The Journey of a Vaccine

In the early 2000s, when international health organisations such as PATH and the World Health Organization (WHO), supported by a grant from the Bill & Melinda Gates Foundation, decided to come up with a vaccine to eradicate the deadly meningitis A epidemics from sub-Saharan Africa, they got stuck over one question: who would manufacture it?

The ‘meningitis belt’ is a region that comprises 25 countries in Africa, from Ethiopia in the east to Senegal in the west. The disease manifests as an infection of the lining of the brain and spinal cord. People in this region have suffered from epidemics caused by this bacteria for nearly a century. Reports of the disease usually start at the beginning of the calendar year, when the dry sand of the Saharan desert blows southwards carrying tiny spores of the bacteria with it. Every year, many get infected and die. And every few years, a fullblown epidemic breaks out. What had got the world startled when organisations such as PATH stepped in was the region’s worst reported outbreak. Around 25,000 people had died and over 250,000 infected in 1996 and 1997.

It wasn’t as though a vaccine could not be developed. Just not an affordable one.

For a vaccine to work in this region, researchers realised, it would have to be priced no more than half a dollar. According to a PATH report, a local official from Niger told Dr Marc LaForce, the director of the Meningitis Vaccine Project (MVP), a partnership between PATH and WHO, “Please don’t give us a vaccine that we can’t afford. That’s worse than no vaccine.”

The MVP team began to scour through the developed world, looking to interest a pharmaceutical company that could mass-produce such a vaccine. But no one was willing to come on board at that price. It just wouldn’t cut it.
That’s when the Serum Institute of India stepped in.

The Pune-based company, already a major vaccine manufacturer then, was expanding its reach. It was tying up with international bodies, negotiating deals with foreign governments and health bodies, importing the latest equipment and enlarging its facilities and capacities. To anyone else, a 50-cent vaccine made no sense. But for Serum Institute, it fit just right in.

The company had built, and was further building, a vaccine empire based on a model of scale. Working on the economies of scale, it churned out mass volumes of vaccines cheaper than anyone else and yet turned a profit.

It came out with MenAfriVac, a meningitis A vaccine that cost just $0.50 for a single dose in 2010. According to a 2015 report by WHO, just five years after its introduction, the disease has been nearly eliminated from that region. Dr SV Kapre, the executive director of Serum Institute, was reported as saying then, “Making a vaccine is a technical issue, but making the vaccine available at an affordable price is a real challenge.”

Serum Institute has grown even larger now. Its business model of mass-producing vaccines at cheap rates has led to more orders, which in turn has motivated it to further expand. It has acquired more companies, enlarged its plants and manufacturing capacities, and by manufacturing about 1.5 billion vaccine doses annually become the world’s largest vaccine manufacturer by doses produced. In the 1990s, it exported its vaccines to around 35 countries. Today, the bulk of its business comes from abroad. It exports its vaccines to an estimated 170 countries, and until recently claimed that 80 per cent of its business came from foreign shores (now it claims exports contribute 60 per cent of its business; the rest coming from India). As Cyrus Poonawalla, the founder of Serum Institute, has been known to say, the company reaches more children than Coca-Cola and PepsiCo can ever hope to.

This expansion of its business and manufacturing capacity has now put the company in a crucial position. If the Oxford-AstraZeneca vaccine (or Covishield, as it is known in India) is the vaccine that will lead to the end of this pandemic—especially given how expensive the other two leading vaccines, the Moderna and Pfizer vaccines, are—for India and many other countries in the developing world, it will need Serum Institute to use all its capacities and experience to churn out the vaccine at an incredibly fast clip.

Over the past year, much of the conversation around the world has revolved around whether researchers can develop a vaccine fast enough. Now, there’s another equally important question: can the vaccines be mass-produced fast enough? For the pandemic to end soon, just the fastest developed vaccines in history will not do. It will also have to be the fastest ever produced on such a mass scale.

In the early morning of January 12th, when the clock had yet to strike five and the city was covered in darkness, a small crowd of journalists and camera crew had gathered outside the gates of Serum Institute in Pune. For days now, journalists had stood outside these gates, trying to film the goings-on in the factory, trying to learn just when the vaccines might make their way to the rest of the country.

Now finally, across the steel gate, in the darkness ahead, lay the objective for which they had gathered all of the past few days. Amid a small army of policemen and security personnel lay three trucks, packed to the brim with boxes of what appeared to be vaccines.

But everyone would have to wait. A policewoman, Deputy Commissioner Namrata Patil, materialised in front of the truck to carry out a little prayer ceremony. And then, a little scramble broke out, as the trucks made their way out. For the rest of the day, several trucks left the premises—some to the airport and from there to the rest of the country, and a few later in the day via road to the rest of Maharashtra. Through the day, as these vaccines began to show up elsewhere, their trucks would be garlanded and more prayer ceremonies would take place.

The excitement was understandable. With these vaccines (and some from Bharat Biotech’s Covaxin), India is going to launch its largest vaccination drive in history.

For now, the Centre has contracted Serum Institute to supply 1.1 crore doses of Covishield. Once the vaccination programme officially kickstarts, a larger order is expected. In all, 30 crore are expected to be vaccinated in the first phase. Since both Covishield and Covaxin require double doses, that is at least 60 crore doses. Serum Institute of course will not be producing vaccines just for India. It also has deals and requests from other countries, apart from a commitment to supply 200 million doses to India and other middle and low-income countries by 2021 as part of its deal with COVAX Facility, a vaccine alliance that wants to ensure a rapid and equitable distribution of vaccines across the world (this includes doses of both Covishield and another Covid-19 vaccine that it is manufacturing for the US company Novavax). Overall, it has a licensing agreement with AstraZeneca to supply 1 billion doses of the Oxford vaccine to middle and low-income countries. Serum Institute has now also begun to appeal for a simultaneous rollout of its vaccines for the private market in India.

That is a lot of vaccines.

According to an executive in a rival vaccine manufacturing company in India, Serum Institute has both the scientific expertise and manufacturing capacities, apart from the financial strength to produce vaccines at such a massive scale. “Manufacturing vaccines at such scale is quite complicated. But Serum has a lot of experience in this field. Out of all vaccines sold globally, probably over 60 per cent has been manufactured at a Serum plant,” the executive said requesting anonymity. Serum Institute also has deep pockets. According to MoneyControl, the company clocked a revenue of around Rs 5,900 crore in 2019-2020, about six times the revenue of its nearest rival, the Hyderabad-based Biological E, which generated Rs 952.4 crore.

In 2020, when it was announced that Serum Institute would be manufacturing the vaccines, CEO Adar Poonawalla had said that apart from the 1.5 billion vaccines it produces annually, the firm has an extra capacity of 400-500 million doses.

The Poonawallas have an impressive facility. They have massive bioreactors, cameras that can scan for particles in vials and machines that can fill 500 glass vials every minute. During a recent interview, he stopped by one such machine to explain to a stunned journalist, “So that’s 5,000 doses per minute filled…And by the way that will double in Feb.” He has also begun to construct a massive facility in Pune which, when complete, he claims, will add another 1 billion doses to Serum Institute’s annual capacity.

But even Serum Institute’s massive facilities weren’t going to be enough to mass produce a Covid-19 vaccine in record time. The company reportedly had to build new facilities and rejig old ones, apart from halting the production of other vaccines in some plants to prioritise on a Covid-19 vaccine to scale up production. They also started producing the vaccine even before it was granted a licence or the results of its studies were out, risks probably no listed company could have managed.

A few months ago, Poonawalla told Open that such risks had to be taken to protect lives. “If I had waited till November [2020]… we wouldn’t have seen the vaccine till the end of [2021]. We would have lost countless numbers of lives had I not taken that risk,” he said.

Later in the day when the first batches of vaccines were being sent out, Poonawalla held a press conference where he spoke about the challenges the company faced in producing such large volumes in record time. According to him, the company will continue to produce more than 70-80 million doses every month. “Smaller companies are taking time to bring out their vaccines. Their supply will be scaled up in the second and third quarter [of 2021]. Till that time, the world will be dependent on us,” he said.

Producing millions of vaccines until more supplies from elsewhere begin to show up will be no mean feat.

Adar PoonawallaCoronavirusCovid-19Serum Institute of Indiavaccine