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Bharat Biotech’s nasal vaccine gets nod of regulator for phase 2/3 trial

13/08/2021 at 6:56 PM

New Delhi, August 13: Bharat Biotech’s intranasal vaccine is the first nasal vaccine that has received the regulatory approval for phase 2/3 trials. This is the first of its kind COVID-19 jab to undergo human clinical trials in India. BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. BBIL has in-licensed technology from Washington University in St Louis, USA.

Phase 1 clinical trial has been completed in age groups ranging ≥18 to ≤60 years. The company reports that the doses of the vaccine administered to healthy volunteers in the phase I clinical trial, has been well tolerated. No serious adverse events reported. Previously, the vaccine was found to be safe, immunogenic and well tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit high level of neutralizing antibodies in animal studies.

The regulatory approval has been received for conducting “A Phase 2 randomized, multi-centric, Clinical Trial of Heterologus Prime-Boost Combination of SARS-CoV-2 Vaccines to evaluate the immunogenicity and safety of BBV152 (COVAXIN®) with BBV154 (Adenoviral Intranasal COVID-19 vaccine) in healthy volunteers.”

Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC speaking on the subject said that Bharat Biotech’s BBV154 Covid Vaccine is the first intranasal vaccine being developed in the country entering into late-stage clinical trials.

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