Day After Show Cause Notice, Serum Institute Says Pausing COVID-19 Vaccine Trials In India

 - Sakshi Post

Serum Institute of India (SII) which is manufacturing the coronavirus vaccine said that it is pausing clinical trials of AstraZeneca Oxford COVID-19 vaccine candidate in the country. Earlier this week, AstraZeneca said it stopped the vaccine trials because of an unexplained illness in a volunteer in the study.

The Serum Institute, headed by Adar Poonawala was issued a show cause notice by the country's drug controller DCGI for not informing it about AstraZeneca pausing the clinical trials of the Oxford vaccine candidate in other countries. SII said in a statement, "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials."

The Pune-based vaccine maker also said that it is following instructions of the Drugs Controller General of India (DCGI). In the show cause notice, DCGI V G Somani had asked SII as to why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country be not suspended till patient safety is established.

After the DCGI notice, the Serum Institute had said that, "We are going by DCGI's direction and so far we're not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols."

Former Union minister Jairam Ramesh had tweeted, "I was horrified to read last night that Serum Institute said it was continuing with its vaccine trials. I immediately got in touch with senior govt officials and am glad the Drug Controller has since issued show-cause notice. Safety standards ARE and MUST be the same world over."

Many firms in the world are working hard to develop the coronavirus vaccine. India is the world's second most affected nation with coronavirus. The country's COVID-19 tally rose to more than 44 lakh.

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