The Drugs Controller General of India (DCGI) has directed the Serum Institute of India to suspend till further orders new recruitment in phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate in the backdrop of pharma giant AstraZeneca pausing the trials in other countries. In order, a copy of, DCGI Dr. VG Somani on Friday also directed the 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.
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 central drug regulator DCGI had issued a show-cause notice to SII on September 9 for not informing it about AstraZeneca pausing clinical trials of the vaccine candidate in other countries and also for not submitting casualty analysis of the “reported serious adverse events”.
Following which the Pune-based firm, which has partnered with the British-Swedish biopharmaceutical giant AstraZeneca for manufacturing the Oxford vaccine candidate, on Thursday said it is pausing the clinical trials in India.
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.
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 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,” 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”.