BE’s CORBEVAX® GETS WHO EUL AUTHORIZATION

CORBEVAX® is India’s first indigenously developed RBD Protein Sub-unit Vaccine against COVID-19

CORBEVAX® is India’s first heterologous COVID-19 booster shot for adults 18 & above

 Hyderabad, January 16, 2024: Biological E. Limited (BE), a Hyderabad-based Vaccines and Pharmaceutical company, today announced that the World Health Organisation (WHO) has granted an Emergency Use Listing (EUL) to their CORBEVAX® vaccine, which is India's first indigenously developed COVID-19 vaccine that is based on protein sub-unit platform.

The Drugs Controller General of India (DCGI) already approved CORBEVAX® for restricted use in emergency among adults, adolescents and young children in a sequential manner from December’21 to April’22; as well as India’s first heterologous COVID-19 booster shot for adults age 18 and above in June’22.  BE supplied 100 Million Doses of CORBEVAX®  to the Government of India which were then utilized in pan-India immunization campaigns; mainly in 12-14 yr old children. 

Ms. Mahima Datla, Managing Director, Biological E. Limited, said ``We are pleased with the WHO EUL because it would help us 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 further 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 committment 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.”

Ms. Mahima further added, “While several companies which entered the field of vaccine development & 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 by constantly enlarging its portfolio of offerings.’’

Next-generation COVID-19 Vaccine

 
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 a short notice.

The CORBEVAX® vaccine is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees Celsius temperature and presented as 0.5 ml (single dose) vial, 5 ml (10 doses) vial and 10 mL (20 doses) vial pack.

ABOUT BIOLOGICAL E. LIMITED

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 130 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines and 10 USFDA approved generic injectables in its portfolio.

In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.