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Press Briefing Transcripts

CDC and FDA – Vaccine Recall

Moderator: CURTIS ALLEN, December 12, 2007, 5:00 p.m. EST

OPERATOR: Good afternoon, and thank you for holding. Please continue to hold for the conference to begin. Again please continue to hold for the conference to begin. Thank you.

UNIDENTIFIED PARTICIPANT: Yes.

OPERATOR: Welcome and thank you for standing by. At this time all lines have been placed on listen–only mode until the question–and–answer session. Today′s conference is being recorded, if anyone has any objections, you may disconnect at this time. I would now like to turn the call over to Curtis Allen, CDC Press Office. Sir, you may begin.

CURTIS ALLEN, CDC PRESS OFFICE: Thank you. This is Curtis Allen, I′m in the press office at CDC, today we will – we are having a meeting – a briefing to update you on a recent – something that we recently learned about our childhood vaccine.

Joining us today will be Norman Baylor, N–o–r–m–a–n B–a–y–l–o–r, he is the Director of FDAs Office of Vaccine Research and Review. He will be joined by Dr. Jesse Goodman. Also – and Jesse – Dr. Goodman is Director of FDA Center for Biologics and Evaluation and Research at FDA.

Also Dr. Anne Schuchat, A–n–n–e S–c–h–u–c–h–a–t, and she′s Director of the National Center for Immunization and Respiratory Diseases at CDC. And first to speak will be Dr. Julie Geberding, the Director for CDC – Dr. Gerberding.

JULIE GERBERDING, DIRECTOR, CDC: Yes, thank you, Curtis, and thank you everyone for joining this conversation on such short notice. We′re here today to give you an update regarding the supply of one of the nation′s recommended childhood vaccines, the Haemophilus influenzae type b vaccine, this is commonly known as the HIB vaccine, H–I–B like boy, not V like Victor, HIB vaccine, a vaccine that′s been routinely recommended since 1990.

The FDA and the CDC learned this week that Merck, one of two companies that provide HIB vaccine in the U.S. is initiating a voluntary recall for certain lots of the vaccine. Now it′s important to understand the value of this vaccine, it helps protect children from meningitis, from pneumonia, from severe throat infections and other serious blood stream infections caused by Haemophilus influenzae type b bacteria. And one of the things we want to emphasize, there′ll be a point of confusion here, that although this is called Haemophilus influenzae type b, it is a bacteria, and it has nothing to do with influenza the virus that causes flu. So we′re – we want to help the public to understand that this does not in any way affect the influenza vaccine that we′re still strongly advocating.

Before this HIB vaccine was licensed and used, we experienced about 20,000 cases of HIB disease in the United States, and about 1,000 children died every year from this infection. But thanks to these vaccines that have been around for the last decade or so, there are fewer than 100 documented cases of HIB disease in the entire United States each year, a reduction of over 99 percent. So obviously this is an extremely effective vaccine that has saved the lives of many, many children.

Merck and Sanofi Pasteur both produce this vaccine, and the voluntary recall that we′re describing only affects certain Merck products, those known as PedvaxHIB and COMVAX that were shipped after April 2007, and Jesse Goodman at the FDA is going to provide you more specifics about this, and you can also find the details of the recall on the Merck web site where they′ve posted the specific products, lot numbers, et cetera.

Merck is in the process of alerting physicians and immunization providers of their voluntary recall, they expect most of this will be happening over the next 24 hours, and some providers will get their letters as soon as tomorrow morning. Of course CDC is also reaching out to our immunization partners and our stakeholders, and we′ll be putting information on our Web site and updating people as we go forward.

So let me just kind of frame what the expected short–term impact of this will be. First I want to emphasize that this is right now not a health threatening situation for children, we have had no cases of reported injuries or adverse events associated with the HIB vaccine that′s involved in this recall. The Merck Web site will describe a little bit more about why they are making the recall, it′s on a precautionary basis, and I will let the FDA go into those details. But the important thing is that we have not observed a health threat from this vaccine in children, in fact as I said, we′ve observed health benefits in terms of the hundreds of cases of disease and lives saved that we′ve experienced since it′s been in use.

It′s also very important to understand that this recall has nothing to do with the potency of the vaccine, so children who receive this vaccine are protected against Haemophilus, there′s no need to re–immunize or go back and see these children again, they are completely protected, and therefore we′re not concerned about a requirement for any ongoing special follow up.

We do recognize, unfortunately, that this is going to cause a great inconvenience, this vaccine is currently in physician′s offices, the recall will ask them to return the product that they have that′s involved in this. Right now we have no way of knowing which doctor has Sanofi vaccine, which doctor has Merck vaccine, so it′ll be a lot of checking and some inconveniences at best in terms of sustaining our very successful immunization program.

It also will affect the CDC stockpile, because we have some stockpiled vaccine that we protect for public use, and we know that a portion of our stockpile will also be affected by this recall, so that flexibility for future ability to backfill for shortages and so forth has been lost by this change.

There′s obviously going to be inconvenience for providers in every kind of immunization clinic, and we′re so sorry for that, and we′re sorry especially for the parents of children who may be inconvenienced, and uncertain about how to go about protecting their child, and I think we′ll do everything we can, we′re working with Sanofi, we′re working with the FDA, we′re working with Merck, we′re working with our providers, stakeholders and so forth to try to see what we can do to help equalize access to this vaccine.

We′re also working with our advisory groups to determine if we need to change our recommendations about how the vaccine should be used, and Dr. Schuchat will be talking more about that I think in her comments later on so that we prioritize the vaccine in the best possible way to maximize its benefit for the greatest number of children.

But one very positive aspect of this in terms of the threat of meningitis is that we have such high coverage of protection among the children who are alive today, more than 92 percent of them are completely vaccinated against Haemophilus that we have very low disease rates and very low carriage rates in our population, so we would not expect any meningitis outbreaks because our population is so highly immune for many months. And in fact in other parts of the world there have been experiences with shortages of this same vaccine, and it′s taken more than a year for there to be any noticeable impact on disease rates.

CDC will be continuing our close surveillance for Haemophilus disease in children, and we will be heightening our attention in some of our special programs that we use to give a sentinel look at invasive disease. So we will of course be especially focused on searching for cases that could reflect this difficulty in sustaining the immunization coverage in the short run, but we′re confident that over a long period of time, we will be able to restore access to the vaccine, and that we can minimize any adverse health effects over the long run.

So I′m going to ask others to provide more details for you. But again I want to emphasize, this is not a health–threatening situation in the short run, but it is an inconvenience, and you know, it will cause a disruption in the routine and rhythm of children′s vaccination for this vaccine in at least some practices around the country. And we will promise to work as quickly as we can to facilitate the help that people will need in finding vaccine, and doing everything we can to try to restore access.

So let me ask Dr. Schuchat now from our National Center for Immunization and Respiratory Disease who will provide more detail in how we will be using the vaccine that we have, and what if any changes we may be considering in the recommendations for immunization. Dr. Schuchat?

ANNE SCHUCHAT, DIRECTOR, NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASE: Yes, thanks. I think we′re going to let Dr. Norm Baylor at FDA give a little bit more background about the recall itself, and then I can fill in some details about what practitioners and parents need to know.

UNIDENTIFIED PARTICIPANT: Thank you. Dr. Baylor?

NORMAN BAYLOR, DIRECTOR, FDA OFFICE OF VACCINE RESEARCH AND REVIEW: Yes, thank you. Good evening. As Dr. Gerberding has stated, the FDA and CDC are notifying you this evening of a precautionary voluntary recall by Merck of 10 lots of their Haemophilus b vaccine called PedvaxHIB and two lots of COMVAX, which is a HIB Hepatitis B combination vaccine.

This action was initiated by Merck after they identified through routine testing of their manufacturing equipment an issue that creates the potential for microorganisms to survive a sterilization step performed during manufacturing. Let me – it′s important to emphasize that no documented contamination of the vaccine itself has been found. Vaccines are routinely tested before they′re released, and no vaccine is known or has been found to have been contaminated, nor have there been contamination of vaccine described during the – or found or detected during the manufacturing process.

The FDA continues to interact with Merck as well as the CDC to facilitate actions to resolve this issue, and we have also looked at our adverse event data, and have not seen evidence of adverse events related to this issue as Dr. Gerberding has stated. And we continue to monitor this issue.

Let me state here also that the potential impact of this precautionary recall is on supply, as Dr. Gerberding had stated. And I will turn this over to CDC to provide further information on supply and related issues, and let me emphasize here that we, CDC and FDA and the DHHS continue to work on this issue together along with Merck to resolve this issue.

UNIDENTIFIED PARTICIPANT: And now we′ll hear from Dr. Anne Schuchat, Director of the CDCs National Center for Immunization and Respiratory Diseases. Dr. Schuchat?

SCHUCHAT: Thank you. I just want to repeat Dr. Gerberding′s comments that this is not a health threat, but it′s certainly an inconvenience, and we really value the hard work that parents take to make sure that their children are up to date on their immunizations, and the very hard work that providers carry out to give out vaccines to reduce the burden of disease from these infectious diseases.

While this is not a health threat, it certainly poses some challenges for parents and for doctors. We are working closely together with Merck and with Sanofi, the company that also makes HIB vaccine that isn′t affected by the recall, we′re also working closely with public health and providers to decrease the interruptions in practice that might occur because of this recall. As you heard, HIB is a serious disease, but we′re benefiting right now from a very strong immunization program, high coverage and very low rates of disease, and we basically have a cushion of protection as we go into this recall and the potential impacts on the nation′s supply.

Children who were vaccinated with the lots in question don′t need to come back in, they are protected, they don′t need revaccination, there are no reports, as you heard from the FDA, of any safety problems from these lots. The kinds of things that parents who have recently had their children immunized with either the PedvaxHIB or COMVAX, kinds of things they might look for are local skin bumps or abscesses at the site of infection, those kinds of things might emerge as up to about a week after vaccination, but we don′t have any reports of those. If parents are concerned, they can report that kind of event or providers can report that kind of event through the VAERS system, which is 1–800–822–7967, or through the VAERS Web site at FDA.

Now I want to talk a little bit about next steps. There are some providers who don′t have – who will not be affected at all, the vaccine that they′ve gotten from – for – the HIB vaccine that they use is from – is not from Merck, but there are some providers who may have some vaccine or no vaccine after the recall. Providers who are completely out of HIB vaccine can contact Sanofi Pasteur to find out about availability of product to meet their urgent needs, and of course the recall information that Merck is distributing will describe how providers can return the vaccine that they have.

Over the next several days, experts on HIB disease from both pediatrics and public health and the vaccine community, as well as our advisory committee are reviewing the information we have about the available supply of vaccine, how much vaccine we expect to have through the stockpile, through Sanofi′s current production, and through their potential increased production. And they′re reviewing the demand and need that we have based on the children in the country, and we expect over the next several days to be providing an update about whether there is any need for temporary changes in the vaccine recommendations. For the time being for today, we still urge providers to follow the routine recommended schedule according to the advisory committee on immunization practices, the AAP and the AAFP, the harmonized recommendations.

We have a very strong immunization system in this country, and we all take vaccine safety very seriously. The steps that have been taken are precautionary, we don′t think this is a health threat, but we do think that the strong partnership we have between the public health and pediatric community, the regulatory community and the trust of parents really is going to be vital for us to get through this. We hope here at CDC that we can help smooth the way as we deal with this inconvenience, and we really appreciate the help of the media in getting the word out to reassure parents about this.

So I think we can probably take questions, or I′ll let Curtis close.

CURTIS ALLEN: Would Dr. Goodman like to say anything, you have any comments, Dr. Goodman?

JESSE GOODMAN, DIRECTOR OF FDA CENTER FOR BIOLOGICS AND EVALUATRION AND RESEARCH, FDA: No, but I′ll be happy to jump in if needed during the questions. I just would reiterate that we are all working closely together, that we′re going to do everything we can to both assure safety, that′s our most important priority, but also to work with CDC and the companies involved to deal with trying to facilitate vaccine availability during this disruption. And I′ll leave it at that.

CURTIS ALLEN: Thank you. We′ll take questions now.

OPERATOR: Thank you. At this time if you′d like to ask a question, please press star one. You will be prompted to record your name. Again to ask a question, please press star one.

Our first question comes from Elizabeth Cohen, and please state your media affiliation.

ELIZABETH COHEN, CNN: Hi, this is Elizabeth Cohen with CNN. And you might hear in the background the sound of a child who got this vaccine within the past couple of months, so I have a couple of questions. One is I know this hasn′t happened, but worse case scenario, what could happen, what kind of bacteria could get into these shots? What harm could it cause a child? And if your kid is fine after a week after getting the injection, are you out of the woods? Or could this cause problems later on?

SCHUCHAT: Sure, this is Anne Schuchat responding. The concern about the sterility of the process production is a concern that bacteria might have made their way into the product. As you heard from the FDA, no product has been found to have bacteria in them, they are, you know, the product is meeting the sterility requirements. But this is precautionary because it′s theoretically possible something might have slipped through.

The signs and symptoms that parents would be looking for would be bacterial infections, probably local at the site of infection – I′m sorry, at the site of inoculation. Now or immunosuppressed children, it′s possible there might have been a wider spread infection, I – as you asked about the time period to look at, likely any kind of problems would show up within the first several days after immunization, and by a week you would definitely be out of the woods.

OPERATOR: We′ll take our next question from Daniel DeNoon with WebMD.

DANIEL DeNoon, WEBMD: Thank you very much. I′m interested in how much of the nation′s HIB vaccine supply is affected by this. Is there any rough estimate you could give on how much of our national supply is in – is within these lots?

SCHUCHAT: Yes, we – this is Dr. Schuchat again – we think it′s about a million doses of our nation′s supply that is affected by the recall. Annually we need about 14 million doses to vaccinate fully the children – babies and toddlers in the country. So it′s about a million doses that are in the affected lot.

ALLEN: Next question, please.

OPERATOR: Take our next question comes from Mike Stobbe, and please state your affiliation.

MIKE STOBBE, ASSOCIATED PRESS: Hi, I′m with the Associated Press. Doctors, could you be a little more detailed in terms of what in the plant was apparently contaminated or there were concerns about the sterility? And also could you talk a little bit more about how many of the doses were tested?

ALLEN: Dr. Baylor or Dr. Goodman?

BAYLOR: Yes, I′ll start out with that, this is Norman Baylor. This is a – this is part of a routine testing procedure in the plant, this is to look at the assurance that – of sterility assurance, and make sure all of the processes are in check, and that companies do this on a routine basis. And when they looked at – when they completed this analysis, they found out that the equipment did have a – did – there was a situation in the – where microorganisms could survive during the sterilization process.

So this is – this is – this is routine, but as I said earlier, testing of the product, no product was found to be contaminated, all manufacturers go through as part – as far as their quality assurance, they go through testing procedure of taking media and – actually what′s called media fills and looking at the robustness of their process.

ALLEN: Thank you. Next question please.

OPERATOR: The next question comes from Rita Ruben. Please state your affiliation.

RITA RUBEN, USA TODAY: Yes, Rita Ruben from "USA Today". I – you know, just googling right before the press conference, I came across a story about – well it ran on the AAFP web site about four weeks ago that Merck had notified the CDC that Pedvax was unavailable for shipment. Is that related to this, or is that a separate issue? I mean had there been previous problems with this vaccine?

ALLEN: Dr. Schuchat?

SCHUCHAT: Yes, thank you. That′s right, about a month ago Merck reported that they were not going to be able to make additional supply available for a time period while they were looking into some issues. And so this – that is related to this, but it′s only more recently that the evaluation suggested the need for this precautionary voluntary recall. So as of a month ago, there has been communication in the public health community and the pediatric and family physician community about some changes in the availability of vaccine, and we have been working together with FDA and Merck and Sanofi, who the U.S. producers of HIB vaccine to assess the supply needs. So this is – the situation did begin about a month ago, but it′s much more recently that we became aware that a recall was going to be carried out.

ALLEN: Thank you. Next question, please.

OPERATOR: The next question comes from Steven Smith, and please state your affiliation.

STEVEN SMITH, BOSTON GLOBE: Hi, Steve Smith with the "Boston Globe". Just hoping to drill a little deeper on some of the issues that have already been tackled. I′m wondering if you could help guide us through the calculus here so there are according to Dr. Schuchat 14 million doses given a year, we′re talking about one million doses being withdrawn. Is there an implication for production ongoing? If so, how many doses would you anticipate not being produced in the forthcoming time period? Is there a timeline for when this problem might be resolved?

And I′m – I think what we′re really looking for is a clearer sense of what this issue is, I mean if I had a problem with my car and it wasn′t running, I wouldn′t just say it′s not running, I′d say the oil pan cracked. So can someone there be more specific in what this issue is? Is there a part missing from a machine ...

SCHUCHAT: ... I can – I can help with that, again it′s Dr. Schuchat responding. The recent history has – of HIB vaccine supply in the U.S. is that Merck has produced about 50 percent of the nation′s supply, and Sanofi about 50 percent with the various products that the two companies offer. The recall is affecting a million doses that are out there in the system that will not be usable. But the 50/50 split that we′ve seen in the past is not a fixed amount, and we′ve been working with Sanofi to work on increasing their production while Merck is working on the problem that they have had.

So as we understand it, we can not set a date at – after which Merck′s production will be back in force. And we don′t know as of today exactly how many doses Sanofi will be able to produce, but we know that they are committed to work closely with the needs of the public to increase their production. And it′s basically that math that′s being carried out over the next several days to figure out how many doses can we get for the next several months out there in the system based on that information, we will know whether we need to reduce the number of doses, or prioritize special groups to make sure that we use the vaccine supply that we have in the most affective way possible. So you are right that this may be – it′s a large impact on the current supply, we′re optimistic that we can increase production through Sanofi′s efforts, and that Merck is working very closely with FDA to mitigate the problems that they have had.

We also have a stockpile of vaccine that the CDC manages, and we are using the stockpile to try to put a bit more vaccine out there into the system, so it′s really putting all of those numbers together and looking with Sanofi at their production capability that will help us know whether we need to change the actual schedule or the prioritized groups.

ALLEN: Next question please.

OPERATOR: Take our next question from Bart Line (ph), and please state your affiliation.

LISA BAERTLEIN REUTERS: Hi, I′m with Reuters. I′m wondering if both vaccines have the same HIV component.

SCHUCHAT: Yes, that′s right, the Haemophilus influenzae b or HIB bacteria has a sugar capsule, and the vaccines that – all of the HIB vaccines basically use that same sugar capsule, they use different protein carriers to make what′s called a conjugate vaccine, and that′s the secret behind these vaccines that work so well in. But there – the efficacy and immunogenicity of the HIB vaccines that are licensed in this country is excellent, and both the Merck products and the Sanofi HIB vaccines are very effective at reducing this disease, protecting children and actually preventing transmission of the bacteria, so these are really, really good vaccines, and they′ve nearly eliminated the disease in the U.S., they′re really major public health success stories.

ALLEN: Next question please.

OPERATOR: And our next question comes from Erin Sykes (ph), and please state your affiliation.

ERIN SYKES, NBC NEWS CHANNEL: Hi, yes, I′m with NBC News Channel, and you′ve kind of hinted at answers to these questions, but just to reiterate, how long do you think it will be until the supply is back to 14 million doses of – a year? And if a child has not been vaccinated yet, and their physician is out of a supply, I know the physician′s supposed to call Sanofi to see if they can get extra doses, but are these children at risk for meningitis now? Or what can potentially happen?

SCHUCHAT: You know, we wish we had all of the answers about how long this problem is going to exist. We are operating under an assumption that it may exist for some time, we don′t think this is going to be a problem just for a few weeks, and that′s why we′re convening the group to look into alternate recommendations.

In terms of parents, you know, it′s so important to get your children immunized, the HIB vaccine isn′t the only vaccine that′s due at the two, four, six and 12–month visits, there′s a lot of other protection that you can get. We certainly want to help parents get the answers they need quickly, at this point for providers who are totally out, Sanofi is committed to work with them to meet the urgent needs.

So in terms of, you know, rescheduling appointments, or delaying, I think it′s best to contact the provider about that, but most of the visits where the HIB shot is given, other vaccines are given, and those are quite important.

In terms of how vulnerable – in terms of how vulnerable is the child who′s not able to get HIB vaccine today? Well I think we have a nice cushion of protection in this country, because 94 percent of toddlers have gotten HIB vaccine are, you know, up to date on their HIB vaccine, and there′s very little of this bacteria spreading around in our communities. Of course it′s in other countries still, so people – there is ongoing potential risk, but we′re at much lower risk than we would have been before the vaccination system was so strong for this – for this vaccine.

That cushion of protection can really buy us some time while we′re dealing with the supply problem. As Dr. Gerberding mentioned, we have seen supply interruptions in some other countries as they were going towards introducing HIB vaccine, and they enjoyed some sustained reduced disease in the several months or even a year before a vaccine was available again. So it′s not a no risk situation, but we think we′re in a better shape now because of the strong protection that we have in the community.

ALLEN: Thank you. Next question please.

OPERATOR: Your next question comes from Ricardo Alonso–Zaldivar, and please state your affiliation.

RICARDO ALONSO–ZALDIVAR, L.A. TIMES: Hi, I′m with the "L.A. Times", and thanks for taking my question. And basically can we get a clearer sense of whether you expect there to be a shortage. Are you saying that you expect there to be a shortage, or are you just saying that well maybe there′s the potential for a shortage?

SCHUCHAT: No, I think we do expect there to be a shortage in terms of a mismatch between supply and demand. The extent of that is what we are trying to sort out. We certainly expect in some doctor′s offices for there to be interrupted supply before those providers are able to get some supplies from Sanofi. We think the next – you know, we have a cushion in terms of our stockpile, and we know that Sanofi is committed to increase production, but we don′t think we will have the same supply over the next few months that we have had in the past few months. So I would say a shortage is expected, but it may not be severe enough to require alternate recommendations.

GERBERDING: And this is Dr. Gerberding, I just – I want to emphasize that we absolutely expect a shortage, and the – our ability to compensate for Merck not producing these vaccines and the recall, and the requirements for immunizing children is something that we are working to minimize, as Dr. Schuchat has said. But we don′t want to leave anyone with the impression that this is not going to result in a shortage of vaccine in many practices, and a great deal of inconvenience while we try to create a better match between what we do have and where it′s needed.

ALLEN: Thank you, Dr. Gerberding. Next question please.

OPERATOR: Our next question comes from Jennifer Barrett. And please state your affiliation.

JENNIFER BARRETT, NEWSWEEK: Hi, I′m from "Newsweek". And I′m sorry if you′ve covered this already, but do we know how many doses of the vaccine have already been given to kids from these batches?

SCHUCHAT: I don′t think we know that, unless FDA knows that. We know that it′s about a million doses that are being recalled, but I don′t think we know how many. I think we should stress that we don′t think there is any health threat regarding the children who have received vaccines from these lots, and we have no reports, no evidence of any adverse events in – associated with these lots.

ALLEN: Thank you, next question please.

OPERATOR: Our next question comes from Sarah Rubenstein (ph), and please state your affiliation.

SARAH RUBENSTEIN, WALL STREET JOURNAL: Hi, I′m with the "Wall Street Journal". Merck has said that they′ve had production problems related to the Varicella vaccine as well, I′m wondering if you can tell me which plant specifically produced this vaccine, the HIB vaccine, and it the same plant? And has the – when′s the last time this plant was inspected by the FDA? And if so, what was the – what was the result of that inspection?

ALLEN: Dr. Baylor, Dr. Goodman?

GOODMAN: Yes, this is Dr. Goodman. Just to say some of the information you′re requesting you would have to go to Merck for, but I can say that we actively monitor production in all these facilities, and investigate as appropriate. You know, for the location of what′s produced where, I think you′ll have to go to the company for that. Is that correct, Norman?

BAYLOR: Yes, but I mean we can tell you that most of the licensed vaccines for Merck are produced in Pennsylvania at their West Point facility.

ALLEN: OK, thank you. We have time for two more questions, so next question please.

OPERATOR: Our next question comes from Peggy Peck and please state your affiliation.

PEGGY PECK: Yes, hi, thanks for taking my question. I′m with ‘Med Page Today′. I′d like to get into this issue of the kinds of steps that you would take in terms of prioritizing to handle the vaccine. So tell me, if you will, what would be the profile of the child that you would consider a top priority to get a limited – those limited numbers of doses that are available?

SCHUCHAT: I think the most important priority group in this country to mention are Alaska native American Indian children. They have much higher rates of HIB disease than others do and so, they have been a special population for HIB from the beginning. In fact, many of the vaccine studies were done in that population. It′s also a fairly small group of children. There′s going to – I think we′ve already made the decision that we′ve prioritized our stockpile vaccine for the American Indian Alaska native children. The vaccine doses can stretch pretty far for that community, so we definitely want to address them. What we′re trying to do now is have the experts review risk of disease and available doses and what we know about how this vaccine works in terms of protection, short term and long term protection and I think it′s after that assessment with the available doses and the special population and the program issues of making things as simple as possible for the providers in their offices that we′ll come up with some interim recommendations, if needed.

ALLEN: This is the last question we have time for and then Dr. Gerberding will have a statement. Next question, please?

OPERATOR: Thank you. Our next question comes from Richard Knox and please state your affiliation.

RICHARD KNOX: Yes, hi. Richard Knox from NPR. A couple of things; one is what is the size of the CDC stockpile of HIB vaccine? And secondly, if this was a problem that began to surface a month ago, why was it only now that it was determined a recall was necessary? What piece of information did that? And if I may, a third, I wonder if this is a seasonal kind of disease in that as the winter goes on and the shortage persists, there′s – the worry will mount of a resurgence of the infections.

SCHUCHAT: Yes. Thank you. The stockpile – I think the available stockpile right now is about three quarters of a million doses of HIB containing vaccine. I′ll answer the seasonal question and then, I′m going to let FDA comment about what changed to suggest the need for precautionary recall.

HIB is not as seasonal as many of the respiratory infectious diseases. I just want to remind everybody that one of the most seasonal infectious diseases is influenza and the same children that are supposed to get HIB vaccine are supposed to get influenza vaccine. For six months old up to age five, we do recommend influenza vaccine and that is still available and it′s not too late to get it. But for HIB disease, it′s not – it doesn′t have as striking a seasonal pattern as some of the other infectious diseases. It can occur a little bit more in the winter, but it′s not that seasonal.

ALLEN: And Doctor Baylor?

DOCTOR NORMAN BAYLOR, FDA: Yes. I′ll take the second part of that question. In actuality that timeframe is not that long. I mean these investigations have to be very thorough and Merck actually made the decision recently as a precautionary measure. Again, as they investigate, you have to collect the data, analyze the data, audit the data and then you make a decision on what′s the next step and Merck took the step and we agree with that step as a precautionary measure to do a voluntary recall.

ALLEN: OK. Thank you. Now, we′ll have some closing remarks from Dr. Gerberding. Dr. Gerberding?

GERBERDING: Yes. Thank you. Let me thank all of the participants on the conference call for their collaborative expertise and for those who phoned in and are listening in, we really appreciate your interest in this issue. I want to just emphasize a couple of points. Once again, this is not an immediate health threat, but we do need to do everything we can to restore effective vaccine coverage in the long run because children are at risk for influenza for (INAUDIBLE) influenza disease if we don′t solve this problem over the next several months. Secondly, this is a very important illustration of why it′s important to have more than one vaccine manufacturer in the market because we are vulnerable when we have only one supplier and a production process problem occurs. The more people we have in the business, the more agility we have in responding to these kinds of situations that, unfortunately, continue to come up from time to time.

I think the third thing is we do anticipate that the short term shortages are going to be very inconvenient and very messy to sort out and we, as I said, we′ll pledge to our best, but we don′t want to underestimate that this will create some inconveniences and we are very sorry for the parents and the providers who are affected by this instability. And lastly, as Doctor Schuchat mentioned, it is influenza virus season. It is flu season and we would really encourage everyone to remember that it′s not too late to get your flu shot and that really is a very important part of respiratory health and so, hopefully, we can try to mention that in the process of focusing on this other infectious disease vaccine issue.

So, thank you very much for your attention.

ALLEN: Thank you very much for joining us tonight. There will be a transcript of this media briefing on the Website at www.cdc.gov. It will probably be in the morning before it is posted, but it will be on the Website. So thank you very much.

OPERATOR: ... today′s conference. You may disconnect at this time.

END

####

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

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