DCGI directs Serum Institute to stop Phase 2, 3 trials of COVID vaccine

Orders institute to increase safety monitoring of subjects already vaccinated as part of the trial, and submit the plan and report

covid vaccine
AstraZeneca, the biopharmaceutical giant in a tie-up with the Oxford University to produce the vaccine, described the pause of trials as a "routine" one following what was "an unexplained illness". Photo: iStock

Soon after UK pharmaceutical company AstraZeneca paused the randomised trials of its COVID-19 vaccine candidate due to unexplained illness in one of the volunteers, the Drugs Controller General of India (DCGI) has now directed Serum Institute of India to suspend new recruitment in phase 2 and 3 clinical trials of the vaccine until further orders.

Serum Institute of India (SII) is conducting the human trials of the vaccine, jointly developed by AstraZeneca and Oxford University, in India.  In his order on Friday (September 11), DCGI Dr VG Somani also directed SII to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report. Somani also asked the firm to submit clearance from Data and Safety Monitoring Board (DSMB) in the UK as well as in India to obtain clearance from his office (DCGI) prior to resumption of future recruitment in the trial.

The decision to pause trials of the COVID vaccine candidate by the Pune-based institute was taken after the drug regulator on September 9 issued it a show-cause notice for not informing it about the pausing of the trials by AstraZeneca in other countries and not submitting casualty analysis of the “reported serious adverse events”.

Earlier this week, AstraZeneca said it had paused the trials because of an unexplained illness in a participant in the study.  “We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials,” SII said in a statement on Thursday.

Related news: AstraZeneca halts human trials of COVID vaccine after volunteer takes ill

According to the DCGI’s order issued on Friday, the SII in its reply 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.  In its reply, SII also stated that DSMB further 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 concerns”.

“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 DSMB in India, in 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 the phase 2 and 3 clinical trial till further orders,” the order read.

“Increase the safety monitoring of the subjects already vaccinated with the vaccine under trial and submit the plan and report,” the order further stated.

On August 2, the DCGI had granted permission to the Pune-based SII to conduct Phase 2 and 3 human clinical trials of the coronavirus vaccine candidate. AstraZeneca, the biopharmaceutical giant in a tie-up with the Oxford University to produce the vaccine, described the pause of trials as a “routine” one following what was “an unexplained illness”.

 

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