Serum Institute confirms pausing COVID vaccine trials after DCGI notice
New Delhi | Jagran News Desk: The Serum Institute of India (SII) confirmed on Thursday it has halted the Indian trials of the Oxford University's ‘Covishield’ vaccine after the Drugs Controller General of India (DCGI) issued a show-cause notice to the institute.
The notice had been issued after trials for the vaccine were stopped in four nations as a precautionary measure when one of the recipients in the United Kingdom showed some adverse symptoms.
“We are reviewing situation & pausing India trials till AstraZeneca restarts trials. We are following DCGI's instructions and will not be able to comment further on trials. You can connect with DCGI for more updates on this front.” the SII tweeted.
We are reviewing the situation and pausing India trials till @AstraZeneca restarts them. We are following DCGI's instructions and will not be able to comment further on the same. You can connect with DCGI for more updates on this front.#SII #Latestnews #Covid_19 pic.twitter.com/CUeFY5oLus
— SerumInstituteIndia (@SerumInstIndia) September 10, 2020
Pune-based Serum Institute of India (SII) has partnered with AstraZeneca and Oxford University to manufacture their experimental COVID-19 vaccine. The Phase I and Phase II trails of the vaccine in India have completed and the institute was scheduled to begin the Phase III trials from the next week.
The DCGI’s show-cause notice came in the backdrop of AstraZeneca halting the human trials of the Oxford University’s coronavirus vaccine candidate after a volunteer from the UK had an adverse reaction to it and developed an unexplained illness. AstraZeneca has said that it is investigating whether a recipient's "potentially unexplained" illness is a side effect of the shot. The company, however, did not reveal the location of the volunteer or the nature and the severity of the illness developed in the volunteer.
Posted By: Lakshay Raja