So you say "Dr. Alexander, you keep raising concern about the vaccines, where is the proof? Is there any evidence? Anything, a study or two besides what you, McCullough, Malone, Tenenbaum, Risch say?
para "Do you have anything Sir? You scientists and clinicians are raising concerns but give us something to work with"...well, ok, see these near 1,000 studies/pieces of evidence, to start...
Adverse effects of COVID-19 vaccines and measures to prevent them - Virology Journal
Recently, The Lancet published a study on the effectiveness of COVID-19 vaccines and the waning of immunity with time. The study showed that immune function among vaccinated individuals 8 months after the administration of two doses of COVID-19 vaccine was lower than that among the unvaccinated individuals. According to European Medicines Agency recommendations, frequent COVID-19 booster shots could adversely affect the immune response and may not be feasible. The decrease in immunity can be caused by several factors such as N1-methylpseudouridine, the spike protein, lipid nanoparticles, antibody-dependent enhancement, and the original antigenic stimulus. These clinical alterations may explain the association reported between COVID-19 vaccination and shingles. As a safety measure, further booster vaccinations should be discontinued. In addition, the date of vaccination should be recorded in the medical record of patients. Several practical measures to prevent a decrease in immunity have been reported. These include limiting the use of non-steroidal anti-inflammatory drugs, including acetaminophen to maintain deep body temperature, appropriate use of antibiotics, smoking cessation, stress control, and limiting the use of lipid emulsions, including propofol, which may cause perioperative immunosuppression. In conclusion, COVID-19 vaccination is a major risk factor for infections in critically ill patients.
Prion-like Domains in Spike Protein of SARS-CoV-2 Differ across Its Variants and Enable Changes in Affinity to ACE2 - PubMed
Currently, the world is struggling with the coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Prions are proteins that possess a unique conformational conversion, with the ability to rapidly shift between multiple conformations due …
The emergence of a new form of the neurodegenerative creutzfeldt jakob disease: 26 cases of cjd declared a few days after a covid 19 vaccine jab (Pfizer, Moderna, AZ). Preprint
View of SARS-CoV2 Breakthrough Infections in Elderly Third Booster and Vaccinated Population Considered Vaccine Immune During Omicron (B.1.1.529)Variant Surge in Israel
After the 4th booster dose... significant increase in breakthrough infections were associated with substantially increased severely illness substantially increased percentage of deaths during the December 5, 2021 to January 29, 2021 period. During the same period, we observed signifi-cantly decreased infection rates among “vaccinated without validity” (considered to have no reliable vaccine immunity per vaccination policy) and a trend toward decreased percentages of severely illness and deaths.
Occurrence and transmission potential of asymptomatic and presymptomatic SARS-CoV-2 infections: Update of a living systematic review and meta-analysis
Diana Buitrago-Garcia and co-workers update a living systematic review and meta-analysis on occurrence and transmission of asymptomatic SARS-CoV-2 infections.
Suppressing Scientific Discourse on Vaccines? Self-perceptions of researchers and practitioners
HEC Forum - The controversy over vaccines has recently intensified in the wake of the global COVID-19 pandemic, with calls from politicians, health professionals, journalists, and citizens to take...
Two departing FDA leaders among scientists who say Covid-19 vaccines do not currently 'show a need for boosting'
The current evidence on Covid-19 vaccines does not appear to support a need for booster shots in the general public right now, according to an international group of vaccine scientists, including some from the US Food and Drug Administration and the World Health Organization.
Association of Cerebral Venous Thrombosis with mRNA COVID-19 Vaccines: A Disproportionality Analysis of the World Health Organization Pharmacovigilance Database
Cerebral venous thrombosis (CVT), a rare thrombotic event that can cause serious neurologic deficits, has been reported after some ChAdOx1 nCoV-19 vaccinations against coronavirus disease 2019 (COVID-19). However, there are few reports of associations between COVID-19 mRNA vaccination and CVT. We retrospectively analyzed CVT occurrence, time of onset after vaccination, outcomes (recovered/not recovered), and death after COVID-19 vaccination from adverse drug reactions (ADR) reports in VigiBase. A disproportionality analysis was performed regarding COVID-19 mRNA vaccines (BNT162b2 and mRNA-1273) and the ChAdOx1 nCoV-19 vaccine. We identified 756 (0.07%) CVT cases (620 (0.05%) after BNT162b2 and 136 (0.01%) after mRNA-1273) of 1,154,023 mRNA vaccine-related ADRs. Significant positive safety signals were noted for COVID-19 mRNA vaccines (95% lower end of information component = 1.56; reporting odds ratio with 95% confidence interval (CI) = 3.27). The median days to CVT onset differed significantly between the BNT162b2 and ChAdOx1 nCoV-19 vaccines (12 (interquartile range, 3–22) and 11 (interquartile range, 7–16), respectively; p = 0.02). Fewer CVT patients died after receiving mRNA vaccines than after receiving the ChAdOx1 nCoV-19 vaccine (odds ratio, 0.32; 95% CI, 0.22–0.45; p 0.001). We noted a potential safety signal for CVT occurrence after COVID-19 mRNA vaccination. Therefore, awareness about the risk of CVT, even after COVID-19 mRNA vaccination, is necessary.
Anti-nucleocapsid antibodies following SARS-CoV-2 infection in the blinded phase of the mRNA-1273 Covid-19 vaccine efficacy clinical trial
Importance The performance of immunoassays for determining past SARS-CoV-2 infection, which were developed in unvaccinated individuals, has not been assessed in vaccinated individuals. Objective To evaluate anti-nucleocapsid antibody (anti-N Ab) seropositivity in mRNA-1273 vaccine efficacy trial participants after SARS-CoV-2 infection during the trial’s blinded phase. Design Nested analysis in a Phase 3 randomized, placebo-controlled vaccine efficacy trial. Nasopharyngeal swabs for SARS-CoV-2 PCR testing were taken from all participants on Day 1 and Day 29 (vaccination days), and during symptom-prompted illness visits. Serum samples from Days 1, 29, 57, and the Participant Decision Visit (PDV, when participants were informed of treatment assignment, median day 149) were tested for anti-N Abs. Setting Multicenter, randomized, double-blind, placebo-controlled trial at 99 sites in the US. Participants Trial participants were ≥ 18 years old with no known history of SARS-CoV-2 infection and at appreciable risk of SARS-CoV-2 infection and/or high risk of severe Covid-19. Nested sub-study consists of participants with SARS-CoV-2 infection during the blinded phase of the trial. Intervention Two mRNA-1273 (Moderna) or Placebo injections, 28 days apart. Main Outcome and Measure Detection of serum anti-N Abs by the Elecsys (Roche) immunoassay in samples taken at the PDV from participants with SARS-CoV-2 infection during the blinded phase. The hypothesis tested was that mRNA-1273 recipients have different anti-N Ab seroconversion and/or seroreversion profiles after SARS-CoV-2 infection, compared to placebo recipients. The hypothesis was formed during data collection; all main analyses were pre-specified before being conducted. Results We analyzed data from 1,789 participants (1,298 placebo recipients and 491 vaccine recipients) with SARS-CoV-2 infection during the blinded phase (through March 2021). Among participants with PCR-confirmed Covid-19 illness, seroconversion to anti-N Abs at a median follow up of 53 days post diagnosis occurred in 21/52 (40%) of the mRNA-1273 vaccine recipients vs. 605/648 (93%) of the placebo recipients (p 0.001). Higher SARS-CoV-2 viral copies at diagnosis was associated with a higher likelihood of anti-N Ab seropositivity (odds ratio 1.90 per 1-log increase; 95% confidence interval 1.59, 2.28). Conclusions and Relevance As a marker of recent infection, anti-N Abs may have lower sensitivity in mRNA-1273-vaccinated persons who become infected. Vaccination status should be considered when interpreting seroprevalence and seropositivity data based solely on anti-N Ab testing Trial Registration [ClinicalTrials.gov][1] [NCT04470427][2] Question Does prior mRNA-1273 vaccination influence anti-nucleocapsid antibody seroconversion and/or seroreversion after SARS-CoV-2 infection? Findings Among participants in the mRNA-1273 vaccine efficacy trial with PCR-confirmed Covid-19, anti-nucleocapsid antibody seroconversion at the time of study unblinding (median 53 days post diagnosis and 149 days post enrollment) occurred in 40% of the mRNA-1273 vaccine recipients vs. 93% of the placebo recipients, a significant difference. Higher SARS-CoV-2 viral copy number upon diagnosis was associated with a greater chance of anti-nucleocapsid antibody seropositivity (odds ratio 1.90 per 1-log increase; 95% confidence interval 1.59, 2.28). All infections analyzed occurred prior to the circulation of delta and omicron viral variants. Meaning Conclusions about the prevalence and incidence of SARS-CoV-2 infection in vaccinated persons based on anti-nucleocapsid antibody assays need to be weighed in the context of these results. ### Competing Interest Statement All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf. H.E.J. declares support in the form of grants (paid to her institution) from the National Institutes of Health for the submitted work and within the past 36 months, as well as support from a scientific writer/technical editor (independently contracted with her institution) for the submitted work and within the past 36 months. H.Z. is an employee of Moderna Inc. (sponsor of the mRNA-1273-P301 study) and owns Moderna stocks/stock options. B.G. is an employee of Moderna Therapeutics. K.M. declares support from Gilead Sciences, paid to her institution, within the past 36 months for the conduct of phase 3 remdesivir studies for COVID-19 treatment. K.K. declares support in the form of grants (paid to her institution) from the National Institutes of Health within the past 36 months for the conduct of a trial of Novavax's COVID-19 vaccine. L.C. declares support in the form of grants (paid to his institution) from the National Institutes of Health for the submitted work. K.M.N. declares support to her institution (but no salary support) for her role as an investigator on the Phase 1 trial of the Pfizer Covid-19 mRNA vaccine, and also declares salary support from the NIH for her role in co-leading the Coronavirus Prevention Network, which included work on multiple Phase 3 efficacy studies, including the study of the mRNA-1273 vaccine. K.M.N. also serves on a DSMB for a phase-1, open-label, ascending dose evaluation of a live, recombinant Newcastle disease virus expressing the spike protein of SARS-CoV-2 (NDV-HXP-S) sponsored by Icahn School of Medicine at Mount Sinai, is on the Board of Directors for the National Foundation for Infectious Diseases, and is a member of the WHO Strategic Advisory Group of Experts on Immunization (SAGE). J.M.M. is an employee of Moderna and has stock options/grants in Moderna. H.M.E.S. declares support (in the form of grants paid to her institution) from the National Institutes of Health for the submitted work. L.R.B. declares support (in the form of grants paid to his institution) from the National Institutes of Health/National Institute of Allergy and Infectious Diseases (NIH/NIAID) for the conduct of this study as well as grants (paid to his institution) within the last 36 months from NIH/NIAID, Gates Foundation, the Ragon Institute, and Wellcome Trust, outside the submitted work. L.R.B. is involved in HIV, other pathogens, and COVID vaccine clinical trials conducted in collaboration with the NIH, HIV Vaccine Trials Network (HVTN), COVID Vaccine Prevention Network (CoVPN), International AIDS Vaccine Initiative (IAVI), Crucell/Janssen, Moderna, Military HIV Research Program (MHRP), Gates Foundation, and the Ragon Institute. All other authors declare no support from any organization for the submitted work, no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years, and no other relationships or activities that could appear to have influenced the submitted work. ### Funding Statement This study was supported by the National Institutes of Health/National Institute of Allergy and Infectious Diseases through grants UM1AI068635 (to H.E.J.), UM1AI068614 (to L.C.), 3UM1Al148575-01S2 (to H.M.E.S.), and UM1AI069412 (to L.R.B.). The mRNA-1273-P301 study is sponsored by Moderna, Inc. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The mRNA-1273-P301 study is being conducted in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practice guidelines, and applicable government regulations. The Central Institutional Review Board approved the mRNA-1273-P301 protocol and the consent forms. All participants provided written informed consent before enrollment. Central IRB services for the mRNA-1273-P301 study were provided by Advarra, Inc., 6100 Merriweather Dr., Suite 600, Columbia, MD 21044. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes As the trial is ongoing, access to participant-level data and supporting clinical documents with qualified external researchers may be available upon request and is subject to review once the trial is complete. [1]: http://ClinicalTrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04470427&atom=%2Fmedrxiv%2Fearly%2F2022%2F04%2F19%2F2022.04.18.22271936.atom
Myocarditis-induced Sudden Death after BNT162b2 mRNA COVID-19 Vaccination in Korea: Case Report Focusing on Histopathological Findings - PubMed
We present autopsy findings of a 22-year-old man who developed chest pain 5 days after the first dose of the BNT162b2 mRNA vaccine and died 7 hours later. Histological examination of the heart revealed isolated atrial myocarditis, with neutrophil and histiocyte predominance. Immunohistochemical C4d …
Fit-tested N95 masks combined with portable HEPA filtration can protect against high aerosolized viral loads over prolonged periods at close range
AbstractBackground. Healthcare workers (HCWs) are at risk from aerosol transmission of SARS-CoV-2. Aims: to 1) quantify the protection provided by masks (surgic
Peer Reviewed Medical Papers Submitted To Various Medical Journals, Evidencing A Multitude Of Adverse Events In Covid-19 Vaccine Recipients. Myocarditis after mRNA vaccination against SARS-CoV-2, a case series: https://www.sciencedirect.com/science/article/pii/S2666602221000409 Myocarditis after immunization with COVID-19 mRNA vaccines in members of the US military. This article reports that in “23 male patients, including 22 previously healthy military members, myocarditis was identified within
Calf-Level Factors Associated with Bovine Neonatal Pancytopenia – A Multi-Country Case-Control Study
Bovine neonatal pancytopenia (BNP), a high fatality condition causing haemorrhages in calves aged less than 4 weeks, was first reported in 2007 in Germany and subsequently observed at low incidence in other European countries and New Zealand. A multi-country ...