New Novavax COVID-19 Vaccine Found To Be Safe and Effective in Trial – “Highly Efficacious and Very Safe”

According to the results of a Phase 3 clinical trial published Dec. 15, 2021 in the New England Journal of Medicine, an investigational COVID-19 vaccine made by Novavax was found to be 90 percent effective in preventing COVID-19. -disease. The Center for Vaccine Development and Global Health at the University of Maryland School of Medicine (UMSOM) served as one of the trial sites, and Karen Kotloff, MD, a professor of pediatrics at UMSOM, co-chaired 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. About 20,000 participants received two doses of the vaccine three weeks apart and 10,000 received a placebo. Not only was the vaccine highly effective at preventing COVID disease of any severity, it was 100 percent effective at preventing moderate and severe illnesses that required hospitalization.

“Our study results indicate that this vaccine is highly effective and very safe.” — Karen Kotloff, MD, professor of pediatrics at UMSOM

During the first few months of 2021, when the research was conducted in the US and Mexico, Alpha was the predominant circulating strain. The review did not include Delta or Omicron, the newest variant of care, which had not yet begun to circulate.

Most adverse reactions were mild to moderate and transient. Fever was very rare. The most common adverse reactions in vaccine recipients were pain and tenderness at the injection site, headache, muscle aches, and fatigue lasting an average of one day. None of the recipients developed serious reactions such as inflammation of the heart (myocarditis) or blood clots.

“Our research results indicate that this vaccine is highly effective and very safe. In addition, this vaccine has many attractive properties. It is made from a small piece of protein, like many vaccines currently licensed in the US, and it has easy refrigeration storage requirements, so it will be an important addition to the COVID-19 vaccine portfolio, in the US and in the US. countries where the supply is lacking,” said Dr Kotloff.

The UMSOM site enrolled nearly 500 participants over the age of 18. The participants were demographically diverse to reflect those in the general population at the highest risk of infection and disease, including underrepresented minority groups disproportionately affected by the pandemic. About 12 percent of the study participants belonged to the risk group of people over 65. About 27 percent of study participants at UMSOM identified as black, 19 percent Hispanic, 16 percent Asian, and 7 percent Native American or Alaska Native.

Reference: “Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico” by Lisa M. Dunkle, MD, Karen L. Kotloff, MD, Cynthia L. Gay, MD, MPH, Germán Áñez, MD, Jeffrey M Adelglass, MD, Alejandro Q. Barrat Hernández, MD, Wayne L. Harper, MD, Daniel M. Duncanson, MD, Monica A. McArthur, MD, Ph.D., Diana F. Florescu, MD, R. Scott McClelland, MD, MPH, Veronica Garcia-Fragoso, MD, Robert A. Riesenberg, MD, David B. Musante, MD, David L. Fried, MD, Beth E. Safirstein, MD, Mark McKenzie, MD, Robert J. Jeanfreau, MD , Jeffrey K. Kingsley, DO, Jeffrey A. Henderson, MD, MPH, Dakotah C. Lane, MD, Guillermo M. Ruíz-Palacios, MD, Lawrence Corey, MD, Kathleen M. Neuzil, MD, MPH, Robert W Coombs , MD, Ph.D., Alex L. Greninger, MD, Ph.D., Julia Hutter, MD, Julie A. Ake, MD, Katherine Smith, MD, Wayne Woo, MS, Iksung Cho, MS, Gregory M. Glenn, MD, and Filip Dubovsky, MD, MPH for the 2019nCoV-301 Study Group, Dec. 15, 2021, New England Journal of Medicine.
DOI: 10.156/NEJMoa2116185

Kathleen Neuzil, MD, MPH, FIDSA, de 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 of 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) that aims to develop, manufacture and distribute medical countermeasures for COVID-19. accelerate. Novavax, based in Gaithersburg, MD, and the National Institute of Allergy and Infectious Disease also funded the study.

“Throughout the pandemic, CVD has contributed to the advancement of several promising vaccine candidates. Our researchers worked meticulously and quickly to ensure that Americans and countries around 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 brings us one step closer to getting a license for a new vaccine that will affect millions of people.”