DCGI gives nod for phase 3 trial of Bharat Biotech's COVID-19 vaccine

In a major development, Drugs Controller General of India (DCGI) on Friday gave permission to Bharat Biotech for conducting Phase-III clinical trial for the indigenous COVID-19 vaccine - Covaxin.

"The DCGI thoroughly analyzed recommendation of the Subject Expert Committee for Bharat Biotech COVID-19 vaccine. On Friday, the top drug regulator granted approval to the pharma giant to conduct phase 3 clinical trial in India for Covaxin," a government official said.

had reported on Thursday that Subject Expert Committee (SEC) held detailed deliberation and recommended to DCGI to grant permission for phase III clinical trials subject to the condition that the primary efficacy endpoint for symptomatic cases should be amended.

"On October 5, the firm presented their data from phase I and II along with mal challenge data in two species including NHP on the Inactivated Corona Virus Vaccine (BBV152) along with the proposal to conduct event-driven phase III clinical trial to assess the efficacy of the vaccine," SEC noted.

DGCI had in July granted permission to Bharat Biotech to conduct phase I and II clinical trials to develop the indigenous vaccine for COVID-19.

Bharat Biotech has partnered with the Indian Council of Medical Research (ICMR) for country-made COVID-19 vaccine using the virus strain isolated by ICMR's National Institute of Virology (NIV) based in Pune.

( With inputs from ANI )