Novavax

This Data Sharing Agreement authorises the use of information voluntarily provided to NHS Digital by individuals who have given permission to be contacted about potential participation in COVID-19 vaccine clinical trials. The data will be processed on behalf of the data controller, St Georges University Hospitals NHS Foundation Trust, by the data processor, NHS Digital, for the purpose of supporting recruitment to participate in a COVID-19 vaccine trial being run by the St Georges University Hospitals NHS Foundation Trust.

The following provides background to the Permission to Contact (PtC) Service:

NHS Digital has agreed to work in partnership with the National Institute of Health Research (NIHR) to build and host a first of type online Permission to Contact (PtC) Service on nhs.uk where members of the public can register their details and give their permission to be contacted by researchers working on NIHR approved UK coronavirus vaccine trials about participating in those trials. This PtC Service, which is called “Sign Up to be Contacted about Coronavirus Vaccine Studies” on the nhs.uk website was launched as a national service on 20th July 2020.

This Service enables participants to:

• Provide permission for NHS Digital to share an individual’s details provided through the Service with the researchers undertaking COVID-19 UK vaccine trials for the purposes of researchers contacting that individual about taking part in those trials.

• Provide their permission to be contacted by NHS Digital about progress and outcomes from CV19 vaccine studies and in relation to the development of the PtC Service, including to inform them of opportunities to participate in other types of health research.

The data collected from individuals who sign up includes sufficient information to achieve the following purposes:

• Matching potentially eligible participants to eligibility criteria provided by the vaccine trials for their specific studies. This data will comprise of age, sex, geographic locations, type of employment, and a number health question e.g. about whether they have long-term health conditions.

• Providing relevant details of potentially eligible participants which have been obtained through the Service to researchers. This will allow the researchers to contact the participants with a view to discussing their taking part in a trial and if so, to obtain their further permission to take part in the trial.

• NHS Digital will provide access to the information obtained from individuals through the Service via the existing Data Access Request Service (DARS) process available to researchers working on UK COVID-19 vaccine trials sponsored by the National Institute of Health Research. The Service will only provide researchers with the data collected directly from individuals themselves through the Service.

The contact details will be used to invite potentially eligible individuals to undertake an eligibility assessment and, if eligible, to give informed consent to participate in this trial. NHS Digital, as data processor acting on behalf of the Vaccine Study, will be sending the email to eligible participants.

The clinical trail that the service recruitment will support is a Phase 3 randomised observer-blind placebo controlled trial to evaluate the efficacy and safety of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS CoV 2 rs) with matrix-M1™ Adjuvant in UK healthy adult participants ≥ 18 years of age.

This trial will enable the study to assess if people aged 18-84 years can be protected from COVID-19 with this new vaccine called (SARS-CoV 2 Recombinant(r) Spike (S) Protein Nanoparticle Vaccine (SARS CoV 2 rS) with Matrix-M adjuvant).

It will also give the study valuable information on safety aspects of the vaccine.

The trail aims to recruit up to 9000 volunteers, of which around 4500 will be vaccinated with the COVID-19 vaccine and 4500 will be vaccinated with a saline placebo.

As the purpose of processing is to support recruitment to a vaccine trial, Novavax has commercial licence to the vaccine and has therefore been involved in the development and manufacture of the vaccine and will be a stakeholder in the trial. The UK government has a contract with Novavax which has secured a supply of 60 million doses of the vaccine for HMG. The trial is solely funded by Novavax and delivered via the NIHR Clinical research network as an Urgent public health badged study, approved by the Department of Health and Social care. Novavax would potentially benefit from the future manufacture and sales of a vaccine beyond the period of the pandemic if proven successful as a result of this clinical trial. However, in this instance, the benefit to the UK public is proportionate to the commercial interests of Novavax.

NHS Digital will extract a list of patients meeting the following criteria:

Volunteers must be:

•Adult Males or Females ages 18 to 84 years (inclusive at Screening)

Volunteers must NOT have:

•Positive COVID tests

•Immune system disorders

•Pregnant women

•Cancer treatment

•Bleeding disorder

•Heart conditions

The exclusion criteria noted above is based on the information provided by cohort members on the permission to contact dataset, and is not collected from other NHS data sources. Additional exclusion criteria will be used by the site during the Screening phase.

NHS Digital will identify all individuals within the PtC dataset meeting the above criteria and will extract their names and email addresses.

It is not known in advance how many individuals meeting the above criteria will have records in the PtC dataset. The number may be amended and the process may be repeated depending on the level of response. In the event of the trial not achieving a suitable balance in recruited participants, such as an uneven ratio of males to females, subsequent mail outs may restrict the required criteria to a greater degree than previously, for example, only requesting details for male participants as opposed to both males and females. This could encompass any part of the criteria, such as age, gender, ethnicity or location and various others, depending on how the recruitment progresses.

NHS Digital will write to the individuals in the subset inviting them to participate within the trial using ethically approved text provided by St Georges University Hospitals NHS Foundation Trust. The email will remind the individuals of the background of the permission to contact programme and give them the opportunity to state that they do not wish to be contacted again. The email will direct volunteers to Be Part of Research website to access study information and regional contact information.

Individuals will not be contacted multiple times under this Agreement and NHS Digital will record the fact that the individuals have been contacted to ensure compliance with the maximum number of contacts outlined as part of consent. Furthermore in order to ensure that NHS Digital are able to update the register with which participants are registered with an active trial, and therefore prevent them from being invited to any further trails the regional leads at each trial site will provide regular updates to NHS Digital of those registered participants who have consented. This sharing of information is built into the Permission to Contact signing up information and will also be added to the trial consent and participant information.

Individual trial recruitment sites and / or the lead site will supply NHS Digital with details of those who have signed up to take part in their trial so that NHS Digital can suitably capture this information within the Permission To Contact registry. All data that flows to NHS Digital in this context falls under the controllership of the lead site, regardless of whether they themselves are specifically involved in the processing of that data as it flows to NHS Digital. Depending on how the lead site / data controller manages the processing, there could be single flow directly to NHS Digital, or multiple flows from each individual site. However the data is flowed, once it is received at NHS Digital then NHS Digital become controller for that data in their existing role as controller of the Permission To Contact Registry.

Due to the nature of trial recruitment sites, they often only become confirmed as sites very close to recruitment, and so NHS Digital will leave the responsibility with the lead site / data controller to appointment data processors themselves under their own due diligence. This practice aligns with their obligations under GDPR as a data controller and the emphasis will be on the lead site / data controller to appoint appropriate data processors on their behalf. Ordinarily NHS Digital would carry out these checks, but attempting to do so for this service would cause unnecessary delay to the initial application, as well as potentially multiple and costly amendments thereafter. Therefore all recruitment sites / data processors and their processing activities will be covered under a suitable processing agreement between themselves and the lead site / data controller which does not require NHS Digital’s inclusion. Specific details of recruitments sites, such as key contact, location, will therefore not be made known to NHS Digital unless there is a specific reason to do so.

No other processing of the data will take place and the data will not be linked with information from any other sources.

St Georges University Hospitals NHS Foundation Trust will not hold or access the data directly and no data will be shared more widely. The data will only be accessed by NHS Digital employees.

The information from NHS Digital will be used to facilitate contact with individuals who are potentially eligible and who have indicated willingness to potentially participate in studies/trials of COVID-19 vaccines.

The primary benefit of using the data will be to recruit participants for the clinical study/trial in a manner which:

• Enables individuals to volunteer in advance to participate in COVID-19 vaccine trials as an alternative to other potentially more intrusive mechanisms, e.g. sharing data with researchers about individuals under section 251 consents or COPI notices, which although lawful is initially less transparent.

• Allows researchers to identify a suitable cohort and recruit them quickly into the vaccine trials – thus reducing the overall time to recruit into the trials and to accelerate the delivery of an effective vaccine to treat individuals to manage the COVID-19 outbreak and to save lives.

• Reduces burden on research staff in identifying and contacting potential clinical trial participants.

• Supports the Vaccines Taskforce objectives to drive forward, expedite and coordinate efforts to research and then produce a coronavirus vaccine and make sure one is made available to the public as quickly as possible.

Not stated in the register.