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

7. The investigator, institution, or the head of the medical institution (where applicable) is
responsible for study intervention accountability, reconciliation, and record maintenance
(ie, receipt, reconciliation, and final disposition records), such as the IPAL or
sponsor-approved equivalent. All study interventions will be accounted for using a study
intervention accountability form/record.

8. Further guidance and information for the final disposition of unused study interventions
are provided in the IP manual. All destruction must be adequately documented. If
destruction is authorized to take place at the investigator site, the investigator must ensure
that the materials are destroyed in compliance with applicable environmental regulations,
institutional policy, and any special instructions provided by Pfizer.

Upon identification of a product complaint, notify the sponsor within 1 business day of
discovery as described in the IP manual.

6.2.1. Preparation and Dispensing

See the IP manual for instructions on how to prepare the study intervention for
administration. Study intervention should be prepared and dispensed by an appropriately
qualified and experienced member of the study staff (eg, physician, nurse, physician’s
assistant, nurse practitioner, pharmacy assistant/technician, or pharmacist) as allowed by
local, state, and institutional guidance. A second staff member will verify the dispensing.

Study intervention and placebo will be prepared by qualified unblinded site personnel
according to the IP manual. The study intervention will be administered in such a way to
ensure the participants remain blinded.

6.3. Measures to Minimize Bias: Randomization and Blinding
6.3.1. Allocation to Study Intervention

Allocation (randomization) of participants to vaccine groups will proceed through the use of
an IRT system (IWR). The site personnel (study coordinator or specified designee) will be
required to enter or select information including but not limited to the user’s ID and
password, the protocol number, and the participant number. The site personnel will then be
provided with a vaccine assignment and randomization number. The IRT system will
provide a confirmation report containing the participant number, randomization number, and
study intervention allocation assigned. The confirmation report must be stored in the site’s
files.

The study-specific IRT reference manual and IP manual will provide the contact information
and further details on the use of the IRT system.

6.3.2. Blinding of Site Personnel
In this observer blinded study, the study staff receiving, storing, dispensing, preparing, and
administering the study interventions will be unblinded. All other study and site personnel,
including the investigator, investigator staff, and participants, will be blinded to study

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