Bharat Biotech International Limited on Monday announced that its Covid-19 intranasal vaccine iNCOVACC (BBV154) has received approval from the Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for ages 18 and above in India, for heterologous booster doses.
A press release from the vaccine maker said iNCOVACC, a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised SARS-CoV-2 spike protein, is the world's first intranasal vaccine to receive both primary series and heterologous booster approval.
The vaccine candidate was evaluated in Phases I, II and III clinical trials with successful results and has been specifically formulated to allow intranasal delivery through nasal drops, it said.
The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries, Bharat Biotech said.
The vaccine had earlier received approval under Restricted Use in Emergency Situation for ages 18 and above for primary two-dose schedule. Phase-III trials were conducted for safety, immunogenicity in approximately 3,100 subjects, at 14 trial sites across India.
Krishna Ella, Chairman & Managing Director, Bharat Biotech, said: "Despite the lack of demand for Covid vaccines, we continued product development in intranasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases... We have also initiated development of variant-specific vaccines for Covid for future preparedness."
iNCOVACC was developed in partnership with Washington University, St Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated in pre-clinical studies for efficacy.
Rajesh S Gokhale, Secretary, DBT, and Chairperson, BIRAC, said, "The DCGI's approval of Bharat Biotech's intranasal vaccine iNCOVACC (BBV154) to be used as a heterologous booster dose against currently available Covid-19 vaccines is a moment of great pride for our country. This move will further strengthen our collective fight against the pandemic and broaden vaccine coverage."