Vaccine-maker Serum Institute of India has said that it will follow the Drug Controller General of India’s (DCGI) instructions and abide by the safety protocol.
SII was responding to a show-cause notice from the DCGI, following the pause in global trials on the Covid-19 vaccine candidate from the AstraZeneca-Oxford University combine. SII has a production and supply alliance on this vaccine that is presently undergoing late-stage Phase II/III trials in India.
Regarding the show-cause notice issued by the DCGI, SII said in a late response on Wednesday, “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.”
The DCGI showcause said the company had not informed the Central licensing authority on the clinical trial being paused by AstraZeneca in other countries and it had “not submitted casualty analysis of the reported serious adverse event with the investigational vaccine”. The company has been asked to respond “immediately”.
AstraZeneca had “paused” late-stage clinical trials on the AZ-Oxford University Covid-19 vaccine candidate due to a “potentially unexplained illness” in one participant in the UK. But clarity is awaited on the nature of the adverse event and whether it was linked to the vaccine.
Besides UK, the US, Brazil, South Africa and India are participating in the Phase II/III trials. And the timeline to restart the trial, if indeed it is just a pause, is critical as the number of coronavirus cases increase every day.