Phase 1 clinical trial has been completed in the age groups ranging 18 to 60 years. The company reports that 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 had been found to be safe, immunogenic and well tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit high levels of neutralising antibodies in animal studies.
The regulatory approval has been received for conducting a 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.