Hyderabad: The Central Drugs Standard Control Organisation (CDSCO), on 4 September, gave permission to Hyderabad-based Bharat Biotech to conduct phase II trials of COVAXIN, a vaccine for COVID-19.
On 3 September, the CDSCO, in consultation with COVID-19 experts, examined Bharat Biotech’s proposal to start phase II of the clinical trials. The committee recommended that phase II be conducted with 380 participants subject to the condition that time for screening the participants should be revised to four days, Dr. S. Eswara Reddy, the joint drugs controller, said in a statement.
The trial is a Randomized, Double-blind, Multicenter study to evaluate the safety, Reactogenicity, Tolerability and immunogenicity of the whole-virion inactivated [email protected] Vaccine(BBV152) in Healthy Volunteers.
The first phase of the clinical trial had started on 20 July at NIMS.