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

CoVPN 3006 Study Team, 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-DrepsNadja A Vielot, Corey A Kalbaugh, Kartik Cherabuddi, Karen M Krueger, Molly Rosenberg, Richard N Greenberg, Arnel Joaquin, Lilly Cheng Immergluck, Lawrence Corey

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Article numberofad511
JournalOpen Forum Infectious Diseases
Volume10
Issue number11
DOIs
StatePublished - Nov 2023

Keywords

  • mRNA-1273 vaccine
  • lifestyle circumstances
  • COVID-19
  • SARS-CoV-2 infection

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