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.
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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.