“It has also shown to generate memory T-cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. Its most critical characteristic is the demonstrated safety profile, which is significantly lower than several other vaccines with published data,” it further stated.
The DCGI’s approval to Covaxin came a day after the Subject Expert Committee of Central Drugs Standard Control Organization (CDSCO) made the recommendation.
Bharat Biotech said it had submitted all the data to the DCGI and CDSCO as per the regulatory guidelines.
The product development and clinical trial data thus far has generated five publications, which have been submitted to international peer-reviewed journals, four of which have been accepted and will be published soon. The publication of Phase 2 trial data is undergoing the peer review process, the company said.
The DCGI also stated that Bharat Biotech generated safety and immunogenicity data in various animal…