Hyderabad-based Bharat Biotech has received the top drug regulator’s clearance to move its vaccine candidate against Covid-19, Covaxin, to the second phase of human testing. The trials for the indigenous vaccine are expected to begin from Monday, following ethics committee approvals, said sources in the Drug Controller General of India (DCGI)
A subject expert committee (SEC) studying its request to begin the phase II trial recommended that the trial be conducted on 380 participants, stated Joint Drugs Controller Dr S Eswara Reddy in a letter to the Hyderabad-based firm dated September 3. All participants will now have to be screened for four days after they are administered the vaccine shots.
The letter further mentions that the Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services, Union Health Ministry, “has no objection for conducting the trial titled ‘An adaptive, seamless Phase I, followed by Phase II randomized, double-blind, multicenter study to evaluate the safety, reactogenicity, tolerability and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152) in healthy volunteers’.”
The Directorate General of Health Service said in a statement: “This is to inform you that the subject proposal was examined in consultation with SEC (COVID-19) experts held through virtual meeting on September 3, wherein the committee recommended for the conduct of Phase II part of clinical trials with 380 participants subject to the condition that time for screening the participants should be revised in 4 days.”
Each stage of a vaccine’s clinical trial tests its safety and ability to develop an effective immune response. While the first phase focuses on safety in healthy participants, the second phase looks at the effectiveness. The third phase looks into these aspects in a much larger population that would represent a wider demographic, said a senior official from the DCGI.
In the first phase of the Covaxin trial, around 375 participants were studied across 12 sites. Covaxin is one of the frontrunners in the race for a Covid-19 vaccine in India.