September 16, 2020: The Drugs Controller General of India (DCGI) has allowed Serum Institute of India (SII) to restart its phase two and three clinical trials for COVID-19 vaccine after the pharma major submitted the recommendations of the Data Safety Monitoring Board (DSMB), UK and DSMB India and requested permission to restart enrolment in the subject clinical trial of the vaccine being developed by AstraZeneca and Oxford University.
DCGI VG Somani, in a letter to SII, has said that the institute's reply has been "carefully examined" as also the recommendations of the DSMB in India and in UK.
"You (SII) may recommence the clinical trial dated August 2, 2020, as recommended by the DSMB, India as per already approved protocol and the provisions laid down under New Drugs and Clinical Trials Rules, 2019 subject to the conditions mentioned which are to be scrupulously followed such as extra care during screening, additional information in the informed consent and close monitoring for similar events during the study follow-up," the letter said.
The DCGI has also asked SII to submit the details of the medication used as per protocol for the management of the adverse events.
AstraZeneca had earlier paused the ongoing trial of nCoV19 coronavirus vaccine (recombinant) as a volunteer developed an unexplained illness. It was reported that the clinical trial had been put on hold in the US, UK, Brazil and South Africa.
Following this, the country's top drugs regulator had September 11 ordered the SII to suspend any new recruitment in phase 2 and 3 clinical trials for COVID-19 vaccine till further orders.
AstraZeneca has already resumed trials in the UK for the vaccine.
A government official said that Serum Institute of India submitted the recommendations of the DSMB, UK and DSMB India on September 15 and requested permission to restart enrolment in the subject clinical trial.
"The DSMB, UK recommended that investigators recommend all immunizations in their clinical trials subject to certain conditions. The DSMB, India recommended to continue the study and enroll the remaining participants in the clinical trial as per protocol subject to three conditions to the scrupulously followed," the official said.
These recommendations include revised participant information sheet, revised informed consent form (ICF) and additional safety monitory plans for the enrolled participants incorporating the latest SUSAR and indicating the specific contact numbers for participants for seeking assistants in case of any problem or question.
India's top drugs regulator had in August 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.
STORY HIGHLIGHTS
September 16, 2020: The Drugs Controller General of India (DCGI) has allowed Serum Institute of India (SII) to restart its phase two and three clinical trials for COVID-19 vaccine.
September 16, 2020: The Drugs Controller General of India (DCGI) has allowed Serum Institute of India (SII) to restart its phase two and three clinical trials for COVID-19 vaccine after the pharma major submitted the recommendations of the Data Safety Monitoring Board (DSMB), UK and DSMB India and requested permission to restart enrolment in the subject clinical trial of the vaccine being developed by AstraZeneca and Oxford University.
DCGI VG Somani, in a letter to SII, has said that the institute's reply has been "carefully examined" as also the recommendations of the DSMB in India and in UK.
"You (SII) may recommence the clinical trial dated August 2, 2020, as recommended by the DSMB, India as per already approved protocol and the provisions laid down under New Drugs and Clinical Trials Rules, 2019 subject to the conditions mentioned which are to be scrupulously followed such as extra care during screening, additional information in the informed consent and close monitoring for similar events during the study follow-up," the letter said.
The DCGI has also asked SII to submit the details of the medication used as per protocol for the management of the adverse events.
AstraZeneca had earlier paused the ongoing trial of nCoV19 coronavirus vaccine (recombinant) as a volunteer developed an unexplained illness. It was reported that the clinical trial had been put on hold in the US, UK, Brazil and South Africa.
Following this, the country's top drugs regulator had September 11 ordered the SII to suspend any new recruitment in phase 2 and 3 clinical trials for COVID-19 vaccine till further orders.
AstraZeneca has already resumed trials in the UK for the vaccine.
A government official said that Serum Institute of India submitted the recommendations of the DSMB, UK and DSMB India on September 15 and requested permission to restart enrolment in the subject clinical trial.
"The DSMB, UK recommended that investigators recommend all immunizations in their clinical trials subject to certain conditions. The DSMB, India recommended to continue the study and enroll the remaining participants in the clinical trial as per protocol subject to three conditions to the scrupulously followed," the official said.
These recommendations include revised participant information sheet, revised informed consent form (ICF) and additional safety monitory plans for the enrolled participants incorporating the latest SUSAR and indicating the specific contact numbers for participants for seeking assistants in case of any problem or question.
India's top drugs regulator had in August 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.