Chennai: Serum Institute of India (SII) has announced pausing clinical trials of AstraZeneca Oxford COVID-19 vaccine candidate in the country.
Earlier this week, 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 release.
It is following instructions of the Drugs Controller General of India (DCGI), it added.
DGCI has issued a notice to the Serum Institute of India, which is manufacturing the Oxford University’s Covishield vaccine and will hold the phase 3 clinical trials in India from next week.
Drugs Controller General of India Dr V G Somani asked SII why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country should not be suspended till patient safety is established. Serum Institute of India said it is following all safety protocols.
In a statement, it said, “We are going by DCGI’s direction and so far were not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols.”