Phase 2 trials of Oxford coronavirus vaccine, being manufactured by Serum Institute of India (SII), have begun in India. The clinical trials began at Pune's Bharti Vidyapeeth's Medical College and Hospital where two male volunteers were administered the vaccine.
"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 told PTI. The vaccine was also given to another 48-year-old male volunteer, Lalwani added.
"Before administering the vaccine, doctors checked their temperature, blood pressure and heartbeats," he said. Five volunteers had enrolled themselves for the trial after doses were received from the SII on Tuesday, he added.
"The COVID-19 and antibodies tests were conducted on all the five volunteers. Of them, reports of three volunteers' antibodies test came out positive. So they became ineligible for the trial," Lalwani said.
As a rapid regulatory response, the Drugs Controller General of India (DCGI) on August 3 had given nod to the SII for conducting phase 2 and 3 human clinical trials of the Oxford coronavirus vaccine candidate in the country.
SII has partnered with British-Swedish pharma company AstraZeneca for manufacturing the Covid-19 vaccine candidate, developed by the University of Oxford. Initial results of the first two-phases of trials of the vaccine conducted in five trial sites in the UK reportedly showed it has an acceptable safety profile and homologous boosting increased antibody responses.