Texas Children’s Hospital and Baylor College of Medicine leading COVID-19 subunit vaccine candidate, developed with Biological E. Limited, a Hyderabad-based vaccine and pharmaceutical company, has received approval to proceed with Phase III clinical trials in India.
Biological E. Limited Vaccine Enters Phase III Trials in India this June and Stands Poised to be Delivered to Underserved Nations and Emerge as the “People’s Vaccine”
HOUSTON, June 9, 2021 /PRNewswire/ -- Texas Children’s Hospital and Baylor College of Medicine leading COVID-19 subunit vaccine candidate, developed with Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical company, has received approval to proceed with Phase III clinical trials in India. The initial construct and production process of the antigen was developed at Texas Children’s Hospital Center for Vaccine Development, 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.
The vaccine construct was designed to make a significant impact in the global fight against COVID-19 and is likely to result in being one of the most accessible COVID-19 vaccines available, allowing for many countries to procure sufficient doses for their populations in need. The ability to expedite and disseminate massive quantities of COVID-19 vaccines is an urgent need in addressing the aggressive spread of the virus.
The recombinant protein antigen, developed by Texas Children’s Hospital Center for Vaccine Development, is produced using a reliable and conventional production platform like the one used to produce other widespread licensed vaccines such as Hepatitis B. This well-established technology makes it an ideal candidate for its development as a COVID-19 pediatric and maternal immunization vaccine. Additionally, the COVID-19 vaccine only requires standard refrigeration as opposed to ultra-low freezer storage making it easy to stockpile, transport and deliver.
“In the midst of India’s public health crisis, it is our hope that our Texas Children’s and Baylor COVID-19 vaccine can be released for emergency authorization in India and in all countries in need of essential COVID-19 vaccinations,” said Dr. Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor and co-director, Texas Children’s Hospital Center for Vaccine Development. “The vaccines currently available cannot be manufactured quick enough to meet supply shortages in low-income countries. Our vaccine is truly ‘the people’s vaccine,’ created to serve the most marginalized and underserved populations that are hardest hit by this pandemic. This is the vaccine that could be used to vaccinate the world.”
Following completion of the Phase I/II trials by BE, the vaccine was deemed as safe, well-tolerated and immunogenic by the Central Drugs Standard Control Organization – Subject Expert Committee (SEC). The vaccine, named CORBEVAX in Phase III trials, will be evaluated in 15 sites across India in approximately 1,200 healthy subjects, ages 18 to 80, to establish immunogenicity, safety and protection against COVID-19. CORBEVAX is also intended to be part of a larger global study.
“Having transitioned our vaccine candidate seed and our know-how to BE has enabled the company to rapidly advance into the Phase III clinical studies in India and elevates the likelihood for our vaccine candidate to be globally and rapidly scaled,” 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. “I am proud of our team of scientists for leveraging our extensive expertise in coronavirus research to accelerate the design, production and evaluation of a COVID-19 vaccine candidate that is low-cost and easily administered, especially to low- and middle-income countries, such as my home country Honduras.”
For more information about Texas Children’s Hospital, the Texas Children’s Hospital Center for Vaccine Development, and Biological E. Limited, please visit this link.
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SOURCE Texas Children’s Hospital
