COVID-19 Vaccine Update: Serum Institute Pauses Coronavirus Vaccine Trails Till Further Orders From DCGI, Say Reports
The Serum Institute of India has paused COVID-19 vaccine trials being conducted across 17 different sites till further instructions from the Drug Controller General of India (DCGI), according to a Business Today report.In.
Pune, September 10: The Serum Institute of India has paused COVID-19 vaccine trials being conducted across 17 different sites till further instructions from the Drug Controller General of India (DCGI), according to a Business Today report.In. According to a CNBC alert, the company informed that they will restart the trials, once the AstraZeneca decides to restart. Serum further mentioned that there have been no issues with trials in India, but it is a precautionary measure.
The decision was reportedly taken after the country's drug regulator asked Serum Institute to explain why it was not informed about AstraZeneca Plc pausing the clinical trial of the Oxford coronavirus vaccine candidate in other countries, and also for not submitting casualty analysis of the "reported serious adverse events". COVID-19 Vaccine Update: DCGI Sends Show Cause Notice to Serum Institute of India for Not Pausing Trial of Covishield.
COVID-19 Vaccine Trials halted in India as Precaution:
On Wednesday, DCGI sought an immediate explanation, failing which “action deemed fit will be taken against you". In response, Serum Institute of India replied: “We are going by DCGI’s direction, and so far we’re not told to pause trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols."
UK pharmaceutical company AstraZeneca on Tuesday informed that it had "voluntarily paused" a randomised clinical trial of its coronavirus vaccine. The study was paused after a volunteer developed an unexplained illness. AstraZeneca, which is developing the vaccine alongside Oxford University, called it a ‘routine pause’ in the case of ‘an unexplained illness’.
(The above story first appeared on LatestLY on Sep 10, 2020 02:56 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).