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A Population-Based Threshold of Protection for COVID-19 Vaccines

Article scientifique 2021 Anglais

Résumé

Abstract Correlates of protection for COVID-19 vaccines are urgently needed to license and deploy additional vaccines. We measured immune responses to four COVID-19 vaccines of proven efficacy using a single serological platform calibrated to the international standard. IgG anti-Spike antibodies correlated significantly with efficacies for original virus and alpha variant and were highly correlated with ID50 neutralization in a validated pseudoviral assay. The protective threshold for each vaccine was calculated for IgG anti-Spike antibody. The mean protective threshold for all vaccine studies was 154 BAU/ml (95%CI 42-559), and for the vaccine studies with antibody distributions that enabled precise estimation of thresholds (i.e. leaving out 2-dose mRNA studies) was 60 BAU/ml (95%CI 35-102). We propose that the proportion of individuals with responses above the appropriate protective threshold together with the geometric mean concentration can be used in comparative non-inferiority studies with licensed vaccines to ensure that new vaccines will be efficacious.

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Goldblatt, D., Fioré-Gartland, A., Johnson, M., Hunt, A., Bengt, C., Zavadska, D., Brown, J., Workman, L., Zar, H., Montefiori, D., Shen, X., Dull, P., Plotkin, S., Siber, G., Ambrosino, D. (2021). A Population-Based Threshold of Protection for COVID-19 Vaccines. https://doi.org/10.21203/rs.3.rs-832531/v1

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Auteur(s)

David Goldblatt Andrew Fioré-Gartland Marina Johnson Adam Hunt Christopher Bengt Dace Zavadska Jeremy Brown Lesley Workman Heather J. Zar David C. Montefiori Xiaoying Shen Shen Peter Dull Stanley A. Plotkin George R. Siber Donna M. Ambrosino

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