New Delhi: India’s nasal vaccine candidate against COVID-19, developed by Bharat Biotech, has received the approval for conducting phase 2 and 3 clinical trials, the Department of Biotechnology said on Friday.
“First Nasal Vaccine developed by Bharat Biotech supported by Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC) gets a nod of regulator for Phase 2/3 Trial,” Ministry of Science and Technology said in a statement.
The DBT apprised that Phase 1 clinical trial of the nasal vaccine candidate, BBV154, has been completed in age groups ranging from 18 to 60 years, adding that the doses were found to be ‘well tolerated’, Reuters reported.
BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine.
Renu Swarup, chairperson of the Biotechnology Industry Research Assistance Council said, “Bharat Biotech`s BBV154 Covid Vaccine is the first intranasal vaccine being developed in the country entering into late-stage clinical trials.”
Touted as a game-changer, the drug regulator CDSCO had recommended granting permission for conducting phase 1 clinical trials of an intranasal COVID-19 vaccine in January. The vaccine can be administered by putting only one drop in each of the nostrils, for which one does not require trained healthcare workers. It eliminates needle-associated risks, and is suitable for children and adults.
The Hyderabad-based pharma Bharat Biotech’s Covaxin, a two-dose vaccine administered through injections, is already being used in India’s fight against the COVID-19 pandemic. So far, India has approved three anti-COVID vaccines- Covaxin, Covishield and Russia’s Sputnik V.
(With inputs from agencies)