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NEJM: Moderna COVID-19 vaccine mRNA-1273 94.1% effective. NEJM: Preliminary clinical trials show that Moderna’s COVID-19 vaccine candidate mRNA-1273 has an efficacy of 94.1%.
On December 30, 2020, a peer-reviewed paper titled “Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine” published in NEJM journal provides data from the much-watched COVE clinical study.
The study evaluated mRNA-1273, a vaccine candidate against COVID-19 produced by Moderna. The main analysis results of this two-year study provide evidence that this vaccine can prevent symptomatic infections. Among the more than 30,000 participants who were randomized to receive this vaccine or placebo, 11 in the vaccine group developed symptomatic COVID-19, while among the participants who received the placebo, the number was 185, which indicates prevention The efficacy of symptomatic COVID-19 is 94.1%. Severe COVID-19 cases occurred only in participants who received placebo.
The effectiveness of the mRNA-1273 vaccine in preventing COVID-19. Picture from NEJM, 2020, doi:10.1056/NEJMoa2035389.
The COVE study is part of the COVID-19 Prevention Network (CoVPN) funded by the National Institutes of Health (NIH). The Brigham and Women’s Hospital in the United States is the test site for this clinical trial. In addition, Dr. Lindsey Baden, an infectious disease expert at Brigham and Women’s Hospital and a viral disease vaccine development expert, served as the co-lead researcher of the study and the lead author of this paper.
Baden said, “Our research work continues. In the next few months, we will have more and more data to better determine how this vaccine works, but so far, the results Shows 94.1% efficacy. These data are very convincing. And, importantly, these data show that people can be protected from serious diseases, which means that this vaccine may have an impact on preventing hospitalization and death, at least in This will happen in the first few months after vaccination.”
The study recruited 30,420 adult participants in 99 locations in the United States, of which more than 600 were recruited at Brigham and Women’s Hospital. Eligible participants are 18 years of age or older, have no known history of SARS-CoV-2 infection, and the location or environment puts them at a significant risk of SARS-CoV-2 infection and/or a higher risk of severe COVID-19 . The race and ethnicity ratios in this clinical trial usually represent the demographic structure of the United States (79% are white; 10% are black or African-American; 20% are Hispanic or Latino participants).
These participants received their first injection between July 27 and October 23, 2020, followed by a second injection 28 days later. Each injection is an intramuscular injection with a volume of 0.5 mL, containing 100 μg of mRNA-1273 or a placebo of saline.
In the placebo group, 185 participants developed symptomatic COVID-19 disease; in the vaccine group, 11 participants developed symptoms. In the second analysis, the efficacy of this vaccine was similar among the key interest groups, including those who had SARS-CoV-2 antibodies at the time of enrollment (indicating that they had previously been infected with COVID-19) and those who were 65 years old or older. People above. Thirty participants had severe COVID-19, all from the placebo group.
Starting from randomization, the Data Security Monitoring Committee established by the National Institute of Allergy and Infectious Diseases (NIAID) continued to monitor COVID-19 and severe COVID-19 cases throughout the trial. Participants were closely monitored for adverse events in the weeks following the injection. These researchers have collected and will continue to collect data on any serious adverse events or adverse events requiring medical care within two years of injection.
In general, the participants’ response to the vaccine was mild—about half of the participants experienced fatigue, muscle aches, joint pain, and headaches, especially after the second injection. In most cases, these reactions started about 15 hours after the vaccine was injected and disappeared after two days with no sequelae. The number of adverse events reported in the placebo group and the vaccine group was similar.
Baden said, “While these results are encouraging, they have been limited due to the short follow-up time so far. The long-term data from this ongoing study may allow us to more carefully evaluate the use of this vaccine in different populations. To determine the effect on asymptomatic infections, to understand when immunity is weakened, and to determine whether this vaccine affects infectivity. However, we should not ignore the progress we have made. These developments show that when we work together When it comes to challenging problems, we can do it.”
(source:internet reference only)