Serum Institute of India suspends Covid vaccine trials

The Drugs Controller General of India (DCGI) has directed the Serum Institute of India (SII) to suspend new recruitment in phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate. This is after pharma company AstraZeneca paused trials in other countries.

DCGI head Dr VG Somani also directed SII to increase the safety monitoring of subjects already vaccinated as part of the trial.

DCGI had issued a show-cause notice to SII on 9 September for not informing it about AstraZeneca pausing clinical trials of the vaccine candidate in other countries. The Pune firm is partnering British-Swedish biopharmaceutical company AstraZeneca for manufacturing the Oxford vaccine candidate.

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 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.

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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”.