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INDIA

Government of India Shares Status of Covid-19 Vaccines

Today, the Indian government shared the status of a potential vaccine against the novel coronavirus pandemic. The government is concerning the vaccine manufacturing industry and trying their best to make it available safe and effective as soon as possible.

Ashwini Kumar Choubey, The Minister of State (Health and Family Welfare) in a report written in reply to Rajya Sabha today, stated that the lockdown from 25 March to 31 May was successfully controlled aggressive progression of COVID-19 pandemic against India. Still, there has been a steady rise in the number of cases in the post-lockdown phase.

Centre has constituted a “high-level National Expert Group on vaccine administration for COVID-19which is chaired by Member, Niti Aayog and co-chaired by Secretary, Ministry of Health & Family Welfare,” a statement read.

The committee addressed the issues related to the vaccine delivery, selection of suitable vaccines, prioritization of groups, procurement, logistics: Cold chain requirements, finance and National/International equity. Centre mentioning the development progress of possible Covid-19 vaccine, said that the Central Drugs Standard Control Organisation (CDSCO) has granted testing license permissions for manufacturing vaccine for pre-clinical test, examination and analysis to the following manufacturers in India:

1) Serum Institute of India Pvt., Ltd., Pune

2) Cadila Healthcare Ltd., Ahmadabad

3) Bharat Biotech International Ltd., Hyderabad

4)Biological E Ltd., Hyderabad

5) Reliance Life Sciences Pvt Ltd., Mumbai

6) AurbindoPharma Limited, Hyderabad

7) Gennova Biopharmaceuticals Limited, Pune

Moreover, the Indian Council of Medical Research (ICMR) has informed that the following companies are conducting clinical trials for COVID-19 vaccines in India:

1) An inactivated whole virion candidate vaccine (BBV152) for SARS-CoV-2 has been developed by Bharat Biotech International Ltd (BBIL) using the virus isolate (NIV-2020-770) provided by ICMR-National Institute of Virology (NIV), Pune.

Characterization of the vaccine candidate has been undertaken at ICMR-NIV followed by safety and tolerability studies in small animals like rats, mice and rabbits. Status of clinical trials is as follows:

Phase I clinical trials along with parallel studies in large animals have been completed. The trial has revealed excellent safety of the candidate vaccine. Immunogenicity testing is in progress.

Phase II clinical trials are ongoing.

2) A DNA vaccine (ZyCov-D) has been developed by Cadila Healthcare Ltd. Preclinical 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 the conduct of parallel preclinical studies in large animals. Status of clinical trials is as follows:

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.

3) 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 clinical trials in Brazil. Phase II/III bridging studies have been initiated by ICMR at 14 clinical trial sites. ICMR-National Institute for Research in Tuberculosis (NIRT), Chennai is the lead institution.

ICMR and SII have also partnered for clinical development of a glycoprotein subunit nanoparticle adjuvanted vaccine developed by Novavax from the USA. 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.

As per details provided by 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, the statement added.

The 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.

The Department of Biotechnology is also supporting 08 proposals by Industry and academia for candidate vaccine development and associated research resources at a total cost of Rs 75 crore.

Central Drugs Standard Control Organisation (CDSCO),DNA vaccine (ZyCov-D),Immunogenicity testing,National Expert Group

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