World’s first nasal COVID vaccine by Bharat Biotech cleared for restricted emergency use

Bharat Biotech nasal vaccine: Bharat Biotech International Limited announced on November 28, 2022, that its COVID-19 intranasal vaccine iNCOVACC (BBV154) has received approval from the Central Drugs Standard Control Organisation (CDSCO) under the ‘Restricted Emergency Use’ for ages 18 and above in India.

As per the press release from the vaccine maker, iNCOVACC, a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized SARS-CoV-2 spike protein, is the world’s first intranasal vaccine to receive both primary series and heterologous booster approval.

Bharat Biotech’s intranasal vaccine is to be used as a heterologous booster dose against the currently available COVID-19 vaccines.

iNCOVACC, World's first intranasal vaccine to receive both primary series and Heterologous booster approval. #bharatbiotech #incovacc #intranasalvaccine #vaccine #COVID19 #VaccinesWork #VaccineDevelopment #Booster #COVID #pandemic #firstintranasalvaccine pic.twitter.com/jyTebvwiT6

— BharatBiotech (@BharatBiotech) November 28, 2022

World’s first nasal vaccine receives approval

1. The COVID vaccine candidate was evaluated in Phases I, Phases II, and III clinical trials with successful results. It has been specifically formulated to allow intranasal delivery through nasal drops.

2. As per Bharat Biotech, the nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries.

3. World’s first nasal vaccine by Bharat Biotech had earlier received approval under the Restricted Use in Emergency Situation for ages 18 and above for a primary two-dose schedule.

4. Phase 3 trials were conducted for safety, and immunogenicity in approximately 3,100 subjects, at 14 trial sites across India.

iNCOVACC receives approval: Significance

iNCOVACC has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that enables mass immunization to protect from the emerging variants of concern. The vaccine promises to become an important tool in mass vaccinations during endemics and pandemics.

About iNCOVACC

iNCOVACC was developed in partnership with Washington University, St. Louis, which had designed and developed the recombinant adenoviral vector construct and evaluated it in the pre-clinical studies for efficacy.

As per the Chairman and Managing Director of Bharat Biotech, despite the lack of demand for the COVID vaccines, Bharat Biotech continued the product development in intranasal vaccines to ensure that we are all well-prepared with platform technologies for future infectious diseases.

The company has also initiated the development of variant-specific vaccines for COVID-19 for future preparedness.

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