cronaca

Kate Bingham: Why the UK strategy on Covid vaccines has been a great success

kate-bingham:-why-the-uk-strategy-on-covid-vaccines-has-been-a-great-success

La Repubblica and Die Welt: Kate Bingham, how did you achieve this successful vaccine program? How did you know which of the vaccines to pick?

Bingham: “The instruction I was given by the Prime Minister was to save lives as soon as possible, so we had a very clear goal. We had a very clear focus on being quick and securing the most promising vaccines for the UK as soon as possible. That was my number one priority and what we did. I’m a venture capitalist in my whole job, I’ve spent all my life building companies, developing new pharmaceuticals. So my whole job has always been: look at science, look at data, and then decide what the risks are. And if, from my perspective, it’s an attractive investment or whether or not we should be building a company around that area of science.”

“So the concept of looking at data and establishing what the different strengths of the different data packages were is something that I’m familiar with. But also the team that I put together is familiar with. So the first thing we did was basically to narrow down the landscape to those [vaccines] that could enter the clinic in 2020. So that was our first cut off, because if they couldn’t get into the clinic in 2020, that means they were going to be probably next generation vaccine – and too late for the immediate pandemic.”

“Therefore, we focused, first of all, on what could get into clinic first and then we looked at the data. Now, of course, all the different companies have different types of data. None of the models were comparable and that reduced the list probably to 20. Then we probably did really deep diligence on a dozen, maybe something like that. And then we had to make decisions. That was the basis, the judgment of the team that not only what was the immunogenicity and safety data like, but just as importantly, what was the ability to supply like?”

“Did we actually have confidence that they would be able to scale and generate the numbers of doses we wanted in time? So that’s why we’ve been quite public about it. That was the reason we chose BioNTech over Moderna. Both of them have good data, but the BioNTech supply chain was clearly far advanced for European supply ahead of Moderna who had prioritised supply in the US ahead of Europe. Everyone thinks it was sort of amazing. It wasn’t. It’s what we do.”

Were you told basically you can spend whatever you wanted to?


“Well, they asked me what I thought we needed to spend, and the answer was I didn’t know when they first asked me. So we went in and obviously started doing the work and doing the due diligence. Many of the pharma companies said that they would do it on a non profit basis”.

“So Johnson & Johnson or Janssen has auditors in there to establish their non profit price, AZ is doing it on non profit basis, GSK, Sanofi were doing it on non profit. So price was important, but it wasn’t the driving force. The driving factor was getting the vaccine quickly. As it turned out, we paid a little bit more than 10 pounds a dose [average across all vaccines] and it’s about the same as the US paid. So it wasn’t as if we threw money at it”.

“The government didn’t say to me “you have a blank check”. We had to prepare a business case to secure an overall framework budget from which we would then make recommendations, for example “we suggest you sign this contract for these vaccines”. We weren’t choosing vaccines on the basis of being cheap. We were choosing on the basis of vaccines being effective and available quickly”.

Do you think the UK was better in coordinating the supply of the vaccine?


“Being quick and nimble was definitely important. The fact that I’ve been in the industry for 30 years and the team that I work with have been in the industry at least as long, if not longer, meant that we had connections very broadly across the industry. So that meant I could just pick up the phone and speak directly to a company. With one company we had our first meeting on a Thursday and we had a follow up meeting on Saturday, and would agree the rough outline of a deal the following week.”

“So we had to make ourselves good customers to make people want to supply to the UK because there was going to be limited amount of vaccine initially. Our goal was to do whatever we could do to encourage the companies to talk to us. That meant we had a sort of “UK offer”, as it were, which is if the company needed support in the scale of the manufacturing and fill finish and if we could offer that, we offered it and if the company needed us to help with running the clinical trials, we did that, too.”

“I take Novavax as an example. We have supported them with during the tech transfer of their manufacturing to a company in Teesside, “Fujifilm”. So we help them buy the equipment to manufacture the vaccine so that they would be ready to start manufacturing this year, which is what they’ve done and also launched a national citizen registry on the NHS website so that anybody in the UK could sign up on the NHS website indicating their willingness to be contacted about clinical trials. We’ve now got more than 400,000 people registered, of which over a third are of over 60. It was very important to us to be able to have a broad reach of people that we could enrol in clinical trials, especially those people who are most vulnerable, because those we needed to show that the vaccine worked in those people. So using the registry was the reason that we were able to start that Phase 3 trial and finish enrollment of 15,000 people before the American trial even started.”

“So our offer to Novavax was, we’ll help you with manufacturing, we’ll help you with the clinical trials and then, of course, the broader contribution is that that clinical data can now be used for the European submissions and submissions elsewhere. But our goal basically was really to be a supportive customer as much as we could.”

Did you mainly work with institutions like Oxford and Cambridge?

“Oh no. I did not mind where the vaccines came from and in fact, the only vaccine we secured, the only UK based vaccine is Oxford/AstraZeneca. We also secured rights to the UK/French vaccines from GSK/Sanofi and Valneva. As far as I was concerned, geography didn’t matter. I was only interested in securing the best vaccines. For example BioNTech: Sean Marett, who is the chief business officer, was somebody I had backed in one of my companies before. I’ve known him for, I don’t know, 15, 20 years. So it’s very easy for me to just pick up the phone and had lunch with him a year or two ago when he was in London, easy for me to pick up the phone and have those conversations. I don’t think this was anything to do with the UK being better or anything. I think that is the wrong narrative. I think it’s just a different strategy.”

“The UK had a very strategic approach, which was to secure vaccines quickly. And the European approach seems to be more sort of a more typical procurement approach, which was more about making sure you got the best value for money for your vaccines. It wasn’t related to Brexit and is not related to people being better or more experienced. I think there’s plenty of very, very, very good people obviously in the EU and in fact, you know, if you look at the companies are, you know, BionTech his exceptional, CureVac is exceptional. Sanofi is fantastic. Lots of good companies there.”

You are more happy to take a risk in this country?


“Maybe. I don’t know. Our actual upfront cost was 900 million pounds. It’s in the public accounts committee transcript. But yes, we were willing to write off the upfront money which was largely for manufacturing if actually those vaccines failed.”

However, it’s also clear that the UK moved faster because of Brexit. Don’t you think that maybe Brexit helped the UK to be faster than other countries in stocking vaccines?


“The first thing that was the quickest – the MHRA registered the vaccine under European law, so there was no change. Any other European country could have registered the vaccine under European law, using their own regulator. So in Germany, the Paul Ehrlich Institut could have done exactly the same thing. So that was not to do with Brexit. Whether or not other countries could have done what we did. Again, that’s a political matter. I don’t understand whether they had to opt in or could have been able to opt out. We chose to opt out. I don’t really understand politics, and so I don’t know what the constraints are, I’m afraid.”

But in this context, maybe the EU insisted more on liability of pharma companies, which the UK did not. Is that correct?


“No, I don’t think so. I don’t think our liability claims would be very different from what the Europeans have agreed to.”

So is it not the case that if something wrong happens with vaccines that will then be covered by taxpayers’ money in the UK, while in the EU it will be covered by the pharma company?


“I think it’s highly unlikely if that’s the case. The fact is that all the companies needed indemnities because of the fact they had not worked with the vaccines for very long and it wasn’t a choice. So indemnification was definitely a matter that all the governments, including the UK, were uncomfortable about. But if they/we wanted to secure the vaccines, they/we were going to have to give indemnity. So I think probably the difference is that we just got to that position maybe sooner than others. I can completely understand that if you could get 27 countries all to agree is very difficult. If you look at the US, they’ve actually incorporated that indemnity protection into law. So they have statutory immunity in what’s called the US PREP Act. So we weren’t doing anything that hadn’t already been done in the US.”

You secured 400 million doses for the UK. What do you think is the right level of doses for the UK to start supplying other countries?


“That’s a political question. I don’t have a view. The reason we’ve got so many doses is that we know which of these vaccines would work. So if you go back to May, we didn’t know what, there were no vaccines against any human coronavirus, so we didn’t have any confidence that any of these would work. So what we did was to pick the best vaccines, each of the four categories of different types of vaccines.”

“We had contracts for the two most advanced type of the Adenoviral vaccines, which is the AZ and Johnson & Johnson  (Janssen) and the mRNA ones which are BioNTech and Moderna. They were the most advanced, but those are the ones that we knew least about. So those could all have failed because they’ve never been approved for use before. Then we took the less sexy, but the more reliable vaccines which were the protein-adjuvant vaccines and the whole viral based vaccines, which we’re going to be slower to develop.”

“But if they were going to work and more likely to work because we knew more about those vaccines? So now people are saying, well, why did you buy so many? We didn’t know which if any of these were going to work. In terms of surplus, that is that is purely a political decision. The politicians will have to decide when enough is enough. And that’s for them. Not for not for me, I’m afraid.”

What is the cooperation with CureVac?


“The CureVac deal has been done since I left. The purpose of CureVac is to bring mRNA manufacturing onshore. So one of the manufacturing plants that we bought last year was a veterinary vaccine plant, which we’ve now converted into manufacturing human vaccines. That is now a bulk manufacturing plant that can make mRNA vaccines in the UK. We also funded work to improve the lipid nanoparticles process and scale up. Basically, mRNA genetic sequences are encased in a lipid/fatty envelope to make the vaccine.”

“We were able to develop that lipid nanoparticle technology to support mRNA vaccine manufacturing. So the idea of CureVac is to be able to develop next generation sequences for the new variants. These could be ready for boosting the UK population for next winter, i.e. October or the beginning of next winter for 2021 to specifically address the variants. The plant is in Essex”.

Let’s talk about Covax, the Global Initiative. When will those developing countries get the vaccine, once all British people are immunized?


“The UK has pledged I think 548 million pounds to Covax. That’s independent, completely separate from the contracts that we’ve signed for the UK population. The U.K. has made a very significant contribution to Covax. In fact, we’ve seconded people into Covax to support what they’re doing. Our approach throughout has been as cooperative as we possibly can make it. If you take AstraZeneca, for example, we sent out a team in November to the Dutch plant, the Halix Plant, to help them with the scale-up and the production of the AstraZeneca vaccine in that plant. Where we can, we try to help. That’s been the same the whole way through. So our approach has been to be as co-operative as we can. In fact, I spoke to several of the European negotiators along the way.”

Would it be kind of ethical, once you have vaccinated your whole UK population, then to give the surplus to other countries, whether it’s Europe or other countries?


“That that would be my view. But it’s a decision for politicians.”

The UK is a pioneer also of the one-dose approach. Do you think this should be applied also to other countries?


“I think you need to be a bit careful about calling it a one-dose strategy because there’s no actual one-dose strategy. The only company that is developing a one dose strategy is Janssen, and their data looks very strong in terms of immunogenicity and protection after one dose, so that’s the only company that’s got a single dose regime. What the Oxford data has shown is that by extending the time between two doses, they can improve the immunogenicity. And remember, they got data to show for it because they, like J&J, were planning to do a single dose regime, but it was when they have had two doses arm and when they looked at the two doses arm, they then realized that they got much better immunogenicity after the second dose. So they went back to that the trialist and said, “Would they come back please, for a second dose?””

“Because many of the trials had started in April. By the time they had a second dose, many of them had got to 12 weeks. So the AZ data has a spectrum of data of people who had their second dose after four weeks all the way up to those up to 12 weeks. And what they have been able to show is that the immunogenicity goes up with an extended time between doses. So it is correct that there is data to justify and extended period between doses for the AZ vaccine. I think it’s the right public health response, which is to show that you try and vaccinate as many people as possible, as soon as possible. Better to protect everybody a bit rather than to vaccinate fewer people to give them an extra 10 percent protection. I think it is the right public health response. If I was making that decision, I would have made the same decision”.

Regarding hiccups in UK supply chains. What did AZ tell you when those happened?


“They told us exactly what the issue was – we were working closely with them throughout. The issue is you’re taking a process that normally takes several years and you’re trying to do it in several months. So there’s not any sort of single issue. It’s just you’re trying to accelerate something that is highly complex. So you’re taking mammalian cells and you’re starting off with a  scale process and you’re scaling this up to a thousand liter scale. It’s got to be consistent and high quality. You’re talking about each dose is has 1011 viral particles in it. You’ve got to make sure that everything that you manufacture is completely consistent and has nothing in it that you don’t want to include. So it’s the pace of the scale up which is challenging for AZ – as for all vaccine manufacturers. We have had just as many scale-up issues, it’s just a fact of life. You do not build a racing car from scratch in six hours.”

“It just takes longer than that. And you can’t get cells to grow faster than they grow. So I don’t think the EU has had any different experiences in the scale-up, and as I said, the difference with the UK was because we started earlier. In fact before I even started and before the vaccine task force was even created, the companies in the UK bioprocessing industry came together and started pulling together the key elements that were going to help Oxford scale up their vaccine to industrial scale. This was done because it was the right thing to do. There were no contracts, no agreements to do anything. So the different companies knew that they could manufacture the virus and the people that could put them into vials came together voluntarily. So it was under the Bio Industry Association leadership, and that was only papered, I just think, in May. So they’ve been going for probably three months plus before the AZ deal had even started. It meant we already had some of the balls in motion. We have now scaled up to the thousand liters, but every step you take has to be validated, quality assured and to allow for products to be released and approved and qualified. It’s just complex. It’s just not something you can do overnight.”

There is some AZ production line in Dessau, in former East Germany, where AstraZeneca vaccine is produced, and people in Brussels claim that actually the UK has been supplied from there while Germany didn’t get the supplies they needed.


“I’ve never heard of that. I would bet a lot of money that this is not true. I know that the most productive plant that AZ’s got is the Oxford Biomedica Plant. Oxford Biomedica that is making the bulk of Oxford vaccine. They were part of the original consortium from February last year, they’ve been working on this for almost a year now. So I think that I’m sure that’s fake news, I’d be highly, highly surprised. I’ve never heard that and it’s news to me, but suggest you ask AZ to confirm it.”

You took part in the Novavax trial. Authorities in France and Germany criticised the Oxford-AstraZeneca vaccine because they believe it is not very efficient on over 65s. How do you respond to that?


“The fact is in the Oxford study the way the trial was designed is that they recruited the older adults later on in the study, after it was proven safe in younger adults. Approximately 10,000 people were recruited initially. And then the last 2,000 or 3,000 were older adults that were recruited later. Because they were recruited later, there was less time for infection to occur and also older adults, and I am sure it’s true in Europe as well as in the UK, are being cautious. So their infection rate, relatively to younger people, was lower. So it takes longer to get to an answer on efficacy. But what we’ve seen is good immune responses in healthy older adults, in the Phase 2 paper, and that was published in “The Lancet”. The MHRA then reviewed further data on the immune response to the Phase 3 trial, which I have not seen. So it is fair to say that there is limited information available on the efficacy in elderly patients.”

“But there is nothing to suggest lack of protection or lack of safety. What the Swiss and French regulators are saying is we want more data – completely fair. We all want more data. In a perfect world, nothing would get approved without everything, all the data being ready, and it’s all finished and tied up in a bow. But we don’t have that as we’re not in a perfect world – we are in a global pandemic. So the main judgment from the regulators is: is there sufficient data to suggest that there’s going to be efficacy in the elderly? I think the conclusion was there is. If that’s the case, is it safe and if it’s safe and there’s efficacy on the elderly, those are two pretty good reasons to believe that it’s worth approving it.”

Would you buy Sputnik?


“The UK doesn’t need more vaccines.  But if the experts sees the data and says it’s effective and safe… fine. Then, again, it’s a political decision.”

What is the future of vaccines? Will we have to have a job regularly? Or will we take a pill? Will we take a nasal spray? What do you think?


“We don’t know how long immune protection will last. It’s possible that if there is still virus floating around in the community, that itself may act as an ongoing immune boost for people who’ve been vaccinated. I think it’s probably reasonable to start with the assumption that we will need to do a boost within a year – so this winter and then take a year after that to see how frequently we need to boost after that. It may be five years, it may be one year. I don’t know the frequency. We just need to see the data to see what that’s going to be”.

“We need to get to a point where you can have a flu and a coronavirus jab simultaneously and not have to do them three weeks apart. Novavax was running a study co-administering with flu I think and we need ultimately to get away from two doses because that’s incredibly complex and expensive and logistically challenging. Ideally, we need to get away from needles because if you can induce an immune response by putting a patch on or spray or a tablet, that would be much, much easier, because certainly the cost in the UK of the vaccines is doubled when you add the cost of deployment as well. That’s a very substantial cost. So if you can eliminate the deployment because people can just do it themselves, that would be something that globally we should be focusing on those new formats and, for example, for respiratory viruses in obviously into your respiratory tract”.

“Yet we’re not dosing in the respiratory tract. So a nasal spray might well be a good idea because then you can actually protect in the very compartment where the viruses will be entering. I do think there’s a lot of scope for improvement. I mean, it’s been amazing to have done as much as we globally have been done. But I think there’s a long way to go”.

Regarding the recent accusations of cronysm and others against you, a Whitehall source said to the Guardian that you’re “used to doing things quickly and without bureaucratic bullshit”. Do you think that bureaucracy is something that’s going to be very much of a danger for the development of vaccines?


“I wouldn’t believe everything you read in The Guardian, there’s very little that they’ve written that is correct. In terms of bureaucracy: I think our government did a beautiful job because I reported it to the Prime Minister and we created a process and team just like a venture capital investment for the approval of vaccines. I don’t touch any money of course; I make no spending decisions nor am I involved in any operational contracts etc.”

“I make recommendations to the people that make the decisions in the UK, the Secretaries of State or Business, Health, Cabinet Office and Treasury. We have four very senior ministers who are the decision makers. That was one of reasons why we were able to be quick. If I called and said we need to have a decision on this in 24 hours, we had a decision in 24 hours. I think that is unusual. It is true to say I was not keen on bureaucracy. I’ve never worked in a big company, let alone the government. I think it was very forsighted by the government to allow us to set it up like that.”

But how did you deal with the pressure? The vaccine mission was the biggest investment in your life, after all, even if you’d made no money. But the responsibility you had.


“It’s like any investment. You look at what the opportunity is, what is the potential of the investment you’re making, what are the risks and what’s the potential balance and how you mitigate against all the risk wherever possible. On balance, is this the right thing to do or not? Here people are dying, so the longer we take, the more people will die.”

What did Prime Minister Boris Johnson say when he called you?


“”Just stop people from dying”. I’ve been involved in the development of lots of new medicines for people who have no other clinical options. So my career has been to stop people from dying. I’ve got a company, for example, that was treating people with cystic fibrosis, who had lung transplants where they failed all the medicines to basically control infection in their lungs. They were going to basically bleed to death and die from infection. Our medicines are basically being able to cure them. So the concept of how can we use pharmaceutical intervention to stop people from dying is something that’s my job. This was a 28 year old lady who just had been married and had a lung transplant, had a infection around the stitches where the joint was infection was so bad they couldn’t control it. What was going to happen is, it was going to burst and based on compassionate use, they used our drug, an experimental drug that we’re developing. She was cured and went home. So the concept of how can we do things that are of some significant impact is something that I do understand.”

What is your view of the Prime Minister?


“I think Boris was very, very foresighted. It was actually Sir Patrick Vallance, the Chief Scientific Adviser, who set up a task force. The Vaccine Taskforce was his idea and he could see basically the progress that was being made in manufacturing outside government with all these companies that got together voluntarily. That’s why he said they need to be able to interact with a government body so that we can actually pull this together. That’s why he then created the vaccine taskforce. I think Boris did a good job to agree to Patrick’s advice and to allow us to operate in a nimble way, because it’s not easy for government to basically put in place an investment committee that will meet quickly and make quick decisions. But basically, I was subject to all normal civil service conflict of interest procedures. I have no special rights or anything like that, and of course, I know what I don’t do, any contracting myself or the contracting of advisers and consultants and experts is all done by the Civil Service, not by me. In fact, I didn’t even know half the time who they contracting with. The detailed operations are handled by the Civil Service”.

Is a global effort on vaccine still possible despite the latest “vaccine war”?


“I absolutely think it is a global effort to resolve pandemics now and in the future. It’s only because we had really good, competent, generous community and people that we’ve made as much progress as we have. That’s going to continue irrespective of political rhetoric. The scientists talk to each other irrespective of borders. The clinicians talk to each other irrespective of borders. Venture capitalists do. Politics is separate. But what actually goes on is co-operative. So I would believe anything else other than this is cooperative. This is a wonderful industry. The pharmaceutical industry is often painted as a bad industry. It’s not. These are very thoughtful, generous people, which is really difficult doing this stuff. It’s fantastic that it’s working. So I’m absolutely convinced on that global collaboration.”

The Daily Mail called you a “brilliantly batty heroine of our Jabs Triumph”. How do you feel about that?


“I think it’s entirely fine. I don’t have any problem with that.”

Rispondi

%d blogger hanno fatto clic su Mi Piace per questo: