By Swati Bharadwaj
India’s first indigenous vaccine Covaxin was successful in inducing a robust immune response without any serious adverse events during the Phase 1 triala that were conducted on 375 volunteers, Bharat Biotech said in a research paper.
The company said a majority of the adverse events observed during the study were mild and successfully resolved. “Only one serious adverse event was reported, which was found to be unrelated to vaccination,” the company said in the paper published on medRxiv.org.
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 antigen specific receptors on their cell surfaces to help recognise foreign pathogens and protect the body against viruses and bacteira.
“Neutralizing responses to homologous and heterologous SARS-CoV-2 strains were detected in all vaccinated individuals. Cell-mediated responses were biased to a Th-1 phenotype,” it said.
Covaxin, which is being developed by the Hyderabad-based vaccine maker in collaboration with Indian Council of Medical Research ( ICMR ) is currently undergoing Phase 3 efficacy studies involving around 26,000 volunteers at 25 sites across the country.
The vaccine has to be stored between 2°C and 8°C, which is compatible with all national immunization programme cold chain requirements, the company said. ( TOI )
