Bharat Biotech's intranasal Covid vaccine gets nod for phase II/III trials

HYDERABAD: India’s first intra-nasal Covid-19 vaccine candidate BBV154, which is being developed by Bharat Biotech along with the Washington University in St Louis, has received approval from the drug regulator for conducting Phase II/III human clinical trials.
Bharat Biotech recently completed Phase I clinical trials of the chimpanzee adenovirus vaccine on healthy volunteers in the 18-60 years age group.
According to the ministry of science and technology, the doses administered to volunteers in the Phase I trial were “well tolerated”.
“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 neutralizing antibodies in animal studies,” it said.
The ministry said the regulatory approval has been granted for conducting a Phase-2 randomized, 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 in healthy volunteers.
The development of the intra-nasal vaccine has been supported by the department of biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC), it said.