Serum Institute instructed to pause COVID vaccine trial recruitment

New recruitment for the Phase 2 and Phase 3 trials of the Oxford University's Covishield vaccine being manufactured in India by the Serum Institute of India, along with pharma major AstraZeneca, has to be suspended till further orders, country's drug controller DCGI has informed.

On Thursday, the Serum Institute, headed by Adar Poonawalla, said it would pause Phase 3 trials that were to begin in India next week after AstraZeneca stopped vaccine trials across four nations as a precautionary measure. The pausing of trials by the pharma giant was linked to a UK volunteer showing potentially adverse symptoms.

DCGI issued a show-cause notice to Serum Institute for not pausing the ongoing clinical trial of the COVID-19 vaccine. The apex drug controller issued a show-cause notice after AstraZeneca, which is developing the vaccine candidate against COVID-19 with researchers of Oxford University, paused its trial as a volunteer developed an unexplained illness.

Also Read: ‘Corona is gone, lockdown imposed to block rallies’: Bengal BJP leader

The clinical trial has been put on hold across countries where it was being conducted -- USA, UK, Brazil and South Africa.In an order issued on Friday, a copy of which is with ANI, the drugs regulator has said: "In the view of the above, I Dr V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the Data and Safety Monitoring Board (DSMB) in India, in the exercise of the powers vested under Rule 30 of the New Drugs and Clinical Trials Rules, 2019, direct to you suspend any new recruitment in phase 2 and 3 clinical trials till further orders."

"Increase the safety monitoring of the subjects already vaccinated with the vaccine under trial and submit the plan and report. Submit clearance from DSMB, UK and DSMB, India to obtain clearance from this office prior to the resumption of future recruitment in the trial," read the order.

The country`s apex drugs regulator had on August 2 granted permission to SII to conduct a phase II/III clinical trial of ChAdOx1 nCoV-19 coronavirus vaccine (recombinant) at various clinical trial sites in the country to determine its safety and immunogenicity.

Readers like you make Inside Northeast’s work possible

To support our brand of fearless and investigative journalism, support us HERE.

Download:                                                                       

The Inside Northeast app HERE for News, Views, and Reviews from Northeast India.

Do keep following us for news on-the-go. We deliver the Northeast.