” Our study results show that this vaccine is highly effective and very safe. It is made from a little piece of protein, like many currently accredited vaccines in the U.S. and has practical fridge storage requirements, so it will be a crucial addition to the COVID-19 vaccine portfolio, in the U.S. and in countries where supply is lacking,” stated Dr. Kotloff.
Our researchers worked meticulously and expeditiously to guarantee that Americans and nations throughout the world had access to safe and effective vaccines to slow the pandemic and conserve 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 most current research study leads us an action more detailed to licensure of a brand-new vaccine that will impact millions of people.”
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In addition to being extremely effective in preventing COVID health problem of any severity, the vaccine was 100 percent efficient in preventing moderate and severe disease that required hospitalization.
During the very first few months of 2021 when the research study was performed in the U.S. and Mexico, the primary distributing pressure was Alpha. The assessment did not consist of Delta or Omicron, the most recent variation of concern, which had not begun to flow.
The most common side impacts in the vaccine receivers consisted of pain and inflammation at the injection site, headache, muscle pains, and fatigue that lasted a day on average. None of the receivers developed severe responses like heart inflammation (myocarditis) or blood embolisms.
” Our research study results show that this vaccine is extremely safe and highly effective. In addition, this vaccine has numerous attractive features. It is made from a small piece of protein, like numerous presently certified vaccines in the U.S. and has hassle-free fridge storage requirements, so it will be an essential addition to the COVID-19 vaccine portfolio, in the U.S. and in countries where supply is lacking,” stated Dr. Kotloff.
The UMSOM website registered almost 500 individuals over 18 of age. The individuals were demographically diverse to reflect those in the general population at greatest risk for infection and health problem, including under-represented minority groups who were disproportionately impacted by the pandemic. About 12 percent of the research study individuals remained in the high-risk group of those over age 65 years. About 27 percent of the research study participants at UMSOM determined as Black, 19 percent Hispanic, 16 percent Asian, and 7 percent American Indian or Alaska Native.
Reference: “Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico” by Lisa M. Dunkle, M.D., Karen L. Kotloff, M.D., Cynthia L. Gay, M.D., M.P.H., Germán Áñez, M.D., Jeffrey M. Adelglass, M.D., Alejandro Q. Barrat Hernández, M.D., Wayne L. Harper, M.D., Daniel M. Duncanson, M.D., Monica A. McArthur, M.D., Ph.D., Diana F. Florescu, M.D., R. Scott McClelland, M.D., M.P.H., Veronica Garcia-Fragoso, M.D., Robert A. Riesenberg, M.D., David B. Musante, M.D., David L. Fried, M.D., Beth E. Safirstein, M.D., Mark McKenzie, M.D., Robert J. Jeanfreau, M.D., Jeffrey K. Kingsley, D.O., Jeffrey A. Henderson, M.D., M.P.H., Dakotah C. Lane, M.D., Guillermo M. Ruíz-Palacios, M.D., Lawrence Corey, M.D., Kathleen M. Neuzil, M.D., M.P.H., Robert W. Coombs, M.D., Ph.D., Alex L. Greninger, M.D., Ph.D., Julia Hutter, M.D., Julie A. Ake, M.D., Katherine Smith, M.D., Wayne Woo, M.S., Iksung Cho, M.S., Gregory M. Glenn, M.D., and Filip Dubovsky, M.D., M.P.H. for the 2019nCoV-301 Study Group, 15 December 2021, New England Journal of Medicine.DOI: 10.1056/ NEJMoa2116185.
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, acted as co-authors on this study.
The Novavax trial became part of Operation Warp Speed, a multi-agency collaboration led by the U.S. Department of Health and Human Services (HHS), which intends 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 supplied financing for the study.
” Throughout the pandemic, CVD has actually contributed to the development of several appealing vaccine candidates. Our scientists worked diligently and expeditiously to ensure that Americans and countries throughout the world had access to reliable and safe vaccines to slow the pandemic and save lives,” stated 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 an action closer to licensure of a new vaccine that will affect millions of people.”
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An investigational COVID-19 vaccine made by Novavax was discovered to be 90 percent reliable at avoiding COVID-19 disease, according to arise from a Phase 3 medical trial published on December 15, 2021, in the New England Journal of Medicine. The University of Maryland School of Medicines (UMSOM) Center for Vaccine Development and Global Health served as one of the trial sites, and Karen Kotloff, MD, Professor of Pediatrics at UMSOM, acted as Co-Chair for the trial procedure.
In the research study, researchers hired almost 30,000 adult volunteers at 113 scientific websites in the United States and 6 sites in Mexico. Approximately 20,000 participants got two doses of the vaccine spaced 3 weeks apart and 10,000 received placebo. In addition to being highly efficient in avoiding COVID health problem of any seriousness, the vaccine was 100 percent efficient in avoiding moderate and extreme disease that required hospitalization.
” Our study results indicate that this vaccine is really safe and extremely effective.”– Karen Kotloff, MD, Professor of Pediatrics at UMSOM
