“I hope to announce our own vaccines by the end of 2021”

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█ Exclusive Interview: From the horse’s mouth – Covidshield should cost less than Rs 1000 per pop
Serum Institute from India CEO Adar Poonawalla on his readiness to manufacture 100 million doses per month of the COVID vaccine and ‘the biggest fear hanging over’ everyone in the companyThe Spanish Flu of 1918 wiped out around 50 million people around the world over the next two years. In 2020, at its inception, 17 million are already infected with SARS-CoV-2, while the virus has killed nearly 7.00,000 people worldwide. With the big picture in mind, virologists say flattening the curve is just an answer here and now to minimize damage.

Two weeks ago, amid utter discouragement fueled by an increase in numbers and failing infrastructure, the success of the Phase 1 trials of the Oxford The SARSCoV-2 vaccine shed light on the 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 UK company, as Oxford’s vaccine candidate for COVID-19, it will deliver the vaccine across India and other low and middle income countries (GAVI countries). One billion doses are due to be administered over the next year, 50% of which are distributed nationwide and the remaining half to GAVI countries.

Earlier in the week, five sites were declared for human trials. The SII moved closer to human trials in India on Friday as an expert advisory committee of the Drug Controller General of India (DCGI) approved revised protocols submitted by the pharmaceutical giant. “With the government following everything quickly, we hope to get approvals soon, after which we will begin phase 3 human trials here in India this month,” Poonawalla says.

The Serum Institute has dedicated two facilities equipped with advanced technologies – with six machines – for the manufacture of the COVID-19 vaccine

Serum had partnered with US companies to make COVID-19 vaccines (Novavax and Codagenix). Where are you? Or have they taken over from the Serum-AstraZeneca collaboration?

None of our associations has taken a step back and work is progressing simultaneously. Each of the candidate vaccines progresses at its own pace. We must ensure that all necessary tests and procedures are carried out meticulously and correctly. 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, the Codagenix vaccine is in preclinical trials and we have the rights worldwide. The Novavax candidate is only a month or two behind the AstraZeneca Oxford vaccine and we need to manufacture and distribute it in the GAVI countries. We have also established an mRNA candidate with a company and hope to announce it soon.

Currently, the Oxford-AstraZeneca vaccine is one of the few candidates, which shows satisfactory results based on ongoing trials and has been cleared for the final phase. The vaccine is marked Covishield and we hope that it will be an effective and immunogenic vaccine, viable for mass use. Based on the success of the trials, we plan to launch it by the end of this year. I believe in the first quarter of next year it will start to reach the masses.

How does Serum prepare to manufacture vaccines by volume?

We have dedicated two of our facilities equipped with advanced technologies – with six machines – in the Hadapsar factory for the manufacture of the COVID-19 vaccine, with an investment of more than $ 200 million in the current production phase of Covishield.

Each machine has the capacity to make 500 vials per minute / per machine; 30,000 per hour – but the demand is far too high.

At present, with the pandemic situation in mind and understanding the need to produce millions of doses of vaccine, we are holding back extensive production of other products.

As a first step, we will start producing a few million doses at your own risk. Once we have obtained the necessary regulatory approvals, we will begin manufacturing in high volumes. We will manufacture around 60 to 70 million doses per month (which could reach 100 million doses later). With that, we plan to manufacture around 300 million doses by the end of this year.

You said that each vial will cost 1000 rupees. Is the price likely to drop eventually?

It is too early to comment on the price of the vaccine. However, we will keep it under Rs 1000. We are confident that it will be bought and distributed free by governments. At the moment, our only goal is to provide an effective and affordable vaccine to the masses as soon as possible.

And 60,000 photos will be set aside free of charge for the Parsi community.

It was just an informal and friendly exchange between two Parsis. Once the vaccine is made, everyone will have access to it. In the initial phase, it should be part of the government vaccination program so that people do not have to buy it directly. But it is still early to talk about it.

Fears – what could go wrong?

While we hope for the best, vaccines that don’t prove to be immunogenic are the biggest fear that hangs all over our heads. If you look at the process right now, the risk of OPEX if this vaccine fails, we will be down $ 200 million, which includes peripheral and preparatory expenses for glass vials, chemicals, raw materials. , installation, labor… It still does not count the opportunity cost of other products designed to enter this production line that we have sacrificed.

With the government ramping up everything, we hope to get approvals soon, after which we will begin phase 3 human trials here in India this month.

– Adar Poonawalla

Generations of Indians have not been used to getting vaccinated – how can private actors like you work with government agencies to help turn the situation around? We know the virus will not go away.

Immunization is one of the greatest health interventions in history. It is true that in India this has been a looming concern despite constant efforts to educate people about the benefits of vaccinations. Even though there has been a gradual increase in immunization coverage, a large number in India have witnessed a series of downturns due to various reasons such as lack of immunization awareness among the general population, availability limited finances, high prices of new vaccines for existing vaccines and emerging diseases, in addition to the lack of adequate health care delivery infrastructure.

While addressing the issue of accessibility, one of the main issues facing Indian vaccine makers is the lack of adequate storage facilities and lack of R&D capacity. That said, it must be a collaborative effort among all stakeholders involved, supported by strengthening our health infrastructure, reviewing our health policies, accelerating regulatory approvals while complying with necessary trials and tests. Living won’t be easy – it’s time to review, reassess and reassess our current situation for a better future.

When the University of Oxford declared its Phase 2 trials successful two weeks ago, what was the first reaction of your team? How did you mark this moment?

We were certainly relieved and excited for the next phase of development. So while we are optimistic, we are also pragmatic about this because we still have a long way to go.

You have a long-standing association with the Oxford team, having previously worked with them on the malaria vaccine. Describe your association with Dr Adrian Hill. What was the Eureka moment this time around?

Yes, they were also the first to develop an Ebola vaccine. Dr Adrian Hill is a remarkable scientist and has done a great job in the health field. A vaccine generally takes between five and seven years to be on the market; the very fact that we have a potential vaccine candidate in such a short period of time is a game-changer for the entire health fraternity. Due to the current situation and circumstances, approval processes are being expedited. However, none of the tests, trials or similar conditions are expedited for this. Our goal is to provide an effective, effective and immunogenic vaccine for all.

How will it work – how many doses will need to be given to those under 18 and those between 18 and 50, and older people afterwards?

It is too early to go. Usually vaccines are administered in two doses, at a minimum, the first dose is used to prime the recipient and the second acts as a booster, thus ensuring a stronger immune response for the respective duration of the vaccine. And I believe the same principle will apply for all COVID-19 vaccines that will eventually be available. The vaccine should be given to vulnerable groups first; such as healthcare workers, frontline staff, children and the elderly with weakened immune systems. Healthy young adults can get it later.

Describe your average day at work. How many hours do you and your team spend these days?

Everyone goes above and beyond to achieve the desired results and offer an effective and immunogenic vaccine as soon as possible.

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