iNCOVACC, world's first nasal Covid-19 vaccine manufactured by Bharat Biotech, approved for emergency use

Nasal Covid-19 vaccine iNCOVACC: Hyderabad based biotechnology company Bharat Biotech has launched the world's first nasal Covid-19 vaccine. According to a Tweet shared by Bharat Biotech on Monday evening, iNCOVACC recently received approval under Restricted Use in Emergency Situation for ages 18 and above for heterologous booster doses.

In heterologous boosting, a person administered a different vaccine from the one that was used for the primary dose series.

iNCOVACC is the world's first intranasal vaccine for Covid to receive approval for a primary 2-dose schedule and heterologous booster dose, according to the statement.

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.

iNCOVACC had earlier received approval under Restricted Use in Emergency Situation for ages 18 and above for the primary 2-dose schedule. Phase III trials were conducted for safety, immunogenicity in 3100 subjects at 14 sites across the country.

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

Heterologous booster dose studies were conducted for safety and immunogenicity in 875 subjects with BBV154 intranasal vaccine, administered post 2 doses of the two commonly administered Covid-19 vaccines. The trials were conducted at 9 sites. 

Bharat Biotech Covid-19 Nasal Vaccine

iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised SARS-CoV-2 spike protein.

The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries, Bharat Biotech said.

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."

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