Serums vaccine trials to restart with added riders

PUNE: Advanced human trials of the Oxford vaccine candidate have resumed in the country after the Drug Controller General of India gave an all-clear to Serum Institute of India to restart the process.
The SII is partnering with Oxford University to manufacture the vaccine called Covishield in India. Specialists at 17 trial sites in the country will now start phase 3 of the trials, which is set to test the vaccine on a large number of volunteers.
The trials were paused on September 11 soon after a volunteer at a trial site in the UK developed an adverse reaction. But the DCGI has applied certain conditions, such as additional precautions during screening, additional information to volunteers while seeking informed consent, and close monitoring for adverse events during followups. The top drug regulator said the SII will have to follow these fresh directives “scrupulously”. Adar Poonawalla, owner and CEO of SII, said DCGIs go-ahead will put the process “back on track”. “The trials have no safety issue and thats why the DCGI allowed us to restRead More – Source

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