Categories
Publications

A Systematic Review of Autopsy Findings in Deaths after COVID-19 Vaccination – The Lancet

Background: The rapid development and widespread deployment of COVID-19 vaccines, combined with a high number of adverse event reports, have led to concerns over possible mechanisms of injury including systemic lipid nanoparticle (LNP) and mRNA distribution, spike protein-associated tissue damage, thrombogenicity, immune system dysfunction, and carcinogenicity. The aim of this systematic review is to investigate possible causal links between COVID-19 vaccine administration and death using autopsies and post-mortem analysis. 

Methods: We searched for all published autopsy and necropsy reports relating to COVID-19 vaccination up until May 18th, 2023. We initially identified 678 studies and, after screening for our inclusion criteria, included 44 papers that contained 325 autopsy cases and one necropsy case. Three physicians independently reviewed all deaths and determined whether COVID-19 vaccination was the direct cause or contributed significantly to death. 

Findings: The most implicated organ system in COVID-19 vaccine-associated death was the cardiovascular system (53%), followed by the hematological system (17%), the respiratory system (8%), and multiple organ systems (7%). Three or more organ systems were affected in 21 cases. The mean time from vaccination to death was 14.3 days. Most deaths occurred within a week from last vaccine administration. A total of 240 deaths (73.9%) were independently adjudicated as directly due to or significantly contributed to by COVID-19 vaccination.

Interpretation: The consistency seen among cases in this review with known COVID-19 vaccine adverse events, their mechanisms, and related excess death, coupled with autopsy confirmation and physician-led death adjudication, suggests there is a high likelihood of a causal link between COVID-19 vaccines and death in most cases. Further urgent investigation is required for the purpose of clarifying our findings.

https://web.archive.org/web/20230706021406/https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4496137

Categories
Publications

Titanium dioxide particles frequently present in face masks intended for general use require regulatory control – Nature

Although titanium dioxide (TiO2) is a suspected human carcinogen when inhaled, fiber-grade TiO2 (nano)particles were demonstrated in synthetic textile fibers of face masks intended for the general public. STEM-EDX analysis on sections of a variety of single use and reusable face masks visualized agglomerated near-spherical TiO2 particles in non-woven fabrics, polyester, polyamide and bi-component fibers. Median sizes of constituent particles ranged from 89 to 184 nm, implying an important fraction of nano-sized particles (< 100 nm). The total TiO2 mass determined by ICP-OES ranged from 791 to 152,345 µg per mask. The estimated TiO2 mass at the fiber surface ranged from 17 to 4394 µg, and systematically exceeded the acceptable exposure level to TiO2 by inhalation (3.6 µg), determined based on a scenario where face masks are worn intensively. No assumptions were made about the likelihood of the release of TiO2 particles itself, since direct measurement of release and inhalation uptake when face masks are worn could not be assessed. The importance of wearing face masks against COVID-19 is unquestionable. Even so, these results urge for in depth research of (nano)technology applications in textiles to avoid possible future consequences caused by a poorly regulated use and to implement regulatory standards phasing out or limiting the amount of TiO2 particles, following the safe-by-design principle.

https://www.nature.com/articles/s41598-022-06605-w

Categories
Publications

The EMA covid-19 data leak, and what it tells us about mRNA instability – BMJ

The BMJ has reviewed the documents, which show that regulators had major concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production.

EMA scientists tasked with ensuring manufacturing quality—the chemistry, manufacturing, and control aspects of Pfizer’s submission to the EMA—worried about “truncated and modified mRNA species present in the finished product.” Among the many files leaked to The BMJ, an email dated 23 November by a high ranking EMA official outlined a raft of issues. In short, commercial manufacturing was not producing vaccines to the specifications expected, and regulators were unsure of the implications. EMA responded by filing two “major objections” with Pfizer, along with a host of other questions it wanted addressed.

https://archive.today/2022.12.06-175136/https://www.bmj.com/content/372/bmj.n627