Jane Halton
Well – so, I mean, David’s very right in orienting us and he’s right also, that I spent several years of my life chairing the global negotiations on the PIP Framework, which, you know, finally did result in what was a landmark agreement, but this COVAX Facility is categorically a significant step forward. I mean, it’s something which is much more than was envisaged in the PIP Framework. And, to the question, there are still challenges, as we know, in some countries where not only can there be legislation, but there’s also just the capacity to put on export bans and many of our audience will have heard the discussion about vaccine nationalism, and certainly, I started talking about this in February as being one of the real concerns we had, because – and Seth has really, I think, jointly oriented us to that study, which demonstrates the really significant impact you have in loss of life if we equitably vaccinate the vulnerable around the world, as opposed to targeting vaccines on a country-by-country basis.
But for some domestic governments, this can be a hard choice to make. So, yes, we still have those challenges and short of, can I put it this way, the embarrassment factor, we can’t override domestic legislation or political will in an individual country. But what we are doing this time is throwing a very, very stark light on that kind of behaviour and because, as Seth has already outlined, we are actually putting in place these kinds of purchasing arrangements. It actually does mean that we have the capacity to actually acquire and then distribute vaccine far earlier, in a way that is equitable and, as Seth has said, not just to low to middle income countries, but to many upper middle income countries, who basically don’t have any other capacity to spread their bets across a portfolio. So, this will be – we are very optimistic, a much more equitable approach, there will still be problems though with those kinds of circumstances, that we can’t change, but this is a leap ahead of huge proportion.
Emma Ross
So, Seth, I wanted to ask you, with poorer countries or less – lower income countries that are in COVAX, that you said are eligible, what does that mean? Where is the money coming from them? Are you buying the vaccines for them and giving it to them, or are you negotiating price, cheaper prices for them, and who pays for them, for those countries?
Dr Seth Berkley
So, first of all, let me just add one more point to what Jane said, which I think was very important, and that is that, you know, yes, there was an agreement put together, obviously the test of agreements is what happens in a crisis, and I think that’s really the point,. But if you look at the many things that were not resolved, and they’re trivial things, but they are really important, is there regulatory harmonisation, or do we need to go to 200 separate country’s regulators and get approval of products? Do we have standardised labelling, so that a product can be used in South Africa or in India, or do we have to have them labelled for each individual location? Do we have indemnification and liability for manufacturers? These are things that have happened in previous pandemics and have not been resolved. Can we track and trace vaccines? So, one of the things we’re trying to do in this case, because it’s global, taking advantage of the crisis, is to try to resolve many of these issues, which will have implications for this period, but also going forward.
Now, to answer your – and by the way, going forward because it’s evolutionarily certain this is not the last one, we’re going to have more outbreaks, so – but going directly to your question, for the AMC countries, the idea is that they are eligible for official development aid, and so we have begun a process. We began that at the Global Vaccine Summit the UK hosted in June, where we opened up an Advanced Market Commitment, we received some financing there, but we had a preliminary goal of $2 billion by the end of 2020 to try to jumpstart some of the doses, and we announced, at the Paris Peace Forum last week, that we’ve exceeded that number and we’re now looking for a larger amount of finance that actually would purchase those vaccines. We are asking countries to cost share, which is the normal Gavi experience, but if they don’t have the money to cost share, we will not have that be a barrier for them to engage. But the other good news is that the multilateral development banks have also stepped in now. The World Bank announced a $12bn package for vaccines, the Inter-American Development Bank, the Asian Development Bank, others are working on this and so, the idea is to build a set of finances that could help countries get access to vaccines.
The last thing I’d say is that we are now driving ahead, in fact we have a meeting later today with all of the countries, to have countries do the planning work that’s necessary to do this unprecedented rollout. And what that entails is bespoke plans for each country because the first group to get vaccinated probably health workers, but then high-risk groups, what are the high-risk groups in their situation? Is it the elderly, is it co-morbidities, is it refugees, is it people living in urban slums? What’s the state of their cold chain, their supply chain? What type of help do they need? So, the Gavi Board put $150 million to jumpstart that process, and now we’re working with countries to try to do that preparation, so then we know how much resources they need to build up their systems to be able to deliver, because immunisation is the most widely distributed intervention and there is a system, but obviously, that system is not for the elderly or people with co-morbidities, etc. So, we really are in unprecedented space here.
Emma Ross
And I wanted to ask you about this in the context of solidarity, ‘cause we’ve heard a lot about the need for global solidarity, it’s a refrain from Dr Tedros, and not a great report card on solidarity, but how do you see COVAX, in terms of an expression of solidarity in the pandemic? I mean, the rich countries that can compete on their own, why are they in this, because it’s the right thing to do for solidarity, or is there something else in it for them that’s motivating them, and what’s in it for pharma? And do you think this is an expression of solidarity, or is it – is that really a distraction?
Dr Seth Berkley
As Jane described, you know, every political leader has a responsibility to take care of its population. So, you can interpret that two ways. You can say, “I’m just going to take care of my people and I don’t care,” but in a pandemic, that does not take care of the problem. So, you have to, even if you’re taking care of your people, is making sure that there is availability of vaccine and dampening down the pandemic globally. So, you know, I think that’s one critical motivation that’s there. For high income countries who have joined the Facility, part of it is for support, but part of it is also insurance, ‘cause many high income countries have one or two vaccines and if those work, that’s great, but if they don’t, then they’re at the back of the queue. So, by being part of COVAX they have the largest portfolio of vaccines and we will pivot that portfolio, as new vaccines become available, as science moves forward.
And then, you know, the last part of this is, you know, that we call by the way insurance, in terms of thinking about that, the last part of your question relates to pharmaceutical companies and I think they, first of all, you know, vaccine manufacturers are a little different. They’re kind of public health people in disguise. They understand that these are tools for prevention. They want the world to be prevented. The challenge, in the past, has been that they haven’t had the systems and ways to do it, and so, we’re trying to put that in place. But they also understand, I mean, they’re global companies and if, all of a sudden, the vaccines are just available in 20 high income countries and 180 countries have no access to them, that’s not going to be good for business going forward, it’s not good for public health, and they will be criticised.
So, there are lots of incentives, both positive and some, you know, some carrots and some sticks that have them engaged with this, and they’ve been part of the process. We have the IFPMA, and that’s the international vaccine manufacturers and the developing country manufacturers, as part of COVAX working hand-in-glove with us on trying to make sure that we can get to the two billion doses by the end of 2021 that we’re trying to do.
Jane Halton
And can I…
Emma Ross
Yeah, go ahead.
Jane Halton
…can I support that, Emma, can I support that? I mean, I think this is actually truly a global partnership and I think it’s important to underscore that we can’t do what we are doing with COVAX without, firstly, the countries, obviously, without people who will both self-finance and donate. But also working co-operatively with our colleagues in the pharmaceutical industry, and CEPI has been privileged to be able to assist with funding a number of these vaccine candidates, and that does give us some leverage. But, in truth, the co-operation that we’re getting from the vaccine manufacturing sector goes beyond that and I do think, as Seth rightly says, this issue of public health people in disguise, but also, rightly, concerned about reputation, they have been criticised in the past. And I cannot let this pass without acknowledging that we have had really good co-operation, not just from them, but from regulators and a whole series of other groups, but this co-operation is really necessary at this time.
Emma Ross
Thank you, Jane. David, I wanted to turn to you first, but also Seth and Jane, but David first, and that is a lot of people are putting a lot of expectations on COVAX to come through and really deliver for us on this desire for equitable access. Now, what do you think, for the purposes of expectation management, what do you think we should expect to achieve in reality, beyond the vision, the intention, and over what timeframe? I mean, I guess what I’m really asking is that if, at the end of the day, you know, in a couple of years when we look back on this, and there still wasn’t quite equitable distribution, does that mean COVAX was a complete failure and a disaster, or what do you think is reasonable to expect of COVAX?
Professor David Heymann CBE
Well, COVAX is certainly necessary today and it’s the new way of working globally, which is extremely important. My hope is that the transition team in the US for the Presidency continues to look at COVAX as something that the US should belong to, because to present there’s not been the strong presence of the US in the COVAX initiative. So, I hope that that solidarity will continue to grow and include some of the world’s – and most of the world’s important economies. At the same time, the COVAX Facility is located within the ACT Accelerator, which is also important because it’s making available other interventions that are extremely useful and important in the pandemic, including diagnostic tests and eventually therapeutics. And those diagnostic tests are going out to countries where they haven’t been able to do the expensive PCR testing. They’re doing other types of testing called antigen testing, with rapid diagnostics, and that also is a way of dealing with this pandemic. So, vaccines are extremely important and COVAX is a very important initiative moving forward. It will be one of the tools in the toolbox, a vaccine, because, as it appears now, this infection could become endemic, could remain in human populations, or in some animal populations going forward, it’s not yet – the destiny is not yet clear, but that’s one of the scenarios, and therefore, we need all of these different tools in the toolbox and a vaccine will be very important in preventing mortality, we hope, and in other areas of the work. But we need to have all of these tools together, in addition to this COVAX initiative, which, as I said, is really very, very important for global solidarity.
Emma Ross
Okay, but can I just squeeze out of you an answer to what should we expect in reality for it to achieve, as opposed to the vision and the intention?
Professor David Heymann CBE
Well, I wish I could tell you what we could expect, but I believe the vision of people like Jane and Seth, moving forward, will take this another step to more equitable distribution of vaccine, and if the funding comes in, which we believe it will, everybody believes that, if that funding does come in, then I think COVAX will have taken another step forward in a more equitable world, which is what we all need to strive for. Not just during this pandemic, but as has been done for other vaccines, get these to the people who really need them.
Emma Ross
Well, Seth and Jane, do you want – I’d love you to add something on what standard we should be holding you to, expectation-wise, of what COVAX is going to be able to deliver in reality?
Dr Seth Berkley
Well, first of all, to David’s point, thinking about equity is critical, Gavi was set up and the UK, by the way, is the single largest supporter of Gavi. We’ve introduced 496 new vaccines in developing countries and the vaccination rates are at the highest level in history. So, I mean, there is a track record of moving towards equitable access. In fact, the problem we have now is low income countries have coverage that sometimes exceeds high income countries and the middle-income countries that aren’t Gavi eligible, are way behind, and we’re actually in the process of looking, can we help there? So, that’s for other vaccines.
For COVAX, we already have acquired rights to 700 million doses, that’s public information, plus lots of options for more, plus we’re in the midst of a series of other deal-making and, as you heard, using the same group, the alliance of WHO, UNICEF, the World Bank, civil society, USCDC, etc., we’re in the process of helping countries get ready to receive those vaccines, so there will be deliverer of vaccines.
Now, the last question, and people will judge on this, is, you know, will it be exactly at the same time or not? And part of that depends. What happened, the first vaccine that was announced that had preliminary efficacy trial was a vaccine that needed to be stored at -80o. We are now asking countries, “Do you want that vaccine?” We know we can deliver -80 vaccines. The Ebola vaccine we delivered in DRC in the middle of a warzone was a -80 vaccine, but it’s expensive, it’s complicated, it takes a lot of training, it may be a distraction, so, you know, it may be that countries may say, “Well, you know, we want to wait for a vaccine that maybe is more temperature stable, or easier to use for us.” Is that a failure, or is that a smart decision by the country? I think those are the issues we’re going to have to do, but there will be Ebola – there will be COVID-19 vaccines available for developing countries to rollout across a whole range of the portfolio. And we’ll see how that plays out in countries, including, by the way, there is a small humanitarian buffer, as part of that two billion doses, we talk about up to 5%, 100 million doses, and so that’s available for, you know, situations where, you know, we have to vaccinate groups that are not necessarily recognised by countries or in acute humanitarian crises as well.
Emma Ross
Jane, did you want to add anything, before I go onto the next?
Jane Halton
No, no, no, I think that was what we might describe as a thoroughly comprehensive answer.
Emma Ross
Okay, great. So, I wanted to get to this issue of doses, and I’m sure you’ll each have a view on this, but that is your thoughts on what impact you think there might be on equitable global access of rich countries buying up vaccine through bilateral deals with producers? I mean, does it matter? Is it hypocritical? Can it work for both, to be going on? Will there be enough doses to go into the COVASX pool? Seth, you mentioned the 700 million doses, I read something somewhere that the US, EU and UK, just those three together, have secured 4.8 billion doses so far to your 700 million, and that Scientists are warning that there may not be enough to go around and developing countries may still be left behind. Is this in the way – how do we work with this? Is there anything we can do about it? Who wants to go first on that?
Professor David Heymann CBE
Maybe I’ll say a word, you know, Seth said it earlier that countries do have an obligation to their own people. This is clear. These are elected governments in many countries, and those countries have a responsibility to the people who have elected them. And so, this causes this tension between satisfying national need, because it’s a sovereign country, which has elected their government, which is to protect them, and the global need. And that’s why this COVAX is so important, because it’s dealing with both of these in a new way, and I just can’t say enough about how important this really is, and I’ll stop talking now and let the two who are working with it more closely speak up at this point. But, remember, there is an obligation of governments, as Seth said, to be providing for their own populations.
Jane Halton
Yeah, and let me follow on from that, if I might. We can’t, and actually would not try, to fetter national governments. I mean, there’s no point, they’re going to do what they do. What we can do, however, do is have as much, and I describe this in a rather colloquial way, we can have enough financial muscle, in the procurement market, to be essentially the equivalent of a large financial player, which means we can actually get access to those vaccines on effectively equal terms with the people who would, because they have the wherewithal, the financing and the foresight and the political will, to go and put these arrangements in place. So, I think this is the point that brought together all of these countries, low to middle income countries who, as Seth has indicated, are eligible in respect of Gavi activities normally. But also, other countries, for a variety of reasons, be it insurance, be it their size, be it their sophistication in these purchasing arrangements, for whatever reason, bounded together they actually have a much better chance of getting access in a way, which they probably wouldn’t otherwise. And so, essentially what we’ve done is we’ve shifted the dial on this commercial negotiation, using COVAX in that way to recognise it’s a market and there are governments who have responsibilities. So, we have bounded together a group of people, basically for reasons of insurance, enlightened self-interest and need, in a way that we have never seen before. And, yes, particularly countries that have manufacturing onshore and have significant wherewithal, they’ve put in place those arrangements. But in the past, all these countries, in these circumstances I’ve outlined, would be literally at the back of the queue and that is not the case this time. And, as Seth has rightly said, we are already in a position to talk to countries who are part of the COVAX family to say, “These very low temperature mRNA vaccines, do you have the capacity? Would you like to be considered for those?”
In some cases, the answer will be “Yes” and, as Seth says, because they’ve experienced this with Ebola vaccine. In some cases, they’ll say, “No, we’ll wait,” that is their choice, and this is, for those who’ve ever played that awful game Tetris, this is like a giant game of Tetris. So, working out what vaccine will work and where it will work and the nature of how the vaccine works together with whose in which particular circumstance, but we’ve never been in this position before and that is why this is so different. So, no, we’re not going to stop those other countries, but let’s be clear, the sovereign country that has put in place two pre-purchase arrangements, I describe this as being like Clint Eastwood in that movie, “Do you feel lucky?” because your choice may not work, and that’s the point. For once, many, many, many more countries are in exactly the same position as each other and that’s what’s encouraging solidarity, in my view.
Dr Seth Berkley
So, Emma, let me just add one point and just to say that it’s also not easy because when we started negotiations with manufacturers, you know, there had been this big push from some of the wealthiest countries in the world to build this portfolio up. So, you know, they say to us, “Okay, well, we did this deal with, say, the US Government, and, you know, you guys should do the same deal,” and we have to say, honestly, we have all these countries, we have money from those countries, we have money from donors, but we don’t have the US Treasury behind us, or the British, you know, the Treasury behind it, or others. And so, there has been a process of trying to work to make sure that the deals that are put together make sense for those countries and that is a challenge.
Now, you know, the other thing we didn’t know when we started was, whether any of these vaccines are going to work, and so, the logical thing was to build a very big portfolio of lots of different things. We’ve now seen, you know, in the last two weeks, two examples of early data. It’s not, you know, not comprehensive and looking at all groups, etc., but we’re seeing promising data from at least one class of vaccines, it may be that it’s easier to produce vaccines and therefore, there may be a higher percentage of vaccines that succeed.
Normally, the success rate of vaccines historically is less than 10% pre-clinical and less than 20% clinically. So, if that’s the case, you would need very large numbers of potential candidates to have the successes you want. If it turns out that it’s much easier for this vaccine and we get high success rates, then there will be a lot more doses available because the way we’ve dealt with this is not just buying from multilateral companies – sorry, multinational companies, but also, by doing technology transfers to developing country manufacturers who have the ability to produce very large volumes. So, what that does is not only says we want some slice of the pie that exists normally, but we’re increasing that pie by getting other manufacturers in here to produce large amounts of vaccine, and that’s how we’ll get to originally we were thinking we need four billion doses to get to two billion doses, because a lot of them are going to fail, of course maybe now we’ll need three billion doses to get the two billion doses. That science is going to change as we understand, you know, as different vaccines come through, how effective they are and most important is how effective they are for different sub-populations. Because we need vaccines that work in the elderly, which traditionally is difficult, we need vaccines that work in immunosuppressed populations, in people with other chronic diseases, in pregnant women, etc., etc., and that may not be the same vaccine everywhere.
Emma Ross
Okay, before I – thank you for that. Before I move onto the audience questions, I just had one more on allocation. So, say there is a really suitable, universally suitable vaccine that everybody wants, that hasn’t got complications on storage or whatever, that is, you know, suitable in all environments and it’s in the COVAX pool, what is the mechanism for deciding – how are you going to decide who gets that? Everybody wants it and is it the poorest countries will get it first, the ones with the largest infections will get it first, people who’ve paid more will get it first, how is that physically going to happen to decide who’s getting out of that pool at what time?
Dr Seth Berkley
So, the way that is set up is there is WHO has set up an allocation mechanism, and that’s been discussed with all the member states and, as you know, that is, you know, the vast majority of the world’s population. The idea there is to use a set of algorithms, but then, also to have an independent group that will look to make sure that the rules are being followed. The idea was to have two pools: one for self-financing countries, and one for the COVAX AMC, and within those pools then, one does the distribution, you know, based upon this principle of trying to get vaccines out everywhere.
Now, why do we have to think about it slightly differently? There may be countries that are not ready for vaccines or don’t have the – need more help in their supply chain or in storage, or, you know, so it may be that other factors will affect the distribution of those vaccines, but if there was none of those factors, the idea would be that they would be distributed at an equal speed. Of course, there’s going to be other things, if you’re a small Pacific island, you may not give a slice of their population ‘cause it may be very small doses. You might give a bigger allocation of vaccine because of the difficulties of getting it there and doing it, so there will be practical considerations. But basically, the idea is to try to have that allocation be fair across all countries.
Emma Ross
Okay and one last addition to that is will COVAX be able to control, once the vaccine is given to a country, who gets it, that the allocation of what is envisioned, say, health workers first, or the vulnerable, that it actually goes to those people? For, say, in countries with, you know, less than perfect governance and accountability records, is COVAX doing anything about that, or can you do anything about that? Will you be monitoring and evaluating whether the vaccines go to the people they were intended for…
Dr Seth Berkley
No.
Emma Ross
…instead of being diverted?
Dr Seth Berkley
No and yes. So, they’re sovereign countries, we can’t tell them. We can’t force them to do something, but to get vaccine, you have to apply, and in that application, if you say, “I want to take the vaccine and just give it all to schoolchildren and not vaccinate anybody at risk or anybody else,” that – the independent review of that vaccine will say, “Well, this is not following WHO guidelines, maybe you need to rethink this and put – or put epidemiology in your application that proves that’s the right use for it.” So, there are some checks in intention, but once the vaccine’s in country, you know, they will do what they’re going to do.
The challenge we have though is I think with education and the best example of this is DRC, practical example, we were very worried. Here’s a country at war, here’s, you know, lawlessness, all of these things going on, you know, the vaccine got used. Were there a few people who got vaccinated who didn’t need it? Maybe, but most of the vaccine got used to focus on the contacts of people who were infected, on health workers, on trying to stop the epidemic, and in that case, it was a clinical trial. So, we actually knew every single person that got vaccinated and, you know, in essence, in one of the most difficult situations in the world, people did the right thing and got the vaccines to people who need it. That’s what we expect should happen, in the vast majority of countries.
Jane Halton
And can I just add to that? I mean, I do think we – and look, yes, as Seth says, there’s a risk and, no, we cannot bind and watch every single dose of vaccine that’s administered. But if you think about the straight epidemiology of what’s going on with this pandemic, we know where the most death is. We know where the most challenge is, in terms of people who are exposed to large amounts of virus, and if you actually want to give confidence to your population, if you want your economy to operate again in the way that you wish, if you want to be open for trade and travel and all those things, you would logically, in national interest, direct a vaccine to those who are most vulnerable, because that actually is what will bring the acute phase of this pandemic to an end. And I’m aware of very few counties who ultimately don’t want their country to prosper and their citizens to prosper. So, exactly as Seth said, when we were actually doing our trials on the Ebola vaccine in the DRC, exactly as he said, it went where it should have gone by and large. So, I feel optimistic about that. Now, I’m not naïve, but I do think there’s a coincidence of interest here, which should lead to the right people being vaccinated.
Professor David Heymann CBE
Emma, I might just also give an experience with meningitis vaccine, which was the same thing, and that sort of encompasses what Jane and Seth have been saying. Back in the 1990s, late 1990s, there was a shortage of meningitis vaccine and MSF, Doctors Without Borders, UNICEF, WHO and the Federation of Red Cross and Red Crescent Societies, were all fighting to get this vaccine to give to countries. They bound together, they created a large market, they got the vaccines, and they distributed them to countries that provided to them a virtual plan, which they would review overnight and provide the vaccine, and those countries followed that plan. They got the vaccine to where it was needed. So, countries do have a will to get these vaccines out, and this will work.
Dr Seth Berkley
And that mechanism, by the way, is still being used for not just, you know, meningitis, but for cholera, for yellow fever, and we just actually extended…
Jane Halton
Yeah, exactly.
Dr Seth Berkley
…it for Ebola. So, you know, the point is there is experience on this.
Emma Ross
Okay, great, thank you so much on that. I’m going to move to audience questions, and the first question is from llona Kickbusch and that is, “What about Russian and Chinese vaccines?” Who wants to take that?
Jane Halton
Well, hello, Ilona. Hello, Ilona, how are you? Good to hear from you. So, essentially, COVAX is considering a range of vaccines, in terms of the portfolio. CEPI has certainly considered a range of candidates, in terms of its funding. There’s a very rigorous process of considering vaccine candidates, and indeed, if there is a competent regulatory authority, who we think is going to be in a position to approve a vaccine, we’re open to considering all kinds of vaccines. Now, we already know, certainly in terms of the portfolio, there are things that CEPI’s funded, but it’s not limited to CEPI-funded vaccines, and we already know some of the early results that looked promising and clearly, depending on when others come forward, and if their results are promising, and if there is an expert regulator who, together with the WHO, considers that that vaccine is viable, those will be considered, very definitely.
Dr Seth Berkley
And if I can just add, there is a procurement that was launched by UNICEF and that is open to all manufacturers and to do that they have to submit data and, of course, as Jane has said, what we’re interested in here is transparency and, you know, trials that are done to the highest standards and to make sure the vaccines are both safe and efficacious before we would consider them, after having WHO pre-qualification. So, there’s many different checkpoints that are required here. We are working with countries, including the two countries you specifically described, and by the way China is part of COVAX, and is engaged with it, you know, at this current time. But we are also asking the question, are there countries that may have difficulties, due to language or due to, you know, having certain laboratory assays or whatever, that limits their ability to do some of these activities? And then can we, through WHO, or through CEPI, or through other mechanisms, provide assistance to make it possible that they can, you know, compete on a level playing field?
Emma Ross
Thank you for that. The next question, upvoted, is from Michael Remus, and this is about the three vaccines we’ve heard about recently, the Pfizer/BioNTech news yesterday and last week, the Moderna news on Monday, and reports that the Phase II data on the AstraZeneca/Oxford trial, where do you see timelines for distribution now? Where are the bottlenecks, as you see them, assuming the best-case scenario of approval of the above three vaccines, as well as the J&J vaccine? Who knows about that, anybody?
Jane Halton
Well, I think…
Dr Seth Berkley
Go ahead.
Jane Halton
Well, yeah, well, I mean, Seth can extend on this. Look, certainly, I think everyone is saying, notwithstanding what might happen in respect of emergency use provisions, and it is certainly reported that there will be consideration to some of that in the United States fairly shortly, I mean, we’re not talking about widespread distribution this year, and probably first quarter, more likely second quarter of next year. I mean, essentially, there’s still a distance to go, in respect of a number of these, and there’s both the process of regulatory consideration, but then, of course, there’s the manufacturing distribution piece. So, much as everyone would like this problem to be solved in the first quarter of next year, I think, being realistic, and I know, for example, AstraZeneca are looking at distributed manufacturing around the world and that will certainly speed up access, but that’s not going to happen in the next five minutes. So, certainly first half of next year I would be quite confident about, first quarter of next year I think is a stretch.
Emma Ross
Okay.
Professor David Heymann CBE
Emma, let me just bring some reality into the discussion as well, and, you know, what countries do with these vaccines will depend on what these vaccines do, and we don’t know…
Jane Halton
Exactly.
Professor David Heymann CBE
…yet. We know that they can prevent serious illness. We don’t know whether they can also prevent infection, and we don’t know, if they do prevent infection, if they – the virus can still be carried in the nasal passages and be transmitted that way. So, there’s a lot to be known about these vaccines and that will depend – that will then make it possible for the COVAX initiative to really determine how much vaccine they need for each of these different types of vaccine, because if it only prevents serious illness, it may be used in a different population than if it actually prevents infection with the virus.
Dr Seth Berkley
And let me just come in – let me come in on that, if I can, because the other issue, as I mentioned before, is the different at-risk groups, the elderly and others, so those subgroup analyses are important. But the other thing to think about, the first two vaccines that announced results are mRNA vaccines, they have special handling characteristics, they’re novel, they’ve never been approved before. So, working through the regulatory system, how stable they’ll be, and then, they are more expensive because the manufacturing is not well-distributed. So, those are issues, they will be produced in smaller quantities.
Then, we get to AstraZeneca, which is a more conventional vaccine, although, again, this particular chimp adeno vaccine has not yet been approved either, but that class of vaccines, there is experience, and, as David has said, there’s more widespread manufacturing. There also are vaccines that are coming a little bit later that have characteristics that may make them, for example, single dose vaccines, which would be a very attractive characteristic, and there are other vaccines that have very, very high immunologic response, that may be good in the elderly. So, one of the challenges is going to be, as we learn about science, as we understand the simplicity of manufacturing, to get a sense of what the right balance is of these different products.
Emma Ross
Thank you all for that. The next question is directed specifically to David, and it’s from Damian Chunilal, for David, “If the supply of vaccines, in a given developed country is limited, who should be prioritised in receiving the vaccines first within this country? We have read many different views, I’d like to hear what David thinks.”
Professor David Heymann CBE
Well, Seth has already said that countries will make their own decisions, but certainly, it will depend on what the vaccine does as to where it will be used, and if you’re trying to stop transmission in the country and you have a vaccine that prevents infection, then you would use that in the populations that are at greatest risk of getting infected, because that would decrease the transmission among all populations. If, however, it’s a vaccine that only works in preventing serious illness, then you’d want to target a different group and that would be a group that has serious consequences, including those people who are obese and those people who have co-morbidities. So, it will depend on the vaccine, but, in general, you’ll want to give that vaccine, where epidemiologically it makes the most sense, based on what that vaccine does. Seth may want to add a little bit more, but that’s my view.
Dr Seth Berkley
And just to say that WHO has and will continue through its SAGE, that’s the Strategic Advisory Group of Experts, they will continue to look at both the vaccines and the epidemiology, as we learn about it, and the truth is, we don’t – we still don’t understand, this is a fairly novel, you know, virus, we don’t know, can you get infected a second time? How long will immunity sustain over time? And then, you know, if you were to look at the US, you might say, well, some high risk groups are meatpacking plants and prisons and, you know, and nursing home staff, what’s the equivalent for that in South Sudan or in other countries, what are the epidemiologic groups you’d have to think about? So, we need to really have, as I said, some type of bespoke country planning, but it needs to be based upon some guidelines on the vaccine, what it does, but also, what we understand about risk groups and epidemiology.
Emma Ross
The next one is from Julie Futrell, it’s an upvoted question, “How does this work for countries that are effectively failed states, e.g. Libya, Iraq, and ones with civil war, such as Syria?”
Dr Seth Berkley
You know, we deliver, in many of the most difficult countries in the world, it is not easy, I mean, we have to be honest about that. We work with the state actors, we work with the non-state actors, sometimes we can be transparent about that, sometimes we cannot. But the idea is to try to get vaccine to everybody, because we believe that all lives are equal, and so, that’s what we try to do. And so, working with the humanitarian community, working with WHO, UNICEF, and others, we already have programmes to do this and we will build on those.
I mean, for example, you know, when Syria got to a particularly severe state, even though it wasn’t financially eligible, the Board made a special dispensation, eventually the tragedy was the epidemic brought it down into Gavi eligibility economically. But in that case we’ve been working with them to not only make their – sure there are vaccines, but to also help rebuild the systems that the war had broken down, similarly in places like Yemen, in Somalia, in, you know, DRC, we just talked about. So, it is possible to do, but it’s certainly – peacetime is a much better time to deliver vaccines than is wartime and good governance makes it much easier than bad governance, but we’ll do the best we can.
Emma Ross
Challenging environments. The next most upvoted question is from Axel Lambert Deruvoire, “How does COVAX plan to deal with pharmacovigilance for adverse events, and crucially, product liability?”
Jane Halton
So, maybe I’ll…
Emma Ross
Jane?
Jane Halton
…start on that if I might. Well, certainly pharmacovigilance is something that we are spending quite a bit of time on. I think Seth has already mentioned our objectives, which are to deal with a range of issues that have been hitherto difficult to handle, labelling, regulatory approaches, but pharmacovigilance and particularly this issue, in relation to compensation arrangements. I can’t say that we’ve got all the answers yet. What I can tell you is that this is very much a work in progress, in terms of the discussions that we’re having, particularly on the pharmacovigilance and the – essentially, whether or not we can have an insurance arrangement to actually cover those matters. It’s complicated and in fact, we only had a conversation about this issue, was it only last night, my time, Seth? I think it was 24 hours ago. So, whilst I can’t tell you we’ve got everything locked up and nailed, we are very much alert to those issues and I think showing promising signs, in terms of the development, but Seth might want to provide some more details.
Dr Seth Berkley
Just to say something on the pharmacovigilance and I’ll just give you a funny story, because I presented to the Board, as I always do, you know, a couple of Board meetings ago, and I put up a slide and I said, “Look, here’s the reports of, you know, of adverse events, following immunisation, and you can see that they’ve been increasing,” and initially, the people said, “Oh my God, you know, does that mean that something’s wrong?” And I said, “No, it’s great news,” because we’ve enhanced working with WHO pharmacovigilance and it’s really critical. So like with polio where you want to know there is paralysis that is not polio, and you use that as an indicator that you actually have a good surveillance system, we are doing that with pharmacovigilance as well, and that’s really important with novel vaccines in novel populations. So, it is being built, as Jane said, it’s not perfect yet, but there is a system in place and we will have to strengthen that, you know, and that’s going to be an important part of what we do, and, as Jane said, the indemnification of liability has been a big challenge, we’re trying to solve that, but, as you can imagine, that’s quite complicated.
Emma Ross
Indeed. So, maybe we can fit in one more audience question before we round up, and that will be – what am I going to pick? “What’s being done, in the context of COVAX, in relation to increasing vaccine hesitancy?” An ago-old question and one that’s got a lot of discussion, but what is physically being done to prepare for that, and do we need to get on top of this before the rollout of vaccines, and how are we doing that?
Jane Halton
Well, again, this is an issue that has been discussed, and I think we are blessed that we have at our disposal a series of – well, people who are basically global experts to work with, people like Heidi Larson, who’s very well-known, and this is an issue of great concern to the WHO. So, again, can we unilaterally solve this as a problem? No, we can’t, and I think we’re all very alive to the misinformation that we see currently on social media platforms, and I know that the social media platforms are attempting to deal with those things. But it will come down a lot to leadership in countries, and we are certainly discussing how we might work with them to provide assurances. I have to say, I’ve done an awful lot of media interviews in Australia, and one of the issues that always comes up is vaccine hesitancy, and I talk about how these issues should be resolved. And for individuals who are concerned, what they should do now to go and seek advice, to get assurance, etc. So, will we unilaterally solve this problem? No, we won’t. Is it very much on the agenda of the COVAX group? Yes, it is, and I would be confident, particularly working with our experts, that we will make the best fist of it that we can.
Emma Ross
And just to finish off, David, the vaccine hesitancy, in your – you’ve all got a lot of experience with vaccine campaigns and – but, for David, do you think it is particularly vibrant at the moment in this pandemic? Is it highlighting it or is this pretty routine level that you’re seeing, that really isn’t very surprising?
Professor David Heymann CBE
You know, Emma, what’s important is that our political leaders start to talk realistically about what is and is not possible with a vaccine. And, until the present, unfortunately, many political leaders have seized on vaccine as the solution and they’ve supressed their economies, in order to wait for a vaccine. People are now waiting for a vaccine and hopefully it will be a vaccine that will not disappoint, but if there is a disappointment in the perception of people, that is possibly a means of increasing vaccine hesitancy rather than decreasing it. So, I would just say that transparent communication from our political leaders is extremely important in making sure that vaccine hesitancy is kept at a minimum. Seth and Jane may have other things to add to that.
Emma Ross
Anything? Okay, I’m going to…
Jane Halton
Seth.
Emma Ross
Oh, no, go ahead, Jane.
Jane Halton
Seth’s on mute.
Dr Seth Berkley
I’ll just say one thing…
Jane Halton
No, no, Seth’s on mute.
Emma Ross
Okay.
Dr Seth Berkley
Sorry, just say one thing, which is, you know, traditionally there has been less hesitancy in developing countries ‘cause people know the diseases and therefore, they want to protect their families. Whereas in wealthy countries, vaccines have worked so well, the diseases are unknown, and people can take them for granted. In this case, there has been a horrible coming together of conspiracy theories of different political groups that has led to what I think has been, in a sense, the worst statistics, in terms of vaccine acceptance. But part of that is rightful fear because these vaccines have been rushed, as David has talked about, with such intensity that people are saying, “Are we cutting corners, is this going to be” – I think as soon as we see transparent information on review, as people start getting products and they see them being safe and they see them being able to return to some type of normalcy, I think that will help us a lot in moving forward. And I think now the social media companies are taking a different strategy, given that they’ve seen that they’ve been part of some of this, these terrible rumours and conspiracy theories, to try to do something about it. So, hopefully, all of this together can help us do it better, but we do have to be very concerned about it.
Emma Ross
So, no, that’s a rather sobering note to end on. There’s a lot at stake in this whole thing, so I’m afraid that’s all we have time for today, and, again, sorry we couldn’t get to everybody’s questions. But Seth and Jane, thank you so much for joining us today for really a great discussion. I feel like we got some depth on the promise of COVAX and the challenges and everything that’s at stake here. So, thank you so much for joining us.
Dr Seth Berkley
Thank you, Emma.
Jane Halton
Absolute pleasure.
Emma Ross
And thank you also to the audience for tuning in, sorry we went a little bit over. We’re not here next week, but in two weeks we’ll be back with one of the key architects of Japan’s coronavirus strategy and Virologist, Hitoshi Oshitani, to see what can be learned from their experience. So, wishing you all a great rest of the day, and thank you so much for joining us, and thanks again to Seth and Jane and to David.
Professor David Heymann CBE
Thank you.
