Hyderabad based Bharat Biotech receives an approval from the Central Drugs Standard Control Organization (CDSCO) backed up by Directorate General of Health Services for conducting Phase 2 clinical trials for Coronavirus vaccine – Covaxin, scheduled from Monday (September 7).
The Joint Drugs Controller of India, Dr. Eswara Reddy has issued a letter to Bharat Biotech International regarding the approval. The clinical trials to be conducted on 380 volunteers, who will be subjected to screening for four days post receiving the vaccine shots.
The Directorate General of Health Service passed the information stating, “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.”
The first phase of trials consisted of monitoring the blood samples for any potential side effects. As clarified by Dr. E Venkata Rao, the chief investigator at Institute of Medical Sciences (IMS) and SUM Hospital, faculty of medical sciences, no side effects were observed. Phase 1 consisted of examining 375 participants around 12 sites.
