Bharat Biotech’s nasal Covid vaccine gets nod for phase 2/3 trials

This is the first Covid-19 intranasal jab to undergo human clinical trials in India

Hyderabad: Hyderabad-based Bharat Biotech’s intranasal vaccine 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. Bharat Biotech has in-licensed technology from Washington University in St Louis, USA.

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Phase 1 clinical trial has been completed in the 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 had been found to be safe, immunogenic and well tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit high levels of neutralising antibodies in animal studies.

The regulatory approval has been received for conducting a phase 2 randomised, multi-centric, clinical trial of Heterologous 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 RenuSwarup, secretary, DBT and chairperson, BIRAC, said, “The Department through Mission Covid Suraksha, is committed to development of safe and efficacious Covid-19 vaccines. 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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