain and the 11th is probably due to that but the typing hasn't been completed. About half of the deaths that we've seen in children since September 1st have been occurring in teens between the ages of 12 and 17. These are very sobering statistics, unfortunately, they are likely to increase.
I want to provide some updates about the influenza vaccination program. First I'm going to speak about the 2009 H1N1 vaccination effort, then I'll speak briefly about the seasonal flu vaccine program. As we've said for the past couple of weeks, we will be releasing twice a week the aggregate numbers of doses that were available for ordering by the states and that were ordered by the states. And every Friday, we will be posting to our website the state-specific information on how many doses been shipped to the states or communities. That number is on our website now and will give people the best idea of how much vaccine is available near you. We're in the very beginning of this program and the numbers will be increasing regularly. Today's number on the aggregate, total number of doses ordered and total numbers that were available for order are as of Wednesday. So as of Wednesday, 11.4 million doses of the monovalient H1N1 vaccine were available for order. As of Wednesday, 8 million of those doses had been ordered. For comparison on earlier this week I briefed you about Monday numbers, those were 9.8 million doses available for order. So things increased by 1.6 million there. And 5.8 million doses had been ordered by the states. So between Monday and Wednesday, an additional 2.2 million doses were order by the states. These numbers are going to be changing regularly and what we'll be seeing over time is progress with increased product becoming available for order, increased orders being placed an increased shipments out to the states and providers where vaccine can be given. It is very early in the program.
Just for -- I wanted to provide an update about where we're going to be going in the future. It's very difficult to predict exactly how many doses we'll have in the weeks ahead, but we do want to let people know that some of the manufacturers have let us know that the production of vaccine is likely to be a bit delayed in terms of the number of doses they were expecting to have out in future weeks. We wish that we had more vaccine and there is more vaccine coming out every day but it doesn't look like we're going to be able to make those estimates that we had projected for the end of this month. The production estimates are going to be lower by the end of this month but there will be more vaccine coming out regularly. So we do still expect to have a large number of doses that we've been talking about so that eventually anyone who wants be to be vaccinated will be able to be vaccinated but the next couple of weeks will continue to be a slow start. Forecasting flu vaccine production is difficult. As we have been saying over the months past, we can't with precision estimate exactly how much we'll have at any time. There are many steps involved with producing vaccine and then with testing and releasing vaccine and so unfortunately won't have as much by the end of this month as we had hoped to. We hope that by the end of this month and early next month we'll be able to have widespread availability of vaccine and it will be much more visible to people in the community. But the delays that the manufacturers have let us know will have an impact, a substantial impact for the states in their planning efforts. They are directing vaccine to providers and school located clinics and pharmacies and so forth and this delay is going to shift some of their planning, so you may be seeing some rescheduling of some clinics and again we're just going to all have to bear with the situation. We wish we had better ways to produce vaccines perfectly predictably but this is how influenza vaccine production often goes. All the numbers we're giving you are just a snapshot in time and things will be increasing again every day and every week and again, we do think by the end of October and early November there will be widespread availability and it will be much easier for people to find out where to get vaccinated.
I want to briefly turn to seasonal flu vaccine, we've been hearing in people's frustrations about that there's been lots of interest in being vaccinated with the seasonal flu vaccine and it was available earlier than ever this year. So far, 82 million doses of influenza vaccine have been distributed. That's 5 million more doses were distributeded last week when I reported these numbers to you chbt and we expect a total of 114 million doses over the weeks and months ahead. The season production is estimated to be about 114 million. So we're at 71% of all the doses that are going to be produced that have already been distributed. Most of the seasonal flu sefrt a private sector entity. The public sector only buys about 10% of the vaccine. So I'm report reporting to you where we are with that but it's not something we're directing or in the middle of just something we care deeply about and want to facilitate the uptake of. I want people who are trying hard to find seasonal flu vaccine to know there's time, we know this is frustrating. Keep looking. More vaccine is coming out every week. We know there's time to get your seasonal flu shot or flu spray. We don't usually see the seasonal flu disease increase until September to May so there is more time with that of course, virtually everything that's circulating now is the 2009 H1N1 influenza strain and that's why we're so keen to get vaccine out as quickly as we can with that.
Just to wrap up, this is a challenging time, its hard city these increases in illness and particularly the severe illness that we're seeing in young people and pregnant women, people we asthma and chronic diseases. On something that is challenging for all of us and i know in your communities it's challenging as well. We are seeing more and more vaccine become available, we wish it were more than it is. But at least we have some and we've started vaccinating both in school settings, hospitals for health care workers and local health departments and in some other venues through provider's offices, and there will be more and more coming online regularly. We are working very closely as a public health system with the private sector, state, local and federal health department efforts working together with the private provider community and manufacturers to really try to deliver for the American are public and so the next couple of weeks, we'll continue to be a bit challenging, but there is more vaccine coming. Reminder that there's a lot of information on flu.gov. Particularly want to remind people who are worried, who have children with asthma, diabetes or are pregnant about warning signs to look for. About how to make sure that you seek care promptly, lots of good information on flu.gov that you can access. So let me turn now to the questions and I guess I can start with one from the room and then we'll move to the phones.
Joanne Silberner: Hi Dr. Schuchat, this is Joanne Silberner from National Public Radio. Can you tell us the reason for the slowdown in the H1N1 vaccine manufacturing and can you give us some numbers. What were you expecting by the end of October an now what are you expecting to see?
Anne Schuchat: Yeah. You know, vaccine production for influenza is pretty complex. And the complex process this year is taking a bit longer than we would hope. The companies are making unprecedented amounts of vaccine and the yield of the antigen has been lower than had been hoped for. They need to do potency testing and purity testing and that takes time and of course there's lot release testing that the manufacturers do and that the FDA does. We are not cutting any corners in the safety of the production of this vaccine or the testing and oversight of the vaccine and it's very important to us that this process be done carefully and safely. And so those are the major factors. We had hoped and i think our last estimate about expected vaccine that we made several weeks ago was that by the end of the month we might be around 40 million doses. What i can say is that it's really hard to predict exactly how many we'll have by that point. So i need to caveat the estimate of the decrease in availability. We think at most it might be about a 10 -- about a 10 to 12 million doses less than that by the end of the month. You know, that's still quite a bit of vaccine to have out there. I need to say that those numbers could change every day. So that's what we know as of today. And we're committed to share with you what we know. These numbers are such that it will have impact for the states and when they can offer the large-scale vaccination plans. I want to let the folks on the line know that Dr. Jesse Goodman from the FDA is also listening into the call. As questions come up, I will occasionally let him amplify on the answer. So let's go to a question from the phones.
Operator: Our first question today is Miriam Falco with CNN Medical News.
Miriam Falco: Thank you. I've got two quick questions. One is if you go to the flu.gov vaccine locater, there's not a lot of information there yet which is frustrating for folks because we're getting a lot of kbe kwets, we're looking for it, we can't find it and we know of course you have been telling us it would start becoming available until this week but people want to get it now. So what can you tell folks about that? Then also, there's been some report out there that some of these very serious illnesses are coming with blood clots and lesions. What do you know about that?
Anne Schuchat: Okay. The first question was about flu.gov and vaccine locater function. You know, the state health departments are updating their website or their call center information regularly. This delay in availability of vaccine will have an impact on the ability to announce locations to find vaccine. So i know this is frustrating for people and we're heartened that so many are trying to find the vaccine and are seeking that, which is good. Unfortunately, we only have information when the clinics are plan and when they can be publicly announced. So we'll just need to let people know to keep looking at that site. Again, dates are working hard on being able to announce availability and what they're doing right now with the doses that they've gotten is begin to give them out. A lot of different approaches. Some of the states have set up some appointments through their local health departments. Others are vaccinating health care workers in the larger hospitals in the state. We've heard of some good school located venues that have begun to be offered in certain areas, so there's a lot of var yablt. And public access to more vaccines just might take time. So I'm sorry it's a difficult time looking for vaccine. It should be easier over time. But the next week oar orr are two, limited announcements there. Could you repeat your second question?
Miriam Falco: Is that something you're seeing with severe illness, blood clots or lesions?
Anne Schuchat: the severe illness is just really being looked at. I don't have updated information. You know, there's some nice reports that came out last week, I believe, about critical care patients in Australia and Canada, you know, describing the pretty dramatic course that patients can have with this illness but I don't have information about the blood clot situation. Next question from the phone.
Operator: Our next question is from Betsy McKay from the Wall Street Journal.
Betsy McKay: Hi, there Dr. Schuchat, thanks. I had a couple of questions about the concerns about vaccine. I mean polls show that a lot of people are actually not intending to at least not right now get this vaccine. Is he I'm wondering how concerned you are about that. And how many people do you think you need or need to get shots to slow the spread of the flu or create enough herd immunity to have that happen? And secondly, I also wondered if you could tell us how much of the H1N1 supply vaccine supply will be thimerosal-free?
Anne Schuchat: our primary goal with vaccination is to be sure that there is access and availability for everyone who wants to be vaccinated to be vaccinated. And this is a voluntary program, we want people to be able to make informed choices about being vaccinated. As a doctor and a public health expert and someone who's been hearing a lot about the very severe illnesses, I take this virus very seriously. Based on everything that I know, vaccine is the best protection against this virus. I feel very comfortable with the safety profile that we are seeing. My commitment is for people to get good information to make those kinds of decisions themselves. So in terms of the question of herd immunity, I would say that the most important feature that the vaccine has is providing direct protection to the person who is vaccinated. That's really a key benefit of the vaccine. Vaccine can also reduce the spread of influenza from a person who's vaccinated to someone else. So that's one of the reasons we're so keen to have health care workers vaccinate and to have parents or other care takers who are taking care of babies under 6 months of age. So that very local household protection, we think vaccine can offer. In terms of what proportion of the population needs to be vaccinated for us to see a dampening of the trend in disease, it's very difficult to say. A lot of infectious disease modelers will speculate different percentage, but i think our commitment that the primary goal of the vaccination is for direct protection and that people who want to reduce their own risk or working in an environment like a health care setting want to reduce the risk of those very close around them should really seek vaccination. The second question was about thimerosal-free vaccine. We have put in orders for quite a bit of thimerosal-free vaccine. There are two formulations these generally were come in. All of the nasal spray or mist form of vaccine being produced is a thimerosal-free. Then we've also order prefilled single syringes that will not contain thimerosal in them. I want to remind people that the institute of medicine and other authorities have looked very closely at thimerosal and whether it has long-term health effects, whether it's linked to autism or other neurological problems, there's no scientific basis for those concerns. But we know people have concerns even if the science doesn't support that. So we've procured vaccine that's thimerosal-free. I don't have with me the actual numbers but i know that we wanted to make sure that very young children and pregnant women whom we understand are very keen to avoid thimerosal would have access to thimerosal-free vaccine so that was part of the strategy of procurement. Next question from the phone.
Operator: Our next question is from Brian Hartman of ABC News.
Brian Hartman: Yeah, hello. Getting back to the flu.gov. We're hearing a lot of folks out there are confused, providers and people from the public are confused. I wonder if you think you're doing a good enough job setting appropriate expectation in the public. People are being steered to flu.gov but the first thing that jumps out is get your H1N1 shots immediately and you click through these state health department sites and many of them still say they don't have the vaccine available. It just seems clear a lot of people in the public don't have appropriate expectations and i wonder whether you think you've been doing a good enough job and what you can do to help correct those expectations.
Anne Schuchat: Thanks so much for that question about Flu.gov and messaging. I think these are important points. What I'd like people to know is that more vaccine is becoming available regularly. But we aren't expecting widespread availability until the end of the month or the beginning of November. So it will be pretty challenging to find vaccine in many areas over the next couple of weeks. I do think that it's important that we set expectations realistically, we know there's more doses coming out every day and many people have been vaccinated each day, but we know that it's not enough given the demand that we have and so i think that we -- I appreciate your feedback about the way that we're conveying how to find out about vaccine. Could I get the next question from the phone, please.
Operator: Our next question is from Laura Neergaard from the Associated Press.
Lauran Neergaard: Hi. Can we go into more detail about the actual death rate. I particularly wanted to explore the teenage reports that you've been getting since September which is a little different than we've been expecting given the higher rates that we've we've seen so far in the really young deaths.
Anne Schuchat: Yes. Pediatric deaths are reportable to us. Those that are believed to be from influenza are reportable to us. Since august 30th, there have been 43 reports of pediatric deaths from influenza. 38 of those are -- I think 38 of those are known to be the H1N1 and the others are believed to be, but the typing hasn't been fully completed. What I can say is that three of those deaths occurred in children under 2. Five of the deaths were in children 2 to 4. 16 of the deaths were in children 5 to 11 years of age and 19 of the deaths were in teenagers 12 to 17 years of a these are very sobering statistics. 43 deaths essentially in one month is a lot. We hope that the continuing deaths in children will be as few as possible but this is a very brisk number, usually in a whole season that lasts from going to September all the way to may, you would only have about 40 or 50 deaths so in just one month's time we've had that many. What I can say is it's very important for parents to know the warning signs in their children. We think even viral medicines can be very important in people who have influenza-like illness and have either underlying conditions like asthma, diabetes or are pregnant or other chronic conditions like cancer and aids suppression. In very young children under 2, fever and respiratory systems need to be taken seriously. In all children, there are a couple of warning signs that parents are can look for. Child that's difficult to wake. A child that's not taking feeding well, a child that is having trouble breathing, is turning blue or grayish, an important warning sign for parents is if your child is ill and getting better, then starts to get worse, that's a warning sign. That can be a sign that a second bacterial pneumonia is coming in on the heels of influenza and that's something you need to take seriously and get in touch with your health care provider but influenza can weaken our bodies and a bacterial pneumonia invading on top of flungz can be very, very rapid in its course. But any viral medicines for influenza in particular circumstances can be very helpful and bacterial treatment of suspected bacterial pneumonia is also important. So these -- every death we take seriously but as a society the deaths in the young are very, very hard to take. And many of the children, of course, do have chronic underlying conditions that are very severe, muscular dystrophy, cerebral palsy but some have been totally healthy and that hits home for people. Next question from the phone, please.
Operator: Our next question is from Craig Schneider from the Atlanta Journal Constitution.
Craig Schneider: Hi. We are hearing that some of the community clinics here are saying that the mist should be focused on 2 to 4-year-olds but that anybody can come in and get the mist, but we're also hearing that a lot of people who are just coming in are being turned away. And i think this adds to the confusion. Are you hearing reports about this and how do you think this should be going?
Anne Schuchat: The mist form of the H1N1 vaccine and the mist form of seasonal flu vaccine are indicated for people who are between the ages of 2 and 49. And who are not pregnant and don't have chronic health conditions or asthma, for instance. So there's a restricted set of people that can get the flu mist form of the vaccine or the nasal spray form of the H1N1 vaccine. The health departments are directing vaccine, these small amounts of vaccine they're getting in the first couple of weeks to populations among the priority groups designated by the advisory committee for immunization practices. Some of those groups include children and young adults between the ages of 6 months and 24 years of age. They include health care workers. Those populations who are not pregnant and don't have underlying diseases would be eligible, at least the 2-year-olds up through 24 would be eligible for the flu mist. But each health department really trying to take a practical focused effort to get the vaccine dose this have out in the most effective way and we're going see variety of approaches n some states the first doses went to the 2 to 4-year-olds as you've been mentioning. In others, there were school located clinics, in others, there were health care workers offering the flu spray. Variation is to be expect and it's probably a good thing. We think that the state and large city health departmens communities and populations an are making the very best use of the vaccine that can be made. But we know that more doses are becoming available and right now, we actually have more doses of the injectable vaccine out than the flu spray. So that was a nice adegs to the availability this week so I think for people who are turned away that keep paying attention to this and more vaccine is coming and we are committed to make sure that everyone hoont was to be vaccinated can be vaccinated. Another question from the room.
Joanne Silberner: Two questions actually. When will the clinical trial data on pregnant women be out? And for Dr. Goodman on adjuvants a lot of people who are concerned be at safety of the vaccine are talking about adjuvants. Can he clear that up with H1N1 vaccine?
Anne Schuchat: the date of the result of pregnancy trials in the future relatively distant and i don't have it but we'll try to get it. I'm pretty sure the NIH website has information about their trial. We do think that vaccinating pregnant women with the injectable storm a very good idea. The trials are being done to provide additional information on dose and so forth but i think that if i were pregnant i would not wait for the results of those trials, if there was injectable vaccine available to me. The risk in pregnancy has been just very striking and of course the prompt treatment of symptoms in pregnancy is very important with the antiviral medicines. Let me briefly say something about atjuvants and Dr. Goodman can expand, we're not ewing using them in the voluntary program in the U.S. Other countries have made a decision, some of the other countries are and some aren't. But we purchased some adjuvants to have on the shelves in emergency in case the i have change and we needed a different track against the strain. So none of the vaccine being shipped out has adjuvants and we're not expecting to use it it this season. Dr. Goodman, do you want to expand on that at all?
Jesse Goodman: No, just to reaffirm that the FDA licensed influenza vaccines against this H1N1 virus do not contain adjuvants, i did want to add to Anne's comment about the pregnant women as a risk group that of course they are recommended by CDC's advisory committee on immunization practices to receive seasonal vaccine as well and there is a long, very excellent safety track record with pregnant women receiving seasonal vaccines that are made identically to these current licensed vaccines.
Anne Schuchat: Thank you. We have time for just a couple more questions. Next question, please.
Operator: our next question is from Heather Tesoriero from CBS News.
Heather Tesoriero: Hi, Dr. Schuchat. Question regarding miscommunicationsat ICUs, we're hearing that admissions at ICU units are up. I'm wondering if you can comment on that trend and if you have any data.
Anne Schuchat: I don't have data to supplement that observation. And health, it's nice to hear your voice, having finally met you. The intensive care unit admissions would be expected to be up now that we are seeing these increased levels of hospitalizations and of course the increase in deaths. We know from our emerging infection program network sites that between 15% and 20% of people that are being hospitalized for the H1N1 influenza virus are inquiring going to the intensive care unit. Now this is a an unusual time to have a lot of influenza and so i would expect that in intensive care units are being more influenza patients this time of year than they would usually see. We aren't aware to my knowledge anyway of intensive care units that are not able to manage the increase that they are experiencing. That's one of the things that we are looking out for and that the hospitals have been planning around and it's going to be an important thing to be ready for if the trends that we're seeing continue or act set rate. So I think we have time for just two more questions from the phone.
Operator: our next question is from David Lekowitz from Fox News.
David Lekowitz: Good afternoon, Dr. Schuchat, I appreciate you taking the call. Betsy mentioned the polls and then there was subsequent discussion about perception and messaging is about 56% of the people who say they won't get it because they think it's too risky. Do you think CDC is doing an effective job of getting the message out that this vaccine is safe? Because more than 50% of the population seems to feel it is not.
Anne Schuchat: it's important for people to know that the H1N1 influenza vaccine is being made exactly the same way that the seasonal flu vaccines are made. 100 million people get those every year and we believe there's a very strong safety record for them including many, many pregnant women who get those vaccines every year and many, many children who get those vaccines every year. We have increased our safety monitoring efforts here to be aware and ready and able to investigate any problems or rumors that emerge so that we, although we're all expecting a very safe vaccine, we're not taking that for granted. No shortcuts are being taken at all in the way this vaccine is being produced. And that's very important for people to know. So i think that we just need to keep repeating what we know about the safety and let people make good decisions based on access to good information. The last question from the phone.
Operator: Our last question is from Lisa Schnirring from CIDRAP News.
Lisa Schnirring: Hi, Dr. Schuchat, thanks for taking our questions. I just was wondering if you have a percentage breakdown on how much is injectable and how much is flu mist right now? Off the ball park figure would be great. Thanks.
Anne Schuchat: A little bit more than half of all the vaccine that's out right now is injectable. So thanks, everybody, for dialing in and we'll probably do another one of these on Tuesday. Thanks.