Pune-based Serum Institute of India seeks regulator’s nod to produce Oxford Vaccine for Covid-19

As the coronavirus vaccine being developed by Oxford university and AstraZeneca enters the third phase of the trials, Serum Institute of India (SII) is geared up to procure a licence from the Indian regulator to start clinical trials in the country in a week’s time.

Serum Institute of India, the largest vaccine manufacturer in the world, and a partner in the Oxford vaccine project has already been chosen by AstraZeneca to manufacture the vaccine once it is ready. “The trials have shown promising results and we are extremely happy about it. As soon as they grant us permission, we will begin with the trials for the vaccine in India,” said Serum Institute’s CEO Adar Poonawalla. “In addition, we will soon start manufacturing the vaccine in large volumes.”

The Pune-based Serum Institute of India has been mandated to produce at least a billion doses of the vaccine and the production may start before the final nod as the volume is too large and required urgently in view of no other vaccine showing promising results as Oxford-AstraZeneca vaccine owing to its o serious side effects and elicited antibody and T-cell immune responses.

WHO Cautious

The trial results published in The Lancet medical journal, showed that it was tested on 1,077 healthy adults aged 18-55 years with no history of COVID-19. The World Health Organisation (WHO) has welcomed progress made in developing vaccines but warned there was still much work to be done. While the Oxford vaccine undergoes final stage trial in Brazil, other vaccines are making inroads in different stages of trial.

Apart from Oxford vaccine, India has already started Covaxin, indigenously developed vaccine for COVID-19, developed by the Hyderabad-based Bharat Biotech in collaboration with ICMR and the National Institute of Virology, has been given the nod for human clinical trials from the Drugs Controller General of India.

As per the deal, Serum Institute of India is hoping to produce the first 400 million doses before the end of 2020.