Evidence map›Paper›PMID 39209823›Full record

Trial reportNature communications2024

Long-term safety and effectiveness of mRNA-1273 vaccine in adults: COVE trial open-label and booster phases.

Lindsey R Baden, Hana M El Sahly, Brandon Essink, Dean Follmann, Gregory Hachigian, Cynthia Strout, J Scott Overcash, Susanne Doblecki-Lewis, Jennifer A Whitaker, Evan J Anderson and 15 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04470427 (A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04470427 phase3completednot on this map

A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older

TypeinterventionalSponsorModernaTX, Inc.Ran2020 to 2022Enrolled30,415ConditionsSARS-CoV-2ArmsmRNA-1273, Placebo
3 · Its place in the literature

Who cites it

23 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Safety and Immunogenicity of an mRNA-1273 Booster in Children.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Trial
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Immunology of RNA-based vaccines: The critical interplay between inflammation and expression.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  10. Article
  11. Review
  12. Molecular mechanisms of SARS-CoV-2 entry: implications for biomedical strategies.Microbiology and molecular biology reviews : MMBR · 2025
    Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. A novel and safe SmartCapFrontiers in immunology · 2025
    Article
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Lindsey R Baden *Brigham and Women's Hospital, Boston, MA, USA. lbaden@bwh.harvard.edu.ORCID 0009-0004-1752-1926
Hana M El Sahly *Baylor College of Medicine, Houston, TX, USA.ORCID 0000-0003-0489-0074
Brandon EssinkMeridian Clinical Research Omaha, Omaha, NE, USA.
Dean FollmannNational Institute of Allergy and Infectious Disease, Bethesda, MD, USA.ORCID 0000-0003-4073-0393
Gregory HachigianBenchmark Research, Sacramento, CA, USA.
Cynthia StroutCoastal Carolina Research Center, Mount Pleasant, SC, USA.
J Scott OvercashVelocity Clinical Research, San Diego, CA, USA.
Susanne Doblecki-LewisUniversity of Miami, Miami, FL, USA.ORCID 0000-0001-6535-6698
Jennifer A WhitakerBaylor College of Medicine, Houston, TX, USA.
Evan J AndersonEmory University School of Medicine, Atlanta, GA, USA.ORCID 0000-0002-1576-4420
Kathleen NeuzilUniversity of Maryland, Baltimore, MD, USA.ORCID 0000-0001-9480-2714
Lawrence CoreyFred Hutchinson Cancer Research Center, Seattle, WA, USA.ORCID 0000-0002-2179-2436
Frances PriddyModerna, Inc., Cambridge, MA, USA.
Joanne E TomassiniModerna, Inc., Cambridge, MA, USA.ORCID 0000-0002-9399-2867
Mollie BrownModerna, Inc., Cambridge, MA, USA.
Bethany GirardModerna, Inc., Cambridge, MA, USA.
Dina StolmanModerna, Inc., Cambridge, MA, USA.
Veronica UrdanetaModerna, Inc., Cambridge, MA, USA.
Xiaowei WangModerna, Inc., Cambridge, MA, USA.
Weiping DengModerna, Inc., Cambridge, MA, USA.
Honghong ZhouModerna, Inc., Cambridge, MA, USA.
Avika DixitModerna, Inc., Cambridge, MA, USA.ORCID 0000-0002-8381-3298
Rituparna DasModerna, Inc., Cambridge, MA, USA.
Jacqueline M MillerModerna, Inc., Cambridge, MA, USA.
COVE Trial Consortium

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI Sinead Delany-Moretlwe, RAPHAEL J LANDOVITZ · 2011 to 2026
$779.5M
LC: HIV Vaccine Trials NetworkUM1AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Margaret Juliana McElrath · 2011 to 2026
$483.6M
SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
Leadership Group for the Infectious Diseases Clinical Research Consortium (IDCRCLG) - Momi-Vax DMID #21-0004 {Supplement #6}UM1AI148684 · NIAID · EMORY UNIVERSITY · PI DAVID S STEPHENS · 2020 to 2026
$77.2M
VTEU SupplementUM1AI148689 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI Karen L. Kotloff · 2020 to 2026
$52.7M
NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI148684NIAID NIH HHS UM1 AI148689
6 · The paper itself

Abstract

Primary vaccination with mRNA-1273 (100-µg) was safe and efficacious at preventing coronavirus disease 2019 (COVID-19) in the previously reported, blinded Part A of the phase 3 Coronavirus Efficacy (COVE; NCT04470427) trial in adults (≥18 years) across 99 U.S. sites. The open-label (Parts B and C) primary objectives were evaluation of long-term safety and effectiveness of primary vaccination plus a 50-µg booster dose; immunogenicity was a secondary objective. Of 29,035 open-label participants, 19,609 received boosters (mRNA-1273 [n = 9647]; placebo-mRNA-1273 [n = 9952]; placebo [n = 10] groups). Booster safety was consistent with that reported for primary vaccination. Incidences of COVID-19 and severe COVID-19 were higher during the Omicron BA.1 than Delta variant waves and boosting versus non-boosting was associated with a significant, 47.0% (95% CI : 39.0-53.9%) reduction of Omicron BA.1 incidence (24.6 [23.4 - 25.8] vs 46.4 [40.6 - 52.7]/1000 person-months). In an exploratory Cox regression model adjusted for time-varying covariates, a longer median interval between primary vaccination and boosting (mRNA-1273 [13 months] vs placebo-mRNA-1273 [8 months]) was associated with significantly lower, COVID-19 risk (24.0% [16.0% - 32.0%]) during Omicron BA.1 predominance. Boosting elicited greater immune responses against SARS-CoV-2 than primary vaccination, irrespective of prior SARS-CoV-2 infection. Primary vaccination and boosting with mRNA-1273 demonstrated acceptable safety, effectiveness and immunogenicity against COVID-19, including emergent variants.

Indexed as

2019-nCoV Vaccine mRNA-1273COVID-19COVID-19 VaccinesImmunization, SecondarySARS-CoV-2AdolescentAdultAgedAntibodies, ViralFemaleHumansImmunogenicity, VaccineMaleMiddle AgedVaccinationVaccine Efficacy2019-nCoV Vaccine mRNA-1273Antibodies, ViralCOVID-19 Vaccines

Identifiers

PMID39209823
PMCPMC11362294

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.