Virus Watch: Understanding community incidence, symptom profiles, and transmission of COVID-19 in relation to population movement and behaviour

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Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits, Benefits reported.

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Objective for processing

The Coronavirus (COVID-19) pandemic has caused large numbers of deaths and impacted lives around the world with the closure of schools, workplaces, and limitations on our freedom of movement. Most current knowledge of the COVID-19 COVID- 19 comes from observations at the more severe end of the disease in hospitalised patients. There is currently a lack of understanding of COVID-19 community incidence, symptom profile, severity, infectious [67 words unchanged] will help to inform NHS planning and the national public health response. Virus Watch is a household community cohort study. The cohort size is 58,490. Recruitment has now closed. Participants will be were recruited via one of the following methods: a postal invitation, leaflet drop, social media campaign, SMS Short Message/Messaging Service (SMS) or incentivised letter sent from GP General practitioner (GP) practices. Participants will be directed to the study website and asked to fill out a baseline questionnaire, followed by weekly and monthly update questionnaires, all online. Information will be gathered on all members of participating households. Poland is the most common European country of birth for people born abroad and resident in the UK, and the most common nationality in the UK after British according to the ONS. Polish is also the second most common language spoken in England according to the 2011 Census. The Polish population resident in Britain is therefore a sizable and important minority population that the researchers are interested in in terms of their risks of COVID19 infection. UCL used the Royal Mail Post Office Address File and systematically sampled addresses in order to ensure representative samples were taken within each region of England and Wales. Virus Watch had a targeted recruitment campaign focused on people from minority ethnic backgrounds (Black African, Black Caribbean, Indian, Bangladeshi, Pakistani groups) as there was evidence that people from the BAME group are at greater risk of hospitalisation from COVID-19 and their outcomes are worse. UCL, therefore, oversampled participants from BAME groups. UCL originally aimed to recruit a total of 42,500 individuals, through a targeted recruitment of 12,500 individuals from BAME groups and 30,000 from the general population. This was increased to a total of 50,000+ recognising that UCL’s efforts to recruit BAME participants using the methodology described above have resulted in additional participants from the general population being recruited. The primary purpose of linking the Virus Watch questionnaire data to hospital and mortality data held by NHS England is to estimate population-based COVID-19 related hospital visits (accident and emergency attendances and admissions) and deaths, to address objective h below). A secondary purpose of linkage to HES data is to examine how social distancing measures have affected routine use of health services (e.g. planned procedures and outpatient appointments) to address objective g) below. The primary purpose of linking VirusWatch to Second Generation Surveillance System (SGSS) and National Pathology Exchange (NPEX) data is to identify any laboratory-confirmed infections in the cohort (including individuals who are not part of the sub 10,000 participant-swabbing cohort), addressing objectives a) and i)-k). A subset of 10,000 participants will be recruited for swab and blood sampling to estimate the incidence of COVID-19 infections and development of antibody responses. Participants can also choose to submit geotracking data via their mobile phone. The data has been requested by University College London (UCL) who are acting as the sole data controller who is also acting as the sole data processor. The primary purpose of linking the Virus Watch questionnaire data to hospital and mortality data held by NHS Digital is to estimate population-based COVID-19 related hospital visits (accident and emergency attendances and admissions) and deaths, to address objective h). A secondary purpose of linkage to HES data is to examine how social distancing measures have affected routine use of health services (eg planned procedures and outpatient appointments), to address objective g). The primary purpose of linking VirusWatch to PHE Second Generation Surveillance System (SGSS) and National Pathology Exchange (NPEX)data is to identify any laboratory confirmed infections in the cohort (including individuals who are not part of the 10,000 participant-swabbing cohort), addressing objectives a) and i)-k). [10 paragraphs unchanged] j) To measure COVID 19 clinical profiles (including the range of symptoms of COVID19 disease and the proportion of infections that are asymptomatic) according to the circulating SARS-CoV-2 variant [4 paragraphs unchanged] o) To ensure availability of specimens to measure the protective effect of T and B cell responses and to assess the value of proteomic analysis in assessing vulnerability to severe infection. o) to estimate the effectiveness of coronavirus vaccine in preventing COVID disease p) to estimate the effectiveness incidence of adverse reactions following coronavirus vaccine in preventing COVID disease vaccination q) to estimate the incidence of adverse reactions following coronavirus vaccination The lawful basis for processing personal data under the UK GDPR is: The legal basis for processing personal data for this purpose data at UCL falls under Article 6(1)(e) of the General Data Protection Regulations (GDPR), i.e. “a task carried out in the public interest”. It also falls under Article 9(2)(j), “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes”. The processing of data for this study is a task of public interest as it will help with better understanding of the risk posed by COVID-19 such as likelihood of infection, likely symptoms, those at greatest risk of complications and the effect of risk factors such as social contact will help guide proportionate public responses and reinforce public health messaging. Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller; Due to the nature of this study and the urgent national call to set it up as soon as possible, UCL did not involve participants in its design. UCL have previously conducted Patient and Public Involvement to support similar community cohort studies of acute infections using similar methodologies. UCL have engaged the Young Persons' Advisory Group for research at Great Ormond Street Hospital to provide feedback on the Children's Participant Information Sheets. UCL will provide opportunities for survey participants to comment on survey methodology at the first monthly survey and consider revisions based on this. UCL will produce regular newsletters for survey participants. The lawful basis for processing special category data under the UK GDPR is: AMENDMENT REQUEST Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. A further objective of linkage has been added as a result of the roll-out of the SARS-CoV-2 vaccination programme: to examine the effectiveness of coronavirus vaccines in preventing SARS-CoV-2 cases. Information on vaccination status will be used to assess associated hospital contacts and mortality (objective p as above). UCL are requesting further linkage to the COVID-19 Vaccination Status Data to address this objective. UCL also aim to examine the incidence of adverse reactions following coronavirus vaccination (objective q above). Therefore, UCL request access to the COVID-19 Vaccination Adverse Reactions dataset. UCL request this datasets includes the unique identifier field in order to link this dataset to the other requested datasets (it the token_person_id is available and populated we would not need this variable). The processing of data for this study is a task of public interest as it will help with better understanding of the risk posed by COVID-19 such as likelihood of infection, likely symptoms, those at greatest risk of complications and the effect of risk factors such as social contact will help guide proportionate public responses and reinforce public health messaging. In the previous version of this agreement; UCL only provided motivation for recruitment of Polish groups, however, this has now been expanded to include BAME groups: Information on vaccination status will be used to assess associated hospital contacts and mortality (objective o as above). Linkage to the COVID-19 Vaccination Status Data will enable UCL to address this objective. UCL also aim to examine the incidence of adverse reactions following coronavirus vaccination (objective p above). There is increasing evidence that people from the BAME group (Black African, Black Caribbean, Indian, Bangladeshi, Pakistani groups) are at greater risk of hospitalisation and death from COVID-19. Persons from black and minority ethnic (BAME), and some migrant groups will be oversampled. Due to the nature of the study and the urgent national call to set it up as soon as possible at the time during the pandemic, the researchers did not involve participants in its original design. However, the researchers engaged the Young Persons' Advisory Group for research at Great Ormond Street Hospital to provide feedback on the Children's Participant Information Sheets. The researchers provided opportunities for survey participants to comment on survey methodology at the first monthly survey and considered revisions based on this. At the baseline survey, and each month, the researchers asked participants what questions are important to them (in relation to COVID-19), and what they would like the researchers to answer. The researchers produce regular newsletters for survey participants sharing the results. Participants in the study have been contacted and advised that the study end date is now June 2022 and also that their data will be linked to vaccine data. Participants have been given the opportunity to withdraw from the study (participants have always had the opportunity to withdraw, and continue to do so). The researchers are also monitoring participant queries through the study email and using these to refine methodology where necessary. Patient and Public Involvement For the health equity aspect of the study, UCL has set up an advisory group that has experts with experience as members. UCL was able to achieve this by working with the Race Equality Foundation and Doctors of The World. UCL’s PPIE activity was led by experienced people at the Race Equality Foundation and Doctors of The World with advisory meetings held quarterly from November 2020 – March 2022. The PPIE activities have substantially informed the research in several areas including the identification of research questions, interpretation of findings, and the implementation of recommendations. Due to the nature of the study and the urgent national call to set it up ASAP, the researchers did not involve participants in its design. However, the researchers engaged the Young Persons' Advisory Group for research at Great Ormond Street Hospital to provide feedback on the Children's Participant Information Sheets. The researchers will provide opportunities for survey participants to comment on survey methodology at the first monthly survey and consider revisions based on this. At the baseline survey, and each month, The researchers will ask participants what questions are important to them (in relation to COVID-19), and what they would like the researchers to answer. The researchers will produce regular newsletters for survey participants sharing the results. UCL is the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above. There are two Co-Investigators from University College Hospital London named in the Protocol who helped arranged the laboratory testing aspect of the study however they hold no role in determining purposes. A commercial company sent recruitment postcards inviting households to sign up online (they have no influence on the design of the study). The researchers are also monitoring participant queries through the study email and using these to refine methodology where necessary. The researchers developed a PPI programme as part of the health equity arm of virus watch with an advisory group over the past 12 months related to aspects of the study focusing on people from minority ethnic backgrounds with the Race Equality Foundation and Doctors of the World and experts by experience. This advisory group continue to be involved in managing, evaluating and disseminating the research. Amazon Web Services (AWS) is a processor acting under the instructions of UCL. AWS’ role is limited to secure back-up of data stored in UCL’s Data Safe Haven. UCL uses offsite data centre services provided by VIRTUS data centre. VIRTUS does not have access to the data.

Processing activities

UCL will use the Royal Mail Post Office Address File and systematically sample addresses in order to ensure representative samples are taken within each subgroup of interest. There is increasing evidence that people from the BAME group are at greater risk of hospitalisation from COVID-19 and their outcomes are worse. UCL will therefore oversampled participants from BAME groups. UCL will also seek to recruit Polish groups. UCL require the following data to be linked to the VirusWatch cohort: UCL will use a commercial company to efficiently send recruitment postcards inviting households to sign up online. UCL originally anticipated a 25% response rate from the general population yielding approximately 30,000 participants and 15% from the BAME population yielding approx. 12,500 participants (42,500 participants in total). The sample size is required in order to have sufficient statistical power to estimate less common events, including hospital admissions, in different subgroups, including people from Black and Minority Ethnic backgrounds. By June 2021, the total target sample size is now over of 50,000 individuals recognising that UCL’s efforts to recruit BAME participants using the methodology described above have resulted in additional participants from the general population being recruited. postcards will be in English and include a sentence in six languages, pointing participants to the study website containing Patient Information Sheets translated into their language. All information sheets and consent forms have been translated into initially 6 languages (Urdu, Bengali, Punjabi, Portuguese, French, Polish). UCL have recently added translations to Tamil, Arabic and Somali. It is not feasible to obtain verbal consent on the phone, given the number of people participating, and in any case written consent is preferred. An online system for consent and participation is the only feasible option for this size of study. UCL found that response rates were lower than expected and undertook a digital recruitment campaign using social media adverts on the following platforms: Facebook, Google, Twitter, Instagram, LinkedIn. The social media adverts had tailored messages that aim to improve recruitment of BAME communities in addition to achieving an age, sex and geographically representative sample of the UK population. Social media users received recruitment adverts and were directed to the study website http://ucl-virus-watch.net/. Visitors to the Viruswatch website will be asked to join a mailing list (via Mail Chimp) allowing us to follow-up potential participants with email reminders the same day, day 1, 3 and 7 after visiting the Viruswatch website. Potential participants will be able to unsubscribe at any time. This mailing list will be used to send out regular news updates to study participants. From this point onwards the recruitment process remains unchanged. Digital invitations will be created for sharing via WhatsApp, and fliers will be distributed in areas close to blood taking clinics nominated by Local Clinical Research Networks. Text messages inviting patients from GP clinics (organised via LCRNs) to take part were also sent. In order for a household to be enrolled, they must have an internet connection and email address and all household members (no more than 6) must agree to take part. Households will nominate a lead householder with whom the study will communicate and email weekly surveys to. The lead householder needs to be able to read English to support other household members in survey completion. The lead householder will need to be proficient in English in order to answer the weekly and monthly surveys which will be in English only. The concept of a ‘lead householder’ has been successfully used in previous studies run by UCL, including Fluwatch and Bugwatch (see: https://doi.org/10.1093/ije/dyv370; https://doi.org/10.1136/bmjopen-2018-028676). UCL are requesting the following data to be linked to the VirusWatch cohort: [5 paragraphs unchanged] • Public Health England (PHE) Second Generation Surveillance System (SGSS) data on confirmed cases of SARS-CoV-2 and other respiratory infections (influenza, respiratory syncytial virus, seasonal coronavirus, adenovirus, rhinovirus, parainfluenza virus, human metapneumovirus). metapneumovirus) [1 paragraph unchanged] • COVID-19 Vaccination Status data (amendment request) • COVID-19 Vaccination Adverse Events dataset (amendment request) The original* Virus Watch survey data collection took place between June 2020 and August 2021. UCL are requesting require linked data for the period January 2020 (the first UK case of [29 words unchanged] researchers to examine long-term health impacts of COVID-19 infection and monitor vaccine effectiveness (any further NHS Digital data required after December 2023 will be subject to a further amendment to this agreement). UCL will request Civil Registration Deaths data from the start of follow-up up to 5 years after the end of the study. effectiveness. UCL request that linkage to HES, SGSS, NPEX, COVID-19 Vaccination Status & Adverse Events, and Death data are refreshed 5 times during the period of the DSA. (*For the purpose of this agreement, the original study data collection end date of August 2021 is used. Virus Watch surveys have continued and are ongoing (until April 2025) under a no cost grant extension from the Medical Research Council (MRC) (ended 30 March 2022) and the current EU funded END-VOC (ENDing COVID-19 Variants Of concern through Cohort studies) consortium (May 2022-April 2025).) All VirusWatch data, including the data requested from NHS Digital will be stored in the UCL Data Safe Haven (DSH). Patient identifying variables (including names and addresses), which are requested from survey participants, will be kept in a different file in the DSH. Identifiers will be kept separate to survey responses, laboratory test results, linked NHS Digital data and geotracking data. The UCL DSH uses Dual Factor Authentication to access and handle data transferred into the DSH service. This ensures that only the named applicants will have access to the data from the DSH. UCL supplies NHS England with study participants’ Study ID, NHS numbers, names, addresses (including postcodes) and dates of birth for linkage. Under this agreement (v2), UCL will provide an updated cohort of study participants (final cohort March 2023 58,490). NHS England will hold the VirusWatch identifiers throughout the period of the DSA and link the VirusWatch identifiers to HES and Civil Registration Deaths, SGSS, Pillar 2 the COVID-19 Vaccination status & Adverse Events data on a bi-annual basis. Only researchers (UCL substantive employees or PhD students), working under appropriate supervision on behalf of the data controller/processor within this agreement will have access to the data and only for the purposes described in this agreement. These individuals are experienced in handling individual-level, sensitive data and complete annual courses in information governance and data protection (a requirement for accessing the UCL DSH). The data supplied by NHS England will not be shared with third parties or linked to any other datasets. UCL have no requirement nor will attempt to re-identify the supplied data. The data supplied by NHS Digital will not be shared with third parties or linked to any other datasets. UCL have no requirement nor will attempt to re-identify the supplied data. Only de-identified data (Study ID and attribute variables from the datasets held by NHS England) will be returned to UCL. The linked data supplied by NHS England will be uploaded to the Data Safe Haven at UCL by UCL as soon as received. A file transfer mechanism enables information to be transferred into the Safe Haven simply and securely. AMENDMENT REQUEST All VirusWatch data, including the data from NHS England will be stored in the UCL Data Safe Haven (DSH). Patient identifying variables (including names and addresses), which are requested from survey participants, will be kept in a different file in the DSH. Identifiers will be kept separate to survey responses, laboratory test results, linked NHS England data and geotracking data. The UCL DSH uses Dual Factor Authentication to access and handle data transferred into the DSH service. UCL will supply NHS Digital with study participants’ Study ID, NHS numbers, names, addresses (including postcodes) and dates of birth for linkage. UCL originally requested that identifiers from the VirusWatch cohort would only be submitted to NHS Digital once. UCL are now requesting that a further set of identifiers are transferred from UCL to NHS Digital. The NHS Digital Data linkage team will hold the VirusWatch identifiers throughout the period of the DSA and link the VirusWatch identifiers to HES and Civil Registration Deaths, SGSS, NPEX and the COVID-19 Vaccination status & Adverse Events data on a quarterly basis. Amazon Web Services provides cloud hosting services to UCL and will store the data as contracted by UCL. UCL request that this updated cohort will be re-linked to data previously requested. UCL uses offsite data centre services provided by VIRTUS data centre. Only de-identified data (Study ID and attribute variables from the datasets held by NHS Digital) will be returned to UCL. The linked data supplied by NHS Digital will be uploaded to the Data Safe Haven at UCL by UCL as soon as received. A file transfer mechanism enables information to be transferred into the Safe Haven simply and securely. Only researchers (UCL substantive employees including UCL PhD students), working under appropriate supervision on behalf of the controller within this agreement will have access to the data and only for the purposes described in this agreement. These individuals are experienced in handling individual-level, sensitive data and complete annual courses in information governance and data protection (a requirement for accessing the UCL DSH). Dissemination schedule: 5 releases during this data sharing agreement: 1) As soon as the agreement is signed 2) December 2021 3) June 2022 4) December 2022 5) December 2023

Expected output

UCL plans to disseminate the outputs through a number of channels: UCL expect or have delivered the following outputs: 1) Journal publications (open), including The Lancet, the British Medical Journal, Nature Communications, International Journal of Infectious Diseases, Vaccine and Wellcome Open (target dates: March 2021, June 2021) Q1 2022) 2) Presentations to the Scientific Advisory Group for Emergencies (SAGE), (target dates: October & December 2020, February, April, June 2021); presentation to Department of Health and Social Care (target date: October 2020) 2) Two meetings have been held with the public engagement group for the COVID Equity Study (autumn 2020) (Objectives: b, c, d) 3) Presentations at scientific conferences, including European Respiratory Society Annual Congress, European Society for Paediatric Infections Diseases Scientific meeting, Public Health England Annual conference (target dates: April 2021, September 2021) 3) A series of reports have been produced for NERVTAG & PHE including the serial interval of COVID-19 and the effect of Variant B.1.1.7 (April 2021), Symptom profiles and accuracy of clinical case definitions for COVID-19 (Spring 2021) (Objective: j) 4) Regular updates published on the VirusWatch website (http://ucl-virus-watch.net/) and results dashboard, aimed at the general public. These will be published monthly throughout the study. 4) Policy briefing for Public Health England and Greater London Authority on activities and contacts in the VirusWatch cohort (March, 2021) (Objectives: a, b, d, e, f) All outputs will be in aggregate form only with small numbers suppressed in line with the HES analysis guide. 5) An analysis of household overcrowding and COVID risk was featured on BBC Newsnight (March 2021) (Objectives: b & d) 6) UCL’s work on waning of SARS-CoV-2 antibodies targeting the Spike protein in individuals post second dose of ChAdOx1 and BNT162b2 COVID-19 vaccines and risk of breakthrough infections was presented to JCVI, JBC, PHE vaccine evaluation and the Scientific Advisory Group on antibodies. (Nov 2021) (Objectives: m & p) 7) Comparative effectiveness of different primary vaccination courses on mRNA based booster vaccines against SARs-COV-2 infections was referenced by the Australian Department of Health when developing their vaccine program (Spring 2022). (Objectives: m & p) 8) Presentations at scientific conferences, including European Respiratory Society Annual Congress, European Society for Paediatric Infections Diseases Scientific meeting, Public Health England Annual conference (target dates: August 2021, September 2021) 9) Regular updates are published on the VirusWatch website (http://ucl-virus-watch.net/) and results dashboard, aimed at the general public (Nov 2020, Jan, March, May, June, Dec 2021, Feb & Dec 2022). 10) Work on occupation, worker vulnerability, and COVID-19 Vaccination Uptake was published in a report to HSE (Summer/Autumn 2022). (Objectives: b, d, e, f & p) 11) UCL are in the process of finalising a report into the inequities experienced by ethnic minorities and migrants during the pandemic that we are co-writing with our advisory group that includes experts by experience and the Race Equality Foundation and Doctors of The World. (April 2023) (Objectives: b, c, d) 12) Continue to share regular updates on VirusWatch website (http://ucl-virus-watch.net/) (at least twice / annum) 13) Continue to publish research articles in peer reviewed journals In all cases, all outputs are aggregated and suppressed in line with suppression rules.

Expected measurable benefits

It is hoped Virus Watch will provide data relevant to a wide range of audiences [21 words unchanged] is available to all these audiences in a timely way. Audiences include- [1 paragraph unchanged] 2) THOSE RESPONSIBLE FOR PLANNING THE NHS RESPONSE - Understanding of the [9 words unchanged] severity, health care seeking behaviour and the case hospitalisation and mortality ratios will could allow better predictions of surges in NHS activity supporting measures such as [5 words unchanged] cancelling routine activities etc. Understanding vaccine uptake and effectiveness in different groups. 3) THOSE PROVIDING FRONT LINE CARE –Improved –The analysis could provide improved case definitions by age, sex and ethnicity guiding targeting of diagnostics and contact tracing. [1 paragraph unchanged] 5) THE GENERAL PUBLIC AND THE MEDIA. Better understanding of the risk [14 words unchanged] of complications and the effect of risk factors such as social contact will could help guide proportionate public responses and reinforce public health messaging.

Benefits reported

UCL have only very recently received any linked data from NHS Digital, hence there are no yielded benefits using linked VirusWatch - NHS Digital data. However, a number of publications have been produced using VirusWatch data alone. UCL’s analyses contributed to national decision-making at critical time points during the pandemic. Virus Watch data has been presented to NHS England, Department of Health and Social Care, Cabinet Office race disparity unit, NHS Race and Health observatory, Joint Biosecurity Centre (JBC), The New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG), SAGE, Joint Committee on Vaccination and Immunisation (JCVI), Chief Scientific Advisor, Chief Medical Officer and others. 1) THOSE PLANNING AND UNDERTAKING PUBLIC HEALTH MEASURES TO MINIMISE TRANSMISSION a) Policy briefing for Public Health England and Greater London Authority on activities and contacts in the VirusWatch cohort (March 2021) (Objectives: a, b, d, e, f) b) An analysis of household overcrowding and COVID risk was featured on BBC Newsnight and supported local authority work in this area in, for example, Newham (March 2021) (Objectives: b & d) c) Comparative effectiveness of different primary vaccination courses on mRNA based booster vaccines against SARs-COV-2 infections was presented to Joint Committee on Vaccination and Immunisation (JCVI), UKHSA Vaccine monitoring board, Joint Biosecurity Centre on several occasions during the vaccine roll out and was referenced by the Australian Department of Health when developing their vaccine program (Spring 2022). (Objectives: m & p) 2) THOSE RESPONSIBLE FOR PLANNING THE NHS RESPONSE a) A series of reports have been produced for NERVTAG & PHE including the serial interval of COVID-19 and the effect of Variant B.1.1.7 (April 2021), Symptom profiles and accuracy of clinical case definitions for COVID-19 (Spring 2021) (Objective: j). b) UCLs work on waning of SARS-CoV-2 antibodies targeting the Spike protein in individuals post second dose of ChAdOx1 and BNT162b2 COVID-19 vaccines and risk of breakthrough infections was presented to JCVI, JBC, PHE vaccine evaluation and the Scientific Advisory Group on antibodies. (Nov 2021) (Objectives: m & p) c) Work on occupation, worker vulnerability, and COVID-19 Vaccination Uptake was published in a report to HSE (Summer/Autumn 2022). (Objectives: b, d, e, f & p) 3) THOSE PROVIDING FRONT-LINE CARE a) Symptom profiles and accuracy of clinical case definitions for COVID-19 in a community cohort: results from the Virus Watch cohort. This paper led to work analysing variant hotspots that were shared as follows: • PHE roundtable on updating test & trace case definition, CMOs meetings (Feb/March 2021). • Symptom profiles by VOC hotspot areas - NERVTAG (Jan-March 2021). Informed NERVTAG’s assessment of the severity of community cases of the kent strain. Work to be published in upcoming NERVTAG paper. • Swabbing behaviour changes over time and comparison of symptom profiles by variant hotspot (wild type, alpha & delta). Paper to NERVTAG meeting 18 June 2021. 4) ACADEMIC GROUPS INVOLVED IN UNDERSTANDING THE PANDEMIC. a) UCL are sharing individual record level data (excluding any data or variables originating from linkage via NHS England) on the ONS SRS (DOI: 10.57906/s5f5-nq13). The data are available under restricted access and can be obtained by submitting a request directly to the SRS. UCL regularly share results and updates on the study via a "Findings so far" section on the Virus Watch website - https://ucl-virus-watch.net/ b) Presentations at scientific conferences, including: i) European Respiratory Society Annual Congress, Aug 2021 ii) European Society for Paediatric Infections Diseases Scientific meeting, Sept 2021 iii) Public Health England Annual conference Nov 2021 iv) PROTECT COVID-19 Technical Seminar March 2022 v) British Thoracic Society Winter Meeting, Nov 2022 vi) HDR UK Scientific Conference, Dec 2022 5) THE GENERAL PUBLIC AND THE MEDIA. a) Regular updates are published on the VirusWatch website (http://ucl-virus-watch.net/) and results dashboard, aimed at the general public (Nov 2020, Jan, March, May, June, Dec 2021, Feb & Dec 2022). b) At Virus Watch’s 2-year anniversary (June 2022), Virus Watch recorded a video communication to all study participants summarizing the results and thanking them for their commitment. c) Where there has been media interest in the Virus Watch publications, UCL have collated them on the Virus Watch website https://ucl-virus-watch.net/?cat=6 d) UCL are in the process of finalising a report into the inequities experienced by ethnic minorities and migrants during the pandemic that UCL are co-writing with Virus Watch’s advisory group that includes experts by experience and the Race Equality Foundation and Doctors of The World. (July2023) (Objectives: b, c, d)

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Datasets: + COVID-19 Vaccination Adverse Reactions; + COVID-19 Vaccination Status; + HES-ID to MPS-ID HES Outpatients

Objective for processing

[1 paragraph unchanged] Virus Watch is a household community cohort study. Approximately 42,500 participants Participants will be recruited via one of the following methods: a postal invitation or using invitation, leaflet drop, social media platforms, campaign, SMS or incentivised letter sent from GP practices. Participants will be directed to the study website and asked to fill out a baseline questionnaire, followed by weekly and monthly update questionnaires, all online. Information will be gathered on all members of participating households. There is concern about an increased risk of COVID19 infection and death among people who are from a black or minority ethnic or migrant group. Persons from black and minority ethnic (BAME), and some migrant groups will be oversampled. The approximate cohort size of 42,500 will consist of a targeted recruitment of 12,500 individuals from BAME groups and 30,000 from the general population. Persons from Poland will also be oversampled. This is because Poland is the most common European country of birth for people born [52 words unchanged] researchers are interested in in terms of their risks of COVID19 infection. UCL originally aimed to recruit a total of 42,500 individuals, through a targeted recruitment of 12,500 individuals from BAME groups and 30,000 from the general population. This was increased to a total of 50,000+ recognising that UCL’s efforts to recruit BAME participants using the methodology described above have resulted in additional participants from the general population being recruited. [19 paragraphs unchanged] o) To ensure availability of specimens to measure the protective effect of [7 words unchanged] assess the value of proteomic analysis in assessing vulnerability to severe infection. proposal p) to estimate the effectiveness of coronavirus vaccine in preventing COVID disease q) to estimate the incidence of adverse reactions following coronavirus vaccination [2 paragraphs unchanged] AMENDMENT REQUEST A further objective of linkage has been added as a result of the roll-out of the SARS-CoV-2 vaccination programme: to examine the effectiveness of coronavirus vaccines in preventing SARS-CoV-2 cases. Information on vaccination status will be used to assess associated hospital contacts and mortality (objective p as above). UCL are requesting further linkage to the COVID-19 Vaccination Status Data to address this objective. UCL also aim to examine the incidence of adverse reactions following coronavirus vaccination (objective q above). Therefore, UCL request access to the COVID-19 Vaccination Adverse Reactions dataset. UCL request this datasets includes the unique identifier field in order to link this dataset to the other requested datasets (it the token_person_id is available and populated we would not need this variable). In the previous version of this agreement; UCL only provided motivation for recruitment of Polish groups, however, this has now been expanded to include BAME groups: There is increasing evidence that people from the BAME group (Black African, Black Caribbean, Indian, Bangladeshi, Pakistani groups) are at greater risk of hospitalisation and death from COVID-19. Persons from black and minority ethnic (BAME), and some migrant groups will be oversampled. Participants in the study have been contacted and advised that the study end date is now June 2022 and also that their data will be linked to vaccine data. Participants have been given the opportunity to withdraw from the study (participants have always had the opportunity to withdraw, and continue to do so). Patient and Public Involvement Due to the nature of the study and the urgent national call to set it up ASAP, the researchers did not involve participants in its design. However, the researchers engaged the Young Persons' Advisory Group for research at Great Ormond Street Hospital to provide feedback on the Children's Participant Information Sheets. The researchers will provide opportunities for survey participants to comment on survey methodology at the first monthly survey and consider revisions based on this. At the baseline survey, and each month, The researchers will ask participants what questions are important to them (in relation to COVID-19), and what they would like the researchers to answer. The researchers will produce regular newsletters for survey participants sharing the results. The researchers are also monitoring participant queries through the study email and using these to refine methodology where necessary. The researchers developed a PPI programme as part of the health equity arm of virus watch with an advisory group over the past 12 months related to aspects of the study focusing on people from minority ethnic backgrounds with the Race Equality Foundation and Doctors of the World and experts by experience. This advisory group continue to be involved in managing, evaluating and disseminating the research.

Processing activities

[1 paragraph unchanged] UCL will use a commercial company to efficiently send recruitment postcards inviting households to sign up online. UCL anticipate originally anticipated a 25% response rate from the general population yielding approximately 30,000 participants [17 words unchanged] is required in order to have sufficient statistical power to estimate less common events, including hospital admissions, in different subgroups, including people from Black and Minority Ethnic backgrounds. By June 2021, the total target sample size is now over of 50,000 individuals recognising that UCL’s efforts to recruit BAME participants using the methodology described above have resulted in additional participants from the general population being recruited. common events, including hospital admissions, in different subgroups, including people from Black and Minority Ethnic backgrounds. Depending on response rate and demographics of those registering, UCL will undertake a second recruitment that allows them to target any underrepresented groups. Invitation postcards will be in English and include a sentence in six languages, pointing participants to the study website containing Patient Information Sheets translated into their language. All information sheets and consent forms have been translated into initially 6 languages (Urdu, Bengali, Punjabi, Portuguese, French, Polish). UCL have recently added translations to Tamil, Arabic and Somali. It is not feasible to obtain verbal consent on the phone, given [18 words unchanged] and participation is the only feasible option for this size of study. UCL will assess recruitment found that response rates and the representativeness of our sample following the first mail out of 50,000 postcards. If recruitment is were lower than expected and or under-representative of the national population the researcher will create undertook a digital recruitment campaign that will use using social media adverts on the following platforms: Facebook, Google, Twitter, Instagram, LinkedIn. The social media adverts will have had tailored messages that aim to improve our recruitment of BAME communities in addition to achieving an age, sex and geographically representative sample of the UK population. Social media users will receive our received recruitment adverts and be were directed to our the study website http://ucl-virus-watch.net/. In order for a household to be enrolled, they must have an internet connection and email address and all household members must agree to take part. Households will nominate a lead householder with whom the study will communicate and email weekly surveys to. The lead householder needs to be able to read English to support other household members in survey completion. The lead householder will need to be proficient in English in order to answer the weekly and monthly surveys which will be in English only. Visitors to the Viruswatch website will be asked to join a mailing list (via Mail Chimp) allowing us to follow-up potential participants with email reminders the same day, day 1, 3 and 7 after visiting the Viruswatch website. Potential participants will be able to unsubscribe at any time. This mailing list will be used to send out regular news updates to study participants. From this point onwards the recruitment process remains unchanged. Digital invitations will be created for sharing via WhatsApp, and fliers will be distributed in areas close to blood taking clinics nominated by Local Clinical Research Networks. Text messages inviting patients from GP clinics (organised via LCRNs) to take part were also sent. In order for a household to be enrolled, they must have an internet connection and email address and all household members (no more than 6) must agree to take part. Households will nominate a lead householder with whom the study will communicate and email weekly surveys to. The lead householder needs to be able to read English to support other household members in survey completion. The lead householder will need to be proficient in English in order to answer the weekly and monthly surveys which will be in English only. [1 paragraph unchanged] UCL will supply NHS Digital with study participants’ Study ID, NHS numbers, names, addresses (including postcodes) and dates of birth for linkage. The cohort would only be submitted to NHS Digital once. The NHS Digital Data linkage team will hold the VirusWatch identifiers throughout the period of the DSA and link the VirusWatch identifiers to HES, Civil Registration Deaths and SGSS datasets on a quarterly basis. Only de-identified data (Study ID and attribute variables from the datasets held by NHS Digital) will be returned to UCL. The linked data supplied by NHS Digital will be uploaded to the DSH by UCL as soon as received. A file transfer mechanism enables information to be transferred into the Safe Haven simply and securely. [8 paragraphs unchanged] The Virus Watch survey data collection will take place between June 2020 and April 2021. UCL are requesting linked HES and SGSS data for the period January 2020 (the first UK case of COVID-19 was detected in late January) until five years after the end of follow up (2026) as COVID-19 may continue to circulate in the population, and to allow UCL researchers to examine long-term health impacts of COVID-19 infection. UCL will request Civil Registration Deaths data from the start of follow-up up to 5 years after the end of the study. • COVID-19 Vaccination Status data (amendment request) UCL request that linkage to HES, SGSS and Death data are refreshed quarterly during the period of questionnaire data collection (June 2020 and April 2021). UCL may request less frequent updates after April 2021 (depending on COVID-19 circulation). This will be subject to an amended Data Sharing Agreement with NHS Digital. • COVID-19 Vaccination Adverse Events dataset (amendment request) The Virus Watch survey data collection took place between June 2020 and August 2021. UCL are requesting linked data for the period January 2020 (the first UK case of COVID-19 was detected in late January) until five years after the end of follow up (2026) as COVID-19 may continue to circulate in the population, and to allow UCL researchers to examine long-term health impacts of COVID-19 infection and monitor vaccine effectiveness (any further NHS Digital data required after December 2023 will be subject to a further amendment to this agreement). UCL will request Civil Registration Deaths data from the start of follow-up up to 5 years after the end of the study. UCL request that linkage to HES, SGSS, NPEX, COVID-19 Vaccination Status & Adverse Events, and Death data are refreshed 5 times during the period of the DSA. [3 paragraphs unchanged] AMENDMENT REQUEST UCL will supply NHS Digital with study participants’ Study ID, NHS numbers, names, addresses (including postcodes) and dates of birth for linkage. UCL originally requested that identifiers from the VirusWatch cohort would only be submitted to NHS Digital once. UCL are now requesting that a further set of identifiers are transferred from UCL to NHS Digital. The NHS Digital Data linkage team will hold the VirusWatch identifiers throughout the period of the DSA and link the VirusWatch identifiers to HES and Civil Registration Deaths, SGSS, NPEX and the COVID-19 Vaccination status & Adverse Events data on a quarterly basis. UCL request that this updated cohort will be re-linked to data previously requested. Only de-identified data (Study ID and attribute variables from the datasets held by NHS Digital) will be returned to UCL. The linked data supplied by NHS Digital will be uploaded to the Data Safe Haven at UCL by UCL as soon as received. A file transfer mechanism enables information to be transferred into the Safe Haven simply and securely. Dissemination schedule: 5 releases during this data sharing agreement: 1) As soon as the agreement is signed 2) December 2021 3) June 2022 4) December 2022 5) December 2023

Expected measurable benefits

[2 paragraphs unchanged] 2) THOSE RESPONSIBLE FOR PLANNING THE NHS RESPONSE - Understanding of the [31 words unchanged] measures such as triaging, cohorting, care outside hospital, cancelling routine activities etc. Understanding vaccine uptake and effectiveness in different groups. [3 paragraphs unchanged]

Benefits reported

Yielded Benefits is not a requirement for new applications. UCL have only very recently received any linked data from NHS Digital, hence there are no yielded benefits using linked VirusWatch - NHS Digital data. However, a number of publications have been produced using VirusWatch data alone.

Unchanged: Expected output.