InvestorQ : When is Serum Institute going to resume its COVID trials for the vaccine?
manisha Kolvenkar made post

When is Serum Institute going to resume its COVID trials for the vaccine?

Crowny Pinto answered.
2 years ago

In fact, the Drug Controller General of India or DCGI has already allowed the Cyrus Poonawala group’s Serum Institute to resume trials of the AstraZeneca-Oxford vaccine candidate, Covishield. It has revoked its earlier order suspending new test recruitments.

The Serum institute, which is licensed by Astra Zeneca to test and manufacture the vaccine in India has submitted recommendations of the Data Safety Monitoring Board or DSMB, UK, and DSMB, India. Based on these submissions they were allowed to restart.

The regulator has instructed Serum Institute to suspend volunteer recruitments for phase two and three clinical trials of after AstraZeneca reported a case of illness by a patient on being administered this drug. The DCGI is happy with the responses given by Serum.

It may be recollected that earlier, UK based AstraZeneca had already resumed clinical trials in the UK last weekend. The MHRA of UK has already dubbed the process as safe. This allows Serum to start trials on the Astra / Oxford Research vaccine candidate.

After the global trials of the vaccine candidate were put on hold by Astra Zeneca due to an unexplained neurological illness, the DCGI had issued show-cause notice to Serum Institute. They were asked to explain trials should not be suspended. With the latest DCGI order, Serum Institute can commence trials all over again.