CDSCO asks Bharat Biotech to submit previous data trial before phase-3 trials

The expert panel of CDSCO has asked Bharat Biotech drug maker to submit appropriate data of phase -2 on going trial which is based on safety and immunogenicity of Covaxin. After submitting these data only Bharat Biotech can start phase-3 drug trials.

According to the Subject Expert Committee (SEC) meeting “Firm presented Phase III clinical trial protocol along with interim data of Phase I & II clinical trial. The committee noted the interim data of Phase I & II clinical trial. After detailed deliberation the committee opined that the design of the Phase III study is in principle satisfactory except for clarification on definition of asymptomatic, etc. However, the study should be initiated with appropriate dose identified from the Phase II safety & immunogenicity data. Accordingly, the firm should submit safety & immunogenicity data from Phase II trial for consideration.”

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