A research scientist works inside a laboratory at Serum Institute in Pune, May 2020. Photo: Reuters/Euan Rocha
In the western Indian city of Pune, the sprawling headquarters of the Serum Institute of India (SII) could be ground zero in the world’s fight for a coronavirus vaccine.
The massive campus houses machines that can fill 500 glass vials per minute and gleaming steel bioreactors almost two stories high that can produce millions of vaccine doses every month.
The SII is the world’s largest manufacturer of vaccines by volume, producing 1.5 billion vaccine doses annually mostly for countries for the developing world.
Now the SII is throwing its mass production model against the coronavirus, churning out doses of the “Covishield” candidate vaccine being developed by the University of Oxford and the international biopharma company AstraZeneca.
Stage III clinical trials of Covishield continued in India last week after they were paused earlier this month following an “unexplained illness” in a test subject during trials in the UK. The candidate vaccine is also being tested in various stages in the US, Brazil and South Africa.
With a $200-million (€171 million) investment already in place, the SII has already produced over 2 million doses of the vaccine candidate for use in testing. If Covishield is proven to be safe and effective, the SII says it will ramp up production to produce 10 million doses per month.
SII this week also announced a deal with US-based biotech company Codagenix to help develop a vaccine candidate for Phase I clinical trials expected to begin by the end of 2020.
Schott, a German glass manufacturing company, has also tied up with SII for supply of COVID-19 vials.
High volume, low costs
The SII was founded in 1966 by Cyrus Poonawalla and produced anti-venom for snake bites and a tetanus antitoxin. It then began developing polio vaccines for the developing world.
“I remember when I was a medical student in 1971, and international efforts to eliminate smallpox and polio were in high gear. The Poonawalla family decided that was where the future lay,” Dr M.C. Mishra, the former director of the All India Institute of Medical Sciences, told DW.
The SII says an estimated 65% of children in the world currently receive at least one of its vaccines. These include polio, diphtheria, tetanus, pertussis, Hib, Hepatitis B, measles and rubella.
“Their USP is simple – high on volume and low on costs. And it has been able to live up that motto with such amazing regularity. They have an established track record,” Mishra said.
Over the years, the SII has built its production capacity by importing expensive manufacturing equipment from Europe and the US, which allows it to manufacture more products.
“In the early 80s when I visited the institute, it had the largest mixing vessel for producing 200,000 liters of DPT vaccine. Their standards are exacting and their long experience in vaccine making has only enhanced their reputation. It is in the family’s DNA,” Dr T. Jacob John, one of India’s foremost virologists, told DW.
“SII’s final product is already in store. It will be ready to roll out 100 million vaccines tomorrow if the need arises,” John added.
As cheap as €12 per dose
In April, Serum’s CEO Adar Poonawalla told DW that the decision to mass produce the candidate before the vaccine was proven effective was made solely to have a head-start on manufacturing and to have enough doses available. If the vaccine worked, SII and the Indian government committed to reserve half the company’s stock of it for India, and to supply half to low-income nations through GAVI, a sponsor of immunizations for low-income nations.
“If the trials are successful, we will make the product available in as many countries as possible, including India. When a vaccine is developed, we plan to sell it for around €12 ($13) per dose,” said Poonawalla.
In a tweet over the weekend, Poonawalla asked India’s health ministry and the government how it planned to procure 80 billion Indian Rupees (€9.3 billion) to distribute COVID-19 vaccine to everyone in India, spelling out the next challenge before the country.
“I ask this question, because we need to plan and guide vaccine manufacturers both in India and overseas to service the needs of our country in terms of procurement and distribution,” he wrote in another tweet.
Quick question; will the government of India have 80,000 crores available, over the next one year? Because that’s what @MoHFW_INDIA needs, to buy and distribute the vaccine to everyone in India. This is the next concerning challenge we need to tackle. @PMOIndia
— Adar Poonawalla (@adarpoonawalla) September 26, 2020
SII has also started manufacturing a nasal COVID-19 vaccine candidate developed by Codagenix Inc. Dubbed the DX-005, the coronavirus vaccine has completed preclinical animal studies. The drug maker aims to initiate phase I clinical trial of its COVID-19 vaccine in the United Kingdom by the end of 2020.
Currently there are 33 vaccines in human trials, including US Moderna and Russia’s Sputnik, while China is all set to launch its experimental vaccine, produced by Sinovax Biotech Limited for the public by November.
As pharmaceutical companies work their way to a vaccine that is safe, credible and easily available, many are still hedging their bets on SII in this competitive and life-saving endeavor.