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    India-Made iNCOVACC, World's First Intra-Nasal Vaccine To Receive Approval For Both Primary Series, Heterologous Booster

    India-Made iNCOVACC
    Inam Ansari
    November29/ 2022

    Hyderabad: iNCOVACC, on Tuesday, became the world's first intra-nasal vaccine to receive both Primary series and Heterologous booster approval, Bharat Biotech International Limited (BBIL) announced in a press release. "Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and developer of vaccines for infectious diseases, today announced that 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," the release stated. As per the release, iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized SARS-CoV-2 spike protein. This vaccine candidate was evaluated in phases I, II and III clinical trials with successful results. iNCOVACC has been specifically formulated to allow intranasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries, the release stated. iNCOVACC was developed in partnership with Washington University, St. Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated it in preclinical studies for efficacy. Product development related to preclinical safety evaluation, large-scale manufacturing scale-up, formulation and delivery device development, including human clinical trials, were conducted by Bharat Biotech. Product development and clinical trials were funded in part by the Government of India, through the Department of Biotechnology's, COVID Suraksha Program, the release stated. Chairman & Managing Director, Bharat Biotech, Dr Krishna Ella, said "iNCOVACC ...

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