Excellent safety of two indigenous COVID candidate vaccines revealed during Phase-I trials

Phase-I clinical trials have revealed “excellent safety” of the two candidate vaccines indigenously developed by Bharat Biotech in collaboration with ICMR and Cadila Healthcare Ltd and their immunogenicity testing is now in progress. Phase II clinical trials are going on by the Indian Council of Medical Research (ICMR) and other private research centres in the country.

Serum Institute of India (SII) and ICMR have partnered for clinical development of two global vaccine candidates. The first is ChAdOx1-S, a non-replicating viral vector vaccine developed by University of Oxford/AstraZeneca. This vaccine is undergoing phase III clinical trials in Brazil. Phase II/III bridging studies have been initiated by ICMR at 14 clinical trial sites. ICMR and SII have also partnered for clinical development of a glycoprotein subunit nanoparticle adjuvanted vaccine developed by Novavax from USA. The trial will be initiated in the second half of October after the vaccine is manufactured by SII. The trial is led by ICMR-National AIDS Research Institute (NARI), Pune.
An inactivated whole virion candidate vaccine for SARS-CoV-2 has been developed by Bharat Biotech International Ltd using the virus isolate provided by ICMR-National Institute of Virology (NIV), Pune. Characterization of the vaccine candidate has been undertaken at ICMR-NIV followed by safety and tolerability studies in small animals like rats, mice and rabbits.
Phase I clinical trials along with parallel studies in large animals have been completed.The trial has revealed excellent safety of the candidate vaccine. Immunogenicity testing is in progress. Phase II clinical trials are ongoing. Besides, a DNA vaccine (ZyCov-D) has been developed by Cadila Healthcare Ltd, pre-clinical toxicity studies of which were conducted in small animals – mice, rats, rabbits and guinea pigs. The vaccine has been found to be safe and immunogenic.

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