Inside the world’s largest Covid vaccine laboratory, where hopes lie for most of developing world

When the coronavirus pandemic broke out last year and the world clamoured for a vaccine to bring life back to normal, one company in western India was fully confident of playing a key role – indeed, it had spent years preparing for this very moment.

Serum Institute of India (SII), a family-run pharmaceutical giant that started out as a horse farm in the 1960s, is at the centre of the world’s crusade against Covid-19 thanks to its ability to produce over 1.6 billion vaccine doses per year. According to its owners – the billionaire Poonawalla family – its production capacity is unmatched anywhere in the world.

It is a testament to this that the Indian government’s vaccine rollout cannot keep up: even with the country exporting and gifting millions of doses to its neighbours and allies, SII is sitting on stockpiles of upwards of 55 million doses in cold storage.

SII partnered with Oxford University and AstraZeneca to develop, test and manufacture its vaccine, which is both cheaper and easier to store than those of rival pharmaceutical giants like Moderna and Pfizer.

This means hopes for a vaccine – not just in India, where there have been almost 11 million cases and over 156,000 deaths, but across many developing countries – are vested in SII’s sprawling 43-acre facility in Pune, four hours’ drive inland from Mumbai, where The Independent received an exclusive tour earlier this month.

While the likes of Moderna and Pfizer are hoping to have produced totals of 1 billion and 2 billion doses respectively by the end of this year, SII is aiming bigger, says its executive director Dr Suresh Jadhav.

“We started with small consignments; now we are producing 50 to 60 million doses per month. From April we will start producing 100 million per month,” he says. Such numbers are likely to be needed, as experts say yearly booster jabs could be required to beat emergent variants of the coronavirus.

SII’s headquarters are still surrounded by well-manicured stud farms, and its lavishly appointed main offices are adorned with paintings and busts of horses – a nod to where it all began.

Two factory buildings, a giant concrete-and-glass warehouse and a new campus for staff are dedicated to the production of coronavirus vaccines, a project with almost a thousand people involved each day at various levels.

Inside, workers wearing all-white overalls, face masks and goggles move through carefully controlled laboratory environments. The manufacturing units, full of state-of-the-art equipment, include bioreactors that are two storeys high, and production chains that can fill up to 500 bottles per minute.

The factory has been working at full pelt, significantly scaling up its capacity since the start of 2020, to carry out the daunting task of providing enough cost-effective jabs to cater for most of the developing world.

“If you really want to cover the total global population, you should have 16 billion doses. Nobody had that kind of capacity,” says Dr Jadhav.

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As developed countries hoarded vaccines as soon as they were announced, SII has been doing what few other companies have done – mass-producing cheap jabs by signing early deals and beginning production without any guarantee that the vaccine would prove to be successful.

“We started with the higher scale from the beginning to keep them ready,” says Prasad Kulkarni, medical director at SII, explaining that it would normally be routine for manufacturers to only begin production of any medical innovation after trials were complete and final regulatory approvals had been granted.

“We didn’t have the time, so we got the approval to produce at our own financial risk – that’s why the scale was possible,” he says.

Inside the manufacturing facility, human intervention has been minimised in order to reduce the potential for contamination. A small gallery around the edge of the unit provides a view through huge windows into sectors where only key staff members are allowed.

The manufacture of the vaccine itself is divided into three phases: production, filling, and labelling/storage, with every vial going through several quality checks.

During the initial production, cells are grown in huge, single-use bioreactors. The liquid is then shifted to massive tanks for formulation. Several workers stand here to monitor the process at all times in three eight-hour shifts.

The second stage consists of a highly automated vial-washing process, where empty glass bottles are blasted with high-speed water jets and moved through high-temperature tunnels to ensure they are completely sterilised. Large machines then fill the bottles, cap them and apply rubber seals. Five thousand are processed every minute – and with advances in technology, the company hopes to double this capacity.

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The vials then go through labelling machines, where they are marked with the required branding – in India, the Oxford-AstraZeneca jab is marketed as Covishield – before being placed in boxes and taken to a heavily guarded storage facility, where they are kept at a temperature of -4C.

The company is not just limiting itself to the AstraZeneca vaccine, with four other vaccine candidates in the pipeline and an application placed in early February to produce and distribute America’s Novavax jab in India. It is also hoping to launch its own vaccine, based on one for hepatitis B.

SII has pledged to provide 1 billion jabs to lower- and middle-income countries outside India in 2021. “Serum Institute is the only company tipping the balance in favour of poor countries because we are the only one giving it [the vaccine] to the poorer countries,” Adar Poonawalla, chief executive of SII, tells The Independent. 

SII is currently selling its jabs to the government of India at a discounted rate of Rs 210 (£2) per jab, making it the biggest contributor by far to a massive inoculation drive that aims to reach 300 million vulnerable and older Indians in the first phase.

Poonawalla says SII effectively has a monopoly in supplying vaccines to developing nations. “The other manufacturers are too expensive,” he says. “We also could have chosen to sell vaccines for $10-20, but I have chosen not to make a substantial profit in the time of the pandemic.” Poonawalla adds that this will be the case “for two years” at least – a hint that the price could be hiked later.

The 40-year-old inherited SII’s empire from his father Cyrus, becoming chief executive 10 years ago, and for a time the younger Poonawalla became best known for his extravagant lifestyle and fleet of luxury cars.

Today, the family’s fortune stands at around £10bn, with an 85 per cent increase in 2020 alone thanks to SII’s soaring valuation, according to the Bloomberg Billionaires Index. 

Adar Poonawalla’s big early bet on the Oxford-AstraZeneca jab has seen his public image transformed in less than a year. But Dr Jadhav, who has been part of the company for over four decades, also credits the Poonawallas with the decision to build capacity even before the pandemic, which has enabled it to handle the rising demand. 

“I’ve been here for 42 years; I have not seen a single day when construction is not going on,” says Dr Jadhav. “We already had about five to six additional buildings which were ready for the new products in the pipeline, so we could utilise that preparedness for Covid.

“We had to tweak it a little bit here and there, but we were almost prepared,” he says.

According to Dr Umesh Shaligram, head of research and development at SII, the partnership with Oxford-AstraZeneca was natural, as the companies have worked on vaccines together in the past.

“We are known to scale up the technologies and manufacture large volumes, which we have proven. They made the product and proved it clinically,” says Dr Shaligram.

The company received the genetic information for Oxford-AstraZeneca’s vaccine in May 2020. By the time the Indian government granted emergency authorisation to the company on 1 January, SII had already produced 50 million doses.

Poonawalla says that while he was no clairvoyant when it came to the pandemic, he was always mentally prepared for the possibility of a global health crisis like this arising.

“Of course it was obviously at the back of my mind that if there was a pandemic-level event, how will we be able to rapidly ramp up production, warehousing, cold storage, all these things that others are [now] struggling to do,” he says.

“We had already made a lot of provision for this, based on our large volumes and capacity, [meaning] it was relatively straightforward for us to be able to handle a situation like this [pandemic],” he says.

Today, the number of people in India given a first dose of a vaccine has crossed the 10 million mark, and SII’s product is being administered by doctors around the globe. “This is our moment to play a major role in trying to end this pandemic,” Poonawalla says.