Mon 03 August 2020:
Coronavirus cases cross 1.8M mark in India on Monday, over 50,000 new cases reported in last 24 hours
NEW DELHI – India’s drug controller body granted permission to a local firm for conducting clinical human trials of COVID-19 vaccine developed by Oxford University, an authority announced on Monday.
Government officials told PTI that the approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI Dr V G Somani late Sunday night after a thorough evaluation based on the recommendations of the Subject Expert Committee on COVID-19.
“As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals,” the official said.
Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.
The officials said that the SII had submitted a revised proposal on Wednesday after the expert panel on Tuesday, following deliberation over its application, had asked it to revise its protocol for the phase 2 and 3 clinical trials besides seeking some additional information.
The panel has also recommended that the clinical trial sites which have been proposed for the study be distributed across India.
The Drug Controller General of India approved the apply of Serum Institute of India for the phase two and three trials of vaccine, known as ChAdOx1 nCoV-19 or AZD1222, in India as the “trials have shown promising results.”
“Drugs Controller General of India has given approval to Serum Institute of India, Pune to conduct Phase II+III clinical trials of Oxford University-AstraZeneca #COVID19 vaccine (COVISHIELD) in India,” the Health Ministry said on Twitter.
Adar Poonawalla, CEO of the firm, had said that as they were given permission, the trials for the vaccine in India would begin.
He said his company was one of nine companies across the globe which has collaborated with the UK-based AstraZeneca biopharmaceutical company, a co-developer of the Oxford vaccine.
Monday’s development came at a time when the coronavirus infections crossed 1.8 million in India, with the country reporting over 50,000 new cases in the last 24 hours.
