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CORBEVAX, a COVID-19 vaccine by Bio E-India, gains WHO Emergency Use Listing with RBD technology from Texas Children's Hospital

Tuesday, January 23, 2024

Texas Children's Hospital has officially announced that the CORBEVAX® COVID-19 vaccine, a traditional, recombinant protein-based vaccine developed by Biological E Limited, has been granted approval by the World Health Organization (WHO) under Emergency Use Listing (EUL). Biological E Limited, based in Hyderabad, India, is responsible for the development and commercialization of CORBEVAX®.

The vaccine utilizes a yeast strain expressing the Receptor Binding Domain (RBD) protein of SARS-CoV-2, a result of collaboration between Texas Children's Hospital Center for Vaccine Development (CVD) and Baylor College of Medicine (BCM).

The WHO's EUL procedure assesses vaccine quality, safety, and efficacy based on international standards, particularly during public health emergencies. Mark A. Wallace, CEO of Texas Children's Hospital, highlighted the significance of CORBEVAX®'s approval, praising the hospital's methodology for producing crucial antigenic proteins in the global fight against COVID-19. The yeast strains allow for the production of the RBD protein, aiding researchers globally in developing cost-effective vaccines.

The licensing of the yeast strain to Biological E Limited occurred in 2020, and subsequent scaling up of manufacturing technology ensured compliance with Good Manufacturing Practices (GMP) for the production of the RBD protein. Combined with optimized adjuvants (Alum and CpG1018), the RBD protein became the basis for the COVID-19 candidate vaccine, CORBEVAX®.

Biological E conducted multiple clinical trials, leading to CORBEVAX®'s approval in India under Emergency Use Authorization for different age groups. Over 100 million doses have been administered in India, and CORBEVAX® received approval as a heterologous booster.

Dr. Peter Hotez, Co-Director of the Center for Vaccine Development at Texas Children's Hospital, emphasized the importance of the WHO's EUL in expediting the availability of a safe and effective COVID-19 vaccine globally, marking a crucial step toward the goal of developing low-cost vaccines for vulnerable populations.

Mahima Datla, Managing Director of Biological E Limited, expressed pleasure at receiving WHO's endorsement, considering it a significant step in the global fight against COVID-19. Additionally, Biological E has licensed a yeast strain expressing a variant of the SARS-CoV-2 virus and has developed a candidate vaccine to address currently circulating variants.

The work of Drs. Peter Hotez and Maria Elena Bottazzi and their team in vaccine technology development has been recognized with awards, nominations for the Nobel Peace Prize, and acknowledgment in Fast Company's 2022 Most Creative People in Business.




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