Pune, August 4:
The Drugs Controller General India (DCGI) has given nod to the Pune based Serum Institute of India (SII) for conducting phase II and III human clinical trials COVISHIELD, which it is developing in collaboration with Oxford University and AstraZeneca,
”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,” stated the Union Health Ministry in a tweet on Monday.
The Subject Expert Committee (SEC) for Covid-19 related therapies had recommended various amendments to SII’s earlier proposal to conduct the trials. Following these recommendations, the SII amended its proposal and resubmitted it for consideration on Wednesday last.
The SEC, which had reconvened on Friday to evaluate the revised proposal, recommended that Central Drugs Control Standard Organisation (CDCSO) grant permission for SII to conduct phase II/III human clinical trials. DCGI Dr V.G Somani then studied the recommendations and approved the proposal.
The committee has also suggested that the authorisation to market the vaccine, which SII has titled as “Covishield”, be granted after considering clinical data generated both from the India trials and its international trials. In the amended proposal SII expanded the number of trial sites it is looking at, to around 20 facilities across India.
Now that the chief of the Central Drugs Standard Control Organisation has signed off on the proposal, as confirmed by the Union health ministry, SII will be able to kick-off the trials in India, effectively putting it ahead in India’s own race for a Covid-19 vaccine.
SII has a tie-up with Swedish-British firm “Astra Zeneca” which developed the vaccine along with The University of Oxford, to manufacture this vaccine for low- and middle-income countries. Under phase II and II, the SII will be conducting human trials of Oxford vaccine in 1,600 healthy volunteers in India. Two dosages of “Covishield” will be administered to volunteers till four weeks.
The human clinical trials of phase I and II have already began in South Africa. Whereas in UK, the human clinical trials under phase II and III have started. Similarly in Brazil the human clinical trials under phase III have began.
The SII, has decided to conduct clinical trials on 4,000 to 5,000 people in Pune and Mumbai by the end of this month. A number of trial sites across both Mumbai and Pune have been shortlisted, as these cities have many hotspots, which will help us understand the efficacy of the vaccine, SII chief executive Adar Poonawalla said.
Poonawalla said the company aims to manufacture 300 million to 400 million doses by the year-end, following the success of initial and licensure trials. As part of the agreement with “AstraZeneca”, SII can manufacture 1 billion doses for India and nearly 70 low and middle income countries. There are no challenges in the manufacturing of the vaccine doses and the company will be starting by making 60-70 million doses per day.