There have been speculations about the vaccine for the ongoing pandemic. The stage is set for phase II clinical trials of Bharat Biotech's coronavirus vaccine from Monday. The Hyderabad-based vaccine maker received permission from the 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 to Bharat Biotech International, conveying the organization's nod for directing the phase II trials. These trials of the BBV152 coronavirus vaccine or Covaxin will be conveyed on 380 participants, who will have to be screened for four days after they receive the vaccine shots.
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Through the letter, the Joint Drugs Controller said that the directorate had no problem 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 the Subject Expert Committee (COVID-19) experts held through virtual meeting on September 3.
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"This is to inform you that the subject proposal was examined in consultation with SEC (COVID-19) experts held through virtual meeting on 03-09-2020, 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 to 4 days," reads the letter dated September 3. Phase I clinical trials of the vaccine began on July 15 at 12 centers across the country where healthy volunteers were administered two doses of vaccination shots with a gap of 14 days. These trials on 375 volunteers are still continuing.
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