Days after getting the Drugs Controller General of India’s (DCGI) nod for India’s first indigenously-made coronavirus vaccine, Bharat Biotech has again knocked on the doors of the drug controller seeking permission to conduct clinical trials of their intranasal vaccine for the viral disease.
Hyderabad-based Bharat Biotech has applied to the DGCI for permission to start Phase 1 and 2 trials of their nasal coronavirus vaccine, top sources privy to the development told IANS.
Clinical trials of the ‘BBV154’ – a novel adenovirus vectored, intranasal vaccine for coronavirus — will be conducted at various locations. The vaccine will be a single-dose one.
The nasal vaccine is different from the two intramuscular vaccines which recently got approval, due to being non-invasive, needle-free, not requiring trained healthcare workers, eliminating needle-associated risks, and suitable for children and adults, having scalable manufacturing.
According to the firm, an intranasal vaccine stimulates a broad immune response at the site of infection, in the nasal mucosa, which is essential for blocking both infection and transmission of Covid-19.
The vaccine has demonstrated protective efficacy in mice and hamsters. Mice and hamsters immunized with its single-dose conferred superior protection against SARS-CoV-2 challenge, “more so than one or two intramuscular immunizations of the same vaccine and dose”.
“Thus, intranasal immunization of ChAd-SARS-CoV-2-S can create an immune response in the nose, which is the point of entry for the virus, thereby protecting against disease, infection, and transmission,” Bharat Biotech said in a statement.
On January 3, two intramuscular vaccines – Bharat Biotech’s Covaxin and Oxford-AstraZeneca’s Covishield manufactured by Serum Institute of India – were approved for restricted emergency use. Both are two-dose vaccines.
While the full efficacy of Covaxin is yet to be determined, it was given go-ahead by the DCGI citing ‘public interest’. Covaxin is an indigenously developed vaccine by Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR).