World’s 1st Intranasal Covid vax from Bharat Biotech gets CDSCO approval

Leading vaccine maker, Bharat Biotech International Limited (BBIL) announced that the world’s first intranasal vaccine for Covid-19, iNCOVACC (BBV154), has received approval from the Central Drugs Standard Control Organization (CDSCO). It came under Restricted Use in Emergency Situations for ages 18 and above, in India, for heterologous booster doses. 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..

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. Bharat Biotech said that launch dates, pricing, and availability will be announced in due course of time. iNCOVACC is stable at 2-8 degrees Celsius for easy storage and distribution. Bharat Biotech has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra, and Telangana, with operations pan India.

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.

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