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Clinical trial of Oxford Covid-19 vaccine begins in Pune, 2 get first shot
Phase II will determine the safety of the vaccine to check if volunteers report any reactions. Two male volunteers aged 31 and 48 were found eligible and will now be followed up for any symptoms or reactions due to the vaccine
Two volunteers from the city became the first in the country to be administered phase II of the ‘Covishield’ vaccine developed by Oxford University and being mass-produced by Pune based Serum Institute of India (SII).
Of the five volunteers who came forward to get vaccinated, three were declined doses after they were detected with antibodies for Covid.
Phase II will determine the safety of the vaccine to check if volunteers report any reactions. Two male volunteers aged 31 and 48 were found eligible and will now be followed up for any symptoms or reactions due to the vaccine.
The trials were conducted at Pune’s Bharati Vidyapeeth hospital and research centre on Wednesday, where all the five volunteers were tested for infection and for comorbidities.
The volunteers were explained possible reactions that they might experience in a short course of time or in the near future. Like all clinical trials, the participants were covered through an insurance, sponsored by the Indian Council of Medical Research (ICMR) and Serum Institute in this case.
The sponsors also paid travel allowance for the participants. This was the first dose and participants were asked to stay for about 30 minutes to check for immediate reactions and then would be contacted through phone calls for the next seven days.
On the 28th day, they would be called again for the second dose when they would be physically examined again and again, on the 56th day, and then, six months after the first dose.
Dr Sanjay Lalwani, medical director at Bharati Vidyapeeth Medical College, Hospital and research centre said, “This trial will determine the safety of the vaccine, like to check for any pain, fever, nausea or any other reactions. About 100 volunteers at 14 sites across the country will be selected for this trial, who will be checked for any reactions which will determine the safety of the vaccine. Since we have first started, we expect about 25 such volunteers.”
According to Dr Jitendra Oswal, deputy medical director at the hospital said, every fourth person is administered with a placebo to ensure that it is not a placebo effect. Once the vaccine is found safe then the others would be tested for efficacy. “There are many more questions that need to be answered like will the antibodies produced through this vaccine be neutralising antibodies or how long will the antibodies stay in the body. In the worst-case scenario, the vaccine would not work but even if it is able to avoid complications then it would be a great deal. This is a completely new virus and so if we have a vaccine which even prevents complications and brings down case fatality or deaths due to Covid19 then it is definitely a breakthrough. For now, we need to first check that it is safe,” he said.
Maharashtra civil supplies and consumer protection minister, Dr Vishwajeet Kadam said that these volunteers were selected as per ICMR guidelines and those who are eligible will be vaccinated.
“Once the vaccine is found to be safe on these healthy volunteers, the vaccine will be given to Covid-19 patients too. The medical and research team at Bharati Vidyapeeth hospital will keep a watch on these volunteers who are vaccinated,” Kadam said.
Dr Oswal also added that three of the five were asymptomatic Covid-19 positives at some point of time and were recovered from the virus without them realising about the infection. This does show a high prevalence in the city but is also good news that antibodies are being generated. Earlier, the ISSER Sero-survey had found that over 50 per cent of the 1,600 samples collected from highly affected areas tested positive for antibodies.