CORBEVAX®, A COVID19 VACCINE DEVELOPED BY BIO E-INDIA BASED ON THE RBD PROTEIN ANTIGEN TECHNOLOGY FROM TEXAS CHILDREN'S HOSPITAL CENTER FOR VACCINE DEVELOPMENT, RECEIVES WORLD HEALTH ORGANIZATION EMERGENCY USE LISTING APPROVAL

The RBD antigen of SARS-CoV-2 producing yeast strain from Texas Children's Hospital / Baylor College of Medicine was used by Biological E Limited, India to develop & manufacture CORBEVAX^®, the COVID-19 vaccine and approximately 100 million doses have been administered to people in India

HOUSTON, Jan. 22, 2024 /PRNewswire/ -- Texas Children's Hospital announces today that Biological E's CORBEVAX^®, a traditional, recombinant protein-based COVID-19 vaccine has received World Health Organization (WHO) approval under Emergency Use Listing (EUL). CORBEVAX^® is developed and commercialized by Biological E Limited, an established global vaccine supplier based in Hyderabad, India, using Pichia pastoris yeast strain expressing Receptor Binding Domain (RBD) protein of SARS-CoV-2 engineered by Texas Children's Hospital Center for Vaccine Development (CVD) and Baylor College of Medicine (BCM),

WHO's EUL procedure applies international standards to evaluate the acceptability of vaccine quality, safety and effectiveness in the context of a public health emergency. The mission of WHO pre-qualification is to work in close cooperation with national regulatory agencies and other partner organizations, such as UNICEF and other UN agencies, to make quality priority medical products available for those who urgently need them.

"The latest approval of CORBEVAX^® under WHO's EUL procedure is a testament to Texas Children's Hospital's established methodology to express important antigenic proteins which will help in the worldwide fight against COVID-19," said Mark A. Wallace, Chief Executive Officer of Texas Children's Hospital. "The recombinant yeast strains enable production of the RBD protein which can be further utilized by vaccine researchers globally to develop & manufacture effective and low-cost vaccines. By providing access to the yeast strains via non-exclusive licensing, we continue our mission to support global vaccine accessibility and availability."

Texas Children's Hospital Center for Vaccine Development and BCM Ventures, Baylor College of Medicine's integrated commercialization arm, licensed the recombinant Pichia pastoris yeast strain that expresses the RBD protein of SARS-CoV-2 to Biological E Limited in 2020. Biological E subsequently developed large scale manufacturing technology for production of the RBD protein complying with Good Manufacturing Practices (GMP) as well as testing & characterization suitable for use as vaccine antigen. The RBD protein was then used as an antigen and formulated with optimized adjuvants (Alum and CpG1018) to develop a COVID-19 candidate vaccine. 

Biological E advanced the candidate vaccine through multiple clinical trials which led to the approval of CORBEVAX^® in India under Emergency Use Authorization by Drugs Controller General of India (DCGI) in a two-dose regimen for the primary immunization. These approvals were first granted for adults (18+ years) in December 2021, followed by adolescents (12-18 Years) in February 2022 and then children (5-12 Years) in April 2022. In June 2022, CORBEVAX^® received EUA from DCGI, for use as a heterologous booster for people over the age of 18 who received COVAXIN or COVISHIELD for their primary immunization. Over 100 million doses of CORBEVAX^® have been administered to people in India so far.

"Achieving approval under WHO's EUL procedure represents an important step toward our goal of helping development of low-cost vaccines for the world's most vulnerable populations," said Dr. Peter Hotez, Co-Director of the Center for Vaccine Development at Texas Children's Hospital and Dean of the National School of Tropical Medicine at Baylor College of Medicine. "Countries around the world will rely on the WHO's EUL to CORBEVAX^® and Biological E's established manufacturing and supply capacity to provide safe, effective inoculation against COVID-19."

"WHO's recognition that CORBEVAX^® qualifies under its EUL procedure will expedite the availability of a safe and effective COVID-19 vaccine developed using the RBD antigen of SARS-CoV-2 producing strain from Texas Children's Hospital," said Dr. Maria Elena Bottazzi, Co-Director of the Center for Vaccine Development at Texas Children's Hospital and Associate Dean of the National School of Tropical Medicine at Baylor College of Medicine. "Our team of scientists has worked diligently for years to bring effective and affordable technologies to those who have been overlooked, with the ultimate goal of providing global solutions to health emergencies."

Ms. Mahima Datla, Managing Director, Biological E Limited, said: ``We are pleased to receive this significant endorsement from WHO for CORBEVAX^®, our COVID-19 vaccine. This approval will provide us with an opportunity to get closer to complete the fight against COVID-19 and make our vaccine available worldwide."

Biological E has also licensed a yeast strain expressing XBB.1.5 RBD variant of SARS-CoV-2 virus from BCM/CVD and has developed a candidate vaccine based on CORBEVAX^® platform as per WHO TAG-CO-VAC guidelines for future COVID19 vaccines to address the currently circulating variants. Biological E has completed requisite pre-clinical studies and have received approval from the Central Drugs Standard Control Organization (CDSCO) to begin pivotal clinical trials in India

Drs. Peter Hotez and Maria Elena Bottazzi and their team received the David and Beatrix Hamburg Award for Advances in Biomedical Research and Clinical Medicine for their vaccine technology development work from the National Academy of Medicine. In 2022, Drs. Hotez and Bottazzi were nominated for the 2022 Nobel Peace Prize and also named two of Fast Company's 2022 Most Creative People in Business for their work in bringing a safe, streamlined, low-cost vaccine technology to the world.

ABOUT TEXAS CHILDREN'S HOSPITAL
Texas Children's Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children's hospital in Texas, and among the top in the nation, Texas Children's has garnered widespread recognition for its expertise and breakthroughs in pediatric and women's health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Tower for pediatric research; Texas Children's Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children's Hospital West Campus, a community hospital in suburban West Houston; and Texas Children's Hospital The Woodlands, the first hospital devoted to children's care for communities north of Houston. The organization also created Texas Children's HealthPlan, the nation's first HMO for children; has the largest pediatric primary care network in the country, Texas Children's Pediatrics; Texas Children's Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that's channeling care to children and women all over the world. Texas Children's Global Health program leads efforts that advance health care equity through innovative collaboration in care, education and research for underserved populations globally. Texas Children's Hospital is affiliated with Baylor College of Medicine. For more information, go towww.texaschildrens.org. Get the latest news by visiting the online newsroom and Twitter at twitter.com/texaschildrens.

ABOUT TEXAS CHILDREN'S HOSPITAL CENTER FOR VACCINE DEVELOPMENT
Texas Children's Hospital Center for Vaccine Development is one of the leading vaccine development centers in the world. Established in Washington DC as the Sabin Vaccine Institute Product Development Partnership (PDP) in the year 2000 and after relocating to the Texas Medical Center in 2011, it rebranded as Texas Children's Center for Vaccine Development. For the past two decades it has acquired an international reputation as a non-profit PDP, advancing vaccines for poverty-related neglected tropical diseases (NTDs) and emerging infectious diseases of pandemic importance. In addition, it builds and strengthens capacity for vaccine development locally and with foreign nations and leads global efforts to guide and influence vaccine policy and advocacy through "vaccine diplomacy" as an international bridge for peace and vaccine development capacity.

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 more than 130 countries and its therapeutic products are sold in India and the USA, Europe. 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 organizational expansion such as developing specialty injectable products for global markets as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

SOURCE Texas Children's Hospital