Serum Institute of India’s Plans for Its Game-Changing Malaria Vaccine

11 minute read

When the World Health Organization awarded prequalification status to the R21/Matrix-M malaria vaccine, developed by the Serum Institute of India and the University of Oxford, it was a game-changing moment. It allowed for a mass rollout that could significantly reduce fatalities from the deadly mosquito-borne disease, which claims more than 600,000 lives a year, predominantly among children in Africa. To meet demand, Serum will produce 100 million doses every year, and shipped the first doses to the Central African Republic at the end of May. 

As the world’s biggest vaccine maker, Serum is no stranger to churning out billions of vaccines—it makes 3.5 billion doses every year, including for measles, polio, and most recently, HPV. Serum’s CEO Adar Poonawalla says the company’s success can largely be chalked up to its private ownership. Not being beholden to shareholders allows it to keep vaccine prices low (the R21 will cost $4 a shot). “We've always looked at growth not in terms of pricing, but in providing access,” he says. 

TIME spoke with Poonawalla in May about Serum’s plans for the vaccine’s rollout, the lessons learned from the COVID-19 pandemic, and how it can continue to innovate in the future. 

This interview has been condensed and edited for clarity.

Tell us about the Serum Institute’s production and plans for rolling out the R21/Matrix-M  malaria vaccine. 

For many years, children were dying of malaria despite all interventions, including mosquito nets and tablets. The vaccine was a key tool to change that, but there was only one company doing it, and many countries couldn't afford to pay $10 for a dose. We wanted to make a vaccine that was affordable. If we were to rewind six, seven years ago, when we reached out to partner with Oxford University, the logic was to have an alternative supply and supplier of vaccines. After a lot of work and clinical trials, we got excellent results, and now, we're rolling it out. The vaccine will go out to many countries in Africa, and we're giving it at less than $4, which will make a huge difference. It’s very exciting and it's been quite a journey.

What were the main lessons you learned from this process—particularly in the critical role that Serum can play in responding to future outbreaks in less than 100 days?

There are a lot of lessons to be learned, but the most important thing is regulatory harmonization: all countries agree that if a vaccine is approved by an organization like the WHO—which has a certain quality standard—then it should automatically be available to those who need it.

We have already established that we can make a vaccine in 100 days. When there was an Ebola outbreak last year, we made vaccines and shipped them out to do clinical trials in that country. We learned that vaccines were available in certain cases but countries couldn't take them because of regulatory or other issues like the free movement of raw materials. If we're talking about a global health community, we need to be able to share these resources. 

We will hopefully start stockpiling outbreak vaccines for diseases like Monkeypox, Ebola, or Nipah virus, which need to be rushed within 90 or 100 days to vaccinate as many people as possible when there's an outbreak before it spreads even within that country, or to other countries. So we're working on that. 

What role did Serum play in ensuring India was safe during the COVID-19 pandemic?

We provided 90% of the vaccines for India, and after that, we began exporting the vaccine to other countries as well. In fact, at the end of 2021, we stopped manufacturing COVID-19 vaccines, and in 2022, we destroyed around 210 million doses of vaccines sitting in stockpiles. We had even offered it for free to other countries, but the need to vaccinate their population wasn't so dire. Still, Serum will always be a key supplier to the world in terms of vaccines and the world is, in a sense, very dependent on Serum because of its philosophy of providing these vaccines at a low price. It's very critical that we continue to do this work because otherwise, these countries just won't get the vaccines. 

What did you learn about making vaccines affordable to everyone during outbreaks, especially in the global south?

The World Health Organization is currently drafting the Pandemic Accord because you need a multilateral organization to reach out to all countries and get them to agree to respond to a crisis. But any political leader in any country will naturally look at protecting their constituents first because that's what they've been elected to do before sharing resources like raw materials, vaccines, PPE kits, etc. with other countries. So what can a company like ours do to avoid the same situation as in 2020 and 2021? Serum has built the world's largest pandemic facility with a 2-billion-dose capacity. These doses will now be kept in reserves, which we will be funding ourselves, but the idea is that in the future, countries pay a reservation fee. 

Whenever I talk to leaders of other countries, I explain that this is the kind of insurance that their country should have, because imagine the billions each country loses on a monthly basis when the economy shuts down. People can't go to work and health systems are over overburdened. This is a way for the country to secure its vaccine supply, and what the private sector can do to innovate beyond general conventional thinking to be better prepared for any future outbreak or pandemic.

Serum is a privately held company (although there has been a lot of speculation about whether it will go public). How has this been beneficial, and what are the drawbacks?

It is definitely a double-edged sword. We could have grown much faster over the last 10 to 15 years if we had gone to capital markets and added billions of dollars for disposal to be able to fund clinical trials to be able to make these facilities even 10 years ago. But we chose not to because we would have to compromise on pricing and on the kind of products we make. We wouldn't be able to take care of the needs of countries in the developing world. So instead, we work with other partners to be able to do that. We have gone to philanthropies like the Gates Foundation and others to help fund our trials. 

If we were a listed company, we'd just be chasing the quarterly results and growth. I wouldn't have been able to invest in producing a lot of these vaccines that aren’t really viable. For example, I started building facilities and capacity ahead of time with absolutely no demand and opportunities six years ago. I did it because I felt that there would be projects that would come up. But if I was a publicly listed company, my board would have sacked me as a CEO for doing something like that. But that came in very handy when the pandemic struck and we were able to supply so many vaccines otherwise. 

Because we're a privately listed company, we have investors and stakeholders hounding us every year to grow. Yet, we hardly grow by 5% or 10% every year. Sometimes, we don't grow at all. But then, every three or four years, there might be a big, big jump because of an outbreak or a pandemic. We've taken the decision to look at growth not in terms of pricing, but in terms of making more vaccines affordable to as many countries as possible. 

Is the way to keep afloat by partnering with organizations or governments, or is there also a strategy in place to try and make some profit at the end of the day? 

We are still quite profitable. The turnover is upwards of 200 million, but all of that profit is nothing compared to what we need every year to invest in our CapEx, research, and innovation for doing trials to develop new vaccines. 

For example, we now need to invest in AI. That's one of the potential ways to develop new drugs and vaccines, which again ties into this mission of responding to outbreaks within 90 to 100 days. If AI can predict the next pandemic strain ahead of time, then instead of chasing mutant variants and making new vaccines, AI can also cut short the time and expense of clinical trials. It all sounds a bit like science fiction at the moment, but I think over the next five, maybe 10 years, you will have regulators also validating and agreeing with this method, and you are going to see vaccines and drugs being made in a far shorter time. So we're working with some people in the AI field now to try and find ways of making vaccines. 

I'm glad you brought up AI because it ties to my next question: how does the company innovate using new technologies like AI? 

Let's say that AI can predict the next pandemic strain. The only challenge here is that unless a regulator agrees with what the AI system has found as an alternative to doing the clinical trials and research, you're not going to be able to have a product that can be licensed using AI tech. Normally, you start with a molecule, which you try on animals. If you're safe in terms of efficacy, you go into phase one, which is a safety trial on human beings. Then, you go into a large trial to show that your vaccine is effective in preventing the disease in question among a large population. Even if AI can predict that and do all of that in a matter of months, validating the AI’s modeling in real terms and real practice is going to be a challenge for all regulators before they can give you a stamp of approval. 

You have quite a practical approach to innovation. 

Generally speaking, we wait for a technology to be proven. In the pandemic, for example, I could have gone with a messenger RNA candidate that had never proven itself before, but I particularly insisted on a proven technology platform because you don't want to reinvent the wheel when time is against you and you want to make sure it's safe and effective. So innovation during a crisis is perhaps not the best strategy. Innovation at Serum comes in while developing the process. It's proprietary. Anyone can isolate a virus strain and develop a vaccine, but someone has to develop the process and scale it up. That's where our innovation really excels and is different from most companies. 

How do you think your leadership and execution of ideas at Serum have differed from when the company first started under your father?

My father started with very small means in 1966 and it was always a challenge to get capital. India was in a very different situation at that time. When I joined the business about 20 years ago, I wanted to really put Serum on the global map by exporting it all over the world. I didn't want to restrict our supply only to India and to deal only with the Indian government, which at that time was very bureaucratic and slow-moving on approvals. What I realized is that if I could just add five or 10 countries, we would be in a different situation over the next 10 to 15 years. My approach was to improve our quality and recruit talent to be able to do that. I then started getting into the science and manufacturing, to find innovative ways to scale up without compromising on the quality. By the time I took over as CEO in 2011, I had the confidence and experience to be able to invest in large-scale facilities, robotics, automation, and hire the best talent because by then I really had a free hand.

Serum has this vision of being the vaccine provider of the world, but for you personally, what's exciting about the job and what keeps you up at night?

The thought of another pandemic certainly keeps me up at night, because COVID-19 was a very chaotic time. I think what motivates me and keeps us all really excited to come to work every day is that every day there's a new challenge, but more than that, it's the satisfaction of knowing that we're making a difference in people's lives. 

What’s next after the rollout of the R21/Matrix-M malaria vaccine?

We've made 100 million doses, and we're expecting about 20 to 25 million doses to go out this year. But getting countries ready in terms of preparedness, training their staff, accepting the cold chain, and getting parents in to bring their children to get vaccinated usually takes a little time. I'd really like to get to 50 to 60 million annual supply to the African continent in three years. We have the capacity, the demand, and the will of the people to want this vaccine, now we just need to get enough funding from Gavi [the vaccine alliance] and donors to be able to support that.

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