India's first COVID vaccine human trial begins in Pune

Closing his eyes tight, the 48-year health professional braced himself to make history as one of the first volunteers for the shot of Covishield vaccine at Bharti Vidyapeeth’s Medical College and Hospital, Pune.  Earlier a 32-year-old was administered the shot as part of Phase II clinical trial of the Oxford Covid-19 vaccine, which is manufactured by the Pune based Serum Institute of India (SII).

A total of 5 volunteers were selected for the trials today but three of them, 2 females and one male tested for antibodies thus were left out of the trials.

“This is the phase 2 human trials of the Oxford University’s Covid-19 vaccine, manufactured at the Pune-based Serum Institute of India, where we had screened three men and two women and only after the reports of the screening of the RT- PCR and antibody test did we select two volunteers today. Most of the volunteers are within 5 km radius for us to monitor in case of emergencies,” said Dr Sanjay Lalwani, medical director of Bharati Vidyapeeth’s medical college and hospital. This first human trial was conducted after Drug Controller General of India (DCGI) had given the go-ahead to Serum Institute for conducting phase-2 and -3 human clinical trials of the vaccine candidates. The Serum Institute has tied up with British-Swedish pharmaceutical firm AstraZeneca to produce 1 billion doses of the vaccine in the country.

“Covishield will be administered as a two-dose schedule as a 0.5 ml dose intramuscularly on Day 1 and Day 29, while Placebo will be administered as a two-dose schedule on Day 1 and 29 as a  0.5 ml dose intramuscularly, which will be done and randomised controlled study will determine the safety and immunogenicity of Covishield vaccine on healthy Indian adults,” said Dr Lalwani.

He further added, “In phase 2, approximately 100 participants will be enrolled and vaccinated across various sites. Bharti hospital will be testing the vaccine on 25 volunteers. This vaccine test is mainly to assess the vaccine’s safety; its side-effects, which will be recorded.”

Dr Sonali Palkar, Incharge of the Pediatric Research Cell which has conducted over 50 tests for vaccines, said, “The vaccine doses have to be administered within seven days of enrolment, and this safety cohort will be followed for a week. After 10 days, the phase 3 part of the study will begin, which will include 1,500 trial participants. Volunteers above 18 years have to provide informed consent to participate in the trial. Once the vaccine is administered the trial participant will be monitored for the next half hour and then sent home. There will be a follow-up for the next six months.”

Speaking of their experiences of being the first volunteers, the 48-year-old health care professional said that he is pro-science and the need of the hour to help find a cure for COVID. “My wife ( 47) and daughter (22) have also volunteered for the trial. Everyone should step forward for it is our social responsibility,” added the volunteer who had also volunteered for the Swine Flu testing.  

The other volunteer is 32-year-old PHD statistics professional working in the private sector said, “My parents who are farmers and my brother all have supported my decision to be part of the human trials. The pandemic effect on the economy and the state my city is made me decide besides the youth should come forward and be part of these trials to help find a vaccine for COVID-19.”