New Delhi | Jagran News Desk: In the backdrop of AstraZeneca pausing their COVID-19 vaccine candidate’s trials, the Drug Controller General of India (DCGI) on Friday ordered the Serum Institute of India (SII) -- manufacturing the Oxford’s COVISHIELD vaccine -- to suspend any new recruitment in phase 2 and phase 3 clinical trials for the vaccine till further orders.  

The DCGI also directed Serum Institute of India (SII) to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.

In an order issued on Friday, 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", read the order by DCGI, as reported by news agency ANI.

"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," the order added.

This DCGI's orders came days after the SII submitted its reply to the drug controller giving an explanation on the show cause notice issued to them as to why they did not halt the ongoing clinical trial of the ChAdOx1 nCoV-19 coronavirus vaccine candidate till doubts about patient safety are cleared.

"You (SII) have submitted your reply to the show cause notice vide your letter dated September 10. In your reply you have stated that DSMB has noted no safety concerns from the Indian study (part 1-phase-2 study) with the first dose and seven days post-vaccination safety data," the order further reads.

The DCGI earlier this week issued a show-cause notice to SII after AstraZeneca halted its trial as a volunteer developed an unexplained illness, across countries -- USA, UK, Brazil and South Africa -- where it was being conducted.

Further DSMB recommended 'to pause further enrolment into the study until ongoing investigations of SAE reported in the UK study is completed and the sponsor and the UK DSMB are satisfied that it doesn't pose any safety concern, stated DCGI's order.

On Thursday, Serum Institute of India issued a statement and said, "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions."

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.

 

 

(With ANI Inputs)

Posted By: Talib Khan