August 1: Privately-owned vaccine manufacturer Serum Institute of India is ready to market a repurposed BCG vaccine which, it claims, has been found to afford immunity against Covid-19. “We applied to the government (of India) mid-July for the marketing licence, giving details of our trials, and expect to receive permission by the end of this month (August),” a top Serum source told this website.
Since it emerged late December 2019 from Wuhan, China, Covid-19 has turned into a global pandemic, infecting 17, 296, 303 persons, of whom 673, 290 persons succumbed by July 31, 2020, said the European Union’s European Centre for Disease Prevention and Control.
Serum Institute of India is based in the western Indian city of Pune, 150-km east of India’s commercial hub Mumbai and is one of the nearly dozen companies across the world racing to develop and market a vaccine against Covid-19, which continues to ravage the global economy as well.
Covid-19 primarily attacks the lungs, just like tuberculosis, against which the BCG vaccine gives protection. So, Serum repurposed the BCG vaccine. “During human clinical trials we found that those injected with our ‘Recombinant BCG’ (RBCG) vaccine get positively protected against Covid-19.” Among the human clinical trial volunteers were some of Serum’s staff living in a few ‘Covid-19’ affected containment zones of Pune. Added our Serum source: “I have also been injected with this (RBCG) vaccine.”
Nevertheless, Serum will not market this product specifically as a vaccine against Covid-19. “This (BCG vaccine) is one of our ongoing products that we have repurposed and found to be effective (against Covid-19),” said Serum, which sees India and the United States as markets for this RBCG vaccine.
Separately, late July, Serum received the original ‘cell bank’ for a single-dose, intranasal Covid-19 vaccine candidate from US-based developer Codagenix Inc to start production for human clinical trials due in London, autumn onwards, on 48 healthy young adult volunteers by pharmaceutical Clinical Research Organisation (CRO) Open Orphan plc. From Codagenix’s ‘cell bank’ Serum will develop cell cultures, propagate the virus, purify the antigens and carry out other processes before filling the vials – from August 28 – for Phase-I human trials.
Typically, Phase-I human trials are conducted on less than 100 healthy adult volunteers to evaluate the vaccine’s safety and immunogenicity. Phase-II trials are on up to 1000 volunteers and Phase-III trials are on more than 1000 volunteers.
As part of business strategy, Serum does not restrict itself to being a contract manufacturer of successful Covid-19 vaccine candidates but negotiates marketing rights as well for some parts of the globe. “We don’t sign any pure contract manufacturing agreements, we want marketing rights as well (for some countries/regions),” said Serum.
Meanwhile, Serum expects to receive government of India approval by August 10 or 15, for late stage human clinical trials for a Covid-19 vaccine candidate developed by the University of Oxford. “Trial protocols are being worked out, we are finalising the CRO and plans are to do these Phase-II and III trials on a total 2500 human volunteers, over 45 days,” Serum tells us. Some 30 million doses of this vaccine candidate are ready for trials and further research.
From late August onwards, while these trials are in progress, Serum has readied plans to produce between 60 million and 70 million doses of this vaccine every month for the domestic and global markets.
Serum has also in hand two Covid-19 vaccine candidates developed in-house, both based on existing vaccines for other illnesses. One is based on the Hepatitis-B vaccine and the other on the measles vaccine. Permissions have been sought from the government of India to begin Phase-I human clinical trials, planned from end-August or early September in the UK, which is Serum’s main target market for this vaccine. All three phases of the human clinical trials are likely to be concluded by June 2021, says Serum.
Serum Institute of India was set up in 1966 by horse racing enthusiast and stud farm owner Cyrus Poonawalla to manufacture vaccines that were, till then, being imported. Serum’s website says it exports to 170 countries and is the world’s largest vaccine manufacturer, producing 1.5 billion doses annually against illnesses such as tuberculosis, measles, polio, influenza.
Cyrus Poonawalla is chairman and managing director of the company and his son Adar Poonawalla is the CEO.
Forbes magazine estimated 79-year-old Cyrus Poonawalla’s net worth as US$11.8bn as of July 31, 2020 and listed him as India’s 12th richest man in 2019.