A Non-Interventional Post-Approval Safety Study of Pfizer-BioNTech COVID-19 Vaccine in the United States

19/10/2021
02/06/2026
EU PAS number:
EUPAS43468
Study
Finalised
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Documents
Study protocol
Initial protocol

C4591009_PROTOCOL_19AUG2021 (1)

English (3.62 MB - PDF) View document
Updated protocol

C4591009_PROTOCOL AMENDMENT 3_V4_30JUN2023

First published: 22/02/2024
English (2.16 MB - PDF) View document
Study results
Study report
Abstract of study report

c4591009-final-abstract.pdf

English (726.62 KB - PDF) View document
Study report

c4591009-final-report-body.pdf

English (11.12 MB - PDF) View document
Other information
Study, other information

C4591009_PROTOCOL AMENDMENT 2_V3_07JUL2022

English (4.63 MB - PDF) View document