Minister Choubey sure of 'Excellent safety' of 2 Covid vaccines in Phase I trialstext_fields
Their phase II clinical trials are going on, Choubey said in reply to a question on the status of the vaccine programme/clinical trials for COVID-19 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 ongoin, although no formal studies have been initiated.
Serum Institute of India (SII) and ICMR have collaborated for clinical development of two global vaccine candidates. 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, adding that the ICMR-National Institute for Research in Tuberculosis, Chennai is the lead institution.
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.
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".
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.