Covid Vaccine: India moves an inch closer to get the vaccine for coronavirus as India’s apex drug regulatory body has granted approvals to Serum Institute of India to conduct late-stage human trials for the Oxford Covid-19 vaccine candidate in India.
Serum Institute has been given DCGI nod to conduct human trials of Oxford’s coronavirus vaccine after it was asked by an expert committee to resubmit a revised protocol of carrying the clinical trials of the vaccine. The DCGI’s nod will now hasten the development of the coronavirus vaccine.
Drugs Controller General of India has given approval to Serum Institute of India, Pune to conduct Phase II+III clinical trials of Oxford University-Astra Zeneca #COVID19 vaccine (COVISHIELD) in India.@PMOIndia @drharshvardhan @AshwiniKChoubey @UniofOxford
— Ministry of Health (@MoHFW_INDIA) August 3, 2020
SII has a tie-up with Swedish-British firm AstraZeneca, which developed the vaccine along with The University of Oxford, to manufacture this vaccine for low- and middle-income countries.
Observer Blind Trials
According to the revised protocol, the SII will conduct trials on 1600 people aged above 18 across 17 selected sites which includes AIIMS Delhi, BJ Medical College, Pune, RMRIMS Patna, AIIMS Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Vishakhapatnam, Graduate Institute of Medical Education and research in Chandigarh and JSS Academy of Higher Education and Research In Mysuru.
The pharmaceutical company will perform an observer-blind, randomized controlled study to determine the safety and immunogenicity of ‘Covishield’.
About the pricing of Oxford’s COVID-19 vaccine in India, Adar Poonawalla said, “It is too early to comment on the vaccine’s price. However, we will keep it under ₹1,000 per dose.”
He further added it is extremely likely that the COVID-19 vaccine would require two or more doses, like in the case of antidotes for measles and other diseases.
“I don’t think any citizen of India or of any other country is going to have to pay for it because it is going to be bought by the government and distributed free,” Poonawalla said. They expect the vaccine to reach the people of India in large numbers by the first quarter of 2021, he added.