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UPDATE ON INFLUENZA VACCINE SUPPLIES AND VACCINATION EFFORTS

Monday, October 19, 2006 12:30 p.m.

OPERATOR: The briefing will begin momentarily. Introducing our speakers today is Dr. Glen Nowak. As he makes his way to the podium, you will hear room noise from the auditorium or silent moments until he begins. We would like to remind you if you would like to ask a question during the call, please press star one on your touch-tone phone. If you would like to withdrawal your question, please press star two.

As a reminder, if you're on a speaker phone, please pick up your handset before registering your question. All participants are on a listen-only mode until the Q&A segment.

This call is being recorded. If you have any objections, please disconnect at this time. Please stand by, thank you.

MR. NOWAK: Hi, this is - I'm Glen Nowak, I'm Director of Media Relations at CDC. And we're here to have a press update on the nation's influenza vaccine supplies as well as some efforts that will be undertaken to try to encourage influenza vaccination.

We have four people participating in the press briefing this afternoon. Dr. Julie Gerberding, Director of the CDC who will be speaking first. Dr. John Agwunobi who is the Assistant Secretary for Health and Human Services will be speaking as well and he is joining us from Washington, DC via video - Dr. Agwunobi.

We will also have Dr. LJ Tan from the American Medical Association. The American Medical Association is one of the co-sponsors of the National Influenza Summit, an organization of over 100 organizations involved in influenza vaccines manufacturing distribution administration. And Dr. Tan will be speaking on behalf of the influenza vaccine summit.

And then we have Dr. Don Williamson, who is the State Health Officer in Alabama who will be giving an update on state and local efforts related to the influenza vaccine.

So I will turn this now over to Dr. Julie Gerberding.

DR. GERBERDING: Good afternoon and thank you for joining us for this press briefing on influenza. We're going to be focusing on seasonal influenza during this press conference and I just wanted to thank those who are here and on the phone for joining us.

I also wanted to thank particularly the CDC Press Office because in part of our ongoing preparedness we are exercising our capacity to directly link to the Department of Health and Human Services and bring Dr. Agwunobi on live. So this is ongoing evolution at CDC in terms of our communication capacity.

We are here today to talk about seasonal influenza. And just a quick update on where we are, we have ongoing activity in just a few locations around the state - around the country and only one state, the State of North Carolina is showing regional activity.

We are at the very beginning of the season and as always, influenza is unpredictable so we're not going to be able to say how fast it's going to evolve, where it will hit next, how bad it will be, how serious it would be and we're just at the very beginning of the flu season.

This means that there's time to get vaccinated against influenza, and that's our major message today. This year we have more doses of vaccine than we have ever produced in the United States. We are still projecting between 110 and 115 million doses.

We have been informed by the manufacturers that they have distributed about 77 million doses. That compares to the total highest ever distribution of 83 million in years past. So we are only at the beginning of November and we have already distributed almost as many doses of vaccine as we have ever made.

The challenge that we are facing is that distribution is not equitably distributed across America and there are still certain providers in certain health agencies who are having trouble getting their doses. Manufacturers and the distributors have said that they are making every effort to provide partial shipments and to distribute the vaccine as quickly as it is becoming available.

But there are still mismatches between the need and the supply in specific parts of the country. CDC has only a limited capacity to do anything about that because the vast majority of this vaccine is in the private sector.

But we are working hard to encourage the members of the vaccine summit and others to come together and try to understand where the biggest mismatches are and what we can do to try to encourage the distributors to address those needs as quickly as possible.

We also recognize that this is an important time of year in that we tend to have most of our vaccination for influenza done before Thanksgiving. This year, we are going to take an additional step. We are going to support a National Influenza Vaccination Week, which will be held November 27 through December 3.

The purpose of this week is to draw attention to the importance of getting influenza vaccination whenever it is available in the clinic and that it is never too late to get your flu shot even if you weren't able to do it in the months of September, October, early November.

We are going to put a lot of visibility on encouraging immunization through the winter months and we are here to invite Dr. John Agwunobi - Admiral Agwunobi, I should say, who is the Assistant Secretary of Health and Human Services, a former health officer in Florida, an expert on the realities of seasonal influenza and he is going to talk a little bit more about what Secretary Leavitt and the Department of Health and Human services is doing to encourage seasonal vaccinations - Dr. Agwunobi.

DR. AGWUNOBI: Thanks Dr. Gerberding. As a pediatrician, I know the value of preventative medicine. Receiving a flu shot is the most effective way to protect yourself and those you care about from influenza. In an average year, approximately 36,000 Americans (INAUDIBLE).

As you heard, there will be a record number of doses of vaccine (INAUDIBLE) vaccination. Last year, the amount of vaccine available caused us to issue prioritization guidelines to ensure that the most vulnerable were (INAUDIBLE). This year however, due to this year's vast supply, we are able to encourage anyone who would like to be vaccinated (INAUDIBLE).

The Department of Health and Human Services is (INAUDIBLE). In addition to the great work of the CDC, some of the other activities supported by HHS include 500 medical reserve corps, units around the country with support from the Office of the Surgeon General, who are currently mobilizing to make sure that their volunteers and their families are vaccinated to raise awareness in the general public about influenza vaccination.

(INAUDIBLE) who is community health center program encouraging all of its staff and clients to get an influenza vaccination. The Indian Health Service has organized large vaccination clinics where its patient population continues to promote awareness. CMS has been raising awareness of the immunizations in the elderly populations as it goes out and goes about Medicare Part D, the Bus Tour to mark open enrollment season.

The time to get an influenza vaccine comes well into winter through early 2007 when the influenza season typically peaks. Dr. Gerberding, I thank you for your leadership and for allowing me to participate from Washington. Back to you Julie.

DR. GERBERDING Thank you Admiral Agwunobi and we appreciate the success of this communication first for CDC. Let me now introduce you by phone to a very important supporter of CDC's ongoing vaccination program, that person is Dr. LJ Tan, T-A-N, from the American Medical Association.

The American Medical Association, or the AMA, is a co-sponsor of the National Influenza Vaccine Summit, which is a coalition of many partners, including governmental public health partners, but also people from the private sector and the medical community to work together to try to encourage immunization, but also to do everything possible to address the miss-match between the supply and the distribution of the vaccine.

So, Dr. Tan, we'd like to hear from you on how the AMA is going to support the National Influenza Vaccine Week and the other activities that the AMA is supporting.

DR. TAN: Thank you very much. I hope you all can hear me. Thank you Dr. Gerberding and Dr. Agwunobi for this very important initiative and also thanks for inviting the National Influenza Vaccine Summit to partner with you all on this event.

And thank you also for this opportunity to present the Summit's position on this issue. And I am speaking for the National Influenza Vaccine Summit.

The Summit is a partnership, as you have mentioned, co-sponsored by the CDC and the AMA and it includes more than 100 organizational stakeholders from, you know, all arenas of influenza vaccine research, production, distribution, public health as well as medical providers.

The Summit applauds HHS and CDC for this effort. Influenza is a very serious illness, it kills more than 36,000 persons annually, hospitalizes more than 200,000. So it is extremely vital that we continue to raise awareness on the importance of influenza vaccination as the best way to protect yourselves and the ones that you love from flu and provide an incentive for immunization after Thanksgiving into December and beyond.

We know that there are substantial medical benefits to receiving the vaccine after Thanksgiving and beyond, but it is often mistakenly believed that the only time to get the vaccine is before Thanksgiving and I think this initiative will be a significant step towards shattering that myth.

With the upcoming holiday season, the partners of the Summit pledge to work with the CDC and HHS to get as many people as possible vaccinated so that they can enjoy the holiday season free from influenza and to start the new year with new year resolutions and not influenza.

The Summit has already established an influenza vaccine availability tracking system, which will help providers locate vaccine sources into Thanksgiving and beyond, has created an online tool kit to assist providers with vaccinating after Thanksgiving, is working with the National Foundation for Infectious Diseases on consumer education to help extend the influenza vaccination season and we'll be planning, certainly, a regional vaccination activities with all our partners during this actual National Influenza Vaccination Week to promote influenza immunization.

The AMA of course, supports a lot of these activities as a co-sponsor of the Summit. And thanks again for this very important initiative and for inviting the Summit to speak today.

Back to you Dr. Gerberding.

DR. GERBERDING: Thank you Dr. Tan, we really thank you and the AMA for your support and the whole coalition and Summit for their support.

I do want to make one very important point to people around America who are thinking about their flu vaccine this year. As we have been trying to emphasize, it is never too late to get our flu shots. It is important to do it as soon as you can in your community.

So it is a good idea to check now with your provider or your health officials to determine where and when vaccine is expected in your community and get ready to step up to the plate and get vaccinated. We want you to go to your holiday gatherings with your good food and your gifts and your good cheer and not with the flu virus.

And this is a really important thing to do to protect yourselves, but also to protect all of your family members who might be at risk for acquiring influenza during family gatherings and other holiday festivals. Let's try to have the safest possible holiday season.

And with that, let me turn to someone who is really on the front line of all of this, my good friend and colleague Dr. Williamson, who is the State Health Officer in the State of Alabama, who knows first hand how important it is to look locally to our local health officials as well as to our state health officials for the bottom line on what is going on in one's particular community.

Dr. Williamson is also representing the Association of State and Territorial Health Officials and he is also precariously representing his colleagues from NACCHO, the National Association of County and City Health Offices.

DR. WILLIAMSON: Thanks, Julie.

Well it is a real privilege on behalf of the Association of State and Territorial Health Officials and with my personal experience as Health Officer in Alabama to be here.

The opportunity to support National Influenza Vaccination Week is extraordinarily important. State health officials throughout this nation are committed to insuring that all individuals in need of influenza vaccine receive it.

As you have heard many times, 36,000 Americans die each year from influenza. It is the most common cause of vaccine preventable death in the United States. Delays in the delivery of influenza vaccine this year have meant that some individuals were unable to receive vaccine earlier in the fall when they would have like to have.

And when we gave fewer doses of vaccine, people historically were able to always receive it. But fortunately more vaccine is becoming available as we continue to move into the beginnings of flu season. As we speak, state and local level health departments are already conducting influenza vaccine clinics.

They are educating the public about the importance of this vaccine. To reiterate, there is an abundance of time to get vaccinated. Getting vaccinated in November and December or even in January is beneficial because the flu season generally does not peak until January or in many cases into February.

Protecting the public from vaccine preventable diseases is a top priority for state and local health departments. Reducing hospitalizations and death due to flu is essential. During national influenza vaccine week, we in the public health community will continue to work diligently with our federal, local and private sector partners to insure that all people seeking vaccine are able to receive it.

So let me in closing just encourage individuals to take advantage of the month of, the rest of November, of the month of December and even into January, find vaccine and to avail themselves of that to reduce their risk of death and hospitalization due to influenza. Thank you.

DR. GERBERDING: Let me emphasize one more time why it is important for people to get their flu shots. Reason number one is because it is the best defense against influenza and that means illness and days lost from school or work. But it can mean hospitalization or even death, especially for vulnerable people.

Number two, a flu shot is the best way to protect your family and make sure that wherever they are in the world, that they're protected to the best extent possible from a virus that can be at best, non-friendly and at worse, sometimes deadly. Number three, it's important because we know that if you are vaccinated against influenza, you have broad protection against the flu strains that are likely to be circulating in your community.

Sometimes people think if the flu is already present in their community, there's no benefit from the flu shot, but there's more than one strain in the vaccine and so you can still benefit from additional protection.

And finally, there's some chance that the immunization that you get will give you a little bit of a head start on your immunity for next year. That's not always the case, but it's another good reason to just keep your flu immunity as high as possible. And the best way to do that for it is to get a flu shot.

One very important component of all of this, is that you do not get influenza from the flu shot. There's a lot of misunderstanding about that and we never miss an opportunity to remind people that the flu shot does not give you the flu and it's very, very important not to use that as a reason not to be vaccinated.

So once again, National Influenza Vaccine Week, the last week of November, beginning on November 27 through December 3 as our reminder of how important it is to get vaccinated against influenza any time that it's available for you in your community.

So let me take some questions, and I'll be asking Dr. Williamson and others to stand by to address the questions also.

MIKE STOBBE-ASSOCIATED PRESS: Dr. Gerberding, two part question. First, the first part is how many people are - how many Americans are eligible to get the flu shot and how many do we think have gotten flu shots so far? And the second part is, are we looking at a situation where a lot of doses of flu vaccine will have to get thrown away at the end of the year?

DR. GERBERDING: So let's just say we have 300 million people in our country. Any person is eligible for a flu shot. So anybody who wants to be protected can get a flu shot this year. In terms of those people that we specifically recommend vaccinations for, it's now about 218 million.

This includes the newest group this year, which are the children between ages six months and five years of age who we now know vaccination will help keep them in school, out of emergency rooms and off antibiotics or out of the hospital.

So there are a couple hundred million people who we know that science tells us will specifically benefit from the flu shot. Obviously, that's far more people than we have doses for this year, but based on our past pattern, we are never able to get all of those people stepping up to the plate.

We hope some day we can, and we're going to continue to push and push and push until we have every person we can possibly protect, protected but we are a long way from getting that kind of uptake.

And so that's part of the reason for the aggressive efforts that we make every year and certainly the aggressive effort we're making for the National Influenza Vaccination Week.

One group of people that we must encourage immunization for are healthcare personnel. They are at risk because they're taking care of patients with flu, but they're also at risk because there are family members that could be brining influenza into the healthcare setting and potentially posing a risk to their patients.

So it's very important if you're a healthcare worker, if you're caring for someone who's vulnerable for influenza because they have chronic medical conditions, please make a special effort to get the flu shot this year. It really is important for you and your family, but also for the people that you care for.

In terms of ultimately what will happen this year with our flu supply is it's too soon to predict. We are concerned that we're going to have more doses of flu than we might use and that's part of the reason we're making an aggressive effort.

The most important positive thing that we shouldn't lose sight of is this really is an expansion of our flu vaccine supply. This represents the efforts that have been made since the flu vaccine shortage as well as our pandemic preparing this effort to really aggressively expand the capacity of manufacturers to develop and use flu vaccine in the United States.

So we intend to do everything we can to try to get every dose used and we hope we don't end up with large numbers of doses. But if we do, it is still far better to have that manufacturing capacity and we will catch up with our ability to distribute and use it as we go forward.

We hope that in the future the changes in modernization that the pandemic preparedness effort will bring will help us get past this distribution bottle neck as vaccines slowly come out of the manufacturing process early in the year. We would love it if that happened faster and the distribution could go faster.

But there is no way to really accelerate a manufacturer's ability to produce doses using the technology that they currently have available to them. Let me take other questions. Well we can take a question from the telephone.

OPERATOR: Ms. Judy Fortin from CNN, your line is open.

MS. FORTIN: Dr. Gerberding, my question is for you. Could you please address the delay in shipping flu vaccines for children, specifically Fluzone.

DR. GERBERDING: There is not a specific delay in any particular category of vaccine. The supply of flu vaccine, specifically targeting children is much smaller than it is for the vaccine that can be used successfully for adults.

And so the fact that the manufacturer has to make that at a certain rate does mean that we are particularly concerned about the distribution of the pediatric vaccine.

We recognize that the distribution generically is a system that is in the private sector marketplace. While we have some distributors who really helped to provide partial doses, we don't have complete transparency into how the decisions about distribution are made.

And that is one of the things that we are continuing to negotiate and work on, trying to make sure that everyone has an equitable opportunity to at least get part of their flu vaccine supply. Hopefully, some the lessons we learn this year will help us be able to do that better next year. I will take another question from the telephone.

OPERATOR: Mr. John Lauerman from Bloomberg News, your line is open.

MR. LAUERMAN: Thanks for your taking my question. I have two questions. I was wondering if you cold go into a little bit more detail about what kind of efforts you are making with the distributors and manufacturers about, in other words what can you do to improve, I don't know if equity is the right word, but to improve the effectiveness of distribution.

And I also wanted to ask Dr. Tan if he has been hearing, what he has been hearing from his members about supplies of flu vaccine, whether they are sufficient. Thanks.

DR. GERBERDING: Let me start with the big picture, with the manufacturers. Each year there is always uncertainty about the timing of the release of vaccine because different virus strains grow faster or slower than others. And this year we didn't have a particularly fast growing strain. So that put the pressure on the manufacturer right from the beginning.

We also want manufacturers to create vaccines as safely and in accordance with good manufacturing practices. We have seen what happens when there is a failure in those practices, where a couple of years ago we lost basically half of our vaccine supply.

So the last thing we want to do is put undue pressure on manufacturers. We want this vaccine quickly, but we also want it safely. And we can't sacrifice speed for safety.

In terms if distribution, it is very complicated. The system of distribution varies from one manufacturer to another and the way people order vaccines varies from one consumer to another.

Some people actually contract for vaccine, which means they have a specified date on which that vaccine must be delivered to them or there could be a breach of contract. Naturally distributors are particularly concerned about holding to their contracted supply chain.

Some people, instead of contracting use a mechanism called pre-booking, which means they make an offer to purchase vaccine and the manufacturer makes an offer to have it available, but there's no contract and later in the year, that individual can decide well, never mind I don't want to purchase my vaccine from that person or I don't want to purchase it at all.

So there's no binding agreement in the pre-booking arrangement in most cases. Therefore, some distributors feel contract then to deliver their contracted doses and the pre-booking doses may not have the same order or priority, understandably.

They're in a business and they have to do the proper thing in terms of their business plan. What we're hoping for is that the best practices, that the distributors have voluntarily come up with to try to ease the early season distribution challenges will really ultimately allow us to do a better job of partially supplying the largest proportion of providers and make it easier for the very small vaccinators to have a fair chance to get some of their flu doses in their clinics.

This is important from a medical perspective, because many of the providers that are most challenged this year are the people who are taking care of people at the highest vulnerability for flu complications.

Now most of the large vaccine clinics are still functioning and have plenty of vaccine and there are many ways that people in the community can receive vaccine, but not all of them are finding it easy to get from their own provider and particularly for children and others with chronic medical conditions, it's preferable to get the vaccine from the provider if that's possible.

So these are the kinds of things, the realities of the private sector. If you know much about vaccines in this country, you know that it's a very different situation for pediatric vaccines where CDC and the government owns a much larger market share and we have a lot more flexibility to move vaccine around. We also know where it is, who's getting it and who's not getting it and we can more aggressively intervene.

That's just not possible with the adult flu vaccine market right now. And so we have to rely on good cooperation, a shared interest in trying to get the right thing done and the efforts of people like the Summit who really are bringing providers, distributors, manufacturers together in ways to try to solve these problems.

You can take another telephone question.

OPERATOR: Ms. Anita Manning from USA TODAY, you may ask your question.

MS. MANNING: Yes, Dr. Gerberding, can you tell us where there are still areas of shortage? You mentioned that there are some, I'm just wondering if they're geographic areas or if it's a buying sector?

DR. GERBERDING: I'm going to let Dr. Williamson take that question because I know he has the answer to that.

DR. WILLIAMSON: Well, I don't have all the answers. I can tell you what our members are finding. In some public health agencies around the country they are adequately applied and they have gotten their vaccine.

In other public health departments, we are struggling. In our own, we've gotten, driving over this morning, I'm told we're now up to about to about 40 to 45 percent of what we've ordered. We've received normally before the last five or six years, by now we would have had it all in place and we would probably be giving -- have given most of it by now.

I think the comments that Dr. Gerberding made about the pediatric vaccine is pretty obvious. If you look at our VFC vaccine, the vaccine for children vaccine, we've only gotten about 30 percent of that. So there are, in the public sector there are places in health department both at the state and local level where there are shortages.

We have every confidence that over the next several weeks we are going to see this supply that really is out there and this production that really has occurred move through the distribution system and be in place in health departments to vaccinate our clients.

Anecdoctally talking to private providers, many private providers that LJ will talk about in a bit are experiencing shortages. So I don't think it is so much there are geographic shortages as there are isolated pockets of shortage.

DR. GERBERDING: I understand that if you are a person trying to get vaccine, whether you are the patient or the provider that there is a shortage right now. But it is probably better to characterize this as a delay because overall we do not have a vaccine shortage this year.

As we have said, we have distributed 77 million doses, which is more than we typically would have had out by this time. It is just a question of who is getting it, not what the total amount is. So, there are people and places that don't have what they need. There is no doubt about it and we wish we could solve the problem faster. But we predict by National Immunization Week that we are not going to be talking about vaccine shortages. We are gong to be talking about what can we do to aggressively get even more people vaccinated. And that is really the important message that we are trying to communicate today.

Dr. Tan, I think the previous questioner had a specific question for you and I neglected to give you a chance to answer it. So can you follow back on that question about private providers?

DR. TAN: Oh yes I can Dr. Gerberding, thank you. You know, to be honest I think it is fact out there that as Dr. Williamson was saying, that there are regional areas where particularly the smaller providers, those in family practices for example have not received the bulk of their vaccines.

We are looking at numbers, anything from 15 to 40 percent of their vaccines. But, at the same time as I say that, we are also hearing from members who complained last year that they had not gotten vaccine who are actually sitting quite satisfied with what they have received so far.

So I think there has been a general improvement in the national distribution of influenza vaccines. But that is not to say, as Dr. Williamson has already said, that there are areas where we acknowledge that there are problems.

But I think the key of the message here is that by Thanksgiving, we anticipate that all of our providers will have ample vaccine to be vaccinating all their patients and we are working towards encouraging them to do so.

I think one of our biggest challenges has been the fact that a lot of patients, especially chronically ill, high risk patients seek vaccine in early October and think that if they can't get their vaccine in the first week of October, they should go somewhere else.

And what we would like to try and encourage these patients is that actually they can be vaccinated later on in October, in early November and to go back to their physicians so that they can also receive attention for some of their other conditions as well.

DR. GERBERDING: Thank you Dr. Tan. I want to make sure that we don't have a question here in the room before I go back to the queue ion the telephone. Anybody here in the room. Let's go right to the phone.

OPERATOR: Ms. Lisa Stark from ABC News, you may ask your question.

MS STARK: Thank you. A lot of providers we have talked to are having trouble getting their vaccine. So a couple of things. One is that even if it does start coming in late, they say it is a missed opportunity and just due to logistical reasons they will not be able to use all their vaccine or vaccinate all the people who might need it. I am wondering how concerning is that.

And the second part of that question is some of them especially sort of the family practitioners that you're talking about that are so critical for say the young child or the more chronically ill patient, some of them are saying this is - the distribution problems this year are making them wonder if they should just give up doing vaccines, flu vaccines because it's just too financially and logistically impossible and how concerning would that be? Thank you.

DR. GERBERDING: You know, I wish we had an easy solution for the providers because we know how important they are to our overall effort. Having said that, I think we've got to change the way we think about flu immunization in our medical environment.

For many years when we've had such a small amount of flu vaccine, we could push it out very quickly at the beginning of the season and use most of it before we got to the late season phase.

But as we have more supply, we've got a lot more people who need vaccination, we've got to understand that the season for vaccination doesn't end at Thanksgiving, the season for vaccination is any time that people in the community are at risk for influenza and that means we have to broaden our schedule for flu clinics and we have to be prepared to accommodate patients who need flu vaccine in December and potentially even into January.

You know, some years flu season doesn't even peak until the early spring. So there is a very important adjustment that needs to be made in the medical community to try to extend the opportunity for flu vaccine.

When we used to have 80 million people to be vaccinated and maybe 40 million would show up, we could crunch it all together. But now we're talking about 218 million people who need vaccine and 115 million who will have the opportunity and we just simply have to be able to use all opportunities to vaccinate, extend the season of vaccination and do special things like we're doing this year with the National Influenza Vaccination Week as well as the special public service announcements, the efforts of the AMA and the state and local health officials and even the efforts that are underway by the manufacturers to really promote the concept that this isn't do it now or it's too late, it's the do it as soon as you can in your community and it's never too late.

So we hope that that will help providers transition into a more extended environment for offering flu vaccines to those people who still need it. We really are going to do everything we can to keep them in there and to help them. I think that's why the AMA is so important.

We don't want people to give up, that is certainly not the solution. The solution here is to work harder and do more and we at CDC are certainly committed to doing what we can to help spread the word and provide more opportunities. I can take this question here in the room.

MIKE STOBBE-ASSOCIATED PRESS: Dr. Gerberding, there's at least one parents group that's advising Americans not to get flu shots if the shots contain thimerosal. I understand it's a complicated situation and only nine million doses are thimerosal free, but do you mind speaking to that, the fact that you're trying to get out this message and how you respond to groups that are advising people not to get the shot.

And also, will the supply change in future years in terms of (INAUDIBLE) thimerosal in there?

DR. GERBERDING: You know, one of the most poignant experiences that I've had in this role at CDC was listening to a mom who three years ago during the flu season that was especially hard for young children describe the devastating illness that her little girl picked up in the daycare center.

And that mom is very zealous about why it's so important for children to be protected against influenza because she learned from very tragic personal experience what happens if children are not protected.

And I think what we know is that children are at risk for influenza and they can have very serious disease and complications from influenza and the flu shot is the best way to protect them. There's no doubt about that. Concerns about thimerosal are concerns that I know are still on the minds of many parents.

We have not been able to identify any data that indicates a flu shot poses any risk associated with thimerosal that might be in it as a preservative or in trace amounts. And so if you are balancing the benefit of immunization, which to protect your child with what is an unknown or no risk situation from thimerosal, it seems pretty clear to me what needs to be done.

And that is why we in the public health community are definitely encouraging parents to get their kids vaccinated. The risk of flu far outweighs any theoretical complications from the vaccine. Let me take one more question from the phone please.

OPERATOR: Ms. Jai-Rui Chong your line is open from the Los Angeles Times.

MS. CHONG: Hi, these are some questions for Dr. Gerberding. But first, I just wanted to mention that I had some trouble hearing the comments from Dr. Agwunobi. I don't know if other people did. But I thought you just might like to know. Any...

DR. GERBERDING: We do appreciate that.

MS. CHUNG (ph): Well the first question I had was, could you quantify how much flu vaccine was delayed and how much more will be delivered in the coming months? And then the second question was about Guillain-Barre Syndrome. There is a study coming out this afternoon in the "Archives of Internal Medicine" saying that there is a small but increased risk of getting this syndrome with influenza shots. So I was wondering how that might affect, you know, your recommendations that everybody get it.

DR. GERBERDING: Let me first talk about the distribution.

Again, we have distributed 77 million doses of flu vaccine from the manufacturers. That is a very high amount of flu and is more that we had two years ago in total. So we are experiencing delays from the standpoint of the recipients, but not necessarily delays from the standpoint of how much is coming out of the manufacturer.

The second point is, how much will we ultimately be distributing and the expected amount is at least 110 million doses, up to 115 million doses. But a lot of that vaccine is going to be coming out in December and will be considered sort of post- Thanksgiving vaccine.

That is part of the reason why we are really emphasizing ongoing immunization. I just can't emphasize enough that we don't know when flu season peaks, but we have new cases of flu well into the spring and it is never too late for people to get their flu shots.

With respect to vaccine complications from this year's flu vaccine, it would be far too premature to make any predictions about any unexpected complications because we have just started using the vaccine. And I will ask Dr. Nancy Cox and Dr. Jeanne Santoli, who are flu experts here if they want to comment on the specific paper in "Archive."

DR. NANCY COX: Thanks very much Dr. Gerberding. The paper that is coming out from our Canadian colleagues in the "Archives of Medicine" has findings in it, which are consistent with findings that were published in a few years ago by researchers from the CDC and other organizations.

These findings indicate that there is an increased risk of about one in a million, GBS cases among those who are vaccinated compared to those who are not vaccinated. But when we compare the risks associated with influenza in sections with those, with the risk of either GBS occurring after vaccination, or the risk of not actual recovering from GBS, we see that the risks of not being vaccinated far outweigh the risks for GBS.

So in summary, the results that are coming out in the publication are very consistent with findings that have been published previously and certainly will not affect our recommendation.

DR. GERGDING: I think we could just take one more question from the phone.

OPERATOR: Mr. Bill Hendrick from the Atlanta Journal-Constitution, your line is open.

MR. HENDRICK: Thank you very much. Is the vaccine that's out there protective against the various strains, A, B, whatever? Is it - what is it protective against?

DR. GERBERDING: The vaccine that we're using this year has protection against two strains of influenza A and one strain of influenza B. We're very early in the year to know exactly what strains are going to predominate at any given part of the country.

Our very early work, not surprisingly, has shown that in some areas there's a good match between the strains in the vaccine and some areas the match may not be perfect. But it's very early and we have a lot more work to do as the season progresses to really get that information.

So far we're not seeing any unusual complications from influenza or any indication that it's a worse than usual season, but it is way too early to make any projections in one direction or another.

So, we will continue to provide regular updates about the severity of the season, the geography of the season as well as any emerging concerns about the match between the vaccine and the strains that are affecting people in the communities. Thank you very much for your attention. Don't forget National Influenza Vaccination Week November 27 through December 3. Thank you.

END

####

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