Bharat Biotech International Limited (BBIL) on Tuesday announced that its iNCOVACC (BBV154), world’s first intranasal COVID-19 vaccine has received approval from Drugs Controller General of India under Restricted Use in Emergency Situation for ages 18 and above.
iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. This vaccine candidate was evaluated in phase I, II and III clinical trials with successful results, a press release from the city-based vaccine-maker said.
Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule, as heterologous booster dose for subjects who have previously received two doses of the two commonly administered Covid vaccines in India.
Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “We are proud to announce the approval of iNCOVACC, a global game changer in intranasal 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.” Phase III trials of the vaccine were conducted for safety, immunogenicity in about 3,100 subjects, in 14 trial sites across India, Bharat Biotech said.