Sustainable COVAX Vaccine Funding & Voluntary Manufacturing Licenses are Better Solutions than IP Waiver, Says IFPMA Head Inside View 16/05/2021 • Elaine Ruth Fletcher Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) The real challenge is manufacturing the vaccines, not the patents for them, say industry figures such as IFPMA’s Thomas Cueni. In preparation for the next pandemic, the COVAX global vaccine facility “needs a pot of money, where they can be early movers” in competing for, and securing, vaccine doses. That could help scenarios like the ones seen recently, in which rich countries cornered the market on the first available COVID-19 vaccines, leading to severe shortages in low- and middle-income countries “because COVAX didn’t have money in the bank” at the time the first big contracts were being made. That is just one key lesson learned from the COVID pandemic, says Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations. Cueni spoke to Health Policy Watch in the wake of the US decision to support a World Trade Organization waiver on vaccine IP. Whether or not the waiver initiative is ultimately approved, having the patent “recipe” without the knowledge or tools for “baking” could leave the cake flat, Cueni argues in this exclusive interview. What’s more, he contends that a waiver could have unintended consequences – intensifying the competition over already scarce raw inputs. Rather, the world should focus short-term on dose- sharing by rich countries and the removal of trade and export restrictions on vaccines’ scarce raw ingredients. Longer-term, industry is well-positioned to support more equitable redistribution of vaccine manufacturing capacity – “an increase in more agile, flexible, ever-warm vaccine facilities in more continents” to combat vaccine inequity. Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). Health Policy Watch: What’s the upshot of the IP waiver. Despite industry resistance, couldn’t it still help expand supplies more rapidly? Thomas Cueni: As Stéphane Bancel said, the IP for the Moderna vaccine is available online. And on top of that, Moderna said they would not enforce their patents during the pandemic. However, he did also say that [just] having the patent, the technical blueprint …- well….good luck. We’ve seen compulsory licenses used for example in hepatitis, it happened in HIV/AIDS, but there has not been a compulsory license on vaccines. As Sai Prasad, from Baharat Biotech [Indian developer of COVAXIN®, the first indigenous COVID vaccine], and a top expert on quality assurance has said, just waiving patents would create more problems than it solves. Right now you have tech transfer happening on a very large scale. Within 12 months, you have 275 contracts between vaccine manufacturers to help each other scale production. More than 200 include technology transfer. That involves sharing know-how, sharing expertise, sending teams to make sure that you not only have the machinery and the equipment, but also know how to use it. Training of skilled workers. In Geneva, I’m sure you followed with as much interest as I did the debate about the delays in the delivery of the Moderna vaccine. Stéphane Bancel called this out very openly and said they have the equipment, machinery, but they don’t have sufficient numbers of skilled workers to scale up as fast as one would hope. Lonza, Moderna’s manufacturing partner for active COVID vaccine ingredient, nestled in the Swiss town of Visp, has faced an uphill road to rapidly scale up manufacturing capacity. HP-Watch: Given all of that, doesn’t the industry still risk being on the wrong side of this issue, at least rhetorically – as per the debate over Africa’s access to HIV/AIDS anti-retroviral drugs two decades ago? Cueni: You know when you look at it, it is more an issue of political symbolism. What is really interesting, and not much talked about, is that when you talk to, say, Indian vaccine manufacturers, they invoke our language. They say that tech transfer is a complex process, which is built up over the years, which involves much more than patents. As for IP standing in the way of vaccines getting to the patients – this was the debate 20 years ago on HIV AIDS but it is not the same [today]. Because when you look at the HIV/AIDS debate, the first effective anti-virals were approved by the US FDA in 1995. And literally, it took almost 10 years for them to reach patients in Sub Saharan Africa. It also needed the establishment of the Global Fund. In COVID-19 you had the industry responding on a large scale from Day 1. Few people would have expected, not one but several vaccines, within less than a year. You know mRNA technology goes back thirty years to 1990. But only now, we have seen the first products, vaccines, reaching the market, and not just from one company BioNTech, but also CureVac and Moderna. And therefore, industry from Day 1 has acted very differently from what you had in the HIV/AIDS crisis. But three of the four largest vaccine manufacturers in the world (Sanofi, GSK, Merck/MSD) don’t have a COVID vaccine yet. And it’s not for want of trying. But this shows that this is high risk. Pfizer, so far, is among the lucky ones; they succeeded by teaming up with the right partner. And when you look at Moderna or Pfizer, they do basically sell at cost, not for profit, to COVAX. Not only with COVAX but also in striking partnerships – Johnson & Johnson with BioE in India for a billion doses, AstraZeneca [with the Serum Institute of India] on a large scale, they have behaved responsibly. And I think that’s something which people also underestimate. AstraZeneca vaccine production. As with most other COVID vaccine manufacturers, there have been setbacks and delays in scaling up manufacturing capacity. And when you look at the partnerships, by and large these partnerships happened between organizations with proven expertise for large scale manufacturing. That’s why you do have in India, the Serum Institute or BioE. Also, you do have now Bayer, Sanofi, GSK, and Novartis coming in [as partners with vaccine developers] – because there is little doubt that they do know how to manufacture on a large scale. What’s behind the call for the patent waiver is the impatience for scaling up. It’s the lack of understanding that, moving from zero to 10 billion doses – trebling global vaccine capacity in a complex manufacturing process – that’s really challenging. HP-Watch: Did industry make a mistake, perhaps, by agreeing to sell too many doses to high income countries. Could manufacturers have put a cap on those sales whereby some countries, like Canada, pre-ordered 5-10 times the number of doses that they need? Cueni: We could put it the other way around. What went wrong, or why is COVAX [the global vaccine facility] struggling? I’ve heard some say they don’t have the money; that’s not true. COVAX actually more or less met its investment needs with cash injections for this year. Where COVAX was really handicapped was that they couldn’t sign contracts, before they had the money in the bank. When you look at when most of the MOUs/contracts [were signed] – that was in December 2020 – at the time when it was clear that the mRNA vaccines Madonna, Pfizer/BioNTech as well as AstraZeneca would make it. But COVAX was not able to sign these – in contrast to the US, where BARDA, (Biomedical Advanced Research & Development Authority) put in money at risk, for scaling up, and they immediately secured a huge number of doses. And you had the same with the UK, you had with a little delay the same in the EU, you had Canada.. If COVAX would have been able to sign up with the companies, but [GAVI head] Seth Berkley probably would have been challenged by his board. Which means that if you walk about what needs to be done, when you look at vaccine rollouts now, the benchmark is not When you look at the rollout.. The benchmark is not HIV AIDS – that disaster, it’s H1N1 [2009 flu pandemic], which was also a disaster. And I’ve looked at some numbers comparing roll-out of H1N1, where the rich countries basically bought up all of the antivirals and all of the vaccines, until they found out that H1N1 was not so traumatic, and then they tried to get rid of them. Ghana’s WHO representative, Francis Kasolo, on left, with UNICEF’s Anne-Claire Dufay, as first COVAX vaccine doses arrive on 24 February in Accra, The COVAX situation is different because in COVAX, we did get a rollout within 100 days, or less. In 88 days after the granting of the first emergency use license by WHO, you had vaccines in quite significant numbers reaching Accra, Nairobi, Kigali – and on the same day as Tokyo. Therefore, the problem was that manufacturers who did invest, also at risk, in addition to getting some quite significant co-funding, in particular from BARDA – in return secured [contracts for] doses. Then the companies would not have been in liberty to release these doses. And therefore, when I look in terms of future pandemic preparedness, COVAX needs a pot of money, where they can be early movers. It’s also a question for CEPI (Coalition for Epidemic Preparedness Innovation). Because when you look at the big manufacturers they, by and large, teamed up with BARDA early on. The smaller biotech companies, such as Novavax, they got quite significant sums from CEPI. But CEPI is a relatively small organization. Therefore, I think one needs to talk about how can we improve pandemic preparedness for the future; we need to make sure that COVAX and CEPI are equipped to have a level playing field for the deliveries to the poorer countries. Novavax, a smaller biotech firm that received significant support from CEPI, the Coalition for Epidemic Preparedness and Innovation, showed robust results for its COVID vaccine in clinical trials, but still faced an uphill battle to scale up manufacturing. “I don’t think that you can fault the companies for signing up [orderes]. The companies took risks, and when you look at MSD/Merck & Co., two projects, nothing came out of it, and they invested at risk. When you look at Sanofi, delayed by at least a year, and nobody knows whether, by the time they reach market, there’s a surplus. All of them are now teaming up with somebody else to help in fill and finishing, or even active substance producing. HP-Watch: You have talked about the need to have a pot of money available, so COVAX can move more quickly. But where do you go from here in terms of industry interests, the broader well-being and this waiver, which is a big debate now? Cueni: Even if the waiver would pass, which is still a question mark notwithstanding the US, I would expect that it would create a huge frustration because people will realize that we were right. Short-term, what do we need? We need a willingness of rich countries to start dose-sharing now, and not as President Biden said, once we have every single American vaccinated. We need some significant gestures of solidarity now. We have seen early signals: New Zealand announced, France announced, but you know these are in the hundreds of thousands, not in the millions. I think (WHO Director General) Tedros has mentioned we need 20 million doses now. And that can only happen if the rich countries that bought up these doses are willing to give priority to COVAX, and that needs to happen now. Also, in terms of the supply chain and manufacturing bottlenecks – for which COVAX set up a Manufacturing Task Force. One of the short-term priorities is to tackle trade barriers. (WTO Director General) Ngozi Okonjo-Iweala, has called out to world leaders to stop export bans, export restrictions. When you look, for example, at the Pfizer/BioNTech vaccine, you have 280 ingredients from 86 different suppliers from 19 countries. If you have trade restrictions, these are usually disruptive. You’ve seen [Adar] Poonawalla from the Serum Institute in a tweet calling out to President Biden to ‘please help; we are stuck because you don’t allow [export of] critical ingredients.’ [Addressing] that is something that would be immediately impactful. Respected @POTUS, if we are to truly unite in beating this virus, on behalf of the vaccine industry outside the U.S., I humbly request you to lift the embargo of raw material exports out of the U.S. so that vaccine production can ramp up. Your administration has the details. 🙏🙏 — Adar Poonawalla (@adarpoonawalla) April 16, 2021 HP-Watch: OK, but if indeed the waiver passes, why indeed would it be disruptive? Cueni: Short-term it would be disruptive because we have identified a number of critical ingredients, like the giant plastic bags, the single use bioreactors, filters, lipids – that are in huge demand and in short supply. I’ve heard some people say that for some of these ingredients you have to wait for three-six months. Under normal circumstances, when you have bottlenecks, the normal reaction of human beings, and you saw it with hoarding of toilet paper last year, is that you have compensatory actions, and that leads to additional bottlenecks. Therefore, what we identified in this joint Task Force effort with CEPI, the DCVMN, our developing country colleagues, BIO and IFPMA, we do believe that if we set up a matchmaking place where companies can submit information on [items] for which they in desperate need, or may have excess stocks, you could improve the efficiency and address some of these bottlenecks. Rajinder Suri, CEO, Developing Country Vaccine Manufacturers Network, with Pfizer, GSK and Bharat Biotech execs at 23 April IFPMA session. HP-Watch: So how does the IP waiver have an effect on this mission? Cueni: The IP waiver potentially would mean that you get 100 more companies that want to participate, and have access to these scarce raw materials, scarce ingredients. Unknown whether they would be able to manufacture, but they would compete on the ingredients. And in that context, in the case of a waiver, you will have more players coming in trying to tap into the same scarce resources, irrespective of whether they can make good use of them or not. The other element is that the waiver, as such, is that it wouldn’t really give you the tools to manufacture. You would need teams of engineers or scientists or experts from Moderna or others to be willing to visit you, and share, and teach you how to use your know-how. That is happening now on a large scale. But it’s happening based on voluntary, established trust, established confidence – where you have a contract and a process for doing this. Can you imagine companies confronted with ‘your patent is no longer valid. You cannot enforce it; there is no contract it’s a free for all?’ The guy who takes your bike, basically comes to you and says, ‘now you need to give me the PIN code to unlock the bike so they can run away with it.’ This would be a huge distraction, when the skilled workforce is so limited, when a serious bottleneck is the lack of a skilled workforce. Therefore, short term we would likely see more disruption and distraction from the efforts that are really needed. Because we need to expand further. If we can reach 10 billion doses this year, then I think the the world is pretty much vaccinated by March 2022. Of course, everyone would love the world to be vaccinated by July 2021. HP-Watch: So long-term you are optimistic? Cueni: For next year, I’m very optimistic. We will not only have the capacity, but we will also have the adaptive vaccines for new variants. In terms of the waiver, there is a willingness, and needs to be a willingness, among industry to …get a better geographic diversity of manufacturing hubs. “I was five weeks ago at the African Manufacturing Summit. The basis for that Summit was an absolutely excellent study, which was I think commissioned by the UK’s Foreign Commonwealth & Development Office, and the conclusion was short term, there isn’t really the capacity or the skill sets in Africa to add hundreds of millions of doses for Africa. It’s much more likely to come from the 500 million dose [COVAX] contract with J&J or AstraZeneca, and also Novavax will come in certainly. Medium term, I think we will see a much more constructive discussion on how can we make sure that we help to establish infrastructure capacity. BMGF [Gates Foundation] is interested, Germany, France, and the UK are all talking, and manufacturers are involved. But that, I think realistically, is not for this pandemic, that’s for the next one. HP-Watch: Just to recap, you said that if there was an IP waiver, then in the immediate future, more players would come in and tap into the same vaccine inputs that you’re so short on already. But wouldn’t that also drive more production of those same items? Cueni: I expect that we will continue to see significant expansion of capacity, it will primarily come from those with expertise in scaling up, and the partnerships they signed with others that also have that expertise, whether it’s in India or within Europe and the US. Short term, I could expect that we may see some additional fill and finish. But even on fill and finish, don’t underestimate the requirements of standardized, manufacturing, quality control, and quality assurance. Pfizer’s COVID-19 vaccine manufacturing. Quality assurance is key. HP-Watch: And what about patents on the many other vaccine manufacturing inputs required, from filters and bioreactors to vials? What if the waiver helps remove bottlenecks on those components, as advocates inputs and open up their production more widely? Cueni: It is simplistic to think that a blunt tool like an IP waiver would be an appropriate solution for the scarcity of raw ingredients. There are different technologies and market circumstances in the production of each ingredient, and each case needs to be taken into account individually. In the very rare case that one may find an IP-related bottleneck on a pharmaceutical ingredient, there are already mechanisms in place available to governments to address them. Just like with finished pharmaceuticals, the waiver would only send a major disincentive for investments in technologies related to COVID-19, without any measurable impact on production. HP-Watch: You spoke about the COVAX Manufacturing Task Force, in which industry is participating actively. What about the WHO’s new initiative to create an mRNA vaccine hub? Cueni: WHO, in my view, should focus on norm-setting functions. When it comes to operational execution, WHO is probably not the best equipped organization. That is one of the reasons you have organizations like the Global Fund, GAVI and CEPI springing up over the last 20 years – all of them have a track record, and the willingness and ability to work with the private sector. I haven’t really seen this in WHO. HP-Watch: Going back again to the text-based negotiations on this IP-waiver one more time – what are your final conclusions? Cueni: Basically companies have the responsibility for the quality of their products. You cannot coerce the sharing of what is here in your brain.. Companies really need to have the ability to pick their partners on the basis of checklists, which is really about quality, quality, quality. It can’t be coercion, either in a pandemic treaty, or in the WTO. I think what you could do, in my view, is to get a pretty strong commitment from the Industry to be more engaged in tech transfer. You can have a strong commitment from industry to be constructively engaged in more tech transfer, as such, on mRNA and other [technologies], for the future. The discussion is ongoing right now on regional hubs, with BMGF, CEPI, and others – and the industry is really interested to engage. That I see a little bit in the sense of the Third Way, that Dr Ngozi is talking about now. Because we need to address the bottlenecks now, the capacity expansion, dose-sharing. But we need to look at what we can do to be better prepared for the future. That’s where I mentioned the pot, you know, COVAX, being well-funded before the pandemic and not just starting to fundraise during the pandemic. And the second element is what can we do to make sure there is an increase in bioresearch, an increase in more agile, flexible, ever-warm vaccine facilities in more continents, because that is one of the issues which did lead to vaccine inequity, which we’ve seen now. But all that has to take place with industry at the table. Image Credits: Marco Verch/Flickr, World Health Summit, Lonza.com, AstraZeneca, Novavax, Pfizer. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. 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