The Central Drugs Standard Control Organisation (CDSCO) has advised the Serum Institute of India (SII) to submit a revised protocol to perform the clinical trials for potential Oxford Covid-19 vaccine in India. The Subject Expert Committee evaluated the submitted protocol by SII and asked the Pune-based firm to revise its protocol for the phase 2 and 3 clinical trials, besides seeking some additional information.
On Wednesday evening, SII submitted a revised protocol for conducting the trials to the DCGI. Additional Director, Government Affairs, SII, Prakash Kumar Singh said, "We have submitted our revised protocol to DCGI office today evening for further action by SEC and DCGI."
"The company on Tuesday was asked to clearly define phase 2 and phase 3 part of the protocol and resubmit their application for evaluation by the SEC," an official source said. The panel also recommended that the proposed clinical trial sites be distributed across India, the source said.
Oxford's COVID-19 vaccine India trial: What we know so far:
Serum Institute partnered with AstraZeneca for manufacturing 'Covidshield'
The SII which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19 'Covidshield'.
How SII plans Phase 2, 3 trials of Oxford vaccine
The pharmaceutical company will perform an observer-blind, randomised controlled study enrolling at least 1,600 participants to determine the safety and immunogenicity of 'Covishield'. The Pune-based firm said that an around 1,600 participants of more than 18 years would be enrolled in the study. The firm plans to start the phase 2 and 3 human trials in India in August.
What will be the price of Covishield
Asked about the pricing of Oxfords's COVID-19 vaccine in India, 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 coronavirus vaccine would require two or more doses, like in the case of antidotes for measles and other diseases.
Last week, Oxford University announced the satisfactory progress with the vaccine, making it one of the leading ones among the dozens of vaccine candidates being developed around the world. The clinical trials of a potential COVID-19 vaccine on humans began in April.
-With Agency inputs