Bharat Biotech’s Covaxin receives approval for Phase III trials: Reports


1 month ago

By Administrator_India

Capital Sands

Bharat Biotech’s coronavirus vaccine Covaxin has received approval for carrying out Phase III trials on October 22, reports suggest.

The approvals were reportedly given after assessing data from Phase I and II and animal challenge study.

Phase III is likely to start next month, Business Today reported. The report said an expert committee met on October 20 to give its nod to Phase III trials and suggested some ‘minor amendments’ in the protocol.

Bharat Biotech had applied to the Drugs Controller General of India (DCGI) seeking permission for the crucial Phase III of trials on October 2, NDTV reported.

In its application, the firm said the study would cover over 28,500 subjects, aged 18 years and above. The study would be conducted at 19 sites in 10 states across the country, the report said.

The potential vaccine against COVID-19 is being developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

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