If the advanced clinical trials of COVID-19 vaccine succeed, then an effective vaccination is likely to be available by the end of first quarter of 2021, Minister of State for Health Ashwini Choubey informed Lok Sabha on Friday. He was responding to a question about the time by which an effective COVID-19 vaccine is likely to be commercially launched.

The minister further said that no advance purchase agreement with any vaccine manufacturers have been entered into. Responding to another question, Choubey said that the phase-I of clinical trials have revealed excellent safety of the two candidate vaccines indigenously developed by Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR) and Cadila Healthcare Ltd and now their immunogenicity testing is in progress.

Their phase II clinical trials are ongoing. The government of India has formed a National Expert Group on Vaccine Administration for COVID-19 chaired by Member (health), Niti Aayog, which is creating a strategy on the procurement mechanisms for vaccine, including both indigenous and international manufacturing, along with guiding principles for prioritisation of population groups for vaccination, Choubey said.

The Expert Group has deliberated on broad parameters guiding the selection of COVID-19 vaccine candidates for the country and working in close coordination with Standing Technical Sub-Committee of National Technical Advisory Group on Immunization (NTAGI), he said in a written reply to Lok Sabha. The Central Drugs Standard Control Organisation (CDSCO) 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.

The 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 I 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 of clinical trials are ongoing," Choubey said. A DNA vaccine has been developed by Cadila Healthcare Ltd. Pre-clincial toxicity studies 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 rhesus macaques. Phase I 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. 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 III of clinical trials in Brazil. Phase II and III bridging studies have been initiated by 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 the 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.

The government of India conveyed its intent to be part of the Vaccine Pillar of the Access to COVID-19 Tools (ACT) Accelerator, which may be beneficial in providing access to the global vaccine candidates in advanced stages, for their further utilization in the country. Under this pillar, COVAX facility has been created, which is led by GAVI and the World Health Organisation (WHO), for fair and equitable distribution of COVID-19 vaccine across the world, Choubey informed.

The Department of Biotechnology through the IND-CEPI Mission is involved in key partnerships with 'Coalition for Epidemic Preparedness Innovations (CEPI)' for supporting Indian researchers for development of clinical immune assays to advance vaccine research. "No advance purchase agreement with any vaccine manufacturers have been entered into," the minister said.

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