There’s a one-word exit strategy for the devastating Covid-19 pandemic, which is crippling economies around the world: vaccines.

Political leaders and captains of industry know preventing Covid-19 infections is the only way to get the global economy back on its feet, said Richard Hatchett, CEO of an organization tailor-made to help spur the critical work of making vaccines. They also know, he said, that vaccine development will not be cheap.

Hatchett heads CEPI — the Oslo, Norway-based Coalition for Epidemic Preparedness Innovations. By the third week of January, CEPI had already signed funding agreements with three groups racing to develop vaccines. Since then, its portfolio has grown to eight, with more on the way.

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STAT asked Hatchett about the work in early February. Late last week, we spoke with him again to see how the effort is progressing. The interview has been lightly edited for clarity and length.

Bring us up to speed on where things stand with the work you’re doing. You tweeted that the organization had raised $430 million toward your $2 billion goal, which feels like a long way off still.

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We have eight vaccines that we’re supporting at this point. We actually have a couple more that we will be announcing soon. We’ve got obviously the partnership with GSK [GlaxoSmithKline] about the use of their adjuvants, which is great. Norway recently announced it is providing roughly $220 million. So we’re actually up, I believe, to around $660 million toward the $2 billion goal.

Kudos to Norway and everybody else who has contributed. But it feels like the world is not yet fully grasping that you don’t get vaccine unless people pony up.

I’m actually fairly sanguine that we will receive the funding that we need, because I do think that political leaders do understand that vaccine is the exit strategy. And, you know, every other attempt to get back to normality leaves very significant risk. So the quicker we can get a vaccine, the quicker we can put this pandemic and its consequences hopefully behind us. And the longer it takes to get to a vaccine, the deeper those consequences are going to be.

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I’m also not clear why some of the major vaccine manufacturers, the people who have significant production capacity, are still on the sidelines. [Sanofi, Pfizer and Johnson & Johnson are working on Covid-19 vaccines; Merck and GSK to date are not.]

You’ve seen J&J and Sanofi have signed up for work with BARDA [the Biomedical Advanced Research and Development Authority], which will develop vaccines. In the first instance, those are vaccines to address U.S. requirements. But you know, if they succeed in developing vaccines, those vaccines can also be manufactured outside the United States and they can contribute to a global solution.

I don’t want to betray anybody’s confidence, but I’ve talked to all of the major manufacturers and they’re all really interested in helping. And I think you will see them play a very important role ultimately in the global response.

I will say that many of those manufacturers had over many years, whether it was with Zika or Ebola or dengue, had a series of experiences that somewhat disincentivized their participation in developing vaccines against epidemic diseases. This is different. This is an extraordinary historical event of unbelievable proportions. And I don’t think that the kinds of considerations that make them not want to jump into Ebola vaccine development are operative here.

This case is not only different because of the substantial need, but it’s clear that there is going to be a market for this. People are going to need to be vaccinated against this pathogen into the foreseeable future, wouldn’t you think?

I do. When it first emerged, there were different camps talking about whether it would self-extinguish or whether it would be contained or whether it would become endemic. I haven’t really heard anybody arguing anything other than that it is likely to become an endemic virus that we deal with forever. The long-term commercial calculus would tend toward making this a reasonable thing to invest in developing.

The challenge is we’re in a pandemic and we need vaccine super fast — as fast as we can possibly get it in very large quantities. We’re going to probably — I’ll speculate here — vaccinate a very large percentage of the world’s population in a very short period of time. That probably will take two or three or four years. But in a compressed period of time, we’re going to want to vaccinate 5, 6, even 7 billion people.

My own sense is that this will be a lot easier for companies if there are very substantial purchase commitments. One way to conceive of that would be a global advanced purchase commitment over several years to buy an awful lot of vaccine. And probably in the order of billions of doses over several years, that could be from multiple manufacturers. But I do think the world needs to think about it.

It also needs to think about how we’re going to allocate vaccine fairly. This is a case of enlightened self-interest. Countries can’t really protect themselves or protect their economic interests until the pandemic goes away. And that means getting vaccine to as many people globally as possible. And I don’t think you can just leave that to market mechanisms or even necessarily to tiered pricing. Because, you know, the vaccine supply is going to be limited initially. So there’s going to have to be some kind of prioritization of vaccine.

Bill Gates was talking recently about the need to build vaccine production capacity now, on spec. The problem with that is we don’t know what vaccine platforms are going to work. How do you anticipate that? Or do you think a lot of platforms are going to work with this?

I think you have to assume that a lot of platforms are going to fail because that’s just our experience with vaccine development.

I think — we’ve been quite candid with our donors about this — if we want vaccines as fast as we possibly can and we don’t want to compromise safety, i.e. we want to have a rational clinical development program, we’re going to have to take an awful lot of financial risk, which means doing exactly what Mr. Gates was describing. It means investing in manufacturing capacity for everything — right now — and scaling it up — right now — and even beginning full-scale manufacturing before we know if the vaccine even works.

And that means a huge commitment of resources. That’s well beyond the $2 billion that I’ve been talking about. That’s talking tens of billions of dollars if you include the cost of manufacturing hundreds of millions or billions of doses.

And that’s the reality that political leaders need to understand. They also need to weigh that reality. I mean they shouldn’t balk at that. They’re financing trillion-dollar rescue packages for the economy. The fastest path out of this is having lots of vaccine as fast as possible. And if that means making a $30 billion bet, then it means making a $30 billion bet.

CEPI is funding the Moderna-NIAID vaccine, which has already started clinical trials. When we last spoke, you talked about the fact that any vaccine that CEPI funds needs to be available to the global community. I have a hard time imagining the U.S. government allowing anything out of the United States until it felt that American needs had been met. How do you enforce that contract stipulation?

That’s a pressure that any government, anywhere, of any political persuasion is going to face, to be fair. And the solution that we are pursuing with all of our partners is to focus on how can we globalize the manufacturing capacity. How can we replicate manufacturing in multiple locations around the world?

That’s a core part of our strategy to really improve global access to the vaccines. Because you’re going to face the same pressures in India, in China, in Belgium. Everywhere the vaccine is manufactured, political leaders are going to feel the same pressure. It’s going to be a real challenge.

One thing that I would offer is that right now, no government knows who the winners and losers are going to be. And no government can be certain that they’re going to have access to vaccines. Securing access to vaccine for your health care workforce and your most vulnerable populations as part of a globally brokered fair allocation system may be an attractive deal right now. Otherwise, you’re taking your chances. And over time, as the winners and losers begin to emerge, I think the opportunity to have such conversations will be more restricted.

  • No doubt it will work as poorly as the flu vaccine but your employer will force you to get it.

    If you get sick from it, too bad, you will have no recourse since no doubt there will be a law prohibiting seeking redress from gov, employer or vaxx manufacturer.

  • They must test the vaccine first, in animals and then humans. There is a VERY strong possibility that any vaccine against coronavirus would simply potentiate the cytokine storm that causes the fatal pneumonia, as was the case with Dr. Peter Hotez’s SARS vaccine developed a decade ago, and as was the case with the vaccine against RSV. There is a significant chance of doing great harm, with vaccination against coronavirus. It may cause more severe pneumonia and increase the death rate.

    • I read about ADE, Antibody Dependent Enhancement, and it sounds scary, and somehow unfair, but not like a good reason not to test vaccines which MIGHT do this on large numbers of people. Ultimately, I would think you can design testing for the ADE effect which involves little risk for people, but is there time for it? And, even if you think a vaccine does not cause this effect, aren’t you still going to test it on a large number of people before putting it in production? I am not sure you save anything by not trying it.
      As you likely know, Dengue fever infection is known to cause ADE so that the second infection with it is much more dangerous than the first – if there is some similar effect with coronavirus, we will get the cytokine storms anyway during the second wave, so we may not be saving anyone – bad as it sounds, controlled study of the cytokine storms – on the vaccine volunteers – not deliberately caused, but if it happens- may be necessary research.
      But, there is thought to targeting parts of the virus other than the spike, and hope those vaccines will not cause ADE. So, since I am advocating all vaccines be tested at once, the “bad” ones which cause ADE would soon be washed out, while the other ones would go into production much, much sooner.

    • the prospects of being forced to get any vaccine is frightening, these people have thrown the US constitution out the window

  • I believe the war paradigm is correct. If you look at WW2, as soon as we were into it, contracts which came close to blank checks, were written to all kind of industries – get us as many planes as you can, as fast as you can. Get as many ships as you can, as fast as you can. Is there a good analogy between a medicine and an instrument of war? Hell Yes!!! Sure, the medicine can harm you, but having a plane which was not that great, not the best, which would be discovered later, meant our guys died when they would not have if the plane was better – but we got the better plane and other inventions sooner, because they were developed and built in parallel with the others.
    We do not have time for traditional clinical trials. I read Phase 1 is testing on a very small number of people for safety – NO, give them to 1,000 people in an area where some will get infected rapidly and thereby test effectivity at the same time, so you know in just a couple months if it works -and, as the man said, you set up the manufacturing NOW – so that if something works you can make it immediately – the $30B he is talking about is peanuts, as he correctly points out.
    There are possible issues with Antibody Dependent Enhancement and such – there are real risks to the test subjects, which is why they should be paid well -but we need to know ASAP.

    And, to answer the last thing you said – yes, the vaccine companies need to be made immune to liability, because they are not going to be allowed to do all the safety testing they normally would. And, despite holding them harmless from liablity, before that, the government writes huge checks to them None of that matters, we need the vaccines ASAP, that is all that matters.

  • It would behoove the ‘expert’ and readers to brush up on their history before rushing to push mass vaccination programs. Do you know why the US Government hasn’t gotten behind mass vax programs over about the last 45 years? That’s because in 1976 everyone was screaming their heads off that we faced a dire threat from the swine flu and that millions would die. Pharma rushed to develop a vaccine but only under the stipulation that Uncle Sam would eat all liabilities if anyone got injured from it. And lo and behold guess what happened? There were more people who got injured from Guillain Barre syndrome than the number of people who actually contracted the swine flu. Later it was found out that the phsrmceutical industry was cutting all sorts of corners with respect to quality control for the vaccine and that they were pushing a vaccine formulation that was twice the strength as what had been tested for safety (meaning what was actually being administered en masse hadn’t even been tested before). Uncle Sam ended up having to pay hundreds and millions of dollars in damages because the government was on the hook for liabilities. Ever since USG has not backed required mass vaccination programs.

    The pharmaceutical industry can demand mass vaccination as long as they eat the liabilities for their endeavors as well. Don’t ask taxpayers and the government to do it again. Learn your history. Public health crises aren’t an excuse to cut corners and do bad science.

    • Although not all the numbers are known, there is not much doubt that the purely medical consequences of this NOVEL disease epidemic are so great that no vaccine is likely to even approach the level of harm from the disease itself. Being 30 times more deadly, (I hate more bad news but the latest is significant harm to the heart in many survivors) , and 3 times more contagious, as most influenza variants have been, makes the math entirely different. ‘
      And that is just medical, completely ignoring the huge economic/emotional/societal/geopolitical harm.
      The numbers are radically different for this one.

    • Steve White, you seem to overlook the important statistic that the vast majority of people who are infected have either no symptoms at all, or mild to moderate symptoms. At least 80% if not higher. Only 5% need ICU care. While it is still spreading, there are about 1.2 million confirmed cases, out of a global population of 7 billion. About 50 million get the flu every year. Countries like Germany and South Korea, where extensive testing has been conducted since January, report a mortality rate of 0.5%. It is not that deadly, and certainly not 30 times more deadly than the flu, which has a mortality rate of 0.1% or so.

      It is most certainly not the risk of using an untested vaccine, especially one that may be given to a very large number of people. Early polio vaccines caused polio, as an example. The risk is far greater than the benefit, unless you’re over 80 or have a serious underlying health condition.

    • Roxanne Nelson:
      First off I would say, ALL the numbers are disputed, but i feel you are wrong about the death rates in Germany, because what I read is 3 times higher, not .5% but 1.5%.
      The 5% needing ICU statistic is also being questioned now by people going back and reviewing deaths by pneumonia, formerly attributed to influenza or bacteria, where in retrospect it appears it could have been coronavirus. So, that may add greatly to the death rate, and of course that 5% ICU rate.

      But the main problem I have with your number is that current stats in America, and particularly California where I am, consistently indicate around a 2% case fatality rate. I realize the claim is made there are so many infected people who are never identified as infected, that this number is way too high, but though we know there are many infected people not identified, the fact is, of the identified people, many are still to die. They have just been diagnosed, but are still in the early stage of the disease. Most people live a couple weeks or more, even those who will not survive. And yet, the stats keep steady around 2%, even though we have a lot more testing than we did. This to me indicates a MINIMUM of 2% death rate, not maximum.
      I would also point out, now there is talk of some cases resulting in a heart infection where the heart is damaged significantly and the person becomes permanently impaired.

      But, all those things are debated. The main point is that the very tiny numbers of infected people will grow hugely. You have cited the very low numbers right now, compared to world population, as reason not to do anything radical or risky. Basing any decision NOW, with at least many, many months of lead time to get even a proven vaccine into enough production to stop this thing, means you commit to those low numbers staying the same – but we know they will not do so. They will grow exponentially. Tracking the beginnings of the epidemic may be hard, but we know now, even with the extreme measures taken, that it still doubles every week or so, and there are so many uninfected people that it can keep growing until millions more are infected.

      But, LEAVING ALL THAT ASIDE – the numbers still favor experimenting more aggresively -even the lowest projected deaths, 80,000, justify, if you had say 10 good candidate vaccines, giving them to out to 1,000 people each, so you are experimenting with 10,000 people. Since you know 80,000 are slated to die in the short term, those deaths alone are reason enough to take more chances.

    • Steve White, the percentage from Germany that I cited is correct-0.5%. South Korea has the same, 0.5%. Even China, when they broke down the stats on the death rate, showed a 0.7% mortality for healthy people younger than age 80. So you can believe what you like, but those are their stats. Both countries began widespread testing in Jan, along with Taiwan and Singapore. Couple that with excellent healthcare systems that are accessible to everyone, with no one turned away due to lack of insurance, or people afraid to go and get help because of their high deductible.

      As far as the 5% in ICU, that does hold true in places where people are getting care. I have not seen that disputed anywhere, and I’ve been writing about Covid-19 since November.

      I would not use any data from the US to track mortality, ICU use, or anything. Our testing is still in its infant stages, and we probably have missed several hundred thousand people–and we will never know because they have long died or recovered. Even today, people still can’t get tested, even healthcare workers. So the CA stats are woefully incomplete, and of course mortality is going to be higher if you are only testing sick people, and a fraction at that. And it is also going to be higher if people can’t get healthcare–in NYC they were splitting a ventilator between two patients! Uh, are we in some village in Africa, or is this NYC in the USA??? We have the people, the intellect, the capacity and the money to have mustered up a stellar response–but we failed and are still failing. So CA statistics of 2% mortality are totally meaningless given the circumstances.

      And yes, I have heard that it can damage the heart. All that considered, the virus is still not all that virulent to unleash an untested vaccine on the public which could have dire consequences.

      But that said….

      If people are willing to get vaccinated with an experimental agent–and are informed that it has not been tested and it could have detrimental side effects (informed consent is not always the best)–and are willing to try it anyway, then go for it. But they should be well aware that the vaccine could be worse the the disease, and that is key. Also, there is the question of liability. If the vaccine kills them or disables them, then who is responsible? If no one is going to take the fall, people should also be well aware of that if they decide to be part of the “experiment.” That is my primary concern–I believe that people should have that option, but it must be very clear what they will be receiving and the risk vs benefit made very loud and clear.

      I do think that there should be more of an effort to find effective treatments, but therapeutics for viruses have been rather elusive overall. HIV took a long time, and still no cure even though it can be controlled, and Hep C has been another–but took decades to achieve a cure.

  • the game seems to be either give them away for free or hugely overprice them.
    I am pretty sure governments are willing to pay 1.5-2 time the cost of production per dose, and companies should be content to make “just” up to 100% profit, instead than the usual 1000% or more.

  • Human trials will begin imminently – but even if they go well and a cure is found, there are many barriers before global immunisation is feasible.
    About 35 companies and academic institutions are racing to create such a vaccine, at least four of which already have candidates they have been testing in animals.
    They advise to everyone to wear a mask , but nobody can get hands on. Even us older people.
    Does anyone know where can I get it delivered to me?

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