Efficacy of Messenger RNA-1273 Against Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition in Young Adults From March to December 2021

Kathryn E Stephenson; Jasmine R Marcelin; Audrey E Pettifor; Holly Janes; Elizabeth Brown; Moni Neradilek; Catherine Yen; Jessica Andriesen; Nicole Grunenberg; Nicole Espy; Meg Trahey; Rebecca S B Fischer; Christopher A DeSouza; Joanna L Shisler; Elizabeth Connick; Eric R Houpt; Helen Y Chu; Russel J McCulloh; Sylvia Becker-Dreps; Nadja A Vielot; Corey A Kalbaugh; Kartik Cherabuddi; Karen M Krueger; Molly Rosenberg; Richard N Greenberg; Arnel Joaquin; Lilly Cheng Immergluck; Lawrence Corey; James G Kublin

doi:10.1093/ofid/ofad511

Efficacy of Messenger RNA-1273 Against Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition in Young Adults From March to December 2021

Open Forum Infect Dis. 2023 Nov 2;10(11):ofad511. doi: 10.1093/ofid/ofad511. eCollection 2023 Nov.

Authors

Kathryn E Stephenson^{1

2}, Jasmine R Marcelin³, Audrey E Pettifor⁴, Holly Janes⁵, Elizabeth Brown⁵, Moni Neradilek⁵, Catherine Yen⁶, Jessica Andriesen⁵, Nicole Grunenberg⁵, Nicole Espy⁵, Meg Trahey⁵, Rebecca S B Fischer⁷, Christopher A DeSouza⁸, Joanna L Shisler⁹, Elizabeth Connick¹⁰, Eric R Houpt¹¹, Helen Y Chu¹², Russel J McCulloh¹³, Sylvia Becker-Dreps^{4

14}, Nadja A Vielot¹⁴, Corey A Kalbaugh¹⁵, Kartik Cherabuddi¹⁶, Karen M Krueger¹⁷, Molly Rosenberg¹⁸, Richard N Greenberg¹⁹, Arnel Joaquin²⁰, Lilly Cheng Immergluck²¹, Lawrence Corey^{5

12

22}, James G Kublin⁵

Affiliations

¹ Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
² Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts, USA.
³ Division of Infectious Diseases, Department of Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA.
⁴ Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
⁵ Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
⁶ Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA.
⁷ Department of Epidemiology and Biostatistics, School of Public Health, Texas A&M University, College Station, Texas, USA.
⁸ Department of Integrative Physiology, University of Colorado, Boulder, Colorado, USA.
⁹ Department of Microbiology, University of Illinois, Urbana, Illinois, USA.
¹⁰ Department of Medicine, University of Arizona, Tucson, Arizona, USA.
¹¹ Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia, USA.
¹² Department of Medicine, University of Washington, Seattle, Washington, USA.
¹³ Children's Hospital and Medical Center, University of Nebraska Medical Center, Omaha, Nebraska, USA.
¹⁴ Department of Family Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
¹⁵ Department of Public Health Sciences, Clemson University, Clemson, South Carolina, USA.
¹⁶ Department of Medicine, University of Florida, Gainesville, Florida, USA.
¹⁷ Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
¹⁸ Center for Sexual Health Promotion, Indiana University School of Public Health-Bloomington, Bloomington, Indiana, USA.
¹⁹ Department of Medicine, University of Kentucky, Lexington, Kentucky, USA.
²⁰ Department of Medicine, Charles R. Drew University of Medicine and Science, Los Angeles, California, USA.
²¹ Department of Microbiology, Biochemistry and Immunology, Morehouse School of Medicine, Atlanta, Georgia, USA.
²² Department of Laboratory Medicine, University of Washington,Seattle, Washington, USA.

Abstract

Background: The efficacy of messenger RNA (mRNA)-1273 against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is not well defined, particularly among young adults.

Methods: Adults aged 18-29 years with no known history of SARS-CoV-2 infection or prior vaccination for coronavirus disease 2019 (COVID-19) were recruited from 44 US sites from 24 March to 13 September 2021 and randomized 1:1 to immediate vaccination (receipt of 2 doses of mRNA-1273 vaccine at months 0 and 1) or the standard of care (receipt of COVID-19 vaccine). Randomized participants were followed up for SARS-CoV-2 infection measured by nasal swab testing and symptomatic COVID-19 measured by nasal swab testing plus symptom assessment and assessed for the primary efficacy outcome. A vaccine-declined observational group was also recruited from 16 June to 8 November 2021 and followed up for SARS-CoV-2 infection as specified for the randomized participants.

Results: The study enrolled 1149 in the randomized arms and 311 in the vaccine-declined group and collected >122 000 nasal swab samples. Based on randomized participants, the efficacy of 2 doses of mRNA-1273 vaccine against SARS-CoV-2 infection was 52.6% (95% confidence interval, -14.1% to 80.3%), with the majority of infections due to the Delta variant. Vaccine efficacy against symptomatic COVID-19 was 71.0% (95% confidence interval, -9.5% to 92.3%). Precision was limited owing to curtailed study enrollment and off-study vaccination censoring. The incidence of SARS-CoV-2 infection in the vaccine-declined group was 1.8 times higher than in the standard-of-care group.

Conclusions: mRNA-1273 vaccination reduced the incidence of SARS-CoV-2 infection from March to September 2021, but vaccination was only one factor influencing risk.

Clinical trials registration: NCT04811664.

Keywords: COVID-19; SARS-CoV-2 infection; lifestyle circumstances; mRNA-1273 vaccine.

Associated data

ClinicalTrials.gov/NCT04811664

Abstract

Associated data

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