HYDERABAD: India’s first indigenous vaccine, Covaxin, managed to induce a robust immune response without any serious adverse events during phase 1 trials that were conducted on 375 volunteers, Bharat Biotech said in a research article.
The company said that most of the adverse events seen during the study were mild and resolved successfully. “Only one serious adverse event was reported, which was found to be unrelated to vaccination,” the company said in the document.
Bharat Biotech also said that Covaxin, codenamed BBV152, is the first inactivated SARS-CoV-2 vaccine that has been reported to induce a Th1-biased response. Th1 cells have specific antigen receptors on the surface of their cells to help recognize foreign pathogens and protect the body against viruses and bacteria.
The company said that most of the adverse events seen during the study were mild and resolved successfully. “Only one serious adverse event was reported, which was found to be unrelated to vaccination,” the company said in the document.
Bharat Biotech also said that Covaxin, codenamed BBV152, is the first inactivated SARS-CoV-2 vaccine that has been reported to induce a Th1-biased response. Th1 cells have specific antigen receptors on the surface of their cells to help recognize foreign pathogens and protect the body against viruses and bacteria.
“Neutralizing responses to homologous and heterologous SARS-CoV-2 strains were detected in all vaccinated individuals. Cell-mediated responses were biased towards a Th-1 phenotype, ”he said.
Covaxin, which is being developed by the Hyderabad-based vaccine manufacturer in collaboration with the Indian Council for Medical Research (ICMR), is currently in phase 3 efficacy studies involving around 26,000 volunteers at 25 sites across the country.
The vaccine should be stored between 2 ° C and 8 ° C, which is consistent with all cold chain requirements of the national immunization program, the company said.
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