Coronavirus Efficacy Trial - COVE

Feb 08, 2021
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Moderna; Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases
Date Published:
02/03/2021
Date Updated:
02/08/2021
Original Posted Date:
02/08/2021
References

Contribution To Literature:

The COVE trial showed that an mRNA-1273 coronavirus disease 2019 (COVID-19) vaccine was associated with 94% efficacy at preventing COVID-19 illness.

Description:

The goal of the trial was to evaluate an mRNA-1273 COVID-19 vaccine compared with placebo among patients at high risk for COVID-19 infection or its complications.

Study Design

  • Randomized
  • Parallel
  • Stratified

Healthy adults were randomized to an mRNA-1273 COVID-19 vaccine 100 μg (n = 15,210) versus placebo (n = 15,210). Subjects received a booster injection at 28 days.

  • Total number of enrollees: 30,420
  • Duration of follow-up: Median 62 days
  • Mean patient age: 51 years
  • Percentage female: 47%
  • Percentage with diabetes: 9.5%

Inclusion criteria:

  • Healthy adults ≥18 years of age
  • No known history of COVID-19 infection

Other salient features/characteristics:

  • Positive COVID-19 serology at baseline: 2.2%
  • White race: 79%

Principal Findings:

The primary outcome, symptomatic COVID-19 illness, occurred in 3.3 per 1,000 person-years of the mRNA group compared with 56.5 per 1,000 person-years of the placebo group. Vaccine efficacy was 94.1% (p < 0.001). Vaccine efficacy was 95.2% 14 days after the first dose. Efficacy was the same in various tested subgroups, including age (older vs. younger), sex (men vs. women), and race (non-white vs. white).

Secondary outcomes:

  • Severe COVID-19 illness: 0 in the vaccine group vs. 30 in the placebo group; vaccine efficacy: 100%
  • Local adverse events after the second injection: 88.6% in the vaccine group vs. 18.8% in the placebo group
  • Serious adverse events were rare with a similar incidence between treatment groups

Interpretation:

Among healthy adults, an mRNA-1273 vaccine was effective at preventing COVID-19 illness. The vaccine was associated with 94% efficacy at preventing COVID-19 illness and 100% efficacy at preventing severe COVID-19 illness at a median of 62 days. Protection appeared to be conferred 14 days after the first dose; however, the trial was not designed to evaluate vaccine efficacy after a single dose. This trial was also not designed to assess asymptomatic infection. Serious adverse events were rare and occurred at similar efficacy between the treatment groups. Local reactions at the injection site were more common with the vaccine. It is unknown how long immunity will last after the mRNA vaccine. Follow-up to 2 years is planned.

References:

Baden LR, El Sahly HM, Essink B, et al., on behalf of the COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med 2021;384:403-16.

Editorial: Haynes BF. A New Vaccine to Battle Covid-19. N Engl J Med 2021;384:403-16.

Clinical Topics: COVID-19 Hub, Prevention

Keywords: Coronavirus, COVID-19, Critical Illness, Immunization, Primary Prevention, RNA, Messenger, Vaccination, Vaccines


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