Phase 1 Clinical trial has been completed in age groups ranging 18 to 60 years. The company reports that the doses of the vaccine administered to healthy volunteers in the Phase I trial have been well tolerated, and no serious adverse events were 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.
‘Bharat Biotech’s intranasal vaccine is the first nasal vaccine that has received the regulatory approval for Phase 2/3 trials.’
The regulatory approval has been received for conducting “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.
Secretary, Biotechnology and BIRAC Chairperson, Dr Renu Swarup, said that “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.”
Source: IANS
