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.
In the study, researchers recruited nearly 30,000 adult volunteers at 113 clinical sites in the United States and six sites in Mexico. Approximately 20,000 participants received two doses of the vaccine spaced three weeks apart and 10,000 received placebo. In addition to being highly effective in preventing COVID illness of any severity, the vaccine was 100 percent effective in preventing moderate and severe disease that required hospitalization.
During the first few months of 2021 when the study was conducted in the U.S. and Mexico, the predominant circulating strain was Alpha. The assessment did not include Delta or Omicron, the newest variant of concern, which had not begun to circulate.
Most side effects were mild to moderate and transient. Fever was very rare. The most common side effects in the vaccine recipients included pain and tenderness at the injection site, headache, muscle aches and fatigue that lasted a day on average. None of the recipients developed serious reactions like heart inflammation (myocarditis) or blood clots.
“Our study results indicate that this vaccine is highly efficacious and very safe. In addition, this vaccine has many attractive features. It is made from a small piece of protein, like many currently licensed vaccines in the U.S. and has convenient refrigerator storage requirements, so it will be an important addition to the COVID-19 vaccine portfolio, in the U.S. and in countries where supply is lacking,” said Dr. Kotloff.
The UMSOM site enrolled nearly 500 participants over 18 of age. The participants were demographically diverse to reflect those in the general population at highest risk for infection and illness, including under-represented minority groups who were disproportionately affected by the pandemic. About 12 percent of the study participants were in the high-risk group of those over age 65 years. About 27 percent of the study participants at UMSOM identified as Black, 19 percent Hispanic, 16 percent Asian, and 7 percent American Indian or Alaska Native.
Kathleen Neuzil, MD, MPH, FIDSA , the Myron M. Levine, MD, DTPH Professor of Vaccinology and Director, Center for Vaccine Development and Global Health (CVD) at UMSOM, and Monica McArthur, MD, Assistant Professor of Pediatrics, served as co-authors on this study.
The Novavax trial was part of Operation Warp Speed , a multi-agency collaboration led by the U.S. Department of Health and Human Services (HHS), which aims to accelerate the development, manufacturing and distribution of medical countermeasures for COVID-19. Novavax, based in Gaithersburg, MD, and the National Institute of Allergy and Infectious Disease also provided funding for the study.
“Throughout the pandemic, CVD has contributed to the advancement of several promising vaccine candidates. Our researchers worked meticulously and expeditiously to ensure that Americans and nations throughout the world had access to safe and effective vaccines to slow the pandemic and save lives,” said E. Albert Reece , MD, PhD, MBA, Executive Vice President for Medical Affairs, UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor and Dean, University of Maryland School of Medicine. "This latest study leads us a step closer to licensure of a new vaccine that will impact millions of people.”
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 46 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 nearly $600 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 over $6 billion and an economic impact of nearly $20 billion on the state and local community. The School of Medicine, which ranks as the 8th highest among public medical schools in research productivity (according to the Association of American Medical Colleges profile) is an innovator in translational medicine, with 606 active patents and 52 start-up companies . In the latest U.S. News & World Report ranking of the Best Medical Schools, published in 2021, the UM School of Medicine is ranked #9 among the 92 public medical schools in the U.S., and in the top 15 percent (#27) of all 192 public and private U.S. medical schools. The School of Medicine works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit medschool.umaryland.edu
New England Journal of Medicine
Randomized controlled/clinical trial
People
Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico
15-Dec-2021
Supported by Novavax; the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (contract Operation Warp Speed: Novavax Project Agreement number 1 under Medical CBRN [Chemical, Biological, Radiological, and Nuclear] Defense Consortium base agreement no. 2020-530; Department of Defense no. W911QY20C0077); and the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health. The NIAID provides grant funding to the HIV Vaccine Trials Network (HVTN) Leadership and Operations Center (UM1 AI68614), the HVTN Statistics and Data Management Center (UM1 AI68635), the HVTN Laboratory Center (UM1 AI68618), the HIV Prevention Trials Network Leadership and Operations Center (UM1 AI68619), the AIDS Clinical Trials Group Leadership and Operations Center (UM1 AI68636), and the Infectious Diseases Clinical Research Consortium leadership group (UM1 AI148684).