Effectiveness against severe COVID-19 of a seasonal booster dose of bivalent (original/Omicron BA.4-5) mRNA vaccines in persons aged ≥60 years: Estimates over calendar time and by time since administration during prevalent circulation of different Omicron subvariants, Italy, 2022–2023

•We estimated rVE against severe COVID-19 of a seasonal booster dose in 2022–2023.•A seasonal booster dose of bivalent mRNA vaccines was effective up to spring 2023.•rVE early after booster was 83% (95% CI: 79–86%) during circulation of Omicron BA.5.•rVE early after booster was 37% (95% CI: 25–47%)...

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Veröffentlicht in:Vaccine 2024-10, Vol.42 (23), p.126026, Article 126026
Hauptverfasser: Fabiani, Massimo, Mateo-Urdiales, Alberto, Sacco, Chiara, Fotakis, Emmanouil Alexandros, Battilomo, Serena, Petrone, Daniele, Del Manso, Martina, Bella, Antonino, Riccardo, Flavia, Stefanelli, Paola, Palamara, Anna Teresa, Pezzotti, Patrizio
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container_issue 23
container_start_page 126026
container_title Vaccine
container_volume 42
creator Fabiani, Massimo
Mateo-Urdiales, Alberto
Sacco, Chiara
Fotakis, Emmanouil Alexandros
Battilomo, Serena
Petrone, Daniele
Del Manso, Martina
Bella, Antonino
Riccardo, Flavia
Stefanelli, Paola
Palamara, Anna Teresa
Pezzotti, Patrizio
description •We estimated rVE against severe COVID-19 of a seasonal booster dose in 2022–2023.•A seasonal booster dose of bivalent mRNA vaccines was effective up to spring 2023.•rVE early after booster was 83% (95% CI: 79–86%) during circulation of Omicron BA.5.•rVE early after booster was 37% (95% CI: 25–47%) during circulation of Omicron XBB.•The Omicron XBB subvariant might have partly escaped the vaccine-induced immunity. Evaluating how a COVID-19 seasonal vaccination program performed might help to plan future campaigns. This study aims to estimate the relative effectiveness (rVE) against severe COVID-19 of a seasonal booster dose over calendar time and by time since administration. We conducted a retrospective cohort analysis among 13,083,855 persons aged ≥60 years who were eligible to receive a seasonal booster at the start of the 2022–2023 vaccination campaign in Italy. We estimated rVE against severe COVID-19 (hospitalization or death) of a seasonal booster dose of bivalent (original/Omicron BA.4-5) mRNA vaccines by two-month calendar interval and at different times post-administration. We used multivariable Cox regression models, including vaccination as time-dependent exposure, to estimate adjusted hazard ratios (HR) and rVEs as [(1-HR)X100]. The rVE of a seasonal booster decreased from 64.9% (95% CI: 59.8–69.4) in October-November 2022 to 22.0% (95% CI: 15.4–28.0) in April-May 2023, when the majority of vaccinated persons (67%) had received the booster at least 4–6 months earlier. During the epidemic phase with prevalent circulation of the Omicron BA.5 subvariant, rVE of a seasonal booster received ≤90 days earlier was 83.0% (95% CI: 79.1–86.1), compared to 37.4% (95% CI: 25.5–47.5) during prevalent circulation of the Omicron XBB subvariant. During the XBB epidemic phase, rVE was estimated at 15.8% (95% CI: 9.1–20.1) 181–369 days post-administration of the booster dose. In all the analyses we observed similar trends of rVE between persons aged 60–79 and those ≥80 years, although estimates were somewhat lower for the oldest group. A seasonal booster dose received during the vaccination campaign provided additional protection against severe COVID-19 up to April-May 2023, after which the incidence of severe COVID-19 was much reduced. The results also suggest that the Omicron XBB subvariant might have partly escaped the immunity provided by the seasonal booster targeting the original and Omicron BA.4-5 strains of SARS-CoV-2.
doi_str_mv 10.1016/j.vaccine.2024.05.074
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Evaluating how a COVID-19 seasonal vaccination program performed might help to plan future campaigns. This study aims to estimate the relative effectiveness (rVE) against severe COVID-19 of a seasonal booster dose over calendar time and by time since administration. We conducted a retrospective cohort analysis among 13,083,855 persons aged ≥60 years who were eligible to receive a seasonal booster at the start of the 2022–2023 vaccination campaign in Italy. We estimated rVE against severe COVID-19 (hospitalization or death) of a seasonal booster dose of bivalent (original/Omicron BA.4-5) mRNA vaccines by two-month calendar interval and at different times post-administration. We used multivariable Cox regression models, including vaccination as time-dependent exposure, to estimate adjusted hazard ratios (HR) and rVEs as [(1-HR)X100]. The rVE of a seasonal booster decreased from 64.9% (95% CI: 59.8–69.4) in October-November 2022 to 22.0% (95% CI: 15.4–28.0) in April-May 2023, when the majority of vaccinated persons (67%) had received the booster at least 4–6 months earlier. During the epidemic phase with prevalent circulation of the Omicron BA.5 subvariant, rVE of a seasonal booster received ≤90 days earlier was 83.0% (95% CI: 79.1–86.1), compared to 37.4% (95% CI: 25.5–47.5) during prevalent circulation of the Omicron XBB subvariant. During the XBB epidemic phase, rVE was estimated at 15.8% (95% CI: 9.1–20.1) 181–369 days post-administration of the booster dose. In all the analyses we observed similar trends of rVE between persons aged 60–79 and those ≥80 years, although estimates were somewhat lower for the oldest group. A seasonal booster dose received during the vaccination campaign provided additional protection against severe COVID-19 up to April-May 2023, after which the incidence of severe COVID-19 was much reduced. The results also suggest that the Omicron XBB subvariant might have partly escaped the immunity provided by the seasonal booster targeting the original and Omicron BA.4-5 strains of SARS-CoV-2.</description><identifier>ISSN: 0264-410X</identifier><identifier>ISSN: 1873-2518</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2024.05.074</identifier><identifier>PMID: 38834428</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Age groups ; Bivalent mRNA vaccines ; Calendars ; Circulation ; COVID-19 ; COVID-19 vaccines ; Effectiveness ; Elderly population ; Epidemics ; Estimates ; Health surveillance ; Hospitalization ; Infections ; Laboratories ; mRNA ; mRNA vaccines ; Omicron subvariants ; Population ; Regression analysis ; Regression models ; SARS-CoV-2 ; Severe acute respiratory syndrome coronavirus 2 ; Time dependence ; Vaccines</subject><ispartof>Vaccine, 2024-10, Vol.42 (23), p.126026, Article 126026</ispartof><rights>2024 The Author(s)</rights><rights>Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.</rights><rights>2024. 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The rVE of a seasonal booster decreased from 64.9% (95% CI: 59.8–69.4) in October-November 2022 to 22.0% (95% CI: 15.4–28.0) in April-May 2023, when the majority of vaccinated persons (67%) had received the booster at least 4–6 months earlier. During the epidemic phase with prevalent circulation of the Omicron BA.5 subvariant, rVE of a seasonal booster received ≤90 days earlier was 83.0% (95% CI: 79.1–86.1), compared to 37.4% (95% CI: 25.5–47.5) during prevalent circulation of the Omicron XBB subvariant. During the XBB epidemic phase, rVE was estimated at 15.8% (95% CI: 9.1–20.1) 181–369 days post-administration of the booster dose. In all the analyses we observed similar trends of rVE between persons aged 60–79 and those ≥80 years, although estimates were somewhat lower for the oldest group. A seasonal booster dose received during the vaccination campaign provided additional protection against severe COVID-19 up to April-May 2023, after which the incidence of severe COVID-19 was much reduced. 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Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>ProQuest Consumer Health Database</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Health Management Database (Proquest)</collection><collection>PML(ProQuest Medical Library)</collection><collection>ProQuest_Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>ProQuest Biological Science Journals</collection><collection>Research Library (Corporate)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Vaccine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fabiani, Massimo</au><au>Mateo-Urdiales, Alberto</au><au>Sacco, Chiara</au><au>Fotakis, Emmanouil Alexandros</au><au>Battilomo, Serena</au><au>Petrone, Daniele</au><au>Del Manso, Martina</au><au>Bella, Antonino</au><au>Riccardo, Flavia</au><au>Stefanelli, Paola</au><au>Palamara, Anna Teresa</au><au>Pezzotti, Patrizio</au><aucorp>on behalf of the Italian Integrated Surveillance of COVID-19 study group and of the Italian COVID-19 Vaccines Registry group</aucorp><aucorp>Italian Integrated Surveillance of COVID-19 study group and of the Italian COVID-19 Vaccines Registry group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness against severe COVID-19 of a seasonal booster dose of bivalent (original/Omicron BA.4-5) mRNA vaccines in persons aged ≥60 years: Estimates over calendar time and by time since administration during prevalent circulation of different Omicron subvariants, Italy, 2022–2023</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2024-10-03</date><risdate>2024</risdate><volume>42</volume><issue>23</issue><spage>126026</spage><pages>126026-</pages><artnum>126026</artnum><issn>0264-410X</issn><issn>1873-2518</issn><eissn>1873-2518</eissn><abstract>•We estimated rVE against severe COVID-19 of a seasonal booster dose in 2022–2023.•A seasonal booster dose of bivalent mRNA vaccines was effective up to spring 2023.•rVE early after booster was 83% (95% CI: 79–86%) during circulation of Omicron BA.5.•rVE early after booster was 37% (95% CI: 25–47%) during circulation of Omicron XBB.•The Omicron XBB subvariant might have partly escaped the vaccine-induced immunity. Evaluating how a COVID-19 seasonal vaccination program performed might help to plan future campaigns. This study aims to estimate the relative effectiveness (rVE) against severe COVID-19 of a seasonal booster dose over calendar time and by time since administration. We conducted a retrospective cohort analysis among 13,083,855 persons aged ≥60 years who were eligible to receive a seasonal booster at the start of the 2022–2023 vaccination campaign in Italy. We estimated rVE against severe COVID-19 (hospitalization or death) of a seasonal booster dose of bivalent (original/Omicron BA.4-5) mRNA vaccines by two-month calendar interval and at different times post-administration. We used multivariable Cox regression models, including vaccination as time-dependent exposure, to estimate adjusted hazard ratios (HR) and rVEs as [(1-HR)X100]. The rVE of a seasonal booster decreased from 64.9% (95% CI: 59.8–69.4) in October-November 2022 to 22.0% (95% CI: 15.4–28.0) in April-May 2023, when the majority of vaccinated persons (67%) had received the booster at least 4–6 months earlier. During the epidemic phase with prevalent circulation of the Omicron BA.5 subvariant, rVE of a seasonal booster received ≤90 days earlier was 83.0% (95% CI: 79.1–86.1), compared to 37.4% (95% CI: 25.5–47.5) during prevalent circulation of the Omicron XBB subvariant. During the XBB epidemic phase, rVE was estimated at 15.8% (95% CI: 9.1–20.1) 181–369 days post-administration of the booster dose. In all the analyses we observed similar trends of rVE between persons aged 60–79 and those ≥80 years, although estimates were somewhat lower for the oldest group. A seasonal booster dose received during the vaccination campaign provided additional protection against severe COVID-19 up to April-May 2023, after which the incidence of severe COVID-19 was much reduced. The results also suggest that the Omicron XBB subvariant might have partly escaped the immunity provided by the seasonal booster targeting the original and Omicron BA.4-5 strains of SARS-CoV-2.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>38834428</pmid><doi>10.1016/j.vaccine.2024.05.074</doi><orcidid>https://orcid.org/0000-0002-0480-8723</orcidid><orcidid>https://orcid.org/0000-0002-5893-7117</orcidid><orcidid>https://orcid.org/0000-0001-8193-5446</orcidid><oa>free_for_read</oa></addata></record>
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identifier ISSN: 0264-410X
ispartof Vaccine, 2024-10, Vol.42 (23), p.126026, Article 126026
issn 0264-410X
1873-2518
1873-2518
language eng
recordid cdi_proquest_miscellaneous_3064922041
source Elsevier ScienceDirect Journals Complete; ProQuest Central
subjects Age groups
Bivalent mRNA vaccines
Calendars
Circulation
COVID-19
COVID-19 vaccines
Effectiveness
Elderly population
Epidemics
Estimates
Health surveillance
Hospitalization
Infections
Laboratories
mRNA
mRNA vaccines
Omicron subvariants
Population
Regression analysis
Regression models
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
Time dependence
Vaccines
title Effectiveness against severe COVID-19 of a seasonal booster dose of bivalent (original/Omicron BA.4-5) mRNA vaccines in persons aged ≥60 years: Estimates over calendar time and by time since administration during prevalent circulation of different Omicron subvariants, Italy, 2022–2023
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