AstraZeneca trials only after review by UK’s Drug and Safety Monitoring Board: Serum Institute

Serum Institute of India (SII) on Thursday informed India’s drug regulator that it will restart the trials only after a review by UK’s Drug and Safety Monitoring Board (DSMB). It said that the DSMB is reviewing the data and will provide its recommendations, as it halted the trial of the AstraZeneca-Oxford University Covid vaccine in the country.
The decision to put the trials on hold was taken by the members of the DSMB after they were informed about the serious adverse events reported in Phase II/III trials in UK.

“The subject has been diagnosed with neurological disorder,” it has informed the the Drug controller General Of India (DCGI).

It has told the drug regulatory that they would restart the recruitment of the Indian phase II/III study following the outcome of the DSMB meeting. Till that time trial has been put on hold.

We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's (Drug Controller General of India)instructions and will not be able to comment further on trials", said Serum Institute of India CEO Adar Poonawala in a statemen

The company had received a showcause notice on Wednesday from the DCGI for not informing it about the adverse event that was reported in the global trial and which had resulted in AstraZeneca suspending the trials. THe company stopped the trials after a volunteer developed an unexpained illness.

The Pune based company, which has tied up with AstraZeneca to manufacture the University of Oxford’s vaccine candidate for Covid-19, would have begun Phase 2 trials last week with the recruitment of 1,600 participants across the country.