This study summary is an excerpt from the book 2 Minute Medicine’s The Classics in Medicine: Summaries of the Landmark Trials
1. In this phase 3 trial, the mRNA-1273 vaccine was found to be efficacious in preventing symptomatic infection from coronavirus disease 2019 (COVID-19) in comparison to a placebo control.
2. All serious cases of COVID-19 occurred in the placebo group and no major safety concerns were identified for the mRNA-1273 vaccine.
Original Date of Publication: February 2021
Study Rundown: The Coronavirus Efficacy (COVE) trial evaluated the efficacy of the mRNA-1273 at preventing symptomatic COVID-19 infection as compared to a placebo injection. The placebo group had significantly higher rates of COVID-19 infection at 14-day follow-up, which was consistent in subgroup analysis of participants with a previous COVID-19 infection and those aged 65 years or older. No cases of severe COVID-19 infection were seen in the intervention group and the incidence of serious adverse events did not differ significantly between groups. The primary limitation of the COVE trial was the short follow-up time for measuring efficacy and adverse events. Although, a two-year follow-up duration is planned for enrolled patients. The COVE trial was the first to demonstrate that the mRNA-1273 vaccine washighly efficacious at preventing COVID-19 infection with a low-risk safety profile for serious adverse events.
In-Depth [randomized control trial]: The participants of the COVE trial received two doses of either the mRNA-1273 vaccine (n = 15 210) or a placebo control injection (n = 15 210) with 28 days between doses and a 14-day follow-up time. The mRNA-1273 vaccine had 95.2% efficacy (95%CI 91.2-97.4) at preventing symptomatic COVID-19 infection as compared to placebo control. Notably, the mRNA-1273 vaccine was found to be 100% efficacious at preventing severe COVID-19 infection. Injection-site adverse events were higher in the mRNA-1273 group after both the first (84.2% versus 19.8%) and second injections (88.6% versus 18.8%). Similarly, systemic adverse reactions were also increased in the intervention group following the first (54.9% versus 42.2%) and second doses (79.4% versus 36.5%). Serious adverse event rates did not differ significantly between the mRNA-1273 and placebo injection groups.
Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. New England Journal of Medicine. 2021 Feb 4;384(5):403–16.
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