Stay tuned....

Schistoglossia? 1 the risk/benefit is largely in favour of vax 2 however [.] excessive & persistent ectopic production of synthetic SP should be [.] analysed [.] to identify subjects at risk for major adverse events & answer [.] urgent needs of [.] vax [.] with poor side effects

Ordinary folk, extraordinary heroes youtu.be/HSkcdNJyr8U

Right direction? Discuss Based on immunogenicity [.] FDA anticipates [.] favorable benefit–risk findings for those >65y & >6m with >=1 risk factor [.] for severe C19 [.] For healthy 6m-64yo, FDA anticipates the need for RCTs evaluating clinical outcomes nejm.org/doi/full/10.10…

"The FDA will continue to balance Regulatory felxibility with gold standard science" "there are important safety considerations whose long term impact not fully known and we will continue to monitor"

About 50-66% of American wil probably qualify at being high risk and therefore the C19 vax will be approved with immunogenicty data only.

IV Spike protein induces neuroinflammation and alpha-synuclein accumulation most pronounced in brain regions associated with Parkinson’s disease pathology. trialsitenews.com/a/sars-cov-2-s… frontiersin.org/journals/immun…

Spike activates HIF-1 > TGF-β > immune checkpoint proteins > suppresses Th & Tc cells. "Spike [.] triggers activation of immune evasion machinery similar to the one operated by cancer cells & most likely could support malignancies" trialsitenews.com/a/sars-cov-2-s… frontiersin.org/journals/immun…

LNPs: Unexpectedly, we observed a significant presence of Igs [.] especially anti-PEG antibodies within the LNP corona [which] drive [.] phagocytosis by human myeloid cells. [Highlighting] the pivotal role of anti-PEG Abs in LNP circulation pubmed.ncbi.nlm.nih.gov/39993835/

"preliminary study identified altered metabolic pathways in leukemia bone marrow & suggests metabolomic differences associated with BNT162b2 vax. While the findings do not support a causal link between mRNA vax & leukemia [.], they highlight the need for further studies..."

In "those with a prior-year history of SARS-CoV-2 infection, the overlapping period showed a significantly increased risk (RI=2.74 [95%CI 1.07–7.07]), [.]. Further research is needed to validate these ischemic stroke findings." ?Before or after future approvals?

re: foreign drug manufacturing "FDA first silently followed a "trust & not verify" strategy [.] [which] recurred after the C19 pandemic [.] [harming] US citizens, exposed them to cancer-causing agents, & provided products without the expected benefits. journals.sagepub.com/doi/10.1177/10…

Prasad/Makary "The history of vaccine-associated myocarditis reflects missed opportunities for safety mitigation. " A step in the right direction... jamanetwork.com/journals/jama/…

BioNTech’s Acknowledgment of PEG Risks: A Silent Contradiction BioNTech’s patent history concerning PEG (polyethylene glycol) includes the first patent, US20220001025A1, filed on October 1, 2018—well before the onset of the COVID-19 pandemic and prior to the implementation of

Bizzare but not surprised, as Prasad's CENTER DIRECTOR OVERRIDE MEMO for mnexspike left me scratching my head. fda.gov/media/187671/d… reuters.com/business/healt…

Honored to be named as second author on this important initiative from the ACS. Proceedings of the American College of Surgeons Surgical Adhesions Improvement Project Summit journals.lww.com/journalacs/cit…

Sound familiar? USCG TITAN report: "inadequate design, certification, maintenance & inspection process [.] toxic workplace culture at OceanGate, an inadequate domestic & international regulatory framework [.] an ineffective whistleblower process, news.uscg.mil/Press-Releases…

"more C19 vaccinations are associated with a higher risk of influenza-like respiratory illness & workdays lost. For influenza-like respiratory illness, the association is stronger with a more recent timing [.] rather than the number of vaccinations" nature.com/articles/s4385…

How to Sell Health Pseudoscience: A Crash Course in Con Artistry facebook.com/watch/?v=17498…

Important document & debate: "While medtech industry stakeholders are asking the US FDA to limit requirements in its guidance on hernia mesh labeling, patient and physician groups argue the guidance doesn’t go far enough to address patient safety." raps.org/News-and-Artic…