The Indian government on Tuesday said that the Phase-I clinical trials of the two candidate vaccines indigenously developed by Bharat Biotech in collaboration with ICMR and Cadila Healthcare Ltd have revealed 'excellent safety'. The immunogenicity testing of the vaccines is now in progress, Minister of State for Health Ashwini Choubey stated in a report written to the Rajya Sabha on the second day of the Monsoon Session in the Parliament.
"The trial has revealed excellent safety of the candidate vaccine. Immunogenicity testing is in progress. Phase II clinical trials are ongoing," Choubey said.
Choubey further said their phase II clinical trials are going on, in response to a question asked about the present status of the vaccine programme/clinical trials for COVID-19 undertaken by the Indian Council of Medical Research (ICMR) and other private research centres in the country. Adding further he said that lockdown from March 25 to May 31 successfully controlled the aggressive progression of COVID-19 in India however there has been a steady rise in the number of cases in the post-lockdown phase.
Choubey further asserted that the Serum Institute of India (SII) and ICMR have partnered for the clinical development of two global vaccine candidates. The first vaccine is ChAdOx1-S, a non-replicating viral vector vaccine developed by the University of Oxford/AstraZeneca. Currently, this vaccine is undergoing phase III clinical trials in Brazil, he said. Meanwhile, phase 2 and 3 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, he added.
The minister also informed that ICMR and SII have also partnered for clinical development of a glycoprotein subunit nanoparticle adjuvanted vaccine developed by Novavax from USA and the trial will be initiated in the second half of October after the vaccine is manufactured by SII, adding that the vaccine trial is led by ICMR-National AIDS Research Institute (NARI), Pune.
Stressing 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. 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, he added. A DNA vaccine (ZyCov-D) has also been developed by Cadila Healthcare Ltd.
The vaccine has been found to be safe and immunogenic. Cadila has partnered with ICMR for the conduct of parallel pre-clinical studies in large animals, he added.
"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," he said.
Other companies in India involved in COVID-19 vaccine development are Gennova, Premas Biotech, Mynvax, Epygen Biotech, Luxmatra Innovations, Biological Evans. All candidates are in preclinical development stages, the minister said.
According to the details provided by the Department of Biotechnology (DBT) and the Department of Science and Technology(DST), more than 30 vaccine candidates have been supported which are in different stages of development. Out of which 3 candidates are in the advanced stage of phase-I/II/III trials and more than 4 are in the advanced pre-clinical development stage, the minister said.
(With PTI inputs)