Pregnancy and Lactation Cumulative Review

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BNT162b2/Pfizer Of the 673 case reports identified in the search, 458 involved BNT162b2 exposure during pregnancy (mother/fetus) and 215 involved exposure during breast-feeding. … The cases reviewed above are indicative of what is in the Pfizer safety database as of28 February 2021. The sponsor (Pfizer/BioNTech) will continue to monitor and report on all pregnancy exposure […]

Pfizer documents: Pharmacokinetics Written Summary

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Released March 1, 2022 The ADME profile of BNT162b2 (BioNTech code number BNT162, Pfizer code number PF-07302048) included evaluation of the PK and metabolism of two novel lipid excipients (ALC-0315 and ALC-0159) in the LNP and potential biodistribution using luciferase expression as a surrogate reporter or a radiolabeled lipid marker … Over 48 hours, the […]

Pfizer documents: Cumulative Analysis of Post-authorization Adverse Event Reports

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Released April 1, 2022 Although the report contains a list of adverse events spanning 9 pages (Appendix 1), Pfizer still concludes that these findings of their “signal detection analyses are consistent with the known safety profile” of their product BNT162b2 and the “cumulative post-marketing experience confirms a favourable benefit-risk balance”.