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

All screening evaluations must be completed and reviewed to confirm that potential
participants meet all eligibility criteria. The investigator will maintain a screening log to
record details of all participants screened and to confirm eligibility or record reasons for
screening failure, as applicable.

Every effort should be made to ensure that protocol-required tests and procedures are
completed as described. However, it is anticipated that from time to time there may be
circumstances outside the control of the investigator that may make it unfeasible to perform
the test. In these cases, the investigator must take all steps necessary to ensure the safety and
well-being of the participant. When a protocol-required test cannot be performed, the
investigator will document the reason for the missed test and any corrective and preventive
actions that he or she has taken to ensure that required processes are adhered to as soon as
possible. The study team must be informed of these incidents in a timely manner.

For samples being collected and shipped, detailed collection, processing, storage, and
shipment instructions and contact information will be provided to the investigator site prior
to initiation of the study.

The total blood sampling volume for individual participants in this study is approximately up
to: 515 mL for participants in Phase 1, 110 mL for Phase 2/3 participants ≥16 years of age,
and 50 mL for participants in the 12- to 15-year age stratum. Additionally, 20 mL of blood
for participants ≥16 years of age and 10 mL for participants in the 12- to 15-year age stratum
will be taken at an unplanned convalescent visit at any time a participant develops respiratory
symptoms indicating a potential COVID-19 infection. Select participants in Phase 1 will also
be asked to provide an additional blood sample of approximately 170 mL at either Visit 5, 6,
or 7. These participants would therefore have a total blood sampling volume of 700 mL
during the 24-month study period. Other additional blood samples may be taken for safety
assessments at times specified by Pfizer, provided the total volume taken during the study
does not exceed 550 mL during any period of 60 consecutive days.

8.1. Efficacy and/or Immunogenicity Assessments

Efficacy will be assessed throughout a participant’s involvement in the study through
surveillance for potential cases of COVID-19. If, at any time, a participant develops acute
respiratory illness (see Section 8.13), for the purposes of the study he or she will be
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considered to potentially have COVID-19 illness. In this circumstance, the participant
should contact the site, an in-person or telehealth visit should occur, and assessments should
be conducted as specified in the SoA. The assessments will include a nasal (midturbinate)
swab, which will be tested at a central laboratory using a reverse transcription–polymerase
chain reaction (RT-PCR) test (Cepheid; FDA approved under EUA), or other equivalent
nucleic acid amplification–based test (ie, NAAT), to detect SARS-CoV-2. In addition,
clinical information and results from local standard-of-care tests (as detailed in Section 8.13)
will be assessed. The central laboratory NAAT result will be used for the case definition,
unless no result is available from the central laboratory, in which case a local NAAT result
may be used if it was obtained using 1 of the following assays:

• Cepheid Xpert Xpress SARS-CoV-2

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