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The recently authorized COVID-19 vaccine developed by Moderna and the National Institute of Allergies and Infectious Diseases (NIAID) was 94.1% effective in preventing symptomatic COVID-19, according to the results of the trial. of phase 3 published on December 30 a The New England Journal of Medicine.
There were no cases of severe COVID-19 among participants who received the vaccine, known as mRNA-1273, and there were no safety concerns.
On December 18, the U.S. Food and Drug Administration issued an emergency use authorization for the vaccine, a lipid-nanoparticle-encapsulated mRNA vaccine that expressed spike glycoprotein stabilized by prefusion.
The trial began in July and enrolled 30,420 adults in the United States. Volunteers were randomly assigned a 1: 1 ratio to receive two doses of the vaccine or two shots of saline placebo 28 days apart. The mean age of the participants was 51 years.
In total, 196 cases of symptomatic COVID-19 occurred at least 14 days after participants received the second shot: 185 cases in the placebo group and 11 in the vaccine group.
In a secondary analysis that included cases that occurred at least 14 days after the first shot, the effectiveness of the vaccine was 95.2%, according to study author Lindsey R. Baden, MD, of the Hospital Brigham and Women, Boston, Massachusetts, and colleagues.
Approximately half of the participants who received mRNA-1273 experienced moderate to severe side effects, such as fatigue, muscle aches, joint pain, and headache, after the second dose. Most adverse events resolved within 20 days
Future studies
Future studies will evaluate the effect of the vaccine on the infection.
Both the Modern Vaccine and the Pfizer-BioNTech vaccine “begin to protect receptors approximately 10 days after the first dose, with maximum protection after the second dose,” Barton F. Haynes, MD, said in an attached editorial.
That both have “an almost identical vaccine efficiency of 94% to 95% – and that both vaccines were developed and tested in less than a year – are extraordinary scientific and medical triumphs,” said Haynes, director of the Duke. Human Vaccine Institute, Durham. North Carolina.
“MRNA technology has the potential to radically change vaccine design for future viral outbreaks,” he said.
There will be continuous monitoring of the safety and analysis of virus leakage from protective immune responses.
Subgroup analyzes by age, sex, race / ethnicity, and severe COVID-19 risk showed “a maintenance of overall efficacy.” he tweeted Medscape Editor-in-Chief Eric Topol, MD, leader of the Scripps Translational Science Institute in La Jolla, California.
Subgroup analysis, maintenance of efficacy across the board pic.twitter.com/SbxeQMTYRz
— Eric Topol (@EricTopol) December 30, 2020
Topol highlighted the absence of severe COVID-19 among participants who received the vaccine. The 30 trial participants who developed severe COVID-19 were part of the placebo group. One death among these participants was attributed to COVID-19.
The study was supported by the Biomedical Authority for Advanced Research and Development and NIAID. Baden is an assistant editor at the The New England Journal of Medicine and received NIH grants during the study. Baden collaborates with federal agencies, companies, and foundations in clinical trials on HIV and COVID-19 vaccines. Some co-authors of the study are employees of Moderna or have revealed links to pharmaceutical companies or grants from foundations and federal agencies. Haynes owned shares of Moderna at one point during the past year, has received grants from the NIH outside of the work submitted, and has pending patents related to the development of the COVID-19 vaccine. He has collaborated with Baden on research projects on HIV vaccines.
N Engl J Med. Published online December 30, 2020. Full text
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