New Delhi: Phase-I clinical trials have revealed ‘excellent safety’ of the two candidate vaccines indigenously developed by Bharat Biotech. It should be stated here that Bharat Biotech is developing the vaccines in collaboration with Indian Council of Medical Research ICMR and Cadila Healthcare Ltd. Currently their their immunogenicity testing is now in progress, Minister of State for Health, Ashwini Choubey informed the Rajya Sabha, Tuesday.
Their Phase-II clinical trials are going on, Choubey said in response to a question on the present status of the vaccine programme/clinical trials for COVID-19 undertaken by the ICMR and other private research centres in the country. He further said that discussions on collaborations on the recombinant vaccine developed by Russia are ongoing. However, no formal studies have been initiated.
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, Choubey said. The ICMR-National Institute for Research in Tuberculosis, Chennai is the lead institution.
Choubey further informed that 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, he said.
Elaborating on the two indigenously developed candidate vaccines, Choubey said 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.
Characterisation 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,” he said.
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. Cadila has partnered with ICMR for conduct of parallel pre-clinical studies in large animals.
“While the government and Industry are trying their best to make available a safe and effective vaccine for COVID-19 at the earliest, it is difficult to comment on the exact timelines in view of various complex pathways involved in vaccine development,” Choubey pointed out.
Other companies in India involved in COVID-19 vaccine development are Premas Biotech, Gennova, Mynvax, Epygen Biotech, Luxmatra Innovations, Biological Evans. All candidates are in preclinical development stages, the minister said.
