Currently in the spotlight for a possible COVID-19 vaccine, the company has been producing low-cost doses since 1966.
The hopes of millions are riding on a partnership between Pune-based Serum Institute of India (SII), which is the world’s largest manufacturer of vaccines in terms of volume (1.5 billion vaccine doses a year), and British-Swedish pharmaceutical giant AstraZeneca, to manufacture the experimental COVID-19 vaccine candidate formulated at the University of Oxford.
If human trials prove successful in both nations, SII CEO Adar Poonawalla said that they would launch the vaccine under the name ‘Covidshield’ by early next year.
Earlier this week, reports emerged about a study in medical journal The Lancet which suggests that early human trials of this vaccine have garnered some success.
“Trials involving 1,077 people showed the injection led to them making antibodies and T-cells that can fight coronavirus. The findings are hugely promising, but it is still too soon to know if this is enough to offer protection and larger trials are underway…It is made from a genetically engineered virus that causes the common cold in chimpanzees…The vaccine prompted no serious side effects and elicited antibody and T-cell immune responses with the strongest response seen in people who received two doses,” notes a BBC report.
More than 10,000 people will participate in the next stage of the trials in the United Kingdom.
Meanwhile, in India, human trials on up to 5,000 volunteers in Pune, a city ravaged by the epidemic, is expected to commence by the end of August. The AstraZeneca-SII partnership is expected to help manufacture and supply the vaccine to India and more than 60 nations.
“The vaccine under development will be injected into 4,000-5,000 volunteers in Pune and Mumbai, which have high rates of coronavirus infections, as part of the crucial phase three of the trial which will determine if the antidote can be introduced in the market or not,” said Adar Poonawalla, speaking to various publications.
He went on to add that by the first quarter of 2021, the vaccine will reach Indian citizens, and is expected to be priced at Rs 1,000. He has also gone on to claim that SII has put nearly $200 million of its own money at risk by manufacturing about 300 million doses of the experimental vaccine even before the final clearances are given by regulators in both India and the United Kingdom.
Founded by Adar’s father and billionaire Dr. Cyrus Poonawalla (75), SII has, for more than five decades, manufactured critical vaccines for diseases including tetanus, measles and meningitis, amongst others, which are then sold predominantly in the developing world.
Before the Poonawalla family got into the business of manufacturing vaccines, they were major players in the national horse racing circuit through their Poonawalla Stud Farms. However, by the time he was 20 years old, Dr Cyrus Poonawalla realised that horse racing had “no future in the socialist India of the time”.
There was a brief dalliance with the idea of manufacturing commercial sports cars, but he soon realised it wasn’t a viable business proposition. It was a “chance conversation” with a vet at their farm, which inspired Dr Poonawalla to get into the business of vaccines.
“At the time, the farm’s retired horses were donated to the government-owned Haffkine Institute in Mumbai, which made vaccines from horse serum. Dr. Poonawalla figured he could take up the challenge of meeting the demand for vaccines in the country by extracting the serum from horses himself and producing cheaper vaccines. In 1966 Dr Poonawalla founded the Serum Institute of India (SII) which launched its first therapeutic anti-tetanus serum within two years, and began producing the anti-tetanus vaccines,” notes his biography.
Since then, SII has grown exponentially in the vaccine manufacturing business from the DTP vaccine (1974) to the Measles Vaccine M-Vac (1989). They claim credit for ensuring India became self-sufficient in vaccines for Whooping Cough, Diphtheria and Tetanus in the 1980s. By the turn of the ‘90s, SII had become the largest manufacturer of vaccines in India.
Recognition soon followed from global agencies with SII receiving accreditation from the World Health Organization in 1994 to export quality vaccines and supply global agencies like the UNICEF (United Nations Children’s Fund). By 1998, SII was exporting vaccines to over 100 countries, particularly those in the low-income bracket, and by the turn of the 21st century “one out of every two children in the world was vaccinated by a vaccine of SII”.
How Did SII Succeed?
Today, SII is able to supply a significant portion of the 1.5 billion vaccine doses a year thanks to the partnership it forged with the likes of GAVI, the Vaccine Alliance founded by Bill and Melinda Gates in 2000.
According to its website, the objective of GAVI is to “bring together public and private sectors with the shared goal of creating equal access to new and underused vaccines for children living in the world’s poorest countries.” What it does is utilise donor money to purchase vaccines in bulk quantities for poorer nations that can’t afford them.
While the money comes from GAVI, companies like SII deliver WHO-standard vaccines. By some estimates, 4 out of the 10 vaccines that GAVI funds are supplied by SII. As a consequence of such tie-ups, the company claims that about 65 per cent of children from around the world receive at least one vaccine manufactured by SII.
The company’s business model centers on creating low-cost high quality vaccines.
“Cheaper production costs in India are part of what Poonawalla says is the Serum Institute’s advantage over big Western players like Sanofi and GlaxoSmithKline. Yet the Serum Institute has never created a first-of-a-kind vaccine — meaning its entire business model is based on having its scientists piggyback on the basic research of other companies to understand a disease and the body’s immune response. Once the Serum Institute has produced a quality version of the same vaccine created by Big Pharma, it is able to manufacture huge numbers of doses quickly and inexpensively,” says a Politico report.
While some of the vaccines it produces specifically fit the need of poorer countries like the oral rotavirus vaccine, which requires no cold storage, others are essentially variants of products developed by global drug giants.
It is able to manufacture quality versions of vaccines created by Big Pharma in huge volumes inexpensively. SII churns out “medically comparable knockoffs of brand name products at a fraction of the cost, for sale in the world’s poorest countries,” notes Politico. As a result, Big Pharma has massively resisted SII’s entry into European and American market.
In the past, the Gates Foundation has credited SII for helping rid of meningitis in the worst-affected parts of Africa. But make no mistake, the company is extremely profitable as well. According to Business Insider, it clocked a revenue of around Rs 5,900 crore in FY19.
“Serum has scientific expertise, financial strength, ability to produce vaccines at massive scale, and a large distribution network. All these make it attractive for potential licencing deals,” said a pharma analyst, speaking to Moneycontrol.
What’s Next on The Horizon?
Speaking to GQ last month, Adar Poonawalla said, “[We are looking] to develop and produce even more vaccines and monoclonals. For example, I have a cure for dengue, which we will probably launch at the end of this year. Nobody has this in the world. So far there’s one dengue vaccine. But there’s no monoclonal cure that you can take when you’re in the hospital.”
In the meantime, we hope that they deliver on a Coronavirus vaccine.
(Edited by Gayatri Mishra)