Covaxin, the Coronavirus vaccine that is being prepared by Bharat Biotech collaborating with the Indian Council of Medical Research has been given permission to go ahead with the Phase 3 clinical trials on Thursday. Bharat Biotech earlier submitted the request to the Drugs Controller General of India on October 2 for permission of proceeding with the third phase. The trial is expected to happen in over 19 sites with Delhi, Mumbai, Lucknow, and Patna along with other 10 states.
Savita Verma, Prime Investigator, PGI Rohtak said that there were some minor negative effects of the vaccine on some but the comprehensive result of the Covaxin is favorable. The DGCI said, “In continuation of the SEC meeting dated 05.10.2020, the firm presented their data from Phase I and II along with animal challenge data in two species including NHP [National Health Portal] on the Inactivated Corona Virus Vaccine (BBV152) along with the proposal to conduct event-driven Phase III clinical trial to assess the efficacy of the vaccine”.
Covaxin, the first domestic vaccine of India, is an inactivated vaccine that is prepared from the stress of the contagious SARS-CoV-2virus. The Subject Expert Committee at the Central Drugs Standard Control Organisation has allowed the company to conduct the Phase three trials.
The first and second phase trials were conducted on 1125 candidates, out of which 375 were immunized in Phase 1 and 750 in Phase 2. The second phase trial was conducted on children above 12 years of age.
