Phase 3 human clinical trial of Oxford vaccine begins in Pune
Pune, Sep 17 (PTI): The phase-III human clinical trial of the Covid-19 vaccine being developed by Oxford University, and manufactured by the Serum Institute of India (SII), began at the state-run Sassoon General Hospital here in Maharashtra on Monday, a senior official said.
“We have started the phase-III trials of the vaccine (candidate Covishield). We will administer dose to 150 to 200 volunteers,” said Dr. Muralidhar Tambe, Dean, Sassoon General Hospital.
Under phase-II, trials had been conducted at the Bharti Vidyapeeth Medical College and also KEM Hospital in the city.
The SII has partnered with British-Swedish pharma company AstraZeneca for manufacturing the Covid-19 vaccine candidate, being developed by the University of Oxford.
Earlier this month, the SII had paused the clinical trials of the vaccine candidate in the country.
The Drugs Controller General of India (DCGI) had on September 11 directed the SII to suspend any new recruitment in the phase-II and III clinical trial of the vaccine till further orders after AstraZeneca paused the trials in other countries because of “an unexplained illness” in a participant in the study.
However, on September 15, the DCGI gave permission to the SII to resume clinical trial of the vaccine.