NEW DELHI: The Controller General of Medicines of India (DCGI) has directed the Serum Institute of India to suspend until new hires are ordered in the phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate in the context of the pharmaceutical giant AstraZeneca stopping trials in other countries.
In an order, a copy of which has been accessed by PTI, DCGI Dr. VG Somani on Friday also directed the Serum Institute of India (SII) to increase safety monitoring of already vaccinated subjects as part of the trial, and to present the plan and report.
Somani also asked the company to submit clearance from the Data and Security Monitoring Board (DSMB) in the UK and India to obtain clearance from their office (DCGI) before resuming future recruitment in the trial.
Central drug regulator DCGI had issued a show of cause notice to IBS on September 9 for failing to inform it that AstraZeneca has paused clinical trials of the candidate vaccine in other countries and also for failing to submit a victim analysis of “adverse events. serious reported “.
After which the Pune-based firm, which partnered with British-Swedish biopharmaceutical giant AstraZeneca to make the Oxford vaccine candidate, said on Thursday that it is pausing clinical trials in India.
Earlier this week, AstraZeneca said it had stopped the trials due to “unexplained illness” in a study participant.
“We are reviewing the situation and stopping the trials in India until AstraZeneca restarts the trials,” the SII said in a statement Thursday.
According to the DCGI order issued on Friday, the IBS in its response stated that DSMB has not noticed any safety concerns from the Indian study (part 1-phase-2 study) with the first dose and seven days after the data of vaccination safety.
In its response, the SII also stated that DSMB further recommended “stopping enrollment in the study until the ongoing SAE investigations reported in the UK study are completed and the sponsor and UK DSMB are satisfied that no Raises no security concerns. ” .
“In view of the above, I, Dr. VG Somani, Indian Drug Controller General, Central Licensing Authority, after careful examination of your response and the DSMB’s recommendations in India, in exercise of the powers conferred per Rule 30 of the New Rules on drugs and clinical trials, 2019, directly to you suspend any new recruitment in the phase 2 and 3 clinical trial until further orders, “said the order.
“Increase the security control of subjects already vaccinated with the test vaccine and present the plan and the report,” the order also stated.
On August 2, the DCGI had granted permission to the Pune-based IBS to conduct phase 2 and 3 human clinical trials of the coronavirus vaccine candidate.
AstraZeneca, the biopharmaceutical giant in partnership with the University of Oxford to produce the vaccine, described the pause in trials as “routine” after what was “an unexplained illness.”
In an order, a copy of which has been accessed by PTI, DCGI Dr. VG Somani on Friday also directed the Serum Institute of India (SII) to increase safety monitoring of already vaccinated subjects as part of the trial, and to present the plan and report.
Somani also asked the company to submit clearance from the Data and Security Monitoring Board (DSMB) in the UK and India to obtain clearance from their office (DCGI) before resuming future recruitment in the trial.
Central drug regulator DCGI had issued a show of cause notice to IBS on September 9 for failing to inform it that AstraZeneca has paused clinical trials of the candidate vaccine in other countries and also for failing to submit a victim analysis of “adverse events. serious reported “.
After which the Pune-based firm, which partnered with British-Swedish biopharmaceutical giant AstraZeneca to make the Oxford vaccine candidate, said on Thursday that it is pausing clinical trials in India.
Earlier this week, AstraZeneca said it had stopped the trials due to “unexplained illness” in a study participant.
“We are reviewing the situation and stopping the trials in India until AstraZeneca restarts the trials,” the SII said in a statement Thursday.
According to the DCGI order issued on Friday, the IBS in its response stated that DSMB has not noticed any safety concerns from the Indian study (part 1-phase-2 study) with the first dose and seven days after the data of vaccination safety.
In its response, the SII also stated that DSMB further recommended “stopping enrollment in the study until the ongoing SAE investigations reported in the UK study are completed and the sponsor and UK DSMB are satisfied that no Raises no security concerns. ” .
“In view of the above, I, Dr. VG Somani, Indian Drug Controller General, Central Licensing Authority, after careful examination of your response and the DSMB’s recommendations in India, in exercise of the powers conferred per Rule 30 of the New Rules on drugs and clinical trials, 2019, directly to you suspend any new recruitment in the phase 2 and 3 clinical trial until further orders, “said the order.
“Increase the security control of subjects already vaccinated with the test vaccine and present the plan and the report,” the order also stated.
On August 2, the DCGI had granted permission to the Pune-based IBS to conduct phase 2 and 3 human clinical trials of the coronavirus vaccine candidate.
AstraZeneca, the biopharmaceutical giant in partnership with the University of Oxford to produce the vaccine, described the pause in trials as “routine” after what was “an unexplained illness.”
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