New Delhi: With pharma giant AstraZeneca pausing the Oxford COVID-19 vaccine candidate’s trials in other countries, the Serum Institute of India (SII) has been suspended by the Drugs Controller General of India (DCGI) for new recruitment in phase 2 and 3 clinical trials of the candidate till further orders.
According to news agency PTI, DCGI Dr VG Somani on Friday, in an order, also directed SII to step up the safety monitoring of the subjects already vaccinated in the trial process, and submit the plan and report.
Somani asked SII to submit Data and Safety Monitoring Board (DSMB) clearance both in the UK and India to get DCGI nod before it resumes future recruitment in the trial process.
It may be recalled that the central drug regulator had show caused SII on September 9 for not informing it about the pausing of the vaccine candidate’s clinical trials in other countries and for not submitting casualty analysis of the “reported serious adverse events”.
Following which the Pune-based firm declared on Thursday that it is pausing the clinical trials in India. “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.
SII, in its reply, said 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,” said the order.
“Increase the safety monitoring of the subjects already vaccinated with the vaccine under trial and submit the plan and report,” the order further added.
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