Covid-19: Serum gets DCGI nod to restart vaccine trials

Serum is partnering AstraZeneca to carry out trials and manufacture the Oxford University's Covid-19 vaccine doses in India.Serum is partnering AstraZeneca to carry out trials and manufacture the Oxford University’s Covid-19 vaccine doses in India.

The Drugs Controller General of India (DCGI) has granted permission to the Serum Institute of India, a Pune-based vaccine maker, to resume the Covid-19 Phase 2 and Phase 3 clinical trials in India. Serum Institute received the DCGI letter revoking the suspension on Wednesday and the company said it would restart the trial process soon.

DCGI had halted Serum’s ongoing Covid-19 vaccine clinical trials in India on September 9 after Serum’s partner AstraZeneca halted trials after a participant in the trial fell ill . Serum is partnering AstraZeneca to carry out trials and manufacture the Oxford University’s Covid-19 vaccine doses in India. Serum was in the process of recruiting 1,600 participants for the India trial and had started administering the shots across the 17 trial sites across the country.

The DCGI had pulled up Serum for failing to inform them about AstraZeneca pausing the clinical trials and failing to submitting casualty analysis of the serious adverse event.

Subsequently, AstraZeneca received regulatory clearance for resuming trials in the UK after confirmation by the Medicines Health Regulatory Authority that the trials were safe. Serum has started manufacturing the Covid-19 vaccine candidates at its Pune facility and was looking at making 60 million to 70 million doses per month.

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