Oxford COVID-19 vaccine’s phase two trial begins at Pune hospital
Dr Lalwani said phase two and three of trial is expected to end within three months and after that a detailed report with all the data of the trial phase will be sent to the government.
New Delhi: The second phase trial of COVID-19 vaccine developed by Oxford University, which would be manufactured by Serum Institute of India, began here with the vaccine candidate administered to two volunteers at Bharati Vidyapeeth Medical College.
Dr Sanjay Lalwani, Medical Director of Bharati Vidyapeeth Medical Hospital and Research Centre, said that five volunteers were tested for RT-PCR and antibodies and reports of three showed they have anti-bodies and vaccine was administered to two volunteers.
He said the human clinical trial began today at Bharati Vidyapeeth’s Medical Hospital and it will soon be carried out at 17 centres across India. “Bharti Vidyapeeth’s Medical Hospital is one of the four selected centres in Pune. The trial began today after we received all clearances yesterday,” he said.
Dr Lalwani said both the volunteers live within five kilometres radius of hospitals and have been asked to report back to the hospital immediately if they experience any discomfort.
“The volunteers live within five kilometres radius of the hospital. They’ll be monitored and if they have any problem within seven days they’ll report to us. After one month, they’ll get their second doses and report back after 56 days. We’ll again check up on them on the 90th day over the phone and they have been asked to report back on 180th day,” Dr Lalwani told ANI.
Dr Lalwani said phase two and three of trial is expected to end within three months and after that a detailed report with all the data of the trial phase will be sent to the government.
“If everything goes well, the government, in collaboration with the Serum Institute, will be able to provide the vaccine by the end of the year,” he added. The volunteers, who were administered the vaccine candidate hoped that youth will come forward for such trials and said there is need to encourage scientific temper.
“Youth should come forward and that’s why I came forward. I am 31 and educated. I understand that it is the need of the hour and I hope more youngsters will come forward. The sooner phase three (trial) ends the better for country,” one of the volunteers said.
“I work in the hospital, and know about the implications of COVID-19. When I heard the news about the trial I volunteered. Encouraging and helping scientific temperament is our duty and a service to nation,” the other volunteer said.
Serum Institute of India has initiated the phase two, three clinical trials to evaluate the safety and immune response of the Oxford Univsersity coronavirus vaccine candidate on healthy Indian adults after the pharma company got approval from Drugs Controller General of India (DCGI) earlier this month.
According to the Clinical Trial Registry India, the scientific title of the study mentions that phase two, three clinical trials will be observer-blind, randomised, controlled study to determine the safety and immunogenicity of Covishield (COVID-19 vaccine) in healthy Indian adults. (ANI)