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August 16, 2021

Bharat Biotech obtains approval for Phase II Covid-19 nasal vaccine trial

The trial will analyse the immunogenicity and safety of BBV154 administered with Covaxin in healthy adult subjects.

Indian company Bharat Biotech has obtained approval from the country’s drug regulator to conduct a Phase II clinical trial of its intranasal Covid-19 vaccine candidate, BBV154, in healthy subjects.

BBV154 is a replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. The technology was in-licensed by the company from Washington University in St Louis, US.

In a statement, the Indian Government’s Ministry of Science and Technology said that the regulatory approval is for ‘a Phase II 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’.

BBV154 is the first nasal vaccine to obtain regulatory approval for Phase II trials and the first Covid-19 shot to enter human trials in the country, the Press Information Bureau release noted.

In January 2021, Indian drug regulator CDSCO’s subject expert committee recommended granting permission for conducting Phase I trial of BBV154.

According to data from the concluded Phase I trial in healthy adults aged between 18 and 60 years, the nasal vaccine was well-tolerated.

Furthermore, no serious adverse events were observed in the trial.

In previous pre-clinical toxicity studies, the shot demonstrated safety, immunogenicity and well-tolerability, as well as induced an increased level of neutralising antibodies in animal studies.

India’s Ministry of Science and Technology Department of Biotechnology Secretary Dr Renu Swarup said: “The department through Mission COVID Suraksha, is committed to the 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 late-stage clinical trials.”

This July, the company reported safety and efficacy analysis data from the Phase III trial of Covaxin, which showed a 77.8% efficacy against mild, moderate and severe Covid-19.

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