UM School of Medicine is First in U.S. to Test Unique RNA Vaccine Candidate for COVID-19
In a significant development in the global effort to discover a safe and effective vaccine for COVID-19, researchers at the University of Maryland School of Medicine (UMSOM) became the first in the U.S. to begin testing experimental COVID-19 vaccine candidates developed by Pfizer and BioNTech. The research, funded by Pfizer Inc., will study the safety, efficacy, and dosing of an experimental mRNA -based vaccine.
At present, there are no licensed vaccines or therapies for COVID-19, a serious respiratory disease detected in December 2019 in the Wuhan, Hubei Province, in China that has now spread across the globe as a pandemic resulting in some 70,000 deaths in the U.S. alone.
The vaccine research is being conducted in the UMSOM Center for Vaccine Development and Global Health (CVD), and it is part of a multicenter study in the U.S. and in Germany that will include up to 360 participants in this initial stage. In Baltimore, the clinical trial includes up to 90 healthy adult participants, between 18 and 85 years of age.
“We are excited to begin testing these vaccine candidates against COVID-19. The research is on a fast track given the extreme consequences of this pandemic and the critical need for preventive measures,” said Kathleen Neuzil, MD MPH, the Myron, M. Levine, MD, DTPH, Professor in Vaccinology, Professor of Medicine and Pediatrics, and Director of the CVD. Dr. Neuzil and Kirsten Lyke, MD, Professor of Medicine, are the investigators for the vaccine trial, which is now recruiting and screening for participants. The first participant was vaccinated on May 4.
This so-called BNT162 program is a collection of at least four experimental vaccines, each of which represent a different combination of mRNA formats and target antigens. -- mRNA – or messenger RNA – is a long molecule, composed of nucleotides linked in a unique order to convey genetic instructions about how to make proteins. Once mRNA in a vaccine is inside of the body’s cells, it directs the cells to produce protein antigens, which stimulate the immune system of the vaccinated individual, generating immune response to the vaccine antigen. It differs from a traditional vaccine because it is does not inject a virus protein into body.
The participants will receive two injections a month apart. The first group to be vaccinated will include healthy adults aged 18 to 55, and the next group will include volunteers aged 65 to 85 years of age. The researchers will investigate different dosages and types of the vaccine candidates to learn which one is best tolerated and produces the strongest immune response.
“A vaccine is urgently needed for COVID-19. Our infectious disease experts and our vaccine experts at the University of Maryland School of Medicine have decades of experience in developing and testing protections from the leading infectious and emerging diseases. This research is an essential first step in protecting populations around the world from this serious illness,” said Dean E. Albert Reece, MD, PhD, MBA, who is also Executive Vice President for Medical Affairs, UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor, University of Maryland School of Medicine.
Read the full article here: https://www.medschool.umaryland.edu/news/2020/UM-School-of-Medicine-is-First-in-US-to-Test-Unique-RNA-Vaccine-Candidate-for-COVID-19.html