BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
5. SUMMARY AND CONCLUSION Review of the available data for this cumulative PM experience, confirms a favorable benefit: risk balance for BNT162b2.
090177e196ea1800\Approved\Approved On: 30-Apr-2021 09:26 (GMT)
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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FDA-CBER-2021-5683-0000082
