The second phase of the human clinical trials of the Oxford Covid-19 vaccine candidate will begin on Tuesday, reported PTI. The vaccine – known as Covishield in India – was developed by Oxford University and British-Swedish pharmaceutical firm AstraZeneca. The Pune-based Serum Institute, which is the world’s largest vaccine manufacturer by volume, is conducting trials of the vaccine candidate in India in partnership with the Indian Council of Medical Research.
The study, which will begin at the Bharati Vidyapeeth Medical College and Hospital in Pune, will ascertain the safety and immunogenicity of the vaccine candidate on healthy Indian adults. “Many people want to enrol,” Dr Sanjay Lalwani, Medical Director of Pune’s Bharati Vidyapeeth Deemed University Medical College and Hospital, told The Indian Express. “We have committed to enrol 350 trial participants.”
“We have got all approvals from the Central Drugs Standard Control Organisation,” said Prakash Kumar Singh, additional director, Government and Regulatory Affairs of Serum Institute of India. “We are going to start the human clinical trial process at the Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital from August 25. We are sure that in line with the philosophy of our group, we are going to make available a world class Covid-19 vaccine for people of our country and make our country ‘AatmaNirbhar [self-reliant]’.”
Around 1,600 people aged above 18 years are likely to participate in the trials which will be conducted in 14 sites across the country. Four of these are in Pune, and two are in Mumbai. Pathik Divate, CEO of Jehangir Clinical Development Centre, another trial site in Pune, said approximately 250-300 participants would be enrolled. The other two trial sites in Pune are KEM Hospital and Research Centre and BJ Medical College and Sassoon General Hospital.
The Serum Institute of India has already received an approval from the Drug Controller General of India to conduct phase two and three human clinical trials of the vaccine candidate. The firm had earlier said that around 5,000 people in Pune and Mumbai would be administered the vaccine by the end of August as part of the trials. The trials will last over two months.
Last month, the Centre identified five sites across the country for the third and final phase of the human trials of the vaccine. The five sites selected by the government were INCLEN Trust International in Palwal, Haryana; KEM Hospital in Pune; the Society for Health Allied Research in Hyderabad; the National Institute of Epidemiology in Chennai; and the Christian Medical College in Vellore.
Oxford’s vaccine, called AZD1222, had produced an immune response against the coronavirus and proved to be safe in early-stage clinical trials, according to trial results published in The Lancet medical journal. The Oxford vaccine prompted an antibody response within 28 days and a T-cell response within 14 days. Neutralising antibodies, which can disable the virus, were detected in most participants after one shot, and in all of them after two.