Phase 2 trials granted for India’s first Covid nasal vaccine
Lagatar24 Desk : The Department of Biotechnology has granted approval for phase 2 trials of India’s first Covid nasal vaccine, developed by Bharat biotech. Phase 1 trials have been conducted and completed on the age group of 18-60 years.
“Bharat Biotech’s intranasal vaccine is the first nasal vaccine that has received the regulatory approval for phase 2 trials,” the DBT said.
The regulatory approval has been received for conducting “a Phase 2 randomised, 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”.
DBT said, “it is first of its kind to undergo Human trials”.
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, US, it said.
“The company reports that the doses of the vaccine administered to healthy volunteers in the phase I clinical trial have been well tolerated. No serious adverse events reported,” the DBT said.
Previously, the vaccine was found to be safe, immunogenic, and well-tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit a high level of neutralising antibodies in animal studies, it added.
The Mission COVID Suraksha was launched to accelerate COVID-19 vaccine development efforts as part of the third stimulus package, Atmanirbhar 3.0.
The focus of this mission is to consolidate and streamline available resources towards a warpath for accelerated vaccine development in order to bring a safe, efficacious, affordable and accessible COVID-19 vaccine to the citizens at the earliest.
“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 into late-stage clinical trials,” Renu Swarup, Secretary, DBT and Chairperson, BIRAC said.
