Aditi Tandon

Tribune News Service

New Delhi, August 13

The first indigenously developed Covid-19 nasal vaccine on Friday received the drug regulator’s nod for phase 2 and 3 clinical trials, paving the way for early completion of a process that could vastly improve Covid shot delivery in India.

The vaccine, developed by Bharat Biotech and supported by the Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC), can revolutionise the Covid vaccine landscape and has been developed under the Mission Covid Suraksha launched to accelerate Covid-19 vaccine development as part of the Atma Nirbhar Bharat scheme.

Bharat Biotech’s intranasal vaccine is the first nasal vaccine to receive regulatory approval for Phase 2-3 trials and the first of its kind to undergo human clinical trials in India.

It is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine and Bharat Biotech has in-licensed the technology from Washington University in St Louis, US.

Phase 1 Clinical trial has been completed in age groups ranging from 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 and no serious adverse events was seen.

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.

The regulatory approval has been received for conducting Phase 2 randomized, multi-centric, clinical trial to evaluate the immunogenicity and safety of the intranasal vaccine in healthy volunteers.

”Bharat Biotech’s BBV154 Covid Vaccine is the first intranasal vaccine being developed in the country entering into late-stage clinical trials,” DBT secretary Renu Swarup said.