Phase-I clinical trials have revealed “excellent safety” of the two candidate vaccines indigenously developed byBharatBiotechin collaboration with ICMR and Cadila Healthcare Ltd and their immunogenicity testing is now in progress, Minister of State for Health Ashwini Choubey informed the Rajya Sabha on 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 Indian Council of Medical Research (ICMR) and other private research centres in the country.
Choubey further informed 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.
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,” 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,” he said.
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. As per details provided by the Department of Biotechnology (DBT)/Department of Science and Technology(DST), “more than 30 vaccine candidates have been supported which are in different stages of development, 03 candidates are in advanced stage of phase-I/II/III trials and more than 04 are in advanced pre-clinical development stage”.
The ICMR has allocated Rs 25 crore for various studies and other research activities pertaining to vaccine development. The Science and Engineering Research Board (SERB), a statutory body under the Department of Science and Technology, has supported three projects under COVID-19 on vaccine research under Intensified Research in High Priority Areas (IRHPA) The sanctioned expenditure is Rs 22,27,579 and the committed expenditure is Rs 3,20,78,161 according to the details. The Department of Biotechnology is also supporting eight proposals by the industry and academia for candidate vaccine development and associated research resources at a total cost of Rs 75 crore, the minister said in response to another question.
As per the World Health Organisation, 35 vaccine candidates are under clinical evaluation and 145 candidates are in pre-clinical evaluation stage as on September 9, Choubey said. The Government has constituted a high-level National Expert Group on vaccine administration for COVID-19 which is chaired by Member, Niti Aayog and co-chaired by Secretary, Ministry of Health.
Other representatives are – Secretary, Ministry of External Affairs, Secretary, Department of Biotechnology, Secretary, Department of Health Research, Director General of Health Services, Ministry of Health & Family Welfare, Director, All India Institute of Medical Sciences, Head ECD, Indian Council of Medical Research, Director Jawaharlal Institute of Postgraduate Medical Education and Research (Member NTAGI) and Representatives from States and D/o Expenditure. The committee is addressing issues related to vaccine delivery, selection of suitable vaccines, procurement, prioritization of groups, logistics including cold chain requirements, finance and national/international equity, Choubey said.