The Electronic Vaccine Intelligence Network (eVIN) system, which provides real-time information on vaccine stocks and storage temperatures across all cold chain points in the country, is being enhanced to address the needs for distribution and tracking of Covid-19 vaccine, whenever it becomes available, the Rajya Sabha was informed on Sunday.
A national expert group on Covid-19 vaccine has been constituted to guide the government on prioritisation of population groups for vaccination, selection of vaccine candidates, delivery mechanism of the vaccine, cold chain and associated infrastructure for roll-out of Covid-19 vaccination, etc. Minister of State for Health Ashwini Kumar Choubey said in a written reply.
The minister also clarified that the government has not entered into any contract with foreign pharmaceutical company in this regard.
Choubey was responding to a question on whether the government has formulated any road map to introduce vaccines for Covid-19 in the country in the immediate future.
Currently, under the Universal Immunisation Program (UIP), vaccine distribution is based on Electronic Vaccine Intelligence Network (eVIN) system, which is an internet-based digital system to track routine immunisation, vaccine stocks, storage temperature in about 25,000 dedicated cold chain storage points across the country as well as movement of vaccine.
The vaccine is distributed to health facilities and outreach station sites, so as to reach all areas. The eVIN system is regularly monitored by health authorities at state and district level.
"The eVIN system is being enhanced to address the needs for distribution and tracking of Covid-19 vaccine, when it becomes available," the minister said.
Choubey said the Central Drugs Standard Control Organisation (CDSCO) has informed that it has granted test license permission for manufacture of Covid-19 vaccine for preclinical test, examination and analysis to the seven manufacturers in India.
These are Serum Institute of India in Pune, Cadila Healthcare Ltd., Ahmedabad, Bharat Biotech International Ltd in Hyderabad, Biological E Ltd., Hyderabad, Reliance Life Sciences Pvt Ltd in Mumbai, Aurbindo Pharma Limited in Hyderabad and Gennova Biopharmaceuticals Limited, Pune.
Choubey said the phase-1 clinical trials have revealed excellent safety of the two candidate vaccines indigenously developed by Bharat Biotech in collaboration with the ICMR and Cadila Healthcare Ltd, and now their immunogenicity testing is in progress. Their phase-2 clinical trials are ongoing.
The Indian Council of Medical Research (ICMR) is facilitating studies related to Covid-19 vaccines. An inactivated whole virion candidate vaccine (BBV152) 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.
"Phase-1 clinical trials along with parallel studies in hamsters and rhesus macaques have been completed and have revealed excellent safety of the candidate vaccine. Immunogenicity testing is in progress. Phase II clinical trials are ongoing," Choubey said.
A DNA vaccine has been developed by Cadila Healthcare Ltd. Pre-clincial toxicity studies were conducted on 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 rhesus macaques. Phase-1 clinical trials 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.
The Serum Institute of India (SII) and ICMR have partnered for clinical development of two global vaccine candidates -- ChAdOx1-S, which is a non- replicating viral vector vaccine developed by University of Oxford/AstraZeneca. This vaccine is undergoing phase-3 clinical trials in Brazil.
Phase-2 and 3 bridging studies have been initiated by the ICMR at 14 clinical trial sites, the minister said.
The ICMR and SII have also partnered for clinical development of a glycoprotein subunit nanoparticle adjuvanted vaccine developed by Novavax from the US. The trial will be initiated in second half of October after the vaccine is manufactured by SII.
The trial is led by ICMR-National AIDS Research Institute (NARI), Pune. Department of Biotechnology (DBT)/Department of Science and Technology (DST) are also supporting more than 30 vaccine candidates which are in different stages of development, Choubey said.