Valneva Austria GmbH

Commercial

No

DARS-NIC-418208-J1Y6J-v1.2

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, Valneva Austria GmbH, by NHS Digital as a data processor for the purpose of supporting recruitment to participate in a COVID-19 vaccine trial being run by Valneva Austria GmbH. Data secured from individuals as a result of being contacted by the study is not covered within this agreement. This data relates solely to Valneva and not NHS Digital. 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 Valneva Austria GmbH, will be sending the email to eligible participants. This request relates specifically to a vaccine trial. This is a Randomized, Observer-blind, Controlled, Superiority Study to Compare the Immunogenicity of VLA2001 to AZD1222 in terms of GMT of SARS-CoV-2-specific neutralizing antibodies. Participants will be adults aged ≥ 18 years of age who are either generally healthy or are with a stable medical condition. Approximately 4,000 participants will be randomized overall in a 3:1 ratio to receive 2 intramuscular doses of either VLA2001 (n=3,000) or AZD1222 (n=1,000) at the recommended dose level, 28 days apart, on Days 1 and 29. For immunogenicity analyses, samples from approximately 1,200 participants (600 per group) who have been tested sero-negative for SARS-CoV-2 at screening will be analyzed. All visits will be conducted at the clinical site on an outpatient basis. Immunogenicity (neutralizing and binding antibody titers) and safety will be assessed up to month 12 after the first vaccination. Participants will be observed for immediate AEs and/or reactogenicity for at least 30 minutes after the administration of the vaccine. The first 10 participants who are older than 55 years will be treated as a ‘sentinel’ group and will be observed for at least 60 minutes after each vaccination. Participants will be provided with an electronic Diary (e-Diary) and will be trained to record specifically solicited systemic and local symptoms daily as well as any additional AEs during follow-up period after each of both vaccinations up to the next visit to the site until Day 43 visit has been completed. The following information will be collected: - Oral body temperature - Solicited local (i.e. injection site) reactions - Solicited systemic reactions - Other AEs - Any new medications or changes in medication administered after vaccination The initial mailout will aim for around four / five times the number of potential participants to be recruited and therefore the estimate is for 20,000 to be contacted. The data will be used in support of the development of a commercial vaccine that, should the research prove successful, will generate income for Valneva Austria GmbH to cover both the development costs of the vaccine and also generate profit for that organisation.

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.

21/04/2021

De-Personalised

Health and Social Care Act 2012 – s261(2)(c)

One-Off

TRE