Bharat Bio intranasal vaccine gets nod for Phase 2/3 clinical trials

Our Bureau New Delhi | Updated on August 13, 2021

‘The vaccine was able to elicit high level of neutralising antibodies in animal studies’

The world’s first intranasal Covid-19 vaccine, developed by Bharat Biotech India Ltd (BBIL), received regulatory approval for carrying out Phase-2/3 clinical trials, according to an official statement from the Department of Biotechnology (DBT) on Friday.

This is following the successful completion of Phase 1 clinical trials in which the intranasal vaccine, which goes by the name BBV154, was tested in healthy individuals between 18 to 60 years of age. The successful completion of the trials would make it possible to use the intranasal vaccine as a booster shot after a vaccination with Covaxin.

“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 neutralising antibodies in animal studies,” said DBT quoting the firm.

DBT and its public sector undertaking, Biotechnology Industry Research Assistance Council (BIRAC), have been helping Indian firms to develop diagnostic kits, therapeutics and vaccines to fight Covid-19. The Bharat Biotech vaccine, too, received support from these government agencies.

BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine, which uses a technology licensed from Washington University in St Louis in the US.

The regulatory approval has been received for conducting a phase 2 randomised, multi-centre clinical trial of heterologous prime-boost combination of SARS-CoV-2 vaccines to evaluate the immunogenicity and safety of COVAXIN with BBV154 (Adenoviral Intranasal COVID-19 vaccine) in healthy volunteers, the statement said.

“The Department (DBT) 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,” said Renu Swarup, DBT Secretary and Chairperson, BIRAC.

Published on August 13, 2021

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