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

• Full blood count

• Blood chemistry, specifically creatinine, urea, liver function tests, and C-reactive
protein

• Imaging results (eg, CT or MRI scan) to document neurologic dysfunction

• Number and type of any healthcare contact; duration of hospitalization and ICU
stay

• Death

• Schedule an appointment for the participant to return for the potential COVID-19
convalescent visit once he or she has recovered.

• Complete the source documents.

• The investigator or an authorized designee completes the CRFs.

8.13.2. Potential COVID-19 Convalescent Visit: (28 to 35 Days After Potential
COVID-19 Illness Visit)

• Record AEs, as appropriate as described in Section 8.3. Note: Potential COVID-19
illnesses that are consistent with the clinical endpoint definition should not be
recorded as AEs. These data will be captured as efficacy assessment data only on the
relevant pages of the CRF, as these are expected endpoints.

• Record details of any of the prohibited medications specified in Section 6.5.1
received by the participant if required for his or her clinical care.

• Collect a blood sample (approximately 20 mL for participants ≥16 years of age and
approximately 10 mL for participants in the 12- to 15-year age stratum) for
immunogenicity testing.

• Collect/update COVID-19–related clinical and laboratory information (detailed in
Section 8.13.1).

• Complete the source documents.

• The investigator or an authorized designee completes the CRFs.

• Record any AEs that occur within the 48 hours after the blood draw as described in
Section 8.3.

8.14. Communication and Use of Technology
In a study of this nature that requires illness events to be reported outside of scheduled study
visits, it is vital that communication between the study site and the participant or his/her

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