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CDC Telebriefing on Influenza Vaccine Supply and Distribution

Wednesday, October 18, 2006, 12:00 PM ET

OPERATOR: Welcome and thank you for standing by. At this time all participants are in a listen only mode. During the question and answer session, please press star one on our touch-tone phone.

Today′s conference is being recorded. If you have any objections you may disconnect at this time.

Now, I will turn the meeting over to Mr. Curtis Allen. Thank you, sir.

MR. ALLEN: Thank you for joining us today. My name is Curtis Allen. I am with the Division of Media Relations at CDC. Today′s topic is "Vaccine Supply and Distribution." With us is Dr. Jeanne Santoli; that is J-E-A-N-N-E, Santoli, S-A-N-T-O-L-I.

She is an MD and a Master in Public Health. She is Deputy Director of the Immunization Services Division at the National Centers of – National Center for Immunization and Respiratory Diseases at CDC. Dr. Santoli will have a brief statement and then we will open it up for questions. Dr. Santoli.

DR. SANTOLI: Thank you. Well, we have been talking about the projections for influenza vaccines this season for the past month or so and we talked about anticipating as many as 115 million doses that will be available.

Our latest information about how many doses have already been distributed is that there have been 40 million doses that were distributed to providers as of the end of the second week of October and that we are still on track to achieve 75 million doses to be distributed by the end of October.

This is 15 million more doses that are compared to last October in terms of flu vaccine distribution. But I think one thing that is worth explaining further is the way that doses are distributed and the reasons that providers have been receiving partial shipments of vaccine.

Given the number of manufacturing plants that we have in the United States and the large number of doses that are currently being produced each year, it isn′t possible to complete the production and distribution process prior to the vaccination season. So this means that influenza vaccine distribution takes place in a phased fashion over a number of months.

It begins in late summer for some manufacturers and completes near the end of November or early in December. In addition, because the production and approval of doses is ongoing, it isn′t easy to predict exactly when a particular order will be delivered very far in advance.

Unfortunately, this situation leaves providers with the uncertainty about knowing when they can expect to receive their full order and the challenge that makes for their planning of vaccination activities.

Now while it is not possible for us to take away that uncertainty, there are several things that we think can help to address it. First, the manufacturers and distributors are working to try to get some vaccine to as many providers as possible as soon as possible so that providers can begin vaccinating their patients.

Getting some vaccine to all providers early in the season is important, because we know that all providers serve at least some high-risk patients and their household contacts.

Obviously it isn′t possible to ship doses to all providers at exactly the same time. So even with this approach, some providers will have vaccine in their offices and clinics before others. But with the large number of doses that we anticipate being shipped over the rest of this month and then in November, we feel that will really effectively smooth out the differences that we′re seeing right now between providers.

The second thing that′s important is that CDC is encouraging providers to take this phased nature of vaccine production and distribution into account as much as possible when they′re planning how they′ll vaccinate their patients.

Almost all providers have some vaccine to allow them to begin vaccinating their patients and we recommend beginning vaccination now, rather than waiting until more vaccine arrives. And however, for the providers who may not have received their first shipment of vaccine yet, the recommendation there would be to begin vaccinating as soon as vaccine arrives.

In addition, more vaccine will be arriving throughout the season and we expect that there will be more vaccine available this season than ever before.

Lastly, CDC urges providers to make significant effort to offer influenza immunization in December, January and beyond and that is consistent with the most recent recommendations from the Advisory Committee on Immunization Practices.

Vaccinating beyond November is important and beneficial because the peak of the season typically occurs in February or later and we know that many high risk persons and their household contacts are recommended for vaccination but are not vaccinated by the end of November.

In addition, even when there is disease present in a community, individuals may still benefit from vaccinations, so the vaccine is the best way to protect yourself against influenza. Thank you.

MR. ALLEN: OK, we′ll take questions now.

OPERATOR: Thank you. At this time, if you would like to ask a question, please press star one and record your name at the prompt. Once again, to ask a question, please press star one and record your name at the prompt.

One moment for our first question.

Our first question comes from Miriam Falco).

MS. FALCO: Hi. Thanks for taking questions. Do you have any – how do you track how much has gone out? And how many complaints have you gotten from providers saying that they haven′t gotten their vaccine yet? Because as you know, media reports are saying there is a shortage. Are you calling this a shortage? I′m guessing not. And how do you know who has gotten what?

DR. SANTOLI: It′s a great question. We are absolutely not calling this a shortage. We actually have a system that helps us to understand how distribution is occurring and we are able to make that information available to state and local public health officials so that they understand what′s happening with vaccine distribution in their communities.

The system gets information that′s voluntarily provided to CDC. It′s proprietary information by the manufacturers and the major influenza vaccine distributors. And we – it′s put into a secure data network and then state and local pubic health officials can look at their jurisdiction and understand where doses are being distributed.

This is a huge help to state and local public health officials and has been used for the past couple of years and it is an effort to really bring together information with the people who can use the information.

MS. FALCO: But, are doctor – the complaint that I have heard a lot over the past few weeks is the big companies, the big chains are getting the vaccine and the little doctors, the individual doctors aren′t. Do your – does your information reflect that?

DR. SANTOLI: Thanks for the question. Our information from our data tracking system doesn′t allow us to make that distinction. But early on before the season started, we spoke with the manufacturers and the major influenza vaccine distributors and we asked their plans for distributing doses.

And what we have been told, and what we have continued to ask about and confirm, is that they are doing something called "serve a proportionate distribution," where the goal is to get some influenza vaccine to as many providers as possible early in the season.

Now as I said a few minutes ago, it doesn′t mean everybody will have all of their doses on the same day and so there are discrepancies. But that approach is what we have been told by the manufacturers and the major distributors that that is the approach that they are taking this season.

MR. ALLEN: Next question?

OPERATOR: Thank you, our next question goes to Patricia Arnstead. Please state your affiliation.

MS. ARNSTEAD: Yes. I’m with the Detroit Free Press. And indeed my question, I have two questions that follow up the first question. OK, can you hear me?

MR. ALLEN: Sure that is OK.

MS. ARNSTEAD: Thanks for taking the questions. I heard Dr. Santoli say, almost all providers got some vaccine and yet she just acknowledged that we don′t know if individual doctors through the tacking system you have are getting vaccine. So how could you say almost all providers have some vaccine, particularly doctors is question one. Question two, why not give supplies first to those who serve at-risk populations?

DR. SANTOLI: Let me take your second question first.

MS. ARNSTEAD: Thank you.

DR. SANTOLI: I think that we have a sense from surveys about the different locations and venues in which people get their flu vaccine and it is varied. The most common place is provider offices with 40 percent of adults reporting getting their vaccination there. But that means 60 percent of folks are getting vaccinated elsewhere.

And we think that almost all providers serve some high-risk patients and the household contacts of high-risk patients whose vaccination also protects them. So, getting vaccine to as many providers as possible means making vaccine accessible to high-risk patients everywhere. And I am afraid I now have lost track of your first question. Would you mind repeating it?

OPERATOR: One moment.

MR. ALLEN: Hello?

OPERATOR: Patricia your line is open.

MS. ARNSTEAD: Thank you so much. The question was, you said almost all providers have some vaccine and I don′t see how you can say that when indeed you don′t know if doctors in particular, doctors′ offices in particular have it.

The related question is that many people have to go to large community sites, not as a preference but because they have it first. Do you know if indeed 40 percent of people get from provider offices, that the figure would be much higher if the vaccine was provided to doctors?

DR. SANTOLI: Well actually that is a number that has been relatively constant over the past three to five years. So, it is not unique. It is actually information. The 40 percent number I quoted was from last season but it is a number that has been fairly constant.

But your, the first part of the question, you are making a good point. When I expressed that it is our understanding that most providers have some vaccine, it is not because of our tracking system because we are not able to get that information from the tracking system.

But in fact, we speak on a regular basis with the manufacturers and the vaccine distributors for influenza vaccine. And this is what they have told us about the approach they are taking. I think unfortunately when we hear complaints – and we do get phone call just as Public Health gets phone calls at every level – it is hard to know from a call which expresses a very difficult situation, how widespread that concern is.

So, I am afraid I can′t answer how to translate the concerns that we get into something you can quantify.

But we know that the people who are distributing this vaccine have told us an approach that tries to reach as many providers as possible. And that′s sort of where that statement comes from.

MR. ALLEN: Next question please.

OPERATOR: Thank you. Our next question comes from Anita Manning, please state your affiliation.

MS. MANNING: USA Today. I also have a couple questions and I′ll try to be fast. One of them is, is there some – is this vaccine slower growing than previous years vaccines have been? Is there some reason that it seems to be trickling out late? My own doctor doesn′t have vaccine yet, by the way.

But also, the second question is that the – I have an AAP media mailing from Monday saying that the American Academy of Pediatrics is alerting parents there will be a delay in getting flu shots for children. So if it′s not a shortage, would you at least characterize it as a delay?

DR. SANTOLI: Two really good questions. I think early on we did hear from the manufacturers that there were – you know whenever there are new strains that that requires new efforts and can present some challenges. But it is our understanding that really those issues have been overcome and now all the milestones for production and distribution are being met.

In terms of the word “delay,” and I know that that word has been used, I think that from our perspective, what is the most important thing is how many doses are going to be out there in October and November as providers start vaccinating.

And with 15 million doses out there (Editor’s note: should be 15 million more to be distributed than last October), this October, by the end of this October rather, compared to last year, we feel as though 75 million doses in October is a lot of vaccine to start using.

In fact, we have never really used more than about 80 to 83 million doses in a season. So to have 75 million out by the end of the first, you know, full month of the vaccination season to use feels like it′s timing that will get that vaccine out there when it′s needed.

MR. ALLEN: Our next question please.

OPERATOR: Thank you. Our next question comes from Christine Gorman. Please state your affiliation.

MS. GORMAN: Time Magazine. Getting back to the children′s vaccination, is that FluZone vaccine? Is that going to be coming out soon? I mean what is the delay there? And what should parents of small children, who often, you know, are first to get the flu do in the meantime?

DR. SANTOLI: Well, I think that the thing to remember is how early we are in the vaccination season right now. We, really the vaccination season that we talk about is ideal is sort of October and November, but we also know that the disease tends to peak in February or later.

So though we want to try to get vaccine early, as early as possible, we still have the very best chance possible protecting children and their families by vaccinating them even if the vaccination isn′t completed by the end of November.

So, the advice would be to seek vaccination and, you know if that′s not available at the doctor′s office this week, to continue seeking vaccination because we′re right in the middle of the time when vaccination is ongoing.

MR. ALLEN: Next question please.

OPERATOR: Thank you. Our next question comes from Mike Stobbe, please state your affiliation.

MR. STOBBE: This is Mike at the AP. Thanks for taking the question. This is just for clarification. Doctor, when you said 40 million doses distributed at the end of last week and 75 million expected distributed in October, could you define distributed?

Does that mean from the manufacturer to the distributors, but it might be in a warehouse? Does it mean from the distributors to the providers? Does it mean shots in peoples’ arms so far?

DR. SANTOLI: That is a great question. It actually means vaccine going – well we get information from the manufacturers but they don′t send us information about vaccine they have shipped to distributors.

And we get information from the distributors about vaccine that they have shipped to the next level. Sometimes there are of course pharmacies or sub-distributors. So some of that vaccine is out to providers, some of it is now ready to go out to providers, so it is a little bit of a mixture. Does that answer your question?

MR. STOBBE: Actually not of (INAUDIBLE).

DR. SANTOLI: I am sorry. I didn′t hear you...

MR. STOBBE: I am just going back to that statistic about 40 million doses distributed as of the end of last week. Some of that may still be in factories, is that right?

DR. SANTOLI: Not production factories. That has all left manufacturers and a good chunk of it has also left the distributors. It is a little bit complicated because one of the manufacturers does most of their distribution directly to the customers. So when they tell us about doses, those are in a doctor′s office.

When the distributors tell us about doses, some of those are in doctor′s offices and some are also in a next distributor site where it will then go on the reach providers. So it is a combination. But none of those 40 million doses are actually in the production facility where they were made.

MR. STOBBE: But do you happen to know how many doses providers have received so far?

DR. SANTOLI: No, we don′t have a mechanism in place to know that information. It is a good question but our information sort of stops before we get to the provider reporting.

MR. ALLEN: So, next question please.

OPERATOR: Thank you. Our next question comes from Jon Rockoff. Please state our affiliation.

MR. ROCKOFF: Hi, I am with the Baltimore Sun. Could you just talk a little bit more about proportionate distribution? Does that mean that the larger providers get a proportionately larger share of the early shipments?

DR. SANTOLI: Oh, thanks for asking that question. No, I mean that is they are trying to get a small amount of vaccine often in a similar proportion of the order to as many providers as possible. So that instead of giving some providers 100 percent of their doses and other providers no doses, you would try to get some proportion of doses so that you could give to all providers so that everyone could get started.

MR. ROCKOFF: Thank you.

DR. SANTOLI: Sure.

MR. ALLEN: Our next question please.

OPERATOR: Our next question comes from John Lauerman. Please state you affiliation

MR. LAUERMAN: It is John Lauerman with Bloomberg News. Thanks for taking my question. So, I am looking at the release from the American Academy of Pediatrics and they are specifically calling it a delay. Have you consulted with them at all? Are you, you know, are you working with them in any way?

And they are talking, of course, about flu shots for children. The flu shots for children are in two doses isn′t that right? So is there some problem with the two-dose vaccine that does not exist with the regular one dose vaccine that is given to, single dose vaccine that is given to older children?

DR. SANTOLI: Well one thing that is important to keep in mind of course is that not all children require two doses. That is the first time a child is vaccinated. But I think that you are absolutely right that pediatricians are thinking about giving two doses to many of their patients. And that is different than providers who are serving grown-ups.

But, as we said earlier, the time to be vaccination is in October and November. Vaccination in December is helpful. So the chance to get those two doses in, we don′t think is going to be compromises by the fact that not everybody has all of their order filled in their offices right now.

We are aware of the AAP′s press release. And in fact another thing mentioned in that press release is that we have sent out guidance to providers similar to what we′re talking about today about the phased nature of distribution, what we recommended that they do in terms of beginning to vaccinate as soon as possible and some of the same things that we′re talking about this afternoon.

MR. ALLEN: Next question please.

OPERATOR: Thank you. Our next question comes from Bill Hendrick. Please state your affiliation.

MR. HENDRICK: Hi, Bill Hendrick with the Atlanta Journal-Constitution. I, like others, am hearing complaints from pediatricians and I′m wondering if the immune systems of children, very young children, will have sufficient time to be bolstered by the vaccination, which may be – may have been delayed before the flu, peak flu season hits. And I′ve got a follow up also.

DR. SANTOLI: OK. So I′ll answer that. It′s a good question. As we said a moment ago, children being vaccinated for the first time do require two doses. Those doses need to be spaced a month a part and then just like everyone else, after the completion of their vaccination, it′s two weeks until they have immunity.

So getting vaccinated now is important and I think there is going to be sufficient time if providers vaccinate now and continue vaccinating because as we know, fortunately the influenza disease often peaks in January or February or later. And so there′s time to get children protected now, but it is important for providers to start vaccinating now.

MR. HENDRICK: OK. Could you repeat that? I′m sorry, I missed that. You said you think there′s going to be sufficient time?

DR. SANTOLI: Well, I said a little bit more. Do you want me to repeat the whole answer?

MR. HENDRICK: No. Just the last part.

DR. SANTOLI: Oh. I think if people are vaccinating, beginning to vaccinate children now, then as children come back for their second dose, which is in a month, there will be more vaccine available and I think that there – that it′s very possible that we′ll get those children protected before the season peaks. It′s hard to say because we don′t know when that will happen, but our experience tells us that most years that it′s February or later.

MR. HENDRICK: OK, but…

MR. ALLEN: Do you have a follow up Bill?

MR. HENDRICK: …but you do think that, yes, that two shots a month a part and if they′re received late, the first shot say the end of this month, and then another month that by the time peak season hits, early next year then the immune systems would have been bolstered enough to keep these kids well?

DR. SANTOLI: Well, since the ideal time to vaccinate is in October and November, then a child who completes their series by the end of November isn′t being vaccinated late. So I would be confident that that child would receive a lot of benefit from the vaccine, but I also think even children vaccinated beyond November, who complete their vaccination beyond November are going to get the benefit from the vaccine depending on when the disease peaks, of course.

MR. HENDRICK: OK. Can I squeeze in one more question?

MR. ALLEN: Sure, please.

MR. HENDRICK: We are hearing – when I was down in South Georgia at the military base and they′ve had some outbreaks down there, we′ve heard about some outbreaks of flu, which they said was unusual, even in basic training, and that also there have been a couple of outbreaks in Alabama. What are we seeing? Are we seeing a lot of flu cases already? Last question, I promise.

DR. SANTOLI: Sure, it′s a good question of course because people are always interested. I think at this point, the disease activity (INAUDIBLE) so there is some disease, which we sometimes see this time of the year. We sometimes see it a little earlier. We′re sort of seeing what we often see this time of the year.

MR. HENDRICK: Thank you very much.

MR. ALLEN: You can go to the Web site, www.cdc.gov/flu and look at the surveillance map and that will give you a better idea of what we′re seeing.

MR. HENDRICK: Thank you.

MR. ALLEN: Next question please.

OPERATOR: Thank you. Our next question comes from A.J. Hostetler, please state your affiliation.

MR. HOSTETLER: Richmond Times-Dispatch. My call is regarding the manufacturers of the flu vaccine. Can you give us another breakdown of the number of vaccine manufacturers plus the number of shot vaccinations and the number of flu mist vaccinations that will be available?

DR. SANTOLI: Sure. Well there are currently, the manufacturers there are, there is one manufacturer that makes the nasal spray vaccine. And there are, I am sorry, three manufacturers that make injectable influenza vaccine. And altogether we estimate that somewhere between 110 and 115 million doses will be produced this season.

We don′t typically give manufacturer by manufacturer breakdown when it comes to the number of doses that we are anticipating. But I will say that the nasal doses at this point are still a fairly small proportion of the doses that are out there and available.

MR. ALLEN: Next question please.

OPERATOR: Thank you, our next question comes from Maggie Fox. Please state your affiliation?

MS. FOX: Maggie Fox with Reuters. I just want to follow up on the nasal spray. Is that an option for children whose pediatricians don′t have the shots yet?

DR. SANTOLI: That is a great question. That vaccine is licensed for those who are aged five to 49 and who are in good health and not pregnant. So it wouldn′t be appropriate for the younger children. But for the children who are household contacts of those younger children, who are healthy and between the ages of five and 18, that would be a very appropriate choice.

MR. ALLEN: Our next question please.

OPERATOR: Thank you. Our next question come David Wahlberg. Please state your affiliation.

MR. WAHLBERG: Hi, Wisconsin State Journal. Yes, I am confused because you are saying that pediatricians should start vaccinating now but the AAP is saying the FluZone won′t be at pediatricians′ offices until November and December. So how can they actually vaccinate now?

DR. SANTOLI: Oh, sorry I was pushing the wrong button. I think that there was, the AAP was referring to communications from Sanofi to their customers about the timing of doses. It is my understanding that the timing of doses was talked about but that there is not any indication that none of that dose, none of those doses are in pediatricians’ offices right now.

And in fact, our tracking system shows that there are pediatric doses going to providers’ office. But providers don′t have their full order. And I think that is what the AAP message was talking about as well as the direct message between Sanofi and their customers that was referenced in the AAP′s message.

MR. ALLEN: Next question please.

OPERATOR: Thank you. Our next question comes from Patricia Arnstead. Please state your company name.

MS. ARNSTEAD: Detroit Free Press. Just a statistics question. Of the 115 million doses you expect to have this year, how many of those are the pediatric doses? And if I may, of what has been distributed, how many have been pediatric doses?

DR. SANTOLI: It is a complicated question because there are – there is one product that can only be used in young children, which are children who are less than three. There is one product that can be used in children who are four years and older. So that can catch some older children. One product that can be used in children three years and older – but of course those both include adults. Products for six months and up, which means they can be used in all ages.

So it is very difficult to say how many of these doses are going to be used in children. And so likewise our tracking system doesn′t help us there just because of the wide age ranges that can be covered under each – many of the products.

MR. ALLEN: Our next question please.

OPERATOR: Thank you. Our next question comes from Maura Lerner. Please state your affiliation.

MS. LERNER: Hi. I’m with the Minneapolis Star Tribune. Could you clarify whether you are at this point recommending that anybody reserve vaccine for the high-risk groups?

DR. SANTOLI: I′m sorry, could you repeat the question?

MS. LERNER: Yes. Are you, at this point, recommending that anybody reserve vaccine for specifically the high-risk group or give high-risk groups priority?

DR. SANTOLI: Oh, thank you for that question. In fact, we are not recommending that, which we last year called tiered vaccination, where we want providers to focus on high-risk persons early in the season.

With the large amount of vaccine that we anticipate being available this season, we want to do our best to make as many opportunities as possible for high-risk people, their household contacts and any others who want to prevent influenza to get vaccinated.

And so, we′re not making any kind of recommendations about serving one group before others this year.

MS. LERNER: Thank you.

MR. ALLEN: Next question please.

OPERATOR: Thank you. Our next question comes from John Lauerman. Please state your affiliation.

MR. LAUERMAN: It′s John Lauerman from Bloomberg News again. Yes, I just wanted to follow up on my question earlier. So, in other words, so you′re saying that this is – that contrary to what AAP is saying that this is not a delay because it is – because vaccination later in the season is in fact appropriate? So you′re not – you′re disagreeing with them in effect?

DR. SANTOLI: No. I actually think that AAP and CDC would both agree that the ideal time for vaccination is in October and November, but that you can get benefit beyond that. So I think probably we′d be in synch about that.

I think the definition of delay in terms of distribution is very difficult when we know it′s a phased process. We know that it can′t happen before, you know, be complete before the season starts. So I think that′s a very difficult word to define.

But, I think in terms of when children and others should be vaccinated, I think that there′s consistency between CDC and AAP and most of the other provider organizations on that.

MR. LAUERMAN: OK. So, it – can you hear me still?

DR. SANTOLI: Yes.

MR. LAUERMAN: Yes? OK. So, you agree with them about the correct – about the best time to vaccinate children, but you disagree with them about characterizing this as a delay?

DR. SANTOLI: I think that we′re learning more and more that influenza vaccine distribution is a phased process. And last year, we did characterize distribution as a delay. And we think that what we did was caused individuals to step aside and not seek vaccination and that was not in their best interests.

And so what we′re realizing is that the more important thing is to give people as much information as you can about what distribution is supposed to look like, what it does look like so that people know what to expect and providers and patients can plan according and we can protect as many people as possible.

MR. ALLEN: Next question please.

OPERATOR: At this time, I′m showing no further questions.

MR. ALLEN: OK. Well, thank you very much.

DR. SANTOLI: One other point, I guess I′d like to make is someone had asked a question about doses for children and it′s very complicated as I said because some products are used for multiple ages.

But, a piece of information that we think may be helpful is to say that about 8 to 9 million of the doses that are produced (specifically for young children) this year so that we estimate now is about 115 million by the time we′re done are the doses that are licensed for 6 to 23 month olds only. So they can only be used in that group.

That gives you a sense. But as I said earlier there are other doses and other products that can also be used in those children, so that is an underestimate of the number of vaccines that can be used to protect our youngest children, the 6- to 23- month-olds.

So I just wanted to add that point of clarification.

MR. ALLEN: OK. Well, thank you very much. Again, that′s Dr. Jeanne Santoli, that′s J-E-A-N-N-E Santoli, S-A-N-T-O-L-I, M.D. She′s Deputy Director of the Immunization Services Division of the National Center for Immunization and Respiratory Diseases.

I am Curtis Allen at the Division of Media Relations. Our number here is (404) 639-3286. The transcript of this briefing will be on the web site later this afternoon. Thank you very much.

END

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