Phase 2 trial commences; the men, aged 32 and 48, will get a second dose after 28 days.
The second phase of the clinical trial of the eagerly anticipated University of Oxford COVID-19 vaccine, being manufactured by the city-based Serum Institute of India (SII), commenced at Pune’s Bharati Vidyapeeth Medical College and Hospital on Wednesday.
Hospital authorities said that two male volunteers, ages 32 and 48 respectively, were administered the first shots of the ‘Covishield’ vaccine. The trial began at around 1 p.m. and the volunteers were discharged after half-an-hour of being administered the vaccine.
“Doctors at the hospital administered a 0.5 ml dose of the ‘Covishield’ vaccine to both volunteers after their COVID-19 and antibodies test results returned negative. Their temperature, blood pressure and heartbeat parameters were checked before the vaccine was administered them,” said Dr. Sanjay Lalwani, Medical Director of Bharti Vidyapeeth’s Medical College, Hospital and Research Centre.
He further said that a second dose would be given to both volunteers after 28 days, while they would be summoned to the hospital after a period of 180 days.
Authorities said that only after this six-month period could the success of the vaccine be properly ascertained.
In all, five volunteers had enrolled themselves for the Phase II clinical trial after the vaccine doses were received from the SII on Tuesday, informed Dr. Lalwani.
“The COVID-19 and antibodies tests were conducted on all five volunteers. However, the antibodies test report of three of them returned positive, rendering them ineligible for the trial,” he said.
According to Dr. Lalwani, a further 25 volunteers would be administered the vaccine over the next seven days.
The 32-year-old volunteer, who works for a private company, said he had come to know of the trials at the Bharti Hospital through social media and expressed happiness on being declared eligible to be given the dose after his tests returned negative. He said he was glad to be contributing his small bit towards society and said that his family had fully supported him in the process.
Remarking on the trials, Maharashtra Minister Dr. Vishwajeet Kadam, who is also pro-Vice-Chancellor and Secretary, Bharati Vidyapeeth, said: “Today, the world is eagerly anticipating as to when will the first effective anti-COVID-19 vaccine be out. In this backdrop, I think it is indeed a historic moment that self-declared volunteers are to be administered the first dose of the Oxford vaccine being manufactured by the SII at the Bharti Hospital, the only testing centre in the West zone chosen by the SII. The vaccine will first be administered to these ‘healthy’ cases who will be kept under observation for the next six months.”
Dr. Kadam expressed the possibility that in the next two-three months, after observing the side-effects of the vaccine, the SII, after being given approval by the Indian Council of Medical Research (ICMR), may even begin wholesale manufacturing of the ‘Covishield’ vaccine.
The SII has signed an agreement to manufacture the ‘Covishield’ vaccine, which is being developed by the University of Oxford in collaboration with the British-Swedish pharmaceutical major, AstraZeneca.