Convalescent Plasma (Vaccination Linkage)

NHS Blood and Transplant (NHSBT) require the support of NHS Digital in providing Covid-19 vaccination status on their registered donors. NHSBT routinely collects plasma from 50,000 individual records donors who have registered directly with them as part of their statutory functions.

NHS Blood and Transplant (NHSBT) are the sole Data Controller who also processes data for this application.

All donors have consented to use the data NHSBT collected as part of the donation process “for research, to improve our knowledge about the donor population and the possible health effects of blood donation. This may include linkage of your information to your other NHS records”.

Data provided by NHS Digital will be used to identify which blood donors registered with NHSBT who have previously donated convalescent plasma have been vaccinated and when they were vaccinated. NHSBT require information on the type of vaccine given to each donor and the date of each dose, as well as indicators as to if donors have not been vaccinated.

The convalescent plasma identified will be used in the REMAP-CAP trial (https://www.remapcap.org/). The chief medical officer has approved the trial to assess the use of plasma from vaccinated donors who have previously had a natural SARS-CoV-2 infection in patients who have been hospitalised with COVID-19 and are immunosuppressed.

This data will only be used to:

• identify the units of convalescent plasma currently in storage that can be used within the REMAP-CAP trial, or other ethically approved trials of convalescent plasma or hyperimmune globulin.

• identify which donors, who are now plasma for medicine donors, can also provide new plasma donations for the REMAP-CAP trial or other COVID-19 convalescent plasma or hyperimmune trials that may be approved in the future.

• Identify which blood donors, who were previous convalescent plasma donors, have been vaccinated to assess whether vaccination leads to higher levels of other antibodies e.g. anti-A and anti-B antibodies in plasma-containing components.

The data provided by NHS Digital will not be used by any other party than NHSBT.

NHSBT research, in association with the SUPPORT-E consortium (The Pan-European project SUPPORT-E (SUPPORTing high-quality evaluation of COVID-19 convalescent plasma throughout Europe)), has shown that the anti-SARS-CoV-2 antibody levels in plasma collected from donors who have a natural infection and then are vaccinated are up to ten times higher than those who have not been vaccinated. It is also known that plasma from donors who have been vaccinated demonstrates effective neutralisation of the delta and beta variants of the virus in laboratory assays, whereas stored convalescent plasma from unvaccinated donors is not effective against current variants (unpublished data from C-VELVET study - NCT04954937).

Under GDPR, the Recipient can rely on Article 6(1)(e) "processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller". NHS Blood and Transplant is an executive non-departmental public body and considered a special health public authority. The linkage of donor records and vaccination data is essential for identification of these donors and plasma units, to use the plasma and so to improve the provision of health care and treatment for patients in the NHS

As this is health information and therefore special category personal data the Recipient can also rely on Article 9(2)(h) – "processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3." NHSBT are requesting NHS Digital data to improve the provision of health care and treatment. The data requested, when combined with existing donor records, will allow rapid identification of donors and/or stored plasma units likely to have high levels of anti-SARS-CoV-2 Spike antibodies. Plasma from these donors or the respective stored units could be used to treat patients and/or select units for fractionation of plasma. NHSBT have shown independently in their donors (and consistent with other published work) that a high proportion of donors who had good levels of antibody after natural infection and who are then vaccinated (with any of the approved vaccines) have a high likelihood of developing very high titre of cross-reactive neutralising antibodies to the SARS-CoV-2 (COVID) virus. The linkage of donor records and vaccination data is essential for identification of these donors and plasma units, to use the plasma and so to improve the provision of health care and treatment for patients in the NHS.

NHS Digital is able to process and share COVID-19 tactical data strictly in relation to the current outbreak of Covid-19 under a notice issued to NHS Digital by the Secretary of State for Health and Social Care under Regulation 3(4) of the Health Service Control of Patient Information Regulations (COPI). In this agreement, NHS Digital have satisfied themselves that NHSBT’s purpose for use of Covid-19 Vaccination data aligns to Regulation 3(1) of COPI.

The Common Law Duty of Confidentiality for identifiable data being supplied to NHS Digital from NHSBT, and for NHSBT to re-identify individuals from the pseudonymised data supplied by NHS Digital is lifted by the use of Consent (reasonable expectations). NHS Digital have satisfied themselves that the consent materials supplied to participants are compatible with consent (reasonable expectations) and that this request is appropriate, necessary and proportionate for the performance of the task described in the Purpose statement and that there is no other reasonable means for the data processor to achieve their purpose that is less intrusive to the data subjects.

NHSBT will send a donor cohort of approximately 50,000 individual records to NHS Digital from their donor database to identify the vaccination status of blood donors. The cohort will be all blood donors registered with NHS Blood and Transplant (resident in England) who have completed at least one convalescent plasma or plasma for medicine donation, from April 2020 to the present (i.e. approximately 2 days before the extract is created).

Data NHSBT will send a cohort to NHS Digital via Secure Electronic File Transfer Service (SEFT) which will include some of the following identifiers:

• A unique identifier – to enable linkage of the vaccine data back to NHSBT’s database (a Study ID for pseudonymisation purposes)

• NHS Number

• Person First name

• Person Surname

• Person Gender

• Date of birth

• Post code

Data NHSBT require the following data product fields in return:

• The unique identifier provided (Study ID)

• Date and time

• VACCINATION_PROCEDURE_CODE

• NOT_GIVEN

• VACCINATION_SITUATION_CODE

• REASON_NOT_GIVEN_CODE

• DOSE_SEQUENCE

• VACCINE_PRODUCT_CODE

• TOKEN_PERSON_ID

Therefore data sent back to NHSBT via SEFT will be pseudonymised. Data from NHS Digital will then be linked to the NHSBT donor database (PULSE) held securely within NHSBT servers so that relevant donors and plasma donations can be identified. This will be a one-off linkage and any additional linkages will require an amendment to this agreement.

Data received from NHS Digital will only be used by NHSBT for the purposes stated in this agreement. Only a limited number of NHSBT substantive employees can access the PULSE database.

Data will only be processed by substantive employees of NHSBT who are members of the statistics team and NHS Digital data will be held within NHSBT premises in Bristol on secure servers. Statistical data analysis will be carried out via NHS Blood and Transplant owned remote device connected to the NHSBT network either directly in person or remotely, using an appropriate statistical package. To remotely access the NHSBT network requires a secure authenticator (Citrix) and users are then able to securely access the PULSE database secure server on the NHSBT’s IT framework. All data analysis will be conducted within the confines of the NHSBT’s secure server, and will not be downloaded to remote devices for storage or processing.

*****

Under the original version (v0) of this agreement for NHSBT, one cohort of individuals was supplied to NHS Digital and pseudonymised data supplied as per processing activities.

Version 1 of this agreement is a request for a further three data extracts of Covid-19 vaccination status linked to a cohort of approximately 50,000, to be received over a period of 12-18 months, or until such time as COPI regulations expire. If COPI notice expires, a Certificate of Data Destruction must be completed by NHSBT confirming the data has been appropriately disposed of unless an alternative legal basis has been provided and approved by NHS Digital.

Data will be used to identify stored plasma that can be used within the REMAP-CAP trial – an urgent public health trial and any additional COVID-19 related trials that have been prioritised by the Clinical Trials Accelerator Platform (CTAP) or the Therapeutics Task Force and have been ethically approved. REMAP-CAP trial plans to restart as soon as data are available on suitable plasma donors (September to October 2021).

Data will also be used to easily identify current blood donors who could donate plasma for these prioritised trials. As soon as data are available from NHS Digital this data will be processed and donors identified.

Only aggregated reports with small number suppression applied as per the HES Analysis guidance will be produced and reported internally and to the Department of Health and Social Care (DHSC). The DHSC has funded the collection of the stored convalescent plasma units as part of the convalescent plasma programme.

Currently, there are approximately 20,000 units of convalescent plasma that have already been collected. A proportion of these are from vaccinated donors but NHSBT cannot currently identify which donations are from vaccinated donors.

Units from vaccinated donors can be tested and used within the trials to answer whether this is an effective treatment to prevent serious or fatal COVID-19 in patients who have an impaired immune system and therefore do not have adequate protection from the virus via vaccination. If effective, it is hoped this would improve outcomes for approximately 500,000 individuals within England who are known to have an impaired immune system if they become SARS-CoV-2 positive.

The plasma that is not suitable for use within the trial can be repurposed for other uses including:

• plasma for medicines – currently there is a global shortage of intravenous immunoglobulin and plasma collected could be used for this purpose.

• Treatment of bleeding – plasma can be used as fresh frozen plasma and used to stop bleeding

• NHSBT is committed to using the plasma for the benefit of patients in the NHS.

Use of the current stores of plasma will save the Department of Health, the NHS, and NHSBT both human resources and money. It would save the NHS £130 per unit of plasma identified using NHS Digital data. It would also allow NHSBT staff time to collect other blood components including red cells and platelets, which are currently in short supply.

The study team have used initial data provided by NHS Digital to identify approximately 200 stored convalescent plasma donations (approximately 370 units of convalescent plasma) which are from donors who had already been vaccinated at the date of collection and also having very high antibody levels (Roche-S > 20,000).

This makes these units suitable for use in the REMAP-CAP trial (subject to some further Omicron-specific testing). It is hoped that these donations will provide the majority of the vaccinated convalescent plasma required to meet the needs of the trial.

The study team have also identified a small number of recently-vaccinated donors who have also been invited to return and donate convalescent plasma. This will continue if needed to supplement the historic plasma units. The study team are planning to use the updated data to identify new donors who have been recently vaccinated or have received the booster vaccination within the last 90 days.