The phases II trial of COVID-19 vaccine developed by the University of Oxford started in India this week. Three volunteers were given the vaccine on Thursday at Bharti Vidyapeeth’s Medical College and Hospital in Pune. British-Swedish drug maker AstraZeneca signed a deal with Serum Institute of India to manufacture Oxford’s COVID-19 vaccine candidate.
Pune-based vaccine maker shortlisted 17 sites in India for the Phase II clinical trial of COVID-19 vaccine. At least 1,600 candidates aged between 18 to 55, will participate in the trial.
“On Thursday afternoon, three more volunteers — two females and a male — were administered the vaccine candidate after their reports of RT-PCR test for COVID-19 and antibody test came negative,” said Dr Sunita Palkar, in-charge of the research cell at the medical college.
Two volunteers were given the first shot of Covishield on Thursday. The vital health parameters of the those two are normal, the medical facility’s deputy medical director Dr Jitendra Oswal said.
“Since yesterday, our medical team is in touch with the two volunteers and both are fine. They do not have any pain, fever, injection-side reaction or systemic illness post-vaccination,” he said.
“They have been given all the necessary emergency numbers (to contact in case of need) and our medical team is also conducting follow-ups with them,” he added. The vaccine dose will be repeated on both the volunteers after one month.
Each participant will administer two doses in a gap of four weeks. First dose will be given on day one and second dose will be scheduled on day 29,” according to the study design by Serum Institute of India.
“Phase 2/3 clinical trial will be observer-blind, randomised, controlled study to determine the safety and immunogenicity of Covishield (COVID-19 vaccine) in healthy Indian adults,” the study design mentioned.
“After the completion of phase II trial, reports will be submitted to the Data Safety Monitoring Board, then to the Central Drugs Standard Control Organization for stage 3 of the trial,” Dr Hemant Deshmukh, King Edward Memorial Hospital said.
KEM Hospital, another facility chosen for the vaccine’s clinical trials in the country, is also scheduled to conduct a trial on some persons on Thursday, a senior doctor from the medical facility said.
“We screened five people yesterday and we are now waiting for their reports. As per the results of the report, the vaccine will be injected to the eligible volunteers,” said the doctor.
