A total of 100 volunteers will be enrolled throughout India.
The Phase II clinical trial of the Oxford Covid-19 vaccine, Covishield, began on Wednesday. The first dose was given to two males, aged 28 and 48, in Pune’s Bharti Vidyapeeth’s Medical College and Hospital.
“Two volunteers were given 0.5 ml of the vaccine, observed for half an hour to see if they get any local site reaction or systemic reaction. After half an hour, they were sent home and given an emergency helpline number. They will be observed for seven days,” Medical Director of the medical college Dr Sanjay Lalwani said.
“We received the vaccine yesterday and got clearance from the Serum Institute to start enrolling the volunteers. Five volunteers were called, and a RT-PCR test was performed to screen for antibodies. Three tested antibody positive with no history of Covid-19. They might have been asymptomatic carriers,” he added.
Twenty-five volunteers will be given the dosage in the coming days. A total of 100 volunteers will be enrolled throughout India.
“If the data of all the 100 shows fine, the government will give clearance for phase III on 1,500. It will see the immunogenicity to see how good antibodies are produced and safety of the vaccine. Once the data is compiled by DGCI, the vaccine will get clearance,” said Lalwani.
The vaccine has been developed by Oxford University and British-Swedish pharmaceutical firm AstraZeneca.
The Serum Institute of India has tied up with AstraZeneca to produce doses of the vaccine in India. The trials will be conducted on 1,600 participants across the country.
