NHS Digital Data Release Register - reformatted
Modernatx, Inc projects
- A Phase 2/3, Randomized, Stratified, Observer-blind Study to Evaluate the Immunogenicity and Safety of mRNA-1273.529 (B.1.1.529, Omicron variant) in Comparison with mRNA-1273 (prototype) Booster Vaccine
2 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).
A Phase 2/3, Randomized, Stratified, Observer-blind Study to Evaluate the Immunogenicity and Safety of mRNA-1273.529 (B.1.1.529, Omicron variant) in Comparison with mRNA-1273 (prototype) Booster Vaccine — DARS-NIC-623799-T2J4F
Opt outs honoured: Identifiable (Consent (Reasonable Expectation))
Legal basis: Health and Social Care Act 2012 s261(2)(c)
Purposes: Yes (Research)
When:DSA runs 2022-02-17 — 2023-02-16
Access method: One-Off
Data-controller type: MODERNATX, INC
Sublicensing allowed: No
- Permission to Contact
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, ModernaTX, Inc, by NHS Digital as a data processor for the purpose of supporting recruitment to participate in a COVID-19 vaccine trial being run by ModernaTX, Inc.
ModernaTX, Inc (also known as Moderna, Inc and previously known as Moderna Therapeutics, Inc) is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts that focuses on RNA therapeutics, primarily mRNA vaccines. ModernaTX, Inc solely determine the purposes and means of the processing in this study, and the way the study is conducted and is therefore considered the sole Data Controller for this agreement. Additionally, Informa UK Ltd, who are a publishing company serving tech businesses and professionals, are acting as a data processor on behalf of ModernaTX, Inc by managing the pre-screening website and passing details of potential participants on to the trial recruitment sites.
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 individuals 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 questions 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 ModernaTX, Inc will be sending the email to eligible participants.
This request relates specifically to a vaccine trial. The full title for this study is "A Phase 2/3, Randomized, Stratified, Observer-blind Study to Evaluate the Immunogenicity and Safety of mRNA-1273.529 (B.1.1.529, Omicron variant) in Comparison with mRNA-1273 (prototype) Booster Vaccine"
There is an urgent need for vaccination strategies that induce broader protection against SARSCoV2 variants of concern (VOC), including the Omicron variant, to decrease morbidity and mortality. In addition, it is currently not known whether breakthrough infections could occur long term due to waning antibody titers*. Based on the experience of mRNA1273, available under Emergency Use Authorisation (EUA), and leveraging the flexible nature of the messenger ribonucleic acid (mRNA) technology, ModernaTX, Inc are evaluating a mRNA vaccine to address the Omicron variant.
* An antibody titer is a type of blood test that determines the presence and level (titer) of antibodies in the blood. This test is carried out to investigate if there is an immune reaction triggered by foreign invaders (antigens) in the body.
In November 2021, the SARS-CoV-2 Omicron variant (B.1.1.529) was detected in South Africa and epidemiological information about its spread in other regions is being evaluated. Preliminary evidence suggests that the Omicron variant has transmission advantage over the Delta variant. The Omicron variant has significant antigenic change with a potential growth advantage. In addition, it contains potential antibody escape site mutations (such as the categorised mutations K417N, T478K, E484A, N501Y). Preliminary results from the Sponsor show that 1 month after completing the primary series, mRNA-1273-elicited serum neutralization of Omicron variant pseudovirus was not detectable. However, neutralization was observed at 2 weeks after an mRNA-1273 booster dose, although activity was reduced relative to the prototype D614G strain and remained lower than that observed against the prototype D614G strain at 1 month after the primary series. Further evaluation of the in vitro neutralization of the Omicron variant, using sera (an amber-coloured, protein-rich liquid which separates out when blood coagulates) from vaccines, is currently in progress.
Overall, this study will assess whether a single booster dose of the Moderna mRNA vaccine boosts antibody responses to the Omicron variant and the prototype strain. Participants who previously received 2 or 3 doses of a COVID-19 vaccine will receive a single booster dose of the Moderna mRNA-1273 or Moderna mRNA-1273.529 vaccines in this study
The aim is to recruit a total of 3,000 participants. The initial mailout will aim for around four / five times the number of potential participants to be recruited and therefore the estimate is for around 12,000 - 15,000 individuals to be contacted.
The GDPR legal basis for processing the data is GDPR Article 6(1)(f): (the processing is necessary for your legitimate interests or the legitimate interests of a third party, unless there is a good reason to protect the individuals personal data which overrides those legitimate interests) - The processing is necessary for legitimate interests and ModernaTX, Inc have completed a Legitimate Interests Assessment.
In addition to the above GDPR Legal Basis for Processing, this agreement refers to health data, which is a Special Category of Personal Data and therefore ModernaTX, Inc also relies upon 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). NHS Digital is content that the purpose of this study is 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, thus clearly demonstrating that the study purpose is research into public health and therefore providing benefit to health and social care in the UK.
The data are required for research purposes in the public interest- meeting the conditions in the DPA 2018 Schedule 1 Part 1 (4) - which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data. The ways in which the processing of data will be of benefit to the public thereby demonstrating that the processing is in the public interest are described in section 5d. ii. Expected Measurable Benefits to Health and/or Social Care Including Target Date.
- In accordance with GDPR Article 89(1) processing is subject to appropriate safeguards. These include:
i. The data recipients technical and organisational measures to safeguard the data have been assessed and meet NHS Digitals acceptance criteria (see sections 2 and 5b of this application for further details) although it should be noted that ModernaTX, Inc is not receiving data from NHS Digital in this agreement;
ii. The requested data has been assessed as proportionate to the aim pursued (see section 5a of this application for further details);
iii. Controls, data retention and processing activities have been assessed to ensure respect to the essence of the right to data protection;
iv. Measures to protect the rights and freedoms of data subjects have been assessed including transparency (fair processing) publishing subjects rights.
In the interests of full transparency, it is noted here that the data will be used in support of the development of a commercial vaccine(s) that, should the research prove successful, will generate income for ModernaTX, Inc, to cover the development costs of the vaccine and also generate profit for the organisation.
The primary benefit of using the data will be to allow researchers to identify a suitable cohort and recruit them quickly into the vaccine trial thus reducing the overall time to recruit into the trials. This is expected to accelerate the delivery of an effective vaccine to treat individuals to manage the COVID-19 outbreak and to save lives.
It is expected that this will reduce the burden on research staff in identifying and contacting potential clinical trial participants. It is anticipated this will also support 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.
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.
This is expected to result in individuals entering the trials screening process with a view to them participating in the trial with fully informed consent.
The main results from this trial are expected to inform development of a safe and effective multiple vaccine combination against COVID 19.