Bharat Biotech: CDSCO panel rejects Phase 3 trial of Covaxin, asks to submit safety data from previous trial

According to the Subject Expert Committee (SEC) meeting, the firm presented the phase III clinical trial protocol along with interim data of phase I and II clinical trials on October 2.

"The committee noted the interim data of phase I and II clinical trials. After detailed deliberation, the committee opined that the design of the phase III study is in principle satisfactory except for clarification on the definition of asymptomatic, etc," SEC noted on 114th meeting on October 5, reports ANI.

"However, the study should be initiated with an appropriate dose identified from phase II safety and immunogenicity data. Accordingly, the firm should submit safety and immunogenicity data from the phase II trial for consideration," it said.

In July, the Drug Controller General of India had granted permission to pharma company Bharat Biotech to conduct phase I and II clinical trials to develop an indigenous vaccine for COVID-19.

In this regard, Bharat Biotech has partnered with the Indian Council of Medical Research (ICMR) to develop a fully indigenous vaccine for COVID-19 using the virus strain isolated at ICMR's National Institute of Virology, Pune.

The Medical Dialogues team had earlier reported that the indigenous and the inactivated vaccine was developed at Bharat Biotechs BSL-3 (Bio-Safety Level 3) high containment facility located in the Genome Valley. The Drug Controller General of India CDSCO (The Central Drugs Standard Control Organisation), Ministry of Health & Family Welfare had granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July 2020