The vaccine candidate developed by the Oxford Vaccine Group has a virus named ChAdOx1 nCov-19.
As the world rushes to find a vaccine for Covid-19, an Indian pharmaceutical major is offering a glimmer of hope by betting up to $80 million of its own money on an experimental vaccine for Covid-19 by gearing up to mass-produce it by July. Serum Institute of India, the world’s largest producer of vaccines by the number of doses it produces and exports, claims it can begin bulk manufacturing in two months as human trials continue in the United Kingdom.
“We hope to begin mass production within two months. The cost will be approximately $60-80 million for a new plant we are setting up. We will export the vaccine if we feel there is enough supply, but first, we want to give it to our own country,” Adar Poonawalla, CEO of Serum Institute said.
It could cost as little as Rs1,000 ($13). Regulatory approvals from the Indian Council for Medical Research and other agencies will also need to be obtained. It remains a risky bet but the company hopes to produce 5 million doses per month from July and scale it up to have 40 million doses ready by September, the company’s CEO said. The plan is to fast-track the production process to meet demand even as the vaccine is undergoing trials in the UK.
Serum, a Pune-based company, is among seven backers of the Oxford Vaccine Group to develop the vaccine that is now at the human trials stage. The trials began on April 23 and Poonawalla is guarded yet confident that the core vaccine team in the UK will pull it off in record time.
The vaccine candidate developed by the Oxford Vaccine Group has a virus named ChAdOx1 nCov-19. It is a weakened version of a common cold virus (adenovirus) that has been genetically modified, making it impossible to grow in humans.
“Vaccines made from the ChAdOx1 have been given to more that 320 people so far and it has been found to be safe and well tolerated,” Oxford Vaccine Group said in a statement. It hopes to rope in 1,102 participants in total.
The positive results have encouraged Serum to bank on this vaccine from Oxford.
The Indian company makes about 1.5 billion doses of different vaccines annually and says the scaling up process for a Covid-19 vaccine (if trials are successful) will be done by putting the production of other vaccines on hold.
It has a main manufacturing facility in Pune and two smaller units in The Netherlands and the Czech Republic. The company has also entered into a partnership with Codegenix, a US-based company that has an algorithm to speed up the vaccine development process. “We are experimenting with this technology platform to see if it is possible to produce a vaccine rapidly,” said Poonawalla.
This separate vaccine project is expected to enter human trials next month.
If trials are successful, Serum’s role will be to establish the product on a suitable cell line followed by a scale up and manufacture of the vaccine.
Poonawalla said it normally takes 7-8 years to mass produce a vaccine but the 53-year-old firm has the expertise and has collaborated with other vaccine makers to get the best shot at the preventive treatment.
“We have expertise in manufacturing different vaccines, from live attenuated to protein-based, so it’s not a challenge,” he said.
The real challenge for vaccine makers is the efficacy and safety when a new strain is introduced in humans. Making a vaccine takes time because of animal studies, human trials and also ensuring a more deadly pathogen does not return.