Phase-2 human trial of the Oxford COVID-19 vaccine candidate begins in India

MUMBAI: The phase-2 human trial of the Oxford COVID-19 vaccine candidate, being manufactured by the world's largest vaccine maker Serum Institute of India (SII), began at a medical college and hospital on Wednesday.

Two male volunteers were administered the vaccine at Pune’s Bharti Vidyapeeth Medical College and Hospital at around 1pm.

“Doctors at the hospital administered the first shot of the ‘Covishield’ vaccine to a 32-year-old man after his reports of COVID-19 and antibodies tests came out negative,” said medical director of Bharti Vidyapeeth’s Medical College, Hospital and Research Centre, Dr Sanjay Lalwani, said. Another 48-year-old male volunteer was also given the vaccine, he added.

Five volunteers had enrolled themselves for the trial after the doses were received from the SII on Tuesday. Before administering the vaccine, doctors checked their temperature, blood pressure and heart beats.

“The COVID-19 and antibodies tests were conducted on all the five volunteers. Of them, the reports of three volunteers’ antibodies tests came out positive. So they became ineligible for the trial,” Dr Lalwani said. “The two other volunteers, who were administered the vaccines, are being monitored,” he said.

According to Dr Lalwani, in all, 25 candidates will be given the vaccine in the next seven days. The vitals of the two volunteers were observed for half an hour after the vaccine jab. “The volunteers were allowed to go home. They will be monitored by our team which is in contact with them. There are no issues so far,” he said, adding that the vaccine dose will be repeated on both the volunteers after one month.

“Thereafter, the volunteers who have been given the dose of the (potential) vaccine will be observed for any reaction to the vaccine and also for the generation of antibodies against coronavirus,” said the medical director of the Bharti Hospital.

The phase-2 trial will be conducted on 100 volunteers at some sites across the country. The SII has selected 15 sites in India to conduct the phase-2 trial of the vaccine.

“After ensuring that there are no safety concerns in these 100 trials, 1,500 people will be administered the (potential) vaccine across the country in the next phase and generation of antibodies will be observed,” Dr Lalwani said, adding that if results are positive, the vaccine is likely to be made available.