PERMISSION TO CONTACT - VRR - NextCOVE Study: A randomized, observer-blind, active-controlled Phase 3 study to investigate the safety, immunogenicity, and relative vaccine efficacy of mRNA-1283.222 as a booster dose compared with mRNA-1273.222 in participants aged 12 years+ to prevent CV-19

This Data Sharing Agreement authorises the use of information voluntarily provided to NHS England 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 England 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, Caerus US 1 Inc., 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 England 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 NHS England about researchers working on NIHR approved UK coronavirus vaccine trials with a view to 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. The registry that holds the details provided by members of the public who sign up is called the ‘NHS England COVID-19 Vaccine Research Registry’.

The PtC Service enables participants to:

• Provide their permission to be contacted by NHS England for the purpose of taking part in COVID-19UK vaccine trials.

• Provide their permission to be contacted by NHS England about progress and outcomes from COVID-19 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 participants to eligibility criteria provided by the vaccine trials for their specific studies. This data will comprise of age, sex, geographic locations, and a number of health questions e.g about whether they have long-term health conditions.

• Sending invitations to participants regarding possible studies to take part in.

NHS England will assess applications to invite participants via the existing Data Access Request Service (DARS) process (as utilised by the DigiTrials Team) The contact details will be used to invite potentially eligible individuals to undertake an eligibility assessment. Eligible individuals will be asked to give informed consent to participate in this trial. NHS England, as Data Processor acting on behalf of ModernaTX, Inc, will be sending the communication to eligible participants.

This request relates specifically to a vaccine trial. The full title for this study is "A randomized, observer-blind, active-controlled Phase 3 study to investigate the safety, immunogenicity, and relative vaccine efficacy of mRNA-1283.222 administered as a booster dose compared with mRNA-1273.222 in participants aged 12 years and older for the prevention of COVID-19"

Moderna is conducting a vaccine clinical trial, called the NextCOVE Study, using investigational bivalent vaccines that may protect against COVID-19 variants, including the Omicron variant. A bivalent vaccine addresses multiple variants at the same time. The NextCOVE Study is comparing two investigational bivalent vaccines, mRNA-1283.222 and mRNA-1273.222, so medical researchers can better understand how well the investigational vaccines work.

Participants in the study will be chosen at random to receive either mRNA-1283.222 or mRNA-1273.222.

The aim is to recruit a total of approximately 2,100 participants in the UK. 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 10,500 individuals to be contacted.

It should be noted that whilst the NextCOVE Study aims to recruit study participants from the age of 12 years old and above, the Permission to Contact service will only be contacting potential study participants from the Vaccine Research Registry who are 18 years and over as only individuals of 18 years and over are permitted to sign up to the Vaccine Research Registry.

GENERAL DATA PROTECTION REGULATIONS - LEGAL BASIS FOR PROCESSING OF DATA

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 individual’s 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 England is content that the purpose of this study is the use of information voluntarily provided to NHS England 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 recipient’s technical and organisational measures to safeguard the data have been assessed and meet NHS England’s 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 England 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 subject’s rights.

DUTY OF CONFIDENTIALITY - Data collected through the CV19 PtC Vaccine Service is processed in line with the expectations of the individuals using the Service. The user journey provides clear and unambiguous information at each stage about the purpose of data collection. It is a Service that individuals can choose to sign up to and they can withdraw permission to be contacted and/or for their data to be held at any time.

There is no obligation, incentive or coercion to sign up and only the data provided voluntarily by the individual is used. There is no linkage or access to any other data. User testing has been undertaken to develop the Service using clear and plain language which users understand and with a design, flow and content approach which is in line with the other NHS.UK services and content aimed at members of the public.

NHS England is content that the purpose of this study is the use of information voluntarily provided to NHS England by individuals who have given permission to be contacted about potential participation in COVID-19 vaccine clinical trials and such research is in the public interest for the benefit of public health.

The data will be used to create a research cohort in support of the development or refinement of a commercial vaccine(s) that, should the research prove successful, will generate income for the commercial companies involved, to cover the development costs of the vaccine and also generate profit for that organisation.

COMMERCIAL PURPOSE

In the interests of full transparency, it is noted here that the data will be used in support of the development or refinement of a commercial vaccine(s) that, should the research prove successful, will generate income for the commercial companies involved, to cover the development costs of the vaccine and also generate profit for that organisation.

NHS NHS England will extract a list of patients meeting the following criteria, where that criteria can be ascertained using the NHS England COVID-19 Vaccine Research Registry:

Personal Information:

Age

Location

Sex at birth

Ethic Group

Health questions:

Flu Jab

Diabetes

Asthma

Lung conditions

Liver conditions

Heart conditions

Cancer treatment

Bleeding disorders

Immune system disorders

The selection criteria noted above are based solely on the information provided by members on the NHS England COVID-19 Vaccine Research Registry (where it can be obtained from this dataset). There is no linkage to other data held by NHS England, and such data is not used in assessing the selection criteria.

NHS England will seek to identify the required number of individuals within the NHS England COVID-19 Vaccine Research Registry meeting the relevant criteria and will extract their names and email addresses.

It is not known in advance how many individuals meeting the above criteria will respond to the invitation. The process may be repeated, with amended numbers and selection criteria, depending on the level of response. This could encompass any part of the criteria, depending on how the recruitment progresses.

NHS England will contact individuals in the subset inviting them to participate within the trial using ethically approved text provided by ModernaTX, Inc. The communication 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 communication will also direct volunteers to NIHR’s Be Part of Research website to access study information and regional contact information. NHS England will record the fact that the individuals have been contacted to ensure compliance with the maximum number of contacts outlined as part of the consent taken when joining the Permission to Contact service. Furthermore, to ensure that NHS England are able to update the registry with which participants are registered with an active trial, and therefore prevent them from being invited to any further trials, NHS England will be provided with regular updates 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.

It should be noted that the following inclusion and exclusion criteria will be used by the recruitment sites during the Screening phase:

INCLUSION CRITERIA:

Medically stable individuals, ages 12 and above will be screened and enrolled. Each participant must meet all of the following criteria during the screening period and at Day 1, unless noted otherwise, to be enrolled in this study:

>Age

1. Male or female, at least 12 years of age at the time of consent (Screening Visit).

>Type of Participant and Disease Characteristics

2. Investigator’s assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures. Sex and Contraceptive/Barrier Requirements

3. Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as postmenopausal or permanently sterilized. An FSH level should be measured at the discretion of the investigator to confirm postmenopausal status, if necessary.

4. Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:

• Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1.

• Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1). Adequate female contraception is defined as consistent and correct use of a local health authority approved contraceptive method in accordance with the product label.

• Has agreed to continue adequate contraception through 90 days following vaccine administration.

>Informed Consent

5. Participant has provided written informed consent for participation in this study, including all evaluations and procedures as specified in this

protocol.

>Other Inclusion Criteria

Has previously received a primary series of an authorized/approved COVID-19 vaccine. For participants ≥18 years of age, at least 1 booster dose must have also been received. A heterologous vaccine regimen is acceptable.

EXCLUSION CRITERIA:

Participants are excluded from the study if any of the following criteria apply:

1. Has had close contact, as defined by the CDC, with someone who had a SARS-CoV-2 infection in the past 14 days, or COVID-19 in the past 10 days. Participants may be rescreened after 14 days provided that they remain asymptomatic.

2. Participant is acutely ill or febrile (temperature ≥38.0°C/100.4°F) 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window and will retain their initially assigned participant number.

3. Has tested positive for SARS-CoV-2 using an authorized/approved lateral flow/rapid antigen or PCR test within 90 days of Screening.

4. Has received a COVID-19 vaccine within 90 days of the Screening Visit.

5. Has history of myocarditis, pericarditis, or myopericarditis that has not fully resolved within 3 months prior to Screening.

6. Has received a total of 6 doses or more of COVID-19 vaccine.

7. Has received a COVID-19 vaccine at a dose different from the authorized/approved dose.

8. History of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Clinically unstable is defined as a diagnosis or condition requiring significant changes in management or medication within the 2 months prior to Screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition.

9. Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, or immune-mediated disease requiring immunosuppressive treatment or other immunosuppressive condition.

10. Dermatologic conditions that could affect local solicited AR assessments (eg, psoriasis patches affecting skin over the deltoid areas).

11. Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any components of mRNA vaccine.

12. Reported history of bleeding disorder that is considered a contraindication to IM injection or phlebotomy.

13. Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.

14. Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 181 days prior to Screening (for corticosteroids ≥10 mg/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.

15. Has received or plans to receive any licensed vaccine ≤60 days prior to the study injection (Day 1) or plans to receive a licensed vaccine within 60 days after the study injection.

16. Has received systemic immunoglobulins or blood products within 90 days prior to the Screening Visit or plans to receive during the study.

17. Diagnosis of malignancy within the previous 10 years (excluding nonmelanoma skin cancer).

18. Has donated ≥450 mL of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.

19. Has participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.

20. Is an immediate family member or household member of study personnel, study site staff, or Sponsor personnel.

ModernaTX, Inc are partnering with Caerus US 1 Inc. to support recruitment for the mRNA-1283.222 clinical trial, specifically using their Citeline Connect platform. This platform will be used to host a trial landing page and pre-screener that will send pre-qualified referrals to participating research sites. Interested volunteers will be directed to the trial landing page, where they can learn about the trial and then complete a brief pre-screener to determine if they may be eligible. Qualified volunteers then have the option of submitting their contact information to a nearby site, using postal code matching, and sites will receive these prequalified referrals in the Citeline Connect portal.

ModernaTX, Inc have an appropriate data processing agreement in place with Caerus US 1 Inc. to support the recruitment into the trial under ModernaTX, Inc controllership.

Caerus US 1 Inc. will supply individual recruitment sites with the IDs of those patients who have gone through the pre-screener in order to invite them for further screening. Individual trial recruitment sites will supply NHS England with details of those who have signed up to take part in their trial so that NHS England can suitably capture this information within the NHS England COVID-19 Vaccine Research Registry. All data that flows to NHS England in this context falls under the controllership of ModernaTX, Inc. Once it is received at NHS England then NHS England become controller for that data in their existing role as controller of the NHS England COVID-19 Vaccine Research Registry.

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

ModernaTX, Inc and Caerus US 1 Inc. will not have access to any of the data being disseminated by NHS England under this agreement.

The information from NHS England 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.

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 trial. This is expected to accelerate the delivery and refinement of effective vaccines 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, produce and refine coronavirus vaccines and make sure new and improved vaccines are made available to the public as quickly as possible.

Yielded Benefits is not a requirement for new applications.