Influenza Vaccine Supply Update

Briefing on the Flu Season
Dr. Gerberding with Damian Braga, President,
Aventis Pasteur U.S.

Tuesday, October 12, 2004
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DR. GERBERDING: Secretary Tommy Thompson is conducting a border health event at the U.S.-Mexican border, so he's not able to be here today but he did want me to acknowledge that he is fully engaged in our evolving response to this year's flu crisis, and he also appreciates your taking time to participate in this press briefing.

This has been a very challenging week for all of us and we appreciate that those people who've been worried about flu, those people who are standing in line frustrated because they can't get flu vaccine, are the people who are angry about price gouging and the people who are perhaps confused about why they were asked to get a flu shot last year and this year there's not one available.

All of these people have had a challenging week along with us who are trying to solve the problem. We don't know yet how serious the flu epidemic is going to be this year, so there's always some uncertainty in flu, but we do know that we need to be prepared and we are taking a number of steps that follow on some of the advance planning that we've been doing all along, after last year's aggressive flu season, and certainly since we learned about the potential for Chiron's delays in delivery in August.

We also recognize that there are avian strains of flu still incubating in Western Asia and that creates some additional uncertainty that we have to be planning for as well.

But right now, we can work together to solve this problem, and there are a lot of steps that have been taken and several more than we're going to be taking in the next few weeks that we think will help.

The overall goal of this is to target the vaccine that we do have to the people who will get the most benefit from that vaccine, and to do it in a way that's fair and equitable to the greatest number of people across our country.

We've made some decisions about how to allocate the vaccine, that's probably not going to make everybody happy, but we think that this is the first step toward doing everything we can to protect Americans from flu this year.

So I really appreciate already the people who have stepped up to the plate and who are collaborating and cooperating with the updated ACIP/CDC guidelines about who should receive flu, and we have wonderful reports of grocery stores and pharmacies and clinicians and clinics and people all over our country who are really stepping aside to protect those doses for the people who need them most, and I really want to thank those people.

I also really thank our state and local health officers who have been working very late nights trying to assess the supply and demand of flu in their region and help plan at the very local level for how to meet the demands that are there.

They're the true heroes of public health and without their hard work, we wouldn't be as far along in the path as we are today.

I also very much appreciate my colleague here, Mr. Braga, from Aventis Pasteur U.S., as well as the leadership of Chiron, the manufacturers of the vaccine that we have available in the United States. Their cooperation and collaboration in helping to reallocate vaccine has been absolutely extraordinary and we are extremely grateful to everything that they've done.

What we've been working on for the past several days is to assess the 22.4 million doses of flu vaccine that have not yet been shipped from Aventis Pasteur to determine where were those doses of vaccine expected to go, where are the high priority populations of people where the need is the greatest, where are the gaps the greatest, and also working with Chiron to evaluate where their expected doses of vaccine were intended to go so that we can identify the priorities for Chiron and then reallocate some of the vaccine from Aventis to supply the people who were expecting to receive their vaccine from Chiron.

I think you can understand that this just represents a very major degree of collaboration and cooperation across corporate boundaries.

We have made some decisions about the first 14 million doses of vaccine. We have identified the doses that will be going to high-priority populations as they emerge from the production lines at Aventis. And as you know, this does not happen overnight. Vaccine comes out of the manufacturing facilities in Pennsylvania in an orderly manner, and so over this week we will be identifying, for the people who expect to receive an allocation, when they will receive it and how much they will receive by what date. But we are planning in this first phase of allocation to assure that high-risk children and the Vaccines for Children Program will receive vaccine because obviously they're a very high priority for us. We will also be providing to the pediatricians who have contracted with Aventis to get the supply as well as children in the Indian Health Service.

We also will be prioritizing the seniors over age--65 and older who have not yet been included in the vaccine catchment, so people in long-term facilities and the contracts with the Visiting Nurses Association and other opportunities to service those seniors are included in this first wave.

We also know that there are states in the public sector who have not yet received vaccine, so Aventis has already shipped vaccine--about 50 percent of the state vaccine to most states, and we're going to in this first allocation make sure that states that haven't received vaccine get at least 50 percent of their contracted allotment that they had negotiated with Chiron.

Over time, the states will be working at their updated projections of need because it's possible that their initial contracts were based on the assumption that there would be widely available vaccine and they have included people in their proposed vaccination who don't meet the qualifications for high priority. So there may be some downward adjustment at the state level in true need, and we want to allow for that flexibility, but not wait. So we're going to get that vaccine out to those states that are missing doses as quickly as we possibly can. That's obviously a very high priority.

We also recognize that the VA Medical Center is highly populated with people at very high risk for influenza, and so we will be prioritizing release to meet the demands of the Veterans Administration and, of course, force protection so the full amount of dose needed by the Department of Defense will be supplied.

Now, this leaves us with about eight million doses of vaccine that we have not yet allocated. Four and a half million doses will be in the CDC's stockpile, so we will utilize those doses as we identify high-priority gaps, and we'll have a great deal of flexibility to move that vaccine around in the way that best serves the people at highest risk.

We'll also be working with the state and local health officials that I mentioned to identify ongoing critical needs. And we will be working with the many private providers, both those who contracted with Chiron directly and those who contracted with Chiron and Aventis distributors to make sure that we are identifying the greatest number of people and the greatest needs in those groups for this next wave of vaccine.

So, in summary, what we're saying in this initial allocation is that we're going first to the people who need vaccine the most and where we can logically predict the greatest number of at-risk people. But we have allowed some flexibility so that we can readjust or change or re-evaluate the need for prioritization as we go forward. And we will continue to do this throughout the next several weeks, so we need to remember that this is a work in progress, and as new needs emerge or as people discover they have hopefully excess vaccine somewhere else, we have the best flexibility possible to, again, target vaccine to the people who need it the most.

Let me also say that this is not all we're doing. Vaccine certainly is the best way to prevent influenza, but there are other steps going on right now at CDC and throughout the department to try to assure that we have the best possible outcome from this very difficult flu season.

In particular, CDC is working aggressively to map out where flu is by county so that we will be able to detect, and perhaps even earlier than usual, areas where flu is emerging. We will also be making use of a new tool called BioSense, which is our system for taking in electronic information across our nation from over-the-counter drug prescriptions, from laboratory tests ordered, from the VA and Department of Defense medical facilities, and hopefully getting earlier warnings of places where flu activity is heating up so people can take extra steps to be prepared.

We also are mapping the delivery of vaccine doses to each county across the United States, and this is another example where I have to thank the state and local health offices who are reaching out in their communities to identify doses, but also Aventis and Chiron who have provided us information about intended distribution to the level of the county so that we can, for the first time ever, accurately know where the vaccine actually is or soon will be.

We're also mapping, again, with the help of health officials across our country, the people who need vaccine by county. So what we will end up with in a few days is a comprehensive picture, who needs it and where are they, where's the vaccine, and where's the disease so that we can use that information to help inform the allocation decisions in the next wave of vaccine release. We think this will help us get the best possible match between the doses we have and the need that people have for the product.

CDC also last December, with the help of Congress, had a $40 million appropriation to augment the stockpile. So we have four and a half million doses of flu vaccine in the stockpile that I've already mentioned. We also have a stock flu--a stockpile of Tamiflu, which is one drug used to treat influenza or to prevent it, and we are in the process of purchasing a second drug, Rimantadine, to also have in the stockpile. We are hoping to purchase up to five million treatment courses of that drug.

So when people can't get vaccine, if they're in a high-risk group and they need drug prophylaxis, we're trying to be sure we have a supply of that. We also will have these drugs available if we have illness that requires medical treatment and individual people in the medical sector can't provide the drug.

And finally, I do want to again thank people across the United States who are really, I think, health heroes on the front lines of stepping aside so those who need vaccine the most can get it. But also there are some things that people can do beyond stepping aside for a vaccine that can help protect them and their families. And we just keep emphasizing how important it is to stay home if you're sick. If you have a flu-like illness, if you have a fever, it really helps if you don't go to work or don't go to areas of crowding where you can easily spread flu to somebody else. This is a very transmissible disease, but these kinds of common-sense measures will help. Likewise, kids should stay home from school, and everyone should use the common-sense methods of hand hygiene and covering your mouth and nose when you sneeze or cough to protect others from your respiratory viruses, whatever they might be.

Also, as we move into flu season, people who are in the high-risk groups for complications, if they become ill or develop a fever or are suspicious that they have flu, they should seek early medical attention, because as I mentioned, there's treatment but that treatment is most useful if it's given within the first two days of symptoms.

So we'll be helping to put out more information to give that kind of guidance as flu emerges across our country.

So let me end that with just the final overview and that is that we recognize this is a tough challenge, we are going to do the best we can, we're sorry for the people who need flu vaccine and may not be able to get it this year, that's disappointing for all of us and we wish that wasn't the case, but we will take every step that we can take to get an equitable distribution of vaccine quickly as we can, and we appreciate everyone's help in pulling this together.

Thank you. I'll be happy to take some questions.

QUESTION: How does this happen, this huge market economy ends up with two suppliers, whereas in Japan [inaudible]? Would you explain how that works [inaudible]?

DR. GERBERDING: There have been many evaluations of why our vaccine manufacturing capability is becoming increasingly limited. One of the major reasons is that the manufacturers are leaving the market.

Obviously, if there was a profit to be made, they would be in the market. So there are factors that mitigate against their confidence that this is a good way. One of the issues is that making vaccines is very complicated. These are biologics and we use them for healthy people.

So the risks are very high. Any time you're offering something to someone who is a completely healthy person, the balance between risks and benefits looms large, and I think part of--

QUESTION: [inaudible].

DR. GERBERDING: But in this country it's especially true because of the way our system works, because of the regulatory environment, that sometimes puts a very high value on safety, and we have made it very clear, that what we want is not just affordable, effective, available vaccines, we want safe vaccines, and our government has made every effort to assure that the products we make are safe and that does impose some additional requirements on the manufacturing processing.

Yes?

QUESTION: [inaudible] when will we see some of this first allocation, and can you also update us on some of your other efforts to locate additional vaccine. I know Glaxo has made an offer of a half million doses.

DR. GERBERDING: Your first question in terms of the specific states, basically the states who were to receive their public sector vaccine from Chiron are on that list and we're in the process of notifying them as we speak, so I'd like to give them a little bit of time to get the "heads up" on this before we encourage people to be calling to find out whether they're going to get their vaccine.

And your second question was?

QUESTION: Other efforts [inaudible].

DR. GERBERDING: To find vaccine. As everyone knows, the Food and Drug Administration team is still in the United Kingdom looking there to see if there are any safe doses of vaccine that can be acquired from Chiron at this point in time, and the Secretary has contacted all of the major manufacturers of vaccine to determine if there are additional doses.

There are only two products licensed in the United States besides the nasal vaccine, and so it's not easy to get unlicensed vaccine into the country in time to solve any problems this year.

As I said, we put a high emphasis on safety, and therefore, the need for approval of the manufacturing processes of these plants, using the strict FDA criteria, is one thing that we have to address in order to move additional resources into this country.

But we're not ruling anything out and the Secretary is working with the FDA to explore every possibility.

Yes?

QUESTION: Dr. Gerberding, can you give us an idea of the mechanism for reprogramming these 14 million doses? Were they, were contracts canceled, and what authority is the CDC using to do that? Is it purely voluntary?

Also assuming that a lot of this is still going to be going through private channels, some of it anyway, what's being done to prevent price gouging? Are you watching for that?

QUESTION: Yeah. Let me ask my colleague, Mr. Braga, from Aventis, to answer that question.

MR. BRAGA: In terms of how the mechanism that we'll be using, we are working very closely with our colleagues from the CDC who are identifying the state requirements. They will be transmitting the state requirements for us and I would imagine that the next step would be for us to contact the states directly and understand the mechanism that they would like to use in order to get those doses to their state health departments.

And I'm sorry, I lost your follow-up.

QUESTION: Did you cancel contracts? I mean this-

MR. BRAGA: Did we actually cancel any contract? But as this has been a situation we've faced a number of years in a row, certainly we've been the most reliable supplier in the marketplace over the last few years, but we have had to step up to address market shortages in the past, and we've found that our customers, when presented with the information, are very encouraged to do the right thing and are very willing to take part in what we're trying to accomplish here.

You had one more?

QUESTION: I wanted to follow up quickly. I asked if, what's being done to monitor price gouging, and also Dr. Gerberding, have you spoken with ID Biomedical in Vancouver, which apparently has 100 million doses, maybe not licensed but are you making an effort to--

MR. BRAGA: Hundred? I think that's probably more like a million.

QUESTION: I beg your pardon. I wish it were a 100 million.

MR. BRAGA: Don't scare me. You want to handle that?

DR. GERBERDING: Sure. As I said it doesn't matter where the country is, if the product's not licensed, safety first, so we really have to go through the process of ascertaining whether the manufacturing practices meet the FDA standards and that's one of the things the Secretary has put a high priority on.

In terms of price gouging, I mean all I can say is thank you to all the people who are cooperating so beautifully with the recommendations and shame on the people who are price gouging. This is a reprehensible thing to be doing, I think an immoral thing in this context, and we are working with the state governments and hope to be able to tell you in the future that these people have been prosecuted to the full extent of the law. There's no room for this kind of behavior in an environment where we need to pull together as a country to protect our vulnerable populations.

The definition of price gouging and the management of it varies from state to state, so you need to refer back to the state where the reports are coming in to assess the legal of it and how it's handled and prosecuted. It's not the way same everywhere. It's not a federal issue. It is a state by state jurisdiction.

Back there.

QUESTION: First, many of the at-risk population that you cite are people under medical care or kids who go to the pediatrician routinely for their inoculations. But some of the people over 65 were counting on, let's say, the mere supermarket, or what have you, for the cheap inoculation without paying the cost of a medical visit.

What is your advice to these people? And I wonder also if Mr. Braga would comment on the earlier question: Is it really tougher to do business in the United States than in Europe where you do business?

DR. GERBERDING: Let me first say that we have been scanning the grocery stores and the pharmacies and the large vendors of vaccine for seniors and one thing they almost all have is a Web site where you can put in your zip code and figure out where the nearest dose is.

So they're trying to, you know, make things a little more convenient and letting people know where the vaccine is and where it isn't.

But the advice to seniors is basically go where you would normally go or call where you would normally receive your vaccine, and if it's not there to contact your clinician.

We are working with local health officials who, as I said, we're mapping right now where the vaccine supply is, and once we have a better handle on the gaps, who has it, who doesn't, our local and state health officials will be helping provide local information about where people can go if they're having trouble.

So we say be patient but also be persistent because it will take some time and, you know, it's not easy, and we're very sorry for the inconvenience but it is going to be more difficult this year for some people than it's been in the past.

Let me ask you to respond to the question about manufacturing challenges.

MR. BRAGA: Yeah. Obviously I can only speak for myself or our company on this one, but as the global leader in flu production, flu manufacturing, with roughly 50 percent of the doses produced, you know, the flu business--Dr. Gerberding was correct--manufacturing vaccines is difficult, can be very complex, but from our perspective in the U.S. market, as we produce vaccine in Swiftwater, Pennsylvania, we produce about 50--this year 55.4 exactly--we have almost doubled that capacity over the last five years.

So for us, you know, I think this is an important mark for us, this is an important business for us, and this is an important health need that we fulfill.

I think the question that you would ask to a new entrant into the market might be a little bit more complex in terms of the investment, the lead times for a facility. I think there are some significant challenges, regulatory hurdles to get over, where a new entrant into the market has some significant challenges to address, but from our perspective, we're extremely committed to this market, extremely committed to global vaccine manufacturing for influenza.

DR. GERBERDING: Yes, with the red tie on?

QUESTION: In reference to the high-risk patients, is there any way that the HHS can enforce the distributors from only giving to the high-risk patients, or is it just simply the honor code that they're going by?

DR. GERBERDING: Right now we are relying on the honor code from the standpoint of the federal government. We have used this strategy before with some significant success and we're so far seeing very good evidence that it's working this time out too.

I also think it's important to recognize that this is confusing for people who last year were told to get a flu vaccine and now this year we're saying, oh, guess what? You’re not on the high-priority list. So we don't want to blame individual people who have made a different decision. This is not an easy change and it takes time for people to understand the big picture. So all in all, I'm very pleased with how fast we've been able to adjust our plan for flu season this year and I think we'll see even better adherence to those recommendations as people get more comfortable with them and as the word gets out.

Yes?

QUESTION: [inaudible] country has been identified as the highest need for this, for the limited doses?

DR. GERBERDING: The question is what regions of the country. Right now, there are gaps in all regions of the country. I mentioned that some states had solely contracted with Chiron, so in the public sector those states are priorities for this reallocation. But, for example, the veterans hospitals are everywhere in the country, so that encompasses the entire United States and there are other examples, for example, the vaccines for high-risk children are in many different areas of the country.

So we will recognize first, who needs it, and then the second strata of adjustment is on where is the need the greatest, geographically.

The second allocation, we'll look in both of those dimensions as well.

Yes?

QUESTION: Dr. Gerberding, you've done the math. Can you tell us how many people you anticipate in the high-risk group will not get the vaccine this year?

DR. GERBERDING: That's a tough question and very difficult to predict. I wish we had better information to answer it because that would help us prepare better for how much drug we need or what other planning contingencies are going to be necessary.

But as I said, flu is unpredictable. It's also unpredictable what proportion of people will actually request a vaccine, and we've seen, in many years, that far fewer than 50 percent of the people that we strongly recommend vaccine to actually end up getting it.

So we can't say for sure but we're going to base our estimates on the recent experience, and with that estimation, somewhere between 42- and 50 million people we think would meet our high risk, or high-priority criteria, and request vaccination. But right now, that is an estimate and we'll have to adjust that, up or down, as we go forward.

Yes?

QUESTION: This vaccine that you've reallocated, where is that coming from?

DR. GERBERDING: The vaccine that we are reallocating are the doses of the Aventis Pasteur (vaccine) that had not yet been shipped when we learned that Chiron shipments would be stopped.

And so we are taking the unshipped vaccine, in collaboration with Aventis, and then looking at how can we use those remaining 22.4 million doses to meet the priority needs that both Aventis and Chiron had anticipated.

Yes?

QUESTION: That vaccine was shipped but--was blocked but not shipped. So are you saying that everybody who bought that twenty--I don't quite under--

MR. BRAGA: Actually, of the unshipped doses of the 22.4, about 15 million of them had been committed to customers but had not been shipped. When we sat down with the CDC in the first couple days of this crisis, we went through our list of unshipped customers, and actually, as you went through them, about 11 million of those 15 million doses were to high-risk, CDC long-term care. So by actually sitting down and going through those lists, we were able to understand that 15 million of our unshipped doses, of those, approximately 11.8, I think it was, were going to already-targeted high-risk customers, and so then the task was to look at the remaining doses, the doses that we had unsold, the doses that are committed to the stockpile and try and determine what's the best use to get those doses to where they're most needed.

So we're hoping that with some cooperation from our customers, the actual customer disruption here will be at a minimum and we'll be able to move on to next season.

DR. GERBERDING: Let me take one more question but let me just follow your question with a very strong plea that we not get bogged down in tracking, dose by dose, where this vaccine is.

This is a very important need for us to have flexibility to adjust and move things as needs emerge, and so you're not going to see us give precise numbers of doses going to exactly this person or that person because we know that that's going to change, over time. We want to focus on identifying gaps between people who can't get the vaccine and the vaccine resources that we have.

Let me take my last question right here.

QUESTION: A couple of specific questions, Dr. Gerberding. You'd mentioned that between 42- and 50-million high-risk people will probably get the vaccine this year, and that was consistent with, based on your estimates of how many people in high-risk groups in past years have typically followed your advice.

Given that about 50 percent of people, as you said, in past years have followed your advice, is it therefore accurate to say that the 42- to 50-million people who will take the dose represent about half or 50 percent of the overall high-risk group?

And the second question for Dr. Braga is the 4 million doses that were not being shipped to the high-risk groups, that you now presumably have reallocated elsewhere, can you give us a sense of who it was to be shipped to and will not be shipped to now?

DR. GERBERDING: Let me, first of all, clarify something that you said. Last year, when we were talking about the universe of people who could benefit from influenza vaccine and we were casting a broad net, including all of the priority groups this year as well as all of the household contacts and all of the health care workers, we estimated that a large group of people who, there was evidence of benefit from vaccine would be somewhere around 180 million.

Well, of course we have never vaccinated anywhere near 180 million people in our country.

Last year, we had 87 million doses of vaccine, we utilized 83 million doses of vaccine. So we actually ended up with unused vaccine last year.

This year, using a much more restricted definition of who should receive vaccine, and then applying the proportion of those people who in past years have actually requested vaccine, we come up with an estimate of between 42- to 50-million high-priority people would request vaccine. That is an estimate.

Right now, we'll not likely be able to get vaccine to all of those people, even though we have 55 million doses, because some has already been used for people who aren't in that group.

So this is, you know, why we are saying we're doing our very best to get the product to the people who need it the most, but there will be some people who may not be able to get vaccine who really need it, and we have to have these other plans, first of all, the treatments, the prophylactic drugs, and the common sense advice, but also how very, very important it is for those people to seek medical attention early and determine with their clinician whether they should take either prophylactic drugs or treatment drugs if they've actually sick with influenza.

So we are doing everything we can, we appreciate so much the cooperation that has happened so far, and we'll do our best to keep you up to date as additional decisions are made about k allocation in this year's flu season.

Thanks for your interest.

QUESTION: [inaudible] second question.

MR. BRAGA: Okay. I'd like to correct, I'm a civilian, my mother would be very happy if I was a doctor but unfortunately I went to business school. We are actually--I can't really tell you, right this second, where those customers are because it's actually allocated across all our customer classes.

I can tell you that our customer service representatives in Swiftwater are on the phone with all of our customers talking about the ACIP guidelines and recommendations, working with all our customers to implement those guidelines and reduce the number of doses that they're requesting, and we've had tremendous support from our customers.

So I would echo Dr. Gerberding's thanks for our customers for understanding and working with us and we believe in the next week or so we should have those numbers, pretty hard, as to where those doses are coming from.

I think I would also like to reinforce that we actually shipped doses from August all the way through to either, in typical season, mid November, end of November, this year probably into December, so people who don't have doses yet--it's not because--it may not be because they're not getting them but because they weren't expected or forecast to get them until later in the season. So I just need people to be patient, in general.

Thank you.

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