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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001

10.1.3. Data Protection

All parties will comply with all applicable laws, including laws regarding the implementation
of organizational and technical measures to ensure protection of participant data.

Participants’ personal data will be stored at the study site in encrypted electronic and/or paper
form and will be password protected or secured in a locked room to ensure that only
authorized study staff have access. The study site will implement appropriate technical and
organizational measures to ensure that the personal data can be recovered in the event of
disaster. In the event of a potential personal data breach, the study site will be responsible
for determining whether a personal data breach has in fact occurred and, if so, providing
breach notifications as required by law.

To protect the rights and freedoms of participants with regard to the processing of personal
data, participants will be assigned a single, participant-specific numerical code. Any
participant records or data sets that are transferred to the sponsor will contain the numerical
code; participant names will not be transferred. All other identifiable data transferred to the
sponsor will be identified by this single, participant-specific code. The study site will
maintain a confidential list of participants who participated in the study, linking each
participant’s numerical code to his or her actual identity and medical record identification. In
case of data transfer, the sponsor will protect the confidentiality of participants’ personal data
consistent with the clinical study agreement and applicable privacy laws.

10.1.4. Dissemination of Clinical Study Data

Pfizer fulfills its commitment to publicly disclose clinical study results through posting the
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the EudraCT, and/or
www.pfizer.com, and other public registries in accordance with applicable local
laws/regulations. In addition, Pfizer reports study results outside of the requirements of local
laws/regulations pursuant to its SOPs.

In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and
complete manner and are reported regardless of the outcome of the study or the country in
which the study was conducted.

www.clinicaltrials.gov

Pfizer posts clinical trial results on www.clinicaltrials.gov for Pfizer-sponsored interventional
studies (conducted in patients) that evaluate the safety and/or efficacy of a product,
regardless of the geographical location in which the study is conducted. These results are
submitted for posting in accordance with the format and timelines set forth by US law.

EudraCT

Pfizer posts clinical trial results on EudraCT for Pfizer-sponsored interventional studies in
accordance with the format and timelines set forth by EU requirements.

www.pfizer.com

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