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The Challenge of Getting Swine Flu Vaccine to Poor Nations

As the H1N1 swine flu pandemic marches on, western countries have begun vaccinating their most vulnerable populations against the virus. But many countries in the developing world lack the resources to buy the vaccine. With charitable donations from manufacturers and rich countries, the World Health Organization is trying to get cash-strapped countries at least some vaccine. Marie-Paule Kieny, head of WHO's Initiative for Vaccine Research, gave ScienceInsider an update on how this complex operation is moving along. Questions and answers have been edited for brevity and clarity.

Q: At a press conference last week, you said that WHO's plan to distribute vaccine to the developing world is now moving into its operational phase, and that WHO Director-General Margaret Chan has approved a list of 95 countries eligible for vaccine donations. Can we get a list of those countries?

M.-P.K.: No, because some of those countries may decide not to get the vaccine. So far, only about 40 countries have sent us a letter of intent saying they want us to send vaccine. Before we can make the names of the eligible countries public, we must know that they are willing to accept the conditions.

Q: What are those conditions?

M.-P.K.: They have to sign an agreement that they hold the vaccine manufacturers harmless in case of adverse events. WHO cannot bear that responsibility, so we're passing it on to the governments. It's the same as for most developed countries; they had to agree to this as well.

Q: Are the developing countries reluctant to accept that liability?

M.-P.K.: There is a lot of discussion about it, because it is uncommon. Governments want to know what it means and whether the vaccine is safe. Some countries aren't very happy about it. But nobody has said no to us yet.

Q: Do you think some countries will say no? They might also conclude that, because the pandemic is not as severe as some had feared, it's not worth setting up a vaccination campaign.

M.-P.K.: It's true that compared to many other health problems that they have, this is not a high priority for some developing countries. Although interestingly enough, when the [WHO] Director-General [Margaret Chan] was at the Regional Committee for the Eastern Mediterranean recently, all the governments were asking: "When will we have the vaccine? When will it come?" So there is a demand for it. Remember, this is not quite like seasonal flu, because it's killing younger people, and it does have an impact on health care systems. The demand for intensive care units is huge. In addition we don't know what will happen in the months to come. The pandemic could become worse.

Q: How did you select the 95 countries?

M.-P.K.: They needed to be developing countries that do not have H1N1 vaccine manufacturing capacity of their own and that do not have a purchase agreement. As we found out, quite a few middle-income and even some low-income countries have secured an agreement with a manufacturer themselves. They also need to identify target groups and have a plan to distribute the vaccine. It would be most inappropriate if the vaccine stayed unused in a warehouse somewhere or if it were used for ridiculous targets.

Q: So where is all the vaccine coming from, and what kind of vaccine is it?

M.-P.K.:  We will have 50 million doses of adjuvanted vaccine from GlaxoSmithKline. Sanofi Pasteur will give a total of 100 million doses, unadjuvanted to start with, and adjuvanted later, once that is licensed. CSL, from Australia, will give 3 million doses of unadjuvanted. And Medimmune, also 3 million of their live, attenuated vaccine.

Then we will get vaccine from a number of countries, who will donate some of whatever they have purchased themselves; that way, we will probably receive some Novartis vaccine as well. Some countries offer other kinds of support. From the U.K., we may get more money than vaccines. The U.S. will donate 10% of their own vaccine purchase, but they're also providing a lot of technical and financial support for the implementation.

Q: So you'll have at least five different types of vaccine.

M.-P.K.:  Yes. And that complicates things. I hope it will be possible not to give more than one formulation to each country, because that would make the logistics much more difficult.

Q: When will you actually have all these doses? Will they come in gradually?

M.-P.K.: Yes. We expect GSK to start delivering late November and end at the beginning of May. Sanofi is also expected to start before the end of the year and to continue during the first six months of 2010, at least.

Q: And what about the country donations? There's already a debate about when the U.S. donation should start; HHS Secretary Kathleen Sebelius was reported as saying that risk groups in the United State will be taken care of first.

M.-P.K.: The U.S. has promised us that part of the vaccine will arrive early December. But I can't tell you exactly how much. We also have a commitment from Australia to give us vaccine in November. We are discussing with France and the other countries to see what their timelines are. We are aware that domestic politics play a role here. But there are a few countries that will send us vaccine before the end of the year.

Q: A few countries delivering before the end of the year. ... That doesn't sound all that promising, given that the pandemic is moving fast.

M.-P.K.: We will be able to serve the first countries by the end of November or early December. And during the first 3 months, from late November through February, we are confident that that we will get at least 37 million doses, which is enough to vaccinate 2% of the population in the 95 countries.

Q: But isn't that very little, 37 million doses by February?

M.-P.K.:  Well, it's better than nothing. ... Of course we would like to introduce this as soon as possible, but we are dependent on the donations. And 2% should at least take care of the health care workers. After that, perhaps we can have an impact on other target groups as well.

Q: Are you prodding the donors to say: "Hey, we need this vaccine now, if you wait 6 months, it's too late"

M.-P.K.: The donors are sympathetic and they understand that we need to do something. How much of an impact we have also depends on how fast the pandemic develops in the recipient countries. As you know, this varies greatly by country. It's booming in the U.K., but in France it's just starting up. In African countries where there is less international travel, there has been very little H1N1 so far. For the southern hemisphere, even 6 months from now would still be fine.

Q: There has been a lot of debate about international solidarity during pandemics in the past few years. Indonesia stopped sharing samples of H5N1 avian influenza because it wanted guarantees about access to vaccines and drugs. Now that we finally have a pandemic, we hear very little about this issue. Developing countries don't seem to be complaining, and NGO's are silent. Is it because the virus is relatively mild?

M.-P.K.: It does become an issue in places where the pandemic is hitting hard. Right now, there's a great sense of urgency in Ukraine; they're closing schools and there is a little bit of panic. But it's true, things would be much worse if the pandemic had been more severe, and it would be more difficult to create some fairness in the distribution of vaccine. Governments might be less inclined to share the vaccine that they have.

Q: Has Indonesia been active on this front?

M.-P.K.: No, they have been very calm, and they are sharing H1N1 samples with us, like all the other countries. There is a new government now in Indonesia; we have to see whether that changes things.

Q: But fundamentally, the issues around sharing have not been resolved, have they? There have been several rounds of negotiations, but the 'global framework' for the sharing of viruses and benefits from research has not yet been agreend on.

M.-P.K.: No, the process isn't finished yet. And this pandemic is an important opportunity to demonstrate that there is some equity, that the fears about a complete imbalance between countries' duties and benefits were not justified. It's a chance to show that developing countries are not left completely by the wayside.