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DCGI allows phase 2, 3 trials of Bharat Biotech's intranasal COVID vaccine

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eMediNexus    14 August 2021

The DCGI has allowed Bharat Biotech to conduct phase 2 and 3 clinical trials of the first nasal vaccine against COVID-19, stated the department of biotechnology (DBT). 

Phase 1 clinical trial has been concluded in the 18 to 60 years age group. The regulatory approval has been given to carry out a phase 2 randomized, multi-center, clinical trial of heterologus prime-boost combination of SARS-CoV-2 vaccines to assess the immunogenicity and safety of BBV152 (Covaxin) with BBV154 (Adenoviral intranasal vaccine against COVID) in healthy individuals. The DBT stated that this is a one of a kind coronavirus vaccine to undergo human clinical trials in India.

The vaccine administered to healthy participants in the phase I clinical trial has been reported to be well tolerated and no serious adverse events were reported, said DBT… (ET Healthworld – PTI, August 14, 2021)

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