Hyderabad: Bharat Biotech International Limited (BBIL) said on Monday it has submitted phase III clinical trial data for its intranasal Covid-19 vaccine BBV154 to the Indian regulatory authorities. The submission was made after the vaccine proved to be safe, well-tolerated, and immunogenic in subjects in controlled trials as a primary as well as heterologous booster, the company added.
“Immunogenicity was evaluated through serum neutralising antibodies by PRNT assays and serum IgG’s through ELISAs,” Bharat Biotech said in a statement. “To assess vaccine response through the intranasal route, secretory IgAs were evaluated by ELISA in serum and saliva. Evaluation was also carried out for the ability of BBV154 to elicit long-term memory T and B cell responses against the ancestral and Omicron variants.”
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