The Drugs Controller General of India (DCGI) Dr VG Somani on Friday ordered the pharma giant Serum Institute of India (SII) to suspend any new recruitment in phase 2 and 3 clinical trials for COVID-19 vaccine till further orders.
This DCGI's orders come soon after Serum Institute submitted their reply to Dr Somani giving an explanation on the show cause notice issued to the drugmaker 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.
On 9 September ANI first reported that 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. 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.
"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," it read.
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: "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. The vaccine will be manufactured by Serum Institute in India under technical collaboration with Oxford University/AstraZeneca.
