Hyderabad: The stage is set for phase II clinical trials of Bharat Biotech’s coronavirus vaccine from Monday. The Hyderabad-based vaccine maker received the approval from Central Drugs Standard Control Organisation under the Directorate General of Health Services to conduct the phase II trials of indigenous vaccine candidate Covaxin. Joint Drugs Controller Dr S. Eswara Reddy wrote a letter to Bharat Biotech International, conveying the organisation’s nod for conducting the phase II trials.
These trials of the BBV152 coronavirus vaccine or Covaxin will be conducted on 380 participants, who will have to be screened for four days after they receive the vaccine shots.
Through the letter, which IANS has seen, the Joint Drugs Controller said that the directorate had no objection to conducting the trial titled ‘An adaptive, seamless Phase I, followed by Phase II randomized, double-blind, multicentre study to evaluate the safety, reactogenicity, tolerability and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152) in healthy volunteers’.
The letter mentions that Bharat Biotech’s request for approval to initiate phase II clinical trials was examined in consultation with Subject Expert Committee (COVID-19) experts held through virtual meeting on September 3. Phase I clinical trials of the vaccine began on July 15 where healthy volunteers were administered two doses of vaccination shots with a gap of 14 days. (IANS)
