Houston [US], December 29 (ANI): Texas Children's Hospital and Baylor College of Medicine announced on Tuesday (local time) 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 on a large scale making it widely accessible to inoculate the global population. The initial construction 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), Texas Children's Hospital and Baylor College of Medicine said in a statement.
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 the Covishield 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 a significant Th1 skewed cellular immune response, the statement added.
"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 have 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."
With regard to the approval, India's Ambassador to the US, Taranjit Singh Sandhu said in a tweet, "Models of what India and the US healthcare collaboration can achieve for global good! Indian companies working with @TexasChildrens @BCM_TropMed @PeterHotez @Novavax @Merck and Ridgeback Bio."
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 and unceasing support demonstrate that we can collectively overcome any challenge." (ANI)