damning biodistribution data

First posted online: 2 May 2022

Pfizer’s lipid nanoparticle (LNP) delivery platform ensures systemic distribution of its “vaccine”. LNPs distribute everywhere: blood cells, plasma and distant tissues. We know this from Pfizer study 185350, which revealed damning biodistribution data in Wistar Han rats.

At various timepoints, up to 48 hours following injection, 3 male and 3 female rats were euthanised and their organs harvested to determine the extent of LNP distribution. The study was incomplete and inadequate but even its (partial) results are alarming to say the least.

Study 185350 labelled and traced LNPs with tritium, a radioactive form of hydrogen. It replaced spike protein with a surrogate protein, luciferase, responsible for the luminescence of fireflies. Inexplicably, it provides no data on protein synthesis or light emissions.

The study’s first attempt was an abject failure: 100µg doses led to a ~7% acute body weight loss, with 1 of 3 male rats prematurely euthanised at just 30 hours. The other 2 rats were in acute distress. No data was provided for female rats at this dosage.

This toxicity is entirely unrelated to the spike protein! So was it due to the ionisable cationic lipid conferring a positive charge on LNPs once inside the acidic endosome? Toxicity concerns plagued the reputation of cationic lipids prior to the COVID-19 “vaccines”.

Even when repeated at half the dose, 50µg, it still proved acutely toxic to 1 of 3 female rats observed more than 24 hours following injection. Whilst itself not an acute toxicity study, the results suggest LNP toxicity was sorely underestimated by the study researchers.

My questions:

  • Does the positive charge conveyed by novel lipid ALC-0315 in tissues cause toxicity?

  • Which cells endocytose LNPs, synthesise spike protein and express it at their surface? Does this induce autoantibodies, inflammatory and/or cytotoxic NK/T-cell activity?

Of the whole administered dose, ~0.1% in the ovaries at 48 hours may not seem much. But it is a small organ. At a tissue concentration of 12.261µg lipid equiv/g, it was also exponentially rising at the last data point! How much more would it rise if the study continued?

The dose mostly peaked in male tissues. But not in females. Rising at 48 hours: uterus, liver, spleen, adrenal glands, adipose tissue, bladder, femur bone and bone marrow, eyes, large intestine, lymph nodes and pancreas. Why wasn’t the study extended until all plateaued?

LNPs were detected in lymph nodes draining the jaw region and intestines. Maybe ~6% of the dose circulated in the blood at 2 hours. The spleen, which filters blood, contained ~1% of the dose at the data cut-off. Systemic spread by the lymphatic and circulatory systems.

LNPs “did not associate with red blood cells” and yet was significantly detected in blood. Why no attempt to detect LNP uptake by blood cell type? In human blood, RBCs comprise >99% of its cellular fraction. Do white blood cells uptake LNPs? Phagocytic macrophages?

Major limitations of the study:

  • Surrogate luciferase protein used but its expression not studied

  • Urine and faecal samples collected but not studied for shedding

  • Blood cells discarded, LNP uptake by blood cell type was not studied (not even by WBC, RBC and platelets)

Previously filed with the Japanese regulator, the PDMA, the FDA’s report sheds new light on study 185350. It was recently released at phmpt.org under a FOI request. I’m indebted to Dr Bryam Bridle’s excellent primer on the study.

The first attempt at the study, using a 100µg dose, was an abject failure

The drug increasingly concentrated in the ovaries at the 48-hour data cutoff