Mumbai: Pune-based Serum Institute of India Wednesday started human trials of the Oxford University’s Covid-19 vaccine candidate at the city-based Bharati Vidyapeeth Medical College and Hospital with two volunteers having been administered the dosage.
The hospital had screened five volunteers Tuesday to administer the vaccine to as a part of the Phase 2 trial. However, three of them had positive antibody tests.
Dr Sanjay Lalwani, medical director of the hospital, told ThePrint, “I got a clearance to start screening volunteers yesterday (Tuesday) after we got the investigational product from Serum Institute at our centre.”
“We have a list of volunteers of which we called the first five. We did their physical examination and a physician certified that they are healthy. We also explained the pros and cons of being a part of the trial to them and got their consent. We did their RT-PCR test and an antibody test to check for any past infection.”
“Three of them came positive for antibodies, so they could not be part of the study. The other two were given the vaccine. Besides, we have screened 10 more volunteers today (Wednesday),” he added.
The Drug Controller General of India, the country’s apex regulator for clinical trials, gave its nod on 2 August to start Phase 2 and Phase 3 trials of the vaccine at 17 selected trial sites across India. The Oxford candidate, ‘Covishield,’ is among the frontrunners in the race to develop an effective vaccine against Covid-19.
Serum Institute has a tie-up with Swedish-British pharma company, AstraZeneca, for the Oxford vaccine. The company is expected to manufacture a billion doses for low and middle-income countries by 2021.
1,600 volunteers to be enrolled for Phase 2 & 3 trials
Across India, a total of 1,600 people will be enrolled for the Phase 2 and Phase 3 trials of the vaccine.
Dr Lalwani said, in Phase 2, the antibody response and safety of the vaccine will be recorded.
“The first two volunteers to be given the vaccine were both male, aged 32 and 48, and both are well educated and employed in the service sector. In Phase 2, a total of 25 volunteers will be enrolled at our hospital,” Dr Lalwani added.
The dosage for the trial is 0.5 ml, administered intramuscularly (through the muscle) on the shoulder and the side-effects may include localised pain, redness, or in some cases even headaches, fever and rigour, he added.
Being a centre for vaccine trials for the past 15 years, the hospital has tapped its extensive database of children and their parents to draw up a list of more than 250 volunteers to participate in this trial.
Other hospitals that will be part of the trial include Pune’s BJ Medical College, KEM Hospital and Jehangir Hospital, AIIMS in Delhi, Patna’s Rajendra Memorial Research Institute of Medical Sciences, and Chandigarh’s Postgraduate Institute of Medical Education and Research.