This document was acquired with a FOIA request submitted by the Informed Consent Action Network (ICAN) to the United Kingdom’s FDA equivalent – the Medicines and Healthcare Products Registry Agency (MHRA) -- in April 2022. The request sought information relating to the MHRA’s authorization of the AstraZeneca, Janssen, Moderna, and Pfizer COVID-19 vaccines.
Version from December 21, 2020:
“3.2 Distribution …
The biodistribution of AZD1222 following intramuscular administration is expected to be similar to that of AdCh63, confined to the site of injection and draining lymph nodes."
Version from April 21, 2021:
“3.2 Distribution …
In an AZD1222 biodistribution study in mice, there was no biodistribution to blood and faeces samples with the exception of low signal from 2 blood and 1 faeces samples on Day 2. Both blood samples had signals below the limit of quantification (<LLOQ) and the faeces sample returned a low signal of 1.30 x 103 copies/µg DNA (LLOQ was 50 copies/Q-PCR reaction). In tissues, AZD1222 vector DNA showed biodistribution to the intramuscular administration sites, sciatic nerve, bone marrow, liver, lung and spleen. The highest levels of AZD1222 vector DNA (103 to 107 copies/µg DNA) were observed in the intramuscular administration sites and sciatic nerve (close proximity to the administration sites) on Day 2. Lower levels of AZD1222 vector DNA (<LLOQ to 104 copies/µg DNA) were observed in bone marrow, liver, spleen and lung, on Day 2. The levels of AZD1222 and the number of tissues with detectable levels of AZD1222 vector DNA decreased from Day 2 to 29, indicating elimination.”