BNT162b2
5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
CONFIDENTIAL
Page 29
5. SUMMARY AND CONCLUSION
Review of the available data for this cumulative PM experience, confirms a favorable
benefit: risk balance for BNT162b2.
Pfizer will continue routine pharmacovigilance activities on behalf of BioNTech according to
the Pharmacovigilance Agreement in place, in order to assure patient safety and will inform
the Agency if an evaluation of the safety data yields significant new information for
BNT162b2.
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