The New England Journal of Medicine.
No cases of severe COVID-19 occurred among participants who received the vaccine, known as mRNA-1273, and there were no safety concerns.
The US Food and Drug Administration on December 18 issued an emergency use authorization for the vaccine, a lipid-nanoparticle-encapsulated mRNA vaccine expressing the prefusion-stabilized spike glycoprotein.
The trial began in July and enrolled 30,420 adults in the United States. Volunteers were randomly assigned in a 1:1 ratio to receive either two doses of the vaccine or two shots of saline placebo 28 days apart. The average age of the participants was 51 years.
In all, 196 cases of symptomatic COVID-19 occurred at least 14 days after participants received their second shot 185 cases in the placebo group, and 11 in the vaccine group.
Moderna vaccine shows 94.1% efficacy in a Phase 3 clinical trial There were no safety issues found and the side effects have been mild, though more research is needed on its effect on transmission.
, Associate Editor
The investigational vaccine known as mRNA-1273 was 94.1% effective in preventing symptomatic COVID-19, according to preliminary results from a Phase 3 clinical trial reported in
The New England Journal of Medicine. The vaccine also demonstrated efficacy in preventing severe COVID-19, and investigators identified no safety concerns or evidence of vaccine-associated enhanced respiratory disease (VAERD).
The vaccine was codeveloped by Massachusetts-based Moderna and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Moderna and NIAID previously shared initial results from the COVE trial. On Dec. 18, 2020, the FDA issued an emergency use authorization allowing Moderna to make the vaccine available
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IMAGE: Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, receives the Moderna COVID-19 vaccine at the HHS/NIH COVID-19 Vaccine Kick-Off event at NIH on 12/22/20.. view more
Credit: NIH
WHAT:
The investigational vaccine known as mRNA-1273 was 94.1% efficacious in preventing symptomatic coronavirus disease 2019 (COVID-19), according to preliminary results from a Phase 3 clinical trial reported in the
New England Journal of Medicine. The vaccine also demonstrated efficacy in preventing severe COVID-19. Investigators identified no safety concerns and no evidence of vaccine-associated enhanced respiratory disease (VAERD).
The vaccine was co-developed by Moderna, Inc., a biotechnology company based in Cambridge, Massachusetts, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Moderna and NIAID previously shared initial results from the COVE trial. On Dec. 18,
Moderna s COVID-19 Vaccine Efficacy Confirmed in NEJM Study medscape.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medscape.com Daily Mail and Mail on Sunday newspapers.
Last modified on Thu 17 Dec 2020 17.58 EST
An advisory committee for the US Food and Drug Administration (FDA) has recommended the agency authorize a second Covid-19 vaccine, this one developed by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID).
The recommendation paves the way for the FDA to give emergency approval for a second highly effective vaccine to be used in the US. That approval could come by the end of the week. An FDA analysis found Moderna’s vaccine is more than 94% effective at preventing Covid-19 in a trial of more than 30,000 participants.
The likely authorization of the second vaccine comes after more than 300,000 Americans have succumbed to Covid-19, in a winter-time “third wave” of the disease that is filling hospitals with patients and exhausting healthcare workers.