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The recently authorized COVID-19 vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) was 94.1% effective in preventing symptomatic COVID-19, according to the results of phase 3 studies published on December 30 in 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 US Food and Drug Administration issued an emergency use authorization for the vaccine, a lipid-nanoparticle-encapsulated mRNA vaccine that expresses the pre-stabilized peak glycoprotein.
The trial began in July and enrolled 30,420 adults in the United States. Volunteers were randomly assigned a 1: 1 ratio to receive either two doses of vaccine or two photos with placebo saline 28 days apart. The average 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 stroke – 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 vaccine was 95.2 percent effective, said study author Lindsey R. Baden, MD, of Brigham and Women’s Hospital, Boston. , Massachusetts and colleagues.
Approximately half of the participants who received mRNA-1273 had 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 infectivity.
Both the Moderna vaccine and the Pfizer-BioNTech vaccine “begin to protect recipients about 10 days after the first dose, with maximum protection after the second dose,” Barton F. Haynes, MD, said in an accompanying editorial.
That both have “almost identical 94% to 95% vaccine efficacy – and that both vaccines have been 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.
Continuous safety monitoring and analysis of virus escape from protective immune responses will be important, Haynes added.
Analyzes of subgroups by age, sex, race / ethnicity and risk for severe COVID-19 showed “maintaining overall efficacy”. posted on Twitter Medscape Editor-in-Chief Eric Topol, MD, leader of the Scripps Institute of Translational Science in La Jolla, California.
Subgroup analysis, maintenance of efficacy across the board pic.twitter.com/SbxeQMTYRz
— Eric Topol (@EricTopol) December 30, 2020
Topol noted the severe absence of COVID-19 among participants who received the vaccine. All 30 study participants who developed severe COVID-19 were in the placebo group. One death of these participants was attributed to COVID-19.
The study was supported by the Authority for Advanced Biomedical Research and Development and NIAID. Baden is an assistant editor at 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. 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 the Moderna stock at some point in the last year, received grants from the NIH outside of its work and has ongoing patents related to the development of the COVID-19 vaccine. He has collaborated with Baden on HIV vaccine research projects.
N Engl J Med. Published online December 30, 2020. Full text
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