TGA document revelations

Therapeutic Goods administration (January 2021 document)

https://www.tga.gov.au/sites/default/...

Page 4
“Almost similar microscopic lung inflammation was observed in both challenged control and immunised animals (macaques) after the peak of infection (Days 7/8)”

Challenged with infection, (unvaccinated) control animals

Almost similar microscopic lung inflammation

Challenged with infection, immunized (vaccinated) animals

Almost similar microscopic lung inflammation

Page 4
“There are no distribution and degradation data on the S antigen-encoding mRNA.”

A new therapy that uses an intra-cellular pathway to use intracellular ribosomes

We know from page 45 the lipid nanoparticles are systemically distributed,

But the spike protein that the RNA produces, distribution not tested

No data on how long the spike protein persists

Page 5
“Antibodies and T cells in monkeys declined quickly over 5 weeks after the second dose of BNT162b2 (V9), raising concerns over long term immunity”

Page 6 – A few unknowns were identified by the TGA
“Short term protection studies,

lack of pharmacokinetic data for the S antigen-encoding mRNA (BNT162b2 V9),

suboptimal dosing interval in the repeat dose study,

lack of repeat dose toxicity studies in a second species,

and genotoxicity studies with the novel excipients,

(a substance formulated alongside the active ingrediants)

and lack of studies investigating potential for autoimmune diseases were noted.”

Page 6 – Unknown go on
“Long term immunity,