SARS-CoV-2 mRNA Vaccine (BNT162, PF-07302048): 2.6.4 Summary of Pharmacokinetic Studies (Japanese Regulatory Filing)
| Author | Pfizer |
|---|---|
| Format | Report |
TL;DR — The Japanese-language pharmacokinetics summary (CTD section 2.6.4) from Pfizer’s application for its COVID-19 mRNA vaccine, covering absorption, distribution, metabolism and excretion studies.
A 23-page Japanese-language section of Pfizer’s regulatory dossier for the BNT162b2 COVID-19 vaccine: Common Technical Document section 2.6.4, the written summary of pharmacokinetic studies (薬物動態試験の概要文). Pages carry Pfizer’s internal-use marking and carry a note that masking of redacted passages was still being adjusted. The PDF is dated February 2021, around the time of the vaccine’s Japanese approval.
The sections follow the standard CTD outline: analytical methods, absorption, distribution, metabolism, excretion, drug interactions, other studies, discussion and conclusions, with tables and figures. Much of the data concerns animal studies of the lipid-nanoparticle delivery system, including a radiolabelled lipid marker used to track where the nanoparticles distribute in the body.
This document was widely circulated online in 2021 by vaccine critics, who cited its biodistribution tables; this card makes no claim about those interpretations.
What it is: part of an official pharmaceutical regulatory submission (a disclosed company filing, partly redacted). It is technical primary data, but it is best known from its use in vaccine-safety controversy. No official host was verified.
Where this came from
- A copy saved in October 2026.
23 pages. A PDF copy is held in Kyle’s private archive; it is not linked or shared here.