Page 82 - pfizervax

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

In the event of an overdose, the investigator should:

1. Contact the medical monitor within 24 hours.

2. Closely monitor the participant for any AEs/SAEs.

3. Document the quantity of the excess dose as well as the duration of the overdose in the
CRF.

4. Overdose is reportable to Safety only when associated with an SAE.

Decisions regarding dose interruptions or modifications will be made by the investigator in
consultation with the medical monitor based on the clinical evaluation of the participant.

8.5. Pharmacokinetics

Pharmacokinetic parameters are not evaluated in this study.

8.6. Pharmacodynamics

Pharmacodynamic parameters are not evaluated in this study.

8.7. Genetics
Genetics (specified analyses) are not evaluated in this study.

8.8. Biomarkers

Biomarkers are not evaluated in this study.

8.9. Immunogenicity Assessments

Immunogenicity assessments are described in Section 8.1.

8.10. Health Economics
Health economics/medical resource utilization and health economics parameters are not
evaluated in this study.

8.11. Study Procedures

8.11.1. Phase 1
8.11.1.1. Screening: (0 to 28 Days Before Visit 1)

Before enrollment and before any study-related procedures are performed, voluntary, written
study-specific informed consent will be obtained from the participant. Each signature on the
ICD must be personally dated by the signatory. The investigator or his or her designee will
also sign the ICD. A copy of the signed and dated ICD must be given to the participant. The
source data must reflect that the informed consent was obtained before participation in the
study.

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