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India’s drug controller grants approval of first intranasal COVID-19 vaccine



Comptroller General of Drugs

– The Comptroller General of Drugs of India (DCGI) has granted approval for the first intranasal COVID-19 vaccine iNCOVACC, the Department of Biotechnology said on Tuesday.

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Bharat Biotech International Limited (BBIL), the manufacturer of iNCOVACC (BBV154), has received emergency restricted use approval for persons aged 18 years and over in India for heterologous booster doses.

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The vaccine manufacturer said in a statement: “iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a stabilized SARS-CoV-2 spike protein prior to fusion. This vaccine candidate was evaluated in Phase I clinical trials.” , II and III with successful results.”

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“iNCOVACC has been specifically formulated to allow intranasal delivery via nasal drops. The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries.”

According to Bharat Biotech, iNCOVACC was developed in partnership with Washington University in St. Louis, which had designed and developed the recombinant adenovirus-vectored construct and evaluated it in preclinical studies for efficacy. ■


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