According to the document uploaded to ‘medRxiv’, a server containing preprints of the research work before it is peer-reviewed, Covaxin also showed tolerable safety results with enhanced humoral and cell-mediated immune responses in the Phase II study. .
In double-blind phase II clinical trials, 380 healthy children and adults received two vaccine formulations, and 190 volunteers each received the 3 µg and 6 µg vaccine formulation with Algel-IMDG.
Both groups of vaccines elicited more Th1-biased cytokines than Th2-biased cytokines, he said.
“After two doses, the local and systemic adverse reactions seen in both vaccine groups were minimal and most of them resolved within 24 hours of initiation. No serious adverse events were reported in this study, ”the company said.
“The results of the phase 2 study show that both humoral and cell-mediated responses were observed. No differences in neutralizing antibodies were observed between sexes and between age groups. BBV152 was well tolerated in both dose groups with no serious adverse effects, ”said Bharat Biotech.
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