Hyderabad-based Bharat Biotech’s coronavirus vaccine Covaxin has received Centre approval to conduct phase II clinical trials from September 7. Bharat Biotech secured the Centre’s nod to begin phase II trials of indigenous vaccine candidate Covaxin on September 3.
Phase II clinical trials of the BBV152 coronavirus vaccine or Covaxin will be conducted on 380 volunteers, as per the letter issued to Bharat Biotech International by Dr S Eswara Reddy, the Joint Drugs Controller of India. 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, Ministry of Health and Family Welfare, “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.”
Preparations were underway for the commencement of phase II of human clinical trial of ‘Covaxin’, India’s indigenous COVID-19 vaccine. “The Phase I of the trial is still continuing as we are planning for the start of the Phase II trial shortly,” Dr E Venkata Rao, Principal Investigator of the trial at Institute of Medical Sciences and SUM Hospital, faculty of medical sciences told PTI.
The blood samples collected from the volunteers who received the vaccine were to ascertain how effective the vaccine was in terms of the level of antibodies developed, Dr Rao said, adding that there had been ‘no side effects’ in the first phase trial of the vaccine.
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