Serum Institute To Pause Vaccine Trials In India After Drug Controller’s Notice

Serum Institute of India, which is manufacturing the coronavirus vaccine Covishield being developed by the Oxford University along with pharma major AstraZenca, today said it will stop the Phrase 3 trials that were to begin in India next week. The vaccine trial was stopped across four nations as a precautionary measure after one of the recipients in the UK showed some potentially adverse symptoms.

The Serum Institute was issued a showcause by the country’s drug controller DCGI yesterday, where it was questioned why it was continuing the trials in India even though it has been stopped elsewhere.

“We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials,” read a statement from the Serum Institute, which was still doing the groundwork for the trial including listing volunteers.

“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,” added the statement released today by the institute headed by Adar Poonawalla.

AstraZeneca, the British-Swedish pharma giant, had said the volunteer had suffered “an unexplained illness” and such pauses in drug trials are “routine”.

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