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Telebriefing Transcript
CDC Announces New Strategies to Promote
Continued Influenza Vaccination

January 27, 2005

DR. GERBERDING: Thank you for taking part in today's telebriefing. What we're going to do today is update you on the current influenza season and then describe some additional strategies that CDC is taking to help clinicians to continue to vaccinate people against influenza.

I'm joined here today by Dr. Jeanne Santoli, from our National Immunization Program, who has really been working nonstop throughout the flu season with our partners across the public health system and the manufacturing arms of the nation to really do everything possible to make the best use of the limited supply of vaccine we've had this year.

The big perspective here is that the flu season is not over. It may not even have peaked. We know that February is the most common peak season, but we often see through well into March. So we are concerned that we still have a large number of unvaccinated people who are at high risk for flu complications. What we're really dealing with is a national shortage of vaccine, a supply and demand mismatch at the local level.

We know flu is unpredictable. We've learned that flu vaccine supply is unpredictable, and what we're discovering now, of course, is that the demand for a flu vaccine is also very unpredictable, and it's varying from group to group and area of the country to area of the country.

So CDC's broad goal in all of this is to try to make the best use of the vaccine doses that we have, and that means encouraging immunization of people who need it, and it also means using some common sense and not letting vaccine go to waste in areas where the supply is ample or even in excess.

The new steps that we're taking today include measures to help make good use of the supply, as well as measures to encourage immunization of those who need or want to be vaccinated.

The first thing we're doing is, of course, emphasizing our support for local and state jurisdictions who are broadening the availability of flu vaccine to people who are not in the previously recognized priority groups. So, if a local area has vaccine and can't redistribute it, it certainly makes sense that they open up the vaccination to anyone in that jurisdiction who would like to be vaccinated.

The second major change that we're making today is to take advantage of the CDC vaccine stockpile. What we're doing with our stockpile is that we're loaning it to the manufacturer, formerly known as Aventis Pasteur, who is now known as Sanofi-Pasteur, and allowing the manufacturer to market that vaccine to providers. And the wonderful advantage to the providers of this approach is that the manufacturer will provide a return on any vaccine that's not used. So, in other words, if a clinician orders some vaccine and doesn't use it, they can return it to the manufacturer, and they will get a refund of their investment. So this really eliminates any risk to providers who are reaching out to get doses of vaccine for local use, and we have about 3.1 million doses of vaccine that are available through this new program.

The third step that we're taking today is to allow the vaccine that governmental agencies currently have under the Vaccines for Children program to expand the use of that vaccine to anyone who needs to be vaccinated in their jurisdiction. Most jurisdictions have actually met the demand for vaccination of children, but we wanted them to be able to use this vaccine supply for broader populations if that would be helpful to improving the overall coverage in their community.

So these steps are designed to help us make the very best use of the vaccine supply we have. We're still encouraging people, especially those in priority groups, not to give up, to contact local health officials or their provider, and we're also working with professional organizations to encourage providers who have patients with unmet needs to have those providers contact the manufacturer and request doses of vaccine, especially since now there's no financial risk to them.

I think it's also important to emphasize that these are extraordinary measures that are being taken during the year of unprecedented supply-demand mismatches, and we are very grateful to the people who stepped aside and allowed us to concentrate on high-priority people early in the season. We're also extremely grateful to the public health officials at all levels in this government who have really done everything they can to make our vaccine supply go as far as possible.

And, of course, we're very grateful to the manufacturers who have cooperated in unprecedented ways--the private sector, public sector enterprise here has been fantastic--and also to all of the providers who have been worried about their patients and have really tried, to the extent possible, to cooperate with the program and get people vaccinated.

These measures that we're taking this year are really one-time measures. We are certainly not setting a precedent here, but we think this is a strategy that will allow us to continue to vaccinate people and not let our precious vaccine supply go to waste.

So let me take some questions.

OPERATOR: Thank you. Our first question is coming from Charles Seabrook of the Atlanta Journal- Constitution. Your line is open, sir.

QUESTIONER: Thank you.

Dr. Gerberding, I know, of course, you're still trying to get through this flu season, but anything from this that tells you about looking ahead to next year?

DR. GERBERDING: Well, we know that the flu vaccine supply is unpredictable, and we are still uncertain about the status of Chiron's production capabilities. So we are engaged right now in some contingency planning.

The Advisory Committee on Immunization Practices is meeting as we speak to consider prioritization and subprioritization schemes if we have an unusual shortage next year. But in addition, the Department of Health and Human Services, the CDC, the NIH, the FDA, we're all working collaboratively to try to maximize the available vaccine supply, and we're doing that by working with Sanofi-Pasteur to encourage the safest and largest production capability there, but also with international sources of vaccine.

I should also say that governments are working very hard with Chiron. The regulators are working to do everything possible to bring their capability on board, but we have to be prepared for a supply that does not meet our need for optimal immunization coverage. And, again, we'll be in a situation where we would be making the best use of the vaccine that we have available.

OPERATOR: Thank you. And our next question is coming from Miriam Falco with CNN.

QUESTIONER: Hi, Dr. Gerberding. Do we know how many vaccine doses are still unused? And why not, you emphasized that certain local jurisdictions can open up the vaccine program to anyone. Why not make that nationwide the call if the folks aren't going to get the vaccine? And, finally, how long will you continue to run the Thank You PSAs encouraging people to wait?

DR. GERBERDING: Let me try to get to each of your questions, and thank you.

The reason why we are not just opening this up nationally is because the mismatch between supply and demand is very much a local issue. We have local jurisdictions and even local practices who have more vaccine than they can use, and then they have areas where they are still looking for vaccine. So we have to try to accommodate, to the best extent possible, both of these circumstances. And the people who really know best how to manage their local situation is the local health agency.

The total number of doses that are in the hands of clinics and providers right now is relatively small. In the CDC stockpile, we have 3.1 million doses available, and we think there are approximately 1.3 million doses of the Vaccines for Children, a vaccine that is out in the state and local health departments, and that is the vaccine that we will be freeing up for broader use.

So the short answer is somewhere around 4.4 million doses of vaccine that we're making available today through these expansions in our program.

In terms of the PSAs, they will be coming off-line.

OPERATOR: Thank you. And our next question is coming from John Lauerman of Bloomberg News. Your line is open, sir.

QUESTIONER: Hi. Thanks for taking my question.

I was wondering if you could just be very specific about what this situation is in terms of loaning the vaccine to Sanofi. Does that mean that they can sell the shots? Presumably, these are shots that they already sold to you. Will they be able to sell them? At what price will they be selling them? If you could just clarify that a little bit.

DR. GERBERDING: Sure. And I'm going to maybe ask Dr.Santoli to provide some of the specific details, but our authorization and our funding allows us to utilize our stockpile contract so that the manufacturer can distribute vaccine and pay us for what they use. So this is something that is part of the authorization that CDC received when it developed the stockpile. We want, of course, this year to not have that stockpile go unused.

And this is a way that allows us to effectively take advantage of the manufacturer’s capabilities of distributing vaccine and an ordering system that already exists for providers and a lot of the infrastructure necessary to move vaccine out to providers is not something that CDC has, but it is certainly something that the manufacturer can provide. So it's a permissible legal mechanism to allow the manufacturer to basically distribute our vaccine for us.

OPERATOR: Thank you. Our next one is coming from Mary Carey of the Congressional Quarterly. Your line is open, ma'am.

QUESTIONER: Thank you. I just want to make sure I understand. So are you saying, basically, anyone who wants a flu shot now can go get one?

DR. GERBERDING: We're not saying that because keep in mind there are two situations here. One is overall a national shortage of flu vaccine, but at the same time, in local jurisdictions, some have more than they need and some don't have enough. And so we are not encouraging everyone who wants a flu shot to go out and get it. We're encouraging people, particularly those in the priority groups, to continue to check with their provider and their local health official to determine where they may be able to get vaccine in their community. But, really, if the local health officials feel that they have enough vaccine to open it up to the public in that jurisdiction, they'll do so. The demand for vaccine right now is very low, and so we're concerned, of course, first and foremost, that the people who are at risk for serious flu complications still try to get vaccinated and that their providers encourage vaccination. That's why this provider program through Sanofi-Pasteur is such a valuable additional tool to help us.

Next question, please.

OPERATOR: Thank you. Our next one is coming from Anne Wlazelek from the Morning Call.

QUESTIONER: Hi, Dr. Gerberding. Thank you so much. I'm wondering if you have any handle on what percentage of the population at risk who is recommended to get this shot has been vaccinated or has not been vaccinated.

DR. GERBERDING: We've been making some assessments of vaccine coverage in various groups as we've gone through the flu season this year. And we can refer you to estimates from last month that were published in our MMWR, and we will be updating those estimates next week. But, basically, the bottom line is that our high-priority groups are undervaccinated compared to what we achieved the same time last year.

OPERATOR: Thank you. Our next one is coming from Maggie Fox of Reuters. One moment. Your line is open, ma'am.

QUESTIONER: Hi, Dr. Gerberding. Thanks.

I wanted to ask you about what kind of good are you doing for yourself for next year if you get vaccinated this year? I know the formula changes every year, but you can take a gamble that it's not going to change, as it did last year, more than one strain.

If people go ahead and get vaccinated even late in the season, are they giving themselves a little bit of extra protection for next year?

DR. GERBERDING: It's really hard to answer the question because flu is so unpredictable and we just simply don't know what strains are going to be the important strains or whether there would be any cross-protection from this year's vaccine. So I would hesitate to speculate from a forward-looking perspective, but immunity through the vaccine also doesn't remain high for long periods of time. There is some waning of immunity fairly quickly, so the best time to get vaccinated for flu is right before the flu season starts.

Next question, please.

OPERATOR: Thank you. Our next one is coming from Judith Rusk from Infectious Disease in Children.

QUESTIONER: Hi. Thank you, Dr. Gerberding and Dr. Santoli. I was just wondering--I had a couple questions. First of all, is this a judgment call for local physicians in their offices, or are there guidelines to help them decide if they can open this up to more of their patients? Second, could you give us an update on the current situation? And third, the GSK vaccine that was brought in I think under an IND earlier in the season, could that possibly be approved in time for next season?

DR. GERBERDING: The person who has the authority to make decisions about policy for immunization is really the state or the local health official, depending on the state jurisdictional arrangement. So we're recommending that providers really get the advice of the local health agency to really determine what is the best policy for their jurisdiction.

I also think that physicians are the ones who know their patients the best, and we really always want to defer to physician judgment in making decisions. I'm a doctor, and I feel very strongly that when it's my patient I'm probably the person who has the best ability to determine whether the patient can benefit from the vaccine. So that's certainly a matter between physicians and their patients.

Your question about Chiron, I think I've said everything I can really say about what is known of the situation right now. All of the involved parties are working aggressively to support Chiron's ability to bring its vaccine production back on-line. The company has acknowledged some uncertainty in their ability to do that, although they're certainly aiming in that direction, and we are cautiously hopeful that they'll be able to be successful, but we can't count on it, and we need to be prepared for the possibility that they may not be able to come back on-line, and if they don't come--if they do come back on-line, I believe the current projections are that they would not have the production capability that they were expected to have this year. So in either case we will have to make some adjustments in our assessment of what Chiron will be able to produce.

Your third point about the IND vaccine, we have already purchased as a backup, in case the flu (activity) got much worse or evolved more quickly this year, the IND vaccine from GlaxoSmithKline. About 1.24 million doses of that have already been purchased, and we are certainly talking to other manufacturers. We look upon this IND vaccine as an insurance policy for us. If we got into trouble we would have it available, but also it's helping us interact with some of the international vaccine producers in constructive ways that might allow us to more easily access vaccine from these resources in the future, and I think that's very, very important.

Everyone agrees that we need a broader market for flu vaccine, and by engaging now, we're setting the stage for being able to scale up or speed up our ability to make bona fide purchases and get the vaccine license.

Next question, please.

OPERATOR: It is from Betsy McKay, Wall Street Journal. Your line is open.

QUESTIONER: Hi. Thank you, Dr. Gerberding. You may have answered this already, but can you tell us how many vaccine doses have been administered so far this year? And secondly, just following up on what you just said, what you were just talking about, if Chiron is not able to produce at all or only part of a supply for next year, will you be able to buy doses from other manufacturers who are not currently licensed in the U.S. market?

DR. GERBERDING: We don't have exact information about doses of vaccine that are actually administered. We have reliable information about vaccine sales. So we are estimating, based on sales from formerly Aventis Pasteur, now Sanofi Pasteur and MedImmune, who is the manufacturer of FluMist, who by the way, is also anticipating increasing their capability next year.

We are estimating somewhere around 57 or 58 million doses of vaccine have been purchased, and hopefully the majority of that has been used this year. But we won't really know the answer about vaccine coverage until we have a chance to do the kind of retrospective assessment long after this year's season has passed.

The international issue about being able to get licensed vaccine internationally is one that obviously is a high priority. I'm not going to speculate about the timing of the licensure in the United States because I think the FDA is working on this with GlaxoSmithKline and perhaps other manufacturers, but we are unable to say whether or not the product can be licensed in time for next year's flu season at this point.

OPERATOR: Our next question is coming from Anita Manning, USA Today.

QUESTIONER: Thank you very much, Dr. Gerberding. Can you tell us when doctors or hospitals are likely to start to place orders for next flu season, or when they normally would? And what does the CDC advise in this uncertainty? And then the second part of that question is, do you think that this experience has changed forever the way flu vaccine will be distributed? I'm just wondering if doctors are going to start to say, "I'm going to let the Wal-Marts and the public health department deal with it rather than the providers themselves." Thank you.

DR. GERBERDING: These are big strategic questions that the Department of Health and Human Services is engaging in right now, and also working with Congress and working with the administration to really try to establish a more effective long-term solution to the problem, as well as the flexibilities that we may need to provide the mid-term and near-term protection that people really need.

Ordering for next year's vaccine, as I understand it, has been temporarily delayed because of the planning for how to start the season and what the other vaccine company will be able to provide. It's just still uncertain. So right now orders for next year to Sanofi Pasteur are not yet being processed.

And I think what we really need to be prepared for is that as we learn more about the benefits of flu vaccine, we are likely to expand the indications for using the vaccine, and we simply have to come up with some more robust manufacturing process. We need a supply that is reliable. And we need to stabilize the demand for vaccine by creating new mechanisms and new programs to administer vaccine to adults.

I think most of the folks on the phone recognize that we have a very robust immunization program for children in this country, but we don't have a bona fide comprehensive adult immunization program, and that's one of the questions on the table by CDC and by other experts, is what really would be the best way to optimize delivery of flu vaccine every year so that we stabilize demand and got the kinds of coverage levels that we are really hoping to achieve.

Having said that, it's been wonderful this year the kind of cooperation we've had from CMS and from other sister agencies in the Department, certainly the private sector, the trade associations, supporting nursing homes, the Visiting Nurses Association, and so forth. These agencies really have done an excellent job of accelerating access to vaccine among millions of seniors, and that has been something that I think we've learned from. We would like to be able to implement that kind of program every year.

OPERATOR: Thank you. Our next one is coming from Richard Knox, the National Public Radio.

QUESTIONER: Yes, thank you very much. I may have missed something, but just to be clear, the vaccine loan program by which the manufacturer takes on responsibility for distribution, who has financial risk for unused vaccine? Would that be the government rather than the manufacturer?

And secondly, is there a date by which Chiron needs to say we can do it or we can't do it, or we can do so much of it? You know, is there some sort of a deadline that needs to be met?

DR. GERBERDING: The vaccine that is being loaned to the manufacturer is CDC's vaccine. We have already paid for it. So what we are doing is allowing it to be distributed through the manufacturer by loaning it to them, just as people would do if they were purchasing vaccine in the first place from the manufacturer. They will pay for it, but if they don't use it, they get their money back.

With respect to Chiron, we really can't predict at what point Chiron will or will not know its production capability. That's really something that's best addressed to Chiron.

I just can take one more question, please.

OPERATOR: Then our last question is coming from John Lauerman from Bloomberg News.

QUESTIONER: Yes. I was trying to just clear up, if you could--so Sanofi will be selling the shots, and if they sell a shot, they pay you; is that right? And if they--anything that they don't sell, they don't have to pay for it? Is that what the situation is?

DR. GERBERDING: Basically what will happen is that what is sold and used will be credited to the stockpile for next year. So we are sort of revolving this in a way that makes sense from the taxpayer dollars perspective, but still allows us the flexibility to get this vaccine out the door to people who need it this year. This is really a good business strategy to not let vaccine go to waste, but also to protect the stockpile and CDC's, the government's investment in the stockpile. So it's a win-win situation.

Thank you very much for your interest and for taking time to follow up on this important health issue.

Listen to the telebriefing

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This page last updated January 27, 2005

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