Texas Children Hospital | December 29, 2021
Texas Children's Hospital and Baylor College of Medicine announced today 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 ofIndia(DCGI)to launch inIndiawith 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 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 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 COVISHIELD™.
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. 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".
Mahima Datla, Managing Director, Biological E. Limited
ABOUT TEXAS CHILDREN'S HOSPITAL
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 HealthPlan, the nation's first HMO for children; has the largest pediatric primary care network in the country, Texas Children's Pediatrics; 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 Global Health program leads efforts that advance health care equity through innovative collaboration in care, education and research for underserved populations globally. Texas Children's Hospital is affiliated with Baylor College of Medicine.
ABOUT TEXAS CHILDREN'S HOSPITAL CENTER FOR VACCINE DEVELOPMENT
Texas Children's Hospital Center for Vaccine Development is one of the leading vaccine development centers in the world. Established in Washington DC as the Sabin Vaccine Institute Product Development Partnership (PDP) in the year 2000 and after relocating to the Texas Medical Center in 2011, it rebranded as Texas Children's Center for Vaccine Development. For the past two decades it has acquired an international reputation as a non-profit PDP, advancing vaccines for poverty-related neglected tropical diseases (NTDs) and emerging infectious diseases of pandemic importance. In addition, it builds and strengthens capacity for vaccine development locally and with foreign nations and leads global efforts to guide and influence vaccine policy and advocacy through "vaccine diplomacy" as an international bridge for peace and vaccine development capacity.
ABOUT BCM VENTURES
Baylor College of Medicine Ventures is the commercial engine of the health sciences university, created to support the translation of academic knowledge and intellectual assets for the benefit of society. We do this by engaging university innovators, entrepreneurs and industry to fully develop ideas along their best commercial path. We foster a culture of commercialization and engage with industry to identify market opportunities for collaborative ventures.
ABOUT BIOLOGICAL E. LIMITED
Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio. In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.
Innovaccer Inc. | October 13, 2021
Today Innovaccer Inc., the Health Cloud company, announced a partnership with Nemours Children's Health, one of the nation's largest clinically integrated pediatric health systems, to create a unified data platform designed to accelerate Nemours' mission to transform children's health through a holistic care model.
The partnership will integrate and activate clinical and claims data from across the health system to enable intelligent point-of-care analytics that can help identify and close care gaps, optimize management of at-risk lives, and improve clinical outcomes for pediatric patients.
Nemours' clinically integrated network (CIN), Delaware Children's Health Network, will leverage the InnovaccerⓇ Health Cloud for clinical and financial insights for 50K+ patients in their network. The Health Cloud's advanced analytics can then use this unified patient data to generate clinical and business insights that support effective cost, utilization, and risk management across the CIN, and across multiple provider and payer contracts.
Customizable dashboards will allow the CIN leadership to drill into and understand cost, utilization, risk trends; and digitally transform population risk stratification and health management techniques to identify and address specific population management challenges, match risk with levels of care, individualize treatment plans to lower risk and improve function, and ensure alignment with value-based care models.
Indeed, as Nemours Children's Health enters its value-based full-risk contracts they will be using the Innovaccer Health Cloud's intrinsic interoperability and data activation capabilities to integrate payer feeds from both Medicaid and Commercial payers in both the Delaware Valley and Florida—ensuring a 360° actionable view of clinical and financial information.
"Our goal is simple—to redefine children's health by helping our communities and families ensure the healthiest futures for our children. By bringing the full richness of our children's healthcare data together, we can better see and understand 'the big picture,' and address all of the factors that influence a child's health. This partnership will help us continue to deliver the safe, high-quality, whole-person care every child deserves."
Jonathan Miller, Medical Director for the Nemours Value Based Services Organization
About Nemours Children's Health
Nemours Children's Health is one of the nation's largest multistate pediatric health systems, including two free-standing children's hospitals and a network of nearly 80 primary and specialty care practices across five states. Nemours mission is "to provide leadership, institutions, and services to restore and improve the health of children through care and programs not readily available, with one high standard of quality and distinction, regardless of the recipient's financial status." Nemours seeks to transform the health of children by adopting a holistic health model that utilizes innovative, safe, and high-quality care, while also caring for the health of the whole child beyond medicine. Nemours also powers the world's most-visited website for information on the health of children and teens, KidsHealth.org. The Nemours Foundation, established through the legacy and philanthropy of Alfred I. duPont, provides pediatric clinical care, research, education, advocacy and prevention programs to the children, families and communities it serves.
Innovaccer Inc., the Health Cloud company, is a leading San Francisco-based healthcare technology company committed to helping healthcare care as one. The Innovaccer Health Cloud unifies patient data across systems and settings, and empowers healthcare organizations to rapidly develop scalable, modern applications that improve clinical, operational, and financial outcomes. Innovaccer's solutions have been deployed across more than 1,000 care settings in the U.S., enabling more than 37,000 providers to transform care delivery and work collaboratively with payers and life sciences companies. Innovaccer has helped organizations integrate medical records for more than 24 million people and generate more than $600 million in savings. Innovaccer is recognized as a Best in KLAS vendor for 2021 in population health management and is the #1 customer-rated vendor by Black Book.
Texas Children's Hospital | February 23, 2016
Collaboration between two Texas Medical Center institutions has resulted in today’s release of the country’s first hospital-based rapid tests for the Zika virus.Pathologists and clinical laboratory scientists at Texas Children’s Hospital and Houston Methodist Hospital developed the Zika direct test in a matter of weeks as part of the L.E. and Virginia Simmons Collaborative in Virus Detection and Surveillance.