Serum Institute gets DCGI nod for trials of Oxford vaccine

The Drug Controller General of India’s (DCGI’s) office has approved the Serum Institute of India’s application for phase II and III clinical trials of the University of Oxford’s covid-19 vaccine candidate Covishield, the Union health ministry said on Monday.

Pune-based Serum Institute is the third firm to get approval for conducting human trials in India after Bharat Biotech (for Covaxin) and Zydus Cadila (for ZyCoV-D), which got the approval for phase I and phase II trails last month.

The approval from DCGI comes after an expert committee last week recommended that the company be allowed to conduct clinical trials after studying the revised proposal of the firm for a 1,600-patient human trial, according to people aware of the development.

The Subject Expert Committee (SEC) for Covid-19 Related Therapies had on 28 July recommended various amendments to Serum Institute’s earlier protocol to conduct the trials here. Among the eight protocol changes, the panel had asked the company to hold a pan-India trial and also specify the role of the Indian Council of Medical Research (ICMR) in the trial. Mint could not ascertain a link between ICMR and Serum Institute’s trial for the Oxford vaccine candidate.

The company, which is the world’s largest vaccine manufacturer by number of doses produced and sold globally, had signed an agreement with British-Swedish multinational pharmaceutical company AstraZeneca, the co-developer of the vaccine, in June to supply an additional 1 billion doses, principally for low- and middle-income countries.

There are more than 150 vaccine candidates undergoing clinical trials, with human trials of more than two dozen of these underway. However, the University of Oxford’s vaccine candidate is seen as the front runner.

Interim data from a clinical study published in The Lancet journal last week showed that the vaccine candidate was safe and provided dual immunity against the highly infectious respiratory disease. Serum Institute plans to price the vaccine at less than ₹1,000 per dose, chief executive officer Adar Poonawalla had told Mint in an interview last week. Poonawalla also said the company will reserve around half the vaccines it produces for India.