Post-Approval Observational Cohort Study to Evaluate the Safety of the COMIRNATY 2023-2024 Formula in the United States

03/01/2024
26/03/2026
EU PAS number:
EUPAS108135
Study
Ongoing
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Documents
Study protocol
Initial protocol

C4591062_PROTOCOL AND STATISTICAL ANALYSIS PLAN_V1.0_12DEC2023

English (682.6 KB - PDF) View document
Updated protocol

C4591062_PROTOCOL AND STATISTICAL ANALYSIS PLAN V2.0_29AUG2025.pdf

First published: 23/03/2026
English (716.96 KB - PDF) View document

C4591062_PROTOCOL AND STATISTICAL ANALYSIS PLAN_V3 AMENDMENT 2_18MAR2026.pdf

First published: 23/03/2026
English (1.02 MB - PDF) View document
Study results
Study report
Other information