Serum Institute asked to revise protocol for Covid-19 vaccin
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A CDSCO expert panel has sought clarifications from Serum Institute of India (SII) over its application to the Drugs Controller General of India (DCGI) seeking permission for conducting phase 2 and 3 human clinical trials of the Oxford vaccine candidate for COVID-19, official sources said on 29 July.

28 July: The Subject Expert Committee (SEC) asked the Pune-based firm to revise its protocol for phase 2 and 3 clinical trials.

29 July: SII submitted a revised protocol for conducting the trials to the DCGI.

"The company 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.

"They also have not given justification for the proposed enrolment of 1,600 subjects during the trial," the source added.

Source: https://www.timesnownews.com/health/article/dcgi-asks-serum-institute-of-india-to-revise-protocol-for-phase-23-trials-of-oxford-covid-19-vaccine/629269
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