Early Assessment of COVID-19 epidemiology and Vaccine/anti-viral Effectiveness (EAVE II)
Lead Research Organisation:
University of Edinburgh
Department Name: UNLISTED
Abstract
Scotland is an ideal place to carry out this research as there is a unique reference number for every individual. This makes it easy to link together different health datasets and construct an electronic cohort based upon data from 250 general practices and 1.2m individuals (22% of the population). Such a large cohort, gives wide regional coverage and permits investigation of subgroups such as children aged under 5 or adults over 65.
These data are already being collected for routine care - information on GP consultations, prescriptions, out of hours’ consultations, use of accident and emergency and hospital admissions. It also includes laboratory tests to diagnose a person with coronavirus and specifically COVID-19. Individuals will be having routine blood tests and a sample of unused blood will be stored and eventually tested for the presence of COVID-19 antibodies to work out the proportion of the population exposed during the epidemic. We will also sequence virus genomes from a sample of patients. The analysis of these data is carried out in a safe haven using anonymised data so that individuals cannot be identified.
This cohort will be followed up to monitor the progress of the COVID-19 epidemic and to evaluate which interventions are effective for treating and preventing the virus.
These data are already being collected for routine care - information on GP consultations, prescriptions, out of hours’ consultations, use of accident and emergency and hospital admissions. It also includes laboratory tests to diagnose a person with coronavirus and specifically COVID-19. Individuals will be having routine blood tests and a sample of unused blood will be stored and eventually tested for the presence of COVID-19 antibodies to work out the proportion of the population exposed during the epidemic. We will also sequence virus genomes from a sample of patients. The analysis of these data is carried out in a safe haven using anonymised data so that individuals cannot be identified.
This cohort will be followed up to monitor the progress of the COVID-19 epidemic and to evaluate which interventions are effective for treating and preventing the virus.
Technical Summary
This COVID-19 Rapid Response award is jointly funded (50:50) between the Medical Research Council and the National Institute for Health Research. The figure displayed is the total award amount of the two funders combined, with each partner contributing equally towards the project. Some additional funds were added in January 2022 to be paid by NIHR only.
EAVE (Early Estimation of vaccine and Anti-Viral Effectiveness) was a NIHR-funded project on pandemic influenza, which created a Scotland-wide cohort of 227,000 individuals recruited from 40 general practices together with stored serology samples from 1,000 individuals. EAVE established a national electronic cohort though linking health data sets from general practice, prescribing, hospitalisations and virology testing using the unique Community Health Identification (CHI) number for residents of Scotland. We plan to repurpose and expand this cohort to collect electronic data from 1.2m individuals living in Scotland to study COVID-19. We will augment the cohort by collecting and storing residual sera samples and by sequencing virus from patient specimens. Both of these, are being taken as part of routine care from a sample of these individuals.
We will track the progress of the COVID-19 epidemic in near real-time using the EAVE II cohort. We will be able to model the full course of the epidemic from genome sequence data. Once a serological test becomes available we will be able to refine this model and provide precise estimates of the attack rates in different sub-populations, and accompanying hospitalisation and fatality rates. EAVE II will help to identify the clinical features of the epidemic and, in due course, provide estimates of the effectiveness of any vaccines and anti-viral therapies deployed.
Ethical and Privacy Committee approval has previously been given for the EAVE study and we anticipate the same approvals will readily be obtained for this follow-on study.
EAVE (Early Estimation of vaccine and Anti-Viral Effectiveness) was a NIHR-funded project on pandemic influenza, which created a Scotland-wide cohort of 227,000 individuals recruited from 40 general practices together with stored serology samples from 1,000 individuals. EAVE established a national electronic cohort though linking health data sets from general practice, prescribing, hospitalisations and virology testing using the unique Community Health Identification (CHI) number for residents of Scotland. We plan to repurpose and expand this cohort to collect electronic data from 1.2m individuals living in Scotland to study COVID-19. We will augment the cohort by collecting and storing residual sera samples and by sequencing virus from patient specimens. Both of these, are being taken as part of routine care from a sample of these individuals.
We will track the progress of the COVID-19 epidemic in near real-time using the EAVE II cohort. We will be able to model the full course of the epidemic from genome sequence data. Once a serological test becomes available we will be able to refine this model and provide precise estimates of the attack rates in different sub-populations, and accompanying hospitalisation and fatality rates. EAVE II will help to identify the clinical features of the epidemic and, in due course, provide estimates of the effectiveness of any vaccines and anti-viral therapies deployed.
Ethical and Privacy Committee approval has previously been given for the EAVE study and we anticipate the same approvals will readily be obtained for this follow-on study.
Organisations
- University of Edinburgh (Lead Research Organisation)
- UNIVERSITY OF OXFORD (Collaboration)
- Federal University of the Recôncavo of Bahia (Collaboration)
- University College London (Collaboration)
- UNIVERSITY OF STRATHCLYDE (Collaboration)
- UNIVERSITY OF BIRMINGHAM (Collaboration)
- SWANSEA UNIVERSITY (Collaboration)
- UNIVERSITY OF EDINBURGH (Collaboration)
- QUEEN'S UNIVERSITY BELFAST (Collaboration)
- GlaxoSmithKline (GSK) (Collaboration)
- Office for National Statistics (Collaboration)
People |
ORCID iD |
Publications
Adeloye D
(2021)
The long-term sequelae of COVID-19: an international consensus on research priorities for patients with pre-existing and new-onset airways disease.
in The Lancet. Respiratory medicine
Agrawal U
(2021)
COVID-19 hospital admissions and deaths after BNT162b2 and ChAdOx1 nCoV-19 vaccinations in 2·57 million people in Scotland (EAVE II): a prospective cohort study.
in The Lancet. Respiratory medicine
Agrawal U
(2022)
Association between multimorbidity and mortality in a cohort of patients admitted to hospital with COVID-19 in Scotland.
in Journal of the Royal Society of Medicine
Calvert C
(2023)
A population-based matched cohort study of major congenital anomalies following COVID-19 vaccination and SARS-CoV-2 infection
in Nature Communications
| Description | COALESCE Advisory Board meeting |
| Geographic Reach | National |
| Policy Influence Type | Implementation circular/rapid advice/letter to e.g. Ministry of Health |
| Impact | Keen to hear outcome of current studies which analyse healthcare data at scale, from the point of view of (a) the findings and how they will guide public health policy; (b) the opportunities to improve healthcare data linkage; and (c) opportunities to link healthcare data with other non health sources (e.g. social, economic, air quality) to add to the questions we can answer and ultimate policy impact. |
| Guideline Title | Deferral of fertility treatment for patients who are not vaccinated against COVID-19 - Review |
| Description | COPS impact on policy |
| Geographic Reach | National |
| Policy Influence Type | Citation in clinical guidelines |
| Impact | In Jan (without any input from us) the CMO in Scotland wrote to Health Boards recommending that fertility treatment for women who had not received COVID-19 vaccination should be paused/deferred until the impact of Omicron in pregnancy was clearer. The decision was based on the high levels of infection at that time, and the known higher risks of adverse pregnancy outcomes in unvaccinated women infected with previous SARS-CoV-2 variants. Following this, the Scottish Government COPS to contribute to a paper outlining the latest evidence on this to inform a planned review of the recommendation. The latest COPS figures were provided in March 2022. Evidence on the impact of Omicron in pregnancy was very limited due to the short follow up time, but the COPS figures for Dec 2021 and January 2022 suggested that critical care admission rates for pregnant women with Omicron were lower than those seen for women infected with previous variants. Considering all the available evidence, the CMO wrote to Boards again in March 2022 recommending that, whilst all women preparing for fertility treatment remain strongly encouraged to get their COVID vaccination, the pause in treatment for unvaccinated women was no longer required. |
| URL | https://www.sehd.scot.nhs.uk/cmo/CMO(2022)07.pdf |
| Description | Contribution to Scottish Government reports on modelling of the pandemic |
| Geographic Reach | Local/Municipal/Regional |
| Policy Influence Type | Citation in other policy documents |
| Impact | This is evidence of EAVE II findings being used directly by the Director-General Health and Social Care in Scotland, in terms of spread of the disease and demands on the system e.g. in terms of healthcare |
| URL | https://www.ed.ac.uk/usher/eave-ii/key-outputs/scottish-government-reports |
| Description | Early evidence that the Omicron variant is less severe |
| Geographic Reach | National |
| Policy Influence Type | Implementation circular/rapid advice/letter to e.g. Ministry of Health |
| Impact | Early national data suggested that Omicron is associated with a two-thirds reduction in the risk of COVID-19 hospitalisation when compared to Delta and early decisions in the UK and devolved Governments about how to respond to the Omicron wave were based on these early signals in the data. Guidance was updated for working from home, masks in schools and in public places, masks on public transport and a renewed vaccination campaign. These results also contributed to public awareness with significant media coverage: https://www.theguardian.com/world/2021/dec/23/good-news-is-omicron-may-be-less-severe-bad-news-its-surging-faster https://www.thenational.scot/news/19804609.covid-scotland-nicola-sturgeon-responds-latest-encouraging-omicron-data/ |
| Description | Extension of the AZ vaccine to older people in France |
| Geographic Reach | Europe |
| Policy Influence Type | Contribution to a national consultation/review |
| Impact | The French Health Department began offering the AstraZeneca vaccine to those aged between 50 and 74. |
| URL | https://www.bbc.co.uk/news/world-europe-56242617#:~:text=The%20French%20government%20says%20older,%2... |
| Description | Future of EAVE II and infrastructure for near real-time healthcare data access for research in Scotland |
| Geographic Reach | Local/Municipal/Regional |
| Policy Influence Type | Contribution to a national consultation/review |
| Impact | The Chief Scientist Office has continued to lead high level discussions with Scottish Government and NHS colleagues about the major benefits of using near real-time healthcare data in research beyond the acute phase of the COVID-19 pandemic. These discussions have continued and are being prioritised despite a change in the Chief Scientist for Health during this period. The Chief Scientist Office agrees that there is a key need for ongoing health surveillance permissions and infrastructure in Scotland, to support policymaking around areas such as other infectious diseases, other health hazards, antimicrobial resistance and non-communicable diseases of major health burden, as well as to provide ongoing whole system intelligence on the Scottish health and care system. |
| Description | Member of DHSC/UKRI COVID-19 College of Experts |
| Geographic Reach | National |
| Policy Influence Type | Membership of a guideline committee |
| Impact | Aziz Sheikh is a member of the DHSC/UKRI COVID-19 College of Experts. The EAVE-II activities, as well as studies using this resource such as DaCVaP, QCOVID and National Core Studies, have ensured that data for the whole Scottish population are included in the UK Government's COVID-19 disease and vaccination forecasting efforts, and supported identification of individuals at particularly high risk of serious COVID-19 outcomes. |
| Description | Member of Scottish Government's Silver Group for Data & Intelligence and Chair of Task Force: 3 Priority Questions |
| Geographic Reach | Local/Municipal/Regional |
| Policy Influence Type | Membership of a guideline committee |
| Impact | Professor Aziz Sheikh is a Member of Scottish Government's Silver Group for Data & Intelligence and Chair of Task Force: 3 Priority Questions. The EAVE II research has improved the Scottish Government's COVID-19 forecasting capability and supported identification of individuals at particularly high risk of serious COVID-19 outcomes. |
| Description | Member of the Academy of Medical Science's Winter Scenarios Group |
| Geographic Reach | National |
| Policy Influence Type | Membership of a guideline committee |
| Impact | Aziz Sheikh is a member of the Academy of Medical Science's Winter Scenarios Group. This policy related work has resulted in use of the EAVE-II national data platform for COVID-19 surveillance and the UK's main risk prediction algorithms for identifying risk factors for serious COVID-19 outcomes. |
| URL | https://acmedsci.ac.uk/more/news/prepare-now-for-a-winter-covid-19-peak-warns-academy-of-medical-sci... |
| Description | Member of the Royal Society's Data Evaluation and Learning for Viral Epidemics (DELVE) Group |
| Geographic Reach | National |
| Policy Influence Type | Membership of a guideline committee |
| Impact | Aziz Sheikh is a member of the Royal Society's Data Evaluation and Learning for Viral Epidemics (DELVE) Group. This policy related work has amongst other things resulted in the use of the EAVE-II national data platform for COVID-19 surveillance and the UK's main risk prediction algorithms for identifying risk factors for serious COVID-19 outcomes. |
| URL | https://rs-delve.github.io/ |
| Description | Ongoing contributions to public health surveillance measures across the UK |
| Geographic Reach | Multiple continents/international |
| Policy Influence Type | Contribution to new or Improved professional practice |
| Impact | Our contributions to COVID-19 public health surveillance measures across Scotland/the UK has identified those at highest risk of serious COVID-19 outcomes, including effects of the new variants and investigations into the impact of COVID-19 on health system disruption. Most recently this has focused on vaccine safety and effectiveness in the Omicron era, serious COVID-19 outcomes in adults with asthma and children with and without asthma, vaccination uptake and safety in pregnancy, the use of monoclonal antibodies and antivirals, and breakthrough following booster doses. This work contributes directly to government guidelines and laws to protect health, public information about the pandemic, vaccination strategies and guidelines for living with the pandemic. |
| Description | Update on COVID-19 risk groups to JCVI and CMOs |
| Geographic Reach | National |
| Policy Influence Type | Contribution to new or improved professional practice |
| Impact | Our contributions to COVID-19 public health surveillance measures across Scotland/the UK have identified those at highest risk of serious COVID-19 outcomes. This work contributes directly to government guidelines and laws to protect health, public information about COVID-19, and vaccination strategies. |
| Description | Core Funding National Programme Award |
| Amount | £5,038,262 (GBP) |
| Funding ID | HDRUK2023.0027 |
| Organisation | Health Data Research UK |
| Sector | Private |
| Country | United Kingdom |
| Start | 04/2023 |
| End | 03/2028 |
| Description | Data and Connectivity: Vaccine Pharmacovigilance |
| Amount | £203,919 (GBP) |
| Funding ID | HDRUK2020.146 |
| Organisation | Health Data Research UK |
| Sector | Private |
| Country | United Kingdom |
| Start | 01/2021 |
| End | 06/2021 |
| Description | Developing and validating a risk prediction model for long COVID-19 |
| Amount | £189,659 (GBP) |
| Organisation | Chief Scientist Office |
| Sector | Public |
| Country | United Kingdom |
| Start | 03/2021 |
| End | 02/2023 |
| Description | Director's Discretionary Fund |
| Amount | £233,194 (GBP) |
| Funding ID | TF2022.18 |
| Organisation | Health Data Research UK |
| Sector | Private |
| Country | United Kingdom |
| Start | 06/2022 |
| End | 03/2023 |
| Description | EAVE II additional funding |
| Amount | £72,327 (GBP) |
| Organisation | Public Health Scotland |
| Sector | Public |
| Country | United Kingdom |
| Start | 09/2020 |
| End | 09/2021 |
| Description | EAVE II continuation |
| Amount | £497,577 (GBP) |
| Organisation | Public Health Scotland |
| Sector | Public |
| Country | United Kingdom |
| Start | 10/2021 |
| End | 09/2022 |
| Description | NIHR-funded rapid funding call for "Data Science to inform NHS compound winter pressure policy response" |
| Amount | £61,412 (GBP) |
| Funding ID | HRUK2022.0323 |
| Organisation | Health Data Research UK |
| Sector | Private |
| Country | United Kingdom |
| Start | 01/2023 |
| End | 03/2023 |
| Description | National Core Studies - Longitudinal Health & Wealth |
| Amount | £9,862,000 (GBP) |
| Funding ID | MC_PC_20030 |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 10/2020 |
| End | 03/2021 |
| Description | Phase 1 COVID-19 Immunity - National Core Study (Phase 1 IMM-NCS) |
| Amount | £465,114 (GBP) |
| Organisation | United Kingdom Research and Innovation |
| Sector | Public |
| Country | United Kingdom |
| Start | 12/2021 |
| End | 03/2023 |
| Description | Phase 1 COVID-19 Longitudinal Health and Wellbeing - National Core Study |
| Amount | £9,000,000 (GBP) |
| Funding ID | MC_PC_20059 |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 04/2021 |
| End | 09/2022 |
| Description | Post-hospitalisation COVID-19 study (PHOSP-COVID): a national consortium to understand and improve long-term health outcomes |
| Amount | £8,532,683 (GBP) |
| Organisation | Department of Health (DH) |
| Sector | Public |
| Country | United Kingdom |
| Start | 07/2020 |
| End | 01/2022 |
| Description | QCOVID Covid Risk Stratification Tool. Development and evaluation of a tool for predicting risk of short-term adverse outcomes due to COVID-19 in the general UK population |
| Amount | £1,285,333 (GBP) |
| Organisation | National Institute for Health Research |
| Sector | Public |
| Country | United Kingdom |
| Start | 05/2020 |
| End | 05/2022 |
| Description | Rapid Outcomes of COVid therapeutics in Eave II (ROCOVE) |
| Amount | £113,580 (GBP) |
| Organisation | United Kingdom Research and Innovation |
| Sector | Public |
| Country | United Kingdom |
| Start | 01/2022 |
| End | 03/2022 |
| Description | What is the uptake, safety and effectiveness of COVID-19 vaccines in: a. pregnancy; b. children and young people; c. those receiving booster doses; d. those co-administered COVID-19 and influenza vaccines? |
| Amount | £249,775 (GBP) |
| Funding ID | 2021.0158 |
| Organisation | Health Data Research UK |
| Sector | Private |
| Country | United Kingdom |
| Start | 10/2021 |
| End | 09/2022 |
| Title | Sharing code on github |
| Description | We regularly update code (https://github.com/EAVE-II). Health data for our research is stored securely but separately in Trusted Research Environments in England, Scotland, Wales and Northern Ireland. By pooling the number of cases across different parts of the UK, we can create a big enough dataset to analyse rare events. Shared code facilitates common data analysis protocols across different Trusted Research Environments which means that we can perform analyses using much larger samples but without sharing actual data between research teams. |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2021 |
| Provided To Others? | Yes |
| Impact | Our recent paper PLOS Medicine paper (doi.org/10.1371/journal.pmed.1003927) "First dose ChAdOx1 and BNT162b2 COVID-19 vaccinations and cerebral venous sinus thrombosis" is an example of impact from this method. There were not enough people in Scotland who had experienced CVST after a first dose of vaccine for us to analyse the data in a reliable way for this condition. By pooling the data across Scotland, England and Wales to form a sample of £11.6m people, we could create a big enough dataset to analyse possible links with vaccination, without sharing individual data between countries. We were able to show that there is a very small increased risk of CVST for people who had a first dose of the Oxford-AstraZeneca vaccine. We did not find any link between CVST and the Pfizer-BioNTech vaccine. |
| URL | https://github.com/EAVE-II |
| Title | Work with Public Health Scotland to make data available to other researchers |
| Description | eDRIS has developed a COVID-19 Research Database as a direct output from the EAVE II study. This is a reduced set of key datasets and fields to support urgent COVID Research. |
| Type Of Material | Data handling & control |
| Year Produced | 2021 |
| Provided To Others? | Yes |
| Impact | This makes some of the EAVE II data available to a wider group of researchers, in line with Public Benefit and Privacy Panel (PBPP) approvals. |
| URL | https://www.isdscotland.org/Products-and-Services/eDRIS/COVID-19/index.asp |
| Description | Brazil COVID-19 collaboration |
| Organisation | Federal University of the Recôncavo of Bahia |
| Country | Brazil |
| Sector | Academic/University |
| PI Contribution | Analysis of Brazil COVID-19 variant data, vaccination data and occurence of symptomatic SARS-CoV-infection; comparison with Scotland |
| Collaborator Contribution | Provision of data and analysis |
| Impact | Contribution to public health policy in Brazil and research publications: doi: 10.1016/S1473-3099(22)00451-0 doi: 10.1016/S0140-6736(21)02754-9 |
| Start Year | 2021 |
| Description | COVID-19 Longitudinal Health and Wellbeing - National Core Study |
| Organisation | University College London |
| Department | Department of Primary Care & Population Sciences |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | We are collaborating on work to: 1. Identify consequences of C19 infection on physical and mental health, and socioeconomic adversity 2. Evolving impacts of the pandemic on health and socioeconomic inequalities 3. Uptake, safety and effectiveness of C19 vaccination and determinants of antibody response to vaccination. |
| Collaborator Contribution | The wider LHW-NCS programme has 3 work packages: WP1 - establish a centralised, responsive resource linking data assets from a diverse range of longitudinal population studies with health, social and environmental records, with harmonised governance for processing and research interrogation. WP2 - Inform population health and social policy by providing evidence of the medium to long term consequences of infection, and of policies to control the pandemic WP3 - Establish a cadre of highly skilled big data scientists |
| Impact | Work is ongoing. |
| Start Year | 2021 |
| Description | COVID-19 in pregnancy in Scotland |
| Organisation | University of Edinburgh |
| Department | MRC Centre for Reproductive Health |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Explore list of variables to extract from the NI, Scotland and Wales centres. Creating an analysis plan for pooled results. |
| Collaborator Contribution | Share COPS methodology with the team and work with them to identify relevant variables in TREs. |
| Impact | Analysis plan is in progress. |
| Start Year | 2022 |
| Description | Can we enable harmonised, real-time, pharmacovigilance of COVID-19 vaccine(s) using routinely collected linked national data across the UK? |
| Organisation | Queen's University Belfast |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | We led this partnership to access routine healthcare data and use common protocols to understand how safe COVID-19 vaccines are and how well they work across the UK |
| Collaborator Contribution | Our partners looked for patterns in health records for the populations of England, Northern Ireland and Wales relating to COVID-19 vaccines, and we worked together to develop common data analysis protocols. |
| Impact | We were the first group in the world to show using national routinely collected health data that having a first vaccine dose gives very good protection against COVID-19 hospital admission. Between 8 December 2020 and 15 February 2021, we studied over 1.3 million vaccinated people in Scotland. In a follow-on analysis, we found that between 8 December 2020 and 14 April 2021, less than one in 2000 vaccinated people in Scotland had severe COVID-19. This is despite high background levels of infection. Using common analysis protocols, we were able to coordinate a UK-wide analysis with our partners to understand how long vaccine protection lasts. At the request of one of the UK's Chief Scientific Advisers, we used data to look at side effects in the blood from the first dose of a COVID-19 vaccines. We did not find any link between the Pfizer-BioNTech vaccine and bleeding or blood-clotting side effects. We did find in some people given the Oxford-AstraZeneca vaccine a slightly increased risk of a condition known as 'idiopathic thrombocytopenic purpura' (ITP) which increases the risk of bleeding disorders. In our Scottish analysis, we were not able to find a link between the COVID-19 vaccines and a very rare side effect in the brain called 'cerebral venous sinus thrombosis' (CVST). This may have been because the number we studied in Scotland was too small to find such a rare event. To address this, we repeated the analysis in England and Wales and brought results together with the Scottish data into a single analysis of 11.6 million people. We found a slightly increased risk of CVST (0.25 extra cases of clots per million people) in the 28 days after a first dose of the Oxford-AstraZeneca vaccine. This is very, very low compared with the risk of COVID-19 hospitalisation and death in people who have not been vaccinated. We did not find any link between CVST and the Pfizer-BioNTech vaccine. In Northern Ireland, our partners looked at vaccine uptake in people having treatment for mental health disorders. When looking at their healthcare records, it seemed that adults taking medication to aid sleep, anxiety or psychosis were less likely to be vaccinated than the general adult population. We also looked at whether healthcare staff in Wales had been vaccinated. We found that overall, a high number of staff did have their vaccines but the numbers vaccinated depended on their age and what jobs they did. We have shown that vaccines prevent or shorten COVID-19 outbreaks in care home residents in Northern Ireland. We are looking at how well and for how long vaccines protect healthcare professionals in Wales, and are currently coordinating a UK-wide analysis to understand how long vaccine protection lasts. |
| Start Year | 2021 |
| Description | Can we enable harmonised, real-time, pharmacovigilance of COVID-19 vaccine(s) using routinely collected linked national data across the UK? |
| Organisation | Swansea University |
| Department | Swansea University Medical School |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | We led this partnership to access routine healthcare data and use common protocols to understand how safe COVID-19 vaccines are and how well they work across the UK |
| Collaborator Contribution | Our partners looked for patterns in health records for the populations of England, Northern Ireland and Wales relating to COVID-19 vaccines, and we worked together to develop common data analysis protocols. |
| Impact | We were the first group in the world to show using national routinely collected health data that having a first vaccine dose gives very good protection against COVID-19 hospital admission. Between 8 December 2020 and 15 February 2021, we studied over 1.3 million vaccinated people in Scotland. In a follow-on analysis, we found that between 8 December 2020 and 14 April 2021, less than one in 2000 vaccinated people in Scotland had severe COVID-19. This is despite high background levels of infection. Using common analysis protocols, we were able to coordinate a UK-wide analysis with our partners to understand how long vaccine protection lasts. At the request of one of the UK's Chief Scientific Advisers, we used data to look at side effects in the blood from the first dose of a COVID-19 vaccines. We did not find any link between the Pfizer-BioNTech vaccine and bleeding or blood-clotting side effects. We did find in some people given the Oxford-AstraZeneca vaccine a slightly increased risk of a condition known as 'idiopathic thrombocytopenic purpura' (ITP) which increases the risk of bleeding disorders. In our Scottish analysis, we were not able to find a link between the COVID-19 vaccines and a very rare side effect in the brain called 'cerebral venous sinus thrombosis' (CVST). This may have been because the number we studied in Scotland was too small to find such a rare event. To address this, we repeated the analysis in England and Wales and brought results together with the Scottish data into a single analysis of 11.6 million people. We found a slightly increased risk of CVST (0.25 extra cases of clots per million people) in the 28 days after a first dose of the Oxford-AstraZeneca vaccine. This is very, very low compared with the risk of COVID-19 hospitalisation and death in people who have not been vaccinated. We did not find any link between CVST and the Pfizer-BioNTech vaccine. In Northern Ireland, our partners looked at vaccine uptake in people having treatment for mental health disorders. When looking at their healthcare records, it seemed that adults taking medication to aid sleep, anxiety or psychosis were less likely to be vaccinated than the general adult population. We also looked at whether healthcare staff in Wales had been vaccinated. We found that overall, a high number of staff did have their vaccines but the numbers vaccinated depended on their age and what jobs they did. We have shown that vaccines prevent or shorten COVID-19 outbreaks in care home residents in Northern Ireland. We are looking at how well and for how long vaccines protect healthcare professionals in Wales, and are currently coordinating a UK-wide analysis to understand how long vaccine protection lasts. |
| Start Year | 2021 |
| Description | Can we enable harmonised, real-time, pharmacovigilance of COVID-19 vaccine(s) using routinely collected linked national data across the UK? |
| Organisation | University of Oxford |
| Department | Nuffield Department of Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | We led this partnership to access routine healthcare data and use common protocols to understand how safe COVID-19 vaccines are and how well they work across the UK |
| Collaborator Contribution | Our partners looked for patterns in health records for the populations of England, Northern Ireland and Wales relating to COVID-19 vaccines, and we worked together to develop common data analysis protocols. |
| Impact | We were the first group in the world to show using national routinely collected health data that having a first vaccine dose gives very good protection against COVID-19 hospital admission. Between 8 December 2020 and 15 February 2021, we studied over 1.3 million vaccinated people in Scotland. In a follow-on analysis, we found that between 8 December 2020 and 14 April 2021, less than one in 2000 vaccinated people in Scotland had severe COVID-19. This is despite high background levels of infection. Using common analysis protocols, we were able to coordinate a UK-wide analysis with our partners to understand how long vaccine protection lasts. At the request of one of the UK's Chief Scientific Advisers, we used data to look at side effects in the blood from the first dose of a COVID-19 vaccines. We did not find any link between the Pfizer-BioNTech vaccine and bleeding or blood-clotting side effects. We did find in some people given the Oxford-AstraZeneca vaccine a slightly increased risk of a condition known as 'idiopathic thrombocytopenic purpura' (ITP) which increases the risk of bleeding disorders. In our Scottish analysis, we were not able to find a link between the COVID-19 vaccines and a very rare side effect in the brain called 'cerebral venous sinus thrombosis' (CVST). This may have been because the number we studied in Scotland was too small to find such a rare event. To address this, we repeated the analysis in England and Wales and brought results together with the Scottish data into a single analysis of 11.6 million people. We found a slightly increased risk of CVST (0.25 extra cases of clots per million people) in the 28 days after a first dose of the Oxford-AstraZeneca vaccine. This is very, very low compared with the risk of COVID-19 hospitalisation and death in people who have not been vaccinated. We did not find any link between CVST and the Pfizer-BioNTech vaccine. In Northern Ireland, our partners looked at vaccine uptake in people having treatment for mental health disorders. When looking at their healthcare records, it seemed that adults taking medication to aid sleep, anxiety or psychosis were less likely to be vaccinated than the general adult population. We also looked at whether healthcare staff in Wales had been vaccinated. We found that overall, a high number of staff did have their vaccines but the numbers vaccinated depended on their age and what jobs they did. We have shown that vaccines prevent or shorten COVID-19 outbreaks in care home residents in Northern Ireland. We are looking at how well and for how long vaccines protect healthcare professionals in Wales, and are currently coordinating a UK-wide analysis to understand how long vaccine protection lasts. |
| Start Year | 2021 |
| Description | Development and evaluation of a tool for predicting risk of short-term adverse outcomes due to COVID-19 in the general UK population |
| Organisation | University of Oxford |
| Department | Nuffield Department of Medicine |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The EAVE II team has validated the QCovid algorithm with Scottish health data, including conceptualising the study, developing a protocol, carrying out the analysis and publishing the results. |
| Collaborator Contribution | Researchers in our team have carried out validation |
| Impact | QCovid was developed as a model to estimate a person's risk of being hospitalised or dying due to catching coronavirus. |
| Start Year | 2020 |
| Description | GSK COVID-19 MABs |
| Organisation | GlaxoSmithKline (GSK) |
| Country | Global |
| Sector | Private |
| PI Contribution | The BREATHE and EAVE II teams have obtained governance approvals for the data analysis, worked with the external industry sponsor to finalise the protocol, completed the analysis and provided a report to the sponsor. |
| Collaborator Contribution | GSK provided the study question, sponsorship and funding. University of Strathclyde provided pharmacy input to the study protocol and governance, and data analysis / statistical expertise. |
| Impact | A report has been provided to GSK. |
| Start Year | 2022 |
| Description | GSK COVID-19 MABs |
| Organisation | University of Strathclyde |
| Department | Strathclyde Institute of Pharmacy & Biomedical Sciences |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The BREATHE and EAVE II teams have obtained governance approvals for the data analysis, worked with the external industry sponsor to finalise the protocol, completed the analysis and provided a report to the sponsor. |
| Collaborator Contribution | GSK provided the study question, sponsorship and funding. University of Strathclyde provided pharmacy input to the study protocol and governance, and data analysis / statistical expertise. |
| Impact | A report has been provided to GSK. |
| Start Year | 2022 |
| Description | ISARIC CO-CIN |
| Organisation | University of Edinburgh |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Assessing the generalisability of the findings from ISARIC CO-CIN across Scotland |
| Collaborator Contribution | The ISARIC4C study has created an open-access integrated analysis platform for linked clincal data from across the NHS for a range of studies, including ISARIC4C, GenOMICC, PHOSP, COG-UK and UK-CIC. |
| Impact | Shared expertise |
| Start Year | 2021 |
| Description | ONS joined as collaborator |
| Organisation | Office for National Statistics |
| Country | United Kingdom |
| Sector | Private |
| PI Contribution | The EAVE II team and the COVID-19 in pregnancy in Scotland (COPS) team have shared their significant work and expertise with collaborators, to extend our analyses around vaccine effectiveness UK wide. |
| Collaborator Contribution | ONS is leading for England on research questions for follow on work looking at uptake, safety and effectiveness of COVID-19 vaccines in: (1) pregnancy; and (2) Children and Young people |
| Impact | The work is still underway. ONS is was a partner in analyses around COVID-19 vaccination effectiveness in pregnancy, and is a partner in a current vaccine booster effectiveness study. |
| Start Year | 2022 |
| Description | Rapid Outcomes of COVid therapeutics in Eave II |
| Organisation | University of Strathclyde |
| Department | Mathematics and Statistics Strathclyde |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | We are leading this piece of work, which seeks to: 1. estimate the proportion of the population that might be eligible for MAb therapy according to current guidelines, 2. estimate the uptake of MAbs by demographics and risk group, 3. investigate the effectiveness of these treatments (alone and in combination) in real world settings, stratified by viral strain, 4. identify factors associated with severe outcomes in those treated with MAbs, 5. determine the safety profile of MAb therapies. |
| Collaborator Contribution | Our partners at Strathclyde are providing high level statistical input and pharmacy expertise to this study. |
| Impact | Initial analysis led to a research publication. GSK commissioned a further collaboration through BREATHE. |
| Start Year | 2022 |
| Description | Use of national linked healthcare, serology and viral genomic data to identify and characterise post-third and -booster dose vaccine breakthroughs at a population level |
| Organisation | University of Birmingham |
| Department | School of Immunity and Infection |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Our primary aim is to investigate COVID infection breakthrough after third and booster vaccination and the potential influence of viral variants. This includes post-vaccine re-infection with prior history of COVID-19 illness. |
| Collaborator Contribution | The University of Birmingham (UoB) has been awarded up to £6,674,199 on behalf of UKRI, funded as part of the COVID-19 National Core Studies (NCS), for "Phase 1 COVID-19 Immunity - National Core Study (Phase 1 IMM-NCS)" to coordinate research programmes and infrastructure to ensure key questions on immunity are being answered from basic understanding of the immune response, through duration and nature of natural infection and vaccine induced immunity in clinically at risk and general populations. By working collaboratively we draw fresh insights and increase our collective understanding of how to accelerate control of the COVID-19 pandemic. |
| Impact | This work is at an early stage, having only began in December 2021. Our objectives are to: 1) Estimate the frequency of post-vaccine breakthroughs from linked electronic health records and viral genomic data in Scotland in near real-time. 2) Characterise the demographic, ethnic, socio-economic, immunological and clinical features of post-vaccine breakthroughs. 3) Investigate how these risks vary by vaccine dose, vaccine type, and viral variants. 4) Develop and internally validate a prediction model to assess predictors for post-vaccine breakthroughs. 5) Analyse viral variants, mutations and lineages in post-vaccine breakthroughs, and compare these to viruses in the general population over the same time interval. 6) Replicate the above findings using research-ready national linked surveillance datasets across the other UK nations. |
| Start Year | 2021 |
| Description | BPNA Annual Conference 2023 |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | The meeting (January 2023) provided opportunities to share the latest research from diverse areas of child neurology, from lab-based basic science to clinical trials and patient experiences. Professor Sir Aziz Sheikh presented in the session on Health Informatics, on "Data-enabled responses to the COVID-19 pandemic". |
| Year(s) Of Engagement Activity | 2023 |
| URL | https://bpna.org.uk/conference/2023/index.php?contentid=1310 |
| Description | Bowser Administration Delegation visit |
| Form Of Engagement Activity | Participation in an open day or visit at my research institution |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Industry/Business |
| Results and Impact | The Washington DC Mayor's Office organised a visit to the University of Edinburgh by 16 companies and 4 government as part of an inward trade mission. The visit was designed to promote the UK as an investment destination for DC companies and position the UK as a strategic partner for investment, as well as to attract UK Healthcare and Life Science organisations to Washington DC. The presentations included discussion of the work done during the COVID-19 pandemic under the EAVE II platform umbrella of research projects. |
| Year(s) Of Engagement Activity | 2022 |
| Description | COVID-19 Recovery Committee |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Policymakers/politicians |
| Results and Impact | Road to recovery: the impact of the pandemic on Scotland's labour market. The COVID-19 Recovery Committee launched this inquiry to consider what impact COVID-19 has had on long-term illness and early retirement as drivers of economic inactivity. Professor Sir Aziz Sheikh gave evidence that the pandemic has shown that Scotland has the potential to be a world-leader in using health data to inform public policymaking, including policies aimed at tackling economic inactivity and its underlying causes. The Committee heard in evidence that the biggest barriers to realising this ambition appear to be a lack of "instruction, resources and permissions". The Committee seeks clarification from the Scottish Government on its response to this evidence, including what amount, it is investing in the advances made in health data analysis during the pandemic in wider policy areas, particularly initiatives to support the preventative health agenda and open access public health data. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://sp-bpr-en-prod-cdnep.azureedge.net/published/CVDR/2023/2/7/919d8d85-0210-4adf-a6d3-e196f8883... |
| Description | Media briefing events and working extensively with journalists on their stories |
| Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Media (as a channel to the public) |
| Results and Impact | Presentation of information about safety and effectiveness of COVID-19 vaccines |
| Year(s) Of Engagement Activity | 2021,2022 |
| Description | National Data Assets & Opportunities for Collaboration across the UK Nations and Beyond |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | On 22 September 2022, our team delivered a webinar discussing how they have worked with near real-time healthcare data during the COVID-19 pandemic and what we have achieved and learned from this. We highlighted the importance of using patient and public voices to shape our work throughout. We presented an overview of the national data assets used (EAVE II, RCGP RSC, SAIL and the Honest Broker Service), and explained the practicalities behind how the team went about conducting pooled, UK-wide analyses. We also presented work done with international partners in Brazil looking at effectiveness and waning of the Pfizer BioNTech vaccine in children and young people. Finally, we gave some pointers about how other researchers can request access to these datasets for their own research. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://www.ed.ac.uk/usher/eave-ii/connected-projects/dac-vap-2/watch-our-webinar |
| Description | News article |
| Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Public/other audiences |
| Results and Impact | Multiple news articles reporting risk of unvaccinated women and their babies becoming unwell with COVID-19 during pregnancy. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://www.bbc.co.uk/news/uk-scotland-59986452 |
| Description | News article |
| Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Public/other audiences |
| Results and Impact | News article in Healthcare in Europe.com focussing on pregnancy in pandemic times, specifically whether COVID-19 vaccine increases the risk of miscarriage. The research reported that COVID-19 vaccines are safe to have before and during pregnancy. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://healthcare-in-europe.com/en/news/covid-19-vaccine-increase-miscarriage-risk-study.html |
| Description | News article |
| Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Public/other audiences |
| Results and Impact | News article discussing the inflated risk of vaccine induced cardiac arrest, and presenting findings from EAVE II reporting no meaningful increase in serious events. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://www.newsbreak.com/news/2879708180222-the-inflated-risk-of-vaccine-induced-cardiac-arrest |
| Description | News article |
| Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Public/other audiences |
| Results and Impact | News article discussing vaccines and masks during the pandemic, and reporting the EAVE II vaccine effectiveness study in Scotland. |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://www.buzzfeednews.com/article/katiecamero/tripledemic-covid-pandemic |
| Description | Patient and public involvement with the EAVE II project |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Patients, carers and/or patient groups |
| Results and Impact | This project has Patient and Public Involvement (PPI) embedded alongside the research. We have established our own Public Advisory Group (PAG) and are working closely with other groups to ensure diversity of input. The intention of PPI is to ensure the research design and outputs are as transparent, understandable and beneficial to patients as possible. Two representatives from the group sit on relevant project Steering Groups and contribute to key project decision making. Group members have contributed to discussions about research priorities and helped to develop new research proposals. Group members have helped us to write lay summaries and fed back to us on infographics developed to communicate our results. Two members of our group - one adult and one teenager - were interviewed by The Lancet Respiratory Medicine about how they have coped with living with asthma during the pandemic. See: https://doi.org/10.1016/S2213-2600(22)00013-3 and https://doi.org/10.1016/S2213-2600(22)00014-5 in publications. |
| Year(s) Of Engagement Activity | 2021,2022 |
| URL | https://www.ed.ac.uk/usher/eave-ii/about-eave-ii/meet-the-team/eave-ii-public-advisory-group |
| Description | Presentation on Health Data at a Research Insights event |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Public/other audiences |
| Results and Impact | The Research Insights series are free online public events exploring the science and research taking place in our College. Prof Sheikh and Dr Vasileiou presented about health data, how it is kept safe and secure, and how information about people's health helps to inform public health policy decisions. They explained how health data helped scientists to figure out how the effectiveness of the first doses of Covid-19 vaccine, and how health data are being used to track the Covid-19 pandemic. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentations to government bodies, including GO-Science, JCVI, MHRA, National Core Studies |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Policymakers/politicians |
| Results and Impact | Presentation of data summarising safety and effectiveness of COVID-19 vaccines |
| Year(s) Of Engagement Activity | 2021,2022 |
| Description | Presentations to inter-governmental bodies e.g. WHO |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Policymakers/politicians |
| Results and Impact | Presentation of data summarising safety and effectiveness of COVID-19 vaccines |
| Year(s) Of Engagement Activity | 2021,2022 |
| Description | World Innovation Summit for Health (WISH) Forum on Health System Resilience |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Professor Sir Aziz Sheikh took part in a moderated panel discussion at WISH 2022 on how real-world data can help us to prepare better for the next pandemic. He used examples from EAVE II, BREATHE and associated projects to set the scene, and highlighted the value of data as one of the greatest assets of government. He was also co-author on a publication which was launched at the event: El Akoum M, Dhami S, Thompson D, Sheikh A. Building health system resilience: A roadmap for navigating future pandemics. Doha, Qatar: World Innovation Summit for Health, 2022. ISBN: 978-1-913991-26-5 |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://2022.wish.org.qa/ |