New Novavax COVID-19 Vaccine Found To Be Safe and Effective in Trial
By UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE
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.
Reference: “Efficacy and
Safety of NVX-CoV2373 in Adults in the United States and Mexico” by Lisa
M. Dunkle, M.D., et al. for the 2019nCoV-301 Study Group, 15 December
2021, New England Journal of Medicine.
DOI:
10.1056/NEJMoa2116185
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.”