The Phase-1 Human Clinical Trials for Covaxin, vaccine candidate from India for COVID-19, has started at Nizam’s Institute of Medical Sciences (NIMS) here on Monday morning. Two healthy volunteers were administered first dose of the vaccine candidate.
Health condition of the volunteers will be monitored for the next six months. Doctors said that the main focus of monitoring will be to check if antibodies get generated in the volunteers, amount of time it took for the antibodies to kick in, and how long do they last in the body. Second dose of the vaccine will be given to them after a gap of 14 days.
Around 12-days back, the institute’s director Dr K Manohar said that they were screening the subjects and that the injection doses will be administered after receiving approval from Indian Council of Medical Research (ICMR).
NIMS is one among the 12 institutions involved in the COVID-19 vaccine trials, as listed by ICMR. Dr Prabhakar Reddy is the principal investigator of the clinical trials at NIMS.
Apart from faculty and senior residents from NIMS Department of Clinical Pharmacology, doctors from General Medicine, Anesthesia, and Respiratory Medicine too are involved in the clinical trials.
The potential vaccine is derived from a strain of SARS-COV-2 isolated by National Institute of Virology, Pune. The inactivated vaccine candidate is developed by Hyderabad-based Bharat Biotech India Ltd (BBIL). They received Drug Controller General of India (DCGI) nod on July 29 for Phase 1- and Phase-2 clinical trials.
On July 2, the ICMR’s Director General Dr Balram Bhargava sent a letter to heads of the 12 institutes that their institute was choose as a clinical trial site for the vaccine. They were strictly advised to ensure that the subject enrollment is initiated no later than July 7.