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BioNTech

About The sharing of health information is fundamental for the good functioning of healthcare services, for patients’ safety, and to advance research and improve public health. BioNTech is committed to disclosing health information, in line with all applicable laws and regulations, including data privacy laws.
How we share on the Vivli Platform To obtain BioNTech data for analysis on the Vivli platform, data requestors must complete a data request on the Vivli platform. If the request is approved and a Data Use Agreement signed, BioNTech will upload the anonymized data into the Vivli platform for use by researchers in the secure Vivli research environment.
Anonymization Standards   Data protection procedures for personally identifiable information are performed in accordance with applicable laws and regulations, and following industry best practices.
Studies available for sharing
 Data are available for sharing from interventional clinical studies conducted by BioNTech with the COVID-19 vaccine COMIRNATY® (and variant vaccines) that were submitted to health authorities in support of applications for marketing authorization in the European Union and/or United States.
Exceptions The following are reasons that would preclude granting access in response to a data request:

  •  Patient privacy – For example, the request seeks clinical data for which patient anonymization is difficult or for which there is a reasonable likelihood of re-identification, or where there are limitations or restrictions due to privacy rights of individuals in accordance with applicable privacy laws.
  •  Permissions – Where the request seeks clinical data that was collected subject to legal, contractual, and/or consent provisions that prohibit transfer to third parties.
  • Where the request seeks data from locally conducted studies in which data and results are only available in languages other than English.
  • Where the request is for case narratives, documentation for adjudication, imaging data (e.g., x-rays, MRI scans, etc.), genetic data and exploratory biomarker data.
  • Where there are substantial practical constraints to providing access via the Vivli platform.
  • Data will not be provided to requesters with potential or actual conflicts of interest, including individuals requesting access for commercial, competitive or legal purposes.
  • Other practical constraints to providing access to the data may also preclude sharing. 
Questions or enquiries BioNTech accepts enquiries regarding the availability of individual patient-level data from clinical studies that are not yet listed on this site. To enquire, complete the enquiry form.
When Studies are available for sharing Data from clinical studies that meet the criteria above are available from 24 months after study completion (i.e., last patient last visit).
Review Criteria for Data Requests
  • The planned analysis can be conducted in the Vivli secure research environment.
  • The scientific rationale and relevance of the proposed research to medical science or patient care.
  • The ability of the proposed research plan (design, methods, and analysis) to meet the scientific objectives. This is a high-level review.
  • The publication plan for the research.
  • Real or potential conflicts of interest that may impact the planning, conduct, or interpretation of the research and proposals to manage these conflicts of interest. Such conflicts may relate to (but are not limited to) the research team, their institutions/ affiliations, or their relationships to independent review panel members and Vivli staff.
  • The qualifications and experience of the research team to conduct the proposed research (a statistician with a degree in statistics or a related discipline must be part of the research team).
Additional Conditions for Access Data requests must be from qualified researchers with the appropriate competencies to perform the proposed analyses.
Data Request Review Process Data requests are initially reviewed by Vivli and BioNTech for completeness and other parameters (relating to scope [see the above exceptions], system-compatibility, and meeting sponsor policies), and are then reviewed by a fully independent review panel.
What information will be provided The following information may be provided:

🗹 Anonymized Individual Patient Data (IPD)

🗹 Protocol

🗹 Statistical analysis plan

🗹 Data dictionary

🗹 Anonymization guidance

🗹 Redacted clinical study reports (excluding appendices)
Access to study documents without participant-level data For further information, see BioNTech’s Transparency Declaration.
Clinical Study Register or Website Irrespective of where a study is performed, all BioNTech-sponsored clinical studies are registered on the website clinicaltrials.gov.
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