Page 57 - pfizervax

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

Study intervention should be administered intramuscularly into the deltoid muscle, preferably
of the nondominant arm, by an unblinded administrator.

Standard vaccination practices must be observed and vaccine must not be injected into blood
vessels. Appropriate medication and other supportive measures for management of an acute
hypersensitivity reaction should be available in accordance with local guidelines for standard
immunization practices.

Administration of study interventions should be performed by an appropriately qualified,
GCP-trained, and vaccine-experienced member of the study staff (eg, physician, nurse,
physician’s assistant, nurse practitioner, pharmacist, or medical assistant) as allowed by
local, state, and institutional guidance.

Study intervention administration details will be recorded on the CRF.

6.2. Preparation/Handling/Storage/Accountability
1. The investigator or designee must confirm appropriate temperature conditions have been
maintained during transit for all study interventions received and any discrepancies are
reported and resolved before use of the study intervention.

2. Only participants enrolled in the study may receive study intervention and only
authorized site staff may supply or administer study intervention. All study interventions
must be stored in a secure, environmentally controlled, and monitored (manual or
automated recording) area in accordance with the labeled storage conditions with access
limited to the investigator and authorized site staff. At a minimum, daily minimum and
maximum temperatures for all site storage locations must be documented and available
upon request. Data for nonworking days must indicate the minimum and maximum
temperatures since previously documented for all site storage locations upon return to
business.

3. Any excursions from the study intervention label storage conditions should be reported to
Pfizer upon discovery along with any actions taken. The site should actively pursue
options for returning the study intervention to the storage conditions described in the
labeling, as soon as possible. Once an excursion is identified, the study intervention must
be quarantined and not used until Pfizer provides permission to use the study
intervention. Specific details regarding the definition of an excursion and information the
site should report for each excursion will be provided to the site in the IP manual.

4. Any storage conditions stated in the SRSD will be superseded by the storage conditions
stated on the label.

5. Study interventions should be stored in their original containers.

6. See the IP manual for storage conditions of the study intervention.

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