Risk of COVID-19 after natural infection or vaccination

the NIAID-funded COVID-19 Prevention Network (CoVPN)

doi:10.1016/j.ebiom.2023.104799

Risk of COVID-19 after natural infection or vaccination

the NIAID-funded COVID-19 Prevention Network (CoVPN)

Mailman School of Public Health

Producción científica › revisión exhaustiva

1 Cita (Scopus)

Resumen

Background: While vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection. Methods: In this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection status at enrolment and treatment: no previous infection/placebo; previous infection/placebo; no previous infection/vaccine; and previous infection/vaccine. The main outcome was RT-PCR-confirmed COVID-19 >7–15 days (per original protocols) after final study injection. We calculated crude and adjusted efficacy measures. Findings: Previous infection/placebo participants had a 92% decreased risk of future COVID-19 compared to no previous infection/placebo participants (overall hazard ratio [HR] ratio: 0.08; 95% CI: 0.05–0.13). Among single-dose Janssen participants, hybrid immunity conferred greater protection than vaccine alone (HR: 0.03; 95% CI: 0.01–0.10). Too few infections were observed to draw statistical inferences comparing hybrid immunity to vaccine alone for other trials. Vaccination, previous infection, and hybrid immunity all provided near-complete protection against severe disease. Interpretation: Previous infection, any hybrid immunity, and two-dose vaccination all provided substantial protection against symptomatic and severe COVID-19 through the early Delta period. Thus, as a surrogate for natural infection, vaccination remains the safest approach to protection. Funding: National Institutes of Health.

Idioma original	English
Número de artículo	104799
Publicación	eBioMedicine
Volumen	96
DOI	https://doi.org/10.1016/j.ebiom.2023.104799
Estado	Published - oct. 2023

Financiación

Funding: This work was supported by National Institutes of Health UM1 AI068614 to LC, GEG for CoVPN Operational Infrastructure; UM1 AI068635 to PBG, YuH, HEJ for CoVPN cross-protocol statistical analyses; K23AI159399 to AMR; UM1 AI069412 to LRB, SRW, P30 AI50410 to CLG; 3UM1AI148575-01S2 to HMES. National Institutes of Health.We are grateful to Victoria Salinas, BA, who provided support through data illustrations, Samuel T. Robinson, PhD, who provided technical writing and editing assistance, and Nicole Na, who provided administrative assistance. Co-authors have reported support for this manuscript from the following entities: National Institutes of Health (AMR, LRB, HMES, PBG, YuH, LC, SRW), AstraZeneca (IH), BARDA (FS), Johnson & Johnson (FS). Funding: This work was supported by National Institutes of Health UM1 AI068614 to LC, GEG for CoVPN Operational Infrastructure; UM1 AI068635 to PBG, YuH, HEJ for CoVPN cross-protocol statistical analyses; K23AI159399 to AMR; UM1 AI069412 to LRB, SRW, P30 AI50410 to CLG; 3UM1AI148575-01S2 to HMES.

Financiadores	Número del financiador
National Institutes of Health	UM1 AI069412, P30 AI50410, K23AI159399, 3UM1AI148575-01S2, UM1 AI068635, UM1 AI068614
AstraZeneca
Johnson and Johnson
Biomedical Advanced Research and Development Authority

ASJC Scopus Subject Areas

General Biochemistry,Genetics and Molecular Biology

ODS de las Naciones Unidas

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@article{99c139eecb2a4eff9017820bded5707f,

title = "Risk of COVID-19 after natural infection or vaccination",

abstract = "Background: While vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection. Methods: In this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection status at enrolment and treatment: no previous infection/placebo; previous infection/placebo; no previous infection/vaccine; and previous infection/vaccine. The main outcome was RT-PCR-confirmed COVID-19 >7–15 days (per original protocols) after final study injection. We calculated crude and adjusted efficacy measures. Findings: Previous infection/placebo participants had a 92% decreased risk of future COVID-19 compared to no previous infection/placebo participants (overall hazard ratio [HR] ratio: 0.08; 95% CI: 0.05–0.13). Among single-dose Janssen participants, hybrid immunity conferred greater protection than vaccine alone (HR: 0.03; 95% CI: 0.01–0.10). Too few infections were observed to draw statistical inferences comparing hybrid immunity to vaccine alone for other trials. Vaccination, previous infection, and hybrid immunity all provided near-complete protection against severe disease. Interpretation: Previous infection, any hybrid immunity, and two-dose vaccination all provided substantial protection against symptomatic and severe COVID-19 through the early Delta period. Thus, as a surrogate for natural infection, vaccination remains the safest approach to protection. Funding: National Institutes of Health.",

author = "{the NIAID-funded COVID-19 Prevention Network (CoVPN)} and Rick, {Anne Marie} and Laurens, {Matthew B.} and Ying Huang and Chenchen Yu and Martin, {Thomas C.S.} and Rodriguez, {Carina A.} and Rostad, {Christina A.} and Maboa, {Rebone M.} and Baden, {Lindsey R.} and {El Sahly}, {Hana M.} and Beatriz Grinsztejn and Gray, {Glenda E.} and Gay, {Cynthia L.} and Gilbert, {Peter B.} and Janes, {Holly E.} and Kublin, {James G.} and Yunda Huang and Brett Leav and Ian Hirsch and Frank Struyf and Dunkle, {Lisa M.} and Neuzil, {Kathleen M.} and Lawrence Corey and Goepfert, {Paul A.} and Walsh, {Stephen R.} and Dean Follmann and Kotloff, {Karen L.} and Atoya Adams and Eric Miller and Rankin, {Bruce G.} and Steven Shinn and Marshall Nash and Green, {Sinikka L.} and Colleen Jacobsen and Jayasree Krishnankutty and Sikhongi Phungwayo and Glover, {Richard M.} and Stacy Slechta and Troy Holdeman and Robyn Hartvickson and Amber Grant and Poling, {Terry L.} and Klein, {Terry D.} and Klein, {Thomas C.} and Klein, {Tracy R.} and Smith, {William B.} and Gibson, {Richard L.} and Jennifer Winbigler and Elizabeth Parker and Justman, {Jessica E.}",

note = "Publisher Copyright: {\textcopyright} 2023 The Authors",

year = "2023",

month = oct,

doi = "10.1016/j.ebiom.2023.104799",

language = "English",

volume = "96",

journal = "eBioMedicine",

issn = "2352-3964",

publisher = "Elsevier BV",

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TY - JOUR

T1 - Risk of COVID-19 after natural infection or vaccination

AU - the NIAID-funded COVID-19 Prevention Network (CoVPN)

AU - Rick, Anne Marie

AU - Laurens, Matthew B.

AU - Huang, Ying

AU - Yu, Chenchen

AU - Martin, Thomas C.S.

AU - Rodriguez, Carina A.

AU - Rostad, Christina A.

AU - Maboa, Rebone M.

AU - Baden, Lindsey R.

AU - El Sahly, Hana M.

AU - Grinsztejn, Beatriz

AU - Gray, Glenda E.

AU - Gay, Cynthia L.

AU - Gilbert, Peter B.

AU - Janes, Holly E.

AU - Kublin, James G.

AU - Huang, Yunda

AU - Leav, Brett

AU - Hirsch, Ian

AU - Struyf, Frank

AU - Dunkle, Lisa M.

AU - Neuzil, Kathleen M.

AU - Corey, Lawrence

AU - Goepfert, Paul A.

AU - Walsh, Stephen R.

AU - Follmann, Dean

AU - Kotloff, Karen L.

AU - Adams, Atoya

AU - Miller, Eric

AU - Rankin, Bruce G.

AU - Shinn, Steven

AU - Nash, Marshall

AU - Green, Sinikka L.

AU - Jacobsen, Colleen

AU - Krishnankutty, Jayasree

AU - Phungwayo, Sikhongi

AU - Glover, Richard M.

AU - Slechta, Stacy

AU - Holdeman, Troy

AU - Hartvickson, Robyn

AU - Grant, Amber

AU - Poling, Terry L.

AU - Klein, Terry D.

AU - Klein, Thomas C.

AU - Klein, Tracy R.

AU - Smith, William B.

AU - Gibson, Richard L.

AU - Winbigler, Jennifer

AU - Parker, Elizabeth

AU - Justman, Jessica E.

PY - 2023/10

Y1 - 2023/10

N2 - Background: While vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection. Methods: In this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection status at enrolment and treatment: no previous infection/placebo; previous infection/placebo; no previous infection/vaccine; and previous infection/vaccine. The main outcome was RT-PCR-confirmed COVID-19 >7–15 days (per original protocols) after final study injection. We calculated crude and adjusted efficacy measures. Findings: Previous infection/placebo participants had a 92% decreased risk of future COVID-19 compared to no previous infection/placebo participants (overall hazard ratio [HR] ratio: 0.08; 95% CI: 0.05–0.13). Among single-dose Janssen participants, hybrid immunity conferred greater protection than vaccine alone (HR: 0.03; 95% CI: 0.01–0.10). Too few infections were observed to draw statistical inferences comparing hybrid immunity to vaccine alone for other trials. Vaccination, previous infection, and hybrid immunity all provided near-complete protection against severe disease. Interpretation: Previous infection, any hybrid immunity, and two-dose vaccination all provided substantial protection against symptomatic and severe COVID-19 through the early Delta period. Thus, as a surrogate for natural infection, vaccination remains the safest approach to protection. Funding: National Institutes of Health.

AB - Background: While vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection. Methods: In this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection status at enrolment and treatment: no previous infection/placebo; previous infection/placebo; no previous infection/vaccine; and previous infection/vaccine. The main outcome was RT-PCR-confirmed COVID-19 >7–15 days (per original protocols) after final study injection. We calculated crude and adjusted efficacy measures. Findings: Previous infection/placebo participants had a 92% decreased risk of future COVID-19 compared to no previous infection/placebo participants (overall hazard ratio [HR] ratio: 0.08; 95% CI: 0.05–0.13). Among single-dose Janssen participants, hybrid immunity conferred greater protection than vaccine alone (HR: 0.03; 95% CI: 0.01–0.10). Too few infections were observed to draw statistical inferences comparing hybrid immunity to vaccine alone for other trials. Vaccination, previous infection, and hybrid immunity all provided near-complete protection against severe disease. Interpretation: Previous infection, any hybrid immunity, and two-dose vaccination all provided substantial protection against symptomatic and severe COVID-19 through the early Delta period. Thus, as a surrogate for natural infection, vaccination remains the safest approach to protection. Funding: National Institutes of Health.

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U2 - 10.1016/j.ebiom.2023.104799

DO - 10.1016/j.ebiom.2023.104799

M3 - Article

C2 - 37738833

AN - SCOPUS:85174937855

SN - 2352-3964

VL - 96

JO - eBioMedicine

JF - eBioMedicine

M1 - 104799

ER -

Risk of COVID-19 after natural infection or vaccination

Resumen

Financiación

ASJC Scopus Subject Areas

ODS de las Naciones Unidas

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