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Bharat Biotech's intranasal COVID-19 vaccine iNCOVACC gets CDSCO nod for heterologous booster doses

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

November 28, 2022 / 07:30 PM IST

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.