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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 nation, has been enhanced to deal with the needs for distribution and tracking of COVID-19 vaccine, whenever it becomes available, the Rajya Sabha was informed on September 20.
A national expert team 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 this 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 explained that the government hasn’t entered into any contract with overseas pharmaceutical company in this regard.
Choubey was responding to a question on whether the government has formulated any road map to present vaccines for COVID-19 in the nation in the long run.
Currently, under the Universal Immunisation Program (UIP), vaccine distribution relies on Electronic Vaccine Intelligence Network (eVIN) system, which will be an internet-based digital system to monitor routine immunisation, vaccine stocks, storage temperature in approximately 25,000 dedicated cold chain storage points across the nation as well as movement of vaccine.
The vaccine is distributed to health centers and outreach channel sites, in order to reach all regions. The eVIN system is regularly monitored by health authorities in the district and state level.
“The eVIN system is being improved to address the needs for distribution and tracking of COVID-19 vaccine, when it becomes available,” the minister said.
Choubey reported the Central Drugs Standard Control Organisation (CDSCO) has informed that it has granted evaluation license consent for manufacture of COVID-19 vaccine for preclinical test, examination and analysis into the seven manufacturers in India.
These are SerumInstitute 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-1clinical trials have revealed excellent security of both candidate vaccines indigenously developed by BharatBiotech in collaboration with the ICMR and Cadila Healthcare Ltd, and their immunogenicity testing is in progress. Their phase-2 clinical trials are ongoing.
The Indian Council of Medical Research (ICMR) is facilitating studies associated with COVID-19 vaccines. An inactivated whole virion candidate vaccine (BBV152) for SARS-CoV-2 was developed by Bharat Biotech International Ltd using the virus isolate provided by ICMR-National Institute of Virology (NIV), Pune.
“Phase-1 clinical trials together with parallel studies in hamsters and rhesus macaques are completed and have shown excellent safety of the candidate vaccine. Immunogenicity testing is in progress. Phase II clinical trials are ongoing,” Choubey said.
A DNA vaccine has been created by Cadila Healthcare Ltd..
“The vaccine has been proven 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 shown excellent security of the candidate vaccine. Immunogenicity testing is in progress. Phase II clinical trials are continuing,” 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 are initiated by the ICMR in 14 clinical trial websites, the minister stated.
The ICMR and SII also have partnered for clinical development of a glycoprotein subunit nanoparticle adjuvanted vaccine developed by Novavax by 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 encouraging more than 30 vaccine candidates that are in different phases of development, Choubey said.
