The Drugs Controller General Of India (DCGI) has directed that there should be no new recruitment for the Phase 2 and Phase 3 trials of the Oxford University’s Covishield vaccine candidate, being manufactured in India by the Serum Institute of India (SII) along with pharma major AstraZeneca.
The SII has also been asked to increase the safety monitoring of the subjects who have already been vaccinated as part of the trial and submit the plan and report.
The latest order comes after it asked SII to pause trials of the vaccine candidate following a U.K. volunteer showing potentially adverse symptoms.
In its order, DCGI V.G. Somani on Friday also directed the SII to submit clearance from Data and Safety Monitoring Board in the U.K. and obtain clearance from his office prior to resumption of future recruitment in the trial.
Prior to pausing the trials in India by the SII, the DCGI had issued a show-cause notice to the company on September 9 for not informing it about AstraZeneca pausing clinical trials of the vaccine candidate in other countries and also for not submitting casualty analysis of the “reported serious adverse events”.
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