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

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 coronavir...

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Detalles Bibliográficos
Autores principales: Stephenson, Kathryn E, Marcelin, Jasmine R, Pettifor, Audrey E, Janes, Holly, Brown, Elizabeth, Neradilek, Moni, Yen, Catherine, Andriesen, Jessica, Grunenberg, Nicole, Espy, Nicole, Trahey, Meg, Fischer, Rebecca S B, DeSouza, Christopher A, Shisler, Joanna L, Connick, Elizabeth, Houpt, Eric R, Chu, Helen Y, McCulloh, Russel J, Becker-Dreps, Sylvia, Vielot, Nadja A, Kalbaugh, Corey A, Cherabuddi, Kartik, Krueger, Karen M, Rosenberg, Molly, Greenberg, Richard N, Joaquin, Arnel, Immergluck, Lilly Cheng, Corey, Lawrence, Kublin, James G
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10655942/
https://www.ncbi.nlm.nih.gov/pubmed/38023544
http://dx.doi.org/10.1093/ofid/ofad511
Descripción
Sumario: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.