Investigating the uptake, effectiveness and safety of COVID-19 vaccines: protocol for an observational study using linked UK national data

Vasileiou, Eleftheria; Shi, Ting; Kerr, Steven; Robertson, Chris; Joy, Mark; Tsang, Ruby; McGagh, Dylan; Williams, John; Hobbs, Richard; Lusignan, Simon de; Bradley, Declan; OReilly, Dermot; Murphy, Siobhan; Chuter, Antony; Beggs, Jillian; Ford, David; Orton, Chris; Akbari, Ashley; Bedston, Stuart; Davies, Gareth; Griffiths, Lucy; Griffiths, Rowena; Lowthian, Emily; Lyons, Jane; Lyons, Ronan; North, Laura; Perry, Malorie; Torabi, Fatemeh; Pickett, James; McMenamin, Jim; McCowan, Colin; Agrawal, Utkarsh; Wood, Rachael; Stock, Sarah Jane; Moore, Emily; Henery, Paul; Simpson, Colin R; Sheikh, Aziz

doi:10.1136/bmjopen-2021-050062

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Investigating the uptake, effectiveness and safety of COVID-19 vaccines: protocol for an observational study using linked UK national data

Eleftheria Vasileiou

, Ting Shi

, Steven Kerr, Chris Robertson, Mark Joy, Ruby Tsang

, Dylan McGagh, John Williams, Richard Hobbs, Simon de Lusignan

, Declan Bradley, Dermot OReilly, Siobhan Murphy, Antony Chuter, Jillian Beggs, David Ford

, Chris Orton

, Ashley Akbari

, Stuart Bedston, Gareth Davies

, Lucy Griffiths

, Rowena Griffiths, Emily Lowthian, Jane Lyons, Ronan Lyons

, Laura North, Malorie Perry, Fatemeh Torabi

, James Pickett, Jim McMenamin, Colin McCowan, Utkarsh Agrawal, Rachael Wood

, Sarah Jane Stock

, Emily Moore, Paul Henery

, Colin R Simpson, Aziz Sheikh

BMJ Open, Volume: 12, Issue: 2, Start page: e050062.

Swansea University Authors: David Ford , Chris Orton , Ashley Akbari , Stuart Bedston, Gareth Davies , Lucy Griffiths , Rowena Griffiths, Emily Lowthian, Jane Lyons, Ronan Lyons , Laura North, Fatemeh Torabi

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DOI (Published version): 10.1136/bmjopen-2021-050062

Abstract

Introduction The novel coronavirus SARS-CoV-2, which emerged in December 2019, has caused millions of deaths and severe illness worldwide. Numerous vaccines are currently under development of which a few have now been authorised for population-level administration by several countries. As of 20 Sept...

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Published in:	BMJ Open
ISSN:	2044-6055 2044-6055
Published:	BMJ 2022
Online Access:	Check full text
URI:	https://cronfa.swan.ac.uk/Record/cronfa59406
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Numerous vaccines are currently under development of which a few have now been authorised for population-level administration by several countries. As of 20 September 2021, over 48 million people have received their first vaccine dose and over 44 million people have received their second vaccine dose across the UK. We aim to assess the uptake rates, effectiveness, and safety of all currently approved COVID-19 vaccines in the UK.Methods and analysis We will use prospective cohort study designs to assess vaccine uptake, effectiveness and safety against clinical outcomes and deaths. Test-negative case–control study design will be used to assess vaccine effectiveness (VE) against laboratory confirmed SARS-CoV-2 infection. Self-controlled case series and retrospective cohort study designs will be carried out to assess vaccine safety against mild-to-moderate and severe adverse events, respectively. Individual-level pseudonymised data from primary care, secondary care, laboratory test and death records will be linked and analysed in secure research environments in each UK nation. Univariate and multivariate logistic regression models will be carried out to estimate vaccine uptake levels in relation to various population characteristics. VE estimates against laboratory confirmed SARS-CoV-2 infection will be generated using a generalised additive logistic model. Time-dependent Cox models will be used to estimate the VE against clinical outcomes and deaths. The safety of the vaccines will be assessed using logistic regression models with an offset for the length of the risk period. Where possible, data will be meta-analysed across the UK nations.Ethics and dissemination We obtained approvals from the National Research Ethics Service Committee, Southeast Scotland 02 (12/SS/0201), the Secure Anonymised Information Linkage independent Information Governance Review Panel project number 0911. Concerning English data, University of Oxford is compliant with the General Data Protection Regulation and the National Health Service (NHS) Digital Data Security and Protection Policy. This is an approved study (Integrated Research Application ID 301740, Health Research Authority (HRA) Research Ethics Committee 21/HRA/2786). The Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub meets NHS Digital’s Data Security and Protection Toolkit requirements. In Northern Ireland, the project was approved by the Honest Broker Governance Board, project number 0064. Findings will be made available to national policy-makers, presented at conferences and published in peer-reviewed journals.</abstract><type>Journal Article</type><journal>BMJ Open</journal><volume>12</volume><journalNumber>2</journalNumber><paginationStart>e050062.</paginationStart><paginationEnd/><publisher>BMJ</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>2044-6055</issnPrint><issnElectronic>2044-6055</issnElectronic><keywords/><publishedDay>14</publishedDay><publishedMonth>2</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-02-14</publishedDate><doi>10.1136/bmjopen-2021-050062</doi><url>http://dx.doi.org/10.1136/bmjopen-2021-050062</url><notes/><college>COLLEGE NANME</college><department>Health Data Science</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HDAT</DepartmentCode><institution>Swansea University</institution><apcterm>Another institution paid the OA fee</apcterm><funders>This research is part of the Data and Connectivity National Core Study, led by Health Data Research UK in partnership with the Office for National Statistics and funded by UK Research and Innovation (HDRUK2020.146). EAVE II is funded by the Medical Research Council (MC_PC_19075) and supported by the Scottish Government. This work is supported by BREATHE - The Health Data Research Hub for Respiratory Health (MC_PC_19004). BREATHE is funded through the UK Research and Innovation Industrial Strategy Challenge Fund and delivered through Health Data Research UK. ConCOV is supported by the Medical Research Council (MR/V028367/1); Health Data Research UK (HDR-9006) which receives its funding from the UK Medical Research Council, Engineering and Physical Sciences Research Council, Economic and Social Research Council, Department of Health and Social Care (England), Chief Scientist Office of the Scottish Government Health and Social Care Directorates, Health and Social Care Research and Development Division (Welsh Government), Public Health Agency (Northern Ireland), British Heart Foundation (BHF) and the Wellcome Trust; and Administrative Data Research UK which is funded by the Economic and Social Research Council (grant ES/S007393/1).</funders><projectreference/><lastEdited>2022-08-05T11:08:25.1342319</lastEdited><Created>2022-02-15T19:19:48.9630322</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>Eleftheria</firstname><surname>Vasileiou</surname><orcid>0000-0001-6850-7578</orcid><order>1</order></author><author><firstname>Ting</firstname><surname>Shi</surname><orcid>0000-0002-4101-4535</orcid><order>2</order></author><author><firstname>Steven</firstname><surname>Kerr</surname><order>3</order></author><author><firstname>Chris</firstname><surname>Robertson</surname><order>4</order></author><author><firstname>Mark</firstname><surname>Joy</surname><order>5</order></author><author><firstname>Ruby</firstname><surname>Tsang</surname><orcid>0000-0002-2520-526x</orcid><order>6</order></author><author><firstname>Dylan</firstname><surname>McGagh</surname><order>7</order></author><author><firstname>John</firstname><surname>Williams</surname><order>8</order></author><author><firstname>Richard</firstname><surname>Hobbs</surname><order>9</order></author><author><firstname>Simon de</firstname><surname>Lusignan</surname><orcid>0000-0001-5613-6810</orcid><order>10</order></author><author><firstname>Declan</firstname><surname>Bradley</surname><order>11</order></author><author><firstname>Dermot</firstname><surname>OReilly</surname><order>12</order></author><author><firstname>Siobhan</firstname><surname>Murphy</surname><order>13</order></author><author><firstname>Antony</firstname><surname>Chuter</surname><order>14</order></author><author><firstname>Jillian</firstname><surname>Beggs</surname><order>15</order></author><author><firstname>David</firstname><surname>Ford</surname><orcid>0000-0001-6551-721X</orcid><order>16</order></author><author><firstname>Chris</firstname><surname>Orton</surname><orcid>0000-0002-9561-2493</orcid><order>17</order></author><author><firstname>Ashley</firstname><surname>Akbari</surname><orcid>0000-0003-0814-0801</orcid><order>18</order></author><author><firstname>Stuart</firstname><surname>Bedston</surname><order>19</order></author><author><firstname>Gareth</firstname><surname>Davies</surname><orcid>0000-0001-9005-1618</orcid><order>20</order></author><author><firstname>Lucy</firstname><surname>Griffiths</surname><orcid>0000-0001-9230-624X</orcid><order>21</order></author><author><firstname>Rowena</firstname><surname>Griffiths</surname><order>22</order></author><author><firstname>Emily</firstname><surname>Lowthian</surname><order>23</order></author><author><firstname>Jane</firstname><surname>Lyons</surname><orcid/><order>24</order></author><author><firstname>Ronan</firstname><surname>Lyons</surname><orcid>0000-0001-5225-000X</orcid><order>25</order></author><author><firstname>Laura</firstname><surname>North</surname><order>26</order></author><author><firstname>Malorie</firstname><surname>Perry</surname><order>27</order></author><author><firstname>Fatemeh</firstname><surname>Torabi</surname><orcid>0000-0002-5853-4625</orcid><order>28</order></author><author><firstname>James</firstname><surname>Pickett</surname><order>29</order></author><author><firstname>Jim</firstname><surname>McMenamin</surname><order>30</order></author><author><firstname>Colin</firstname><surname>McCowan</surname><order>31</order></author><author><firstname>Utkarsh</firstname><surname>Agrawal</surname><order>32</order></author><author><firstname>Rachael</firstname><surname>Wood</surname><orcid>0000-0003-4453-623x</orcid><order>33</order></author><author><firstname>Sarah 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spelling	2022-08-05T11:08:25.1342319 v2 59406 2022-02-15 Investigating the uptake, effectiveness and safety of COVID-19 vaccines: protocol for an observational study using linked UK national data 52fc0c473b0da1b7218d87f9fc68a3e6 0000-0001-6551-721X David Ford David Ford true false 555c622e1f7bd9d2e0341f2ebbfd3e7f 0000-0002-9561-2493 Chris Orton Chris Orton true false aa1b025ec0243f708bb5eb0a93d6fb52 0000-0003-0814-0801 Ashley Akbari Ashley Akbari true false c79d07eaba5c9515c0df82b372b76a41 Stuart Bedston Stuart Bedston true false 98490239b86cc892a382416d048cdb3c 0000-0001-9005-1618 Gareth Davies Gareth Davies true false e35ea6ea4b429e812ef204b048131d93 0000-0001-9230-624X Lucy Griffiths Lucy Griffiths true false 381464f639f98bd388c29326ca7f862c Rowena Griffiths Rowena Griffiths true false db5bc529b8a9dfca2b4a268d14e03479 Emily Lowthian Emily Lowthian true false 1b74fa5125a88451c52c45bcf20e0b47 Jane Lyons Jane Lyons true false 83efcf2a9dfcf8b55586999d3d152ac6 0000-0001-5225-000X Ronan Lyons Ronan Lyons true false a255822cf77a0184cb6922e9fbea39e9 Laura North Laura North true false f569591e1bfb0e405b8091f99fec45d3 0000-0002-5853-4625 Fatemeh Torabi Fatemeh Torabi true false 2022-02-15 HDAT Introduction The novel coronavirus SARS-CoV-2, which emerged in December 2019, has caused millions of deaths and severe illness worldwide. Numerous vaccines are currently under development of which a few have now been authorised for population-level administration by several countries. As of 20 September 2021, over 48 million people have received their first vaccine dose and over 44 million people have received their second vaccine dose across the UK. We aim to assess the uptake rates, effectiveness, and safety of all currently approved COVID-19 vaccines in the UK.Methods and analysis We will use prospective cohort study designs to assess vaccine uptake, effectiveness and safety against clinical outcomes and deaths. Test-negative case–control study design will be used to assess vaccine effectiveness (VE) against laboratory confirmed SARS-CoV-2 infection. Self-controlled case series and retrospective cohort study designs will be carried out to assess vaccine safety against mild-to-moderate and severe adverse events, respectively. Individual-level pseudonymised data from primary care, secondary care, laboratory test and death records will be linked and analysed in secure research environments in each UK nation. Univariate and multivariate logistic regression models will be carried out to estimate vaccine uptake levels in relation to various population characteristics. VE estimates against laboratory confirmed SARS-CoV-2 infection will be generated using a generalised additive logistic model. Time-dependent Cox models will be used to estimate the VE against clinical outcomes and deaths. The safety of the vaccines will be assessed using logistic regression models with an offset for the length of the risk period. Where possible, data will be meta-analysed across the UK nations.Ethics and dissemination We obtained approvals from the National Research Ethics Service Committee, Southeast Scotland 02 (12/SS/0201), the Secure Anonymised Information Linkage independent Information Governance Review Panel project number 0911. Concerning English data, University of Oxford is compliant with the General Data Protection Regulation and the National Health Service (NHS) Digital Data Security and Protection Policy. This is an approved study (Integrated Research Application ID 301740, Health Research Authority (HRA) Research Ethics Committee 21/HRA/2786). The Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub meets NHS Digital’s Data Security and Protection Toolkit requirements. In Northern Ireland, the project was approved by the Honest Broker Governance Board, project number 0064. Findings will be made available to national policy-makers, presented at conferences and published in peer-reviewed journals. Journal Article BMJ Open 12 2 e050062. BMJ 2044-6055 2044-6055 14 2 2022 2022-02-14 10.1136/bmjopen-2021-050062 http://dx.doi.org/10.1136/bmjopen-2021-050062 COLLEGE NANME Health Data Science COLLEGE CODE HDAT Swansea University Another institution paid the OA fee This research is part of the Data and Connectivity National Core Study, led by Health Data Research UK in partnership with the Office for National Statistics and funded by UK Research and Innovation (HDRUK2020.146). EAVE II is funded by the Medical Research Council (MC_PC_19075) and supported by the Scottish Government. This work is supported by BREATHE - The Health Data Research Hub for Respiratory Health (MC_PC_19004). BREATHE is funded through the UK Research and Innovation Industrial Strategy Challenge Fund and delivered through Health Data Research UK. ConCOV is supported by the Medical Research Council (MR/V028367/1); Health Data Research UK (HDR-9006) which receives its funding from the UK Medical Research Council, Engineering and Physical Sciences Research Council, Economic and Social Research Council, Department of Health and Social Care (England), Chief Scientist Office of the Scottish Government Health and Social Care Directorates, Health and Social Care Research and Development Division (Welsh Government), Public Health Agency (Northern Ireland), British Heart Foundation (BHF) and the Wellcome Trust; and Administrative Data Research UK which is funded by the Economic and Social Research Council (grant ES/S007393/1). 2022-08-05T11:08:25.1342319 2022-02-15T19:19:48.9630322 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Eleftheria Vasileiou 0000-0001-6850-7578 1 Ting Shi 0000-0002-4101-4535 2 Steven Kerr 3 Chris Robertson 4 Mark Joy 5 Ruby Tsang 0000-0002-2520-526x 6 Dylan McGagh 7 John Williams 8 Richard Hobbs 9 Simon de Lusignan 0000-0001-5613-6810 10 Declan Bradley 11 Dermot OReilly 12 Siobhan Murphy 13 Antony Chuter 14 Jillian Beggs 15 David Ford 0000-0001-6551-721X 16 Chris Orton 0000-0002-9561-2493 17 Ashley Akbari 0000-0003-0814-0801 18 Stuart Bedston 19 Gareth Davies 0000-0001-9005-1618 20 Lucy Griffiths 0000-0001-9230-624X 21 Rowena Griffiths 22 Emily Lowthian 23 Jane Lyons 24 Ronan Lyons 0000-0001-5225-000X 25 Laura North 26 Malorie Perry 27 Fatemeh Torabi 0000-0002-5853-4625 28 James Pickett 29 Jim McMenamin 30 Colin McCowan 31 Utkarsh Agrawal 32 Rachael Wood 0000-0003-4453-623x 33 Sarah Jane Stock 0000-0003-4308-856x 34 Emily Moore 35 Paul Henery 0000-0003-0380-738x 36 Colin R Simpson 37 Aziz Sheikh 0000-0001-7022-3056 38 59406__22497__167a36002343449f93e49e3ee8b52ec1.pdf 59406.pdf 2022-03-02T14:43:50.0696365 Output 829862 application/pdf Version of Record true © Author(s) (or theiremployer(s)) 2022. Re-use permitted under CC BY. true eng https://creativecommons.org/licenses/by/4.0/
title	Investigating the uptake, effectiveness and safety of COVID-19 vaccines: protocol for an observational study using linked UK national data
spellingShingle	Investigating the uptake, effectiveness and safety of COVID-19 vaccines: protocol for an observational study using linked UK national data David Ford Chris Orton Ashley Akbari Stuart Bedston Gareth Davies Lucy Griffiths Rowena Griffiths Emily Lowthian Jane Lyons Ronan Lyons Laura North Fatemeh Torabi
title_short	Investigating the uptake, effectiveness and safety of COVID-19 vaccines: protocol for an observational study using linked UK national data
title_full	Investigating the uptake, effectiveness and safety of COVID-19 vaccines: protocol for an observational study using linked UK national data
title_fullStr	Investigating the uptake, effectiveness and safety of COVID-19 vaccines: protocol for an observational study using linked UK national data
title_full_unstemmed	Investigating the uptake, effectiveness and safety of COVID-19 vaccines: protocol for an observational study using linked UK national data
title_sort	Investigating the uptake, effectiveness and safety of COVID-19 vaccines: protocol for an observational study using linked UK national data
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author_id_fullname_str_mv	52fc0c473b0da1b7218d87f9fc68a3e6_*_David Ford 555c622e1f7bd9d2e0341f2ebbfd3e7f__Chris Orton aa1b025ec0243f708bb5eb0a93d6fb52__Ashley Akbari c79d07eaba5c9515c0df82b372b76a41__Stuart Bedston 98490239b86cc892a382416d048cdb3c__Gareth Davies e35ea6ea4b429e812ef204b048131d93__Lucy Griffiths 381464f639f98bd388c29326ca7f862c__Rowena Griffiths db5bc529b8a9dfca2b4a268d14e03479__Emily Lowthian 1b74fa5125a88451c52c45bcf20e0b47__Jane Lyons 83efcf2a9dfcf8b55586999d3d152ac6__Ronan Lyons a255822cf77a0184cb6922e9fbea39e9__Laura North f569591e1bfb0e405b8091f99fec45d3_*_Fatemeh Torabi
author	David Ford Chris Orton Ashley Akbari Stuart Bedston Gareth Davies Lucy Griffiths Rowena Griffiths Emily Lowthian Jane Lyons Ronan Lyons Laura North Fatemeh Torabi
author2	Eleftheria Vasileiou Ting Shi Steven Kerr Chris Robertson Mark Joy Ruby Tsang Dylan McGagh John Williams Richard Hobbs Simon de Lusignan Declan Bradley Dermot OReilly Siobhan Murphy Antony Chuter Jillian Beggs David Ford Chris Orton Ashley Akbari Stuart Bedston Gareth Davies Lucy Griffiths Rowena Griffiths Emily Lowthian Jane Lyons Ronan Lyons Laura North Malorie Perry Fatemeh Torabi James Pickett Jim McMenamin Colin McCowan Utkarsh Agrawal Rachael Wood Sarah Jane Stock Emily Moore Paul Henery Colin R Simpson Aziz Sheikh
format	Journal article
container_title	BMJ Open
container_volume	12
container_issue	2
container_start_page	e050062.
publishDate	2022
institution	Swansea University
issn	2044-6055 2044-6055
doi_str_mv	10.1136/bmjopen-2021-050062
publisher	BMJ
college_str	Faculty of Medicine, Health and Life Sciences
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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
url	http://dx.doi.org/10.1136/bmjopen-2021-050062
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active_str	0
description	Introduction The novel coronavirus SARS-CoV-2, which emerged in December 2019, has caused millions of deaths and severe illness worldwide. Numerous vaccines are currently under development of which a few have now been authorised for population-level administration by several countries. As of 20 September 2021, over 48 million people have received their first vaccine dose and over 44 million people have received their second vaccine dose across the UK. We aim to assess the uptake rates, effectiveness, and safety of all currently approved COVID-19 vaccines in the UK.Methods and analysis We will use prospective cohort study designs to assess vaccine uptake, effectiveness and safety against clinical outcomes and deaths. Test-negative case–control study design will be used to assess vaccine effectiveness (VE) against laboratory confirmed SARS-CoV-2 infection. Self-controlled case series and retrospective cohort study designs will be carried out to assess vaccine safety against mild-to-moderate and severe adverse events, respectively. Individual-level pseudonymised data from primary care, secondary care, laboratory test and death records will be linked and analysed in secure research environments in each UK nation. Univariate and multivariate logistic regression models will be carried out to estimate vaccine uptake levels in relation to various population characteristics. VE estimates against laboratory confirmed SARS-CoV-2 infection will be generated using a generalised additive logistic model. Time-dependent Cox models will be used to estimate the VE against clinical outcomes and deaths. The safety of the vaccines will be assessed using logistic regression models with an offset for the length of the risk period. Where possible, data will be meta-analysed across the UK nations.Ethics and dissemination We obtained approvals from the National Research Ethics Service Committee, Southeast Scotland 02 (12/SS/0201), the Secure Anonymised Information Linkage independent Information Governance Review Panel project number 0911. Concerning English data, University of Oxford is compliant with the General Data Protection Regulation and the National Health Service (NHS) Digital Data Security and Protection Policy. This is an approved study (Integrated Research Application ID 301740, Health Research Authority (HRA) Research Ethics Committee 21/HRA/2786). The Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub meets NHS Digital’s Data Security and Protection Toolkit requirements. In Northern Ireland, the project was approved by the Honest Broker Governance Board, project number 0064. Findings will be made available to national policy-makers, presented at conferences and published in peer-reviewed journals.
published_date	2022-02-14T04:16:41Z
_version_	1763754116785373184
score	11.036815

Investigating the uptake, effectiveness and safety of COVID-19 vaccines: protocol for an observational study using linked UK national data

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