Science. 2022 Jan 7;375(6576):43-50. doi: 10.1126/science.abm3425. Epub 2021 Nov 23. PMID: 34812653.
Gilbert PB, Montefiori DC, McDermott AB, Fong Y, Benkeser D, Deng W, Zhou H, Houchens CR, Martins K, Jayashankar L, Castellino F, Flach B, Lin BC, O'Connell S, McDanal C, Eaton A, Sarzotti-Kelsoe M, Lu Y, Yu C, Borate B, van der Laan LWP, Hejazi NS, Huynh C, Miller J, El Sahly HM, Baden LR, Baron M, De La Cruz L, Gay C, Kalams S, Kelley CF, Andrasik MP, Kublin JG, Corey L, Neuzil KM, Carpp LN, Pajon R, Follmann D, Donis RO, Koup RA; Immune Assays Team§; Moderna, Inc. Team§; Coronavirus Vaccine Prevention Network (CoVPN)/Coronavirus Efficacy (COVE) Team§; United States Government (USG)/CoVPN Biostatistics Team§.
In the coronavirus efficacy (COVE) phase 3 clinical trial, vaccine recipients were assessed for neutralizing and binding antibodies as correlates of risk for COVID-19 disease and as correlates of protection. These immune markers were measured at second vaccination and 4 weeks later, with values reported in standardized WHO International Units. All markers were inversely associated with COVID-19 risk and directly associated with vaccine efficacy. Vaccine recipients with post-vaccination 50% neutralization titers 10, 100, and 1000 had estimated vaccine efficacy of 78% (95% confidence interval 54, 89%), 91% (87, 94%), and 96% (94, 98%), respectively. These results help define immune marker correlates of protection and may guide approval decisions for mRNA COVID-19 vaccines and other COVID-19 vaccines.