Page 68 - pfizervax

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

Serum obtained from the additional ~170-mL blood sample from select participants in Phase
1 at either Visit 5, 6, or 7 will be used for exploratory COVID-19 research, intended to
establish a surrogate endpoint that is reasonably likely to predict clinical benefit.

8.1.1. Biological Samples

Blood and nasal swab samples will be used only for scientific research. Each sample will be
labeled with a code so that the laboratory personnel testing the samples will not know the
participant’s identity. Samples that remain after performing assays outlined in the protocol
may be stored by Pfizer. Unless a time limitation is required by local regulations or ethical
requirements, the samples will be stored for up to 15 years after the end of the study and then
destroyed. If allowed by the ICD, stored samples may be used for additional testing to better
understand the immune responses to the vaccine(s) under study in this protocol, to inform the
development of other products, and/or for vaccine-related assay work supporting vaccine
programs. No testing of the participant’s DNA will be performed.

The participant may request that his or her samples, if still identifiable, be destroyed at any
time; however, any data already collected from those samples will still be used for this
research. The biological samples may be shared with other researchers as long as
confidentiality is maintained and no testing of the participant’s DNA is performed.

8.2. Safety Assessments

Planned time points for all safety assessments are provided in the SoA. Unscheduled clinical
laboratory measurements may be obtained at any time during the study to assess any
perceived safety issues.

A clinical assessment, including medical history, will be performed on all participants at
his/her first visit to establish a baseline. Significant medical history and observations from
any physical examination, if performed, will be documented in the CRF.

AEs and SAEs are collected, recorded, and reported as defined in Section 8.3.

Acute reactions within the first 4 hours after administration of the study intervention (for the
first 5 participants vaccinated in each Phase 1 group), and within the first 30 minutes (for the
remainder of participants), will be assessed and documented in the AE CRF.

The safety parameters also include reactogenicity e-diary reports of local reactions and
systemic events (including fever), and use of antipyretic medication that occur in the 7 days
after administration of the study intervention in a subset of participants. These prospectively
self-collected occurrences of local reactions and systemic events are graded as described in
Section 8.2.2. For participants who are not in the reactogenicity subset, these local reactions
and systemic events should be detected and reported as AEs, in accordance with
Section 8.3.2.

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