India / Serum Institute allowed to resume trial of Oxford's COVID-19 vaccine

The Drugs Controller General of India (DCGI) has given permission to Serum Institute of India to resume clinical trial of the Oxford COVID-19 vaccine candidate in the country. The DCGI revoked its earlier order suspending any new recruitment for the Phase 2 and 3 trial. The trial was temporarily paused after a participant in the UK developed an "unexplained illness".

Deccan Herald : Sep 16, 2020, 11:37 AM

Pune: The Drugs Controller General of India's (DCGI) Dr V G Somani has given permission to Serum Institute of India (SII) to resume clinical trial of the Oxford Covid-19 vaccine candidate in the country while revoking its earlier order of suspending any new recruitment for phase two and three trials, according to PTI.

On September 12, Serum Institute of India had said that it would resume clinical trials of AstraZeneca's Covid-19 vaccine candidate after getting the permission from the Drugs Controller General of India (DCGI).

Pharma giant AstraZeneca had on Saturday said that clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that the trials were safe.

Following the suspension of AstraZeneca's Covid-19 vaccine candidate trials, the DCGI had directed Serum Institute of India to suspend till further orders new recruitment in phase 2 and 3 clinical trials of the vaccine candidate.