|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.
|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.
|The following are reasons that would preclude granting access in response to a data request:
|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
|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)
🗹 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.