Losing Ground in the Vaccine Fight? Denialism, Measles, Polio, and Mumps - Old Scourges and New Problems
LAURIE GARRETT: Good morning. I recognize most of you, but for those who may not know, my name is Laurie Garrett. I run the global health program here at the Council on Foreign Relations.
And those of you that may not have been here before, I'd just remind you that we do consider it a bit off-putting if you're examining your BlackBerrys, BlueBerrys, MonoBerrys, iPhones, et cetera while others are speaking. And of course we don't like to hear it ring, so please adjust your devices accordingly.
We'll try to keep the food and coffee out there in case any of you just suddenly feel highly hypoglycemic or caffeine deprived.
And today's discussion uncharacteristically for us is on the record. We home that everybody will still feel free to be relatively candid, but you should know that Seth Berkley has only been in his position now for about two months, and it might be premature to put him in a position of trying to answer some highly controversial issues related, say, to the GAVI budget on the record at this time. But I think we have very important things to talk about without forcing either individual to get into sticky territory that makes them uncomfortable on the record.
We're here for a couple of reasons. One is to celebrate that after four years of work we here at the council in the global health program are launching today our new interactive chart, completely embeddable on anybody's websites. It will auto-update on your website if you put it there, and we welcome and encourage everyone -- open source -- to make use of this.
What we have been doing is acquiring data -- and I'm going to ask Zoe Liberman, who has played the lion's share of the workload on this for the last roughly six, seven months as we've really surged towards finishing this up -- Zoe, perhaps as I'm talking you can maneuver around --
ZOE LIBERMAN: Sure. Let me --
MS. GARRETT: -- and sort of show some of the features.
But the key point is that we will be constantly, on a weekly basis, updating this. It's based on -- it just went away. You just killed it.
MS. LIBERMAN: Oh. I do not know how that happened.
MR. : This plug is loose.
MS. LIBERMAN: Oh, that's -- sorry -- my fault.
MS. GARRETT: OK. There we go. You're back.
MS. LIBERMAN: Oh, OK. Sorry about that. (Laughs.)
MS. GARRETT: Let me screw it in while you're -- go ahead.
MS. LIBERMAN: OK. I was just showing -- you can see the source of the data, the impact scale, the number of cases, the date, and you can even click on the source and find the news article and then return. So it's all -- it's different news articles -- well, so that -- it's going to be live on the website today.
And you can search by disease; you can search by region and go into different regions. You can also search from the dates that we've been monitoring. And we're going to update this and continue to update this. And you can download the data source, you can embed it, you can share it on a variety of social media. And it's a very useful tool to see different sources of outbreak and see how huge a problem this is.
You can also submit your own points with the data.
MS. GARRETT: One of the key reasons that we started this is that I began to realize back in about 2007 that there wasn't much correlation between the sort of gross overall numbers provided by various U.N. agencies and government agencies regarding their success rates in vaccination and outbreaks and what have you, and news reports that were coming out of all sorts of news sources around the world.
Now, since it does rely on the news reports, you have to consider things unverified. But I think one of the things we're going to talk about today is just how well verified are even the databases that we consider the official databases. (Laughs.) If Pakistan tells you a number of kids that have been vaccinated, do you believe that number?
MR. : No. (Laughter.)
MS. GARRETT: So -- we're getting there. (Laughs.) He's so hot to shoot out of the cannon.
So I want to -- I acknowledged Zoe Liberman's efforts. I also want to acknowledge the company MediaStorm which did the final assembly for us, and our team of backers at CFR.org.
Why did we spend so much time at the Council on Foreign Relations trying to track outbreaks of measles and mumps, including in places like Marin County, California? Well, a few reasons. First of all -- first and foremost, the United States, if you combine public and private giving, is the number-one donor and has pretty consistently been the number-one donor for vaccine efforts worldwide. If you combine the well-over $1 billion collected by rotary club chapters, the Gates Foundation, United Way, UNICEF, U.S. government and big, small and generic pharma, you come to a pretty astronomical number over time. Most recently -- and I'm sure Seth will mention this -- we have a huge input from the United Kingdom as well.
We're so close on polio eradication that it hurts. We're down to the last 1 percent, and it's going to be a real challenge to deal with that 1 percent. I hope to have a few minutes to update you on some data I obtained just this weekend. And the United States and the U.K. have become major exporters of carriers of these diseases, of the six most common vaccine-preventable diseases because of the rise of denialist movements and anti-vaccine movements inside our countries. So we are actually exporting measles. We are exporting mumps.
And finally, as we started accumulating news reports over time, we could see a trend, and the trend is not a good one. Even if you say that the absolute numbers of measles in the world, the absolute numbers of pertussis, of typhoid, what have you, have gone down, the numbers of these seemingly spontaneous outbreaks or of sustained, real epidemics such as we now see in the Democratic Republic of Congo with measles, are -- the trend overall is very disturbing.
And then I think -- final little -- you know, from the science person here -- troubling finding -- it has been that if we look at some of the animal models where we heavily vaccinate in animals, particularly some of the newest data with the H5N1 so-called bird flu virus, we can see that where vaccination is used at a very high rate but not a full-coverage rate, we're promoting evolution of vaccine-resistant virus. And if this were to begin to be a real trend in human populations, we would be in very, very serious trouble.
So, why are we seeing this trend? A couple things stand out. Again, they will be extremely obvious when you start navigating our vaccine chart. One is that we're seeing an uptick in preventable viral diseases in very wealthy areas of the world. I think at this moment the highest rate of vaccine-preventable disease is in Marin County, California, and it also has one of the lowest vaccination completion rates in the world. And that's because a lot of wealthy folks think it's not in my backyard. I don't want that probably completely nonexistent risk that my child will be autistic as a result of vaccination or that there will be a breakthrough infection as a result of vaccination, so I will not agree to the social compact of vaccination and public health.
On the other side we're seeing upticks in resource-scarce areas, particularly where conflict is involved and where local public health is highly dependent on external support, and the external support may be variable -- may not be consistent -- whether it's in the supply chain or dollars or what have you.
And then finally, this is the first time that -- in my memory -- since the 1976 swine flu epidemic that the very issue of vaccination has become a national campaign issue in the United States, largely because of Michele Bachmann's statements about the HPV vaccine.
So, I want to first ask our two wonderful guests -- and if any of you for any reason are not familiar with either Seth Berkley or Sophie Delaunay, I urge you to read their bios. I'm not going to waste a lot of time going into that, but we're very honored with their presence -- couldn't ask for two better people to have this conversation today.
I want to ask each of you to begin by giving us an overview of how you see the lay of the land at this time in terms of the most obvious and basic vaccine-preventable diseases -- before we get to anything like the introduction of new vaccines or relatively new -- how you see the situation. What's your sort of overview?
Seth, why don't you start?
SETH BERKLEY: Thank you, Laurie. And I'm delighted to be here with all of you. And of course I'm happy to take questions on the record. I just won't be my irascible, normal self. (Laughter.) I will be more diplomatic -- use constructive diplomacy here.
Today also -- Laurie didn't mention -- is World Polio Day, and so it's a day that the world is celebrating the effort that's going on on polio eradication. And has Laurie has said, we are close, although there remain a number of hotspots, and I suspect we'll come back to those over and over again because they're important on the entire vaccination area.
I do want to make one comment before I talk about the overall vaccine status, and that is about your issue of non-vaccinating and the associated logic with that. And it really is interesting because if you -- if 100 percent of people are vaccinated and you are the one that's not, of course there is logic to that, and all vaccines do have side effects, whether it just be sore arm or, you know, fever or others.
The problem is that you begin to build up a number of susceptible cohorts, and then you end up with these outbreaks and they're really horrible. And we're now seeing deaths. So we're seeing, you know, the granola generation of parents who now are, you know, hoping that they're doing something good for their kids, and now we're seeing that they may actually kill their kids or lead to terrible sequelae.
And how we're going to get people to remember this -- because the magic of vaccines -- and this is really the problem -- is that if you were living in the Democratic Republic of the Congo right now, you know what measles does. You know, it rolls through a community, it kills the most vulnerable, you're burying -- there are child graves the next day -- there are all kinds of sequelae. But if you're a practicing doc in New York City, you're not familiar with these. And if you're a parent you haven't seen it and so you don't remember what's going on.
And so, you know, do you scare people into doing that? It's hard to do, and yet these are very, very serious diseases. We consider measles to be the canary in the coal mine of vaccines because it is so easily spread, much more than most other infectious diseases. And so you really have to have extremely high coverage to block the spread of the disease.
That's unlike some of the other vaccines that are out, like Haemophilus influenza type B, where when you get to pretty modest levels of coverage you begin to see a herd effect. And this is one of the magic of vaccines is that it isn't only the individual that's affected. As a person is vaccinated, becomes immune to that, they're not carrying it anymore, it's not being spread. And so what you can see is, with modest levels of Haemophilus influenza type B, for example, the disease doesn't disappear completely but virtually disappears. And so we have to keep that in mind as we talk about the different vaccines that are out there.
So, to get back to Laurie's question about the state of vaccines, we're in better shape worldwide than we've ever been. So right now the number is about 82 percent coverage with -- the one number we use is DPT3. That's diphtheria, pertussis and tetanus-3. And the reason people use that number is for those three vaccines, which are bundled together, you give three doses of the vaccine at six, 10 and 14 weeks. And it's a good look at the strength of the immunization system if you complete the third dose.
Other people have argued, by the way, that measles is a better indicator, and we're actually debating that now. In fact, we'd like to obviously do both because -- one point Laurie made that's very important is the reliability of data out there is not at the level we need. And I'm happy to give you examples of that, but we know it's not. And we must improve that because if we're going to do a better job at dealing with this, we have to have better data and we have to have real-time data, and that's not what's available.
So, 82 percent of the children are vaccinated. Now, the problem is that doesn't really tell you what you need to know, and that is, in a country, in a -- down to a district level, out to the rural areas, who's note vaccinated. And of course, what you tend to have is you tend to have the stigmatized, you tend to have people in very rural areas, you tend to have people that are -- for whatever reason the very poor aren't able to get to the system. And so those people also happen to be at higher risk not only for disease but then if they get disease, they're more likely to have death or sequelae because they don't have access to treatments, et cetera.
So Tony Lake, who is the head of UNICEF, has describe this -- the fifth child syndrome, and he is making an effort now at UNICEF, which is very welcome, to return to the roots and get focused on equity as an issue. And in that case what they're saying is we want to spend the extra money -- because it's much more expensive to reach that fifth child, but that's where you're going to have the bigger bang for the buck because they are the ones who have the worst sequelae.
So, if you -- if you ask, you know, how we're doing on immunization -- in some places, very well. But you look at a place like India where the coverage rates -- India has the largest number of unimmunized children in the world. They also produce most of the vaccine that's being used in the developing world, so it's a -- it's an interesting situation. But they have about 7.1 million unimmunized children. But if you go to India and break it apart by districts, you see some places have coverage rates of 30 (percent) to 40 percent, some have coverage rates of 80 (percent) to 90 percent.
So we can't think of these places in -- you know, as a -- homogeneous countries. We had a former president who used to talk about the country of Africa. And we really have to break it apart, and that is one of the challenges because to do what we want to do, which is to save all these lives -- now, the children's -- the number of children dying has dropped, you know, now below 10 million down to 8 million, but if we're really going to meet the millennium development goals, we have to do a better job rolling out these vaccines.
So, last point I'd make is that if you look at the other vaccines that are now considered traditional -- I don't know if you consider just the original six -- that's BCG, which is tuberculosis; diphtheria; pertussis; tetanus, which we just talked about; and measles -- those are the kind of traditional vaccines -- and polio, sorry.
More traditional today are the hepatitis B vaccine -- it's been an extraordinary story. Hepatitis B used to kill about 3 million people a year -- and still does actually because we're just on the tail of that -- from liver cancer. It's a big, big problem. It's one of the chronic diseases that kills people. And immunization rates now across the world are around, you know, 70 percent, so -- and they're actually higher in the developing world than they are in developed countries -- or a lot of developed countries. So that's a good success story. Haemophilus influenza type B, somewhat less -- and, you know, there's now a series of new vaccines that are coming forward for pneumonia and diarrhea, which are the two largest killers of the world. That's my priority to roll out now -- HPV, hopefully about to start, and a range of other vaccines.
So we can talk about those later. I'll stop there.
MS. GARRETT: Sophie?
SOPHIE DELAUNAY: Thanks. Thank you, Laurie.
Can you hear me?
MS. GARRETT: Yes.
MS. DELAUNAY: Should I bring the mic -- OK.
Thanks, Laurie, for inviting me. And I'd like to corroborate Seth's statements, but maybe by providing a field perspective to the issue and focusing on measles, which is actually the disease for which we have experienced the largest number of outbreaks in recent years.
In 2009 I think there were 30 countries affected by measles, and in 2010 there were 28. And for us as an organization in Doctors without Borders, we've literally run after outbreaks over the past years. In 2010 we vaccinated 4.6 million people, and by August this year we had already vaccinated 3 million, the vast majority in DRC, as you mentioned, Laurie, which is quite actually -- ironically, this comes after years of intensified default where, as you've said, vaccination coverage has increased from 52 percent to 80 percent.
So there are of course multiple and complex reasons for these -- for these outbreaks, but although we can't go in detail, we need to understand the causes at least at operational and field level if we want to address these challenges. And we also need to acknowledge, which is very specific for measles, that these outbreaks are more a failure to vaccinate than a failure of the vaccine itself.
And there is definitely -- Laurie, you raised the concern about the accuracy of the data. Clearly the vaccination coverage that we have or that we are provided are obviously inaccurate. But not only are they inaccurate but they also lead to biased risk assessment, which as a result are responsible for these outbreaks. There is also a very weak surveillance system that goes with it, resulting in late detection of the cases.
Also, the fact that the -- these outbreaks are a failure to vaccinate makes the recognition of the outbreak itself very problematic and very challenging, and we most of the time have a late recognitions by the country that there is actually an outbreak going on -- not to mention, of course, lack of coordination and if not competing priorities, and maybe this is something we can -- we can talk about when you have to engage -- when a ministry of health has to engage in different vaccination campaign and eradication initiatives. Then in the end these health priorities are competing with each other. And there is certainly a lack of comprehensive approach to this issue.
There are also -- (inaudible) -- level of course -- timely vaccine availability problems, timely funding. I will explain a little bit more. But overall it's very complex logistically to vaccinate because the products that we are using -- how efficient -- they are effective, but they are extremely difficult to manipulate, to administer, and this will remain regardless of the resources and the attention -- the political recognition of the problem. They actually are also responsible for delaying the response.
So what could be done from our perspective in two ways -- first to prevent outbreaks and second to respond to these outbreaks? And the response is actually quite different whether you want to address the prevention side or the response to outbreak.
Of course preventing the outbreaks is about minimizing the number of susceptible, and there are a series of limitations that we face on the ground like the age restriction, which seriously limits the vaccination. Just as an example, measles is administered at nine months of age, right after the DTP has just taken place. So I'll let you imagine the constraints and the lack of motivation at the national health level and within the health staff of addressing again, after a few months, the measles issue.
So there are definitely opportunities, maybe by revisiting these age restrictions, by broadening, by getting more flexibility in this area in reducing these opportunities. Comprehensive package of care is also for us a priority that we are trying to address on the ground -- that is taking advantage of being in contact with the mother and the child to actually provide the whole package of care at that moment. If you're dealing with malnutrition then you can add vaccination; if you're dealing with malaria then why don't you make sure that the kid has received the proper package?
We also -- we had this discussion with UNICEF recently about how to reach the unreached -- that is, the children who have never been vaccinated in the past because indeed we realize that they are much more vulnerable in this situation. And this is certainly a challenge and an ambition that will require totally different approaches to vaccination in terms of operations.
And of course more accurate data -- (inaudible) -- it goes without saying that this is -- this is one aspect that would help us address or prevent outbreaks.
Now, in order to -- when it comes to the response to outbreaks themselves, we believe that one critical aspect is actually to acknowledge that it's OK to have outbreaks. It's a natural thing to have, and when you look at this interactive map you actually realize that, you know, it's happening in a lot of countries -- in Europe, in the U.S. So the political acknowledgement of this outbreak would be the first step toward addressing it.
Having -- for example, having the response to outbreak, therefore, as a part of the policy, having the response to outbreak part of the measles initiative, having the response to outbreak -- an operational and legitimate -- (inaudible) -- of the national policies would actually make things easier for us to intervene.
There is also certainly -- although the vaccine -- the measles vaccine is quite an affordable vaccine -- it's 30 cents a dose -- it's one of the great success and most accessible vaccines -- but there's still a need for renewed funding commitment to the old vaccine. There is currently a legitimate focus on newer vaccine like pneumococcal and rotavirus, but there is a need to keep -- to maintain our funding commitment on this vaccine. I think that the measles initiative is facing a funding gap of about 47 million (dollars) in 2011. So we should certainly not give up on these efforts.
Just to finish, I would like to highlight what would be for us as operators on the ground what would be a game-changer, what would really make things different. And it would certainly be more adaptive products to be able to respond to outbreaks. And being able to use vaccines that are heat-stable would dramatically reduce the logistic burden with the cold chain. Being able to use vaccines that are needle-free would also be extremely useful, with fewer doses to administer because it makes a great, great difference when we have a vaccine that needs one dose and a vaccine that needs three doses. You need to -- especially when you're dealing with displaced population in a conflict area. In very volatile places it's really a challenge to be able to follow through the whole protocol.
And in this more adaptive product we also think it's absolutely necessary to maintain a wide variety of products. You would need multi-vial doses when you're running large vaccination campaign or in a district or provincial hospital. But if you really want to reach the unreached and go in very decentralized areas then you need to have, you know, single-dose vials -- single-dose vials and products that are adapted so that you don't need highly qualified staff to administer them.
So this would be, you know -- in an ideal world this would be what we would need as a medical organization to address the needs.
And just to finish my comments, I'd like to say that although measles is not a -- might not be the best example because, as we say, the vaccine is quite accessible, the problem of affordability of vaccine remains and is a great matter of concern to us as we anticipate the introduction of new and very effective vaccine. And despite the fact that GAVI is subsidizing a lot of them, we do believe that in the long run these vaccines are not affordable enough and accessible enough for the countries who will benefit them. So that's one concern.
MS. GARRETT: So many excellent points covered and very concrete.
I want to make sure that everybody here in the room knows what the phrase "maintain the cold chain" means. So without embarrassing anyone I'll just give you a two-sentence and you can pretend you already knew.
Several of our most important vaccines have high temperature sensitivity. They will be rendered useless and in some cases I believe even toxic if they are allowed to remain at high heat for a high amount of time, and of course much of the world we're targeting is tropical heat. And so it is absolutely essential that you maintain the so-called cold chain, that your vaccines, from the moment they reach the country all the way through to the moment when they're administered as drops or needle injection to child, that they maintain the proper temperature range. And this proves to be extremely difficult, especially in countries where refrigeration is simply not available.
And I want to -- I want to jump to something that just -- I just managed to get ahold of this weekend. I was fortunate to be on a retreat this weekend with, among other people there, Ellyn Ogden, who runs the entire U.S. polio eradication effort for USAID with a staff of one -- herself -- and Gregory Fontenot, the retired major in the United States Army who runs the so-called red team program at Fort Leavenworth.
You may not be aware, but the military realized that most decision-making processes in the United States military were stupid -- (laughter) -- and that in particular what we trained our frontline troops to decide at a moment of gunfire, of every single element working against you, were antiquated and the decision tree was not appropriate. So they created this process called red-teaming, where individuals in the military are trained as professional skeptics and in every decision-making point they ask all the questions people don't usually ask. And the result has been a dramatic change in a lot of the decision-making processes within the United States military.
So Ellyn Ogden asked how can we conquer this last 1 percent with polio when it's just been rigidly stuck for a very long time and the only real shifts have been which countries were the hotspots at any given moment? And so she had the military come in, train her in red-teaming. She in turn ran the entire Gates program and the WHO programs through red-teaming. And the result has been a dramatic reappraisal of what you need to do to get to what UNICEF is calling the fifth child, what polio would call the last hotspots. And in particular the main outcome of it has been a recognition that if you want success at those last hard-to-reach areas, you have to make your vaccine teams on the ground 95 percent or more female because those mothers will not let the man in the house. Will -- you're taking about areas where gender issues are very high.
So as a result of shifting to red-teaming, between 2010 and 2011 they went from India having -- let's see, what was the number -- oh 741 active identified polio cases in 2010 to one in 2011, and Nigeria going from 388 active cases in 2010 to 34 in 2011. With fundamental reappraisal -- we can't just keep doing what worked all along for the first 90-plus percent. We have to come up with new strategies.
So when you go beyond polio and think about these last intractable hot zones -- putting aside this horrible fact that in the United States and Canada last year we hit the world record for the number of active measles cases in wealthy countries, the highest levels since the early 1990s, with 214 identified cases in the United States; 783 in Canada; 90 percent never vaccinated or didn't complete vaccination, most of them in upper-class communities.
MR. BERKLEY: (Off mic) -- is doing better this year.
MS. GARRETT: Oh, that's good.
But how -- if you were to imagine just getting in there with full-out -- and you're new on the job so you have that opportunity as the new CEO to shake GAVI up -- if you're imagining, let's get in there -- GAVI, UNICEF, MSF, all the major players, let's red-team this and just ask ourselves have we been -- are we -- is what we've done that got us this far going to continue to work or do we have to rethink from the bottom up our whole strategic approach?
MR. BERKLEY: Well, first of all -- you have lots of questions there. (Laughs.)
The -- GAVI is an alliance that works on the 73 poorest countries. So it's -- it used to be 72 but South Sudan has now entered. And it's countries below 1,500 gross national income. And what's interesting about that is that's an important part of the world, but what's also interest is that today because partially of success of GAVI, you actually have three-quarters of the unimmunized children are actually in the lower-middle income countries, not in the low-income countries. So that's a huge challenge.
So one of the things you'd have to think about is how do you extend this effort up into those countries, which -- you know, some of which are buying market -- you know, vaccines on the open market. The prices are extremely high, they're not nationally coordinated, they don't have -- they have stock-outs, et cetera. So that's one big point.
To Sophie's point, we'd love to have heat-stable vaccines. Between the time that Jim Grant announced universal childhood immunization in 1990, there was an organization that was formed pre-GAVI, which was called the Children's Vaccine Initiative. And if you don't study history you're doomed to repeat it, and the Children's Vaccine Initiative brought together industry and public health people and said what we need are vaccines that are heat stable that are easy to use. And they said, what's -- industry said, what's the biggest priority? And they said what we need is a heat-stable polio vaccine.
So industry went off, they spent a couple of years, they came back and they solved the problem. They had a heat-stable polio vaccine you could leave out in tropical temperatures. And at that time the world Health Organization said we don't want to change the vaccines in the system. It's going to create a crisis of confidence. Forget about it. And, you know, it took almost a decade to recover trust between the public sector and the private sector after that.
So we do need better vaccines, but the question is where are the incentives?
Third point -- and you talked about cold chain, both of you. Right now for the developing world one of the things we use is we use multi-dose vials because cost does matter. And "fill-and-finishing," which is the term used to put the vaccines in the bottles and, you know, label them and store them and put -- you know, transport them, put vial monitors on them to watch temperature, et cetera -- is quite expensive part of the process. For some vaccines it's the most expensive part.
And so what's happening with that is thimerosal, which is a preservative -- a mercury preservative -- was also thought to be, by the same parents who were worried about vaccine, a problem. You know, they thought mercury's toxic and therefore mercury shouldn't be in vaccines. There is no evidence to suggest the particular type of mercury in vaccines is a problem, but it has -- because of all this concern, they have taken mercury out of vaccines in the West.
And so of course, then what happens is you say, well, in the South -- clearly you know in the West it's toxic, you know, even though you're not saying that. And so there's a huge problem, and right now the U.N. environmental program is talking about banning mercury, which would mean no more multi-dose vials. Well, you can do a little bit of multi-dose vials -- you can have maybe two doses a vial without preservative, but you can't have 10 or 30 or 50 doses because if the vial was to get contaminated you would infect the children who were immunized afterwards. So you won't do that without a preservative.
So having a strategy to have, as Sophie has said -- the right, you know, tools, because the other problem with having single-dose -- it's more expensive, it's harder to transport, and you need more cold storage because of the volume of vaccine. And so this is a big problem in terms of cold stores around the world.
So, you know, to answer your question, those are some of the issues. Do we need a new strategy? Yes and no. The vaccines we have are pretty good. They could be better. There aren't the incentives necessarily for industry to go backwards. So when I talk to my industry colleagues and say what about getting a new preservative, not mercury, they say, you know, we're happy with single-dose prefilled syringes in the Western markets and, you know, we don't want to go and create something new and then go through the testing process because it might even raise questions about our vaccine. So they're not willing to do it. So we have to have other ways to do it.
So, yes, we could use better vaccines, and certainly the world is working on that -- the product development partnerships, the Gates Foundation and others. But the bigger problem, as Sophie said, is getting the existing vaccines out, and it's operational issues, it's how you connect on the ground, it's how you get governments to prioritize it.
So, the last point I'll make is that one of the things that GAVI is trying to do is not only build up health systems to deliver vaccines but also to work with manufacturers to figure out how to have better pricing, because sustainability is critical. Everybody who takes a GAVI vaccines has it co-financed, and the countries co-finance at a very low level to start, and as the countries economically get stronger they finance more. But when they graduate from GAVI at a GDP of 1,500, it is actually calculated that the amount they'd have to spend of their national health budget to pay for all the GAVI vaccines at the current cost is 0.6 percent of their -- of their overall health spend, which is -- if you think about the bio vaccines, is not a big number. The problem is it's a political commitment issue. This is the issue in India. India has money, they've got the ability to deliver; it's a political commitment issue.
So it's absolutely critical to get political commitments. We're going to keep working on better vaccine pricing. We're working with developing country manufacturers; we're working with partnerships between the North and South as ways of getting there. We've had dramatic drops in pricing, but at the end we've got to build up this type of political will, and that's perhaps the most important thing about a new way to work.
So I'll stop there.
MS. GARRETT: Sophie, you want to --
MS. DELAUNAY: Yeah. Maybe I react to -- actually I would like to react the question you asked Seth about where are the incentives. And I would respond by another question, which would be, for whom? Because if you ask a humanitarian medical organization or a ministry of health if they would like to have a more cost-effective treatment, vaccine or approach on the ground, there are very -- you know, very few of them who would be against that. And the story of treating malnutrition, addressing HIV on the ground clearly shows that when you are able to provide more affordable and more effective treatments or response on the ground then it makes a huge difference, and it's usually very well -- (inaudible) -- despite the burden of changing the strategy.
So I would actually think that's the issue of incentives is more from the pharma side and the manufacturing side. And we are quite concerned about the fact that in the vaccines, although it's very -- we acknowledge it's very different from the drug aspect and you cannot get a generic vaccine per se, but we believe there's still space for more competition. There are some mechanisms that can be put in place. GAVI is actually one of them, a successful mechanism to allow for more affordable vaccines. But you don't want -- you don't have the possibility of advance market commitments and partnership, but also prices.
And we believe that all these different instruments that could be mechanisms to stimulate R&D in this area have not been completely explored or developed so far. And if they have been, maybe not enough emphasis has been put to transparency of prices, competition -- promoting competition, et cetera. So --
MS. GARRETT: But I just have to play devil's advocate here with you for a second because Daniel Berman of MSF wrote a lengthy op-ed criticizing GAVI, and he described these advanced-market commitments as, quote, "corporate welfare that is scandalously expensive to donors and taxpayers and should be abandoned."
MS. DELAUNAY: Yeah --
MR. BERKLEY: Can I comment on that?
MS. DELAUNAY: Yeah, yeah, sure. Go ahead. (Laughter.)
MR. BERKLEY: It's very easy in the retrospecto-scope to talk about we could do better. And of course we can do better and we will do better, and maybe after which we'll -- Greg Simon will say something about, you know, what Pfizer is doing about this.
But the tragedy of vaccines was new vaccines would get delivered in the West, and the model was to have a low-volume, high-cost vaccine. And it would be 15 to 20 years before that vaccine would begin to get out in the developing world, and then there was a huge lag to getting it out. And of course that meant that children were dying, that new technologies would occur -- our children would have them but they wouldn't be available.
The AMC idea was to change that dynamic. And so what it said is we will give companies up front some of the profit they would have made if they kept the prices high if they will agree to drop the price. And lo and behold, they dropped the price from $97 public sector price to $3.50 -- a pretty big drop. And the Pfizer vaccine, as it was introduced, within one year was rolled out in the developing world. That had never happened before.
MS. GARRETT: Which vaccine is this?
MR. BERKLEY: PCV-13 -- the pneumococcal 13.
And so, you know, we can debate, could that price -- could Pfizer produce that vaccine for less than $3.50? Maybe. If you had just left the natural mechanism it probably would have taken 10 or 15 years -- I don't know what the number is -- to do that.
So what we're doing with these tools now is changing it and obviously building new relationships and ways of working. And we are committed -- this is one of my highest priorities -- to take on this issue of how do we better work with companies to try to get these products out at the best cost possible.
MS. GARRETT: OK. I want to open it to all of you now.
And as -- those of you who may not be aware, our protocol is please flip your cards and make sure they face away that I can see your name, to indicate, and I will try to call on you in the order in which I see your cards flipping.
So -- all right. Well, Kammerle went first. Kammerle Schneider.
Q Thanks for being here today. I just wanted to know your thoughts on the development of the new malaria vaccine and the challenges and opportunities of integrating a malaria vaccine that's partially efficacious into existing malaria control programs.
MR. BERKLEY: (Off mic.)
MS. DELAUNAY: I don't mind. Go ahead.
MR. BERKLEY: So, for all those that don't know, last week it was announced that a malaria vaccine was done in a product-development public-private partnership, the Malaria Vaccine Initiative, working with GSK, long academics -- you know, a 30-year process -- had had success in a phase 3 trial. Two age groups it was tested in -- it was older-age children -- and this was the report on those, and it had a -- it was 54 percent protection against clinical malaria and high-40s against severe malaria.
Now, the interest in this vaccine would be using it as an infant immunization. And so they didn't report the numbers because it was early on the infant immunizations, but they did do a combined report, and on that the protection had dropped down by about 15 percentage points. So we don't yet know what the protection is in infants.
If the protection is good in infants -- and one thing that's important to note in the trial is that for ethical reasons more than 75 percent of the children in the trial were sleeping under insecticide-impregnated bed nets. And so, you know, we don't know what these vaccines would look like in the general population, but probably better.
Clearly if they're good enough, the second question is going to be what's the cost because with using these tools, these indoor residual spraying, these bed nets, a range of activities, they've been able to drive down malaria. So the question is is it going to be cost-effective as an additional tool. The answer is if it is, it could be put into the existing childhood immunization system, which means that it would be easy to get out. That's very different from HPV vaccines or others where you have to set up a separate system to do it.
So we're watching that closely. We're going to be having discussions. Of course it will need to be done with the other preventive tools, and so for that GAVI would work probably with the global fund and others to make sure that they redundant parallel.
MS. GARRETT: Sophie?
MS. DELAUNAY: Yeah, it's certainly an important step -- but keeping in mind that in the best case scenario this vaccine might not be available, if I'm correct, before three years. So in the mean time we still -- we should not limit our efforts to address malaria through prevention and treatment as we've been doing so far.
I share Seth's concerns about the cost. We don't know how affordable this vaccine is going to be, and clearly maybe GAVI and key actors on the ground play -- might play a significant role in making sure that this vaccine is available, keeping in mind that the countries that are the most affected by malaria are those who are not going to be able to afford a high-priced vaccine.
And just -- not to diminish the importance of this discovery and the benefit that it can bring, but there is also a risk there of neglecting existing effective strategies in order to facilitate the introduction of this vaccine. So I think that seeing it as a compliment to ongoing strategy is certainly the best -- the most, you know, productive way to go.
MR. BERKLEY: Just one quick point on cost -- GSK did something extraordinary, which is they said that they would sell the vaccine at no more than 5 percent above the cost of production, and that that 5 percent would go back to malaria research to make a better vaccine. Of course, the question is what's the cost going to be.
MS. GARRETT: Bret Zbar.
Q: Thanks. Regarding the strength of the anti-vaccination movement, you know, we've had retraction of the Lancet paper, we've had the former head of Autism Speaks now publicly reverse her position 180 degrees and support vaccination. What is it that still gives so much strength to public resistance to vaccination?
MR. BERKLEY: It's interesting. We had a discussion before this started, and one of the real problems today that didn't exist 25 years ago is the Internet. I mean, it's a great thing but it's a problem because once you're on the Internet, you're there and -- you know, I was saying to somebody, I -- you know, you can go and search on vaccines and some of the sites that will pop up have names like the National Center for Immunization, which turns out to be an anti-vaccine site. It sounds like it's -- so unless you know you're at the Center for Disease Control or the World Health Organization or GAVI or something else, a lot of misinformation spreads.
And so even though the Andrew Wakefield -- Andrew Wakefield, not Steve -- paper was withdrawn, that information continues to circulate and people still talk about it.
So what we need is an information campaign, and unfortunately government's at an all-time low in terms of their own, you know, confidence levels -- (laughs) -- and so it's hard to get the message out. But we have to keep going at it.
And by the way, it isn't only -- we talked about it in Marin County. The reason polio broke out in northern Nigeria was because of problems with an anti-vaccine problem there related to concerns, you know, religious leaders had on what was being done. We've had the same thing happen recently in Pakistan. We had a situation where, you know, the military used immunization as a potential way to try to get into and get samples of bin Laden's family.
So this is a risky compact, if you think about it. You go into people's houses, strangers, and you say -- hopefully the female vaccinator says, you know, I'm here, I'm going to inject this thing into you, you have to trust me it's safe because we tell you it's safe, and any of these breaks in confidence are huge problems.
MS. GARRETT: That's -- I should just note, that's one of the reasons that in -- when we -- I was an adviser on the movie "Contagion" -- we made Jude Law's character, the blogger, the bad guy. And what's been very interesting since is that the blogging community that deals with health-related stuff on a very active basis has largely supported the portrayal of Jude Law's character and said, you're right, there are scandals among us.
And Hong Kong took a big step I think to help on this matter by trying and ultimately imprisoning two individuals that were actively opposing vaccination during the H1N1 outbreak in Hong Kong and hawking their own products as alleged alternatives to vaccination products that, of course, proved useless. So they were jailed on fraud charges.
Q: Thanks. Daniella Ballou-Aares from Dalberg.
Getting to the -- back a little bit to the cost question on vaccines, in addition to the price of the vaccine itself, the cost of the supply chain can be a rally significant contributor. And it strikes me there's been pretty limited innovation on the supply chain for vaccines over time. And I'm wondering, given that it's so important both from a cost perspective and an ultimate reliability and effectiveness perspective if you're seeing new business models emerge, new ways to actually push for some kind of innovation and increased efficiency?
MR. BERKLEY: That's a great question.
So, for people to understand, the six original vaccines we talked about, the EPI vaccines, they cost together less than a dollar. The delivery cost for those vaccines are somewhere between 20 (dollars) and $45 depending upon the labor market you're in and what happens. So that is the big -- the big cost for vaccines.
And you're right, it has been fairly standardized. But there are new tools and new ways of working, and what we also have to do is learn from logistical efforts. The public sector tends to be very isolated and stick to its methods. So this is one of the areas that is coming up.
There's also new technologies. And so I was with Bill Gates last night and some of the investments he's making in his private side go to an innovation lab, and they've created, for example, new thermoses that have space-age walls that allow a -- kind of a cold thing to exist between them, and they can sit for months at a time and keep cold without any electricity. And now they've created solar refrigerators that don't have batteries that actually directly cool, and the idea would be to combine the two so that you could have a solar panel -- could get these cold and keep them cold indefinitely.
So there's lots of kind of cool things coming down the line. the challenge is going to be the incentive structure to get them out, to produce them in large quantities at an inexpensive cost.
MS. GARRETT: I want to follow with Sophie. How frequently, particularly in sub-Saharan Africa, are the supply chain issues your primary problem?
MS. DELAUNAY: Most -- yeah, most of the time. And -- I mean, and we are in a constant situation of having to innovate, or if not innovate, adapt -- just the simple fact that roads are not necessarily accessible in the rainy season, and this is also when you have to vaccinate sometimes.
And another issue also is that -- what you described, Seth, might be appropriate in the small-scale operation, but when you have -- and I remember in the years 2008 and 2009, we had to vaccinate 8 million people from meningitis. It required, you know, large-scale operations, and at this state we don't have available the kind of instruments, so we are dealing with very basic material -- generators -- in order to create and make the ice packs. And you need large trucks, you need, you know, all this very traditional material that is the only material you can use in these types of circumstances.
But we're definitely looking forward, you know, to this kind of instruments and products.
MS. GARRETT: Rohit?
Q: Thanks. Rohit Malpani from Oxfam.
Just one clarification on the advance market commitment and a question. The advance market commitment was designed in 2005 to develop a vaccine that didn't exist. Pneumococcal vaccine had already been on the market, and the two new vaccines which are now being purchased were pretty far along in clinical development. So some of the concern comes from channeling money towards vaccines that were already going to be introduced, taking into account that there are gaps.
The real problem isn't so much the price that was being charged. It's the way the advance market commitment was designed basically excluded emerging market manufacturers from getting access to the funds. Potentially none of those manufacturers are going to get access to the funds, so I think it's really about the legal barriers that were being created. That led to a lot of the criticism and, that's tied into the concerns around the costs that are then being charged by multinational manufacturers.
My question's on a separate issue, which is around the new malaria vaccine, which is, in our discussions with GSK Bio last year, it seemed like they had a very aggressive plan put into place to raise money to fund the distribution of the vaccine, let's say after 2015. And I -- for us that sort of raised some concerns that they were going to move out of the accepted channels to try to raise funding and the governance and evaluation. So just wanted to hear from Seth whether or not you were concerned that GSK was going to work through GAVI or in fact might go around GAVI or through the World -- around the World Health Organization in order to raise funding for distribution of the vaccine.
MR. BERKLEY: (Off mic.) Yeah. So let me comment on both of the issues.
On the AMC issue, as you well know, the original championing of an AMC was for an AIDS vaccine, which certainly wasn't ready at the time. The initial discussion was that was far enough out that they were worried that if we tested the mechanism we wouldn't see the results. And so then they wanted something more near-term, and that's how we ended up with pneumococcal vaccines.
And so I think we can quibble about those issues, but I think the bigger issues is is that we're beginning to shift the paradigm. And to me the paradigm is very simple: A new vaccine appears -- it should be available in North and South simultaneously -- it ought to be available at the most inexpensive price for the poor -- it ought to tier-up until whatever they can charge in the (most ?) markets and the company can make a lot of money under that curve, and we can make sure we get vaccines out to the poorest. And if they're too expensive to start with, we subsidize it, but over time we drive the cost down. So that to me is the model. And so I understand the controversies.
On the developing country manufacturers, the problem is they didn't have prequalified vaccines. And this is one of the issues of pricing and why it's complicated. It's not like drugs. You can't easily make them. The factories have to be qualified. It takes a long time. And therefore we're often operating in a monopoly situation or a biopoly situation, and that becomes a problem in terms of how you deal with prices. And so it's a little bit more complicated than it would be on a mature project -- product where you've got, you know, lots of issues.
On the malaria vaccine, we had heard that there was an attempt to go out and start talking about that, but my understanding is that this will go through existing channels.
There are some innovative thoughts that are going on. The vaccine for malaria is composed of two different components. It's an adjuvant, which is a device you put -- a chemical you put in to simulate, and that adjuvant's very important to GSK because it's part of many of their other vaccines. And then there's the actual product. And so one of the things that's being discussed now is could they do a tech transfer to a developing country manufacturer, work together to produce large quantities of vaccine, and might that be funded by the public sector so that you could drive the cost down even less in terms of, you know, being able to produce it. That probably won't happen for the adjuvant, so that might have to be added to it. But they are thinking out of the box. They really are trying to get it out. And so at least at the moment I can't complain.
Q: But just to clarify -- my
MS. GARRETT: No, I just want to make it -- a chance. There's only time for one more question.
Q: Thank you, Laurie.
Actually, I want to go back to the red team idea that you raised, which I think is absolutely a wonderful one.
But before I do that, I want to say that this map is absolutely fantastic, and I think it's something that I hope you'll be able to introduce into the school systems with this focus that we have in this country on STEM. This is a great way to get school kids interested in the topic. So I home that somehow, with the council's focus on U.S. -- increasing U.S. interest in the world that this will be one way of doing it.
So, red team -- I feel like I'm in a time warp. I was at the World Health Organization in the 1980s -- very involved in the EPI program -- peripherally involved, I should say. And I feel like Ralph Henderson, who really innovated that program, was here talking about all the very same issues -- new vaccines, same issues. And what I'm interested in the -- (inaudible) -- for both -- and very important comments -- that the history seems not to have changed, that we're in the middle of history still, the same history with EPI.
So what I don't hear -- and I think maybe the red team idea of women vaccinators is a good one -- but I haven't heard, except for the anti-vaccination movement in Marin County and northern Nigeria -- where is the community, the community that's going to sustain the demand and that's going to see that vaccines are actually what they want as opposed to drugs, as opposed to more of a primary health care perspective? And so I'm just wondering how is GAVI, how is MSF working --
MS. GARRETT: Are you referring to developing countries, middle-income, wealthy?
Q: I'd say it's a general issue, but I would be -- I think I'm most concerned about the last mile question in developing countries because in fact that's where the problems keep -- where we really have the equity issue. And I think it's wonderful UNICEF has rediscovered equity.
MS. GARRETT: Well, I see Sophie smiling. I think she wants to take this question. (Laughter.)
MS. DELAUNAY: Yeah. Well, you know --
Q: (Off mic) -- necessary for sustaining the one case --
MS. DELAUNAY: No, I fully understand. But it's also -- you give me an opportunity to actually deconstruct a sort of myth that we would be an international organization just landing on the ground, vaccinating people and then leaving. As we speak, there are 24,000 MSF colleagues working on the ground, only 10 percent of whom are international staff, which means that the communities you are talking about are those who are actually vaccinating people and working with us and engaged within their own communities and trying to respond to these permanent outbreaks.
So we're aware of this necessity, and we believe that the communities at our level are very much engaged as individuals and as communities also because there is no way you can vaccinate in a village if you don't have the approval and the political support of the community leaders. Right? So it does require a huge engagement of the communities.
But the reason why we are here is that we believe that there are also some needs and resources that needs to be allocated to this problem and, you know, and we believe this is the right venue to address these concerns.
MS. GARRETT: Yeah. I think it's a great way to end our conversation. Let me give, therefore, Seth a chance to respond to the same question.
MR. BERKLEY: So, I mean, obviously demand is critical, but the interesting thing is that in general -- and I don't want to overstate it, but in general there is demand in the developing world because people see these diseases. They want to protect their children. And the problem really has been how do you have the facilities, the equipment, the trained health care workers that are there to do that.
And you're right, these problems have existed through time. And that's why leadership at the local level is critical. It's not only at the global level, it's getting countries to say this is important because it isn't just the vaccines.
I mean, the measles vaccine -- which, by the way, the measles initiative has vaccinated 1 billion people with supplemental cases. But the measles vaccine is the cheapest vaccine. It's, of course, incredibly important. And in one sense you can say if you can't afford to pay for measles vaccine then the whole thing is, you know, is a game of cards. And yet we're not getting the type of co-finance that we need form many of these countries because countries just aren't prioritizing it. They don't prioritize prevention over treatment, and they certainly aren't prioritizing, you know, these types of issues. And so we absolutely have to get that to be something that happens.
MS. GARRETT: Well, I think this has been a great start, food for thought to get us off and running. And I hope that all of you took away a great sense of pleasure and honor in having Sophie Delaunay -- who was very humble and didn't tell you the other dynamic, what it's like to try and vaccinate in conflict zones with active insurgent groups that may in fact endanger your personnel -- and Seth Berkley, who was also very humble and didn't tell you of his many accomplishments in this specific area going back to the 1980s actually.
But I want to thank them all. I hope that any one of you that has a chance to manipulate the vaccine interactive chart -- if you are at all interested in putting it on your organization's website or encouraging other organizations -- including, as Patricia said, school systems and so on -- we would be delighted, and Zoe is your person to contact for details about how, if you have any difficulty in downloading for embed, how to go about it.
And I welcome all of you and thank you all for being here. (Applause.)
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THIS IS A RUSH TRANSCRIPT.
Session One of A Council on Foreign Relations Symposium, "Food and Drugs: Can Safety Be Ensured in A Time of Increased Globalization?"
food and drugs
Join the experts discussing potential solutions to the challenges of ensuring food and drug safety in the global era.
Seth Berkley, president, chief executive officer, and founder of the International AIDS Vaccine Initiative (IAVI) and incoming chief executive officer of the Global Alliance for Vaccines and Immunization (GAVI) joined us for this unique insider look at his plans for the future of GAVI, and its position in the larger landscape of global health.