TY - JOUR
T1 - Efficacy of Messenger RNA-1273 Against Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition in Young Adults From March to December 2021
AU - CoVPN 3006 Study Team
AU - Stephenson, Kathryn E
AU - Marcelin, Jasmine R
AU - Pettifor, Audrey E
AU - Janes, Holly
AU - Brown, Elizabeth
AU - Neradilek, Moni
AU - Yen, Catherine
AU - Andriesen, Jessica
AU - Grunenberg, Nicole
AU - Espy, Nicole
AU - Trahey, Meg
AU - Fischer, Rebecca S B
AU - DeSouza, Christopher A
AU - Shisler, Joanna L
AU - Connick, Elizabeth
AU - Houpt, Eric R
AU - Chu, Helen Y
AU - McCulloh, Russel J
AU - Becker-Dreps, Sylvia
AU - Vielot, Nadja A
AU - Kalbaugh, Corey A
AU - Cherabuddi, Kartik
AU - Krueger, Karen M
AU - Rosenberg, Molly
AU - Greenberg, Richard N
AU - Joaquin, Arnel
AU - Immergluck, Lilly Cheng
AU - Corey, Lawrence
PY - 2023/11
Y1 - 2023/11
N2 - 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.
AB - 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.
KW - mRNA-1273 vaccine
KW - lifestyle circumstances
KW - COVID-19
KW - SARS-CoV-2 infection
UR - http://www.scopus.com/inward/record.url?scp=85178463394&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85178463394&partnerID=8YFLogxK
U2 - 10.1093/ofid/ofad511
DO - 10.1093/ofid/ofad511
M3 - Article
C2 - 38023544
SN - 2328-8957
VL - 10
JO - Open Forum Infectious Diseases
JF - Open Forum Infectious Diseases
IS - 11
M1 - ofad511
ER -