On Monday, Hyderabad-based Bharat Biotech announced that they had received approval from the Central Drugs Standard Control Organization (CDSCO) for iNCOVACC (BBV154) under Restricted Use. The makers of the world’s first intranasal vaccine stated that the vaccine is approved for heterologous booster dosage use in an emergency for the 18 and older group in India.

The vaccine was approved as a first-line treatment for COVID-19 in September 2022. The iNCOVACC vaccine is a recombinant replication-deficient adenovirus vectored vaccine containing a SARS-CoV-2 spike protein that has been pre-fusion stabilized. The company added that the vaccine showed a significant efficacy and safety profile in the phases I, II, and III clinical trials.

They added that the vaccine was specifically formulated to allow intranasal delivery through nasal drops in collaboration with Washington University in St. Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated it in preclinical studies for efficacy.

Additionally, they pointed out that iNCOVACC has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that enables mass immunization to protect from emerging variants of concern. 

(Source: https://health.economictimes.indiatimes.com/news/pharma/bharat-biotechs-intranasal-vaccine-incovacc-receives-cdsco-approval-under-restricted-use/95831541 )