Vaccine-maker Serum Institute of India said on Thursday that they are "pausing" India-trials on the Covid-19 vaccine candidate from the AstraZeneca-Oxford University combine.
"We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials," a note from the company said.
The development comes a day after AstraZeneca said it had "paused" late-stage clinical trials on the AZ-Oxford University vaccine candidate due to a "potentially unexplained illness" in one participant in the United Kingdom. Serum Institute has a production and supply alliance on this vaccine that was presently undergoing late-stage Phase II/III trials in India.
In fact, Serum Institute had on Wednesday said that it was continuing with the trail, as they had not found any issue here.
But given that AstraZeneca had stopped its trials in other countries as well, the Drug Controller General of India sent Serum Institute a show-cause notice. The notice said that the Central licensing authority had not been informed about the clinical trial being paused by AstraZeneca in other countries and the company had "not submitted casualty analysis of the reported serious adverse event with the investigational vaccine". Serum was asked to respond "immediately".
Later at night, the company clarified, they were going by the DCGI's directions. "If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols," a note from the company said.
Greater clarity is awaited from AstraZeneca and the Oxford University on the nature of the adverse event and whether it was linked to the vaccine. Besides the UK, the US, Brazil, South Africa and India were participating in 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.