Indian company Bharat Biotech International has secured approval from Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for its intranasal Covid-19 vaccine, iNCOVACC (BBV154), for usage in people aged 18 years and older.
A recombinant replication-deficient adenovirus vectored vaccine, iNCOVACC has a prefusion stabilised spike protein and is claimed to be the first intranasal vaccine globally to obtain primary two-dose schedule approvals.
It is formulated to permit intranasal delivery via nasal drops.
The nasal delivery system was created and developed to be cost-efficient in low- and middle-income countries.
The company developed the vaccine in collaboration with Washington University St. Louis.
Washington University developed the recombinant adenoviral vectored constructs for the vaccine and assessed them for efficacy preclinically.
Bharat Biotech carried out the product development linked to preclinical safety assessment, large-scale production scale-up, as well as the development of formulation and delivery device, including trials in humans.
The Government of India partly funded the product development and clinical trials via the Covid Suraksha programme of the Department of Biotechnology.
The vaccine was assessed in Phase I, II and III clinical trials with successful data.
In the trials, iNCOVACC was analysed as a primary vaccine regimen, heterologous booster in people who have priorly received the initial series doses of the two commonly administered vaccines used in the country.
The shot has the double benefit of facilitating quicker development of variant-specific vaccines and making nasal dosing easier, allowing mass vaccination to offer protection from emerging viral variants.
Bharat Biotech chairman and managing director Dr Krishna Ella said: “We are proud to announce the approval of iNCOVACC, a global game changer in Intra Nasal vaccines technology and delivery systems.
“Despite the lack of demand for Covid-19 vaccines, we continued product development in intra nasal vaccines to ensure that we are well prepared with platform technologies for future infectious diseases.
“iNCOVACC has been designed for efficient distribution and easy administration.”
In December 2020, the company announced plans to begin Phase I trials of its intranasal Covid-19 vaccine candidate.