In 1966, a prize thoroughbred horse, owned by the Poonawalla family, was bitten by a venomous snake. They sent the horse to the Haffkine Institute, a government funded biomedical laboratory to whom they normally donated their horses once they retired. But due to the scarcity of antivenom, they needed government permission to administer it. It took nearly four days to receive permission but by then the horse succumbed to the venom.
Frustrated with India’s then-cumbersome bureaucracy, Cyrus Poonawalla, the family patriarch, decided to start developing serums from his own horses rather than donate them. With his son, Adar, he founded the Serum Institute of India. Initially, they worked on serums to treat snake bites and tetanus. Soon, however, the company branched out into vaccines.
SII’s current business model is to be a platform company that does not manufacture products of its own. In one direction, it works with pharmaceuticals to help them mass produce their formula, with economies of scale. In another direction it mass produces low-cost and high-efficacy vaccines whose patent protections have already expired.
Today, India is the world’s largest vaccine manufacturer and SII is its driving force. Even before the pandemic the SII had already manufactured more vaccine doses than any other company in the world. As of 2021, SII produces generic versions of vaccines for measles, hepatitis, and tetanus along with other diseases. Approximately 1.5 billion doses annually (excluding COVID-19 vaccines) are exported to over 150 countries worldwide. It is estimated that two out of three children worldwide are vaccinated with SII’s shots.
In May 2020, SII took a gamble to mass produce the Oxford-AstraZeneca adenoviral vector vaccine in human embryonic kidney cells when there was still no clinical data available on its performance. Seven months later, when countries began approving emergency use authorizations for this vaccine, now branded as COVISHIELD, SII had already millions of doses ready to ship. Although this co-developed vaccine has been suspended for use in Europe due to reported side-effects of blood clot formation, the World Health Organization (WHO) still recommends its use, claiming that “benefits of the AstraZeneca vaccine outweigh the risks”. SII currently manufactures COVISHIELD for distribution in low-income countries and India, where it accounts for roughly 90% of the inoculations. As of December 2021, SII has produced 1.3 billion doses of COVISHIELD.
In May 2021 SII partnered with the university to produce the vaccine, R21/Matrix-M, which was “the world’s second malaria vaccine candidate to enter a phase III licensure trial” in four Sub-Saharan countries following reports of 77% efficacy in a Phase II trial with no adverse events reported. SII is committed to producing more than 200 million doses per year after licensure, which is sufficient supply for inoculating at-risk children in the region.
In September 2021 SII purchased of a 3.9% stake in Oxford Biomedica, a company specializing in developing gene-based therapies, for $68 million. Oxford Biomedica was a supplier of viral vectors for the Oxford-AstraZeneca vaccine and is also a contract manufacturer of the recent WHO-approved Novavax COVID-19 vaccine candidate. This investment enables Oxford Biomedica to expand its current 45,000 sq ft of GMP manufacturing facilities at its Oxbox site by another 39,000 sq ft dedicated to producing COVID-19 vaccines.
Serum Life Sciences, in December last year, also pledged $66 million to fund the construction of the Poonawalla Vaccines Research Building for Oxford University’s Jenner Institute, which will house over 300 scientists. A university press release described this human capital investment as the “largest ever single gift for vaccines research”.
The Serum Institute of India does for vaccines and biologics what Gutenberg’s printing press did for books. SII’s presence and credibility could also nurture an ecosystem of suppliers and partners to grow with it. We can expect its presence in Oxford to expand, especially given the many spinouts and researchers related to vaccine pipelines that can be its customers someday. Having access to this network could provide SII with a suite of vaccines for different diseases, as it sits ready to scale up for the medical challenges the world faces.
Image Credit: The Asian Awards/CC Attribution 3.0 Unported License