Hyderabad based Biological E's Corbevax vaccine secures WHO Emergency use listing approval

Hyderabad-based company Biological E. Limited (BE) has received Emergency Use Listing (EUL) approval from the World Health Organisation (WHO) for its COVID-19 vaccine, Corbevax. This marks a significant milestone as Corbevax is India's first locally developed COVID-19 vaccine, utilizing a protein sub-unit platform. Notably, it is the second WHO-approved vaccine from Hyderabad, following Bharat Biotech's COVAXIN.

Corbevax had previously gained approval from the Drugs Controller General of India (DCGI) for emergency use among adults, adolescents, and young children in the period from December 2021 to April 2022. Additionally, it was granted approval as India's first heterologous COVID-19 booster shot for adults over 18 in June 2022.

BE has supplied 100 million doses of Corbevax to the Government of India, primarily for use in immunization campaigns targeting 12-14-year-old children. The vaccine is administered intramuscularly in two doses spaced 28 days apart and is stored at temperatures ranging from 2 to 8 degrees Celsius. It is available in 0.5 ml (single dose), 5 ml (10 doses), and 10 ml (20 doses) vial presentations.

Mahima Datla, Managing Director of Biological E. Limited, expressed confidence that the WHO Emergency Use Listing would enhance their global efforts against COVID-19. She emphasized the company's commitment to providing affordable and accessible vaccines of high quality, particularly in countries facing fiscal challenges due to the pandemic.

Datla highlighted BE's perseverance in the field of vaccine development, contrasting it with other companies that entered the sector during the pandemic but later exited due to financial constraints or lack of success. Additionally, BE is actively working on a next-generation COVID-19 vaccine based on the XBB1.5 variant of the SARS-CoV-2 virus, aligning with WHO TAG-CO-VAC recommendations. The candidate vaccine has completed necessary pre-clinical animal studies, indicating potential protection against currently circulating variants. BE has received final approval from the CDSCO to commence clinical trials for the XBB.1.5 variant vaccine in India, leveraging its qualified manufacturing infrastructure to facilitate prompt supply.