Skip to main content

UM School of Medicine is First in U.S. to Test Unique RNA Vaccine Candidate for COVID-19

May 05, 2020 | Joanne Morrison

Researchers will Test COVID-19 RNA-Based Vaccine Candidates Developed by Pfizer and BioNTech

Kathleen Neuzil, MD, MPHIn 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.

Kirsten Lyke, MDWe 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.

E. Albert Reece, MD, PhD, MBAThe 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.

 

For individuals interested in participating in this important vaccine trial:

Call 1 (410) 706-6156, text COVID19Vaccine to #555888, email clintrial@som.umaryland.edu, or visit:
https://www.medschool.umaryland.edu/cvd/trials/Experimental-COVID-19-Vaccine/

 

About the University of Maryland School of Medicine

Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world -- with 45 academic departments, centers, institutes, and programs; and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Medicine and the National Academy of Sciences, and a distinguished two-time winner of the Albert E. Lasker Award in Medical Research.  With an operating budget of more than $1.2 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic and clinically based care for nearly 2 million patients each year. The School of Medicine has more than $540 million in extramural funding, with most of its academic departments highly ranked among all medical schools in the nation in research funding. As one of the seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total population of nearly 9,000 faculty and staff, including 2,500 student trainees, residents, and fellows. The combined School of Medicine and Medical System (“University of Maryland Medicine”) has an annual budget of nearly $6 billion and an economic impact more than $15 billion on the state and local community. The School of Medicine faculty, which ranks as the 8th highest among public medical schools in research productivity, is an innovator in translational medicine, with 600 active patents and 24 start-up companies. The School of Medicine works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit medschool.umaryland.edu.

About the Center for Vaccine Development and Global Health

For over 40 years, researchers in the Center for Vaccine Development and Global Health have worked domestically and internationally to develop, test, and deploy vaccines to aid the world’s underserved populations. CVD is an academic enterprise engaged in the full range of infectious disease intervention from basic laboratory research through vaccine development, pre-clinical and clinical evaluation, large-scale pre-licensure field studies, and post-licensure assessments. CVD has worked to eliminate vaccine-preventable diseases. CVD has created and tested vaccines against cholera, typhoid fever, paratyphoid fever, non-typhoidal Salmonella disease, shigellosis (bacillary dysentery), Escherichia coli diarrhea, nosocomial pathogens, tularemia, influenza, malaria and other infectious diseases. CVD’s research covers the broader goal of improving global health by conducting innovative, leading research in Baltimore and around the world. CVD researchers are developing new and improved ways to diagnose, prevent, treat, control, and eliminate diseases of global impact. Currently, these diseases include typhoid, Shigella, E. coli diarrhea, malaria, and other vaccine-preventable infectious diseases. CVD researchers have been involved in critical vaccine development for emerging pathogens such as Ebola and Zika. In addition, CVD’s work focuses on the ever-growing challenge of antimicrobial resistance.

Contact

Joanne Morrison
Director of Marketing and Public Relations
Center for Vaccine Development and Global Health
University of Maryland School of Medicine
jmorrison@som.umaryland.edu
Office: (410) 706-2884
Mobile: (202) 841-3369

Related stories

    Monday, October 02, 2023

    UM School of Medicine Researchers Present Interim Results on Meningococcal Vaccine for Infants and Young Children in Africa

    University of Maryland School of Medicine (UMSOM) researchers, as part of the Infectious Diseases Clinical Research Consortium (IDCRC), provided an interim analysis showing that the pentavalent (NmCV-5) meningitis vaccine is safe for use in 9-month-old infants in the meningitis belt of sub-Saharan Africa. They presented their results to the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) on Immunization on September 26.


    Tuesday, December 20, 2022

    COVID Vaccines Prevented 3 Million Deaths in the U.S., New Analysis Finds

    In the two years since the first COVID-19 vaccines were given to patients in the U.S., the vaccines had the cumulative effect of preventing 18 million hospitalizations and 3 million deaths. That is based on a new modeling analysis conducted by a researcher at the University of Maryland School of Medicine (UMSOM) and her colleagues. Results of the analysis were published by the Commonwealth Fund.


    Wednesday, February 16, 2022

    Study Shows New Drug Combination More Effective Against SARS-CoV-2

    Researchers at the University of Maryland School of Medicine (UMSOM) and University of Pennsylvania Perelman School of Medicine have identified a powerful combination of antivirals to treat COVID-19. The researchers showed that combining the experimental drug brequinar with either of the two drugs already approved by the U.S. Food and Drug Administration for emergency use, remdesivir or molnupiravir, inhibited growth of the SARS-CoV-2 virus in human lung cells and in mice. Their findings suggest that these drugs are more potent when used in combination than individually.


    Wednesday, January 26, 2022

    Trial Co-led by University of Maryland School of Medicine Scientist Confirms Safety of “Mix-and-Match” COVID-19 Vaccine Booster Dosing

    A University of Maryland School of Medicine (UMSOM), Center for Vaccine Development and Global Health (CVD), expert is co-leading an ongoing study that was pivotal in recommending adults and teens receive booster COVID-19 shots of their choosing starting in fall 2021. The preliminary clinical trial results, reported today in The New England Journal of Medicine, found that is safe and effective to receive boosters that are the same or a different one from the person’s primary vaccine(s).


    Thursday, December 16, 2021

    Novavax COVID-19 Vaccine Found to be Safe and Effective in Phase 3 Trial Conducted by UM School of Medicine Researchers

    An investigational COVID-19 vaccine made by Novavax was found to be 90 percent effective at preventing COVID-19 illness, according to results from a Phase 3 clinical trial published today in the New England Journal of Medicine. The University of Maryland School of Medicine’s (UMSOM) Center for Vaccine Development and Global Health served as one of the trial sites, and Karen Kotloff, MD, Professor of Pediatrics at UMSOM, served as Co-Chair for the trial protocol.


    Tuesday, December 14, 2021

    UM School of Medicine’s Office of Public Affairs and Communications Honored with 2021 PRSA ‘Best In Maryland’ Award

    The University of Maryland School of Medicine (UMSOM)'s Office of Public Affairs & Communications received the Public Relations Society of America (PRSA) 2021 “Best in Maryland Award,” the PRSA’s highest honor, for its COVID-19 Communications program. The award was given at the PRSA Maryland Gala, held on December 9, 2021.


    Thursday, September 16, 2021

    First Efficacy Results from Africa find Typhoid Vaccine to offer 84 Percent Protection against Typhoid Fever

    A new study, published in the New England Journal of Medicine, finds a single dose of typhoid conjugate vaccine (TCV) – the only typhoid vaccine licensed for children as young as 6 months – is safe and 84 percent effective in protecting against typhoid in Blantyre, Malawi. These are the first efficacy results from Africa and part of a five-year, multi-country project to accelerate introduction of TCV.


    Wednesday, September 08, 2021

    UM School of Medicine Reaching Underserved Communities Through Grass Roots Efforts to Increase COVID-19 Vaccination Rates

    In an effort to increase COVID-19 vaccination rates among children and families, and ultimately help bring the pandemic under control, the Department of Family & Community Medicine (DFCM) and the Department of Psychiatry at the University of Maryland School of Medicine (UMSOM) are partnering with key community and faith-based groups in Baltimore city to reach the most vulnerable and underserved communities. This partnership will also extend across Maryland, Delaware, Virginia, and West Virginia.


    Wednesday, July 07, 2021

    UM School of Medicine Researchers Develop Two Rapid Tests for COVID-19 Using Innovative Techniques

    Researchers at the University of Maryland School of Medicine (UMSOM) have developed two rapid diagnostic tests for COVID-19 that are nearly as accurate as the gold-standard test currently used in laboratories. Unlike the gold-standard test, which extracts RNA and uses it to amplify the DNA of the virus, these new tests can detect the presence of the virus in as little as five minutes using different methods.


    Wednesday, June 09, 2021

    Global Study of Microbes in 60 Cities Finds Each Has Unique Fingerprint of Viruses and Bacteria

    Each city has its own unique microbiome, a “fingerprint” of viruses and bacteria that serves as type of city profile, according to a new study from an international consortium of researchers that included a team from the University of Maryland School of Medicine (UMSOM). The international project, which sequenced and analyzed samples collected from public transit systems and hospitals in 60 cities around the world, was published today in the journal Cell.


    Tuesday, March 16, 2021

    New Study Finds Healthcare Settings Do Not Pose Added Risk Factor for Covid-19 Infection Spread Among U.S. Healthcare Personnel

    Healthcare personnel who were infected with COVID-19 faced stronger risk factors outside of the workplace than in their hospital or healthcare settings. That is the finding of a new study published today in the Journal of the American Medical association's JAMA Network Open conducted by University of Maryland School of Medicine (UMSOM) researchers and colleagues at the Centers for Disease Control and Prevention (CDC) and three other universities.


    Wednesday, January 27, 2021

    Dr. Wilbur Chen, Nationally-Recognized Vaccine Researcher, Selected for Federal Committee that Guides Immunization Policies

    Wilbur H. Chen, MD, MS, FIDSA, FACP, Professor of Medicine at the University of Maryland School of Medicine (UMSOM), has been named a new voting member of the federal government’s Advisory Committee on Immunization Practices (ACIP), the prestigious board of experts that makes recommendations on the safe use of vaccines for Americans. The U.S. Department of Health and Human Services selected Dr. Chen for the 15-member advisory committee based on his expertise and national leadership in vaccinology, infectious diseases, public health, and preventive medicine. He will remain in his current role at UMSOM while he serves in his four-year term, which began last month.


    Thursday, January 21, 2021

    UM School of Medicine Hosted Media Availability for Ensuring Trust in COVID-19 Vaccine Event

    On January 22, 2021 at 2 p.m., the University of Maryland School of Medicine (UMSOM) hosted Black faith-based leaders, COVID-19 research volunteers, and “America’s Doctor,” Anthony Fauci, MD. The event provided straight talk about fears, trust issues, and why we need our Black and Brown community to be a part of COVID-19 vaccine research.


    Tuesday, January 05, 2021

    Dr. Kathleen Neuzil, World-renowned Leader in Vaccine Research, Receives Moderna Vaccine

    Kathleen Neuzil, MD, MPH, FIDSA, the Myron M. Levine, MD, DTPH, Professor of Vaccinology and Director of the University of Maryland School of Medicine’s (UMSOM)’s Center for Vaccine Development and Global Health (CVD), received her first injection of the Moderna vaccine for COVID-19 on December 31. Researchers at the University of Maryland School of Medicine (UMSOM) played an integral part in the dedicated work that led to the U.S. Food and Drug Administration issuing an Emergency Use Authorization for the Moderna vaccine in December.


    Tuesday, January 05, 2021

    University of Maryland School of Medicine Begins Phase 3 Trial of Novavax COVID-19 Vaccine Candidate

    Researchers at the University of Maryland School of Medicine (UMSOM) will participate in a Phase 3 clinical trial of an investigational COVID-19 vaccine to protect against SARS-CoV-2, the coronavirus causing COVID-19 that continues to impact millions of people around the world. The clinical trial will test the safety and effectiveness of NVX-CoV2373, being developed by U.S. biotechnology company, Novavax, Inc., based in Gaithersburg, MD.


    Thursday, November 19, 2020

    Promising Results Seen in Pfizer/BioNTech COVID-19 Vaccine After Phase 1 Trial by University of Maryland School of Medicine

    Just six months after beginning a clinical development program that first enrolled here at the University of Maryland School of Medicine (UMSOM), Pfizer and BioNTech report interim results showing an mRNA COVID-19 vaccine had no serious safety concerns and has been found to be 95 percent effective in protecting individuals from COVID-19.


    Friday, November 13, 2020

    UM School of Medicine and School of Pharmacy Researchers Identify Promising New Compounds to Potentially Treat Novel Coronaviruses

    Researchers at the University of Maryland School of Medicine (UMSOM) and School of Pharmacy (UMSOP) have discovered new drug compounds to potentially treat the novel coronavirus that causes COVID-19. The compounds disrupt the functioning of a protein complex inside human cells that the researchers discovered is critical for the replication and survival of coronaviruses. This finding could lead to the development of new broad-spectrum antiviral drugs that target viruses such as influenza, Ebola and coronaviruses, according to a new study published today in the Proceedings of the National Academy of Sciences (PNAS) journal.


    Tuesday, June 16, 2020

    UM School of Medicine Researchers Receive Federal Funding to Rapidly Test New Treatments for COVID-19

    Researchers at the University of Maryland School of Medicine (UMSOM) will be partnering on an agreement funded by the federal government’s Defense Advanced Research Projects Agency (DARPA) to rapidly test hundreds of drugs, approved and marketed for other conditions, to see whether any can be repurposed to prevent or treat COVID-19. The compounds will be tested in studies using state-of-the-art technologies in the laboratory of coronavirus researcher Matthew Frieman, PhD., Associate Professor of Microbiology and Immunology at the University of Maryland School of Medicine. UMSOM will receive up to $3.6 million over the next year to fund this effort.


    Tuesday, June 02, 2020

    UM School of Medicine’s Institute of Human Virology Awarded Grants to Strengthen COVID-19 Response in Sub-Saharan Africa

    The Center for International Health, Education and Biosecurity (Ciheb) at the University of Maryland School of Medicine’s Institute of Human Virology was awarded $4 million from the U.S. Centers for Disease Control and Prevention (CDC) to support coronavirus disease 2019 (COVID-19) response activities in Botswana, Nigeria, Malawi, and Mozambique.


    Monday, June 01, 2020

    In A COVID-19 World, Another Threat to the Health of Our Children

    In the U.S., our children rarely fall ill to grave infections because they are protected by vaccines. Serious illnesses like measles, mumps, congenital rubella syndrome, chickenpox, diphtheria, tetanus, whooping cough, rotavirus diarrhea, hepatitis (A and B), polio and bacterial meningitis are all preventable through routine childhood vaccinations.


    Thursday, May 28, 2020

    UM School of Medicine Researchers Develop Experimental Rapid COVID-19 Test Using Innovative Nanoparticle Technique

    Scientists from the University of Maryland School of Medicine (UMSOM) developed an experimental diagnostic test for COVID-19 that can visually detect the presence of the virus in 10 minutes. It uses a simple assay containing plasmonic gold nanoparticles to detect a color change when the virus is present. The test does not require the use of any advanced laboratory techniques, such as those commonly used to amplify DNA, for analysis. The authors published their work last week in the American Chemical Society’s nanotechnology journal ACS Nano.


    Thursday, May 21, 2020

    UM School of Medicine Begins First Innovative Trial of Experimental Stem Cell Therapy to Reduce Deaths in Sickest COVID-19 Patients

    Researchers at the University of Maryland School of Medicine (UMSOM) have begun testing an experimental stem cell therapy developed by Mesoblast Limited to treat hospitalized COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) who are on ventilators to help them breathe. The trial, which is being conducted at the University of Maryland Medical Center (UMMC) and additional sites across the U.S, will involve a total of 300 patients randomized to receive either the drug remestemcel-L or a placebo in addition to the recommended standard of care to manage severe COVID-19 infections. The first patient in this national trial was treated at UMMC.


    Thursday, April 23, 2020

    UM School of Medicine Researchers Test Remdesivir as Potential Therapy for COVID-19 Patients

    Researchers at the University of Maryland School of Medicine (UMSOM) are testing the effectiveness of the investigational antiviral drug remdesivir in hospitalized adult patients with SARS-CoV-2 (COVID-19). The randomized controlled clinical trial is evaluating the safety and effectiveness of the drug, and it is part of a national study funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).


    Friday, April 10, 2020

    University of Maryland School of Medicine Launches New Large Scale COVID-19 Testing Initiative

    University of Maryland School of Medicine (UMSOM) Dean E. Albert Reece, MD, PhD, MBA, announced today the launch of a large-scale COVID-19 Testing Initiative that will significantly expand testing capability over the coming weeks, enabled by new funding of $2.5 million from the State of Maryland.


    Wednesday, April 01, 2020

    Important Coronavirus Update from Dean Reece 04-01

    I am sure you are aware of Governor Hogan’s Executive Order that requires all residents of Maryland to stay at home, except for essential activities. The Governor continues to emphasize that we are still just at the beginning of this crisis in Maryland. While the State has been taking the lead with early containment efforts, we are now at a critical point. Each of our actions can lessen the expected surge in cases over the next few weeks.


    Wednesday, March 25, 2020

    Kids & COVID-19 Website Provides Resources for Pediatric Healthcare Providers and Families

    The University of Maryland School of Medicine has launched a special COVID-19 website for pediatric healthcare providers and practices, parents, and children. This resource brings together important research, professional guidance for pediatric practices, and practical tips for parents and caregivers.


    Wednesday, March 25, 2020

    Important Coronavirus Update from Dean Reece

    As we continue to move forward in these challenging times, I would like to bring you a message of encouragement and hope. First and foremost, please be assured and confident that we are, and will continue to do, everything we can to ensure the health and well-being of all within our community. As you will see in this briefing, significant steps are being taken by the State of Maryland, the University of Maryland Medical System and the University of Maryland, Baltimore to ensure that everyone is healthy and safe. We must each do whatever is necessary to ensure that our health comes first.


    Tuesday, February 25, 2020

    Washington Post Visits UM School of Medicine Laboratories, Meets with Scientists About Coronavirus

    Result is front-page feature coverage of UMSOM’s leading work in studying the Virus


    Wednesday, January 29, 2020

    University of Maryland School of Medicine Mobilizes Virus Experts to prepare for Potential Coronavirus Outbreak

    As public health officials around the world are monitoring a new coronavirus strain (2019-nCoV) first identified in the Wuhan City, Hubei Province, China, the University of Maryland School of Medicine (UMSOM) is mobilizing its physicians and scientists in the UMSOM’s Center for Vaccine Development and Global Health (CVD), and in its Department of Microbiology & Immunology, to study the virus and test potential vaccines and other therapies. In addition, the UMSOM is collaborating with the University of Maryland Medical Center (UMMC) on rapid response and preparedness planning in the event of a growing outbreak.


    Monday, May 15, 2017

    UM SOM Vaccine Researcher Receives Top Award in the Study of Infectious Diseases

    Myron M. Levine, MD, DTPH, the Simon and Bessie Grollman Distinguished Professor and Associate Dean for Global Health, Vaccinology and Infectious Disease at UM SOM, has been awarded the Maxwell Finland Award for Scientific Achievement by the National Foundation for Infectious Diseases (NFID). The award honors his extensive accomplishments in public health; over his career, he has identified solutions to major sources of disease in the developing world, including cholera, typhoid, and Shigella dysentery. The award will be presented on Thursday, May 18, 2017 at the Hyatt Regency Bethesda in Bethesda, Md.