THE FLU VACCINE SHORTAGE

	October 5, 2004
	A look at the potential flu vaccine shortage after the British government has suspended the license of leading vaccine-producer Chiron Corporation.

JEFFREY BROWN: Today's surprise vaccine announcement comes just as flu season is about to begin, and means that nearly half of this year's expected flu vaccine will not be available. The shortage is the result of a decision by British regulators to suspend the license of a vaccine manufacturer called Chiron after problems were found at a production plant in Liverpool. That plant had been preparing to ship close to 50 million doses of vaccine to the U.S. American health officials responded this afternoon with new vaccine guidelines for the coming season. One of those officials is with us: Dr. Julie Gerberding, the head of the Centers for Disease Control. Welcome, Dr. Gerberding. DR. JULIE GERBERDING: Thank you. JEFFREY BROWN: I want to get at a couple of facts just for the record here and some of the background. What was the problem with the vaccine manufactured by Chiron? DR. JULIE GERBERDING: Well, during some routine quality control testing at the manufacture, they discovered that some batches of the vaccine were contaminated with bacteria. They thought that was limited to just a few batches, maybe six to eight million doses but apparently the regulators feel that there's a chance that more of the vaccine could be unsafe so they suspended the license. JEFFREY BROWN: Now, the head of Chiron, Howard Pien, said today at a press conference that not a single dose of this suspect vaccine had been sent to the United States, is that correct? DR. JULIE GERBERDING: I think what's important is that not a single dose of the Chiron vaccine has been used to protect any American. There are some doses that may have been shipped but they're being held. We certainly won't use them unless there's been a full safety assessment. JEFFREY BROWN: They've been shipped but the steps are being taken to make sure they're not used. DR. JULIE GERBERDING: Absolutely. JEFFREY BROWN: Okay. So how large a gap do you see between the available doses and the expected demand of the season? DR. JULIE GERBERDING: This is a tough question. We think that with our guidelines for using vaccine for the high-risk people, somewhere around fifty or sixty million people would fall into that category. However, the problem is that where the vaccine is is very different than the number of doses. We've got not only to get the doses out there for people but we've got to get them in the right place. JEFFREY BROWN: Just for perspective, I understand last year something like 80 million Americans were vaccinated. DR. JULIE GERBERDING: Altogether last year a little more than 80 million people got vaccine. That was the first year we had encouraged vaccine of the youngest children in the six month to twenty-three month group. This year we're recommending vaccine for those very young infants. So it's always unpredictable to know not only who should receive the vaccine but who will actually step up to the plate to get it. So those uncertainties make a very challenging to try to distribute this vaccine in the best way possible to make sure the most people who need it get it. JEFFREY BROWN: In light of this announcement today, you issued some new guidelines that were characterized as a kind of voluntary rationing in order to get it to the people with the highest risk. Who were those people? DR. JULIE GERBERDING: Well, the people who need the vaccine the most are the people at risk for the serious complications. Of course, that includes people who are 65 years of age or older because we know our seniors are the most vulnerable to serious flu complications. We also want those very young children, the six-month to twenty-three- month old children to receive the vaccine because there's a high risk for hospitalization and other complications as well. And then anybody who has a medical condition of a serious nature or a chronic nature should receive the flu vaccine because again they are more vulnerable to the serious complications. We're also recommending that women who are going to be pregnant during flu season and caretakers including health care workers or those who are taking care of people in the home should be vaccinated so they don't spread flu to the people who are vulnerable in that environment. Lastly, of course, people in chronic care facilities or long-term care who again because of crowding and just the nature of their situation are at increased risk for complications. JEFFREY BROWN: If you total up all the people in these categories, about how many people are we talking about? DR. JULIE GERBERDING: Well, altogether there are certainly more than 100 million people in those categories but we know from past experience that we never get anywhere near that number of people to actually receive the vaccine. So that's where the guesswork comes in. If we focus immunization on the high risk group and get the same proportion of them this year as we generally did last year, we'll probably come out pretty close. The challenge is not on the numbers but it's where are the doses of vaccine and how can we assure that they are where they need to be. JEFFREY BROWN: The more of these high risk people that come to get vaccinated the more the gap. DR. JULIE GERBERDING: That's exactly right. That's where we have the dilemma every year. If we were able to get everybody vaccinated that we'd like to get vaccinated, we'd need about 180 million doses of vaccine. Last year was a record at the 80 million. You can see that isn't even 50 percent. JEFFREY BROWN: Now, if you're not in one of these high risk categories you're suggesting that you just hold off? DR. JULIE GERBERDING: Well, right now given what we understand to be our total available supply in the short run, we're encouraging people who have no risk factors to defer vaccination this year. We want them.... JEFFREY BROWN: For the entire year. DR. JULIE GERBERDING: For the entire year. Unless something changes and we have more vaccine than we predict or we have less uptake in the other groups than we've hoped for. We're asking healthy people to step aside and let those who are most vulnerable to the complications receive their vaccines first. JEFFREY BROWN: But it's a voluntary request. There's no enforcement or something like that. DR. JULIE GERBERDING: It is a voluntary request. You know, we've been here and done this before. In the 2000-2001 flu season we had a very similar vaccine shortage. And what we found is that clinicians and people really can cooperate with this kind of voluntary recommendation. And we can do a pretty good job of matching the supply to the demand under these circumstances. Folks really do want to try to do the right thing. We're going to help them with that by making sure that we put out the best communication we can to help people make individual decisions. JEFFREY BROWN: I read that in a normal year flu kills about 36,000 American and hospitalizes some 200,000 more. So with this gap, would you predict that there would be more sickness and perhaps more death? DR. JULIE GERBERDING: It's very hard to predict what one flu season is going to bring. Last year we had the pre-dominant strain in H-3 strain of flu. We know that those usually are more serious so you expect more illness and more hospitalization. That may be the case this year but we just can't predict how serious the season itself would be and then compounded by the difference in the availability of vaccine. I just can't tell you right now what we would anticipate, but we're going to do everything we can to get the doses we do have to the people who need it the most. JEFFREY BROWN: Is there a brief answer to the question I think a lot of people would wonder is, why is the system so vulnerable to one company? This is one company that has made a big mistake and here we have a big gap. DR. JULIE GERBERDING: Well, in a very short answer, our entire vaccine production system is very fragile. We actually have very little reserve. Any time there's a problem in the system we run into these temporary shortages. We've seen this over and over again. We are committed now to really step up to the plate and look at ways that we can solve this problem in the long run. JEFFREY BROWN: You said several times at the press conference today for everybody, everybody should take a deep breath. It's not an emergency. Here's your chance. What is it that you want to say to people about what the situation is? DR. JULIE GERBERDING: This is very serious. It's going to be very challenging but it's not an emergency. What we don't want is for people to race out and try to get that dose of vaccine tomorrow because we are going to need some time to look at the best way to distribute it fairly and equitably. So we say take a deep breath, relax. We're going to work through this. It will be tough. It will be inconvenient but we're going to do everything we can to have a fair and equitable access to the vaccine for those people who need it. JEFFREY BROWN: Dr. Julie Gerberding of the CDC, thank you very much. DR. JULIE GERBERDING: Thank you.