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The Guardian

‘We took a huge risk’: the Indian company made more Covid jabs than anyone else

Adar Poonawalla, Chief Executive of the Serum Institute of India, on Vaccines, Regulation and What Comes Next Coronavirus – Latest Updates View All Our Coronavirus Coverage Adar Poonawalla says the Serum Institute of India produces about 70 million doses per month. Photo: Francis Mascarenhas / Reuters Adar Poonawalla, 40, is the CEO of the Serum Institute of India (SII), the Pune-based family vaccine manufacturer that produces more Covid-19 vaccines per dose than any other in the world. For now, the Oxford / AstraZeneca vaccine is rolling off production lines, but SII has signed contracts with three other developers – Novavax, Codagenix and SpyBiotech – all of which have candidates in the works. Have you ever imagined making vaccines for a global pandemic? Nobody wants a pandemic, but we were almost designed for it. We produce 1.5 billion vaccine doses every year for about 170 low and middle-income countries. True, we could never have imagined the entire world being so dependent on us, but no one else has our ability to scale up. What has scaling-up seen in practical terms? In March, we committed to Covid-19. We took a huge risk because nobody knew then that a vaccine would work. Of the $ 800 million (£ 579 million) we needed, we invested $ 270 million and raised the rest from the Gates Foundation and various countries. We dedicated approximately 1,000 employees to the program and delayed all product launches scheduled for 2020 for two to three years so that we could claim the facilities allocated to them. Then it was a matter of equipping those facilities and validating them for use, which we did in record time. In August, we were manufacturing and stocking a vaccine that we predicted would be approved around December. The first doses were shipped in January, and we’ve shipped 30 million so far. When will you reach full capacity? At the moment our production is about 70 million doses per month. By the end of March when we have a third Covid-19 facility up and running it will be 100 million and could go higher by the end of the year if we can optimize our processes. Among other things, we supply the Covax scheme, which aims to distribute Covid-19 vaccines fairly around the world. The goal is to ship 2 billion doses by the end of 2021. I realistically think that could take 18 months because if we’re lucky we’ll have produced 400 million by the end of the year. If the vaccines have to be modified to protect against future emerging varieties, how much of a challenge will that be? It would be easy with the processes running. We’re growing the virus in living cells, so we’d just change the master clone – the virus we’re infecting those cells with – and it spreads through it. It would take us two to three months to produce the new vaccine at full throttle. Some people think the rollout in many countries has been slow because the developers who own the patents on the vaccines have not licensed enough manufacturers to make them. Do you agree? No. There are plenty of manufacturers, it just takes time to scale up. And, by the way, I’ve been overwhelmed by the collaboration between the public and private sectors over the past year in developing these vaccines. What I find really disappointing, which has contributed to the delivery of vaccines – not just ours – for a few months is the lack of global regulatory harmonization. What have the US, UK and European regulators been doing in the past seven months while I was busy making vaccines? How difficult would it have been to get together with the World Health Organization and agree that if a vaccine is approved in the six or so major manufacturing countries, it will be approved to ship around the world? Instead, we have a patchwork of approvals and I have 70 million doses that I cannot ship because they were bought but not approved. They can be kept for six months; these expire in April. What do you think when you see rich countries bicker about vaccine supplies? I think manufacturers promise too much and have not managed expectations well. I had promised too little. I said I would be taking 50 million doses from day one. If everyone had said, ‘Don’t expect large volumes until May or June,’ I think all of this could have been avoided. There are reports that in some countries rich people are finding ways to get vaccinated earlier than poorer people. Does that also happen in India? Here it is reversed. SII is legally required to supply to the Indian government and the government gives priority to the poor, the vulnerable and the frontline workers. That means that everyone else, unless they are older or meet other specific criteria, will stand at the back of the queue. Do not forget that the population of India is so large that 200 million Indians are classified as vulnerable. That’s already 400 million doses. Can you explain the situation in India about compensation in case of vaccination damage? In many countries, the government indemnifies the manufacturer for costs related to vaccine injuries, but here the manufacturer is responsible. I have no problem paying compensation if an injury turns out to be vaccine-related, but at this point it is possible for the Indian courts to ban my vaccine production pending the investigation of a such case, whether the injury turns out to be vaccine-related or not. I have asked the government to say that in a pandemic this should not be possible because it means that such a claim could halt our global rollout. In fact, we have already had such a case and the Ministry of Health had to intervene to prevent us from being shut down. Do you think the way vaccines are made will change forever as a result of Covid-19? Yes. Almost every country now wants to establish local production so that it never has to look for vaccine again. Not all of them may succeed, but for now it looks like the political will and capital are there. Many pharmaceutical companies and generic manufacturers have also recognized that there is room for new players in the field of vaccines. I predict that the landscape will be transformed in the next five years. It is quite a journey from its inception in 1966 to becoming the world’s largest vaccine producer in 2021. How did it start? The Haffkine Institute, a government agency in Mumbai, used to produce anti-snake bite and tetanus serums by injecting the poison or bacteria into horses and mules, drawing their blood a few days later, and extracting the antibodies. Mine is a family of farmers and horse breeders and my father, Cyrus, used to sell animals to the institute. Finally he thought, “Why don’t I cut out the middle man and make the serums – later vaccines – myself?”

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