Towards a population-based threshold of protection for COVID-19 vaccines

David Goldblatt; Andrew Fiore-Gartland; Marina Johnson; Adam Hunt; Christopher Bengt; Dace Zavadska; Hilda Darta Snipe; Jeremy S. Brown; Lesley Workman; Heather J. Zar; David Montefiori; Xiaoying Shen; Peter Dull; Stanley Plotkin; George Siber; Donna Ambrosino

doi:10.1016/j.vaccine.2021.12.006

Towards a population-based threshold of protection for COVID-19 vaccines

David Goldblatt (Corresponding Author), Andrew Fiore-Gartland, Marina Johnson, Adam Hunt, Christopher Bengt, Dace Zavadska, Hilda Darta Snipe, Jeremy S. Brown, Lesley Workman, Heather J. Zar, David Montefiori, Xiaoying Shen, Peter Dull, Stanley Plotkin, George Siber, Donna Ambrosino

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Abstract

Correlates of protection for COVID-19 vaccines are urgently needed to license additional vaccines. We measured immune responses to four COVID-19 vaccines of proven efficacy using a single serological platform. IgG anti-Spike antibodies were highly correlated with ID50 neutralization in a validated pseudoviral assay and correlated significantly with efficacies for protection against infection with wild-type, alpha and delta variant SARS-CoV-2 virus. The protective threshold for each vaccine was calculated for IgG anti-Spike antibody. The mean protective threshold for all vaccine studies for WT virus was 154 BAU/ml (95 %CI 42–559), and for studies with antibody distributions that enabled precise estimation of thresholds (i.e. leaving out 2-dose mRNA regimens) 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.

Original language	English
Pages (from-to)	306-315
Journal	Vaccine
Volume	40
Issue number	2
DOIs	https://doi.org/10.1016/j.vaccine.2021.12.006
Publication status	Published - 21 Jan 2022
Externally published	Yes

Keywords*

Correlates of protection
COVID vaccines
COVID-19
SARS-CoV-2

Field of Science*

3.3 Health sciences
3.2 Clinical medicine

Publication Type*

1.1. Scientific article indexed in Web of Science and/or Scopus database

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.vaccine.2021.12.006Licence: CC BY-NC-ND

Towards a population-based threshold of protectionFinal published version, 1.58 MBLicence: CC BY-NC-ND

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title = "Towards a population-based threshold of protection for COVID-19 vaccines",

abstract = "Correlates of protection for COVID-19 vaccines are urgently needed to license additional vaccines. We measured immune responses to four COVID-19 vaccines of proven efficacy using a single serological platform. IgG anti-Spike antibodies were highly correlated with ID50 neutralization in a validated pseudoviral assay and correlated significantly with efficacies for protection against infection with wild-type, alpha and delta variant SARS-CoV-2 virus. The protective threshold for each vaccine was calculated for IgG anti-Spike antibody. The mean protective threshold for all vaccine studies for WT virus was 154 BAU/ml (95 %CI 42–559), and for studies with antibody distributions that enabled precise estimation of thresholds (i.e. leaving out 2-dose mRNA regimens) 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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AU - Goldblatt, David

AU - Fiore-Gartland, Andrew

AU - Johnson, Marina

AU - Hunt, Adam

AU - Bengt, Christopher

AU - Zavadska, Dace

AU - Snipe, Hilda Darta

AU - Brown, Jeremy S.

AU - Workman, Lesley

AU - Zar, Heather J.

AU - Montefiori, David

AU - Shen, Xiaoying

AU - Dull, Peter

AU - Plotkin, Stanley

AU - Siber, George

AU - Ambrosino, Donna

PY - 2022/1/21

Y1 - 2022/1/21

N2 - Correlates of protection for COVID-19 vaccines are urgently needed to license additional vaccines. We measured immune responses to four COVID-19 vaccines of proven efficacy using a single serological platform. IgG anti-Spike antibodies were highly correlated with ID50 neutralization in a validated pseudoviral assay and correlated significantly with efficacies for protection against infection with wild-type, alpha and delta variant SARS-CoV-2 virus. The protective threshold for each vaccine was calculated for IgG anti-Spike antibody. The mean protective threshold for all vaccine studies for WT virus was 154 BAU/ml (95 %CI 42–559), and for studies with antibody distributions that enabled precise estimation of thresholds (i.e. leaving out 2-dose mRNA regimens) 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.

AB - Correlates of protection for COVID-19 vaccines are urgently needed to license additional vaccines. We measured immune responses to four COVID-19 vaccines of proven efficacy using a single serological platform. IgG anti-Spike antibodies were highly correlated with ID50 neutralization in a validated pseudoviral assay and correlated significantly with efficacies for protection against infection with wild-type, alpha and delta variant SARS-CoV-2 virus. The protective threshold for each vaccine was calculated for IgG anti-Spike antibody. The mean protective threshold for all vaccine studies for WT virus was 154 BAU/ml (95 %CI 42–559), and for studies with antibody distributions that enabled precise estimation of thresholds (i.e. leaving out 2-dose mRNA regimens) 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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KW - COVID vaccines

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Towards a population-based threshold of protection for COVID-19 vaccines

Abstract

Keywords*

Field of Science*

Publication Type*

UN SDGs

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