HYDERABAD: Hyderabad-based vaccine maker Bharat Biotech received permission from the Central Drugs Standard Control Organisation (CDSCO) of the Directorate General of Health Sciences for conducting the phase-II clinical trial of Covaxin, its vaccine against Covid-19. The trial will be with 380 participants. According to a letter by the CDSCO to Bharat Biotech dated September 3, its proposal for the conduct of the phase-II trial was examined in consultation with the Subject Expert Committee through a virtual meeting on the same day, wherein the proposal was recommended.
The letter stated that the Directorate has no objection to conducting the clinical trial titled ‘An adaptive, seamless phase-I, followed by phase-II randomised, double-blind, multi-centre study to evaluate the safety, reactogenicity, tolerability and immunogenicity of the whole-virion inactivated SARS-CoV-2 Vaccine(BBV152) in healthy volunteers’.