India / Phase II human trial of Oxford coronavirus vaccine begins in Pune, 2 get first shot

Pune: The Phase II human clinical trial of the Oxford COVID-19 vaccine candidate, being manufactured by the Pune-based Serum Institute of India (SII), began at a medical college and hospital in the city today.

Two male volunteers were administered the vaccine at Bharti Vidyapeeth's Medical College and Hospital, a senior office-bearer of the hospital said. The trial began around 1 pm, he added.

"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," 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.

While the 32 year-old volunteer works for a private company, the other one is associated with the healthcare sector, he said.

"Before administering the vaccine, doctors checked their temperature, blood pressure and heart beats," he said.

Five volunteers had enrolled themselves for the trial after the doses were received from the Serum Institute of India on Tuesday, he added.

"The COVID-19 and antibodies tests were conducted on all the five volunteers. Of them, the reports of three volunteers'' antibodies test 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.

Serum Institute of India, the world's largest vaccine maker has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute of Oxford University in collaboration with British-Swedish pharma company AstraZeneca.

Dr Lalwani said vitals of the two volunteers were observed for half an hour after the vaccine jab.

"The volunteers are 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.

Dr Lalwani said 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," he said.

The phase-2 trial will be conducted on 100 volunteers at some sites across the country, he said.

"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.

Meanwhile, one of the volunteers said he was elated as he could become part of the fight against the coronavirus.

"Besides me, my wife and daughter have also enrolled for the trial. In fact, I and my daughter had volunteered during the clinical human trials of H1N1 vaccine," the 48-

year-old said.

Another volunteer, a 32-year-old man, echoed similar sentiments.

According to the Bharti Vidyapeeth's Medical College and Hospital, a total of 350 volunteers will be administered the potential vaccine.