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Telebriefing Transcript
Update on current influenza season and
vaccine supply in the United States

December 16, 2004

DR. GERBERDING: Good morning and welcome to this update on influenza season, and also happy holidays to everyone here in the room and everyone in the studios. We hope everyone has a very safe and pleasant holiday season, without the flu.

Today, we are reporting on the update of flu activity. This is still a season that's getting off to a pretty slow start. We have some activity reports here that are updated, showing that one state, New York state, is experiencing widespread flu activity, but most of the country is still only experiencing sporadic activity. The states in green have just very little or limited activity, and two states in yellow are showing no flu activity whatsoever.

So compared to last year, this season is getting off to a slow start, but we always know that flu is unpredictable and that the most common season for flu to peak is February, so we are certainly not assuming that we're out of the woods yet, and we will continue to prioritize immunization and flu prevention activities across our whole health system.

I'd like to give you a few facts on vaccine distribution because obviously this has been a priority for us at CDC and we've been working hard to get flu (vaccine) allocated and apportioned to places that need it the most.

Over 21 million doses of vaccine have been distributed since the shortage was announced in October and we have been successfully targeting those doses of vaccine to the places that need them the most.

We also have another 3.5 million doses of licensed vaccine still to come, so we have not released all of the vaccine that Aventis will be producing this year, and additional doses are still coming out of the manufacturing process and will be delivered as they're available.

As you know, Secretary Thompson also negotiated the purchase of an additional 1.2 million (doses) of investigational vaccine from Europe. That vaccine is not yet being used because we still have licensed vaccine available; but it's important to have it, just in case we need it, and we're certainly glad that purchase moved forward as quickly as it did.

Our partners in the state health agencies and members of ASTHO, the Association of State and Territorial Health Officials, have done a lot of heroic favors this flu season. One of the most recent is to survey states to identify how well they're doing with supply meeting the demand for vaccine. Not all states have responded but of the 49 that we have information on, 82 percent indicate that they do have a sufficient supply of vaccine to meet their needs this year, to meet their demand this year. And I do want to distinguish between demand and need.

Demand is based on who's coming forward and requesting vaccine. Need is our assessment of, in an ideal world, if everyone were vaccinated, how many doses would we need. Of course, we have never met the CDC base need for vaccine, we've never had a 100 percent coverage, but we are working hard this year to at least meet the demand for it, and in cases where the demand is too low, we're going to continue to promote the concept that it's not too late to get flu vaccine and we want people stepping up to the plate to be vaccinated, if they're in a priority group.

Of the states that are indicating they don't have a sufficient amount of vaccine, so far we've been able to assess that the deficiency is about 400,000 doses, but we have three more states that haven't, or, actually, four more states that haven't provided that perspective.

So if we are unable to meet their needs based on the Aventis vaccine, we do have that reserve supply of the IND vaccine, and that's exactly how it can be used, to meet unmet demands in areas that are experiencing insufficient supplies.

We also have some good news today. In today's Morbidity and Mortality Weekly Report, which just was released this morning, we have a set of articles that are describing some of our flu activities this year and I think one of the important pieces of information we've gleaned is that overall, about 75 percent of the doses of vaccine that have been released this year have gone to high priority people, or, in other words, three out of every four doses of vaccine are going to the people who need it the most, and that's a remarkable achievement, given that 33 million doses were released before the high-priority scheme was even released.

So that effort has been successful. We also have I think, on the next graphic, a depiction of our success in getting children immunized. This is the first year that vaccine has been recommended for children between the ages of six months and three years.

The red dot here indicates that our survey has identified a vaccine coverage rate in that population of about 37 percent. Compared to the first year of vaccination for a variety of other childhood vaccines, this is a remarkable progress in just one year.

When we started the Hepatitis B recommendation for kids, only 8 percent got it the first year.

When we started varicella vaccination for kids, only 16 percent got it the first year.

For the pneumococcal vaccine, we're at 48 percent.

So for us to be out at a 37 percent level, year one, for influenza, for kids, we're considering this a very excellent coverage rate for the first year out and we really thank the clinicians and the parents and the health officials who worked hard to get the message out and to get vaccine to these children and keep in mind that we do not have a shortage of this vaccine.

This vaccine was originally available from Aventis and so it is not a consequence of the overall Chiron shortage, that we don't have a 100 percent coverage in kids, so it's typical for a vaccine program to be off to this kind of a start and we do still have vaccine available for children. So there is not really any reason why people in this group should not be covered.

We also have an article in the MMWR describing people's understanding of influenza and the need and success of prevention measures. 83 percent of people surveyed indicated that if they went to their doctor's office and were asked to wear a mask to protect someone else from their influenza-like illness, they would be willing to do it.

So the fact that people are accepting of a simple infection control measure that could protect others in clinician waiting rooms, and so forth, is I think a sign that people understand how flu is transmitted and are willing to take steps to protect others.

About 70 percent of adults believe that flu vaccine is effective and that's also a very important part of the decision to seek vaccine or to receive vaccine.

And as always, CDC is very intent on advocating universal respiratory hygiene, or the kinds of common sense precautions necessary to keep flu droplets from being spread from one person to another in close quarters. That's why we recommended the kinds of protection measures that reduce that opportunity and also especially why we're still recommending that when people have a flu-like illness they not go to work, and they don't send their kids to school or day care if they can avoid it, because keeping your droplets to yourself is a very good way to prevent the transmission of flu.

All right. Included in this same MMWR is some information about ongoing challenges. We have some good news but we also have some not so good news.

One of those pieces of information pertains to the fact that we still have many adults who have not received the flu vaccine. Overall in those priority groups in our country, about 34 percent of people have been vaccinated and that coverage is lower than we would have seen at mid flu season last year.

So we are seeing the impact of the shortage. But, interestingly, about 50 percent of people in high-risk groups have not gone out to get vaccinated. They're stepping aside and that is not what we want them to be doing.

We want people in the high priority groups to seek vaccine because we still have doses and there's still time to be vaccinated.

Flu has not yet arrived everywhere in the country and so there is an opportunity for protection even in December and January and people should not be afraid to go out there and ask clinicians or ask their health officials where they can get the vaccine.

And this really does speak to some misunderstandings that people have about flu. First of all, many people believe that no vaccine is available, and as we've described, that's just simply not the case.

Some people in high priority groups have not recognized that they are eligible to receive vaccine. So just as a reminder, anyone who's 65 years of age, and older, is eligible and encouraged to receive immunization. Anyone with a chronic medical condition, including diabetes or sickle cell disease, is encouraged to get vaccinated against influenza and health care workers who have direct patient contact are also encouraged to get vaccination.

So keep trying and be persistent. We'll do everything we can to get doses to you.

I also want to thank the people who stepped aside to make those doses available for the high-priority people. We've had millions of public health heroes this year and we really do appreciate their willingness to let others go first.

We also know that there are geographic differences in vaccine coverage. On this map, the darkest states which are these states right here, Michigan, that's Wisconsin--sorry, Secretary Thompson--Wisconsin, South Dakota, Nebraska and Wyoming are states that have the best coverage for immunization, and so we are impressed that they've been able to receive 50 percent or better coverage of the high- priority population.

Likewise the lightest states here, not Nevada and New Mexico, cause we don't have data from those states, but the other light blue states are states where vaccine coverage is very low, and so we've been inquiring to understand why is coverage low in these regions of the country.

One reason is that many of these states were purchasers of Chiron vaccine and so they got off to a late start because they couldn't really initiate their immunization program until the Aventis vaccine became available to them.

These are also states that have a large number of people over 65 years of age, and we have recognized that some people mistakenly believe that influenza vaccine causes the flu. There's absolutely no information to even suggest that could be the case. Based on the kind of vaccine production and experience we've had, we know that flu vaccine does not cause flu; at least injectable flu vaccine does not cause flu. But there's a disproportionate number of people in the old age groups who are afraid that it does. And so where states have large numbers of elderly people, there is a disproportionate reluctance to get vaccine because of fears of the vaccine itself. And so I'm trying to send a very strong message today that flu vaccine does not cause flu, and if you are 65 or older, please get the flu shot. Please ask your clinician or your health officials where you can find the flu shot in your jurisdiction, because it can protect you and it's not too late to receive your immunization.

We also know that some states have a surplus of vaccine in the hands of some private providers who ordered vaccine, had it on hand, and really haven't had the demand for it that they expected. So we know that if people in those areas ask clinicians for vaccine, they ought to be able to get it. We know that some states have made the decision to expand immunization beyond the high-priority groups so that those doses don't go to waste. But we're asking providers who have large numbers of doses to please make it available to state health officials so they can redistribute it to states that do have deficiencies or haven't yet vaccinated people to meet their demand.

So our goal is just common sense. Let's use the vaccine for the high-priority people, but if we have extra doses in small volumes that can't be used, let's vaccinate the next group of people, which would include people age 50 and older who last year we did recommend immunization for, health care workers, household contacts and so forth. But we want to make what we have go as far as possible, so anybody who can return their vaccine to state health officials and have it be reallocated to others, we're definitely from a CDC perspective encouraging that.

So let me stop at this point with just one final message, and I'll say it over and over again: Flu is unpredictable. It's not too late to be vaccinated. There still is flu vaccine. So if you're in a priority group and you haven't got your shot, don't give up. Please check with your clinician or check with your health officials to find out where you can get it. And we're doing everything we can to meet that demand as quickly as possible.

Thank you.

Let me start with a question from the telephone, please.

OPERATOR: Thank you, Dr. Gerberding. Your first question comes from Maggie Fox with Reuters. You may ask your question.

QUESTIONER: Hi, Dr. Gerberding. I have to ask about this report that money for the low-income children's vaccination program is being reallocated to the flu vaccination program.

DR. GERBERDING: First of all, the allegation that we would somehow subtract from childhood immunization to support adult immunization is ridiculous. CDC has a $7 billion budget; $1 billion--more than $1 billion of that $7 billion goes to support childhood vaccination programs. This is an overall agency priority, and we would never do anything to jeopardize the program to vaccinate children.

In addition, the money that was used to purchase the 1.2 million doses of vaccine did originally come out of the 317 budget line because that was the only budget line available to us. At the time that the Secretary negotiated the contract, the President hadn't yet signed the FY05 budget. So it was a fast way for us to negotiate a purchase. Speed is very important under these circumstances, and we wanted to take the appropriate steps to get the contract negotiated.

It's also important to recognize that the 317 money or the source of this purchase is money that is available to states on a calendar-year basis. As of today, there are actually $14 million still in the 317 fund account that are available to states. If they don't make $14 million worth of orders in the next two weeks, that money will go unused. And so we actually have unused dollars that can help offset this expense.

In addition, we have $17 million in our other fund for vaccines, the Vaccines for Children fund, so that we have actually a total of $30 million FY04 dollars that can be used to make purchases of vaccine, and that is, of course, where we're going first to purchase the vaccine.

If it turns out that we have a need for these '04 dollars for children's immunization, then we can renegotiate our decision about what fund line the money came from, and we will not do anything that would in any way jeopardize the immunization of any children in this country. That is an overarching principle at CDC, and I know the Secretary is fully on board with that, and we will do everything we can to get the same very high rates of immunization for kids next year that we achieved last year.

Next question, please, from the phone.

OPERATOR: Thank you. Daniel Yee with The Associated Press. Your line is now open.

QUESTIONER: Thanks for doing this. I was wondering, I understand the ACIP is going to discuss the flu shot prioritization issue tomorrow. Do you think there should be a recommendation--do you think the previous recommendation should be modified to allow more people, even those in non-high-risk groups, to get their flu shot? And I was just wondering how great nationally is the access in the flu shot supply, the surplus.

DR. GERBERDING: The ACIP is planning to meet tomorrow. They will look at the evidence and the information that we've been able to collect from the states, and they'll make a decision about whether there should be a change in the recommendation about prioritization of the vaccine. So I'm not going to second-guess their decision. That's why we have a board of advisors to really help us make those kinds of decisions in an evidence-based way.

And in terms of the actual number of doses of excess vaccine, keep in mind that "excess" is a relative term. We have no excess vaccine, but we do have places where private providers have not been able to utilize the supply they ordered to meet the demands of their patient population. The first step is to make sure that everyone has reached out to try to get to the high-priority patients, and then if there are doses that can't conveniently or safely be reallocated to other places in the state or to other states, we will be working with state health officials to do that. And at this point in time, I can't tell you exactly how many doses that is because we're hoping that we'll be able to increase demand through some of the information that we're putting out today.

I'll take a question from the room.

QUESTIONER: Do you know how many states have a surplus--if that's the right word?

DR. GERBERDING: Well, what we do know is that 82 percent of states say they have a sufficient supply, and we have a handful of states who feel that they may have extra. But most states are not declaring that quite yet because they know that the demand could change. For example, if a state suddenly has widespread influenza activity, their demand could go up. So I think they're being a little bit cautious about asserting a surplus until they see how this all plays out.

A few states have indicated that they have surplus and they are broadening their recommendations, and that's a common-sense approach. They've all been cooperative with allowing us to redistribute whatever publicly available vaccine is not being utilized.

So it is, again, just an example of how the communication and collaboration across the states and local health agencies has been successful in helping us solve a problem, and I just can't thank these health officials enough. Once again, they're at the front line of the effort, and they have just really stepped up to the plate here and made some hard decisions and have really created a capacity that we weren't confident we would be able to achieve when we got started.

So is it perfect? No. Do we wish we had more vaccine? Absolutely. But in the meantime, we are very pleased with the targeting efforts, and that's not something we did from CDC. That's something that happened in clinicians' offices and in health agencies around our country.

I'll take another telephone question, please.

MODERATOR: Thank you. Seth Borenstein with Knight Ridder, your line is now open.

QUESTION: Thank you, Dr. Gerberding, for doing this. If 82 percent of the states have enough to meet demand, that means eight states do not. Can you name those eight states for us, and can you also provide or tell us where to get the percentages, state by state, that you have in the map, I mean, in other words, the percentages by those lovely colors, behind those lovely colors, so we could check out our states to see what their percentage is.

And what is the number, I guess for readers, if you're below 30 percent, that's where you have everything to be--you know, that's those white states.

What percentage do you start to worry about when the vaccination rate for at-risk hits below that threshold?

DR. GERBERDING: Let me refer you to today's MMWR for some of the detailed information that you're asking for. This map is reproduced in that MMWR and some of the background information that contributed to those states.

If you have specific questions about a given state, the best resource for that information is the state health officials, so I would encourage you to make contact there.

From a CDC perspective, we will never be satisfied until we have received a 100 percent vaccination coverage of the people who are at risk for flu vaccine. So it's very difficult to grade. Anywhere between no coverage and a 100 percent coverage is where we're worried, or where we're satisfied.

I think we're satisfied that our targeting efforts have been successful so far. We're not giving up on that and we will use every dose of vaccine that we have at our disposal in the most effective way that we can.

The gap between needs based on number of priority people, demand based on the number of people seeking vaccine, flu activity which is always unpredictable is a gap that's going to change on a day-to-day basis, and we will do everything we can to try to fill it.

I can take another question from here in the room.

MODERATOR: Harry Chandler [ph] with WXIA TV, also representing NBC News.

QUESTION: Would you mind commenting, just locally, for the state of Georgia, and for also the metropolitan area, how things are looking here?

DR. GERBERDING: I again would have to refer you to the state health officials and the city health officials because even though we're in Georgia, we are a federal agency and we don't step on the toes of our partners in state and local health departments.

I'll take another telephone question.

MODERATOR: Thank you. Anita Manning with USA Today, your line is now open.

QUESTION: Hi, Dr. Gerberding. Regarding the 1.2 million doses of GlaxoSmithKline vaccine, did I understand you to say that's going into a stockpile and not going to be distributed immediately?

And the other part of that question is could you--it's being referred to as an experimental vaccine and I'm wondering if you could explain that, if it's truly an experimental vaccine.

DR. GERBERDING: The investigational new drug status, or IND status, of this vaccine is based on the fact that although it's been licensed and seems safe in Europe, it hasn't gone through the FDA licensure process in the United States and therefore we can't claim it as a fully licensed vaccine.

The 1.2 million doses are not being sent out to states yet, although we're interested in hearing from those states that feel they need this vaccine, or for other sources that need this vaccine, so that we can develop the distribution plan accordingly, and it's not technically correct to say it's in a stockpile. We're just simply counting on using the licensed Aventis vaccine first, and if we still have unmet jurisdictional needs after that vaccine is distributed and utilized, then we have this additional resource available to us.

We're just taking a little bit of time because the vaccine does require a consent form, and so we want to make sure that we've gotten a fair and equitable and understandable mechanism in place. We have approvals that we've obtained to be able to do this safely.

But it's a challenge to deliver this many doses of investigational vaccine across a wide number of jurisdictions and we are using this time to make sure we get that right.

So as soon as we have a plan and we begin utilizing it, we'll give you an update on the status and the mechanism.

There's one point of clarification that I wanted to emphasize. It pertains, again, to the financing of the IND vaccine, and that is when we use 317 funds to purchase vaccine, we are allowed to be reimbursed for the purchase.

So CMS, the Centers for Medicare and Medicaid Services, have, in an unprecedented way, agreed to pay CDC back for the doses of vaccine that we utilize for Medicare-eligible people, and that's most of the people who are receiving vaccine this year.

So it is a way to offset that cost of the vaccine by the payment back into the fund that CMS is making on behalf of our seniors, and I think that's another reason why we use 317 money, because some of our other ways of purchasing do not allow for that reimbursement to occur.

I'll take another telephone question, please.

MODERATOR: Thank you. John Lauerman with Bloomberg News, your line is now open.

QUESTION: Hi. Thanks for taking my question. Dr. Gerberding, what is the plan in terms of the other 2.8 doses of Glaxo vaccine that have been cleared? That's the first question.

And the second question is, Do you have any plans to do anything to boost vaccine consumption besides, you know, some of the media outreach that you've done already, like this? Would there be anything that would go direct to patients, et cetera?

DR. GERBERDING: The 2.8 million additional doses of vaccine is available for purchase. Secretary Thompson has negotiated the opportunity for us to expand our purchase, if we feel that we need that vaccine.

Right now, we're still in the assessment phase to try to understand who does need or want the investigational vaccine, and we'll base our decision on whether we need more of it from the input and perspective that we're getting from our primary customers in the state health departments.

So it's available. If it turns out we need it, it's there. If we don't need it, we won't purchase it and we'll go from there next year.

Outreach to try to encourage immunization of high priority people is ongoing. We recognize that there is a difference in the need for that kind of outreach on a state-by-state and a community-by-community and a population-by-population basis.

So, again, we're really working closely with health officials in various jurisdictions, to ask them what do you need from us, how can we help, and how can we augment your ongoing efforts in your facility or in your community, to target the people who need vaccine the most.

And we are especially working from a CDC level on targeting vaccine to people in underserved populations, or people in minority populations who traditionally have experienced the greatest disparity in access to vaccine.

I should also mention that the statistic that we are talking about in the MMWR, reporting on the targeting, do not include people institutionalized in long-term care facilities, and we have independent information from long-term care facilities that we were able to target supplies of vaccine to those locations, but we will have to conduct an independent assessment of how well that coverage met their needs through other mechanisms.

These data reported here are based on landline telephone surveys and other mechanisms that would not typically reach people in nursing homes.

So we're still getting information and as we learn more about coverage and where the gaps are, we'll let you know.

I think I can take another telephone question.

MODERATOR: Thank you. Maryn McKenna with the Atlanta Journal-Constitution, your line is now open.

QUESTION: Hi. Thanks for doing this. As you said at the start of your remarks, 1.2 million doses of GlaxoSmithKline vaccine already purchased and 2.6 million still coming from Aventis.

At the same time 82 percent of the states saying that there is, they have sufficient amounts of vaccine and certain states already relaxing their restrictions on who may receive the vaccine.

If the flu season doesn't get any worse, the possibility exists that the rest of that vaccine that's still coming won't be used any more than doses currently sent to states have been used.

Are you content with the possibility that the government may have done this buy of almost 4 million doses of vaccine to have on the shelf and potentially to be thrown away?

DR. GERBERDING: I'm actually proud that the government was able to negotiate this purchase. This is very difficult to do. Best case scenario is that we don't need it and it does represent an investment that we didn't need to use. That's always the case with just-in-case scenarios and purchases where you can never get a perfect match between what we need. But we made a decision and the Secretary acted on that decision that it was better to have extra vaccine on hand than to run with an additional shortage and not feel like we had done everything we could to address the shortage.

So we hope that we have a perfect match between the demand and the supply, but if we have extra, if we don't use this IND vaccine, I'm not going to be ashamed about that. I think we made a prudent decision to have it available. And if a worst-case scenario occurs and we have a dramatic uptick in the influenza late in the season, then we've got some extra doses there that we can utilize to protect the people who need it the most.

So it's difficult to get the balance right, but we feel like this was a prudent decision, and that's why we didn't buy all of it, because we weren't sure how much we would need, and we have that option to exercise later in time.

I think I'll take two more questions. If there's a question in the room, I'm happy to do that. Otherwise, I'll take another phone question.

QUESTIONER: You talked about this a little bit already, but what your message to people that might have avoided going for the vaccine because of the long lines and the widespread coverage of that? What would you say to them now that maybe now that they're eligible for that?

DR. GERBERDING: Yes, thank you. I think that early in the season when there were long lines, people did get discouraged, and it's no fun to have to stand in line and be uncomfortable while waiting to get a flu shot. Our message is that there's still vaccine available and people who are at risk should first check with their clinician or check with their local newspaper to find out where vaccine supplies are and then reach out and try to get it. Be persistent. And I don't anticipate anyone will be standing in line at this point in time, but they can access vaccine if they make the right connection with their clinician. And CDC has a hotline, 1-800-CDC-INFO, that's available. If people are seeking vaccine and can't find it, we can help refer people back to their local resources and get the information they need to try to find the vaccine.

One last question from the phone, please.

OPERATOR: Thank you. Richard Knox of National Public Radio, your line is now open.

QUESTIONER: Yes, thank you. As you know, the British regulators have extended the suspension of Chiron's license to possibly April, early April, and the GlaxoSmithKline vaccine may or may not achieve licensure in the United States by next spring. Are you beginning to think about, plan for, anticipate a shortage of vaccine for next season?

DR. GERBERDING: Well, we have been thinking about next season long before today. We were thinking about next season back in August when the Chiron delay was first announced, and certainly on October 5th, we recognized that our strategic outlook had to take into consideration the possibility that there could be no Chiron vaccine next year and that we needed to take the steps now to augment whatever suppliers we have and to speed up the process of modernizing the vaccine, which, of course, is not going to help us in the short run, but it is an important part of the long-term solution.

It's too soon to say when Chiron will be able to initiate vaccine production. I do know that the Food and Drug Administration as well as the regulatory agencies in the United Kingdom are working very hard with Chiron to make sure that there's a clear understanding of what needs to be done and that they have the full support of our regulators in taking the steps necessary to come back online. It's in everyone's best interest to do this, but as you know, we put the highest priority on safety, and we don't want vaccine out of anybody's manufacturing process if we can't warrant its safety.

So if worst case happens and we don't have the Chiron vaccine, we'll be working with the other international suppliers to try to get licensure of their product. We'll be working with domestic suppliers to see what, if anything, we as a government can do to scale up their production. And we'll be planning on our immunization programs to take under consideration whatever contingencies are necessary to meet the demands of the high-priority populations.

So it's a work in progress. We're confident that we have full cooperation of all the involved parties, and we'll do the very, very best we can to get that 100-percent coverage that we all aspire to

Thank you again and have a happy holiday.

OPERATOR: Thank you. That does conclude today's conference call. You may disconnect at this time.

[Whereupon, the conference call was concluded.]

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