Bharat Biotech’s Covaxin or BBV152 coronavirus vaccine will now enter phase II of clinical trials. The firm developing India’s indigenous vaccine candidate for COVID-19 received the Centre’s approval of beginning phase II trials on September 3. This will be conducted on 380 volunteers across the country.
The decision was made after the phase I trials of Covaxin went as per expectations. No side-effects were reported in volunteers who administered the COVID-19 vaccine shots.
According to the letter issued to Bharat Biotech International by Dr S Eswara Reddy, the Joint Drugs Controller of India, for the phase II clinical trials of Covaxin, all 380 participants will have to be screened for four days after they are administered the vaccine.
The Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services, Ministry of Health and Family Welfare mentions in the letter that, “CDSCO 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 Indian Council for Medical Research (ICMR) has chosen twelve medical centres to conduct the human clinical trials of the vaccine developed by Hyderabad-based Bharat Biotech.