Serum Institute of India CEO Adar Poonawalla on getting ready to manufacture 100 million doses a month of the Covid vaccine and “the biggest fear looming over” everybody’s head in the company.
The Spanish flu of 1918 wiped out around 50 million people across the world within the two subsequent years that it held sway. In 2020, in its infancy yet, 17 million are infected already by SARS-CoV-2, while the virus has claimed nearly 7,00,000 lives worldwide. Keeping the big picture in mind, virologists say flattening the curve is merely a here-and-now response to minimise damages.
Two weeks ago, amid utter despondency fueled by rising numbers and failing infrastructure, the success of the phase 1 trials of the Oxford vaccine for SARSCoV-2 brought the spotlight on Pune-based Serum Institute of India (SII), which had partnered with AstraZeneca, the British pharmaceutical company, to produce the Oxford vaccine.
In partnership with the British company, as the Oxford vaccine candidate for COVID-19, it will supply the vaccine across India and other low-and middle-income countries (GAVI countries). One billion doses are to be made over the next one year, with 50 per cent distributed in the country and the remaining half to GAVI countries.
Earlier in the week, five sites were declared for the human trials. On Friday, SII inched a step closer to human trials in India as an expert advisory committee to Drug Controller General of India (DCGI) approved the revised protocols submitted by the pharma giant. “With the government fasttracking everything, we are hoping to get approvals soon, post which we will begin phase 3 human trials here in India this month,” says Poonawalla.
Adar Poonawalla, CEO of Serum Institute of India
The man bringing us the Covid vaccine
♦ Serum had partnered with American companies to manufacture vaccines for COVID-19 (Novavax and Codagenix). Where are you at with those? Or have they taken backseat to the Serum-AstraZeneca collaboration?
Neither of our associations has taken a backseat and work is progressing simultaneously. Each of the vaccine candidates are proceeding at their own pace. We must be mindful in ensuring that all requisite trials and procedures are conducted meticulously and appropriately. We have five candidates so far, including two of our own. We hope to announce the availability of our own vaccines by the end of 2021.
As for our associations, Codagenix vaccine is in pre-clinical trials and we have worldwide rights for it. The Novavax candidate is just a month or two behind the AstraZeneca Oxford vaccine and we are to manufacture and distribute it across GAVI countries. We have also tied up with a company for an mRNA candidate and hope to announce it soon.
Presently, the Oxford-AstraZeneca vaccine is one of the few candidates, which is showing satisfactory results based on the ongoing trials and has been cleared for the final phase. The vaccine is branded Covishield and we are hopeful that it will be an efficacious and immunogenic vaccine, viable for mass use. Based on the success of the trials we are expecting to launch it by the end of this year. I believe by the first quarter of the next year it will start reaching the masses.
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♦ How is Serum readying to manufacture the vaccines in volume?
We have dedicated two of our state-ofthe-art technology equipped facilities — with six machines — in the Hadapsar plant for manufacturing the COVID-19 vaccine, with an investment of over $200 million in the current phase of Covishield production.
♦ Each machine has the capacity to manufacture 500 vials per minute/per machine; 30,000 per hour — but the demand is way too high.
Presently, keeping in mind the pandemic situation, and understanding the need to produce millions of doses of the vaccine, we are withholding vast production of other products.
Initially, we will start producing a few millions of doses at personal risk. Once we get necessary regulatory approvals, we will start manufacturing in large volumes. We will manufacture about 60 million to 70 million doses per month (which might stretch to 100 million doses later). With this, we are looking to manufacture around 300 million doses by the end of this year.
♦ You have said that each vial will be priced at Rs 1,000. Is the price likely to come down eventually?
It is too early to comment on the vaccine’s price. However, we will keep it under Rs 1,000. We are certain that it will be procured and distributed by governments without charge. At present, our only aim is to provide an efficacious and affordable vaccine for the masses at the earliest.
♦ And 60,000 shots will be set aside free for the Parsi community.
It was just a casual and friendly exchange between two Parsis. Once the vaccine is made, everyone will have access. In the initial phase, it should be a part of the government immunisation programme so that people don’t have to buy it directly. But it’s still early to talk about this.
♦ Any fears — what could go wrong?
While we are hoping for the best, the vaccines not proving immunogenic is the biggest fear that looms all over our head. If you look at the process right now, the risk of the OPEX if this vaccine fails, we will be down $200 million, which includes the peripheral and preparatory expenses of the glass vials, the chemicals, the raw materials, the facility, the manpower… This still doesn’t count the opportunity cost of the other products that were designed to go into that production line that we have sacrificed.
♦ Generations of Indians have not had the practice of getting immunised — how can private players such as yourself collaborate with government bodies to help turn this situation around? We know that the virus will not go away.
Immunisation is one of the greatest health interventions in history. It’s true that in India it has been an impending concern despite the constant efforts employed to make people aware of the benefits of vaccinations. Even though there has been a gradual increase in immunisation coverage, vast numbers in India have witnessed a set of fallbacks due to various reasons like lack of awareness on vaccination among the general populace, limited availability of finances, high prices of new vaccines for existing and emerging diseases, in addition to lack of adequate health delivery infrastructure.
While addressing the issue of accessibility one of the major issues faced by Indian vaccine manufacturers is lack of adequate storage facility and lack of R&D capacity. Having said that, it must be a collaborative effort amongst all the stakeholders involved, buoyed by strengthening of our healthcare infrastructure, revisiting our healthcare policies, fast-tracking regulatory approvals while complying with necessary trials and tests. Living is not going to be easy — it is time to revisit, re-evaluate and reassess our current situation for a better tomorrow.
♦ When Oxford University declared the success of its phase 2 trials two weeks ago what was your team’s first reaction? How did you mark this moment?
We were certainly relieved and excited for the next phase of the development. So, while we are being optimistic, we are also being pragmatic about it as we still have a long way to go.
♦ You have had a long-standing association with the team at Oxford, having worked with them earlier on the malaria vaccine. Describe your association with Dr Adrian Hill. What was the Eureka moment this time?
Yes, they were also the first ones to develop a vaccine for the Ebola virus. Dr Adrian Hill is a remarkable scientist and has done some great work in the healthcare space. A vaccine usually takes between five and seven years to be in the market; the very fact that we have a potential vaccine candidate in such a short period of time is a big game-changer for the entire healthcare fraternity. Owing to the current situation and circumstances, the approval processes are being fast-tracked. However, none of the tests, trials or similar requisites is being fast-tracked for this. Our aim is to provide an efficacious, effective and immunogenic vaccine for all.
♦ How will it work — how many doses will have to be administered to those below 18 and those between 18 and 50, and senior citizens thereafter?
It’s too early to go there. Usually vaccines are administered in two doses, minimum, the first dose is used to prime the recipient and the second acts as a booster, thereby ensuring stronger immune response for the respective term of the vaccine. And I believe that the same principle will be applicable for all COVID-19 vaccines that will be available eventually. The vaccine should be given to the vulnerable groups to start with; such as healthcare workers, front line staff, children and elderly people with weak immune systems. Healthy young adults can get it later.
♦ Describe your average day at work. How many hours are you and your team putting in these days?
Everybody is going above and beyond to achieve the desired results and come up with an effective and immunogenic vaccine at the earliest.
Source :Google News