The Central Drugs Standard Control Organization (CDSCO) has advised the Serum Institute of India (SII) to submit a revised protocol in order to perform clinical trials for potential Oxford vaccine candidate. The protocol submitted by SII was evaluated by the Subject Expert Committee. The Pune- based firm will be revising protocols for phase 2 and phase 3 clinical trials.
On Wednesday evening, SII submitted a protocol for conducting the trials to DCGI. Prakash Kumar Singh said, Additional Director, Government Affairs, “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,"Livemint cited an official source. The panel has recommended that the clinical trials should be held in different parts across the country.
SII is in partnership AstraZeneca for manufacturing the Oxford vaccine. "It is too early to comment on the vaccine’s price. However, we will keep it under ₹1,000 per dose,” Adar Poonawalla, the CEO of the company said.
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