Flu Vaccine Update The Chinese government rushed 3 million doses of avian flu vaccine to a threatened province this week. After finding almost 200 dead geese, health officials worry the disease could spread to other birds and possibly humans. Can we modernize how we make vaccines? And should we start stuffing our medicine cabinets?
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Flu Vaccine Update

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Flu Vaccine Update

Flu Vaccine Update

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IRA FLATOW, host:

This is TALK OF THE NATION/SCIENCE FRIDAY. I'm Ira Flatow.

You know, experts say we could be facing a flu pandemic as severe as the flu of 1918. If you were around--perhaps you know someone who was--you know that that killed millions of people around the world. And yet today, in 2005, we are as vulnerable to attack, perhaps even more so with the way that, you know, the viruses can travel around the world much quicker. We may be even more vulnerable to attack than we were back then. But making a vaccine is--well, it's not really quite modern. It's not as modern as you might think. It's slow. It takes a lot of money and, believe it or not, it takes a whole lot of chicken eggs. The vaccines have to be made in chicken eggs. It's been done the same way for decades. So your Department of Health doesn't make a vaccine. The drug companies do. And they don't really like to make them; they are expensive and they are difficult to make.

So it seems now, just about every flu season, we are seeing a shortage of one kind of vaccine or another, and this year, that flu season is taking on a very sinister meaning because of the avian flu, the bird flu, that is spreading through animals in Asia. Should it evolve into a strain that can spread to people, it could be very deadly, because the death rate is very high and, at present, we have no vaccine to fight it.

So this hour we're going to talk about the flu, the efforts to create a vaccine, how to protect the public if a vaccine is not available. Some cities, you know, like New York, they are talking about possibly making plans to deal with that avian flu should it get here. Maybe we'll stockpile anti-viral drugs, like Tamiflu. Could we do this for the whole country? Should we? Is there enough to go around? We're also going to talk about how we might encourage drug companies to beef up their development and production of vaccines. Maybe we have to make them sexier, so to speak, as they say in the advertising trade. What do you think? Our number: 1 (800) 989-8255. As always, you can surf over to our Web site.

Let me introduce my first guest. Dr. Michael Osterholm is the director of the Center for Infectious Disease Research & Policy at the University of Minnesota in Minneapolis. He joins us today.

Welcome back to the program.

Dr. MICHAEL OSTERHOLM (Director, Center for Infectious Disease Research & Policy): Good afternoon. Thank you for having me back.

FLATOW: You're one of these people who believe that it's not if that pandemic is coming, but when that pandemic comes.

Dr. OSTERHOLM: Well, first of all, one has to put pandemic influenza into some perspective. This is not a new phenomenon for humans or animals. Influenza viruses normally reside in the wild birds, aquatic birds of the world, and every so many years over our history, a new virus has emerged out of that population, has gotten into domestic animals, where it's undergone some changes, and then ultimately on to humans, causing a pandemic. In the last 300 years, there have been 10 pandemics. And while you referenced the 1918 pandemic as being very severe, in fact, the one in 1830 to '32 also was equally severe. So this is not something that's just theoretical. These happen. There will be another pandemic. That is not a question; it's just a matter of if and when, and which agent it will be that will ultimately be responsible.

FLATOW: You say `which agent'; does that mean you don't believe it might necessarily be this avian bird flu that's out there now?

Dr. OSTERHOLM: I think that there is every indication this will be it, but I think sometimes we get caught on the point of `Is this going to do it or not,' and people then have to realize that that ignores the fact that there will be another one. So we're not discussing, like, a terrorist hit, where there may or may not be another one. There will be another pandemic, and I think most of us believe that the H5N1 really is the very, very likely causative agent for the future.

FLATOW: Could you give us a scenario of when it might happen and how we might react, given the state of readiness we have now?

Dr. OSTERHOLM: Well, Ira, for all I know, it happened last night. Maybe we started seeing widespread transmission in human-human form in Asia. What people have to understand is the virus has transmitted from birds and potentially other animal species to humans already. But when it got to humans, it ended there because it had not genetically changed enough so that it readily got into the human lung and out of the human lung. When those changes occur, then all bets are off. It'll spread quickly in humans in wherever that area that it occurred, and we believe it'll literally spread around the world overnight, as we saw with SARS. Even though SARS was largely not a very infectious agent, it was one that, for just a few individuals, was the really high potential for spread, and yet we had one individual who exposed people, and the next day those individuals were in five different countries on three different continents as cases. So influenza will spread very quickly like that.

If it happens tonight, we're in deep, deep, deep trouble, because we won't have any vaccine. Even the anti-viral issue has been, unfortunately, grossly overplayed. We don't know for certain that this anti-viral drug will actually work against H5N1 in terms of reducing or preventing severe disease. Second of all, the only manufacturer of it has very limited supply, and at this point we couldn't even take care of a very small, small percentage of the world if we geared up production over the next months to years and pumped it out.

When we hear this news media context about anti-viral drugs being purchased by Great Britain or Canada or whatever, know that those orders are not going to be delivered for years into the future, so that there isn't a lot right there now that we can use that will protect us or even potentially treat when we have this happen.

FLATOW: How about developing a vaccine?

Dr. OSTERHOLM: Well, this is the point in your introduction which was right on target. You know, we're still using a 1950s technology with just some slight modifications. Imagine today, instead of using your personal computer or your calculator, you were still using your slide rule. Well, that's where we had our last real advances in influenza vaccine technology. Instead of using chicken eggs, we need to be able to go to modern technologies, cell cultures and others.

And the other piece of it--it's really important and I worry about very much--is when a pandemic of influenza finally hits the world, the implications from the death and disease is obvious, but what people don't understand is that this also is going to bring our global just-in-time economy to a screeching halt, which today has tremendous implications, just as we saw with SARS two years ago when a region of the world--Asia and part of North America--was brought to a halt. This will bring the whole world to a halt. Even a country that, if they were so lucky, if there was some miracle that they had vaccine that they could protect their own individuals in that country with, they will still seriously suffer from the economic disaster that'll occur as a result of the pandemic when the rest of the borders around the world are closed.

So we need a worldwide vaccine that will take care of 6.5 billion people, and we don't even have close to that surge capacity. We could vaccinate right now, with our current capacity, maybe 500 million people in a period of one year after the pandemic begins, and that's it. That's less than 14 percent of the world's population.

FLATOW: This is shocking. I mean, this is--we're up the creek without that paddle, it sounds like.

Dr. OSTERHOLM: Well, you know what? It's a situation, if it happens tonight, we just have to figure out how to get through. You mentioned about 1918. If you take the 1918 numbers, the number of people who died in that pandemic, and extrapolate them to today's population--in 1918 there was 1.8 billion people; recent, really very well-done research shows that the number who died in 1918 was clearly between 50 and a hundred million, not this previous estimate. And this was done by a group of historians who went back country by country to look at those mortality data. Today, that same number would be somewhere between 180 million and 360 million deaths worldwide, because today there are 6.5 billion people.

We know that what killed us in 1918 was not from bacterial infections secondary to the influenza, which is what a lot of garden-variety influenza does. It was a thing called a cytokine storm. I detailed this in a New England Journal of Medicine article that I published earlier this month, and basically, we don't have a treatment for that today. We don't have the health-care resources that would make a big difference, and this is exactly what we're seeing right now with H5N1 in Vietnam, in Thailand and Cambodia--the same kind of deaths we saw in 1918.

So, in a sense, we will have a very, very serious impact, and we have not taken this seriously as a world. We still have basically tried to just incrementally eke up the amount of vaccine we produce each year. In your introduction you appropriately noted we still have problems with that. And so we do have to get serious about this and figure out how to get through it.

FLATOW: And so what do we do? Can we get in a crash program somehow?

Dr. OSTERHOLM: If we did crash a program right now, in a year's time, maybe, just maybe, we could do something called antigen sparing, where we could take those 500 million doses and be able, instead of giving a full dose, to give each person a much smaller dose and therefore extend the amount of vaccine. So in other words, instead of putting it deep into your muscle, we might put it right underneath your skin. But we're still talking about only having double or triple the amount of 500 million doses in a year's time. What we need, frankly, right now--and the G8 has to put this at the top of their agenda--we need a crash Manhattan-like project, involving both the private and public sectors of the world, to put this together, and just pray to God that this pandemic doesn't come in the next five to seven years. If it does, history is already written.

And I will say right now, the post--9-11 Commission very clearly detailed how there were many, many opportunities to have anticipated 9/11, and we missed them. We are going to have the same thing happen following the next pandemic, where there will be a commission which will go back, and they will look at what did scientific leaders, government leaders and the private sector do with the information they had. And this thing is like watching a tornado come across the plains of Kansas. You can see it coming miles away.

FLATOW: All right. Stay with us. I want to bring on another couple of guests. Dr. Walter Orenstein is director of the Program for Vaccine Policy and Development, the associate director of the Emory Vaccine Center, professor of medicine at Emory University in Atlanta. He joins us from the campus there.

Welcome to the program, Dr. Orenstein.

Dr. WALTER ORENSTEIN (Director, Program for Vaccine Policy and Development): Good afternoon.

FLATOW: Do you agree with this--really, this Manhattan Project that we need to have here? And also, do you agree with the alarm that I'm hearing from Dr. Osterholm?

Dr. ORENSTEIN: Well, I certainly am very concerned about what we're hearing from Asia and the virulence of this virus. And we know that the population is susceptible. Whether this will be the next pandemic or not, I do not know. I do feel we need to get more prepared than we are.

And where I perhaps disagree a little with Mike is I think we need to focus on what to do for next year, but we also need to begin building an infrastructure and more vaccination for routine flu vaccination, which overall will increase our capacity. Because if the pandemic doesn't come for 10 years, at least if we've got a functioning capacity, we can be more ready than we would be otherwise.

FLATOW: Mm-hmm. Also want to bring in Dr. Paul Offit, chief of infectious diseases in the Department of Pediatrics at Children's Hospital in Philadelphia.

Welcome back to the program, Dr. Offit.

Dr. PAUL OFFIT (Chief of Infectious Disease, Children's Hospital, Philadelphia): Thank you.

FLATOW: I've got about a minute before the break. What are your views on what we've talked about so far?

Dr. OFFIT: Well, I agree with both speakers. I think that, you know, we tend to ignore those interpandemic periods where there are, at least in the United States, routinely 35,000 to 40,000 deaths. And I think that if we take that seriously and realize that flu is a killer between epidemics. And, in fact, if you--between pandemics. Even if you just add up those interpandemic periods, you know, you approach, frankly, the number of deaths in a pandemic. If we take flu seriously, build up the infrastructure, then I think when the pandemic comes it'll make life a lot easier for us.

FLATOW: Well, gentlemen, thank you. Stay with us. Thank you for joining us, Dr. Osterholm.

Dr. OSTERHOLM: Thank you.

FLATOW: We'll talk to you again.

We're going to come back, speak with Dr. Offit and Dr. Orenstein. Stay with us. Your calls, talking about vaccines, pandemics and the Four Horses of the Apocalypse. So stay with us. We'll be right back after this short break.

I'm Ira Flatow. This is TALK OF THE NATION/SCIENCE FRIDAY from NPR News.

(Soundbite of music)

FLATOW: You're listening to TALK OF THE NATION/SCIENCE FRIDAY. I'm Ira Flatow.

We're talking this hour about vaccines, vaccine development and a possible flu pandemic with my guests: Walter Orenstein, director of the Program for Vaccine Policy and Development at Emory University in Atlanta; Paul Offit, chief of infectious disease and a member of the Department of Pediatrics at Children's Hospital in Philadelphia, and also professor of pediatrics, University--Pennsylvania Medical School. Our number, 1 (800) 989-8255.

Dr. Offit, we have the capability to make vaccines in a few months, but do we have the capability to make vaccines? I mean, do we have the drug companies that will make them?

Dr. OFFIT: I mean, I think--I don't think so, is the answer to the question. I think if you look back at the last time a pandemic was predicted, it was predicted in 1957. It was predicted by a man named Maurice Hilleman, who in April reads an article in The New York Times that says, you know, there is an outbreak of influenza in Hong Kong. He says to himself, `I think this is it.' He sends a telex to Zama Japan, gets throat washings from people who were infected, and realizes that this is a strain of virus no one has ever seen before. He has that realization in mid-May. He then essentially co-opts six pharmaceutical companies, all of whom were American-based, to make 40 million doses within three months. He does it in part, actually, by going around what was then the Division of Biologic Standards, which was the sort of principal regulatory agency for vaccines in this country, and saved, no doubt, tens of thousands of lives.

I don't think that could happen today, I think in part because there's no infrastructure to make vaccines and make it quickly, and I think it's because, at the time that Maurice Hilleman made that vaccine, there were 26 companies that made vaccines in the world. Now there's four. Most of that has been--or some of that's been merger, but a lot of it's been just dropout.

FLATOW: So what do we do about this?

Dr. OFFIT: I think what we do is what Dr. Orenstein said earlier, which is that you have to take this disease seriously. I'm not just talking about the pandemics, because I think if we sort of hook into this notion that what we have to worry about is the pandemic and the pandemic only, this kind of tsunami thinking, then we're going to miss the point, because the point is that influenza every year kills people in this country and in the world. And if we realize that, realize the importance of getting a vaccine, making vaccines attractive to manufacturers, build up an infrastructure where you're routinely making, you know, hundreds of millions of doses a year--I mean, the roughly 200 million doses a year that would benefit the United States--do that, have people pay for the vaccine that they clearly benefit from, then I think we'll be much farther on our way to building up an infrastructure should there be a pandemic.

FLATOW: So how did--but the drug companies don't like to make these. They have good reasons not to like them?

Dr. OFFIT: Yeah. The reason is that pharmaceutical companies, you know, aren't public health agencies. They're businesses. And vaccines are just not a particularly lucrative business.

FLATOW: So how do you make it more attractive? Do you require them to make them, you know, as--by law?

Dr. OFFIT: Well, I think probably the better way to do it is--as probably the principal form of purchase of vaccines in the United States, through both the Vaccine for Children program and the 317 state programs, is the government. They pay for roughly 55 to 60 percent of vaccines. So they can, you know, make sure that the payment there for those vaccines is robust and consistent. I mean, what happens when you have a single payor and that payor is the government--you know, I think companies can feel that that's an inconsistent way of supporting that product.

FLATOW: Dr. Orenstein?

Dr. ORENSTEIN: I think there are several things that could be done. When we looked at influenza going into 2000, we did have four US-based manufacturers. Two of them--one of them dropped out now, one of them dropped out later, because the return on their investments weren't adequate. One of them was stuck with millions and millions of doses of vaccine year after year. So I think the government has an ability to try and facilitate entry into the US market. I think that there are various ways to do that. One is to help out on basic research. And, in fact, the NIH does a lot of that. Number two is helping with the regulatory process. It's a very complicated process. We don't have generic vaccines as opposed to drugs. It's a much more complicated undertaking to produce a vaccine.

I think there are a few things that could be done, such as harmonization of regulations. For example, now a company that wants to bring a vaccine to market in one country may have to have one set of regulations and one set of studies, and have to do another set of studies to go into the US market. To the extent we can harmonize regulations, it makes it easier. A second issue deals with the issue of the many, many requirements. The National Vaccine Advisory Committee recommended in 2003 that there be a review of those requirements to assure that we don't compromise safety or effectiveness, which is absolutely critical, but that we assure we only have requirements that are absolutely necessary to fulfill those functions.

A third issue is more funding for the FDA organization that reviews those applications. That has not happened, and they need to have top-notch scientists doing research and helping--and review it. And then, as Dr. Offit mentioned, the issue of financing--if we provide a good market for vaccines, companies will come in.

FLATOW: But what about liability issues, that companies are afraid of being sued for side-effects that might be coming from the vaccine?

Dr. OFFIT: Would you like me to answer that?

FLATOW: Yeah. Sure.

Dr. OFFIT: The good news about vaccines--vaccines actually were the first medical product almost eliminated by litigation. That happened in the early 1980s. But what that gave birth to was something called the National Childhood Vaccine Injury Act, which includes the Vaccine Injury Compensation Program, which largely protects vaccine makers from, you know, frivolous lawsuits. So I think, you know, were there to be an influenza--you know, if as we built up an influenza infrastructure--I think that, for the most part, the vaccine manufacturers can be protected by that system.

FLATOW: 1 (800) 989-8255. Let's go to Jan in Highland, Illinois. Hi, Jan.

JAN (Caller): Hi. It turns out that I have the flu today. I have a couple of questions. The first one has to do with the actual production of the vaccine, and one of the gentlemen mentioned that cell culture was a possibility, an alternate possibility to this, quote-unquote, "Stone Age" method of producing them from eggs. I was wondering, how close would we be to getting a cell-culture-based vaccine up and going in an industrial manufacturing setting? And my second question is--and I think this has to do--this ties in a little bit to the pandemic scare. Something that happens to me a lot, it seems, is I get my flu shot in the early fall. I don't get the flu until, like, now, like spring. I get a late-season kind of flu, which arguably could be a virus that has mutated and I no longer have immunity from my initial vaccination. So that's my comment and those are my questions.

FLATOW: All right. Thank you.

Dr. ORENSTEIN: I think if--can I try answering her?

FLATOW: Sure, go ahead. Jump in there.

Dr. ORENSTEIN: I think those are two very good questions. Number one is there are many causes for respiratory illness. Influenza virus is only one of them. In fact, at the moment, influenza virus appears to be extremely low. But even during peak influenza periods, about two-thirds of the specimens being tested at sea during peak weeks are not--there is no influenza virus detected. So even then there's a lot of other causes. So we're only protecting against influenza virus, not flulike illness, because they have many causes.

The second issue is on technology. It's not that we're using Stone Age technology. The vaccines we use today are a lot more pure than the vaccines we used 50 years ago. For example, today when the do placebo-controlled trials in adults, the incidence of events like fever is no different between the vaccinees and the placebo recipients. Nevertheless, we'd like to move to cell-based culture for a variety of reasons. The US government has provided some financial incentives to do that. There is at least one licensed manufacturer in Europe that is moving--that has a license for cell-based technology, so I think we're moving in that direction.

FLATOW: What would it take to retool people here, companies here? What do they want?

Dr. ORENSTEIN: Well, I think they have to...

FLATOW: Share with us what's going on in their minds about...

Dr. ORENSTEIN: Well, I think...

Dr. OFFIT: You know there are several things--I'm sorry.

FLATOW: Let me go with Dr. Orenstein first and then I'll get back to Dr. Offit.

Dr. ORENSTEIN: There are a variety of things that have to happen with cell-based technology. You have to retool the plants. There are regulatory hurdles that have to be overcome. You need to assure you get good yields out of your process, as good a yield as you get with the egg-based technology. And you have to assure that there are no contaminants, nothing at what's called adventitious agents, nothing that is carried along that with this new technology could occur. So there are a variety of barriers that have to be overcome, but I think they will be overcome.

FLATOW: Dr. Offit?

Dr. OFFIT: Yeah, I completely agree with Walter. I think that, you know, having--being able to grow influenza viruses in mammalian cells was something that we were quite capable of doing in the 1960s, but so you ask yourself the question: Since that's arguably an easier thing to do and even would shorten production cycles as compared to eggs, why continue to do eggs? And I think part of the reason is that, you know, companies, when they get licensed, they license both the product and they license the building. You know, to ask the company to retool, which means, you know, essentially either refiguring a building that currently exists or building another building, and also to, you know, make a new vaccine which is going to require a new license--you know, for a vaccine that sells for $10 or $12 a dose largely hasn't been worth it for them.

So it has to be something that we pull for, and I think the National Institutes of Health and others are trying to now at least provide funds to move to a mammalian cell-based system and to use things like reverse genetics, which I think would also shorten the production times. So I do think--I think we're thinking about the right things. It's moving somewhat slowly, but we're getting there.

FLATOW: All right. Well, let me bring in another voice on the issue. Joining me to talk about the federal government's role, and someone who, if you read congressional testimony, has sort of been asking these sort of same questions herself in Congress, Nita Lowey, a representative from New York's 18th Congressional District in White Plains. She's on the Appropriations Committee and the Labor, Health and Human Services and Education Subcommittee. She joins us by phone from Westchester.

Welcome to the program, Congresswoman.

Representative NITA LOWEY (Democrat, New York): Well, thank you very much. And I just caught some of the last discussions, and it's clear the federal government is not where it should be. The country is not where it should be, even in terms of the stockpile of treatment for a flu pandemic. Putting aside the vaccine for a minute, we have less than 2 percent of the population covered, where England has ordered enough doses to cover about 25 percent of its population; France, about 20 percent; Canada, about 17 percent. And we're depending upon one plant here in the United States. Remember what happened with Chiron with the normal flu vaccine, although I don't know that anything's normal. We learned how risky it can be when 46 million doses, almost half of the anticipated supply for the United States from a plant in Liverpool, was redirected for import.

So I think we have to work on both fronts. We have to give incentives to produce more vaccine because when you look at the statistics, it's an absolute essential focus for the government. Even a mild pandemic, the Centers for Disease Control predicts, could kill at least a hundred thousand people if we're not prepared.

FLATOW: You know, I was reading a testimony when the federal health officials were testifying and it was almost...

Rep. LOWEY: You talking when they came before my committee?

FLATOW: Yeah. Yeah. It's almost it was like pulling teeth to find out from them what they needed...

Rep. LOWEY: And you know, they...

FLATOW: ...if I might characterize it that way, you know?

Rep. LOWEY: Well, you're absolutely right, and they came to see me afterwards, and you probably heard if you read the testimony, my argument is we give the military anything they need, and they should get it so that we're prepared. Well, this has the potential of killing hundreds of thousands if not millions of people. We're operating out of one plant. Building another plant we're told would cost $100 million. My argument with them, `Tell us what we need.' We recently put in 58 million in the supplemental, but believe it or not, and I've had these discussions with Dr. Fauci and Julie Gerberding, we still don't have a plan finalized and put into action. Secretary Leavitt has to sign off. We still don't have a preparedness plan.

FLATOW: Let me just--to remind everybody, this is TALK OF THE NATION/SCIENCE FRIDAY from NPR News. I'm Ira Flatow, talking about flus and preparations with Congresswoman Nita Lowey.

So, you know, and this is what some of the doctors on my program, Dr. Orenstein and Dr. Offit, are saying also. `We don't have a plan.' They look to the government for money and then you look to them for a plan, and it doesn't seem to be gelling here anywhere.

Rep. LOWEY: Well, I can assure you, just as I did at that hearing and we have a mark-up--that's kind of lingo in our appropriations committee. But we're putting a bill together, and I intend to make this point very clearly. We need to know, number one, when they're going to sign off on a plan; number two, how are they going to respond? I have to repeat the number I mentioned before--the fact that we have, again, putting aside the vaccines, only 2 percent of the population covered when other countries have over 25 percent in case there is an outbreak is just unacceptable.

FLATOW: We've heard stories now--a story about New York City to try to come up with its own plan, stories about cities thinking about, because there is no vaccination available for the avian flu, of stockpiling things like Tamiflu, and we've just heard today that if you put an order in today, they couldn't fill it for another year for all the doses that you would need.

Rep. LOWEY: Well, first of all, I certainly commend New York City for attempting to address this threat. However, I still feel it's the responsibility of the federal government to prepare for a pandemic. Virus is not going to stop at the state or city borders, and the federal government has to take the lead. We certainly should work with New York City and other local governments, but the federal government has to provide the leadership on this issue. And unfortunately, while I'm fighting to get more attention to the issue, right now many states and cities are taking the initiative, but the federal government must take that responsibility.

FLATOW: They have to see it as a national security issue.

Rep. LOWEY: Well, this is exactly--you're reading probably from my testimony.

FLATOW: No, I don't have it open, but we say this about a lot of other things...

Rep. LOWEY: Yeah, I mean...

FLATOW: ...having to do with health and science here.

Rep. LOWEY: Well, this is exactly my point. When it comes to the military, we prepare for every eventuality. We purchase weapons, we test weapons that we may not need because of the chance we might need it, and in my judgment pandemic flu literally has the ability to bring the world to a halt. And the human and economic costs of failing to prepare for the pandemic are immeasurable. We have to treat it with the same urgency.

FLATOW: Congresswoman Lowey, thank you for taking time to be with us.

Rep. LOWEY: My pleasure. Good to be with you.

FLATOW: Have a happy holiday weekend to you.

Rep. LOWEY: Thank you. Bye.

FLATOW: Nita Lowey is representative from New York's 18th Congressional District; that's up there in White Plains, right above there in New York. She's on the Appropriations Committee and the Labor-Health and Human Services-Education Subcommittee.

We're talking about pandemics that might happen, will happen, could happen, and the shortages of vaccine this hour on TALK OF THE NATION/SCIENCE FRIDAY from NPR News.

I just got a little bit of time before we have to take a break. Paul Offit, she sounds like she's having a lot of trouble up there on Capitol Hill.

Dr. OFFIT: Yeah, you know, I'd just like to sound this warning. I think there is a danger in focusing solely on the pandemic because it does miss the point. The point is that we have a general crumbling of the infrastructure for the support and manufacture of vaccines against flu, a virus which kills 35 to 40,000 people a year. By continually talking about the pandemic as the thing we need to prepare for, I think we miss the fact that in general the infrastructure has crumbled, and two, I think we're going to suffer potentially from the `boy who cried wolf' syndrome, which is if the bird flu currently circulating in Southeast Asia doesn't become a pandemic, then people will just throw up their hands and say, `See, this was no big deal.'

FLATOW: Yeah. All right. Stay...

Dr. OFFIT: And I think--yeah, sorry.

FLATOW: No, we'll make the point when we come back on the other side of the break, so stay with us. We'll be right back after this short break.

I'm Ira Flatow. This is TALK OF THE NATION/SCIENCE FRIDAY from NPR News.

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FLATOW: You're listening to TALK OF THE NATION/SCIENCE FRIDAY. I am Ira Flatow.

We're talking this hour about vaccines, vaccination programs and the lack thereof with my guests Paul Offit, professor of pediatrics, University of Pennsylvania Medical School; Walter Orenstein, professor of medicine, Emory University in Atlanta. Our number, 1 (800) 989-8255. Let's go to Susan in Waterford, Connecticut. Hi, Susan.

SUSAN (Caller): Hi.

FLATOW: Hi there.

SUSAN: My question is it's all well and good that you're--I don't actually trust the government to come up with a vaccine in a timely manner. Why isn't anyone talking about what I as a mother can do to protect my family? I mean, families on the ground need to know information--whether it's herbal formulas we can use or things in the home--something to give us some kind of, you know, empower us to help ourselves.

FLATOW: Let me throw this out to the pediatrician on the line. Dr. Offit?

Dr. OFFIT: Yeah. I think, you know, that what happened last year is that the influenza vaccine recommendation extended to include children between six and 23 months of age, and I think what we'll probably move to over the next few years frankly is something closer to a universal influenza recommendation where everybody is, frankly, recommended to go--at least everybody over six months is recommended to get it because everybody benefits from it, and I think that the government and pharmaceutical companies actually have been quite good at predicting what strains are likely to circulate that year, and to make vaccines to protect against those strains.

I think where we haven't been good, and I think because the infrastructure just hasn't been there to support it, is good at reliably making all the doses that I think ultimately we really do need, which is frankly close to a couple hundred million doses. So we have to find a way to make sure that is out there, but in terms of other things that protect against influenza virus infection, I think the magic bullet for protecting against influenza virus infection is an influenza virus vaccine, so I think that's where we really need to focus our efforts, even frankly more so than on these antiviral medications.

SUSAN: Ira?

FLATOW: How 'bout washing your hands? Things like that?

SUSAN: Ira?

Dr. OFFIT: Sure.

FLATOW: Yes, Susan?

SUSAN: I think that means we're screwed then because if he's saying the only way that my family can be protected is using a vaccine which who knows how long that'll be available to us, then I think that we're up the creek without a paddle, and I won't accept that. I...

Dr. OFFIT: Well, I think--sorry, I think that...

SUSAN: ...if you can't tell us what else we can do with our home pharmacy, you know, with the natural ingredients in our home to help us protect our families.

Dr. OFFIT: Well, influenza virus is unfortunately a natural thing. I mean, it's, you know, a natural disaster that frankly happens every year. The good news is we in the early 1940s figured out an excellent way to prevent that disease, and that's to take the virus, completely inactivate it by treating it with a chemical and giving it to people, and when you do that, what you find is that you dramatically reduce the chance that that person will get a severe influenza that could cause hospitalization and death. It's better than any natural remedy; it's the best thing we have.

FLATOW: Yeah, but Dr. Offit, Susan is saying we've just heard 40 minutes of people saying we're not going to be able to make enough doses of this vaccine or the Tamiflu to protect people and she wants to...

Dr. OFFIT: OK. So what I'm trying to do is say...

SUSAN: Right, and it's ...(unintelligible).

FLATOW: She's not buying that argument.

Dr. OFFIT: OK. Well, what I'm saying is that I think where we've failed is that we don't recognize flu for what it is. I think we've sort of gen--as Dr. Orenstein said earlier, I think we tend to lump under the notion of flu, you know, all these other respiratory infections which largely are mild, and I think that if we take flu seriously, if we immunize all the people who benefit from it, and send that message essentially to the infrastructure that makes those vaccines that we view this as an important disease and we want to pay for this and do what it takes to make sure we can build this infrastructure, then I think that we'll find that the incidence of influenza dramatically decreases in the United States, including your caller's children.

FLATOW: Susan, that's all we can offer you. Get...

SUSAN: OK. I thank you for...

FLATOW: Get mad and get vocal.

SUSAN: Thanks. I will.

FLATOW: OK. Thanks for calling. Have a good weekend. 1 (800) 989-8255. And that goes back to your point, I guess, that you made before the break is that if we just harp on this avian flu that's out there, we're going to miss the bigger picture about how unprepared we are for all the flus.

Dr. OFFIT: Yeah, to be perfectly honest with you, I don't think that the avian flu currently circulating in Southeast Asia will be the next pandemic. I think there's many reasons to believe that it won't be. If you look at the pandemics of, say, the last 120 years, they've occurred in a reproducible pattern and the viruses that cause that have all been caused by something called the H1, H2 or H3 viruses. H just stands for hemagglutinin; it's the spike protein on the virus that sort of allows the virus to attach to cells. The bird flu is an H5 protein. Now that's not to say that H5 couldn't, you know, mutate in a manner that allows it to become a pandemic frame, which is to say easily transmitted from one human to another, it just never has. So I think it certainly makes sense to prepare for it, but I think if we see H5 truly causing a pandemic disease, that's the first time that would have ever happened.

FLATOW: But people now are worrying--you know, Susan and other listeners I have on the line are saying, `What am I going to do?' You know, it's almost like, `How do I build my fallout shelter?'

Dr. OFFIT: Here's how you build your fallout shelter. What you do is you realize that influenza causes 200,000 hospitalizations a year, and many of those hospitalizations occur in otherwise healthy children who are less than four. And although--you know, children less than 18 years of age don't typically die of flu. There are still about 150 deaths every year from influenza; many of those deaths occur in healthy children. And the virus kills about 35 to 40,000 people every year in this country. Yet we seem to for whatever reason grandfather that death and disease in; we just don't take that disease seriously enough to demand an infrastructure for flu vaccine that would largely prevent it. I'm telling you, Ira, if we immunized 90 percent of children less than five years old with influenza vaccine, not only would we decrease hospitalization in that group, we would decrease hospitalization and death in the elderly.

FLATOW: All right. Give us this `Manhattan plan.' We talked about it a little bit. Give us a step-by-step of a kind of `Manhattan plan' we would need for--to get ready for all the viruses throughout the...

Dr. OFFIT: You talking to me or Dr. Orenstein?

FLATOW: I'm talking to both of you--you and Dr. Orenstein. Dr. Orenstein, you have a thought for us?

Dr. ORENSTEIN: Well, I don't have a specific plan per se, but there are groups that have recommended a series of steps that need to be done, including a national vaccine advisory committee. I think first is a need to support basic research on development. The NIH, as I said, has done that and I think we need to do that more and perhaps increase that funding, so we get the kind of breakthroughs we need with many infectious diseases. We're not only dealing with flu, but there are many other infectious diseases that we could use vaccines for that we currently don't have. A second issue is I think to try and stimulate more companies to come into the US market, either indigenously, hopefully, or even international, and we can do that by providing more--decreasing their risk with regard to research, development and assuring them a market. And I think the government has a role to do that. We do that in part through the Vaccines for Children program, which is an entitlement program, for about 40 percent of the nation's children. We need to assure that the prices paid in that are fair and allow a fair return on investment, and we need to do something about vaccines for adults, where we can enhance that market share.

I think we need to have, in my opinion, an adult immunization program in this country. We have a childhood program where we routinely achieve about 90 percent immunization coverage for about 11 diseases that we currently vaccinate children for of the 12 that are recommended. We need to do something to enhance in adults. When Dr. Offit was talking about influenza vaccine, whereas we get 90 percent of children vaccinated, we only--when we have good supply only about 60 to 70 percent of adults over 65 vaccinated. For younger adults for whom the vaccine is already recommended, we only get 12, 14, 18 percent coverage. We need to try to build demand and we need to get public health more integrated into the system. At the present time, public health plays a major role in childhood vaccination; it plays virtually no role in adult vaccination.

FLATOW: 1 (800) 989-8255. Let's go to Angela in Madison. Hi, Angela.

ANGELA (Caller): Hi. Thanks for taking my call. My question is specific to some of the humanized vaccines that are currently in development in phase II and III for some of the solid tumors. And I guess I'm wondering, A, how you would define humanized vaccines, and two, what your thoughts are on those kinds of vaccines in general, and three, if because of the fact that they're humanized would that somehow then simplify the manufacturing process so that we wouldn't be looking at some of the shortages that we are looking at for vaccines derived in other ways.

FLATOW: OK. Gentlemen, who wants to tackle that one? Can you just--tell us what you mean by humanized, first of all.

ANGELA: Well, that's how, for example, there's a couple of vaccines in development for solid tumor, and if you look them up on the company webs, they're defined as humanized, or they're written out as humanized vaccines. And so I didn't know if that had to do with--I didn't know.

FLATOW: We'll find out.

ANGELA: I thought I would ask...

FLATOW: That's good. You bluffed that one very well.

Dr. ORENSTEIN: There are some vaccines that are being used for therapeutic purposes, and they're very different than the vaccines we've been talking about earlier, which are for prevention.

ANGELA: Right.

Dr. ORENSTEIN: There are efforts, for example, with HIV vaccines to harvest an individual's certain cells, called dendritic cells, and then exposed them outside the body, sort of stimulate them and send them back into the body as a way of controlling HIV, and there are other kinds of techniques. Those kinds of individual vaccines may be helpful on a therapeutic level, but I don't think they have much application with regard to preventive vaccines where we want to vaccinate large numbers of people. And so I'm not sure that technology would be as helpful for preventing influenza, for preventing human papillomavirus, the most common cause of cervical cancer, for preventing shingles, for preventing a whole variety of other kinds of infectious disease burdens.

FLATOW: All right. Thanks for calling.

ANGELA: All right. Thank you.

FLATOW: Have a good weekend.

ANGELA: Thanks. You too.

FLATOW: 1 (800) 989-8255. What other--Dr. Orenstein, what other vaccines are in the pipeline right now?

Dr. ORENSTEIN: I think--I look at the vaccine things as at the beginning of Charles Dickens' "A Tale of Two Cities": `It was the best of times, it was the worst of times.' We have an unprecedented number of new vaccines coming into the immunization schedule. We've just had--licensed a new vaccine against meningococcal disease; this is a cause of very serious bacterial meningitis or inflammation of the membranes around the brain. It caused severe bloodstream infection causing death of parts of limbs and amputation. This is a great vaccine; it was just licensed for adolescents. We just have licensed a vaccine as a booster dose for whooping cough for adolescents. I think this is another major breakthrough at reducing an illness that has been underappreciated in adolescents and adults. We have also potentially coming back a vaccine against rotavirus; rotavirus is the most severe disease, cause of diarrhea and dehydration in young children, very significant cause of hospitalization. There is real promise. There's another vac--two companies are developing a vaccine against human papillomavirus, which is in phase III trials now--the pivotal trials. The preliminary data are very promising that we can prevent up to about 70 percent of cervical cancers in women. There's a vaccine against shingles that has completed trials; we hope to learn soon and we may soon have a vaccine that can prevent shingles or zoster. And there are a whole variety of other vaccines under development.

But I think what Dr. Offit and I have been talking about is despite all these great accomplishments, the system is vulnerable. We only have four major manufacturers that produce vaccines for children under four years of age of this country. And so what we're hoping is to continue that development, as well as to build the pharmaceutical base.

FLATOW: We're talking about the vaccine programs in the United States and other parts of the world on TALK OF THE NATION/SCIENCE FRIDAY from NPR News. I'm Ira Flatow.

And that's the nugget there. I mean, you know, we talk about vaccines for the bird flu or vaccines for any of the other flus that might be coming up. We don't have production to do both at the same time, do we?

Dr. ORENSTEIN: We currently do not, but we do have other companies besides the big pharmaceutical companies out there. We just need to provide the right incentives to move them forward, to have...

FLATOW: Do we need to guarantee that we'll buy the doses from them no matter what happens? Is that the right kind of incentive?

Dr. ORENSTEIN: I think that certainly is a help. That's what the program BioShield is doing with regard to a number of biodefense vaccines, and so we have smallpox vaccine being produced by Acambis, a smaller manufacturer. We have manufacturer VaxGen that is producing an anthrax vaccine. We have vaccines being developed against a variety of agents, plague and botulinum toxoid and a variety of others. I think there's perhaps some lessons in what the military does in stimulating a production of vaccines that we need to think about for the civilian sector.

FLATOW: Yeah, we have to think--like Congresswoman Lowey said, we have to think of this as national security, you know? And then we'll get it in perspective--which, in my view, it is. You know, when you have possibility of a pandemic and, as you say, all of these other--we have to take care of our own infrastructure too.

Let me also bring up, before we run out of time, that there are techniques that some people are using, like the Gates Foundation--Right?--it's proven that it's possible to help pharmaceutical companies make vaccines. Dr. Offit, can you explain how they've done this?

Dr. OFFIT: Yeah, sure. Actually, you know, you can look at what the Gates Foundation does and see it 50 years ago. I mean, when Jonas Salk made a polio vaccine, what the National Foundation for Infantile Paralysis and March of Dimes did was they essentially said, `All right. We'll pay for all the research. We'll pay for Jonas Salk's work and then we essentially turn over these protocols on how to make the vaccines to these, you know, five different pharmaceutical companies. And then what--I'll tell you what we'll do. You make it and we promise we'll pay for every dose of vaccine you made.' It was the ultimate pull mechanism; got five companies to make the vaccine and I think it worked great. I think it's a model. And I think Gates in some ways is also--parallels that model in that they, you know, are trying to essentially serve as a pull mechanism for vaccines that especially have impact in the developing world, such as rotavirus and papillomavirus and AIDS virus, etc. So I do think that is of value.

But I think there's--it's hard. I think the biggest--the thing that's hardest about this is that the fact of the matter is vaccines are only given once or a few times in your life. They're never going to successfully compete against drugs that are given, you know, every day.

FLATOW: Right.

Dr. OFFIT: I mean, like lipid-lowering--cholesterol-lowering agents and obesity products and pain medications, depression medications, etc. So you have to find a way to make it lucrative or attractive for pharmaceutical companies, and that's a challenge, especially in these days where, you know, liability is certainly an issue, and I think, you know, regulatory issues are sort of burdensome. We sort of push those companies to make the home-run products and then we wonder why it is that they're not making, you know, antibiotics or vaccines.

FLATOW: All right. That's the last word we're going to have on this issue today. It's something that we'll continue to watch. I'd like to thank both my guests, Walter Orenstein, director of the Program for Vaccine Policy and Development, associate director of the Emory Vaccine Center, professor of medicine at Emory; Paul Offit, chief of infectious disease, member of the Department of Pediatrics at the Children's Hospital of Philadelphia and professor of pediatrics at Penn Med School there. Thank you both for taking time to talk with us this hour.

Dr. ORENSTEIN: Thank you.

FLATOW: You're welcome.

(Credits)

FLATOW: Surf over to our Web site at sciencefriday.com. SCIENCE FRIDAY's Kids' Connection there, free curricula. Also you can iPod SCIENCE FRIDAY and download it on your audible player or listen to it on RealAudio.

Have a great holiday week. We'll see you next week. I'm Ira Flatow in New York.

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