Moderna recently announced that the first participants in the Phase 2/3 KidCOVE study were dosed in what is the first vaccine trial involving children aged six months to 12 years old. Focusing on the COVID-19 vaccine known as mRNA-1273, the study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS). TrialSite recently introduced the two part open label, dose-escalation, age de-escalation and randomized observer-blind, placebo-controlled expansion study that evaluates the safety, tolerability and reactogenicity and effectiveness of two doses of the experimental vaccine given 28 days apart. The sponsor will enroll in total 6,750 pediatric participants in the U.S. and Canada. While some trial sites were bypassed, others were invited to participate in this heavily watched study, including a trial site organization with an urgent care clinic called Pininos Pediatric Clinic in El Paso, Texas.
Chief Executive Officer Stéphane Bancel went on the record, “We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy children in the U.S. and Canada and we thank NIAID and BARDA for their collaboration.” Bancel continued, “It is humbling to know that 53 million doses have been administered to people in the U.S. We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above and this pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population.”
Trial Sites Compete
TrialSite recently reported on one trial site organization in Florida that wasn’t able to secure a contact for this study while an El Paso pediatrician and his clinic were able to secure a contract. Dr. Jorge Sainz from Pininos Pediatric Clinic located in the West El Paso area is the only clinic in this South Texas city participating in this North American-based study. Apparently, Moderna invited the clinic to participate, Dr. Sainz told reporters from local media NBC 9 KTSM.
Urgent Care Center Differentiation
Apparently one of the decision criteria for Moderna was the fact that this particular clinic includes an extensive urgent care center as part of the overall clinic. This represents the ability to monitor at ICU scale, suggests Dr. Sainz, suggesting competitive advantage for this particular trial site location.
Undoubtedly, other factors include the bid for diversity in trial participant representation as this becomes ever more important for vaccine research. El Paso is a predominantly Hispanic city.
Care to Research to Care
El Paso-based Pininos Pediatric Clinic positions itself as the best pediatric care provider in West El Paso. Accredited by the American Board of Pediatrics, the American Down Syndrome Society and the Society of Critical Care Management, they tout over 50 years of experience in this field of medicine.
The group is led by Dr. Jorge G. Sainz, a Pediatric Critical Care and General Pediatrics doctor in El Paso since 2005. He has hired an array of additional professionals including Certified Pediatric Nurse Practitioners, Pediatric Acute Nurse Practitioners, Registered Nurses and Pediatric Medical Assistants.
El Paso on the Research Rise
TrialSite has showcased El Paso as an urban center of importance for research. While a TrialSite clinical trial survey revealed less research in El Paso than other major Texas cities, the concept of research as a care option gains attraction in this regional hub. TrialSite has showcased the Medical Center of Americas Foundation (MCA) in El Paso. Located on a modern biomedical campus in the heart of the city, MCA has become an increasingly influential player in supporting the research ecosystem in this growing city. They have taken a grassroots, community-based approach to connecting health systems, academic medical centers, local clinics, and the private sector with the biopharmaceutical industry to serve as a catalyst to attract new studies and drive new innovative partnerships. With the continuous march to precision medicine comes an urgent need for dynamic research as a care option culture, which emerges in El Paso.
Call to Action: This clinic, which includes a substantial urgent care clinic, was selected for the first North America vaccine study involving children under 12. An elite site, many other centers were bypassed for this study. Dr. Sainz is building a prominent organization that should be considered by other sponsors for critical and important pediatric research.