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 United States 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 Wuhan, China, that has spread across the globe as a pandemic and resulted in over 70,000 deaths in the U.S. alone.

Kirsten Lyke, MD, and Kathleen Neuzil, MD, MPH

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 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 CVD. Neuzil and Kirsten Lyke, MD, professor of medicine, are the investigators for the vaccine trial, which is 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 the body.

The participants will receive two injections a month apart. The first group to be vaccinated will include healthy adults ages 18 to 55, and the next group will include volunteers ages 65 to 85. 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 also is executive vice president for medical affairs, University of Maryland, Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor, UMSOM.