Press Briefing Transcripts

Weekly 2009 H1N1 Flu Media Briefing

November 25, 2009, XXpm

• Audio recording (MPEG)

Operator: Welcome and I′d like to thank you all for holding and inform you your lines are in a listen only mode until time for questions and answers. Today's call is also being recorded. If you have any objection, you may disconnect. And now I′ll turn it over to Glen Nowak.

Glen Nowak: Thank you for calling in and for being here today for this update on H1N1 influenza and H1N1 influenza vaccine. This will be our only update press briefing this week, so there won't be a CDC press briefing on Friday. I also want to make note that the weekly activity report, FluView will come out on Monday. So that will also not be updated this Friday. We typically update that on Fridays for this next FluView, it will come out on Monday. For todays press briefing, we have Dr. Anne Schuchat, the Director for the CDC′s National Center for Immunization and Respiratory Disease and I will turn the podium over to Dr. Schuchat.

Anne Schuchat: Today I′ll focus mostly on two areas. One is a worrisome spike that we're seeing in serious pneumococcal disease and also a quick update on vaccine safety findings as well as the usual quick update on supply. We don't have flu activity updates today. We're going to publish our usual weekly FluView information on Monday giving you all a nice four day holiday before you assess the information. So look for that on Monday and we'll be updating the press next week. So I want to talk a little bit about a worrisome finding that we've found with pneumococcal disease. We're seeing an increase in serious pneumococcal infections around the country. Flu infections can increase the risk of pneumococcal disease. Pneumococcus is a bacteria that commonly affects the lung or sometimes the bloodstream. In a typical non-pandemic year, most serious pneumococcal infections occur in people 65 and over. In previous pandemics, there has been an increase in pneumococcal infections in younger people. It turns out that in the 2009 pandemic, we are seeing an increase in pneumococcal infections in younger persons. We're looking in our active bacterial core surveillance, what we call our ABCs site, and it's in those sites that we have seen this increase in what's called invasive pneumococcal disease. That's the serious type of pneumococcal disease where the bacteria invades the blood or other internal sites. On our website, we have more details about this pneumococcal increase.

In particular, I want to mention what we're seeing in the Denver metropolitan area. That's one of the ten ABC sites where collaborative investigation is ongoing. When they looked at their five year average of how much invasive pneumococcal disease occurs in October, the average for five years is about 20 cases. But in October 2009, they had nearly triple that number, 58 serious pneumococcal cases. Most of that increase has been in adults under the age of 60. So non-elderly adults 20 to 59. The findings in Denver probably reflect findings that are occurring in other parts of the country where the surveillance hasn't been as intensive. And I think these findings really highlight two things. One, that pandemics put us at risk for not just flu problems, but also bacterial pneumonia problems. And, two, they highlight a really important prevention opportunity. There's a vaccine for adults to prevent these serious pneumococcal infections. It's a 23 valiant polysaccharide vaccine, the new pneumo-vac. Unfortunately only one quarter of high risk adults have received the pneumococcal vaccine in their life. This is a vaccine you pretty much get once as an adult, not every year the way that the flu vaccine works. But only 25 percent of high risk adults under 65 have gotten that vaccine. Vaccination is the best way to protect against serious pneumococcal infections and we strongly recommend that adults with chronic conditions like diabetes, emphysema, chronic heart, lung, liver, disease take advantage of the pneumococcal vaccine. You can get the pneumococcal vaccine from your doctor, at the doctor's offices. A lot of pharmacies and retail centers also offer the pneumococcal disease the way they often stock other vaccines. So I do strongly urge people to sort out whether you're in one of those high risk groups and talk to your doctor or ask your pharmacist whether you can be vaccinated.

Next I want to turn to the H1N1 vaccine supply. Our supply does continue to increase and as of today there are 61.2 million doses of H1N1 vaccine available for the states to order. Still a little less than a quarter of that is available as a spray. On Friday, since this past Friday, more than 7 million doses have become available. This is sort of a short week we′re having, but we've made good progress. We're expecting to see vaccination efforts step up in concert with these improved supplies. We're likely to see more places including more doctors' offices, more clinics able to offer the H1N1 vaccine. Several states are planning major activities after Thanksgiving to promote more vaccination, both efforts at targeted groups like adults with chronic health conditions and children, so stay informed and look for them. We really do think that December will be a big month for vaccinations.

I next want to give a brief update on the H1N1 safety situation. Again, there's going to be more information on our website about this and you can just go to the news part of the website for details. By this point there a lot of doses of H1N1 vaccine that have been used and we've gotten the chance to look at a lot of data about adverse events, possible side effects or just other events that happen after the vaccine is given. So far, everything that we've reviewed is extremely reassuring. We've been talking about the H1N1 vaccine being produced and manufactured and made essentially the same way as the seasonal flu vaccine. In our look at all of the safety data here in the U.S. so far, we're seeing patterns that are pretty much exactly what we see with the seasonal flu vaccine. Very reassuring about the safety of the H1N1 vaccine. The number, pattern and types of adverse event reports that we are getting are pretty much what we see for seasonal flu vaccines, as well. Almost all of the reports that have come into our vaccine adverse event report system, or VAERS, about 94 percent of those reports are classified as not serious. They're pretty much a sore arm or redness in the arm, a little tenderness, which are quite common to any injected vaccine.

We in particular looked in detail at a rare neurologic problem called Guillain-Barré Syndrome or GBS. Now, people have asked us about this over the months passed. In 1976, the swine flu vaccination effort in that year was troubled by an increase in Guillain-Barré Syndrome. So in particular, we wanted to look for that. We have three different systems that we're looking to understand whether Guillain-Barré Syndrome is occurring in any kind of excess amount with the H1N1 vaccine. So in a thorough review of these three systems so far, we don't see any problems at all. Those systems include the VAERS that I just mentioned, our Emerging Infections Program Network sites, and the vaccine safety data link. Again, there's more information on our website about these systems. Review of those three systems shows that there are no indications of Guillain-Barré Syndrome safety problems with the H1N1 vaccine. Again, we don't really have problems with the seasonal flu vaccine, so we weren't expecting them, but we knew people were interested and we wanted to look. Currently ten reports to VAERS have come in about potential Guillain-Barré Syndrome cases. They have been or are under review and the number of reports given the number of doses that have gone out there are not at all notable. The vaccine data so far really suggests this is a safe vaccine. We've also looked in a little more detail at severe allergic reactions, something called Anaphylaxis, and, again, those are not showing up more commonly than we would expect. So this first report that we're giving you about vaccine safety is very reassuring and we know that a lot of people have been waiting for this report and we think it′s good news.

Going forward, I certainly hope that people will be able to enjoy the holiday coming up. We want you to stay healthy and safe and travel well. There will be a lot of people that will be traveling in the next few days, myself included, and it's just a reminder to travel only when you're well and if you or your children are ill, to try to keep them away from other people. Take prevent steps, covering your cough or sneeze, washing your hands, but really enjoy the time with family and friends coming up. Next week and the weeks beyond, we think that vaccination will continue to be a focus. I hope that more and more people will want and be able to receive the H1N1 vaccine in the weeks ahead. I also hope that for everyone for whom the pneumococcal vaccine is recommended, that you're able to take advantage of that and protect yourself against that other serious respiratory infection. As everybody knows, the safe and effective vaccines are the best way to protect yourself from infectious diseases like flu and pneumococcal disease and just want to end with a final sentence to say how thankful I am for this incredible public health, health care, and media partnership we've had over the last several months working together to help keep America healthy and safe. So let's go to questions first from the room. Beth?

Beth Galvin: Thank you, Dr. Schuchat. I′m wondering if you can talk more about the pneumococcal infection. Why is this something that is a little troubling or worrisome for you, how do these work on top of the flu in how can get one of these from the flu?

Anne Schuchat:We know that influenza infections can reduce the lining of the respiratory tract and really set a person up for a secondary pneumonia. Common bacteria that live in the nose and throat can invade the lungs when there's a viral infection like influenza. So that's been known for a long time. And, in fact, we were sort of look for this last spring and didn't really see a problem. But what we're seeing now, now that we're coming into the respiratory season, at the very same time where influenza was really common in the Denver area, there was this big increase in pneumococcal infections. There's an investigation that's ongoing that is finding that in a number of the people, there was confirmed influenza before the pneumococcal infection, but even when that isn't confirmed, we do think the influenza circulating can increase the risk of the severe pneumococcal infection. And I think in the pandemics of the past, when we've seen that shift to the younger age, it's very similar to what we see with the severe flu, that younger people are at greater risk. So I think this is important because we can potentially prevent a lot of these infections going forward. And with this very long flu season ahead of us, the risk of pneumococcal disease is ongoing. Mike?

Mike Stobbe: Hi, Mike Stobbe with the AP. Hi, doctor. Two questions. First, you only mentioned the Denver data. Why is that? Is it possible it was unusual and is it surprising given that we're at the equivalent of the height of flu season? And you mentioned about the 10 GBS reports. What's the denominator or what's the best estimate?

Anne Schuchat:So for Denver, the ABC sites involve ten different states and we have been looking in all of them. There has been evidence in multiple sites of an increase.  In Denver, they had a very big increase of influenza in the month of October and probably because of sort of more timely reporting we′re able to see this big jump in their pneumococcal cases. So we don't think that Denver is the only place in the country where this is going on, but Denver has invited CDC in to collaborate on a more detailed investigation. So we hope using Denver as one example will be able to understand this problem a little more. They're doing things like tracking the underlying conditions that people have, looking at the pneumococcal strains to see whether they're covered by the 23 valiant vaccine, really connecting detailed information, but I don't think that this would be unique to Denver. And, in fact, it's a trend that's apparent in more than one place. You also asked about the GBS cases and someplace I have the number of doses. The data that I've given you are as of the 20th of November, so I think on our website we would have how much had been shipped by the 20th. I think today there are 61.2 million doses. Friday was 54 million doses allocated. The number shipped was much lower than that. But this is after many, many millions of doses have been given but only ten GBS cases had occurred. And we'll double check when our web information has how many doses because I′m not recalling. Another one?

Diana Davis: Diana Davis from WSB Atlanta. Just clarifying, the people who got the pneumonia, they had not been vaccinated against the H1N1 and then the second question is just review for us, you've done it before, but, again, after a flu-like illness, the symptoms to watch for that could indicate the pneumonia.

Anne Schuchat:The Denver investigation is looking in to a history of both the seasonal flu vaccine, H1N1 vaccine and the pneumococcal vaccine. I don't have those details with me. Many of these cases happened in early October when there wouldn′t have been very much of the H1N1 vaccine available. The second question was about warning signs. And when we're worried about flu that gets complicated by a bacterial pneumonia, the key warning sign is that someone is getting better from flu-like symptoms and then starts to get worse. So having high fever and cough and feeling miserable and then starting to feel a bit better and suddenly really taking a turn for the worse. That is an important warning sign. We can see that in children or in adults. And it doesn't necessarily always mean bacterial pneumonia, but it very much can mean that. Pneumococcal is not the-- pneumococcus is not the only cause of that secondary bacterial pneumonia. We've been seeing staph infections quite frequently in children. But those two are very common bacteria in our nose and throat and they really invade once the flu has set you up for an infection. Let's take one from the phone.

Operator: If you'd like to ask a question, please press star one on your touch tone phone. You will be prompted to state your name. Again, star one to ask a question. Star two to withdraw your question. And our first one comes from Maggie Fox. Your line is open. State your affiliation, please.

Maggie Fox: I′m with Reuters. And I wanted to ask about this pediatrician in West Virginia who was confirmed as having H1N1 twice. I know you can't answer the question, but does it suggest that you can get it more than once commonly? Does it suggest anything about the efficacy of the vaccine and you can talk about what kind of surveillance you would need to do to answer those questions? Thanks.

Anne Schuchat: Thanks. Yeah, there is a report in the media about a person who's got two separate laboratory confirmed infections with the H1N1 virus. That is not impossible. That can happen. There are a variety of reasons that that might happen in an individual. We don't think that's a common event in a population, but that there are some reasons why an individual might not really get protected after one natural infection and might be at risk for a future infection with even the same strain. With vaccination, we believe that any vaccine is not 100 percent protective. The H1N1 vaccine in clinical trials looked very good. One dose provided very high levels of the population that was tested in getting a good antibody response eight to ten days later, but it wasn't 100 percent. So it's possible that after a natural infection or after the vaccine some people may get it again if you′re naturally exposed or get it for the first time if you're vaccinated. But we are expecting very high efficacy of the H1N1 vaccine based on the clinical trial data that shows such high immune response and based on the strains that we're still characterizing that are very good matches with the vaccine. But even a H1N1 vaccine with a high efficacy, it will not be 100 percent effective. And, of course, this year we are vaccinating at a time of a lot of influenza transmission, so we may see people in even large numbers, we may see who get confirmed H1N1 disease following the vaccine just because there's so much flu going around if the vaccine is not 100 percent effective. Okay. Another question from the phone.

Operator: Our next one comes from Miriam Falco.

Miriam Falco: I′m with CNN Medical News. Thank you for taking questions on the eve of Thanksgiving. I have a question about the pneumococcal cases in Denver. You can it tell me a little bit more about the age of the folks who got sick. Did they all have underlying conditions and is there enough pneumococcal vaccine to go around?

Anne Schuchat:Thank you. About 2/3 of them were in the age group 20 to 59. And in most years without a big flu increase, most invasive pneumococcal disease would be in people 65 and over. I believe the majority had underlying health conditions. A reminder: People at higher risk for invasive pneumococcal disease include adults with chronic health conditions like diabetes, asthma, emphysema, chronic lung disease, chronic heart disease, chronic kidney or liver disease, cancer and other immunosuppressant conditions like HIV. So a lot of adults are at higher risk for pneumococcal complications like invasive disease and, of course, this polysaccharide vaccine we do think is effective against the serious types of pneumococcal infections. The question about the supply of polysaccharide vaccine, we do believe the company has supply, we checked on that before we pushed aggressive use of the vaccine. I don't have numbers about exactly how many doses are out there. Before today's press conference, really in the past several weeks, we've tried to alert providers-- actually for the past several months-- about this possibility that pneumococcal infections might increase and about the underuse of this vaccine. So we hope that there's a good amount of supply out there in the commercial sector. To clarify, we're not giving out pneumococcal polysaccharide vaccine as part of the government H1N1 vaccine program. This is distributed and used in the private system. But we think that the pharmacies and the doctors′ offices and hospitals do have vaccine supplies available. Another question from the phone.

Operator: Next question comes from David Lekowitz.

David Lekowitz: I′m with Fox News Channel. A question about the Duke situation last week of the four Tamiflu resistant cases. I know there were two others in North Carolina in the summer, a dozen plus in the United States, 50 plus worldwide. You've dispatched some CDC folks to North Carolina. What have those investigators learned about the Tamiflu resistance, mutation, et cetera?

Anne Schuchat: The investigation is ongoing. The CDC team is working closely with the state health department and investigators from Duke to understand what happened in that particular facility. So I don't have the final results of that investigation, but we're going to learn from that, I′m sure. One thing I can tell you is that our scientists here at CDC have been able to compare the strain of influenza, the 2009 H1N1 influenza that was identified in campers last summer with the strain that's part of this cluster in North Carolina today. And apparently there's a different strain, so not a link with this particular hospital investigation. That's about as much results as I have, but of course as you said, the vast majority of the H1N1 influenza vaccine strains right now are totally sensitive to Tamiflu and we think that that's a reasonably-- that there's no reason to doubt the efficacy of that antiviral medicine. This cluster is important, it needs to be looked into, but for pretty much everybody who is coming down with flu and needs to be treated, the Tamiflu or Relenza should be reasonable option. Another question?

Operator: Stephen Smith, your line is open.

Stephen Smith: I′m with the Boston Globe. Thanks for doing the call today. Two questions unrelated. The first, I′m hoping that you might be able to unpack in more granular detail what you're seeing in terms of I believe you said the figure was ten GBS cases. I′m unclear. Are these confirmed cases, what was the temporal relationship between vaccination and when symptoms appear and what is the strategy for investigating those? And the second question unrelated to that is I′m wondering what you're seeing vis-à-vis social marketing and specifically YouTube, Twitter, Facebook, those being used to convey prevention messages and any thoughts about their efficacy thus far.

Anne Schuchat: Those are both really good areas to explore. The ten Guillain-Barré Syndrome cases or the ten Guillain-Barré Syndrome reports to the VAERS system are a mixture. Some will turn out to be confirmed Guillain-Barré Syndromes. Some are still under review and may not actually end up meeting the case definition for Guillain-Barré Syndrome. Theirs accepts reports really with no cutoff in terms of the time window, so these are not limited to report that's occurred within six weeks; for instance, of vaccination which is what we really think is the outer window of when vaccine related Guillain-Barré Syndrome would occur. So these would just be cases or events that someone thought was Guillain-Barré Syndrome reported in to the VAERS system. VAERS goes through a review involving a clinical review of the records from possible reports-- or reports from possible cases to understand whether the clinical information is consistent with the case definition. And to really hone in on issues like the timing, when was the vaccine given, when did the symptoms begin, what were the lot numbers and so forth. And so essentially what we've seen so far with Guillain-Barré Syndrome doesn't raise any red flags at all. But as you know, these reports will be-- continue to be reviewed and on our website, as well as the FDA website, you can every week see updated information about what's coming in to VAERS that's under review.

Your second question was about social marketing and I think that will prove to be an extremely important part of the pandemic response and probably only time will tell about the effectiveness and the aspects of these efforts that really are the ones that we should focus on in future responses. Certainly a lot of the H1N1 problem has been in younger people who use social medium more than some of us older people do and we have been trying to reach the medium to reach them and I think peers are reaching each other. So there's a lot that′s going on. If you go to flu.gov, there are a lot of tools, I think they′re called Widgets and Buttons and all kinds of things that you can link to and you can understand. I know we have a Facebook and twitter account here at CDC for this H1N1 problem and, in fact, I have to admit I believe it was Monday; I personally participated in a bloginar with mommy bloggers to try to communicate with these leaders of their peers and help them get good information about the flu. So whether these investments of information sharing are the most important ones or just good complements to the traditional media I think time will tell. Another question from the phone?

Operator: Our next question comes from David Brown. Your line is open. State your affiliation.

David Brown: Yes, I′m with the Washington Post. Thanks a lot for doing this. Dr. Schuchat, you can give us some sense of what percentage of people in the under 60 age group who have H1N1 infection will get a post-influenza bacterial pneumonia and what fraction of the people with bacterial pneumonia will have pneumococcal pneumonia?

Anne Schuchat: No, unfortunately, I can't give you those statistics. I can say that on our web, we have a little more detail about the ABC system which tracks both invasive pneumococcal infections and the same sites actually are tracking influenza, so I believe we have a graph that might put it in context. Yeah it does. On the website, there's a graph that you might be interested in that will have the flu hospitalizations in that same Denver metro area during that same time period as the invasive pneumococcal cases were seen. So an important thing to mention is that just like with influenza, not everybody with influenza gets hospitalized. With pneumococcal infections, there are a lot more pneumococcal infection that are not serious or not invasive than there are invasive ones. So the system that ABCs is tracking, the serious ones very specifically where we can look in the lab at the bacteria and grow it from blood and do typing and so forth. So it's not easy to give a ratio of x flu to y pneumococcal complications. We do see in a number of different ways of looking at it that bacterial pneumonia can complicate flu. We reported on a series of fatalities in the MMWR this summer about 77 fatalities were autopsy was done. And in about 30 percent of those, we found bacterial pneumonia on the autopsy information from the lungs. Similarly when we look at our pediatric fatalities from the H1n1 influenza, we're seeing about a third of those fatalities in children are complicated by a bacterial co-infection. Pneumococcal has been one of the leading causes of the bacterial co-infection. Not the only one, because common one. So those don't answer your question directly, but are other ways for us to say that we believe the pneumococcal risk is important. Another question from the phone?

Operator: Next one comes from Philip Boffey. Your line is open. State your affiliation.

Philip Boffey: The New York Times. I was wondering what the status of those mutations that allowed the virus to go deeper into the lung. When's the status of looking into those in.

Anne Schuchat: Yes, thank you. I think you're referring to the reports a few days ago from Norway about a few serious patients with H1N1 influenza who had a mutation which had expected to be associated with more virulent disease and really attachment in the deep lung area. Among the many strains of H1N1 that have been genetically sequenced, those mutations have been seen in a number of countries. We′ve seen them in the U.S. and we have seen them in a number of other countries. They have been associated with severe disease. More often than you would expect by chance alone. But they're also associated with milder disease that doesn't result in death. There's a lot of the influenza community looking at the genetic sequences-the patterns that we have- to try to understand what will happen. Right now we have no evidence that this is a dominant strain or dominant mutation that's going to cause most of the future illness. We do know it can cause severe or less severe disease and the jury's out whether it will turn out to be an important public health problem or not. Again, our influenza virologists are looking closely at it. Do we have anymore there the room? Okay. We'll going back to the phones.

Operator: Next one comes from Tom Maugh. Your line is open. State your affiliation.

Tom Maugh: Los Angeles Times. Can you address the mutants that were identified in China and also the encephalopathy′s that have been observed associated with the H1N1 in Japan?

Anne Schuchat: In Japan, okay. I′m sorry. The mutants that were-- the first question was the mutants that were-- I′m blanking on your first question.

Tom Maugh: In China.

Anne Schuchat: Right. Okay. I′m probably blanking on your first question because I cannot address the mutants-- I′m not familiar with the report that you're describing. It may be that I've heard about that in a different form or that I′m not at all familiar, so maybe we can get somebody to follow-up with you. And in terms encephalopathy in Japan, I can't comment on that. The only thing I can say is that we did one MMWR about neurologic complications of the H1N1 influenza that were seen in our spring outbreak and we are aware of more neurologic complications. I′m not sure whether we have a full summary of that experience yet here in the U.S. Again, I′m not familiar with the Japan report. I′m sorry about that. Are there other questions from the phone, preferably about something I′m familiar with?

Operator: Our next one comes from Daniel DeNoon. Your line is open. State your affiliation.

Dan DeNoon: I′m with WebMD. Dr. Schuchat, going back to the pneumococcal cases, is there any sense of what percentage are occurring this people who do not have the traditional risk factors for pneumococcal disease, and with regard to the recommendations for vaccination, are there any recommendations to give the vaccine to people that would not normally be recommended to get it or are there recommendations that only people who have the risk factors should be vaccinated? Thank you.

Anne Schuchat: Yes, thanks. The investigation in Denver is ongoing. What I have seen in terms of the preliminary results, the majority but not 100 percent of the adults that have been identified with invasive pneumococcal disease have a risk factor, a chronic health condition. I should add that the Advisory Committee for Immunization Practices this year expanded the list of risk conditions for which invasive-- for which pneumococcal polysaccharide vaccine should be given. They added asthma to the list. That was not on the list until this year. And they also added smokers. Current smokers are now recommended to receive the pneumococcal polysaccharide vaccine because there's pretty good data that they are at higher risk of invasive pneumococcal disease. There was consideration last spring and in the years before actually on the Advisory Committee for Immunization Practices about whether the circumstances of a pandemic should broaden the use of pneumococcal polysaccharide vaccine; to vaccinate people who usually wouldn′t get vaccinated. One thing they said was, of course, you'd want to look at the specific details of who is getting pneumococcal disease during a pandemic, but they actually reaffirmed the traditional focus really because risk is higher in people with these chronic health conditions and vaccine use is so low. So the recommendations for the setting of an H1N1 or any pandemic are also on our website at CDC.gov going into detail about who should be getting the pneumococcal polysaccharide vaccine given the circumstances of a pandemic. And they didn't go to sort of the healthy adult population. They went really focusing on trying to get more people who have-- already have an indication into that vaccinated group. Time for one last question.

Operator: Next question comes from Liv Osby. Your line is open. State your affiliation.

Liv Osby: I′m with the Greenville News. I believe you mentioned that 94 percent of the adverse events were not serious. Then I was wondering if could you tell us what some of the other serious adverse events were in that other 6 percent.

Anne Schuchat:Serious in the VAERS lingo means are you hospitalized or have a fatal or life threatening problem. Sometimes these hospitalizations are essentially being observed in the emergency department. There is a mix of conditions and the VAERS information is actually publicly reported every week, so I don't have the details of the specifics. Certainly those ten Guillain-Barré Syndrome cases that I mentioned or possible cases that I mentioned would be among conditions that were considered serious, so serious allergic reactions like anaphylaxis that I mentioned also would be in that. Fatalities would be in that. Those types of things. But the details are at the VAERS site. A really important thing to say is that VAERS is a system that basically collects everything and doesn't at all go to causality. If something happens after the vaccine is given, if you die in a car crash, in fact, you can be reported in to the VAERS system and there is one of those reports of someone who died in a car crash shortly after they were vaccinated with the H1N1 vaccine. So I think there's some language on the VAERS website that talks about how the system works and the usual caveats. With conditions like Guillain-Barré Syndrome, we think it's important for to remember that that happens with or without vaccines, that every week between 80 and 160 people in the United States are diagnosed with Guillain-Barré Syndrome. So it's not really surprising that we have a few in our reports right now. The question of causality is a different matter. And lastly I should just mention that the Health and Human Services Department has identified an external group of advisers from the Vaccine Safety Risk Assessment Working Group that is an external group of advisors from the National Vaccine Advisory Committee Framework who are periodically reviewing safety data such as what I went over with you today. They're looking at these data regularly to understand whether there are any flags that the government might not think they're flags, but the external group thinks they're flags. And at their recent meeting, they didn't find anything that there was anything of excess concern. So we're using that as a sounding board to make sure that the data is being carefully reviewed. Thanks, everybody. Have a fantastic holiday and enjoy your turkeys.

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES