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December 30, 2020New England Journal of MedicineOpen Access

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

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Overview

Randomized observer-blinded trial shows 94.1% efficacy of mRNA-1273 against Covid-19 in high-risk individuals, indicating strong protection against severe disease.

Key Points

  • To evaluate the efficacy and safety of the mRNA-1273 vaccine in preventing symptomatic Covid-19 illness in individuals at high risk for SARS-CoV-2 infection or severe complications.
  • Phase 3 randomized, observer-blinded, placebo-controlled trial conducted across 99 centers in the United States (NCT04470427).
  • Enrolled 30,420 participants randomly assigned 1:1 to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo spaced 28 days apart.
  • The primary endpoint was the prevention of symptomatic Covid-19 starting at least 14 days after the second injection in individuals without prior SARS-CoV-2 infection.
  • Symptomatic Covid-19 occurred in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0) versus 185 in the placebo group (56.5 per 1000 person-years; 95% CI, 48.7 to 65.3), demonstrating a vaccine efficacy of 94.1% (95% CI, 89.3 to 96.8%; P<0.001).
  • Severe Covid-19 occurred in 30 participants (including one death), all of whom were in the placebo group.
  • Moderate and transient reactogenicity occurred more frequently in the mRNA-1273 arm, but serious adverse events were rare and balanced between groups.

Cite This Study

A 2020 study studied this question.

synapsesocial.com/papers/6a7d04fdb97b7d2d4f83d18ehttps://doi.org/10.1056/nejmoa2035389
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