Texas Children’s Hospital and Baylor College of Medicine COVID-19 Vaccine Technology Secures Emergency Use Authorization in India

Texas Children’s Hospital and Baylor College of Medicine announced that CORBEVAX, a protein sub-unit COVID-19 Vaccine, whose technology was created and engineered at its Center for Vaccine Development (CVD), has received Emergency Use Authorization (EUA) approval from the Drugs Controller General of India (DCGI) to launch in India with other underserved countries to follow.

Dubbed “The World’s COVID-19 Vaccine”, it 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 Hospital CVD, led by co-directors Drs. Maria Elena Bottazzi and Peter Hotez and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, to Hyderabad-based vaccine and pharmaceutical company Biological E. Limited (BE).

CORBEVAX after completing two Phase III clinical trials involving more than 3000 subjects was found to be safe, well tolerated and immunogenic:

  • CORBEVAX demonstrated superior immune response in comparison with COVISHIELDTM vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant. CORBEVAX vaccination also generated significant Th1 skewed cellular immune response.
     
  • CORBEVAX nAb GMT against Ancestral-Wuhan strain is indicative of vaccine effectiveness of >90% for prevention of symptomatic infections based on the Correlates of Protection assessment performed during Moderna and Astra-Zeneca vaccine Phase III studies.
     
  • CORBEVAX nAb GMT against the Delta strain indicates a vaccine effectiveness of >80 percent for the prevention of symptomatic infections based on published studies.
     
  • While none of the subjects who took CORBEVAX or COVISHIELD had serious adverse events, CORBEVAX had 50 percent fewer adverse events than COVISHIELDT.
     
  • In the continuous monitoring of phase II studies, CORBEVAX showed high persistence of immune response as indicated by <30% drop in nAb GMT till 6 months second dose as compared to >80% drop observed with majority of the vaccines.

“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 Dr. Maria Elena Bottazzi, Professor and Associate Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children’s Hospital Center for Vaccine Development. “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 and that today are still not able to be quickly scaled for global production.”

The need for safe, streamlined, low-cost vaccines for middle- to low-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. Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability the low- and middle-income countries face against the delta variant,” said Dr. Peter Hotez, Professor and Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children’s Hospital Center for Vaccine Development. “Widespread and global vaccination 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 variant. 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. With this as our backdrop, we resolved to develop an affordable and effective COVID-19 vaccine. It has now become a reality,” said Mahima Datla, Managing Director, Biological E. Limited. “We deeply appreciate Texas Children’s Hospital Center for Vaccine Development, Baylor, CEPI, the Bill and Melinda Gates Foundation, and the government of India for their continuous support and cooperation during this journey. The combined efforts & unceasing support demonstrate that we can collectively overcome any challenge”.

Texas Children’s Hospital CVD received philanthropic support for the development of this vaccine from many generous donors across the country, including a significant contribution from The JPB Foundation in May 2020.

Baylor College of Medicine, BCM Ventures, CORBEVAX, Texas Children’s Hospital

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