Influenza Vaccine Supply Update

August 27, 2004

DR. JULIE GERBERDING: Good afternoon. Thank you for joining us here today for our press briefing on flu. I guess it's flu news, even though it's not flu season. Joining me today are some experts from CDC from our various influenza and immunization programs. Dr. Steve Cochi, who's the director of the national immunization program. Dr. Greg Wallace from the same program, and Dr. Keiji Fukuda, who's a flu expert from the national center for infectious diseases. And also joining us by phone is Dr. Karen Midthun from the FDA. She's the deputy director of medicine in the center for biologics at the Food and Drug Administration. Karen, can you hear us okay?

DR. KAREN MIDTHUN, FDA: Yes, I can. Thank you.

DR. JULIE GERBERDING: Okay. We'll be back with you in time for the question and answers. Yesterday, Chiron announced that it would have a delay in the delivery of some doses of influenza vaccine because of some production problems related to sterility of a small number of doses in their manufacturing plant in Liverpool. This delay is something that we were apprised of. I spoke directly with the CEO of Chiron, and we are in constant touch with them on a day-to-day basis to understand exactly what implications this will have for our vaccination program this fall. Right now, what we understand is that they expect to fix the problem, they believe they have identified exactly what the source of the production problem was and they're aggressively pursuing all steps to assure that they have the safest and, of course, an effective vaccine on the market for us in time to protect people. We've had problems with delay in vaccine delivery in the past, as recently as 2001. We had some shipments that were delayed until October, so this is not a problem that we haven't experienced before. But it is a problem that we're staying on top of. And what we want to do today is help put this in context so people understand what they will need to do and what they can expect in October in terms of their flu vaccine. What we expect at this point in time is that actually we'll end up having more vaccine doses than we ever have had before.

We're expecting more than 100 million doses of flu vaccine this year. So, ultimately, all people who need flu vaccines should be able to get their shots and can be protected. Some people who are used to receiving their vaccine in clinics in early October may find that their clinics are delayed because they are receiving the Chiron vaccine and it hasn't arrived in time to be distributed to those clinics. So we will continue to keep you updated on the status of the delivery and also we'll keep people informed of when they can expect to have the delivery in their communities, but for folks who are trying to plan now for their immunization, the best thing is to stay tuned and to be alert to the messages from your local health officers and your clinician, who will advise you when those flu clinics get opened.

It's really important that people get the flu vaccine, especially if they're in the risk categories. And I just want to review those categories so those folks can be especially attentive to the information that's coming out in their communities about this supply. People who are 50 years of age and older should definitely receive the flu vaccine. People who have any kind of chronic medical condition or conditions that weaken their immune system should be vaccinated. People who expect to be pregnant during flu season should be vaccinated. Children between the ages of 6 months and 23 months should be vaccinated. Healthcare workers should be vaccinated, in part because they need to be taking care of the sick patients, and in part because sometimes health care workers pick up the flu from their patients and bring it home to their families.

So it's very important that Healthcare workers plan on getting the flu vaccine for their sake as well as their patients' and their family's sake. In addition, household contacts or other close contacts, those people who are at high risk for flu complications should receive the vaccine. Now, those people will be able to get their vaccine if the manufacturer's projections are correct.

The timing of the vaccine is what's in question today. As I said, we will keep you posted on the evolution of the vaccine delivery and update you on a very regular basis if there are changes in their projections right now. What this really means for us at CDC is that we're walking a fine line here because we want people to understand and to expect perhaps some delay in their particular vaccine clinic if they normally receive their vaccine in October, but on the other hand, what we don't want is for people to race out and stand in the head of the line to get their vaccine at the beginning of October because there is not expected shortage of vaccine and we don't need to jump to the conclusion that it's important to worry about access to the vaccine. We also don't want people who need to be vaccinated to avoid it with unnecessary concerns about the availability of the product. So we have to take a deep breath and recognize we've been here before, we've done this before. We're handling this.

We're in contact with all of the manufacturers on a very regular basis. And if anything changes in our expected production or supply, we will update you and the media and we will certainly do our best to update all of our partners in public health and the health care delivery system, so that people know what to expect. We certainly anticipate that arrival of the flu season sometime this fall or early winter, but when that will happen and where it will happen first is, of course, something that we can never predict. Flu is always unpredictable and we're doing all we can to be prepared for that and to help people plan. The bottom line is that right now we're expecting to have enough flu vaccine to assure that everybody who needs vaccination can receive it and we're working hard with all of our partners and the manufacturers to make sure that it is delivered as soon as it can be so we have the best lead time to inform people and get folks ready to receive their vaccine.

So let me at this point ask if there are any questions.

MARK PICARD, WXIA-TV, ATLANTA: Yes, thank you, Dr. Gerberding. Do you consider the current situation potentially a health crisis?

DR. JULIE GERBERDING: Absolutely not. What we know from the manufacturer today is that there will be a delay in the delivery of the vaccine from one of our manufacturers. That manufacturer only has about half of the market share for flu vaccine and the other manufacturer, Aventis, right now is predicting on time delivery of their doses of vaccine.

And so we will certainly have a significant supply ready at the beginning of the season to get started. This is not a crisis. This is just important information and we wanted to give people the best information we could about what to expect so that we didn't have a panic or we didn't have people deferring vaccination who really need to get it.

DIANA DAVIS, WSB: Hi. Diana Davis from WSB in Atlanta. Just go over for people watching that even, let's say you get the vaccine in mid-November, about how soon they would be protected even if it does go that late?

DR. JULIE GERBERDING: CDC recommends that people get their flu vaccine as early as possible -- typically in October and November, but December is not too late. And the flu is still circulating in the community, even in January or February. So it's never too late to get the vaccine. We just advise to get it earlier in the season rather than later so that you're protected when it arrives, not after it's already present. Yes?

MICHELLE MERRILL, HOSPITAL EMPLOYEE HEALTH NEWSLETTER: Last year we had an -- sorry, I'm Michelle Merrill with Hospital Employee Health newsletter.

Last year we had an earlier flu season. I'm just wondering if you have any advice for hospitals whose manufacturer or supplier is Chiron and is there any way for them to get earlier vaccine in order to protect their health care workers that work with the most vulnerable patients? And the second part of my question is, does this affect pandemic influenza preparedness in any way?

DR. JULIE GERBERDING: With respect to your first question, the manufacturers work with various vaccine distributors. The best thing for the hospital to do is to contact its vaccine distributor and identify how they might best be able to get earlier delivery of vaccine. That's something that just generally gets worked out on a case-by-case basis. I also know that Aventis is planning to fulfill its commitment to the people who had already ordered vaccine, but it's going to then do its best to add additional supply to those places that are still waiting for their Chiron. So both manufacturers of the flu vaccine, as well as the people who make FluMist, which is the nasal vaccine, are working very closely with CDC and FDA to try to assure a continuous supply of vaccine in places where it's needed the most.

With pandemic flu planning, as you know, CDC has posted its draft pandemic influenza plan on the Internet. This is a copy of it. It's a fairly large document. It's large because it represents a comprehensive strategy that the department of Health and Human Services has put together. Secretary Thompson has motivated us to put this on a fast track for development and implementation, and we are working hard with our partners at FDA and the other federal agencies to do what is necessary to get prepared for a pandemic flu. Pandemic influenza means an influenza outbreak that affects a large number of people around the world.

Unlike the usual flu season, where it's bad enough, we see typically 36,000 deaths from flu in this country and the more than 114,000 hospitalizations. In pandemic influenza years you can see much greater health impact around the globe. We need to prepare for that because we've learned from SARS and we've learned from the situation with the bird flu in Asia right now that these viruses continue to evolve and they can very quickly connect with every corner of the world. The flu vaccine that we're talking about this fall is the flu vaccine that will target the flu strains that we know from our flu watch, are circulating in the world right now. None of these strains at this moment indicate a potential for pandemic development. But, of course, anything can happen. And we remain very vigilant for the early identification of a pandemic strain. Likewise, although we're very concerned about bird flu in Asia, it still is only rarely transmitted to people and it has not demonstrated any end indication of becoming highly efficiently transmitted from person to person. But if that happens, obviously that would present a serious threat and we want to be able to recognize and respond to that as quickly as we can, also. Let me take a question from the telephone, please.

RICHARD KNOX, NATIONAL PUBLIC RADIO: Yes, thank you. When you mentioned earlier, Dr. Gerberding, that you expect that there will be enough of the flu vaccine available, does that indicate that you already know that the contamination in the Chiron process was late in the process and, therefore, affects relatively few lots or could it be early in the process in which it would affect potentially lots of lots?

DR. JULIE GERBERDING: The information we have from Chiron is that only a small proportion of the lots of vaccine that they have produced so far have been affected by the sterility problem. They're holding all of the lots until they get to the bottom of the problem. But as I said, right now what they're telling us is that they anticipate they have identified the source of the problem. They're fixing it and they're just taking extra steps to be absolutely sure they've got a safe product before they deliver it for use in humans. If you have any additional questions about those details, you probably want to get in touch with the people at Chiron to lend their perspective. Take another question from the phone, please.

OPERATOR: Thank you. Anita Manning with "USA Today". Your line is now open.

ANITA MANNING, USA TODAY: Hi, Dr. Gerberding, thank you for doing this. I wanted to ask about pediatrics in influenza vaccine. Will this affect the availability of the vaccine?

DR. JULIE GERBERDING: Right now, my information is that the affected lots from Chiron do not include the pediatric doses of vaccine. But again, I refer you to them for specific details of where they are in the process. We are not expecting a decrease in the total predicted number of vaccine doses available for children at this point in time.

I'll take another question from the room. Yes?

GREG (Inaudible), ASSOCIATED PRESS: How can the country come as close to vaccinating as many people as needed when they have such a delayed start, and what was the source of the contamination?

DR. JULIE GERBERDING: Well, typically in the United States we estimate that more than 180 million people should receive influenza vaccine. We have never come anywhere close to vaccinating that number of people. Even last year where we had an aggressive immunization program because there were concerns about the rapid spread of flu, we ended up the season with some doses of vaccine unused. So the issue here is not the ability to protect people who need vaccinations. The issue is simply when will clinics start in a given community. As we said, October and November are the times when most people receive their flu vaccine. We usually try to get as many people vaccinated before Thanksgiving as possible. So, this is not likely to have an impact on our ability to protect people, at least based on what we know from the manufacturers so far. So it is not an issue of protecting people. It's an issue of convenience and meeting expectations about when vaccine will be available.

Sometimes people have very regular habits about where and when they get their vaccine, and those habits might be disrupted in this fall because of the changes in the delivery schedule. And again, we've been here before.

We've done this before. We know it's important to stay in touch with the manufacturers and to anticipate any additional reasons for delay, but we're not seeing any evidence of that at this point in time. So we are cautiously hopeful that everything else will be on schedule and we'll be able to start the season like we normally do.

Is an incident like this something that gives you concern that this is a process that's very fragile and vulnerable to small bumps along the way?

DR. JULIE GERBERDING: No, our entire vaccine development system in this country is one that is very prone to short-term delays and shortages because we don't have a lot of excess capacity. What we are grateful for is that the manufacturers do have such high quality standards and certainly the FDA is a major player in assuring that the manufacturing processes are completely up to speed.

So if there's any doubt about the safety of a product, do suspend production and get in there to find out what the problem is. We know how critically important the credibility is of the vaccine program, and is dependent on people's confidence and the safety and sterility of the product. But any time there is an issue about safety or a delay in production, it can create glitches and sometimes more serious interruptions in our ability to vaccinate. That's part of why these experts are here today. It's their job to stay on top of the production and to make whatever adjustments we need to make to assure that the people who need vaccine the most will always be able to get it. I think they do a fine job, but, you know, it is a balancing act.

Take another phone question, please.

OPERATOR: Robert Bazell with NBC news, your line is now open.

ROBERT BAZELL, NBC NEWS: Hi, Dr. Gerberding. Just following up on the same point – if there were a pandemic necessity to develop a vaccine to a new strain, what do these ongoing difficulties tell you about how the complications that arise if you had to do that?

DR. JULIE GERBERDING: As we look at our overall vaccine production capability right now, in this year when the manufacturers have done everything they can to scale up production, we're making about 100 million doses of the vaccines that we need.

Now, remember, this vaccine that we're talking about, actually is three vaccines. It contains vaccines to three products. If we were dealing with a pandemic and we were focusing on one product, we might be able to have more absolute doses because we wouldn't be doing the same thing three times. Nevertheless, in the context of a global outbreak of influenza, right now we don't have enough capacity to reliably create all the vaccine that we could need in that situation. That's why this plan is so important, because it brings into play all the other things that we need to do to protect people when we have a shortage of vaccine or antiviral treatment.

Those things we learned with SARS where we didn't have a vaccine, and we didn't have effective treatment, including things like isolating people who have infection, cohorting people in hospitals and offering a maximum protection to the health care workers who are taking care of them, and quarantining people who have been exposed that are not yet sick, so that they don't serve as sources to other people.

These are old-fashioned but tried and true methods for protecting people. The pandemic plan includes provision to make sure that our communities are prepared to take those kinds of steps in the short run if we were faced with a pandemic situation now. I'll take another telephone question.

OPERATOR: CBS evening news, you're line is now open.

CBS EVENING NEWS: Good afternoon. I was wondering if you could tell us what exactly was the nature of the problem with the vaccine and, again, if you could say whether or not that occurred early or late in the manufacturing process.

DR. JULIE GERBERDING: Again, I would refer you to Chiron for the specific details about the steps in the manufacturing process and where they have identified a potential problem. But the specific issue is that a small number of lots of the vaccine -- Vaccine is made in batches.

So a few batches of the vaccine did not meet the stringent tests for sterility. This is something that happens from time to time. It happens almost every year. In this case, Chiron made the decision to take no chances and to really hold delivery of the vaccine until they had completely assessed their entire manufacturing process. If Dr. Midthun has anything to add to this, from the FDA, please chime in here at this point.

She is with us on the telephone.

DR. KAREN MIDTHUN, FDA: I would be happy to.

This is Karen Midthun from FDA. There is routine testing for lot release before any lots get released to market. And all of this testing has to be completed and meet the expectations of the company and also is reviewed by us at FDA before it is released. And as Dr. Gerberding was saying, you know, occasionally a product may not meet all the specifications and then it cannot be released. And then an investigation is often times required to determine what the cause was for this problem.

DR. JULIE GERBERDING: Sorry, Dr. Midthun, we lost you there. So we'll ask our audio people to check the connection and I'll take another call from the telephone, please.

OPERATOR: Thank you. Victoria Elliott with American Medical News. Your line is now open.

VICTORIA ELLIOTT, AMERICAN MEDICAL NEWS: Yes, hi. I was wondering if you had any breakdown as far as, okay, we're going to have 100 million doses for the season. Do you know how many are going to arrive in September, October, November, December?

DR. JULIE GERBERDING: I can tell you that we have projections from both

Aventis and Chiron as well as the people who manufacture FluMist about when they anticipate delivery. I would be happy to have our press office provide you those details after the press conference. Basically, right now Chiron is expecting somewhere around 40 million doses to be delivered in October and Aventis is delivering a few doses in August. Somewhere between 15 and 20 million doses in September. And then the remainder of their delivery will occur in October. The Medimmune people who make their nasal vaccine, will be delivering their vaccine in October as scheduled. Again, in many different years, we've seen differences in what comes in August, what comes in September, what comes in October. This is something that generally equalizes out and we are confident at the moment that we'll be able to get the vaccine program started on time with the doses that we do have. And the people in the affected clinics will have to accelerate their clinics in order to get the same number of people vaccinated before November. But people will be able to get vaccinated. Take another telephone question.

OPERATOR: Your line is now open.

Hi, thanks for taking my question.

In the past you've informally asked the people to let the recommended group get to the front of the line at the beginning of the flu season. Might you consider stronger recommendations or some guidelines for clinics to use to make sure your recommended patients and groups get the vaccine early on in the vaccination process?

DR. JULIE GERBERDING: Again, we have recommended vaccination for people who are at high risk for the complications of flu and for those who are contact with people and for Healthcare workers. We always emphasize the importance of those people receiving their vaccine and receiving their vaccine as early as possible. That's not changing in the context of where we are today.

If we identified any additional delays or any unexpected shortages in vaccine, then we'll have to revisit whether or not we want to ask certain people to be vaccinated first and others to delay their immunization.

We're not there yet. Hopefully we won't need to go there. If we do, we can handle it and we've had the experience to suggest that people cooperate with that kind of advice when we need to, to ensure that the highest-risk people are protected. Are there any other questions here in the room? Yes?

Do you think people, especially those already leery of vaccinations and those with young children, will find a reason to avoid the shots?

DR. JULIE GERBERDING: I would emphasize that flu is a serious disease. 36,000 people on average die even in a year that is not a pandemic in this country. Last year, 152 children under the age of 18 died from influenza. I think that is a very ominous statistic and a very heart-wrenching situation for the families who were affected by that loss. Flu is something that is preventable and certainly the complications of flu, even among children, can be reduced by immunization. So, nothing about the announcement from Chiron or the status of our current vaccination program should discourage parents, especially those parents of children between the ages of 6 months and 23 months, from receiving the flu vaccine. It's life saving and we strongly encourage people to get the facts they need to make an informed decision and get the kids vaccinated. I can take a couple more questions by the phone.

OPERATOR: David Brown with the Washington Post, your line is now open.

DAVID BROWN, WASHINGTON POST: Thank you. Dr. Gerberding, is the -- is there more than one factory that is making Chiron's vaccine or are there some factories in some part of the production that is completely unaffected by this?

And the second question is, is this related at all to Thimerisol and attempts to reducing the amount of Thimerisol in flu vaccine?

DR. JULIE GERBERDING: My understanding, and I think the understanding of our experts here from CDC is that all of the Chiron product is made in a single factory in England. And that's why the whole production line is being temporarily delayed, so that the entire process can be reviewed and double checked for safety. There is no link, in my knowledge, between this problem and the production of Thimerisol preservative, or Thimerisol containing vaccine. Take one more question.

OPERATOR: Tina Hudson with the St. Louis Post-Dispatch, your line is now open.

TINA HUDSON, ST. LOUIS POST-DISPATCH: Yes, I was wondering if you can give us a breakdown of how many of the doses of the flu vaccine come from each manufacturer and is the nasal vaccine included in the count that you gave of more than 100 million? And in relation to the nasal vaccine, last year we saw that the formulation of the vaccine wasn't quite adequate to cover the fujian strain but there's some suggestion that perhaps the nasal vaccine conferred a broader community. Could you address that?

DR. JULIE GERBERDING: This year, the vaccine that we are producing does contain the fujian strain. In fact, all three manufacturers are using the same strains in their vaccine product. To the Aventis products, the Chiron products, and the Medimmune products all contain the same three strains of flu vaccine virus. Aventis and Chiron have roughly half of the 100 million doses of flu vaccine. Medimmune is -- early projections were that they were making 1.5 million doses of the vaccine. That may increase, depending on the yield of their production and expanded need. But the bulk of vaccine that we would be using this year is created by Chiron and Aventis. Both manufacturers are working very hard to develop a maximum supply. I just would end by reminding you that CDC has also worked with Secretary Thompson and the department to assure that we can purchase about 4.5 million doses of vaccine for the stockpile. So we will be adding some vaccine to be held in case of a shortage or of a distribution problem in the stockpile that we can use to equalize out access to the vaccine if we need that by the end of the flu season. This is the first time we've really had this large supply available in our vaccines for children stockpile. And that, I think, is another step toward overall flu preparedness.

Each year we make more vaccine. Each year we deal with the distribution and the timing issues, but I think overall we're taking a lot of the very important steps that we need to be prepared for flu and also for pandemic influenza and we really appreciate the interest of the media and your help in translating this really important information to people who need to get vaccinated because it will save lives and save hospitalization, but also because we have a tendency, I think, in our society, to be complacent about flu.

We take it for granted and we forget that it can be a devastating illness. It's very, very important that people who need vaccine get it. That's what we're here to accomplish.

Thank you.

OPERATOR: Thank you. That concludes today's conference call. You may disconnect at this time. We thank you for your participation.

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