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Severe COVID-19 outcomes after full vaccination of primary schedule and initial boosters: pooled analysis of national prospective cohort studies of 30 million individuals in England, Northern Ireland, Scotland, and Wales

Utkarsh Agrawal, Stuart Bedston, Colin McCowan, Jason Oke, Lynsey Patterson, Chris Robertson, Ashley Akbari Orcid Logo, Amaya Azcoaga-Lorenzo, Declan T Bradley, Adeniyi Francis Fagbamigbe, Zoe Grange, Elliott C R Hall, Mark Joy, Srinivasa Vittal Katikireddi, Steven Kerr, Lewis Ritchie, Siobhán Murphy, Rhiannon Owen Orcid Logo, Igor Rudan, Syed Ahmar Shah, Colin R Simpson, Fatemeh Torabi Orcid Logo, Ruby S M Tsang, Simon de Lusignan, Ronan Lyons Orcid Logo, Dermot O'Reilly, Aziz Sheikh

The Lancet, Volume: 400, Issue: 10360, Pages: 1305 - 1320

Swansea University Authors: Stuart Bedston, Ashley Akbari Orcid Logo, Rhiannon Owen Orcid Logo, Fatemeh Torabi Orcid Logo, Ronan Lyons Orcid Logo

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DOI (Published version): 10.1016/s0140-6736(22)01656-7

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BackgroundCurrent UK vaccination policy is to offer future COVID-19 booster doses to individuals at high risk of serious illness from COVID-19, but it is still uncertain which groups of the population could benefit most. In response to an urgent request from the UK Joint Committee on Vaccination and...

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Published in: The Lancet
ISSN: 0140-6736
Published: Elsevier BV 2022
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In response to an urgent request from the UK Joint Committee on Vaccination and Immunisation, we aimed to identify risk factors for severe COVID-19 outcomes (ie, COVID-19-related hospitalisation or death) in individuals who had completed their primary COVID-19 vaccination schedule and had received the first booster vaccine.MethodsWe constructed prospective cohorts across all four UK nations through linkages of primary care, RT-PCR testing, vaccination, hospitalisation, and mortality data on 30 million people. We included individuals who received primary vaccine doses of BNT162b2 (tozinameran; Pfizer&#x2013;BioNTech) or ChAdOx1 nCoV-19 (Oxford&#x2013;AstraZeneca) vaccines in our initial analyses. We then restricted analyses to those given a BNT162b2 or mRNA-1273 (elasomeran; Moderna) booster and had a severe COVID-19 outcome between Dec 20, 2021, and Feb 28, 2022 (when the omicron (B.1.1.529) variant was dominant). We fitted time-dependent Poisson regression models and calculated adjusted rate ratios (aRRs) and 95% CIs for the associations between risk factors and COVID-19-related hospitalisation or death. We adjusted for a range of potential covariates, including age, sex, comorbidities, and previous SARS-CoV-2 infection. Stratified analyses were conducted by vaccine type. We then did pooled analyses across UK nations using fixed-effect meta-analyses.FindingsBetween Dec 8, 2020, and Feb 28, 2022, 16&#x2008;208&#x2008;600 individuals completed their primary vaccine schedule and 13&#x2008;836&#x2008;390 individuals received a booster dose. Between Dec 20, 2021, and Feb 28, 2022, 59&#x2008;510 (0&#xB7;4%) of the primary vaccine group and 26&#x2008;100 (0&#xB7;2%) of those who received their booster had severe COVID-19 outcomes. The risk of severe COVID-19 outcomes reduced after receiving the booster (rate change: 8&#xB7;8 events per 1000 person-years to 7&#xB7;6 events per 1000 person-years). Older adults (&#x2265;80 years vs 18&#x2013;49 years; aRR 3&#xB7;60 [95% CI 3&#xB7;45&#x2013;3&#xB7;75]), those with comorbidities (&#x2265;5 comorbidities vs none; 9&#xB7;51 [9&#xB7;07&#x2013;9&#xB7;97]), being male (male vs female; 1&#xB7;23 [1&#xB7;20&#x2013;1&#xB7;26]), and those with certain underlying health conditions&#x2014;in particular, individuals receiving immunosuppressants (yes vs no; 5&#xB7;80 [5&#xB7;53&#x2013;6&#xB7;09])&#x2014;and those with chronic kidney disease (stage 5 vs no; 3&#xB7;71 [2&#xB7;90&#x2013;4&#xB7;74]) remained at high risk despite the initial booster. Individuals with a history of COVID-19 infection were at reduced risk (infected &#x2265;9 months before booster dose vs no previous infection; aRR 0&#xB7;41 [95% CI 0&#xB7;29&#x2013;0&#xB7;58]).InterpretationOlder people, those with multimorbidity, and those with specific underlying health conditions remain at increased risk of COVID-19 hospitalisation and death after the initial vaccine booster and should, therefore, be prioritised for additional boosters, including novel optimised versions, and the increasing array of COVID-19 therapeutics.</abstract><type>Journal Article</type><journal>The Lancet</journal><volume>400</volume><journalNumber>10360</journalNumber><paginationStart>1305</paginationStart><paginationEnd>1320</paginationEnd><publisher>Elsevier BV</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>0140-6736</issnPrint><issnElectronic/><keywords/><publishedDay>15</publishedDay><publishedMonth>10</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-10-15</publishedDate><doi>10.1016/s0140-6736(22)01656-7</doi><url/><notes/><college>COLLEGE NANME</college><department>Health Data Science</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HDAT</DepartmentCode><institution>Swansea University</institution><apcterm/><funders>National Core Studies&#x2013;Immunity, UK Research and Innovation (Medical Research Council), Health Data Research UK, the Scottish Government, and the University of Edinburgh.</funders><projectreference/><lastEdited>2022-11-10T15:42:24.8157280</lastEdited><Created>2022-10-17T22:55:49.0831136</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Medicine</level></path><authors><author><firstname>Utkarsh</firstname><surname>Agrawal</surname><order>1</order></author><author><firstname>Stuart</firstname><surname>Bedston</surname><order>2</order></author><author><firstname>Colin</firstname><surname>McCowan</surname><order>3</order></author><author><firstname>Jason</firstname><surname>Oke</surname><order>4</order></author><author><firstname>Lynsey</firstname><surname>Patterson</surname><order>5</order></author><author><firstname>Chris</firstname><surname>Robertson</surname><order>6</order></author><author><firstname>Ashley</firstname><surname>Akbari</surname><orcid>0000-0003-0814-0801</orcid><order>7</order></author><author><firstname>Amaya</firstname><surname>Azcoaga-Lorenzo</surname><order>8</order></author><author><firstname>Declan T</firstname><surname>Bradley</surname><order>9</order></author><author><firstname>Adeniyi Francis</firstname><surname>Fagbamigbe</surname><order>10</order></author><author><firstname>Zoe</firstname><surname>Grange</surname><order>11</order></author><author><firstname>Elliott C R</firstname><surname>Hall</surname><order>12</order></author><author><firstname>Mark</firstname><surname>Joy</surname><order>13</order></author><author><firstname>Srinivasa Vittal</firstname><surname>Katikireddi</surname><order>14</order></author><author><firstname>Steven</firstname><surname>Kerr</surname><order>15</order></author><author><firstname>Lewis</firstname><surname>Ritchie</surname><order>16</order></author><author><firstname>Siobh&#xE1;n</firstname><surname>Murphy</surname><order>17</order></author><author><firstname>Rhiannon</firstname><surname>Owen</surname><orcid>0000-0001-5977-376X</orcid><order>18</order></author><author><firstname>Igor</firstname><surname>Rudan</surname><order>19</order></author><author><firstname>Syed Ahmar</firstname><surname>Shah</surname><order>20</order></author><author><firstname>Colin R</firstname><surname>Simpson</surname><order>21</order></author><author><firstname>Fatemeh</firstname><surname>Torabi</surname><orcid>0000-0002-5853-4625</orcid><order>22</order></author><author><firstname>Ruby S M</firstname><surname>Tsang</surname><order>23</order></author><author><firstname>Simon de</firstname><surname>Lusignan</surname><order>24</order></author><author><firstname>Ronan</firstname><surname>Lyons</surname><orcid>0000-0001-5225-000X</orcid><order>25</order></author><author><firstname>Dermot</firstname><surname>O'Reilly</surname><order>26</order></author><author><firstname>Aziz</firstname><surname>Sheikh</surname><order>27</order></author></authors><documents><document><filename>61579__25730__093cae79276d470e9179ea89093d3100.pdf</filename><originalFilename>61579.pdf</originalFilename><uploaded>2022-11-10T15:40:56.9682214</uploaded><type>Output</type><contentLength>1071542</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>&#xA9; 2022 The Author(s). This is an Open Access article under the CC BY 4.0 license</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language><licence>https://creativecommons.org/licenses/by/4.0/</licence></document></documents><OutputDurs/></rfc1807>
spelling 2022-11-10T15:42:24.8157280 v2 61579 2022-10-17 Severe COVID-19 outcomes after full vaccination of primary schedule and initial boosters: pooled analysis of national prospective cohort studies of 30 million individuals in England, Northern Ireland, Scotland, and Wales c79d07eaba5c9515c0df82b372b76a41 Stuart Bedston Stuart Bedston true false aa1b025ec0243f708bb5eb0a93d6fb52 0000-0003-0814-0801 Ashley Akbari Ashley Akbari true false 0d30aa00eef6528f763a1e1589f703ec 0000-0001-5977-376X Rhiannon Owen Rhiannon Owen true false f569591e1bfb0e405b8091f99fec45d3 0000-0002-5853-4625 Fatemeh Torabi Fatemeh Torabi true false 83efcf2a9dfcf8b55586999d3d152ac6 0000-0001-5225-000X Ronan Lyons Ronan Lyons true false 2022-10-17 HDAT BackgroundCurrent UK vaccination policy is to offer future COVID-19 booster doses to individuals at high risk of serious illness from COVID-19, but it is still uncertain which groups of the population could benefit most. In response to an urgent request from the UK Joint Committee on Vaccination and Immunisation, we aimed to identify risk factors for severe COVID-19 outcomes (ie, COVID-19-related hospitalisation or death) in individuals who had completed their primary COVID-19 vaccination schedule and had received the first booster vaccine.MethodsWe constructed prospective cohorts across all four UK nations through linkages of primary care, RT-PCR testing, vaccination, hospitalisation, and mortality data on 30 million people. We included individuals who received primary vaccine doses of BNT162b2 (tozinameran; Pfizer–BioNTech) or ChAdOx1 nCoV-19 (Oxford–AstraZeneca) vaccines in our initial analyses. We then restricted analyses to those given a BNT162b2 or mRNA-1273 (elasomeran; Moderna) booster and had a severe COVID-19 outcome between Dec 20, 2021, and Feb 28, 2022 (when the omicron (B.1.1.529) variant was dominant). We fitted time-dependent Poisson regression models and calculated adjusted rate ratios (aRRs) and 95% CIs for the associations between risk factors and COVID-19-related hospitalisation or death. We adjusted for a range of potential covariates, including age, sex, comorbidities, and previous SARS-CoV-2 infection. Stratified analyses were conducted by vaccine type. We then did pooled analyses across UK nations using fixed-effect meta-analyses.FindingsBetween Dec 8, 2020, and Feb 28, 2022, 16 208 600 individuals completed their primary vaccine schedule and 13 836 390 individuals received a booster dose. Between Dec 20, 2021, and Feb 28, 2022, 59 510 (0·4%) of the primary vaccine group and 26 100 (0·2%) of those who received their booster had severe COVID-19 outcomes. The risk of severe COVID-19 outcomes reduced after receiving the booster (rate change: 8·8 events per 1000 person-years to 7·6 events per 1000 person-years). Older adults (≥80 years vs 18–49 years; aRR 3·60 [95% CI 3·45–3·75]), those with comorbidities (≥5 comorbidities vs none; 9·51 [9·07–9·97]), being male (male vs female; 1·23 [1·20–1·26]), and those with certain underlying health conditions—in particular, individuals receiving immunosuppressants (yes vs no; 5·80 [5·53–6·09])—and those with chronic kidney disease (stage 5 vs no; 3·71 [2·90–4·74]) remained at high risk despite the initial booster. Individuals with a history of COVID-19 infection were at reduced risk (infected ≥9 months before booster dose vs no previous infection; aRR 0·41 [95% CI 0·29–0·58]).InterpretationOlder people, those with multimorbidity, and those with specific underlying health conditions remain at increased risk of COVID-19 hospitalisation and death after the initial vaccine booster and should, therefore, be prioritised for additional boosters, including novel optimised versions, and the increasing array of COVID-19 therapeutics. Journal Article The Lancet 400 10360 1305 1320 Elsevier BV 0140-6736 15 10 2022 2022-10-15 10.1016/s0140-6736(22)01656-7 COLLEGE NANME Health Data Science COLLEGE CODE HDAT Swansea University National Core Studies–Immunity, UK Research and Innovation (Medical Research Council), Health Data Research UK, the Scottish Government, and the University of Edinburgh. 2022-11-10T15:42:24.8157280 2022-10-17T22:55:49.0831136 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Utkarsh Agrawal 1 Stuart Bedston 2 Colin McCowan 3 Jason Oke 4 Lynsey Patterson 5 Chris Robertson 6 Ashley Akbari 0000-0003-0814-0801 7 Amaya Azcoaga-Lorenzo 8 Declan T Bradley 9 Adeniyi Francis Fagbamigbe 10 Zoe Grange 11 Elliott C R Hall 12 Mark Joy 13 Srinivasa Vittal Katikireddi 14 Steven Kerr 15 Lewis Ritchie 16 Siobhán Murphy 17 Rhiannon Owen 0000-0001-5977-376X 18 Igor Rudan 19 Syed Ahmar Shah 20 Colin R Simpson 21 Fatemeh Torabi 0000-0002-5853-4625 22 Ruby S M Tsang 23 Simon de Lusignan 24 Ronan Lyons 0000-0001-5225-000X 25 Dermot O'Reilly 26 Aziz Sheikh 27 61579__25730__093cae79276d470e9179ea89093d3100.pdf 61579.pdf 2022-11-10T15:40:56.9682214 Output 1071542 application/pdf Version of Record true © 2022 The Author(s). This is an Open Access article under the CC BY 4.0 license true eng https://creativecommons.org/licenses/by/4.0/
title Severe COVID-19 outcomes after full vaccination of primary schedule and initial boosters: pooled analysis of national prospective cohort studies of 30 million individuals in England, Northern Ireland, Scotland, and Wales
spellingShingle Severe COVID-19 outcomes after full vaccination of primary schedule and initial boosters: pooled analysis of national prospective cohort studies of 30 million individuals in England, Northern Ireland, Scotland, and Wales
Stuart Bedston
Ashley Akbari
Rhiannon Owen
Fatemeh Torabi
Ronan Lyons
title_short Severe COVID-19 outcomes after full vaccination of primary schedule and initial boosters: pooled analysis of national prospective cohort studies of 30 million individuals in England, Northern Ireland, Scotland, and Wales
title_full Severe COVID-19 outcomes after full vaccination of primary schedule and initial boosters: pooled analysis of national prospective cohort studies of 30 million individuals in England, Northern Ireland, Scotland, and Wales
title_fullStr Severe COVID-19 outcomes after full vaccination of primary schedule and initial boosters: pooled analysis of national prospective cohort studies of 30 million individuals in England, Northern Ireland, Scotland, and Wales
title_full_unstemmed Severe COVID-19 outcomes after full vaccination of primary schedule and initial boosters: pooled analysis of national prospective cohort studies of 30 million individuals in England, Northern Ireland, Scotland, and Wales
title_sort Severe COVID-19 outcomes after full vaccination of primary schedule and initial boosters: pooled analysis of national prospective cohort studies of 30 million individuals in England, Northern Ireland, Scotland, and Wales
author_id_str_mv c79d07eaba5c9515c0df82b372b76a41
aa1b025ec0243f708bb5eb0a93d6fb52
0d30aa00eef6528f763a1e1589f703ec
f569591e1bfb0e405b8091f99fec45d3
83efcf2a9dfcf8b55586999d3d152ac6
author_id_fullname_str_mv c79d07eaba5c9515c0df82b372b76a41_***_Stuart Bedston
aa1b025ec0243f708bb5eb0a93d6fb52_***_Ashley Akbari
0d30aa00eef6528f763a1e1589f703ec_***_Rhiannon Owen
f569591e1bfb0e405b8091f99fec45d3_***_Fatemeh Torabi
83efcf2a9dfcf8b55586999d3d152ac6_***_Ronan Lyons
author Stuart Bedston
Ashley Akbari
Rhiannon Owen
Fatemeh Torabi
Ronan Lyons
author2 Utkarsh Agrawal
Stuart Bedston
Colin McCowan
Jason Oke
Lynsey Patterson
Chris Robertson
Ashley Akbari
Amaya Azcoaga-Lorenzo
Declan T Bradley
Adeniyi Francis Fagbamigbe
Zoe Grange
Elliott C R Hall
Mark Joy
Srinivasa Vittal Katikireddi
Steven Kerr
Lewis Ritchie
Siobhán Murphy
Rhiannon Owen
Igor Rudan
Syed Ahmar Shah
Colin R Simpson
Fatemeh Torabi
Ruby S M Tsang
Simon de Lusignan
Ronan Lyons
Dermot O'Reilly
Aziz Sheikh
format Journal article
container_title The Lancet
container_volume 400
container_issue 10360
container_start_page 1305
publishDate 2022
institution Swansea University
issn 0140-6736
doi_str_mv 10.1016/s0140-6736(22)01656-7
publisher Elsevier BV
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
active_str 0
description BackgroundCurrent UK vaccination policy is to offer future COVID-19 booster doses to individuals at high risk of serious illness from COVID-19, but it is still uncertain which groups of the population could benefit most. In response to an urgent request from the UK Joint Committee on Vaccination and Immunisation, we aimed to identify risk factors for severe COVID-19 outcomes (ie, COVID-19-related hospitalisation or death) in individuals who had completed their primary COVID-19 vaccination schedule and had received the first booster vaccine.MethodsWe constructed prospective cohorts across all four UK nations through linkages of primary care, RT-PCR testing, vaccination, hospitalisation, and mortality data on 30 million people. We included individuals who received primary vaccine doses of BNT162b2 (tozinameran; Pfizer–BioNTech) or ChAdOx1 nCoV-19 (Oxford–AstraZeneca) vaccines in our initial analyses. We then restricted analyses to those given a BNT162b2 or mRNA-1273 (elasomeran; Moderna) booster and had a severe COVID-19 outcome between Dec 20, 2021, and Feb 28, 2022 (when the omicron (B.1.1.529) variant was dominant). We fitted time-dependent Poisson regression models and calculated adjusted rate ratios (aRRs) and 95% CIs for the associations between risk factors and COVID-19-related hospitalisation or death. We adjusted for a range of potential covariates, including age, sex, comorbidities, and previous SARS-CoV-2 infection. Stratified analyses were conducted by vaccine type. We then did pooled analyses across UK nations using fixed-effect meta-analyses.FindingsBetween Dec 8, 2020, and Feb 28, 2022, 16 208 600 individuals completed their primary vaccine schedule and 13 836 390 individuals received a booster dose. Between Dec 20, 2021, and Feb 28, 2022, 59 510 (0·4%) of the primary vaccine group and 26 100 (0·2%) of those who received their booster had severe COVID-19 outcomes. The risk of severe COVID-19 outcomes reduced after receiving the booster (rate change: 8·8 events per 1000 person-years to 7·6 events per 1000 person-years). Older adults (≥80 years vs 18–49 years; aRR 3·60 [95% CI 3·45–3·75]), those with comorbidities (≥5 comorbidities vs none; 9·51 [9·07–9·97]), being male (male vs female; 1·23 [1·20–1·26]), and those with certain underlying health conditions—in particular, individuals receiving immunosuppressants (yes vs no; 5·80 [5·53–6·09])—and those with chronic kidney disease (stage 5 vs no; 3·71 [2·90–4·74]) remained at high risk despite the initial booster. Individuals with a history of COVID-19 infection were at reduced risk (infected ≥9 months before booster dose vs no previous infection; aRR 0·41 [95% CI 0·29–0·58]).InterpretationOlder people, those with multimorbidity, and those with specific underlying health conditions remain at increased risk of COVID-19 hospitalisation and death after the initial vaccine booster and should, therefore, be prioritised for additional boosters, including novel optimised versions, and the increasing array of COVID-19 therapeutics.
published_date 2022-10-15T04:20:30Z
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