COVID PAPERS/Links
Fauci: “The best vaccination is to get infected yourself”
Vaccine/COVID Adverse Effects/Safety/Mortality/Monitoring
SARS-CoV-2 vaccination can elicit a CD8 T-cell dominant hepatitis
https://www.sciencedirect.com/science/article/pii/S0168827822002343
SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8091897/
The novel coronavirus’ spike protein plays additional key role in illness
Ab2 antibodies could also mediate neurologic effects of SARS-CoV-2 infection or vaccines, given the expression of ACE2 on neuronal tissues, the specific neuropathologic effects of SARS-CoV-2 infection,and the similarity of these effects to Ab2-mediated neurologic effects observed in other viral models.
😅Translation: Ab2 antibodies to spike in this case are specific for ACE2 which decrease ACE2 activity. This could lead to an increase in the abundance of Ang II, which causes a proinflammatory state that triggers symptoms of PASC(Long Covid)
https://www.nejm.org/doi/full/10.1056/NEJMcibr2113694
Cytokine Hub Classification of PASC, ME-CFS and other PASC-like Conditions
New-Onset Kidney Diseases after COVID-19 Vaccination: A Case Series
https://www.ncbi.nlm.nih.gov/pmc/a
Molecular mimicry between SARS-CoV-2 spike glycoprotein and mammalian proteomes: implications for the vaccine
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7499017/
Towards the emergence of a new form of the neurodegenerative Creutzfeldt-Jakob disease: Sixteen cases of CJD declared a few days after a COVID-19 “vaccine” Jab
We subsequently recall the usual history of this dreadfull subacute disease, and compare it with this new, extremely acute, prion disease, following closely vaccinations. In a few weeks, more 40 cases of almost spontaneous emergence of Creutzfeldt-Jakob disease have appeared in France and Europe very soon after the injection of the first or second dose of Pfizer, Moderna or AstraZeneka vaccines
Author Luc Montagnier died same month this paper was published
ADE-antibody-mediated enhancement
FcγR-mediated SARS-CoV-2 infection of monocytes activates inflammation
About 6% of blood monocytes in COVID-19 patients are infected with SARS-CoV-2.Monocyte infection depends on uptake of antibody-opsonized virus by Fcγ receptors. Vaccine recipient plasma does not promote antibody-dependent monocyte infection.
[me: Bruce Patterson detected intermediate and non-classical monocytes containing S1 protein as long as 15 months after infection
These findings taken together suggest that antibody-mediated SARS-CoV-2 uptake by monocytes/macrophages triggers inflammatory cell death that aborts production of infectious virus but causes systemic inflammation that contributes to COVID-19 pathogenesis.
FcγR-mediated monocyte infection is an example of antibody-mediated enhancement (ADE) of infection.
[Now for the obligatory praise for Vaccines necessary to get published]
Nonetheless, overwhelming evidence shows that vaccine-generated neutralizing antibod- ies prevent infection and improve clinical outcome of breakthrough infections, suggesting that anti-spike antibodies are highly beneficial.
Plasma from vaccinated individuals did not promote monocyte infection, indicating that ADE is not a concern with respect to vaccination. [me: Authors still engaging in damage control to get past censors-no evidence for this is presented in the paper]
https://www.nature.com/articles/s41586-022-04702-4_reference.pdf
Early Convalescent Plasma for High-Risk Outpatients with Covid-19
Five patients in the plasma group and 1 patient in the placebo group died. Outcomes regarding worst illness severity and hospital-free days were similar in the two groups.
while not conclusive suggest the possibility of ADE due to afucosylated antibodies
https://www.nejm.org/doi/10.1056/NEJMoa2103784
Early non-neutralizing, afucosylated antibody responses are associated with COVID-19 severity
The study below seems to confirm vaccines dont produce afucosylated antibodies but thats only because they measured this 28 days after the 1st dose and not earlier
Funders are Zuckerberg Foundation, NIAID, Big Pharma, etc
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8939764/#__ffn_sectitle
The BNT162b2 mRNA SARS-CoV-2 vaccine induces transient afucosylated IgG1 in naive but not antigen-experienced vaccinees
The findings reveal that the level of afucosylated anti-spike antibodies increases transiently in infection-naïve individuals after the first vaccine dose.
In infection-naïve individuals, about 25% of anti-spike IgG1 Fc were found to be afucosylated initially after administration of the first vaccine dose. However, the level decreased gradually with time.
In individuals with previous infection, about 2 – 10% of anti-spike IgG1 Fc were found to be afucosylated before vaccination. The level increased slightly after vaccination. The level of afucosylated anti-spike antibodies remained significantly lower in previously infected individuals after vaccination compared to that in naïve individuals
https://www.biorxiv.org/content/10.1101/2022.02.14.480353v1
The mRNA-LNP platform’s lipid nanoparticle component used in preclinical vaccine studies is highly inflammatory
https://www.biorxiv.org/content/10.1101/2021.03.04.430128v1
Potential adverse effects of nanoparticles on the reproductive system
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6294055/
Pregnancy
Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons
https://www.nejm.org/doi/full/10.1056/nejmoa2104983
Risk of Myocarditis following sequential COVID-19 Vaccination
https://www.medrxiv.org/content/10.1101/2021.12.23.21268276v1.full.pdf
Innate Immune Suppression by SARS-CoV-2 mRNA Vaccinations: The role of G-quadruplexes, exosomes and microRNAs
The SARS-CoV-2 Spike protein disrupts human cardiac pericytes function through CD147-receptor-mediated signalling: a potential non-infective mechanism of COVID-19 microvascular disease
https://www.biorxiv.org/content/10.1101/2020.12.21.423721v2.full.pdf
mRNA COVID-19 Vaccination and Development of CMR-confirmed Myopericarditis (withdrawn)
This is the largest series in the literature to clearly relate the temporal relationship between mRNA COVID vaccination, symptoms and CMR findings.
https://www.medrxiv.org/content/10.1101/2021.09.13.21262182v1
Myocarditis after Covid-19 Vaccination in a Large Health Care Organization
The highest incidence of myocarditis (10.69 cases per 100,000 persons; 95% CI, 6.93 to 14.46) was reported in male patients between the ages of 16 and 29 years.
https://www.nejm.org/doi/10.1056/NEJMoa2110737
Cardiac Troponin for Assessment of Myocardial Injury in COVID-19:
https://www.sciencedirect.com/science/article/pii/S0735109720358885
The BNT162b2 mRNA vaccine against SARS-CoV-2 reprograms both adaptive and innate immune responses
https://www.medrxiv.org/content/10.1101/2021.05.03.21256520v1.full-text
Suppression of RNA Recognition by Toll-like Receptors: The Impact of Nucleoside Modification and the Evolutionary Origin of RNA
Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge in young adults
https://www.nature.com/articles/s41591-022-01780-9.pdf
The Pfizer mRNA vaccine: pharmacokinetics and toxicity
Michael Palmer, MD and Sucharit Bhakdi, MD July 23rd, 2021
https://doctors4covidethics.org/wp-content/uploads/2021/07/Pfizer-pharmacokinetics-and-toxicity.pdf
Comprehensive investigations revealed consistent pathophysiological alterations after vaccination with COVID-19 vaccines
our study recommends additional caution when vaccinating people with pre-existing clinical conditions, including diabetes, electrolyte imbalances, renal dysfunction, and coagulation disorders.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8546144/
Long-lived macrophage reprogramming drives spike protein-mediated inflammasome activation in COVID-19
https://www.embopress.org/doi/full/10.15252/emmm.202114150
Comment from J. Patrick Whelan MD PhD to FDA on Vaccine
https://www.regulations.gov/document/FDA-2020-N-1898-0246
The Flimsy evidence to vaccinate children
Young Adult Mortality in Israel (deleted from web)
The Safety of COVID-19 Vaccinations—We Should Rethink the Policy (retracted)
https://res.mdpi.com/d_attachment/vaccines/vaccines-09-00693/article_deploy/vaccines-09-00693-v2.pdf
COVID-19 vaccine safety update
Advisory Committee on Immunization Practices (ACIP) January 27, 2021
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-01/06-COVID-Shimabuku
The Pfizer mRNA vaccine: pharmacokinetics and toxicity
Michael Palmer, MD and Sucharit Bhakdi, MD July 23rd, 2021
https://doctors4covidethics.org/wp-content/uploads/2021/07/Pfizer-pharmacokinetics-and-toxicity.pdf
Addressing anti-syncytin antibody levels, and fertility and breastfeeding concerns, following BNT162B2 COVID-19 mRNA vaccination
https://www.medrxiv.org/content/10.1101/2021.05.23.21257686v1
SARS-CoV-2 binds platelet ACE2 to enhance thrombosis in COVID-19
https://jhoonline.biomedcentral.com/articles/10.1186/s13045-020-00954-7
Infection of human sweat glands by SARS-CoV-2
https://www.nature.com/articles/s41421-020-00229-y
Transmission, Breakthroughs
High rate of BA.1, BA.1.1 and BA.2 infection in triple vaccinated
Booster vaccine doses offer protection against severe COVID-19 caused by omicron but are less effective against infection.
https://www.medrxiv.org/content/10.1101/2022.04.02.22273333v1.full
COVID-19 Aerosolized Viral Loads, Environment, Ventilation, Masks, Exposure Time, Severity, And Immune Response: A Pragmatic Guide Of Estimates
https://www.medrxiv.org/content/10.1101/2020.10.03.20206110v6
Comparison of Respiratory Virus Transmission Outdoors Compared to Indoors Ordered by Virus Studied
https://academic.oup.com/view-large/228745163
Simple quantitative assessment of the outdoor versus indoor airborne transmission of viruses and COVID-19
https://www.sciencedirect.com/science/article/pii/S0013935121004837
In truth, the share of transmission that has occurred outdoors seems to be below 1 percent and may be below 0.1 percent,
Cross-reactive memory T cells associate with protection against SARS-CoV-2 infection in COVID-19 contacts
https://www.nature.com/articles/s41467-021-27674-x
Omicron may turn pandemic to endemic
https://edition.cnn.com/2022/01/22/world/omicron-changed-pandemic-intl-cmd/index.html
Transmission of SARS-CoV-2 Delta Variant Among Vaccinated Healthcare Workers, Vietnam
Findings: Between 11th–25th June 2021 (week 7–8 after dose 2), 69 fully vaccinated healthcare workers were tested positive for SARS-CoV-2. 62 participated in the clinical study. 49 were (pre)symptomatic with one requiring oxygen supplementation. All recovered uneventfully.
Viral loads of breakthrough Delta variant infection cases were 251 times higher than those of cases infected with old strains detected between March-April 2020. Time from diagnosis to PCR negative was 8–33 days (median: 21).
Interpretation: Breakthrough Delta variant infections are associated with high viral loads, prolonged PCR positivity, and low levels of vaccine-induced neutralizing antibodies, explaining the transmission between the vaccinated people.
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3897733
Significant Difference in Viral Load Between Vaccinated and Unvaccinated, Asymptomatic and Symptomatic Groups Infected with SARS-CoV-2 Delta Variant
In our study, mean viral loads as measured by Ct-value were similar for large numbers of asymptomatic and symptomatic individuals infected with SARS-Cov-2 during the Delta surge, regardless of vaccine status, age, or gender.
A substantial proportion of asymptomatic, fully vaccinated individuals in our study had low Ct-values, indicative of high viral loads. Given that low Ct-values are indicative of high levels of virus, culture positivity, and increased transmission [11], our detection of low Ct-values in asymptomatic, fully vaccinated individuals is consistent with the potential for transmission from breakthrough infections prior to any emergence of symptoms.
https://www.medrxiv.org/content/10.1101/2021.09.28.21264262v1.full.pdf
Viral Shedding and Transmission Potential of Asymptomatic and Paucisymptomatic Influenza Virus Infections in the Community
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5967351/
Variants of concern are overrepresented among post-vaccination breakthrough infections of SARS-CoV-2 in Washington State
https://www.medrxiv.org/content/10.1101/2021.05.23.21257679v1
Aerosol transmission of SARS-CoV-2 by children and adults during the COVID-19 pandemic
https://onlinelibrary.wiley.com/doi/10.1002/ppul.25330
Post-lockdown SARS-CoV-2 nucleic acid screening in nearly ten million residents of Wuhan, China
https://www.nature.com/articles/s41467-020-19802-w.pdf
Upper respiratory viral load in asymptomatic individuals and mildly symptomatic patients with SARS-CoV-2 infection
https://pubmed.ncbi.nlm.nih.gov/32963115/
The central role of the nasal microenvironment in
the transmission, modulation, and clinical progression
of SARS-CoV-2 infection
https://www.nature.com/articles/s41385-020-00359-2.pdf
Viral dynamics in asymptomatic patients with COVID-19
https://www.ijidonline.com/article/S1201-9712(20)30337-4/fulltext
Airborne transmission of respiratory viruses
https://www.science.org/doi/10.1126/science.abd9149
Influenza vaccination and respiratory virus interference among Department of Defense personnel during the 2017-2018 influenza season
Vaccine derived virus interference was significantly associated with coronavirus and human metapneumovirus; however, significant protection with vaccination was associated not only with most influenza viruses, but also parainfluenza, RSV, and non-influenza virus coinfections.
https://pubmed.ncbi.nlm.nih.gov/31607599/
Natural or Pre-existing Immunity and Immunology
Immune imprinting, breadth of variant recognition, and germinal center response in human SARS-CoV-2 infection and vaccination
Viral variant infection elicits variant-specific antibodies, but prior mRNA vaccination imprints serological responses toward Wuhan-Hu-1 rather than variant antigens. I
https://web.archive.org/web/20210526193152/https://
assets.researchsquare.com/files/rs-558954/v1/8c30a186-e9e2-47c1-a76c-dc3bdf10c22a.pdf
Protection afforded by prior infection against SARS-CoV-2 reinfection with the Omicron variant
https://www.medrxiv.org/content/10.1101/2022.01.05.22268782v1
Innate Immune Suppression by SARS-CoV-2 mRNA Vaccinations: The role of G-quadruplexes, exosomes and microRNAs
Omicron could offer 'natural Covid immunity' without need for boosters, says EMA
MUCOSAL IMMUNITY AND VACCINES
https://www.stritch.luc.edu/lumen/meded/hostdef/Mucosal_Immunity_Vaccines.pdf
Transcriptional regulation of memory B cell differentiation
https://www.nature.com/articles/s41577-020-00446-2.pdf
Protracted yet coordinated differentiation of long-lived SARS-CoV-2-specific CD8+ T cells during COVID-19 convalescence
https://www.biorxiv.org/content/10.1101/2021.04.28.441880v1
Antibody and B cell responses
to SARS-CoV-2 infection and vaccination
https://www.cell.com/cell-host-microbe/pdf/S1931-3128(21)00287-0.pdf
Local and systemic responses to SARS-CoV-2 infection in children and adults
https://www.nature.com/articles/s41586-021-04345-x_reference.pdf
Pre-existing polymerase-specific T cells expand in abortive seronegative SARS-CoV-2
https://www.nature.com/articles/s41586-021-04186-8.pdf
Highly-specific memory B cells generation after the 2nd dose of BNT162b2 vaccine compensate for the decline of serum antibodies and absence of mucosal IgA
https://www.medrxiv.org/content/10.1101/2021.06.08.21258284v1
Cross-reactive memory T cells associate with protection against SARS-CoV-2 infection in COVID-19 contacts
https://www.nature.com/articles/s41467-021-27674-x.pdf
Innate immunity: the first line of defense against
SARS-CoV-2
https://www.nature.com/articles/s41590-021-01091-0.pdf
Affinity maturation of SARS-CoV-2 neutralizing antibodies confers potency, breadth, and resilience to viral escape mutations
https://www.cell.com/immunity/fulltext/S1074-7613(21)00294-6
Selective and cross-reactive SARS-CoV-2 T cell epitopes in unexposed humans
https://pubmed.ncbi.nlm.nih.gov/32753554/
IgA dominates the early neutralizing antibody response to SARS-CoV-2
https://www.science.org/doi/10.1126/scitranslmed.abd2223
Pre-existing immunity to SARS-CoV-2: the knowns and unknowns
https://www.nature.com/articles/s41577-020-0389-z.pdf
Covid-19: Do many people have pre-existing immunity?
https://www.bmj.com/content/370/bmj.m3563
Nano-Enabled COVID-19 Vaccines: Meeting the Challenges of Durable Antibody Plus Cellular Immunity and Immune Escape
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8029448/pdf/nn1c01845.pdf/?ref=pdf
Mucosal Immunity in COVID-19: A Neglected but Critical Aspect of SARS-CoV-2 Infection
https://www.frontiersin.org/articles/10.3389/fimmu.2020.611337/full
Pre-existing polymerase-specific T cells expand in abortive seronegative SARS-CoV-2 infection
https://www.medrxiv.org/content/10.1101/2021.06.26.21259239v1.full.pdf
A majority of uninfected adults show preexisting antibody reactivity against SARS-CoV-2
https://insight.jci.org/articles/view/146316
Immunodominant T-cell epitopes from the SARS-CoV-2 spike antigen reveal robust pre-existing T-cell immunity in unexposed individuals
https://www.biorxiv.org/content/10.1101/2020.11.03.367375v1
Pre-existing T-cell immunity to SARS-CoV-2 in unexposed healthy controls
https://pubmed.ncbi.nlm.nih.gov/33582369/
Apoptosis, Pyroptosis, and Necrosis: Mechanistic Description of Dead and Dying Eukaryotic Cells
https://journals.asm.org/doi/10.1128/IAI.73.4.1907-1916.2005
Preexisting and de novo humoral immunity to SARS-CoV-2 in humans
Mucosal and Cutaneous Immunity
https://www.sciencedirect.com/topics/neuroscience/secretory-immunoglobulin
Detection of cross-reactive IgA against SARS-CoV-2 spike 1 subunit in saliva
https://www.medrxiv.org/content/10.1101/2021.03.29.21253174v1.full
Secretory IgA antibodies provide cross-protection against infection with different strains of influenza B virus
https://onlinelibrary.wiley.com/doi/abs/10.1002/jmv.20173
A majority of uninfected adults show preexisting antibody reactivity against SARS-CoV-2
we determined that more than 90% of uninfected adults showed antibody reactivity against the spike protein, receptor-binding domain (RBD), N-terminal domain (NTD), or the nucleocapsid (N) protein from SARS-CoV-2. This seroreactivity was evenly distributed across age and sex, correlated with circulating coronaviruses’ reactivity, and was partially outcompeted by soluble circulating coronaviruses’ spike. Using a custom SARS-CoV-2 peptide mapping array, we found that this antibody reactivity broadly mapped to spike and to conserved nonstructural viral proteins. We conclude that most adults display preexisting antibody cross-reactivity against SARS-CoV-2
https://insight.jci.org/articles/view/146316
The Effectiveness of mRNA Vaccine Boosters for Laboratory-Confirmed COVID-19 During a Period of Predominance of the Omicron Variant of SARS-CoV-2
Results: The estimated effectiveness (95% confidence interval) during days 7 to 34 after a booster was 51.3% (50.2, 52.4) overall, higher for females and people aged 60-79. Estimated effectiveness was 52.5% (51.3, 53.7) for an mRNA-1273 booster and 46.2% (43.5, 48.7) for a BNT162b2 booster
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4035396
Presence of SARS-CoV-2-reactive T cells in COVID-19 patients and healthy donors
https://www.medrxiv.org/content/10.1101/2020.04.17.20061440v1
Targets of T Cell Responses to SARS-CoV-2 Coronavirus in Humans with COVID-19 Disease and Unexposed Individuals
Cross-reactive memory T cells and herd immunity to SARS-CoV-2
https://www.nature.com/articles/s41577-020-00460-4
Predicting the Immunogenicity of T cell epitopes: From HIV to SARS-CoV-2
https://www.biorxiv.org/content/10.1101/2020.05.14.095885v2
Scientists uncover SARS-CoV-2-specific T cell immunity in recovered COVID-19 and SARS patients
the team showed that patients who recovered from SARS 17 years ago after the 2003 outbreak, still possess virus-specific memory T cells and displayed cross-immunity to SARS-CoV-2.
https://www.sciencedaily.com/releases/2020/07/200716101536.htm
Exposure to SARS-CoV-2 generates T-cell memory in the absence of a detectable viral infection
https://www.nature.com/articles/s41467-021-22036-z
Immunodominant T-cell epitopes from the SARS-CoV-2 spike antigen reveal robust pre-existing T-cell immunity in unexposed individuals
https://www.nature.com/articles/s41598-021-92521-4
Negligible impact of SARS-CoV-2 variants on CD4 + and CD8 + T cell reactivity in COVID-19 exposed donors and vaccinees
https://pubmed.ncbi.nlm.nih.gov/33688655/
Cross-Reactivity of T Cells and Its Role in the Immune System
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3595599/
SPIKE PROTEIN
The S1 protein of SARS-CoV-2 crosses the blood–brain barrier in mice
https://www.nature.com/articles/s41593-020-00771-8.pdf
SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8091897/
The novel coronavirus’ spike protein plays additional key role in illness
Immune imprinting, breadth of variant recognition, and germinal center response in human SARS-CoV-2 infection and vaccination
Vaccine spike antigen and mRNA persist for weeks in lymph node GCs
Spike protein was detected in the plasma of 96% of the vaccinees at days 1–2 (median spike concentration of 47 pg/mL) and in 63% at day 7 (median spike concentration of 1.7 pg/mL) after the prime vaccine dose. In contrast, spike antigen detection after the vaccine boost on day 21 was reduced, with half of the study participants being positive on days 1–2 (median spike concentration of 1.2 pg/mL) and only one individual on day 7 post-boost (Figure 7J).
Snip
The observed extended presence of vaccine mRNA and spike protein in vaccinee LN GCs for up to 2 months after vaccination was in contrast to rare foci of viral spike protein in COVID-19 patient LNs.
Ab2 antibodies could also mediate neurologic effects of SARS-CoV-2 infection or vaccines, given the expression of ACE2 on neuronal tissues, the specific neuropathologic effects of SARS-CoV-2 infection,and the similarity of these effects to Ab2-mediated neurologic effects observed in other viral models.
😅Translation: Ab2 antibodies to spike in this case are specific for ACE2 which decrease ACE2 activity. This could lead to an increase in the abundance of Ang II, which causes a proinflammatory state that triggers symptoms of PASC(Long Covid)
https://www.nejm.org/doi/full/10.1056/NEJMcibr2113694
S1 protein in the plasma of nurses after vaccination for up to 28 days after vaccination, and also the entire spike protein for a shorter period
https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab465/6279075
New-Onset Kidney Diseases after COVID-19 Vaccination: A Case Series
https://www.ncbi.nlm.nih.gov/pmc/a
The S1 protein of SARS-CoV-2 crosses the blood–brain barrier in mice
https://www.nature.com/articles/s41593-020-00771-8.pdf
Molecular mimicry between SARS-CoV-2 spike glycoprotein and mammalian proteomes: implications for the vaccine
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7499017/
Cutting Edge: Circulating Exosomes with COVID Spike Protein Are Induced by BNT162b2 (Pfizer–BioNTech) Vaccination prior to Development of Antibodies: A Novel Mechanism for Immune Activation by mRNA Vaccines
https://www.jimmunol.org/content/207/10/2405
Evidence for SARS-CoV-2 Spike Protein in the Urine of COVID-19 Patients
https://kidney360.asnjournals.org/content/2/6/924
The SARS-CoV-2 Spike protein disrupts human cardiac pericytes function through CD147-receptor-mediated signalling: a potential non-infective mechanism of COVID-19 microvascular disease
https://www.biorxiv.org/content/10.1101/2020.12.21.423721v2.full.pdf
Persistence of SARS CoV-2 S1 Protein in CD16+ Monocytes in Post-Acute Sequelae of COVID-19 (PASC) Up to 15 Months Post-Infection
https://www.biorxiv.org/content/10.1101/2021.06.25.449905v1.full
Implications of the SARS-CoV-2 spike protein interaction with type-1 macrophages via α7-nAChR
https://www.qeios.com/read/26GTOD.2
SARS-CoV-2 spike protein S1 induces fibrin(ogen) resistant to fibrinolysis: Implications for microclot formation in COVID-19
https://www.medrxiv.org/content/10.1101/2021.03.05.21252960v1
Free SARS-CoV-2 Spike Protein S1 Particles May Play a Role in the Pathogenesis of COVID-19 Infection
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7772528/
The SARS-CoV-2 spike protein alters barrier function in 2D static and 3D microfluidic in-vitro models of the human blood-brain barrier
https://pubmed.ncbi.nlm.nih.gov/33053430/
Domains and Functions of Spike Protein in SARS-Cov-2 in the Context of Vaccine Design
https://res.mdpi.com/d_attachment/viruses/viruses-13-00109/article_deploy/viruses-13-00109-v3.pdf
Activation of the SARS coronavirus spike protein via sequential proteolytic cleavage at two distinct sites
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2660061/#__ffn_sectitle
The BNT162b2 mRNA SARS-CoV-2 vaccine induces transient afucosylated IgG1 in naive but not antigen-experienced vaccinees
The findings reveal that the level of afucosylated anti-spike antibodies increases transiently in infection-naïve individuals after the first vaccine dose.
In infection-naïve individuals, about 25% of anti-spike IgG1 Fc were found to be afucosylated initially after administration of the first vaccine dose. However, the level decreased gradually with time.
In individuals with previous infection, about 2 – 10% of anti-spike IgG1 Fc were found to be afucosylated before vaccination. The level increased slightly after vaccination. The level of afucosylated anti-spike antibodies remained significantly lower in previously infected individuals after vaccination compared to that in naïve individuals
https://www.biorxiv.org/content/10.1101/2022.02.14.480353v1
Long-lived macrophage reprogramming drives spike protein-mediated inflammasome activation in COVID-19
https://www.embopress.org/doi/full/10.15252/emmm.202114150
Trials
Pfizer Clinical Trial-FDA
https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf#page45
Pfizer Clinical Trial-EMA
Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
https://www.bmj.com/content/375/bmj.n2635
5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021
BNT162B2
[COMIRNATY (COVID-19 VACCINE, MRNA)]
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE BRIEFING DOCUMENT Meeting Date: 26 October 2021
https://www.fda.gov/media/153409/download
PFIZER-BIONTECH COVID-19 VACCINE (BNT162, PF-07302048) VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE BRIEFING DOCUMENT
MEETING DATE: 10 December 2020
https://www.fda.gov/media/144246/download
Summary Basis for Regulatory Action
Date:
11/8/2021
https://www.fda.gov/media/151733/download
Vaccines and Related Biological Products Advisory Committee Meeting September 17, 2021
FDA Briefing Document
Application for licensure of a booster dose for COMIRNATY (COVID-19 Vaccine, mRNA)
https://www.fda.gov/media/152176/download
Covid-19 vaccines: In the rush for regulatory approval, do we need more data?
https://www.bmj.com/content/373/bmj.n1244
Avoiding the Subject: On Pfizer Vaccine Quality Control, FDA Says Less than European Counterpart
SUMMARY OF CLINICAL EFFICACY
Nonclinical Evaluation Report
BNT162b2 [mRNA] COVID-19 vaccine (COMIRNATYTM)
https://www.tga.gov.au/sites/default/files/foi-2389-06.pdf
Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine
https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1.full-text
Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products
https://www.fda.gov/media/89036/download
A prefusion SARS-CoV-2 spike RNA vaccine is highly immunogenic and prevents lung infection in non-human primates
https://www.biorxiv.org/content/10.1101/2020.09.08.280818v1.full.pdf
Reverse Engineering the source code of the BioNTech/Pfizer SARS-CoV-2 Vaccine
https://berthub.eu/articles/posts/reverse-engineering-source-code-of-the-biontech-pfizer-vaccine/
DNA
No evidence of human genome integration of SARS- CoV-2 found by long-read DNA sequencing
SARS-CoV-2 RNA reverse-transcribed and integrated into the human genome
https://www.biorxiv.org/content/10.1101/2020.12.12.422516v1.full.pdf
SARS–CoV–2 Spike Impairs DNA Damage Repair and Inhibits V(D)J Recombination In Vitro
https://mdpi-res.com/d_attachment/viruses/viruses-13-02056/article_deploy/viruses-13-02056-v2.pdf
Testing
False-positive COVID-19 results: hidden problems and costs
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30453-7/fulltext
Correlation Between 3790 Quantitative Polymerase Chain Reaction–Positives Samples and Positive Cell Cultures, Including 1941 Severe Acute Respiratory Syndrome Coronavirus 2 Isolates
It can be observed that at Ct = 25, up to 70% of patients remain positive in culture and that at Ct = 30 this value drops to 20%. At Ct = 35, the value we used to report a positive result for PCR, <3% of cultures are positive
https://academic.oup.com/cid/article/72/11/e921/5912603
Comparison and correlation of commercial SARS- CoV-2 real-time-PCR assays, Ireland, June 2020
Viral load and Ct values – How do we use quantitative PCR quantitatively?
https://chs.asu.edu/diagnostics-commons/blog/how-do-we-use-quantitative-tests-quantitatively
Understanding cycle threshold (Ct) in SARS-CoV-2 RT-PCR
cultures for COVID-19 infectious potential assessment – a systematic review
. Two studies reported the odds of live virus culture reduced by approximately 33% for every one unit increase in Ct. Six of eight studies reported detectable RNA for longer than 14 days but infectious potential declined after day 8 even among cases with ongoing high viral loads. Four studies reported viral culture from stool specimens.
Conclusion
Complete live viruses are necessary for transmission, not the fragments identified by PCR. Prospective routine testing of reference and culture specimens and their relationship to symptoms, signs and patient co-factors should be used to define the reliability of PCR for assessing infectious potential. Those with high cycle threshold are unlikely to have infectious potential.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7799320/pdf/ciaa1764.pdf
Duration of Culturable SARS-CoV-2 in Hospitalized Patients with Covid-19
SARS-CoV-2 was cultured in 29 of the 89 samples (33%) (Figure 1). The median time from symptom onset to viral clearance in culture was 7 days (95% confidence interval [CI], 5 to 10), and the median time from symptom onset to viral clearance on real-time RT-PCR was 34 days (lower boundary of the 95% CI, 24 days) (Fig. S1 and Table S4). The latest positive viral culture was 12 days after symptom onset (in Patient 6). Viable virus was identified until 3 days after the resolution in fever (in Patient 14). Viral culture was positive only in samples with a cycle-threshold value of 28.4 or less. The incidence of culture positivity decreased with an increasing time from symptom onset and with an increasing cycle-threshold value
https://www.nejm.org/doi/full/10.1056/NEJMc2027040
Viral RNA load as determined by cell culture as a management tool for discharge of SARS-CoV-2 patients from infectious disease wards
Correlation between successful isolation of virus in cell culture and Ct value of quantitative RT-PCR targeting E gene suggests that patients with Ct above 33–34 using our RT-PCR system are not contagious and thus can be discharged from hospital care or strict confinement for non-hospitalized patients.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7185831/
The performance of the SARS-CoV-2 RT-PCR test as a tool for detecting SARS-CoV-2 infection in the population
https://www.journalofinfection.com/article/S0163-4453(21)00265-6/fulltext#relatedArticles
Optimization of the CDC Protocol of Molecular Diagnosis of COVID-19 for Timely Diagnosisin Taiwan
https://www.mdpi.com/2075-4418/10/5/333/htm
Comparison and correlation of commercial SARS- CoV-2 real-time-PCR assays, Ireland, June 20
Treatments
Insights from a computational analysis of the SARS-CoV-2 Omicron variant: Host-pathogen interaction, pathogenicity, and possible therapeutics
https://arxiv.org/pdf/2201.08176.pdf
Attenuation of clinical and immunological outcomes during SARS-CoV-2 infection by ivermectin
https://www.embopress.org/doi/full/10.15252/emmm.202114122
Off-label’ drug use: an FDA regulatory term, not a negative implication of its medical use
the FDA has specifically stated that its procedures and requirements have no effect on the practice of medicine and that the FDA does not prohibit doctors from prescribing drugs in an ‘off-label’ manner. Second, the FDA's approval of a drug is immaterial to the effectiveness in the drug's ‘off-label’ use. In fact, prescribing medication in an ‘off-label’ manner can constitute the standard of care in many cases.
https://www.nature.com/articles/3901619
The Global Disinformation Campaign Against Ivermectin in COVID-19
Israeli scientist says COVID-19 could be treated for under $1/day
Interim Guidelines for Clinical Management of SARS-CoV-2 Infection (5th edition)
https://www.cdc.gov.tw/En/File/Get/_Dv_q75ZjLcNeRvlnrPgUg
Early Outpatient Treatment: An Essential Part of a COVID-19 Solution, Part II
Efficacy
Immunity/Vaccine Effectiveness
The Effectiveness of mRNA Vaccine Boosters for Laboratory-Confirmed COVID-19 During a Period of Predominance of the Omicron Variant of SARS-CoV-2
Results: The estimated effectiveness (95% confidence interval) during days 7 to 34 after a booster was 51.3% (50.2, 52.4) overall, higher for females and people aged 60-79. Estimated effectiveness was 52.5% (51.3, 53.7) for an mRNA-1273 booster and 46.2% (43.5, 48.7) for a BNT162b2 booster
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4035396
Early effectiveness of COVID-19 vaccination with BNT162b2 mRNA vaccine and ChAdOx1 adenovirus vector vaccine on symptomatic disease, hospitalisations and mortality in older adults in England
https://www.medrxiv.org/content/10.1101/2021.03.01.21252652v1.full.pdf
Estimating the effectiveness of the Pfizer COVID-19 BNT162b2 vaccine after a single dose.
After initial injection case numbers increased to day 8 before declining to low levels by day 21.
https://www.medrxiv.org/content/10.1101/2021.02.01.21250957v1.full.pdf
Vaccination results in a rise in covid infection rates for the first week or two before there is a fall.
https://www.hartgroup.org/it-gets-worse-before-it-gets-better/
Sage-increased infection/hospitalization after vax
400% increase in symptomatic covid from before vaccination to the day of vaccination, in the hospitalised population. They say:
“We observed an abundance of patients admitted to hospital within 7 days of vaccination “.
A separate study from Brazil, later published in the Lancet, showed a 69% higher rate of covid in vaccinated healthcare workers (HCWs) compared to the unvaccinated in the first 13 days after vaccination.
https://www.thelancet.com/journals/lanam/article/PIIS2667-193X(21)00017-X/fulltext#seccesectitle0017
Monoclonal not effective but booster dose (3rd shot or 1st shot in naturally infected recovered person ) is (briefly)
It is capable of spreading to individuals who have received two vaccine doses and to previously infected individuals.
Age-associated SARS-CoV-2 breakthrough infection and changes in immune response in a mouse model
Importantly, two-dose COVID-19 mRNA vaccination conferred limited adaptive immune response among the aged mice, making them susceptible to SARS-CoV-2 infection.
https://pubmed.ncbi.nlm.nih.gov/34989330/
Breakthrough infections with SARS-CoV-2 omicron despite mRNA vaccine booster dose
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00090-3/fulltext#sec1
Effectiveness of COVID-19 vaccines against Omicron or Delta symptomatic infection and severe outcomes
In contrast to high levels of protection against both symptomatic infection and severe outcomes caused by Delta, our results suggest that 2 doses of COVID-19 vaccines only offer modest and short-term protection against symptomatic Omicron infection. A third dose improves protection against symptomatic infection and provides excellent protection against severe outcomes for both variants.
https://doi.org/10.1101/2021.12.30.21268565
Omicron: 3 vaccine doses are not enough to stop the new COVID variant, warns BioNTech CEO
Breakthrough infections with SARS-CoV-2 omicron despite mRNA vaccine booster dose
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00090-3/fulltext#sec1
Increases in COVID‐19 are unrelated to levels of vaccination across 68 countries and 2947 counties in the United States
https://link.springer.com/content/pdf/10.1007/s10654-021-00808-7.pdf
Waning Immune Humoral Response
to BNT162b2 Covid-19 Vaccine over 6 Months
https://www.nejm.org/doi/pdf/10.1056/NEJMoa2114583?articleTools=true
Shedding of Infectious SARS-CoV-2 Despite Vaccination
https://www.medrxiv.org/content/10.1101/2021.07.31.21261387v4
Transmission of SARS-CoV-2 Delta Variant Among Vaccinated Healthcare Workers, Vietnam
Findings: Between 11th–25th June 2021 (week 7–8 after dose 2), 69 fully vaccinated healthcare workers were tested positive for SARS-CoV-2. 62 participated in the clinical study. 49 were (pre)symptomatic with one requiring oxygen supplementation. All recovered uneventfully.
Viral loads of breakthrough Delta variant infection cases were 251 times higher than those of cases infected with old strains detected between March-April 2020. Time from diagnosis to PCR negative was 8–33 days (median: 21).
Interpretation: Breakthrough Delta variant infections are associated with high viral loads, prolonged PCR positivity, and low levels of vaccine-induced neutralizing antibodies, explaining the transmission between the vaccinated people.
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3897733
Antibody Evolution after SARS-CoV-2 mRNA Vaccination
https://www.biorxiv.org/content/10.1101/2021.07.29.454333v1
Mortality Rates
COVID vaccination and age-stratified all-cause mortality risk
Vaccination correlated negatively with mortality 6-20 weeks post-injection, while vaccination predicted all-cause mortality 0-5 weeks post-injection in almost all age groups and with an age-related temporal pattern consistent with the US vaccine rollout. Results from fitted regression slopes (p<0.05 FDR corrected) suggest a US national average VFR of 0.04% and higher VFR with age
Young Adult Mortality in Israel (deleted from web)
New ICD code introduced for COVID-19 deaths to accurately capture mortality data for Coronavirus Disease 2019 (COVID-19) on death certificates.
Guidance for Certifying Deaths Due to Coronavirus Disease 2019 (COVID–19)
https://www.cdc.gov/nchs/data/nvss/vsrg/vsrg03-508.pdf
A LITERATURE REVIEW AND META-ANALYSIS
OF THE EFFECTS OF LOCKDOWNS ON
COVID-19 MORTALITY
Official mortality data for England suggest systematic miscategorisation of vaccine status and uncertain effectiveness of Covid-19 vaccination
All Cause Mortality in the United States During 2021
The CEO of the OneAmerica insurance company recentlydisclosedthat mortality in the 18-64 age group was 40 percent higher during the 3rd and 4th quarters of 2021 than during pre-pandemic levels. For reference, the CEO indicated that a 10 percent increase would have been a 1-in-200-year event. Furthermore, most of the deaths were not attributed to Covid.
https://www.aier.org/article/all-cause-mortality-in-the-united-states-during-2021/
3,440,550 deaths of all ages for the year 2020. Expected deaths were 3,028,959. That is an increase of 411,591 deaths (+13.6%).
United States reported 3,459,886 deaths of all ages for the year 2021. Expected deaths were 2,971,452. That is an increase of 488,434 deaths (+16.4%).
https://www.usmortality.com/excess-absolute
Monitoring Adverse Events -Deaths and COVID cases-deaths/All cause Mortality
Covid hospitalizations overstated
With vs from
Our Most Reliable Pandemic Number Is Losing Meaning
A new study suggests that almost half of those hospitalized with COVID-19 have mild or asymptomatic cases.
10/26/2020 COVID INFECTION FATALITY RATES
https://www.evergreenfamilymedicine.com/post/10-26-2020-covid-infection-fatality-rates
FDA Is struggling to start up its comprehensive monitoring system for Vaccinations
CBER Biologics Effectiveness and Safety (BEST) System
CDC Data delay
Taiwan Household Registration Stats
https://www.ris.gov.tw/app/en/2121?sn=1586485228128&p=2
CDC Provisional Death Counts for Coronavirus Disease 2019
https://www.cdc.gov/nchs/nvss/vsrr/covid19/index.htm
Taiwan COVID stats
https://covid-19.nchc.org.tw/index.php
COVID Disease Pathology
Omicron’s feeble attack on the lungs could make it less dangerous
https://www.nature.com/articles/d41586-022-00007-8
https://www.medrxiv.org/content/10.1101/2021.12.24.21268382v2.full.pdf
Cdc
Persistence of SARS CoV-2 S1 Protein in CD16+ Monocytes in Post-Acute Sequelae of COVID-19 (PASC) Up to 15 Months Post-Infection
https://www.biorxiv.org/content/10.1101/2021.06.25.449905v1.full
High-dimensional characterization of post-acute sequelae of COVID-19
https://www.nature.com/articles/s41586-021-03553-9.pdf
Long COVID symptoms and duration in SARS‐CoV‐2 positive children — a nationwide cohort study
Conclusions: Long COVID in children is rare and mainly of short duration.
https://link.springer.com/content/pdf/10.1007/s00431-021-04345-z.pdf
Circulating multimeric immune complexes drive immunopathology in COVID-19
Here, we document that patients who develop soluble circulating IgG immune complexes (sICs) during infection are subject to enhanced immunopathology driven by FcγR activation
https://www.biorxiv.org/content/10.1101/2021.06.25.449893v4
PANDEMIC mitigation Measures
COVID-19 Aerosolized Viral Loads, Environment, Ventilation, Masks, Exposure Time, Severity, And Immune Response: A Pragmatic Guide Of Estimates
https://www.medrxiv.org/content/10.1101/2020.10.03.20206110v6.full
https://www.nber.org/system/files/working_papers/w28930/w28930.pdf
Miscellaneous
GENERAL PRINCIPLES TO ADDRESS VIRUS AND VECTOR SHEDDING
mRNA Vaccine Era—Mechanisms, Drug Platform and Clinical Prospection
https://res.mdpi.com/d_attachment/ijms/ijms-21-06582/article_deploy/ijms-21-06582.pdf
Sequencing 101: why are long reads important for studying viral genomes?
https://www.pacb.com/blog/long-reads-for-studying-viral-genomes/
Sequencing 101: the evolution of DNA sequencing tools
https://www.pacb.com/blog/the-evolution-of-dna-sequencing-tools/
Development of mRNA Vaccines: Scientific and Regulatory Issues
there remain gaps in our understanding of the mechanism of action of mRNA vaccines, as well as their long-term performance in areas such as safety and efficacy.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7910833/#__ffn_sectitle
Baric Resume
Measles virus-induced suppression of immune responses
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2908915/
Mit Study on vaccine hesitancy
https://arxiv.org/pdf/2101.07993.pdf
Lipid Nanoparticles as Delivery Systems for RNA-Based Vaccines
Wellcome Trust invests £27m in world-class sequencing facility for Genomics England and Sanger Institute
https://wellcome.org/press-release/wellcome-trust-invests-£27m-world-class-sequencing-facility-genomics-england-and
Advisory on Prep Act
The PREP Act and COVID-19: Limiting Liability for Medical Countermeasures
https://crsreports.congress.gov/product/pdf/LSB/LSB10443
When technocracy replaces democracy-Taiwan
https://www.policyforum.net/when-technocracy-replaces-democracy/
https://www.pnas.org/doi/10.1073/pnas.1410465111
http://book.bionumbers.org/how-many-proteins-are-made-per-mrna-molecule/
The Hallmarks of Aging
https://www.cell.com/cell/fulltext/S0092-8674(13)00645-4
What Explains Rising Cases Among the Vaccinated
https://www.ukcolumn.org/article/what-explains-rising-cases-among-the-vaccinated
Covid Vaccines and Cancer
https://swprs.org/covid-vaccines-and-cancer/
30 facts you NEED to know: Your Covid Cribsheet
https://off-guardian.org/2021/09/22/30-facts-you-need-to-know-your-covid-cribsheet/
KO WEN-JE COMES UNDER SCRUTINY OVER LONG-TERM CLUSTERS IN TAIPEI
https://newbloommag.net/2021/06/23/ko-clusters-taipei/
Rockefeller Foundation released “Accelerating National Genomic Surveillance,”
Four New Scientific Discoveries Regarding COVID-19 Immunity and Vaccines – Implications for Safety and Efficacy
CONSPIRACY
WIV databases taken off line
COVID-19 Data Collection, Comorbidity & Federal Law: A Historical Retrospective
Uncanny similarity of unique inserts in the 2019-nCoV spike protein to HIV-1 gp120 and Gag
https://www.biorxiv.org/content/10.1101/2020.01.30.927871v1.full.pdf
mRNA “Vaccines”, Eugenics & the Push for Transhumanism
https://off-guardian.org/2021/08/28/mrna-vaccines-eugenics-the-push-for-transhumanism/
https://childrenshealthdefense.org/wp-content/uploads/2021-08-26-Letter-to-FDA-re-Comirnaty.pdf
Oppressive COVID Measures for the Unvaccinated Were Based on ‘Software’ Error, Claims German Minister.
Project G-2101: Pentagon biolab discovered MERS and SARS-like coronaviruses in bats
Wuhan lab infected 'humanized mice' with bat coronaviruses in 2019
https://www.taiwannews.com.tw/en/news/4099020
Looks like the Coronavirus may have been created in a lab
https://fitfortis.com/newsfeed/383d8b7d-324d-4914-7a38-08d81e554566?lang=en
Gain-of-Function’ Hall of Shame
https://www.organicconsumers.org/campaigns/covid-19/gain-of-function-hall-of-shame
Pandemic Profiteers
Public health nonfeasance, misfeasance and malfeasance in the U.S. government response to COVID-19
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7657019/
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