New Delhi: Covaxin, the vaccine candidate being developed by Bharat Biotech and ICMR-National Institute of Virology, is ‘safe’ and induced ‘robust’ immune response among Phase 1 trial participants.
Bharat Biotech has sought emergency approval for Covaxin from the drug regulator. The application is under consideration as the subject expert committee has asked for additional data, Health Ministry has said.
Phase-1 results show that Covaxin, a COVID-19 vaccine candidate, is safe. It was well-tolerated in all dose groups and generated a ‘robust immune response’, according to the results released in a preprint paper, titled ‘A Phase 1: Safety and Immunogenicity Trial of an Inactivated SARS-CoV-2 Vaccine – BBV152’.
As per the pre-print of the trial results published on 15 December, the firm conducted a double-blind randomised controlled Phase 1 clinical trial to evaluate the safety and immunogenicity of BBV152, its whole-virion inactivated vaccine. The trial was done on 375 participants.