The Electronic Vaccine Intelligence Network (eVIN) system, which provides real-time information on vaccine stocks and storage temperatures at all points in the country’s cold chain, is being enhanced to address the needs of distribution and monitoring of the COVID-19 vaccine, whenever necessary. is available, Rajya Sabha was informed on Sunday.
A national group of experts on the COVID-19 vaccine has been formed to guide the government in the prioritization of population groups for vaccination, the selection of vaccine candidates, the mechanism of administration of the vaccine, the cold chain and the associated infrastructure for the deployment of the COVID-19 vaccine. etc. The Minister of State for Health, Ashwini Kumar Choubey, said in a written response.
The minister also clarified that the government has not entered into any contract with a foreign pharmaceutical company in this regard.
Choubey was responding to a question on whether the government has formulated any roadmap to introduce COVID-19 vaccines into the country in the foreseeable future.
Currently, under the Universal Immunization Program (UIP), vaccine distribution relies on the Electronic Vaccine Intelligence Network (eVIN), which is an Internet-based digital system for tracking routine immunization, vaccine stocks, and storage temperature in approximately 25,000 dedicated cold chain storage units. points across the country, as well as the vaccine movement.
The vaccine is distributed to health facilities and extension station sites, to reach all areas. The eVIN system is regularly monitored by health authorities at the state and district levels.
“The eVIN system is being improved to address the needs for distribution and monitoring of the COVID-19 vaccine, when available,” said the minister.
Choubey said that the Central Drug Control Organization (CDSCO) has reported that it has granted trial license permission for the manufacture of COVID-19 vaccine for preclinical testing, examinations 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 that phase 1 clinical trials have revealed excellent safety of the two candidate vaccines developed indigenously by Bharat Biotech in collaboration with ICMR and Cadila Healthcare Ltd, and immunogenicity testing is now ongoing. Its phase 2 clinical trials are ongoing.
The Indian Council for Medical Research (ICMR) is facilitating studies related to COVID-19 vaccines. Bharat Biotech International Ltd has developed an inactivated whole virion vaccine candidate (BBV152) for SARS-CoV-2 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 ongoing. Phase II clinical trials are ongoing,” he said. Choubey.
Cadila Healthcare Ltd. has developed a DNA vaccine. Preclinical toxicity studies were performed in small animals: mice, rats, rabbits, and guinea pigs.
“The vaccine has been found to be safe and immunogenic. Cadila has partnered with ICMR to conduct parallel preclinical studies in rhesus macaques. Phase 1 clinical trials have been completed. The trial has revealed excellent safety of the candidate vaccine. Immunogenicity testing is ongoing. Phase II clinical trials are ongoing, “he said.
The Serum Institute of India (SII) and the ICMR have partnered for the clinical development of two global candidate vaccines: ChAdOx1-S, which is a non-replicable viral vector vaccine developed by the University of Oxford / AstraZeneca. This vaccine is in phase 3 clinical trials in Brazil.
The ICMR has initiated phase 2 and 3 bridging studies at 14 clinical trial sites, the minister said.
ICMR and IBS have also partnered for the clinical development of an adjuvanted nanoparticle glycoprotein subunit vaccine developed by Novavax of the USA.The trial will begin in the second half of October after IBS manufactures the vaccine.
The trial is led by ICMR-National AIDS Research Institute (NARI), Pune. The Department of Biotechnology (DBT) / Department of Science and Technology (DST) are also supporting more than 30 vaccine candidates who are at different stages of development, Choubey said.
.
