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Global Immunization in Development and Foreign Policy

Speakers: Jean Stephenne, president, GlaxoSmithKline Biologicals, and Carol Bellamy, director, United Nations Children’s Fund (UNICEF)
Presider: Laurie Garrett, senior fellow for global health, Council on Foreign Relations
October 19, 2004
Council on Foreign Relations

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New York, N.Y.


LAURIE GARRETT: My name is Laurie Garrett. I’m senior fellow for global health here at the Council on Foreign Relations. I’m relatively new to the Council. I just started in March, and this is a new position, signaling a kind of recognition here at the Council that foreign relations is not just about bombs and bullets or nation-state conflicts. It’s also about issues that cross national borders, and among them, health.

And we’re here today to talk about vaccination in foreign policy in particular. Before I get started with a few opening remarks and then some questions I’m going to throw at our two wonderful participants, I want to be sure to thank Belgian Ambassador [Frans] van Daele and the Global Health Fund, Global Health Strategies, for helping us here today, and the [Albert B.] Sabin Vaccine Foundation to make this all possible for us to gather here today. And I want to thank all of you who came, particularly when it seems everybody’s eyes are only on the American elections at this moment, and it’s a little hard to get any other—

CAROL BELLAMY: Or the World Series.

GARRETT: Or the World Series.

BELLAMY: Well, it will be over tonight. [Laughter.]

GARRETT: A little East Coast bias here. Anyway, but I thank you for having interest in this subject. You know, you start by asking the question, What the heck does immunization have to do with foreign policy? Does it have anything to do with foreign policy? You bet. It most certainly does. You can start back in 1776 when the American revolutionaries nearly lost the Revolutionary War because George Washington’s entire army was hunkered down with smallpox in the Battle of Quebec. And they lost that turning-point battle. That is why they speak French in that part of Canada instead of learning slang English. [Laughter.] And it was George Washington who was the first military commander to mandate that his troops be vaccinated. In those days it was a very, very high-risk dangerous procedure called variolation before the smallpox vaccine had been invented. And it involved scraping some smallpox off of one person who had the disease and scraping it deliberately into another person. And you definitely got sick from this. But that is what saved the American Revolution. And we can flash-forward through war after war after war and see examples where infectious diseases and efforts to control them have been decisive factors in military confrontations and strategic confrontations around the world. We come all the way up to today, and we know that our troops in Afghanistan and Iraq have been vaccinated against an incredibly long list of diseases, some of which U.S. civilians will never have reason to be vaccinated against. And of course, we have a global vaccination campaign for a host of childhood diseases, and increasingly diseases that typically have onset later in life.

It is not long ago that infectious diseases for which we now vaccinate were major killers right here in the United States and in Europe. Polio used to claim about 18,500 kids every year in the pre-Salk [vaccine] days in the United States. We had as many as 55,000 measles cases in a typical year when measles vaccination lapsed in America, when we allowed it to get below appropriate herd immunity levels. And of course, we also know that vaccination is incredibly cost effective. Several studies have shown just how cost effective they can be. For every dollar spent on immunization in one set of surveys, you save $29 in downstream hospitalization and medical costs due to potential treatment for [the] same disease. And basically, they also are essential to increasing productivity, as we know, in a typical flu year, which this year is not clearly. And we’ll get to that. We’ll get to flu. I promise you.

But vaccination is not without controversy, and everywhere we turn in the world, whenever you have a large vaccination campaign, you have a whole set of unique controversies that arise, some culturally specific, some scientific, some otherwise. Right now, according to a U.N. study published a year and a half ago, 37 million children are going without appropriate vaccination every year. We are not achieving our global targets. And we have a number of reasons why we’re not getting there, and we’ll hopefully get into that tonight.

With me tonight to help us in understanding these issues, and hopefully taking us someplace new in our thinking, Mr. Jean Stephenne is here from Belgium. He is the president of GlaxoSmithKline Biologicals, which is in Belgium, I think largely because you’re the big beer maker, am I right?--[laughter]--besides— that’s not really a joke. You know, the right facilities for growing yeast are the right facilities for growing yeast, whether you’re growing them to drink them or you are growing them for other reasons. [Laughter.] And at this point GlaxoSmithKline is the largest vaccine maker and the biggest contribution to child vaccine production. So we’re very pleased to have you here.

And Carol Bellamy for 10 years has been the executive director of UNICEF, which is responsible I believe for 40 percent of all child vaccinations in the world, meaning that the wealthy world takes care of itself. And it’s interesting that UNICEF has been in American hands through a succession of four executive directors, which makes it unique among United Nations agencies. And it is a U.N. agency that gets a tremendous amount of its funding from average people around the world who buy Christmas cards and make individual donations. It is therefore in a unique position among U.N. agencies in terms of accountability, and where its money comes from, and to what degree donors have influence over the ultimate program.

Well, before we get into the bad news— the controversy and the flu, I want to start off with some good news. And we actually have some extraordinarily good news that just came out last week published in the Lancet, the very prestigious British medical journal. Your team came up with a vaccine that looks like it may be helpful in preventing acute disease due to malaria in children. A study done in 2,200 children, I believe it was, in Mozambique, age 1 through 4, showed a marked reduction in the number of kids who suffered symptomatic malaria during the study period— about a third less. And then more than a 50 percent reduction in the number who went on to develop acute potentially life-threatening malarial episodes. I wonder if you can give us some more information about that and what you plan to do with it.

JEAN STEPHENNE: So malaria vaccine has a long history with GlaxoSmithKline, because we are working on it since 20 years. And the work on malaria is very complex, because that’s a parasite. It’s not a bacteria, it’s not a virus. So we engage ourselves in that for two reasons: one, because we want to better understand the way we develop vaccines and new vaccines which are more complex, and that’s one of the reasons. And, for example, the technology we develop for malaria we are using now in cancer vaccine. So it means that for us it was good learning. And malaria was a good tool to develop new technology.

The second reason is that malaria was important to U.S. Army, and that is why we engaged with them. And then we during the last three years we worked with the malaria vaccine initiative, which is the [Bill and Melinda] Gates Foundation, to go in Africa and have the best vaccine candidate we have in Africa, in developing countries. So it’s really a partnership between private and public, and that’s the way you reach this type of presence, because if you have to do that alone with a vaccine company, a private company, it’s impossible. You need to collaborate with good institutions like Walter Reed [Army Medical Center] and also with institutions who are ready to go in the field in Africa to test the vaccine. And for us, it was really an important partnership. And I hope that this vaccine will become a reality. But we need to prepare the next step, and the next step is to say, “Can we test this vaccine now in 20,000 kids in Africa?” So that’s a lot of money and a lot of organization. And then the second is, “Can we supply and manufacture this vaccine?” And there you require a big investment, because as you saw it is very complex, and the test of it has to be very good. So the vaccine is exactly the same. So it means the vaccine is still very complex. And we need now to develop the manufacturing if you want to be ready by 2009, 2010. You need to develop the manufacturing today. And without the partnership you cannot do that, which means because the market is mainly in Africa, and later on we will go probably in some parts of Asia and perhaps in Latin America where another strain is circulating. But you cannot do it alone. I think that’s really to be a partnership between public and private.

GARRETT: How much would it cost a dose of this?

STEPHENNE: I think the only thing I can say is that the vaccine will not cost one dollar.

GARRETT: In other words, it won’t be affordable to the people who need it without subsidy or through some mechanism?

STEPHENNE: Today many vaccines are not used— which exist— are not used in developing countries. And so that’s why UNICEF, GAVI [Global Alliance for Vaccines and Immunization], has a big role to play. And there is a gap in financing, and many, many new vaccines are coming, right?--which have to be used in developing countries because this would have the biggest impact and where it saves lives. So it means that the industry cannot do it free of charge. So the industry has to be supported. But we want to work in partnership with the governing board, with UNICEF, and try to develop mechanisms to finance the vaccine.

GARRETT: I know you didn’t ask me, but if it’s only $1, that’s less than the $3 impregnated bed net. Oh, here we go— which form of prevention should we head towards? For those who need to clarify, the notion of, as they say, impregnating a bed net with pesticides and then using this treated bed net under children when they sleep to avert being bitten by mosquitoes, is currently the best approach available to limiting malaria in children at this time. And so Carol is saying, “Well, a dollar a dose would be cheaper than a $3 bed net.”

STEPHENNE: I didn’t say it would cost one dollar. [Laughter.] Let me clarify. I think it will cost a few dollars, because this vaccine is very complex. It’s two components. One is, let’s say, the antigen inside; the other one is the [inaudible], and nobody, let’s say, can do that for $1. I think it’s impossible. And it will cost a few dollars. But for sure, if we have the guarantee of the quantities, then you can have the economy of scale in manufacturing. If you don’t reach that, yes, for sure the vaccine would be very expensive. So that’s something we will debate in the coming years.

GARRETT: And let’s go through a couple of the practical details. In your study it requires three doses over three months. And, as we know, in developing countries corralling very small children in for vaccinations three times in three months is an extremely difficult if not impossible task.

STEPHENNE: I think it has been done in a few countries successfully, due to the work of UNICEF and [inaudible], and I think it’s possible, because malaria is in the mind of everyone in Africa, and I am sure that we’ll find a way to get in touch to do it, but it will be a challenge.

GARRETT: And then the cold chain. For those of you not familiar, the cold chain is an expression meant to describe that a number of vaccines are not heat stable. They either deteriorate or, actually, they become dangerous when exposed to high temperatures. And, not surprisingly, the countries that we’re most worried about are also prone to tropical heat. Maintaining the cold chain so that from manufacture, all the way to going into a child’s arm, the vaccine remains at the appropriate temperature range is exceedingly difficult. Do you think this vaccine will require that it remain cold?

STEPHENNE: This vaccine will require cold chain because it’s a [inaudible], and if you expose the vaccine to a very high temperature— I don’t know, 60, 70 degrees— you will degrade the [inaudible].

GARRETT: That’s not a very high temperature. Oh, centigrade. [Laughter.]

STEPHENNE: Yes, but if you put the vaccine in the sun— centigrade, centigrade.

GARRETT: OK, big difference. [Laughter.]

STEPHENNE: If you put the vaccine in the sun, believe me, you reach very easily these temperatures.

GARRETT: Well, I wonder— I want to ask Carol in the years that UNICEF has existed, obviously we scaled up to have massive campaign to target in the millennium development goals achieving full vaccination around the world of children, right? So how do we— but we have this 37 million child shortfall failure each year. What are the key reasons why we are not getting there? What are the obstacles? What are the road blocks?

BELLAMY: I think there’s still— I want to come back and comment a little bit on cold chain, but I think there is still a sense that immunization is one of the least expensive, most effective, least infrastructure-demanding— although the cold chain plays a role in this— way of either preventing death or disability in children. So I think that’s still understood.

So why aren’t we there? Well, several things have happened. One, there was an enormous kind of vertical type of campaign in the ’80s, child survival revolution— very important, but quite vertical— a lot of health departments with a very top-down approach, which assumes a modest functioning health system. And what we saw coming into the ’90s was, in a number of ways, not frankly an increase in immunization coverage. I mean, I think it’s important to note that if you look at immunization coverage, and certainly in the Americas and East Asia, it’s still quite high. Our challenges remain the places where you have the biggest challenges for children generally, if not population generally, which is sub-Saharan Africa and South Asia— South Asia because of the size of the population.

But what are some of the problems? Well, you’ve got to continue to invest in the cold chain. I mean, you’ve got to maintain these vaccines at a certain temperature. And that cold chain requires not only the refrigeration when the vaccines come to the country— which means if it sits in the port for a while because of various regulations, rules and regulations or red tape and you can’t even get it out of the port. But not just getting it into the cities, into the urban areas, where more people are coming— so that’s good— but getting it out to where people are. So if you’re ever going to get not only 100 percent, but even 80 percent coverage at this point, getting it out— and getting it out means going to places with no electricity, no refrigeration. I mean, I can’t tell you— if I have to think about the things I’ve done the most in my life, it’s inaugurate latrines and put my hand into so-called refrigerators to see whether there was anything cold in this refrigerator, because they might even have something there, but if electricity is only on a limited basis, there may be nothing cold there. So some of the infrastructure has been a problem.

More recently— I mean poverty has always been a problem. Poverty is a challenge. But more recently, in the last 10 years I would say we’ve run into a couple of other problems. One is access— reaching everybody. The access for me is largely the issue around conflict, or the increasing presence of conflict around the world, which isn’t necessarily two countries fighting each other, but conflicts within a country. So the ability to reach part of the Democratic Republic of Congo but not the eastern part, or part of Angola but not another part, or part of Somalia but not another part. So it isn’t as though you don’t have a vaccine, it isn’t as though you don’t have the willingness, it isn’t as though you don’t even have the money— although sometimes you don’t always have the money. But how do you get to the places that are most difficult to reach?

The other enormous obstacle is, frankly, HIV and AIDS. AIDS is ripping apart societies. It’s killing health workers. I mean, health workers today in parts of sub-Saharan Africa, they’re either dying of HIV/AIDS or they’re being recruited by Europe or the U.K. or the United States. If you can speak a language that— I mean, the interesting thing for me, I was talking to the former prime minister in Mozambique, who is actually a doctor, [and] he was saying they weren’t losing their health workers as fast as others, because there was less of a demand for Portuguese speakers. But if you are English-speaking or French-speaking, and you’re a health professional today, if you’re still alive and haven’t died of AIDS, you’re being recruited away.

So the challenges in immunization is still to maintain some modest degree of a health system, to make sure your cold chain works. It’s still the availability of vaccines. The reality is, in recent years there has been a reduction in the number of vaccine producers, although there is a potential that is coming on board, I hope relatively quickly, of more vaccine producers in developing countries. But for us at UNICEF, we can only purchase vaccines from WHO [World Health Organization], which is appropriate, from WHO-approved capacity. The investment in these issues. So it’s a mixture of things. Again, I think there’s still a sense that immunization is one of the least expensive, most effective ways to reach people. But from war, to AIDS, to the weakening of health systems, to the lack of investment in health generally— all of these have taken their toll in the immunization area.

Oh, I’m sorry, one other. I’m sorry. I also want to say that I believe, as important as it is, that the decision in 1988 to eradicate polio— critically important— I’ll throw a little controversy into this discussion— to eradicate it indeed— has created a situation where enormous campaigns have been put in place to eradicate a disease which has in the long run created a negative impact on the support for routine immunizations. And I think we have to—

GARRETT: You’ve got to explain that.

BELLAMY: OK. Campaigns mean you mobilize everybody in the country. You go out for a few days and you just turn everything upside-down, pay extra money, you get extra people— everybody goes out, you have your immunization campaign. In India you— well, it’s not a jab, it’s two drops on the tongue, and you immunize 135 million kids. Routine immunization means you have the capacity within your system to provide immunization— the very basic garden-variety DPT [diphtheria, pertussis, and tetanus], measles— on an ongoing basis so that the kids are immunized. And the problem is, we’ve turned our health care system to the extent to which they function in poor countries upside down to respond more to campaigns than we have to support routine immunizations. We want to succeed on polio, but at least we in UNICEF believe we have got to get back to systems where the capacity is to deliver routine immunization in countries. And we’ve lost a little bit of ground on that, because there’s been such an emphasis on campaigns.

GARRETT: I want to throw out three quick anecdotes for both of you to respond to any way you choose. The first is about 15 years ago Tanzania— I’m in a small town, not a village— and I got to watch, observe, the child vaccination program, and it’s a campaign, and it’s a one-day deal. They have no electricity, no running water. And I see the local barefoot doctor, if you will, take three syringes out of a puddle of alcohol that had clearly been used many times, one of which she had to sharpen with a whetstone, and then there was no cold chain— and line all the children of a certain age group up and jab them down the line. Now, the background rate of HIV in this town was already about 10 percent at that time.

Second anecdote. I was with [Russian Deputy Health Minister] Gennady Onishenko in Russia a year after he was released from Chechnya, where he had gone as a Russian, because there had been a polio outbreak in Chechnya, and he went to give vaccines, and instead was taken captive by the guerrillas. No vaccination was done, polio raged for some time. He was eventually released, and I think ultimately the Chechen leadership was convinced to allow vaccination of their children.

Third anecdote, same region. I was in Ukraine when diphtheria was raging, a disease that we consider ancient history. And what was striking was that in many of the parts of Ukraine I was in, the lapse vaccination for diphtheria in the child population had only been a couple of years. It wasn’t something that had gone wanting in many of these areas for 10 or 15 years before you reached a critical point and got an outbreak, but rather in some of the areas I went to certainly less than 5 years have elapsed in vaccinations. I wonder if either of you want to make any comments based on those three anecdotes.

STEPHENNE: I think that it shows it’s not only the availability of the vaccine. It’s also the infrastructure. And I believe that GAVI, the global immunization board, I think some—

GARRETT: May I say it’s largely founded by the Bill Gates Foundation.

STEPHENNE: I think some progress is being done, and the objective is not only to supply vaccine, it’s also to develop the infrastructure. And that’s the only way. On the other hand, if you have to say that HIV is devastating, the people— why you’re going to do the vaccination in these countries? So it means it’s very complex.

And the big concern for the vaccine industry is that, yes, we are developing a new vaccine, and many new vaccines are coming. But today we have already a difficulty to do it [inaudible] a new vaccine, and I think it’s not the vaccine industry that is responsible to developing countries. I see it’s the public and it’s the developed country who has some responsibility— the World Bank, other organizations, have some responsibility to develop the infrastructure, because I think that many new vaccines will become available, and if we don’t take care of it there will be a gap between immunization of children in developed countries and developing countries.

But we see some progress. I agree that Africa is still difficult. But if you go in certain countries in Asia, you go to Latin America— Latin America is the model for immunization. So there are good things that are happening. So I think we cannot criticize everything. I think there has been progress, but a lot remains to be done. And I think that the new structure with the GAVI board, with the vaccine fund, with UNICEF, the WHO— all parties are speaking together, and trying to work in one direction. I think that’s what is important.

GARRETT: Carol?

BELLAMY: I wanted to comment on GAVI for a second. Let’s talk about GAVI. Bill and Melinda Gates put a huge amount of money into immunization. It went into something called the vaccine fund. GAVI itself, however, isn’t just a vaccine fund. It’s actually a huge—

GARRETT: I mean, [inaudible]--

BELLAMY: --[laughter]--no, it’s a whole bunch of the entities that are involved in immunization. So it’s not that Bill Gates is funding GAVI. Bill Gates put money into something— no, very important— but into something that went into the vaccine fund. So if you look— if I could do a chart. If I did a chart about immunization and vaccines generally, and people vaccinated, I mean, the Gates and the GAVI money doesn’t show up on that— from the costs— because the garden-variety penny vaccines, which is a— penny— I call them penny— but the majority of DPT and all of that, that’s already going on. We need to make it go on more. If you take a look at where the Gates come in, which has made a difference in hepatitis C and flow-in Hib, but Hib is still not financially sustainable.

GARRETT: [Hib is short for] Haemophilus influenzae type b.

BELLAMY: I know, all I ran into were doctors here. I mean, I was like—

GARRETT: Do not make assumptions.

BELLAMY: OK, sorry. Then I won’t. Running into doctors— no idea what I was talking about here. That— then, you see the area where the Gates money has made a real big difference in that area. But GAVI itself— the Global Alliance for Vaccines and Immunizations— is an alliance of a whole range of entities from WHO to UNICEF to the World Bank, foundations from—

GARRETT: Fair enough, I understand.

BELLAMY: I’m sorry.

GARRETT: But let’s get to the issues here. I mean, what I raised in the—

BELLAMY: Well, one of the issues is that there is always this confusion between GAVI as some new thing, and when it’s made up of old things who are operating in the other.

GARRETT: OK, but the anecdotes I gave described non-sterile needles—

BELLAMY: OK—

GARRETT: --described mass use on— in a— where you had an epidemic of HIV—

BELLAMY: Non-sterile needles were— OK, increasingly now in the context of— in the context of routine immunization and also in the context of the vaccine fund-supported newer vaccines, there’s an increasing use of single-use syringes. But in sort of types of jabbing out there, which is still around forever— there’s still this sense [that] I only get better if I get a shot of something— that’s still largely overuse, overuse, overuse, and it is spreading whatever comes— spreading, including HIV/AIDS, which is a very major issue.

In terms of your person, the— like the Chechen person— I said before one of the biggest challenges in immunization, I mean, we’re not just health people anymore— we’re dealing with wars, we’re dealing with people being captured. We’re dealing with people in Angola who are Rotary members helping out in a polio campaign killed. We’re dealing with a doctor— a UNICEF national officer in Somalia who is a doctor killed— killed because they’re in the wrong place at the wrong time. I’m not talking about being mugged— I’m talking about because there are wars going on today. So the issue of conflict is having an impact. I’m talking about having— I’m talking about an immunization campaign in the Democratic Republic of Congo, where you can bring vaccines in for the Kinshasa part through Kinshasa, but you’ve got to negotiate with Rwanda and Uganda to get your vaccines into eastern Zaire— I’m sorry. I mean, this is a— going to say simple— nothing is simple, but this is a simple immunization campaign, and yet you’re out there negotiating with rebel forces.

I’ll never forget I met with one of the rebel forces on some of these issues in eastern Congo, and the guy handed me his card and he said, “Well, be in touch with me on my e-mail.” [Laughter.] I wanted them to say, “Please stop the war, we have an immunization campaign.” [Laughter.] But, I mean, I’m not trying to be funny, except it was funny, but it wasn’t funny because you had to deal with them to be able to conduct an immunization campaign.

So Nepal— let me get out of Africa right now, because it’s not just Africa. In Nepal right now, to do an immunization campaign; Darfur, Sudan, to do a measles campaign in Sudan right now, it’s not just a matter of getting the vaccines in, it’s not just a matter of getting the cold chain, it’s not just a matter of having the people who can go out and do it. It’s a matter of dealing with the Sudanese government and dealing with the [inaudible] and the SPLA [Sudan People’s Liberation Army]. So immunization campaigns these days— not everywhere— Afghanistan is another one— is dealing with multiple factors. So your Chechnya thing is not necessarily unreal, because you were dealing in much more insecure areas in which you were still providing the most simple saving of lives or reducing disability for children. But the way to carry it out today has added several other different layers of having to do it.

GARRETT: Well, now we have polio.

BELLAMY: Right.

GARRETT: We have a situation where, as I understand it, two or three imams in northern Nigeria started last year saying that, alternatively, that HIV was in the vaccine or that something that would sterilize Muslim babies is in the vaccine. It’s in a region where just three years previously— I believe my figures are right— we had a meningitis outbreak, with bogus vaccines distributed by Nigerian companies that contained I believe just saline, so that children died of meningitis— who thought they had been vaccinated. They may have undermined some of the credibility of vaccinations. Add to it imams saying these terrible things are happening, and now at last count 12 countries have active polio outbreaks as a result of the decline and support for immunization in Nigeria. How do we get past these kinds of things?

BELLAMY: Well, I’m going to go back to India first, can I? Because that was the year before.

GARRETT: OK, absolutely.

BELLAMY: Because let’s look at polio. Polio is an extraordinary success story— I’m sorry, I think we have to look at this— 1988, World Health Assembly decides to eradicate polio. I’m not eradication, eradicating anything ever again. But they’re for eradicating polio. We had more than 120 countries that had polio in 1988. By 2000 it was 20 countries. By 2001 it was 15 countries. I mean, it was just an extraordinary effort. It was an effort that— it was the pharmaceutical companies, the governments themselves, WHO, UNICEF, CDC [U.S. Centers for Disease Control and Prevention], Rotary— $600 million Rotary financed— Rotary. But then— but then it started— we started stretching, OK? And we learned from this that it really applies to other kinds of immunizations. The poorest of the poorest of the poor see nothing, but they did see immunization. And so it broke out a couple of years ago, two years ago, in India, where all of a sudden in the northern part of India— not everywhere in India— I mean, it was kind of almost a reaction. How come we have all these problems where the poorest people receive nothing except twice a year you come in and you put those two stupid drops on our tongue. I mean, we’re dying from this, we have no money, we’re poor. And that even had religious connotations to it, because actually in Bihar, in the state where that— that was a Muslim-Hindu situation, and the fact is in that place the Muslims were being— were the secondary population and the Hindus were getting more coverage. So that’s— and some of those same things about sterilization and other kinds of things started, and we just— we— when I say “we”--it’s not UNICEF— I’m talking about this whole coalition— had to just re-gear ourselves, and the government had to get much more involved. But in India, if the government gets more involved— when it does get involved— it’s organized, and it really got involved. And while everything isn’t perfect, things at least started working. But it required an investment of a huge amount of money and a huge amount of people— a whole huge campaign.

Then a year later it hits in Nigeria. Nigeria is less organized. Frankly, the government has been less responsive to the north— Christians in the south, Muslims in the north. We live in a world today where whether it’s the U.K. or Nigeria, technology can spread the world faster. And then you have pieces of paper out there saying these things, that you’re going to get sterilized, you’re going to get HIV and AIDS. Politics starts to play a role. And the same thing— just saying we have malaria, we are dying of other things, and the only thing— the only thing we ever see— if government— I mean, if those of us in immunization on the receiving end, but the only thing we ever see of government— we don’t see— nobody from government cares about us, the only thing they ever come and do is put those two drops on our tongue.

GARRETT: So what you’re really saying— and I think that history bears this out— is that for a unique set of reasons, immunization has been prone to conspiracy theories—

BELLAMY: Well, conspiracy—

GARRETT: But go back here. I mean, think of all the parents who refused to have their children vaccinated for pertussis in the United States because of a one-in-one-billion odds that their child would suffer a child effects. But it’s— we have a whole—

BELLAMY: Well, it’s conspiracy and nothing— they get no services. They are the poorest of the poorest of the poor, and they get nothing.

GARRETT: Well, of course we had [Edward] Hooper [author of “The River: a Journey to the Source of HIV and AIDS”] claiming that HIV originated in the polio vaccination campaign— that that’s where HIV came from. And we’ve had any number of similar notions arising from the wealthy world, not just the poor. But what you’re arguing, if I understand you right, is that unless we move towards integrating immunization campaigns into basic health care across the board—

BELLAMY: Right, you’re not going to do it.

GARRETT: --we’re always going to be vulnerable to this sort of thing. OK—

STEPHENNE: And I think that must be also the commitment that the local ministers have to be involved. I think if you— if we organize instead of them— why have been to Mozambique? Because in Mozambique the prime minister was a doctor, and he recognized that it’s important, and it’s important, and it’s the base of development of his country. If you don’t have the commitment— I see it very difficult for anyone to push immunization.

GARRETT: OK. So here we have this situation where Carol has laid out all sorts of obstacles that make it a serious challenge, and one I think can convincingly argue that because of increasing regional instability and failed-state issues, it’s getting harder and harder and less and less safe for the vaccinators, if you will. Then we have this situation here— the wealthiest country in the world and we can’t come up with flu vaccine. And we’ve got little old ladies lined up on the streets screaming, “I want my damn flu shot.”

BELLAMY: And more.

GARRETT: And more. “And, I want it now.” And we have a real market failure. Here we have a situation where the entire vaccine market is only about $6 billion, and it’s a low-profit market compared to— that’s nothing compared to Viagra. I know I think the last figure I saw— what is Viagra, about $16 billion I think annually, the totally—

STEPHENNE: A few billion.

GARRETT: Oh, OK, [laughter] but anyway the profit margin is way high. And I think the pharmaceutical industry is about $300-plus billion overall with it being— at least pre-Vioxx— it was the highest profit industry in the world. So we have a sort of market failure situation. We can’t [produce enough] flu vaccine in the wealthy world, we can’t find ways to create incentives for production of essential vaccines in the poor world, and we can’t figure out how somebody can make money making your malaria vaccine [and] get to the ground where it might have benefits. We obviously have a market failure.

STEPHENNE: Carol, I would like to comment on what you said. The first thing, I don’t believe you can say that no progress is being done for vaccinating in developing countries. I think progress has been done in the last 10 years, so it’s true that we can be critical, but much progress has already been accomplished, and I think we have to congratulate the people who are working on that, because it’s not easy work, right? That’s what we are hearing. But I think progress has been done. So that’s—

Then if I look to the developed world, what would be the paradox is that when I read the U.K. press, since 10 years, on the first page of the newspaper people speak about measles, mumps, rubella and autism— right? And it never stopped, and there is no scientific story [inaudible].

GARRETT: Let me clarify for those who may not be up to speed on this. There has been a real drumbeat on this issue, especially in the U.K., that supposedly childhood vaccines increase the odds your child will be autistic. So there is no proven scientific studies that demonstrate that connection.

STEPHENNE: But so each day you read that in the press— in the U.K. since 10 years. Do you think you build confidence in vaccination? I don’t think so. So it means the press and everyone around this table has a role to play to increase the confidence in the vaccination.

Then if I go to the United States, if I am in the vaccine industry, I am concerned about the liability in the United States, which means that each time there is a side effect and each time you associate that side effect with the vaccine, the industry is attacked. And the good story has been— a bad story for the vaccine industry— has been the mercury compound. And again it was linked to autism. And it means that in our society we dispute ourselves about the fact that vaccine is not saving lives— vaccines create big injury, which is not the case. So it means that we are in a society which is very rich, and a society who complains about good drugs or good vaccine, right? So we need to find the right balance there.

Then you go to why there is not flu vaccine in the United States, right? I think very simply because if you want the vaccine industry to invest in it, you need to have confidence in the vaccine. And if the confidences disappear, I think it’s very difficult to convince an investor to make vaccines.

GARRETT: What creates that confidence?

STEPHENNE: I think what creates the confidence— first, I think the immunization in Europe and the United States, the rate of vaccination is good, right? And it is due to the action of the government, which means that we see that diseases are controlled in Europe and in the United States. Now, if you take flu, flu is a specific situation to the United States, which means what we have to recognize is that if I look worldwide it’s only a few manufacturers who are still alive, right? Many manufacturers disappear. I think if you go back 20, 30 years ago there were probably 20, 25 manufacturers in the United States. Now we are back to four or five. Why is it? Because I think the value of vaccines is not recognized.

If I go to the doctor when I am ill, and I take an antibiotic or I take another drug, I will pay the bill. If I was to buy a vaccine, it has to be cheap. That’s the way people are thinking. And I think it’s wrong, because the risk benefit for vaccine is high, and it’s not recognized in the society. And we need to work on that. If you don’t do that—

GARRETT: Wait a minute, let me understand then. You’re saying that the solution to the market failure question is to allow a higher price structure for vaccines?

STEPHENNE: No, I’m saying you need to have the right price for the right vaccine, right? And some vaccines have the right price right now, and certainly if you go in Europe there are five or six manufacturers of flu vaccine— there is no shortage. If you go in the U.S. today there is only two, and it is due to the fact that there has been a lot of pressure on the price. It is a fact that some manufacturers have not invested in developing their plan, and so it means some people need the vaccine manufacturers. And I think that’s something you need to handle progressively, but I’m pretty sure that people are ready to manufacture the vaccine, and the industry is ready to do it. But we need to work in the right environment, from a liability point of view and from valuation of vaccines.

GARRETT: Well, I want to give everybody in the audience a chance to ask a question, so I’m going to open it up. First I just want to—

BELLAMY: I only want to say that— I just want to echo one thing which he said, which is—

GARRETT: Carol is known for being incredibly shy.

BELLAMY: I only would say for all that we’ve talked about the problems, the fact is vaccines have saved millions of lives. I just want to come back to— I’m sorry, we talked about some problems, but we have to anchor ourselves in understanding—

GARRETT: What’s the estimate?

BELLAMY: Millions, millions. I mean, still for the kids who aren’t vaccinated, that’s terrible. But it’s millions of kids every year who are vaccinated. That’s all I want to say. Please, I just want to— we can’t anchor this in negative. We have to anchor this in positive, but get it to where it’s even more coverage.

GARRETT: Well, I think one of the ways to look at it is to ask the question, What level of support would there be for vaccination in America if we still had children coming down with infectious diseases routinely? But we’re all pretty far away from that time period. It’s not been since the early 1980s that we had a serious measles problem in the United States, and that was just because we failed to appropriately implement vaccination, not because of a lack of finances or products. But, still, we have to ask the question, How far will this go? How do we deal with the profit motive in the industry, satisfy profit needs and still make product that’s needed? An example today, at CDC they’re having a meeting— it probably has finally ended by now— to discuss meningitis vaccine. And the big question is whether or not America is willing to spend $80 a dose to vaccinate children for meningitis, and whether or not it would be a cost-effective thing to do. As you go down the list there’s— well, I remember hearing very similar controversy over the original Haemophilus B vaccine, that it would be $50 a dose or $40 a dose and therefore be unaffordable and impractical. And the price to you now is— what does UNICEF pay for Haemophilus B?

BELLAMY: I’m sorry, Hib is still not financially sustainable.

GARRETT: What is [it], roughly?

BELLAMY: I don’t know. Does anybody know this? I’m looking at people here. How much?

GARRETT: But it’s still unaffordable. What is affordable for a vaccine?

BELLAMY: It’s not— I mean, nobody is talking about back to necessarily the level— I don’t think we’re talking about getting back to the level of what I call the EPI [expanded program on immunization] vaccines. But one of the problems that’s occurred that we’re challenged with, in terms of the more recent attempt to accelerate the introduction of underused vaccines or user— not underused, but not new in the sense that they’re not tested into developing countries— is that the budgets of these developing countries can’t accommodate them yet, and how do we sustain them? And we’re not able to sustain them.

So hepatitis B, which was already on the market, and which they could take that into account, actually has been— hepatitis B now with this accelerated introduction actually has become what I call a routine vaccine. On the other hand, Hib is not.

GARRETT: All right, for those of you who have not been here before, a couple of quick Council on Foreign Relations rules and then the mikes will be made available for your questions. Rule No. 1 is you don’t give speeches— you ask questions. Now, if you need to say a few background sentences to explain— lead up to your question, that’s fine, but this is not a place for speechifying. Rule No. 2 is please wait until the microphone is in your hands before you start asking your question. And rule No. 3 is please identify yourself. So, with those rules in mind, we have a hand right here. Scott, if you could bring the microphone.

QUESTIONER: Thank you for these presentations. My name is Joel Cohen, and I’m from Rockefeller University and Columbia University. You mentioned that there are 37 million children not immunized currently. The UNICEF Institute of Statistics estimates that there are 112 million children not in primary school who are of primary school age. My question to both speakers is: Do you think there is a potential for a synergy between education systems and public health systems to offer immunizations as an incentive to get children to go to the schools and to enhance the capacity of children to go to school by improving their health?

GARRETT: Carol?

BELLAMY: Well, I think we have to immunize them before they’re of school age. I’m only smiling, because when I was in New York City government I thought there was a relationship between schools and immunization. I mean, I came in city government in 1977, and we discovered that about— I’m sorry, “we” didn’t— CDC had been to New York and discovered that about a third of the kids in 1977 in the New York City school system were not immunized. Why? Because we get all these immigrant kids. And so we had to create a “no shot-no school” situation.

In developing countries, I don’t think you can wait until school, because you don’t have— you barely have the infrastructure in the schools to educate kids, certainly not— I think you have to— I think you can’t wait that long. I think you have to do the immunizations first.

GARRETT: Don’t immunizations mostly have to come before age 5?

BELLAMY: Absolutely. It’s just too late. You could do maybe some catch-up. It’s much too late in the process to connect it to schools at this point, and the education systems are weaker than the health systems in most places.

GARRETT: Laura?

STEPHENNE: I think vaccination is to occur during the first six months of life. We have no choice.

QUESTIONER: Hi, I’m Laura Efros with Merck Vaccines. You talked about some of the challenges to immunization as access, infrastructure, HIV. But you didn’t say very much about political will and by that of developing country governments and of the donors, particularly as we get closer to having vaccines for diseases like malaria that are based on more expensive technology. And the price will never be able to be as low as something like polio. What can be done to make immunization a higher priority both for governments of developing countries and donors?

BELLAMY: First of all, I think if you look at most donor countries, the majority of funding for immunization is still— I’m sorry— most developing countries— the majority of funding for immunization is still from donor countries. Developing country budgets still are not putting money into immunization.

Now, good news— I’m sorry this is all developing gobbledy-gook, but one of the indicators in poverty reduction strategies, PRS— but this is in your poorest countries— one of the indicators is immunization coverage. Now, that has to be pushed and emphasized. But the reality is the majority of funding to this very day for immunization in developing countries is covered by external donors.

No. 2, with all due respect, and the great thing about the investment of Gates and the creation of this Global Alliance— again, investment of Gates is largely in the vaccine fund, and then the Global Alliance is a bigger group— is one of the things that these global funds are starting to create is a sense that immunization is being taken care of, and there’s no need for increased investment in immunization.

GARRETT: Complacency.

BELLAMY: Yes, complacency. And that is unfortunate. Third, frankly, the majority of investment by external donors in immunization these days is still in polio, and it’s not in routine vaccinations. And that is really devastating, because in the long run, unless we have routine immunization— I mean, you’re not going to get the new vaccines in unless you can get your garden variety vaccines in, because you need the cold chain to get that basic EPI vaccine in. And so there needs to be an enhanced understanding among governments themselves and donors of the importance of immunization. But we’re not there. I’m sorry, I’d like— I don’t want to keep talking negative— there are so many good things happening. But there are still these negative things.

STEPHENNE: I want to make two comments. I think that the vaccine industry provides the vaccine to a reasonable price, I think, but you cannot ask the vaccine industry to provide the vaccine for nothing. And we are still some time in this [inaudible], and if I look to a child who is immunized in the United States, probably it cost $500, right? For the child, for the vaccine. And you are discussing sometime, oh, $1 is too expensive to immunize a child in a developing country. And for me I think we need to leave that debate, because you see it’s a question of political willingness to get money allocated to vaccinations. And then I think for sure if we find that money, the second thing we need to do is to develop the infrastructure to make sure these vaccines are being given at the right place. But if we don’t leave this debate, I think we will continue for another 20 years to say, “Yeah, the vaccine industry is not doing this, or the system is not working.” I think we need really to have the political willingness. And then you see I give sometime the image is that when you want to sell a vaccine in the United States, OK, it’s a good bottle of champagne, right? And we are debating for the developing countries that the price of security is too expensive to make a vaccine for developing countries. And it’s wrong. It’s the wrong debate. And you see vaccine manufacturing is complex. Vaccine research and development is no different to any other drug. And the vaccine industry you see like us, and like for other companies, we are building plants in India, we are building plants in China, to have the lowest possible cost that is— truly impossible. We cannot reach the impossible.

GARRETT: Either the wealthy— the wealthy world currently controls— nine nations control about 71 percent of global wealth, and when you get down to the countries we’re talking about, they really are in desperate need of global assistance for immunization— you’re down to the bottom 4 or 3 percent of global wealth. So one way or another, money has got to shift from column A to column C, and probably also support to column B, for the middle-income countries— or you’re not getting there. And so, what’s the incentive for column A to allow its money to shift in the direction of need ? The incentive— if you’re speaking of it in a foreign policy context— I think you need to tell us what happens if epidemics emerge because of lack of immunization. And are people in the wealthy world likely to be afflicted or are we adequately covered? I mean, when we talk, for example, about our current flu shortage, the question is, would we ever be able to have ample flu vaccination to deal with a true pandemic? If we had a 1918-type pandemic again, would we ever be able to protect even the wealthy world? So if you take that beyond to get to the point where we’re saying what Carol is talking about— routine immunizations integrated into routine health care, available on a constant basis, uninterrupted and not part of campaigns, then you’re talking about a sustained level of fiscal commitment by the wealthy world that right now seems unimaginable to us, or—

BELLAMY: Or an understanding of the developing countries of the critical nature. First of all, ministers of health are generally not your most important ministers. They’re not the least important— I’m mean, the ministers of family and women. But the ministers of health are not much above that— I’m sorry. Secondly, there are new trends in development financing. One trend, and which is a good trend on one hand, which is direct budget support, which is not having it go through a million different organizations, but give it right to the government. But then the government makes the choices. So that goes back to the political will even more. There is some pressure on the part of the government to make sure it goes in, among others, into health. But these countries are not so different from us— they want to put it in hospitals.

GARRETT: Buy MRIs [magnetic resonance imaging].

BELLAMY: Well I don’t know— buy MRIs, but put it in hospitals rather than put it in preventative health.

GARRETT: All right, let’s take some more questions.

QUESTIONER: Seth Berkley, the International AIDS Vaccine Initiative. If I could just make a quick comment and then a question. Following up on what Carol just said, we are in a way making this a false dichotomy, talking about immunizations, which is the most cost-effective mechanism— and I agree with the issues we’re not valuing them enough. But, again, it’s prevention that we’re not valuing enough. We always overvalue therapeutics, we undervalue prevention. And this needs to be a shift in all cultures, particularly in the cultures here. When we think of what our ratio of expenses on prevention or treatment, it’s pretty horrible.

Question. Most— we’re shifting more, and more, and more of the vaccines— at least the commodity vaccines— is being produced in the South. Most of the industry in the South— the pharmaceutical industry in the South— is interested in producing products that are going to go to the wealthy markets in the South. What do you think, Jean Stephenne, is the future of the vaccine industry in the South? And, in particular, will they move more toward the R&D [research and development] side of things and begin to be the place where new vaccines are coming out of? Will they continue to be on a commodity focus, or will it be some type of partnership? How do you see that playing into where we might be in vaccines in, say, 2050?

STEPHENNE: I think that your question is more than the vaccine. I think it’s all about my industry. I think that if India wants to be, for example, active in the pharmaceutical industry, we would ask also that they respect intellectual property if they want to reach the open market, the U.S. market. You must have a fair balance between—

QUESTIONER: There will be some gaps—

STEPHENNE: Yes, so it means that actually I believe that India has the capacity to be innovative and develop new vaccines. You go into Korea, it’s the same. It’s not true in each country of the world, but there are countries who are reaching that stage. So that’s why like GSK [GlaxoSmithKline] we’re investing in India, and we are doing some research in India. We are doing some development. And this is the way globalization is taking place. But I think sometimes I compare the vaccine industry to the car industry. Does it mean that Europe or United States manufactured the car for China? No. China is manufacturing its own cars, and it’s a little bit cheaper and it’s a little bit different. So I think the vaccine industry is going through globalization, and that is taking place. Does it mean that it will be present in each country of the world? No. It will be present in the major countries of the world, which means you cannot justify from return on investment to have a vaccine industry in each country of the world. It doesn’t make sense. So if I take it for hepatitis B, yes— if you have two or three plants in the world who manufacture hepatitis B, that’s enough. You reach economy of scale. There will not be 20 plants manufacturing hepatitis B. It doesn’t make economical sense. So it means that for each vaccine there must be a few manufacturers and a few plants, but there will not be 10 or 20 plants. The market doesn’t allow it. And I think more and more for the new vaccines, I think some of these vaccines will be manufactured in India or in China or in Korea.

GARRETT: Brazil.

STEPHENNE: Yes, for sure.

GARRETT: But there [is] no guarantee. And certainly the current track record shows that there is no guarantee that a Southern manufacturer is any more interested in making a product that people really need as opposed to a product that is a high-profit center. I mean, there are many generic manufacturers in the Southern Hemisphere cranking out Viagra and sons and daughters of Viagra right now.

STEPHENNE: But you see, if you start to do vaccine manufacturing, the first thing you need to do is to guarantee quality. It’s not like to make— I don’t know, a pill, a chemical pill. I think vaccine manufacturing is a bit more complex. And if you don’t guarantee quality, you will kill perhaps children or you will kill people, or there will be lack of efficacy. So I don’t believe in the model of technology transfer. And I have said it many times, and I am repeating, but I believe in a model where— GSK is building its plant in India, is sending people to control exactly what they are doing and the quality, and you guarantee the quality. And then you will have for sure some cheaper costs. But does it mean that the vaccine has to cost $1? I don’t believe so. I don’t think that if we continue with the image that each vaccine has to cost less than $1 it’s possible. The new vaccines are more complex. The new vaccines must be well manufactured.

Take the incident of polio manufacturing— I think it was two years ago in India. Look at what’s happening here today. So we have the flu manufacturing problem. Last year Aventis had a problem with [inaudible] vaccine which was manufactured in France. I think GSK, for example, two years ago had difficulty to manufacturing various [inaudible] vaccines. So we were out of the market for a few months. It happens each month. I am coming from the manufacturing. And if people believe that you can manufacture a vaccine like this, it’s totally wrong. And I think people don’t want to recognize the complexity. And then you make a mistake, and then you are in trouble I think. That’s what’s happening.

But this— we come back to what is the value of vaccines to society, and that’s for me the basic question. And we entered into too many debates to say five years ago, 10 years ago, there was an attack on the vaccine industry to say the vaccine industry is not developing vaccines for the developing countries. So now people have to stop to say that, because there are many, many new vaccines coming. And now who will pay for these vaccines? That’s the real question. And—

GARRETT: Who is the buyer?

STEPHENNE: Yes. And for me, don’t ask the developing countries to spend $10 to purchase the vaccines. They don’t have this money. They are suffering of poverty. As you said, they are under war and all that. So it means this is a social responsibility of the West, and this is what we need to discuss.

GARRETT: Another industry representative from Becton, Dickinson.

QUESTIONER: Thank you. My name is Gary Cohen. I’m the president of BD Medical. And I would like to return to a point Laurie had raised about injection safety and provide just a minute of historical context, because there is a major public health issue that exists in the developing world that is not well understood in the developed world. Injection therapy is largely a 20th century pharmaceutical. The first injection of insulin occurred in 1922. The first injection of the first antibiotic penicillin occurred in 1942, and the mass immunization of polio as an injection in 1954. During that time, injection therapy also grew in the developing world, and in fact today the average number of injections given in the developing world per capita is actually higher than in the developed world. But there was a critical difference. There was a divergence in the early 1960s when developed countries introduced mass scale of disposable sterile devices and instituted procedures that were completely intolerant of reuse of disposable devices, whereas in the developing world right through to this day the use of glass syringes that are reused without proper sterilization continues to exist, and even disposable devices are routinely reused. WHO estimates that roughly, in places like India, over 70 percent of injections are unsafe. And, by the way, Carol Bellamy was being very modest: UNICEF has taken an extraordinary leadership role on this issue, because today 70 percent of injections given to children— immunizations— are safe, because the technology won’t allow the syringes to be reused. It physically locks after a single use.

The question I have is that there is a big challenge that lies ahead. The majority of the developing world is giving unsafe injections— the leading cause of hepatitis-spreading in the world— roughly 23 million new cases of hepatitis, at least two million deaths per year.

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