Houston, Texas, USA and Seattle, Washington, USA, May 5, 2020 — The National School of Tropical Medicine at Baylor College of Medicine and Texas Children’s Hospital Center for Vaccine Development have formed a new partnership with PATH, a global nonprofit organization dedicated to improving public health. Together, these institutions will advance the development of a low-cost, safe, and effective vaccine to prevent COVID-19.
Through this alliance, researchers with Baylor, Texas Children’s, and PATH hope to accelerate the vaccine candidate into Phase 1 clinical evaluation later this year. There is an urgent need to advance a COVID-19 vaccine, especially for low- and middle-income nations where diseases often take their greatest toll.
“It is becoming increasingly apparent that this virus poses great risk to low- and middle-income countries of South and Central America, Africa, and Asia,” said Dr. Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children’s Hospital Center for Vaccine Development. “Our goal is to ensure that our development efforts lead to COVID-19 vaccines with global access, so populations can benefit in the many low-resource countries where it is so greatly needed.”
“Throughout my 40-year career in science and global health, I’ve long admired the important role of PATH in accelerating vaccines and other global health technologies,” said Dr. Peter Hotez, also co-director of Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor. “It’s exciting to now join in this endeavor with PATH to address this important global health threat.”
“A vaccine is needed as soon as possible to provide protection against COVID-19, interrupt transmission, and prevent future outbreaks.”— Deborah Higgins, PATH
PATH has expertise in advancing the development and licensure of affordable and effective vaccines and ensuring their availability and accessibility for low- and middle-income countries, including new vaccines for meningococcal A meningitis, malaria, pneumococcal disease, and rotavirus.
Between 2011 to 2016, Baylor and Texas Children’s led a consortium with the New York Blood Center, UTMB Galveston, and Walter Reed Army Institute of Research to advance recombinant protein vaccines for severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS)—and now COVID-19. Their platform is a recombinant protein similar to the technology used to produce and distribute recombinant protein hepatitis B vaccine worldwide.
The new alliance will advance the COVID-19 project to generate proof-of-concept safety and immunological data in humans for a vaccine candidate originally developed by this consortium against SARS, but that also may have the ability to prevent COVID-19 because of genetic similarities, cross-protection, and neutralization between the SARS and COVID-19 coronaviruses. Material produced according to Good Manufacturing Practice standards is already available for study use, enabling an accelerated pathway to the clinic.
“A vaccine is needed as soon as possible to provide protection against COVID-19, interrupt transmission, and prevent future outbreaks globally, but it is especially critical in parts of the world where health systems are weaker and mitigation efforts like hand washing or social distancing are not feasible,” says Deborah Higgins, senior director for PATH’s Center for Vaccine Innovation and Access disease area focused on respiratory infections. “As such, this collaboration is an important step toward understanding this vaccine candidate’s potential as a COVID-19 prevention tool and ensuring that it can be within reach for everyone if successful, no matter where one lives.”
PATH will apply an integrated portfolio and financial management process, providing Baylor support in project and quality management, the execution of the regulated preclinical studies, engagement with US regulatory agencies, and clinical study design and sponsorship. The clinical study is anticipated to be conducted by and at Baylor. Initial funding for this new alliance, provided by Texas Children’s and Baylor, will take the project through Investigational New Drug submission and Phase 1 planning. Additional funding is being sought for the conduct of the Phase 1 study.
“Our goal is to ensure that our development efforts lead to COVID-19 vaccines with global access.”— Dr. Maria Elena Bottazzi, Baylor College of Medicine
Baylor College of Medicine in Houston is recognized as health sciences university and is known for excellence in education, research and patient care. It is the only private medical school in the greater southwest and is ranked 22nd among medical schools for research and 4th for primary care by U.S. News & World Report. Baylor is listed 20th among all U.S. medical schools for National Institutes of Health funding and No. 1 in Texas. The Baylor pediatrics program ranked 8th among all pediatric programs, reflecting the strong affiliation with Texas Children’s Hospital where our faculty care for pediatric patients and our students and residents train. Nationally our physician assistant program was ranked 3rd in the health disciplines category and our nurse anesthesia program ranked 2nd. Located in the Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates Baylor St. Luke’s Medical Center, part of CHI St. Luke’s Health. Currently, Baylor has more than 3,000 trainees in medical, graduate, nurse anesthesia, physician assistant, orthotics and genetic counseling as well as residents and postdoctoral fellows. Follow Baylor College of Medicine on Facebook and Twitter.
PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide. www.path.org
Texas Children’s Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children’s hospital in Texas, and among the top in the nation, Texas Children’s has garnered widespread recognition for its expertise and breakthroughs in pediatric and women’s health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Tower for pediatric research; Texas Children’s Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children’s Hospital West Campus, a community hospital in suburban West Houston; and Texas Children’s Hospital The Woodlands, the first hospital devoted to children’s care for communities north of Houston. The organization also created Texas Children’s Health Plan, the nation’s first HMO for children; Texas Children’s Pediatrics, the largest pediatric primary care network in the country; Texas Children’s Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that’s channeling care to children and women all over the world. Texas Children’s Hospital is affiliated with Baylor College of Medicine. For more information, go to www.texaschildrens.org. Get the latest news by visiting the online newsroom and Twitter at twitter.com/texaschildrens.