Press Briefing Transcript

Dr. Thomas Frieden's Remarks at the 2010 Influenza Workshop for Journalists

Monday, August 23, 2010

DR. FRIEDEN: Well, good afternoon, everybody. Good afternoon. I-I thought I would just speak informally for just a few minutes, then have time for discussion questions.

The media's role in H1N1 was extremely important because, ultimately, disease response is about human behavior, and human behavior is about what people understand and how they think about something. The more – the better informed people are, we feel, the better choices they can make for themselves to protect themselves and their communities. And that's why we feel that one of our roles is to have sessions like this, to provide you with information as it is occurring and to be clear from the day – from day one one of any event—what we know, what we don't know—of what we know, what the implications of that are for what people should do, and of we don't – of what we don't know, how we're trying to find out and when we might know. I-I would say that, looking back at last year, there's one big issue that I think is important to frame, and that's, "Was the pandemic mild?" And I think you will hear many people saying this was a mild wave or a mild flu season. And certainly, compared to 1918, it was very mild. Compared to an average flu season, it's far from clear that it was mild in that sense. And one of the things that gets discussed a lot is the number of deaths per year from flu. And the number you generally hear, as a – as an estimate, is 36,000 a year. There are a few things you should know about that number. One is it's an estimate. Two is it's an average. So, some years may be many fewer. Some years may be more. And three is, it's a combination of two different types of death, one that's directly related to flu and one that's indirectly related to flu. And the directly related to flu is easier to identify, but both of them require estimates. They're models. They're our best guess – educated, sophisticated, but still ultimately an estimate of the number of deaths. And you'll sometimes hear people say, "Well, an – an average flu season kills 36,000 people. H1N1 only killed about 13,000 people in CDC's latest estimate. So, obviously it was much milder." It's apples to oranges. First off, that 13,000 estimate is only of direct deaths, not of indirect deaths, and there are generally more indirect deaths than death – than direct deaths. And second, it's done with a different methodology. So, you can't compare even the direct component of the 36,000 with the 13,000 number for H1N1. One way to look at it, though, is to look at – we know that H1N1 affected people under the age – young people much more than an average flu season. And our best guess is that, for both children and younger adults under the age of 50 or 60, there were about five – at least five times as many flu deaths last year as during an average flu season. So, I-I don't think that by – by that token you can really say it was a mild pandemic.

But looking back to the past year and a half, I think many things went very well. The communication that we had with media I believe went quite well. We provided information regularly before my joining CDC. And after my joining here, Dr. Schuchat, who you know well, was there regularly. Rich Besser was the Acting Director at the outset and all did really a phenomenal job of providing information clearly, and I think that was very important. Some of the diagnostic successes I don't think are widely understood – that within two weeks – Well, first off, this – the virus was first identified in the U.S. because of some research studies that were going on in California with CDC research projects. So, even though it emerged in Mexico, we diagnosed it in the U.S. first. And within about two weeks of the virus being diagnosed for the first time anywhere, we had a diagnostic test for it. And within days of that, we were shipping that diagnostic test to every state in the U.S. and virtually every country in the world so that we could track the presence of the virus. It was a real success story. This is not simple testing. I saw it being done in a trailer in Nigeria a couple of months ago in my travels to Africa recently. It's – and they took me through all the steps. And kind of sometimes in more resource-limited environments, you can see under the hood, as it were, more clearly. This is quite a complex test. It's not easy to be done. It is easy to get wrong, and it was done and done well very quickly, all over the place. Another example of – of what went well was getting – I didn't see Mike Shaw here, sitting quietly in the background, but Mike and his lab were behind that success. Another example of things that go well that aren't necessarily widely appreciated are the changing – the treatment guidelines. So, we rapidly told people, "Treat kids who are severely ill." And in studies, the proportion of kids who were being treated skyrocketed. So, we can come up with some estimates in the next month and years, but many people were prevented from becoming seriously ill, hospitalized, or dying because of more prompt treatment with Tamiflu®.

A third thing that went quite – or a fourth thing that went quite well that doesn't generally get appreciated is the distribution of vaccines. The Vaccines for Children Program is an existing program that CDC operates. It's a large program, more than $3 billion a year, more than 35,000 pediatricians, 40,000 – 45,000 pediatricians who are registered in the program. And that is how we get vaccines out for kids throughout the U.S. We were able to use that existing infrastructure to get the H1N1 vaccine out. And though the supply wasn't nearly as fast as we hoped it would be, once it was available, we were able to get it out as close to instantaneously as you can, logistically. There were more than 330,000 different shipments of vaccine to more than 75,000 doctors, clinics, and hospitals, from 4 different warehouses, including more – about a dozen different flu-vaccine products, as well as the materials you need to vaccinate – syringes, things like that. And that went off essentially without a glitch. You didn't read about it because, you know, you generally read about it when they are problems, not when they are not problems. But that was a real success story. In fact, the contractor, who did an excellent job in this—McKesson—is a more than 120-year-old organization. They told – and they've got annual revenues in the tens of billions of dollars. They told us that this was the largest project they had ever done. And they set up 4 warehouses in a few months, a new I.T. system, did more than 300,000 refrigerated shipments, all within a value. So, a lot went well last year. I think there's a lot that we want to continue to get better. And earlier, just a couple of days ago, you heard Secretary Sebelius announce the results of a medical countermeasure review, which is going to change the way we get new products to the market. And CDC has some important parts in that, and some of them relate very specifically to flu, and I'll discuss them in a bit.

I think as we think about the coming flu season, there are a few things that we need to recognize. First, we continue to work to try to both better develop vaccines and ensure that they're available quicker and more widely taken up. This year, as every year, there will be three different strains vaccinated for in the one flu shot. That's the case every year. This year, H1N1 will be one of them. We're already hearing a lot of misconceptions from the public, like, "I want the flu shot, but not that H1N1 'cause I'm worried about that. It was something new and different, and I might get pandemic from it in some way." If H1N1 had emerged months earlier, it would have been in last year's flu shot. So, you wouldn't have needed two different flu vaccinations. This year, we'll have H3N2, B and H1N1. The H3N2 we're beginning to see some clusters with already. Generally, H3 seasons are a little more severe, particularly for the elderly, than H1 seasons. So, we are concerned about H3N2. The good news is that so far, though it's too soon to say for sure – so far, the match – we switched. You know, within each of these, there are many different types. So, we switched the H3N2 type that we are vaccinating with or against, and it looks like that matches quite well with the outbreak strands that we're beginning to see small clusters of over the summer. It's really a remarkable tribute to global collaboration, that laboratories around the world collaborate, track the spread of different subspecies of flu, and then decide, "This is what we're going to make the vaccine against this year." And it looks like – so far, it looks like it's gonna be the right H3N2. We don't know what this flu season will hold. You need this year's flu shot to protect you against this year's flu, and none of us have a crystal ball. So, we can't predict what the flu season will be like.

We do expect there will be more vaccine available at a better time, relative to – to the peak of flu. Flu usually doesn't peak till around January or February, but all bets are off for each flu season because we just have to track it with time. And that's one of the reasons that surveillance is such a crucial part of public health – tracking what's happening on a real-time basis in the U.S. and around the world. And of course one of the things that could have gone better with last year's pandemic is if we had known sooner and more accurately what was happening in Mexico, it would have made a really big difference. We could have started vaccine production weeks to months earlier, and, even with the delays, could have had it available weeks to months earlier. And we would have had a better understanding of the epidemiology of influenza. I think part of the reason for the – the lay response to flu was those initial reports from Mexico, where it sounded like it was very, very deadly to a large group of people. And as we understood more in this country, we rapidly recognized that it didn't look like it was going to be overall more deadly on a per-infected-person basis than seasonal flu, but it was certainly going to affect young people more than most seasonal flu does.

Some of the other issues that are likely to come to the fore in the coming year is in – exposure or vaccination of healthcare workers. Studies have long shown pretty definitively that, at least in nursing homes, if you're – if the healthcare workers get vaccinated, their patients are much less likely to get sick and to die from flu during flu season and from complications of flu during flu season. And CDC published in the Morbidity and Mortality Weekly Report last year an analysis of different vaccination rates at different facilities. And facilities that require it had vaccination rates in the 90 percent range. Others were down in the 40 to 50 percent range. So, what we're talking about here is exposing – first off, healthcare workers are at risk. They're taking care of people. They're more likely to become infected themselves. They're more likely to expose their families when they go home, and they're more likely to expose their patients. We've also seen that healthcare workers may infect other healthcare workers. So, not only are healthcare workers at risk from patients. They're also at risk in the workplace. And clearly there's a need for a systematic approach – vaccination policies. And we'll be looking very careful at indicators so we can track this over time. One of our core concepts or values is that what gets measured can be managed. And as we systematically measure vaccination rates among healthcare workers, this is something that we hope to see increase substantially.

A second issue that – or another issue that you're likely to see in the coming period is our infection-control guidance. And as you may know, during H1N1, CDC issued new guidance for preventing spread of flu in healthcare facilities. This was issued at a time when it wasn't clear whether H1N1 was more virulent or deadly than a seasonal flu. Now we have revised that guidance, and it will be out in time for flu season this year. The draft guidance is already up. We've received comments on that. And the final guidance will be up in the next few weeks.

The uncertainly principle of physics suggests that the more you know about where something is, the harder it is to predict where it will go next. And I don't thi– I'm not pessimistic enough to think that that applies to our knowledge of flu, but I do think we need to be humble about what we know about flu. We know an enormous amount. We've sequenced the genome. We know the correlates of different parts of the genome with virulence and with how the disease spreads. But we continue to need to do better in a whole variety of areas. Two of them I think are very exciting and were mentioned with last week's announcement on medical countermeasures. The CDC environmental lab—actually, where, by coincidence, I was this morning—has pioneered a new method of helping to determine how much flu vaccine is present in a vial. That may seem like an obvious thing, but it's actually quite complicated, and it's currently done with a pretty tenuous method that involves repeatedly vaccinating sheep and seeing if there's the right amount of flu vaccine or flu antigen in the vial. And we think that within a year or two—and even this year, if it were necessary in an emergency—we have a new method which can cut weeks out of the production time and increase our certainty of what we're actually vaccinating with. I think that's a very exciting – that's very exciting progress.

As we try for better flu vaccines, I think we can think of – the analogy to flu – you know, we talk about "shift and drift" with flu. I presume you've heard that concept, that each year the – the virus drifts a little bit, but when it shifts, there's a big change in the type of flu. Well, I think of that in terms of vaccine production. There are tweaks to vaccine production which may cut weeks or a month or two off the process and may improve the performance. Those are the analogy of the – of the drift. And then there are game changers, which are the analogy of the – of the shift, where, if we had a flu vaccine that worked for every flu and you only had to take it once, that would be a total game changer. But we're a long way from being there. But there are ways we can tweak the vaccine. And then the second – the second way is to try to grow the vaccine faster and more reliably. And our lab has also come up with ways that can help that. One of the big problems last year was that the seed strain, which was a great match with the circulating virus – so, it was a great match, but it grew very slowly in the lab and in the vaccine-production facilities. We have new ways of working with the virus so we can have one that not only matches the circulating strains well, but grows very quickly. And that also may cut weeks or even a month or two off of vaccine production. So, within a few years, we'll go from a 6- to 9-month to, if these just two fairly simple technologies work out, perhaps a 4- to 6-month time frame. And that's a huge benefit. We want new technologies. We want game changers. But we should also tweak what we've got now to be able to make a big difference today. We also need to look really hard at our public-health systems because if they're not robust, then we don't have the defense system, the immune system we need to respond to pandemics, not just influenza, but also other infectious diseases and also noninfectious diseases. And our public-health system around the country is really challenged. I've been traveling around the country over the past year, health departments which have been proposed for elimination, programs which have been cut by 70% to 80%, layoffs and furloughs, real challenges in our public-health infrastructure. And that risks all of us because an outbreak not recognized or not recognized rapidly anywhere is a potential risk to all of us anywhere, as well. We continue to do things like tabletop exercises so that we can build on our prior investments in influenza preparedness and respond as effectively as possible.

And events like this, I think, are very important at the outset of the flu season. Get questions on the table, ask, and we're delighted to answer. If we don't know the answer, we'll say that and get you the answer later or tell you why it can't be obtained. And I think we see the – the media as our partner in a public response to flu. We think the media did overwhelmingly – I won't even say "by and large" – I would say overwhelmingly did very, very well last year, in terms of responsible, prompt, accurate, helpful coverage, and we want to see that extended to the coming year and years and to other public-health programs and issues, as well. Thank you very much.

REPORTER: Dr. Frieden, thank you for taking my question. In this era of budget cuts that you talked about, what role could adjuvants play in reducing the need to discard as much vaccine in the future, for example, as had to happen during the H1N1 situation?

DR. FRIEDEN: The question was about adjuvants. We're looking carefully at adjuvants. We – we think we made the right call this year in not using – last year in not using adjuvanted vaccine. You could have argued, especially early, when there wasn't enough vaccine, "Well, with adjuvant, you could have much more." There's already so much suspicion of vaccines in this country that we're very concerned that before we do anything like that, we need to have absolute confidence in the safety of the vaccine. And so it's certainly an area that we should continue to look at. I think there are probably better ways to cut costs than adjuvants, and I think they tend to raise lots of issues about safety that are still being looked at around the world, in terms of their use. So, absolutely an area to be looked at, absolutely an area to be considered in a different scenario. If we had had a pandemic with a much higher case fatality rates—more like 1918—and we had had real problems with the vaccine delivery, we might have said in the first three months that we were going to make adjuvanted vaccine available for people who wanted it, along with non-adjuvanted vaccine. But we weren't in that scenario. And our concern was that there are so many misconceptions about vaccine, that then what the public would think was, "Oh, all vaccine has adjuvants. It's an experiment. It may cause all sorts of problems that we don't know about." So, I think we think of the bigger – the bigger picture here, which is confidence in vaccines and the importance of keeping that confidence.

REPORTER: Two questions. One is – How worried are you that people will just be complacent this year? I mean, there's more vaccine than ever now. So, how concerned are you that – that people just won't want it? The second question is – should healthcare workers be required to get a vaccine? I wasn't sure if that was what you were saying.

DR. FRIEDEN: In terms of your first question, I-I think actually I'm more hopeful than concerned. More people got vaccinated, more pregnant women got vaccinated, than ever before last year. People understand flu more. I think whether people are vaccinated or not has to do with a few things. First, is it in their pathway? So, getting vaccinated at the workplace or when you're there at your doctor's office or pediatrician. Making it easy for people to be vaccinated is very, very important. And that is probably more important, what we've found, than – than the concerns people have. And people—all of us—generally go with the default value. And if we can get vaccinated as close to the default value as possible—kind of going about my life and I-I get vaccine as I walk into the hospital or do other things—it's going to happen. So, I think I'm more optimistic, and I think last year will be a plus rather than a minus, in terms of vaccine coverage.

In terms of healthcare workers, I believe that healthcare workers should be vaccinated unless they have an egg allergy or a religious reason not to be vaccinated. Generally, what we would like to do is to put into place rigorous monitoring to see how that's going and to work collaboratively with healthcare workers and administrators to try to increase that proportion to protect both healthcare workers and patients, and, if we don't see a big increase, then to consider what other options might be.

REPORTER: You just reminded me of one I forgot to ask. What about ob-gyns? Are they more accepting or more interested in offering vaccinations this year?

DR. FRIEDEN: Yeah, I think there's a lot more interest in the ob-gyn community. It's still not what we would like to see, but we – we think that every ob-gyn should either vaccinate for flu every year or have an easy way to refer their patients to vaccination. And what we saw in many parts of the country were big increases in vaccination rates in pregnant women – I mean, higher last year with H1N1, as I recall, than in an average year. And given supply problems, that's really encouraging. 'Cause each year, flu is hard on pregnant women. We see deaths. We see severe illness. Pregnancy – you know, the – the fetus is a foreign body, and part of pregnancy is down-regulating the immune system so it doesn't reject the foreign body. So, pregnant women tend to be more susceptible to a whole host of infections. That's why we recommend that pregnant women not eat soft cheese – because of the higher risk of Listeria. And by the same token, infections can be more severe. So, vaccination is safe and effective.

REPORTER: Dr. Frieden, every time we have an outbreak or a pandemic—you know, it happened with H5N1 and with H1N1—we always talk about new technologies and how old our current vaccine technology is. Could you address what changes, if any, this past experience – this past year's experience has given us, and are there any changes in priorities to pushing more resources toward that – toward that endeavor? And are the challenges really scientific or financial at this point?

DR. FRIEDEN: Well, I think – really recommend the PCAST report on this, which was just released last week, the President's Council and the "Medical Countermeasure Review," which was also released last week, and we can get you copies of those. I think they're both excellent reviews of exactly that question. The tweaks that I mentioned earlier I think are very important, and I think last year will help us to accelerate implementation of those newer technologies. I think we shouldn't denigrate the egg-based-vaccine manufacture. There are lots of problems with it, but it's tried and true. It works. It works en masse. It's cheap. So – and with some tweaks, it can be significantly faster. So, we have real progress there. There are a lot of both technical and financial barriers to developing kind of breakthrough different flu-vaccine technologies – flu especially because people get it – get the vaccine every year. So, if you end up with a vaccine that's made in a new way, you know, that maybe has just trace quantities of a contaminant in it, but then is given year after year, you could unintentionally get problems. That's not the case with flu vaccine, the current egg-based flu vaccine. So, I think I would summarize that the current egg-based flu-vaccine technology is easier to tweak than some people had recognized and make it faster and more reliable and harder to beat than many people recognize because of its very, very good safety record and its robustness. Of course, we would love not to be based on eggs. We would love not to be reliant on that, but it's better, I think, than it's given credit for, and it can get even better with minor changes. But the real game changer would be a universal flu vaccine that works against all flus and that lasts for many years, and that would be really Nobel Prize-worthy.

REPORTER: Just to go back to the healthcare workers, I'm wondering if we have any numbers on last year, whether H1N1 made that number go up of healthcare workers getting vaccinated or how that played a role in it.

DR. FRIEDEN: I don't remember the numbers offhand. What I remember is that more got vaccine for seasonal flu than usual, and the H1 vaccine was not as high as seasonal vaccine. We would have liked to see it higher, and I think it was largely a question of supply.

REPORTER: Dr. Frieden, you mentioned a long list of things that went well last year. Do you have any – any ideas about what could have gone better?

DR. FRIEDEN: Well, clearly we could have had vaccines sooner.

REPORTER: Right.

DR. FRIEDEN: That would have been – that would have been great, and–

REPORTER: Anything besides that?

DR. FRIEDEN: Sorry?

REPORTER: Anything besides that?

DR. FRIEDEN: I think, you know, in retrospect, the predictions of when vaccine would be available should have been made with more care. [Clears throat] The – no one anticipated that when they looked to see how much vaccine was present – and this is exactly what I'm describing, in terms of the new technology that was developed in the CDC lab, to see the amount of the vaccine antigen there – when they did that with this antiquated technology, there was about 1/5 what they thought there would be. So, the companies had a shock when that happened. But I've often thought that if – if we had predicted from day one that we wouldn't have any vaccine until January 1, the world would have been exactly the same place, but the perception of the response would have been very, very different.

REPORTER: When you were talking about the medical countermeasures and improvement areas and – and looking into determining how much flu vaccine is in a vial, why are you all looking at that now? Was there something that happened that prompted you to decide you needed to determine that, you know, at this time? And I'm just wondering also if – by not knowing, does that speak any way to the effectiveness of, you know, different people getting vaccines – you know, one person gets one, and it doesn't have as much of the medicine in it – or the vaccine in it, and somebody else might get the vaccine and it has a lot more? So, what prompted you all to look into that right now?

DR. FRIEDEN: Right. Actually, this is work that's been going on in our laboratory for a few years. We're accelerating it now. It's been known for a long time that this is a – a real weakness in our vaccine-production methods. It's a weakness because sometimes it just doesn't work out and then you have to start again and you lose a month or two to – to actually get the vaccine from production to vial. It is a – a very antiquated technology of – of repeatedly – you know, you kind of – a little startling that we're still using something like this, where you're using an animal model and routinely or repeatedly vaccinating the animal. And it's not technologically easy to replace that. But our lab now feels that they have figured out a way to do that very effectively and that we have a technology that'll be both quicker and more effective. We have to validate that. We have to work with the Food and Drug Administration, which does the licensure, and do it with other laboratories so that ours isn't the only lab that can do it – other labs can do it, as well. And then we're optimistic that over the next few years, that will become the norm for vaccine production, and that for the coming years we'll do it in parallel so that we can kind of compare the two. We – in all such things, like looking at different vaccines, we're starting with a system that's safe and effective. And we want to make sure that the system that we get to from here is at least as safe and at least as effective. And I think that's an example of one place where we can see real progress. It can, yes. In fact, this technology can determine whether the vaccine is still potent after being on the shelf for a year. So, it can be helpful in that regard, as well. Sure. We can even take two.

REPORTER: What…

DR. FRIEDEN: If they're small. We can two if they're small, so…

REPORTER: …maybe in terms of priorities or percentages, if you want to use that, is your time and the time of the agency spent on the flu?

DR. FRIEDEN: Somewhere between 1 and 100 percent… [Laughter] …depending on the season.

REPORTER: Last year I understand it went up a little bit.

DR. FRIEDEN: Yeah. Yeah, I – you know, in – in public-health agencies, I think what we generally find is that there's something that's taking from 10 to 50 percent of our time at the leadership level, but that something is different at different time periods. And flu is a major concern. It's a major issue. There's a huge economic burden of flu, year in and year out. There's a huge health burden. And it's one of those things that we think we could really make much more difference in addressing with higher vaccination rates and, we hope in the future, better vaccines and with some very simple hygiene methods like, "Stay home if you're sick."

REPORTER: Do you foresee any changes in the distribution system? Do you see the CDC playing a bigger role in that in the future?

DR. FRIEDEN: Yeah. It's an interesting question because in H1N1, CDC did control the distribution system. We don't in seasonal flu, and we – we generally hear complaints from doctors who are very angry that the pharmacy – the, you know, block pharmacy down the street, chain pharmacy down the street, has flu vaccine before the doctor does. And that's really just a reflection of when you put your order in. So, I-I don't see the CDC playing more of a role in that. I think in a usual year it's not broken, and there's some roughnesses that we've worked with the vaccine manufacturers to try to address because they don't like having doctors angry at them, either. But I think we'd like to see the system working without our intervention to the greatest extent possible.

Well, thank you all very much for the work that you do, and we really appreciate you spending time with us here for these days.

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES