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Hyderabad-based Biological E’s Corbevax gets WHO emergency use approval

Hyderabad: Biological E. Limited (BE), a Hyderabad-based vaccines and pharmaceutical company, on Tuesday announced that the World Health Organisation (WHO) has granted an Emergency Use Listing (EUL) to their Corbevax.

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Corbevax is India’s first locally developed Covid-19 vaccine using a protein sub-unit platform and the second WHO-approved vaccine from Hyderabad after Bharat Biotech’s COVAXIN.  

The Drugs Controller General of India (DCGI) had previously approved Corbevax for emergency use among adults, adolescents, and young children from December 2021 to April 2022. It also got the approval as India’s first heterologous COVID-19 booster shot for adults over 18 in June 2022.

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BE supplied 100 million doses of Corbevax to the Government of India, primarily used in immunization campaigns for 12-14-year-old children.

Corbevax is an intramuscular vaccine administered in two doses 28 days apart. It is stored at a temperature of 2 to 8 degrees Celsius and presented as 0.5 ml (single dose) vial, 5 ml (10 doses) vial and 10 mL (20 doses) vial pack.

Mahima Datla, Managing Director, Biological E. Limited, said that WHO EUL would help them to use the platform to continue developing Covid-19 vaccines as and when it starts impacting public health.

“We are confident that this endorsement from WHO will bolster our global fight against Covid-19,” she added.

“We understand that several countries come under a lot of fiscal pressure when it comes to dealing with Covid-19. We aim to reach the people in those countries with Corbevax, just as we have done with all our other vaccines. Our commitment is to provide affordable and accessible vaccines that are of high quality and the WHO EUL lays a path for us to make that possible,” she said.

BE supplied 100 million doses of Corbevax to the Indian government, which were then utilised in pan-India immunisation campaigns; mainly in 12 to 14-year-old children.

Datla noted that while several companies which entered the field of vaccine development and manufacturing during the Covid-19 pandemic exited soon afterwards either due to paucity of funds or lack of success, BE continues to remain committed to develop and provide access to high quality affordable vaccines globally.

Biological E’s COVID-19 vaccines

BE has been working on a next-generation Covid-19 vaccine that is based on the XBB1.5 variant of the SARS-CoV-2 virus, which would conform to WHO TAG-CO-VAC recommendations.

BE’s candidate vaccine has completed all required pre-clinical animal studies, which suggest that it will provide adequate protection against the currently circulating variants.

BE has recently received final approval from CDSCO to begin clinical trials of the XBB.1.5 variant vaccine in India. The clinical trials will commence soon at various trial sites in India.

BE already qualified manufacturing infrastructure for producing variant vaccines to initiate supply at short notice.

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