SII asked to submit approvals from DSMB India & UK to resume vax trial
New Delhi, Sep 12 (IANS) The Drug Controller General of India (DCGI) has directed the Serum Institute of India (SII) to submit approvals from Data Safety Monitoring Boards (DSMB) of India and the UK to the apex drug controller body before making further recruitment of volunteers for the Covid-19 vaccine trial.
Until then, any further recruitment for the trials is suspended, DCGI VG Somani stated.
The direction, issued late Friday has come a day after SII officially halted its ongoing trials in India after receiving a show-cause notice from the office of DCGI.
Earlier, Somani had issued a show-cause notice to the SII asking for an explanation as to why the institute decided to go ahead with the clinical trial of the Covid-19 vaccine candidate despite an advert incident that happened in the UK on Tuesday.
In the incident, one of the participants in the UK reported a suspected severe adverse reaction when administered a booster dose of the vaccine candidate.
After the incident, SII had stated that it would continue with the trials in India as-usual. However, DCGI took note of it and called out the Pune-based vaccine manufacturer as to why it decided to go ahead with the idea of continuing the trials while doubts about patient safety were yet unclear.
The DCGI had further asked the institute why the authority should not suspend the permission given to the SII for the clinical trials of Covishield. Later, the SII officially halted the trials on Thursday till it received approval from the DCGI.
However, IANS had earlier reported that the recruitment for trials by SII was already on-hold since last week as 100 participants, who were administered the first dose of the potential vaccine for Covid-19, were being analyzed by DSMB India.
SII is the manufacturing partner of the Covid-19 vaccine candidate named Covishield, developed jointly by the University of Oxford’s Jenner Institute’s and pharmaceutical giant AstraZeneca. The Pune-based firm is looking after the trails at 17 trial sites across India.
–IANS
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