Washington, Jun 11 (PTI) An influential Republican Congressman has applauded a Texas-based company for having received approval to proceed with Phase III clinical trials of a low-cost easily administered COVID-19 vaccine in India.
Indian Government has announced an advance purchase of 300 million doses of the vaccine, Congressman Michael McCaul, Ranking Member of the powerful House Foreign Affairs Committee said on Thursday after the Texas Children's Hospital in Houston, announced the Phase III clinical trials for their COVID-19 vaccine candidate.
The vaccines have been developed in partnership with Baylor College of Medicine and Biological E Limited, a Hyderabad-based vaccine and pharmaceutical company.
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 commercialisation team.
“Texas Children's Hospital continues to lead in the research and development of treatments and cures to improve the overall health of the global community,” said McCaul.
“From addressing HIV/AIDS globally and pediatric cancer in sub-Saharan Africa to supporting the development of a new COVID-19 vaccine, they continue to excel in their efforts. I applaud the dedicated health care professionals who made this life-saving effort possible and am proud to be from a state that is leading the charge,” McCaul said.
The vaccine, named CORBEVAX in Phase III trials, will be evaluated in 15 sites across India in approximately 1,200 healthy adults to establish immunogenicity, safety and protection against COVID-19. CORBEVAX is also intended to be part of a larger global study, a media release said.
According to it, 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 immunisation 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 authorisation 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 marginalised and underserved populations that are hardest hit by this pandemic. This is the vaccine that could be used to vaccinate the world," Dr Hotez said.
"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.
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