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India’s CEPI centralised network lab to assess immunogenicity of COVID-19 vaccine candidates

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Major focus at present is to help to evaluate new COVID-19 vaccines, using standard analysis and same reagents in all labs so that vaccine produced has global acceptance and repeatability of the results, for global use

The Minister for Science & Technology, Health & Family Welfare and Earth Sciences Dr Harsh Vardhan recently virtually inaugurated one of seven labs globally designated as centralised network labs of the Coalition for Epidemic Preparedness Innovations (CEPI) established at Translational Health Science & Technology Institute (THSTI), Faridabad. The laboratory is also accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL) (ISO 17025:2017).

The inauguration is significant as India has more than 30 COVID-19 vaccine candidates, some of them at crucial stages in their clinical trials, seeking authorisation for use as part of India’s COVID-19 vaccination campaign.

Two of these, AstraZeneca/Oxford University/Serum Institute of India’s Covishield and ICMR/NIV/Bharat Biotech’s Covaxin received emergency use authorisation over the last few days but spurred debate and criticism over the lack of transparency over the norms and data used to arrive at these authorisations.

The Department of Biotechnology, Ministry of Science & Technology, Government of India is implementing the Ind-CEPI mission titled ‘India Centric Epidemic Preparedness through Rapid Vaccine Development: Supporting Indian Vaccine Development Aligned with the Global Initiative of the Coalition for Epidemic Preparedness Innovations (CEPI)’.

Ind-CEPI Mission aims to strengthen the development of vaccines for the diseases of epidemic potential in India as well as build coordinated preparedness in the Indian public health system and vaccine industry to address existing and emergent infectious threats in India.

Importantly, the major focus at present is to help to evaluate new COVID-19 vaccines, using standard analysis and same reagents in all labs so that vaccine produced has global acceptance and repeatability of the results, for global use.

The other six clinical sample testing laboratories selected for this collaborative vaccine network are: Nexelis (Canada) and Public Health England (PHE; UK), VisMederiSrl (Italy), Viroclinics Biosciences BV (The Netherlands), Q2 Solutions (USA), International Centre for Diarrhoeal Disease Research Bangladesh (ICDDR-B, Bangladesh), and National Institute for Biological Standards and Control (NIBSC, UK).

CEPI has approved costs of up to $16million for this network. All COVID-19 vaccine developers can use this network for free to assess immunogenicity of their vaccine candidate against a common protocol, using clinical samples from preclinical, Phase I through Phase III trials.

Secretary, DBT, Dr Renu Swarup, JS, DBT and MD BIBCOL; Chandra Prakash Goyal, Additional Secretary & Financial Adviser; Vishvajit Sahay, Adviser, DBT; Dr Alka Sharma, Executive Director (Officer in Charge), THSTI, Director, NIAB; Dr Subeer S Majumdar, Managing Director, Andhra Med Tech Zone (AMTZ), Visakahapatnam, Dr Jitendra Sharma, Scientist ‘E’, DBT; Dr Jyoti M Logani were present on the occasion and several scientists and officials of DBT and THSTI joined the function  online.

Speaking on the occasion, Dr Harsh Vardhan lauded DBT and BIRAC for “working relentlessly over the past ten months to develop effective interventions for combating the COVID pandemic”. He said, “The CEPI laboratory will be a great addition to the ability of THSTI to enhance quality of services towards making the vaccine and its acceptability at Global level”.

The Minister recalled with great appreciation how the Indian scientists turned around the country from being an importer to an exporter of world class COVID kits and related products during the last year of difficult times. He reminded that scientists, frontline COVID warriors and general people rose to the occasion and fought the pandemic with focussed attention. He said, “Today, the country is in the forefront of developing vaccines against COVID-19”, and added, “already two of the 30 vaccines have already been cleared by the Drug Controller” for use and the rest are in advanced stages.

Dr. Harsh Vardhan also released the e-Book on S & T solutions for COVID -19 that showcases the initiatives undertaken by the Department of Biotechnology for the mitigation of this Pandemic. From the development of indigenous vaccines, novel point-of-care diagnostics and therapeutic formulations based on traditional knowledge, to establishment of research resources and offering services, the Department is focused on creating an ecosystem to foster Atmanirbharta for innovative product development, with societal relevance. The E-Book showcases the indigenous COVID-19 interventions developed by DBT supported initiatives.

(Editing by Team EH)

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