The COVID-19 experimental biological products are touted as safe and effective, yet the FDA and Pfizer are currently fighting in court (again) to delay releasing the safety data? What is there to hide? Where is the transparency? Why can’t independent scientists review the safety data?
Clinical Trials are Ongoing
Concerning Safety Information or Lack Thereof
From the Nonclinical Evaluation Report and biodistribution study:
“Parturition: One ~ in the BNT162b3 group was euthanized on LDl showing hunched posture, pale, marked piloerection, bleeding at the vulva, distended/purple abdomen. One ~ each in the BNT162bl and BNT162b3 groups were euthanized due to all stillborn pups or total litter death. No macroscopic findings were noted in maternal necropsy.”
Fetal malformations/variations were found in the pups of dams in the treatment groups.
Also of concern:
Genotoxicity
No genotoxicity studies were conducted for the vaccine
Carcinogenicity
Carcinogenicity studies were not conducted.
Insufficient Testing of Novel Lipid Nanoparticles
2-[(Polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159) and ((4-hydroxybutyl)azanediyl) bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315) are novel excipients and are not listed on the TGA' s ingredient database.
ALC-0315 (the ester formulation) was minimally metabolized and only 1% was excreted
ALC-0159 (the amide formulation) was more completely metabolized and only 50% was excreted
These novel LNP have very long elimination half-lives, especially ALC-0315 (the ester formulation), which is extremely concerning.
These data prove that the LNP are distributed systemically, not broken down efficiently, and stay in the body for a long period of time. Not only that, but the spike (S) protein expression can occur anywhere in the body, reaches high levels of expression, and may be of long duration (possibly mimicking the length of time antibody titers remain elevated.)
The biodistribution study is also very alarming because it shows that these LNPs accumulate not only at the injection site but also immediately to the liver, spleen, kidneys, and lymph nodes with rising concentrations (at 48 hours, the longest timepoint measured) in the ovaries, bone marrow, thyroid gland, pituitary gland, heart, and lungs. I have not had time to curve fit and mathematically extrapolate the tissue concentrations to further timepoints but it is on my list of to dos.
Updated Safety Concerns
References
https://www.ema.europa.eu/en/documents/rmp-summary/comirnaty-epar-risk-management-plan_en.pdf
Nonclinical Evaluation Report: BNT162b2 [mRNA] COVID-19 vaccine (COMIRNATY ™) 2021. Submission No: PM-2020-05461-1-2 Sponsor: Pfizer Australia Pty Ltd. https://www.tga.gov.au/sites/default/files/foi-2389-06.pdf
https://www.pmda.go.jp/drugs/2021/P20210212001/672212000_30300AMX00231_I100_1.pdf
Health policies are built on safety data and disease data. What happens when both are flawed, and policy is built on flawed data? An additional concern is how health departments are conflating vaccine effectiveness stats with "muddy" data that does not distinguish between many variables (hospitalized with covid, hospitalized because of covid, general admission vs ICU admission, days in ICU, with pneumonia vs covid pneumonia, age and co-morbidity stratification, definitions of injected vs un-injected, clear definitions of all terms in the stats. Also there are at least four groups to analyze, not just the false dichotomy of vaxxed vs unvaxxed. Stats shouls examinef never-injected and covid-naive, covid-recovered and un-injected, covid-recovered and injected, covid-naive and injected. This post does a great job of teasing out conflations and confounders in manipulated data, thought you might like it, Dr. Carver https://metatron.substack.com/p/alberta-just-inadvertently-confessed?utm_source=substack&utm_campaign=post_embed&utm_medium=web