The Drug Controller General of India (DCGI) has asked the Serum Institute of India (SII) to submit approvals from Data Safety Monitoring Boards (DSMB) of India and the UK to resume the COVID19 vaccine trial.
The apex drug controller body directed SII that the firm must submit the approvals before making further recruitment of volunteers for the trial of the vaccine.
Until then, any further recruitment for the trials is suspended, DCGI VG Somani said.
The direction, which was issued on Friday, comes a day after SII officially halted its ongoing trials in India after receiving a show-cause notice from the office of the Drug Controller General of India.
Somani, earlier, issued a show-cause notice to the Serum Institute of India asking for an explanation as to why the institute decided to go ahead with the clinical trial of the COVID19 vaccine candidate despite an advert incident that took place in the UK on Tuesday.
In the incident that happened on Tuesday, one of the participants in the UK, reported a suspected severe adverse reaction when administered a booster dose of the COVID19 vaccine candidate.
With the patient in the UK showing serious adverse reactions during the trial, AstraZeneca, which jointly developed the COVID19 vaccine along with Oxford University, has now temporarily stopped the clinical trials of the Covishield vaccine in 4 nations as a precautionary measure.
The Pune-based vaccine manufacturer said it is pausing the trials of the Covishield vaccine in India till AstraZeneca restarts them.