The first dose of the Oxford University’s Covid-19 vaccine will be administered to six trial participants at the Bharati Vidyapeeth Medical College and Hospital in Pune on Wednesday, The Indian Express reported. This came a day after the hospital screened the individuals – three men and three women – for antibodies.
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, began the second phase of the clinical trials of the vaccine on Tuesday.
“We are enrolling six persons for the trial, and the screening process is underway,” Sanjay Lalwani, medical director of Bharati Vidyapeeth Medical College said. “Their RT-PCR and antibody tests are being conducted. If the reports are favourable, the vaccine doses will be administered.”
The Serum Institute is conducting trials in India in partnership with the Indian Council of Medical Research. A total of 1,600 people will be enrolled for the second and third phase of the clinical trials. In phase two, approximately 100 participants will be enrolled and vaccinated across various sites, primarily to assess the vaccine’s safety and its side-effects, if any.
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Pune-based Serum Institute is the third firm to conduct human trials of a potential Covid-19 vaccine in India after Bharat Biotech (for Covaxin) and Zydus Cadila (for ZyCoV-D) started the first and the second phase of clinical trials last month.
The institute was granted permission by the Drug Controller General of India to conduct phase two and three human clinical trials of the vaccine candidate on August 3. 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.
Over 100 vaccines are being developed around the world to tackle the coronavirus pandemic, according to Reuters. The World Health Organization data shows at least four vaccines are in phase three trials, including those from China and Britain.