Texas Children's 2021 Annual Report

Setting the stage for global distribution of COVID-19 vaccine


Texas Children’s Hospital and Baylor College of Medicine announced on December 28, 2021 that the CORBEVAX vaccine had received emergency use authorization (EUA) approval from the Drugs Controller General of India to launch in India, with other underserved countries to follow. This is a protein sub-unit COVID-19 vaccine whose technology was created and engineered at Texas Children’s Center for Vaccine Development (CVD). The announcement was made as the delta variant of COVID-19 was continuing to spread throughout the world.


This vaccine uses a traditional recombinant protein-based technology that will enable its production at large scales, making it widely accessible to inoculate the global population. The initial construct and production process of the vaccine antigen was developed at Texas Children’s CVD, led by co-directors Dr. Peter Hotez and Dr. Maria Elena Bottazzi. It was in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, to Hyderabad-based vaccine and pharmaceutical company Biological E Limited (BE). Two Phase III clinical trials involving more than 3,000 subjects demonstrated that CORBEVAX was safe, well tolerated and immunogenic.


Addressing a humanitarian crisis

“Protein-based vaccines have been widely used to prevent many other diseases, have proven safety records and use economies of scale to achieve low-cost scalability across the world,” said Bottazzi, who is also Professor and Associate Dean of the National School of Tropical Medicine at Baylor. “Our decade-long studies advancing coronavirus vaccine prototypes has led to the creation of this vaccine, which will fill the access gap created by the more expensive, newer vaccine technologies that are still not able to be quickly scaled for global production.”


The need for safe, streamlined, low-cost vaccines for low- and middle-income countries is central to the world’s fight against the COVID-19 pandemic. Without widespread vaccination of populations in the Global South, additional virus variants will arise, hindering the progress achieved by currently available vaccines in the United States and other Western countries.


“This announcement is an important first step in vaccinating the world and halting the pandemic,” said Hotez, who also serves as Professor and Dean of the National School of Tropical Medicine at Baylor. “Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability that low- and middle-income countries face against the delta variant. Widespread vaccination globally with our Texas Children’s-Baylor-BE vaccine would also forestall the emergence of new variants. We have previously missed that opportunity for the alpha and delta variants. Now is our chance to prevent a new global wave from what might follow.”



“Over the years, we have worked to make quality vaccines and pharmaceutical products accessible to families around the world,” said Mahima Datla, Managing Director of Biological E. Limited. “With this as our backdrop, we resolved to develop an affordable and effective COVID-19 vaccine. It has now become a reality. We deeply appreciate Texas Children’s Center for Vaccine Development, Baylor College of Medicine, the Coalition for Epidemic Preparedness Innovations, the Bill and Melinda Gates Foundation and the government of India for their continuous support and cooperation during this journey. Their combined efforts and unceasing support demonstrate that we can collectively overcome any challenge.”


Texas Children’s CVD received philanthropic support for the development of this vaccine technology from generous donors across the country.



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