Pfizer documents: Pharmacokinetics Written Summary

stack of papers

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

stack of papers

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”.