The Serum Institute of India (SII) on Thursday said that it was pausing the COVID-19 vaccine trials in the country– a day after the firm was issued a show-cause notice by the Drugs Controller General of India (DGCI).
In its notice, the DGCI VG Somani questioned SII about the reason of still proceeding with the trials of Oxford University’s Covishield vaccine after one of the volunteers who got a shot of the experimental vaccine in the UK showed some adverse reactions.
With the patient in the UK showing serious adverse reactions during the trial phase, AstraZeneca, which jointly developed the COVID-19 vaccine along with Oxford University, has now temporarily stopped the clinical trials of the Covishield vaccine in four nations as a precautionary measure.
The Pune-based vaccine manufacturer said that it is pausing the trials of the Covishield vaccine in India till AstraZeneca restarts them.
“We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following Drug Controller General of India’s (DGCI) instructions and will not be able to comment further on trials,”?SII said.
On Wednesday, the phase three trials of AstraZeneca were stopped in the UK and the pharma firm said it has halted global trials, including large late-stage trials, of its experimental coronavirus vaccine due to an unexplained illness in a study participant.
“We voluntarily paused vaccination to allow a review of safety data by an independent committee,” AstraZeneca said in a statement.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” the statement added.
