I take issue with the conclusions of a paper published in the peer-reviewed journal Science of the Total Environment under the title “Managing an evolving pandemic: Cryptic circulation of the Delta variant during the Omicron rise.”
These authors tend to believe that wastewater-based epidemiology combined with mathematical modeling allows for making predictions in regard of the evolutionary dynamics of this pandemic:
“According to the developed model, it can be expected that the Omicron levels will decrease until eliminated, while Delta variant will maintain its cryptic circulation. If this comes to pass, the mentioned cryptic circulation may result in the reemergence of a Delta morbidity wave or in the possible generation of a new threatening variant.”
One should – per definition – always be careful and skeptical about conclusions and predictions proposed by scientists who don’t seem to have an in-depth understanding of the immunology involved!
Variants can only replace previous variants provided they have a higher level of INTRINSIC infectiousness! It’s not because Omicron is highly infectious in vaccinees (i.e., in the vast majority of highly vaccinated population such as the population of Israel) that Omicron will replace Delta in wastewater! It has been published that diminished neutralizing capacity of anti-spike (S) antibodies (Abs)results in disproportionally high binding of non-neutralizing Abs to S-NTD (N-terminal domain of S protein), which explains enhanced susceptibility of vaccinees to breakthrough infection with Omicron but inhibits viral shedding and trans infection of Omicron at distant organs, including the lower respiratory and gastrointestinal tract, thereby reducing the incidence of severe disease in vaccinees (…). So, in other words, Ab-mediated enhancement of infection with Omicron in vaccinees does not translate into enhanced viral shedding from the gastrointestinal tract, which is the primary source of wastewater contamination. On the other hand, diminished shedding in vaccinees is likely compensated by its prolonged duration due to a delay in viral clearance (…). Selective shedding of highly infectious Omicron in vaccinees causes Omicron detection levels in wastewater to rapidly increase to then level off at wastewater detection levels that are higher than those observed for Delta. However, as the amount of Omicron virus shed from the gastrointestinal tract of vaccinees is not determined by the level of Omicron infectiousness in these vaccinated individuals but by the percentage of the population that got vaccinated and because Omicron’s intrinsic infectiousness is similar to that of Delta and, therefore, shed in comparable amounts by the non-vaccinated fraction of the population, it is not surprising to find that – although shed at a somewhat higher concentration in a highly vaccinated population – the Omicron variant is not replacing the Delta variant unless the population were to become vaccinated across all age groups (i.e., including children). Consequently, wastewater-based epidemiology does not supply a real-time image of viral infectivity / transmissibility in highly vaccinated populations as viral infectious behavior in such populations is not primarily determined by the intrinsic infectiousness of the viral variant but by Ab-mediated enhancement of viral infection in vaccinees.
In conclusion, monitoring of Delta and Omicron detection levels in wastewater restricts surveillance of prevalent variants to virus shed from the gastrointestinal tract and thereby ignores antibody-mediated mitigation of shedding. It, therefore, misrepresents differences in viral infectiousness, which is known to be very high for Omicron in a highly vaccinated population due to Ab-dependent enhancement of infection at the level of the upper respiratory tract.
Once again, mathematical modeling may be a challenging and fascinating exercise but is to be considered totally worthless when the immunological assumptions are wrong. It inevitably implies that the essence of the model predictions will also be wrong. There can be no doubt that population-level immune pressure on trans infection-inhibiting Abs is now paving the way for breeding variants that are not only highly infectious but also highly virulent in vaccinees. However, in contrast to what the authors of this publication believe, these new variants will not emerge from previous Delta variants. Delta does not enable highly vaccinated populations (e.g., the Israeli population) to exert immune pressure on viral virulence, simply because it is not fully resistant to potentially neutralizing anti-RBD Abs. So, please forget about any predictions derived from mathematical modeling that – despite lots of complexity – totally ignores the impact of population-level immune pressure on the infectious behavior of the virus. Such predictions are, of course, completely useless when it comes to understanding the evolutionary dynamics and management of a pandemic that has fully changed its natural course as a direct consequence of mass vaccination.
This is the second instalment of Paula Jardine’s five-part investigation into the planning behind ensuring vaccine acceptance and countering vaccine ‘hesitancy’. You can read Part 1, published yesterday, here.
IN 2010, as GAVI, the Global Alliance for Vaccines and Immunisations (now called The Vaccine Alliance) was setting out on its ambitious ten-year strategic plan called the Decade of the Vaccine, Dr Heidi Larson, a professor of anthropology, risk and decision science, set up the ‘Vaccine Confidence Project’ at the London School of Hygiene and Tropical Medicine. It was funded by vaccine manufacturers and their European lobby group in conjunction with the European Commission, UNICEF and University College London. The ubiquitous Bill and Melinda Gates Foundation is unusually absent from this list. The project’s purpose was to challenge vaccine scepticism.
With the number of approved vaccines on national immunisation schedules increasing and with dozens of new vaccines in the pipeline, GAVI’s game plan had become ‘demand generation’, in other words getting people actively to seek out vaccination (the intention being for people to create bottom-up pressure on their governments). Strategic Objective 2 of the Global Vaccine Action Plan (GVAP), the implementation plan for the Decade of the Vaccine, which remains today, is that ‘individuals and communities understand the value of vaccines and demand immunisation as both their right and responsibility.’
The GVAP reframing of vaccination in terms of rights and responsibilities transforms vaccination from an individual (private) medical choice (even in the context of a national public health programme) into a civic rights issue, pitting choice against a (spurious) socio-political ordinance. Writing on her blog, Larson explains, ‘Immunisation, since its beginning, has always walked a tense line between individual rights to choice and societal rights to health. A tense line between rights and responsibilities – the right to choose, with the caveat that it does not injure those around you.’
The principal value of this utilitarian collectivist perspective is that it displaces, for ‘the greater good’ (as defined by certain elites), the well-established medical ethics principle that the benefit of a procedure to each individual recipient must outweigh the risk. The assumption here is that for an act to be morally right it has to be judged only on its consequences for the majority. And since vaccines are supposed to induce immunity and consequently prevent transmission of infectious diseases, mass vaccination in pursuit of disease eradication must be for the greater good. As the utilitarians say, the end justifies the means.
Winning confidence in vaccines, which means winning trust in their safety and efficacy, is therefore imperative. From the health system administering them to the motives of the policy makers, this is the requisite of demand generation. When and where this fails has been dubbed ‘hesitancy’, the reluctance or refusal to be vaccinated despite the availability of vaccines (as though vaccines were, per se and in all circumstances, an unquestionable good regardless of the chequered history of many). According to a World Health Organisation working group report, ‘As hesitancy undermines demand, to achieve the GVAP defined vaccine demand goal, countries will need to address hesitancy. High rates of hesitancy mean low demand.’
Vaccines have been recognised by courts in the US, including its Supreme Court, as unavoidably unsafe products. However, based on the precedent of smallpox eradication, public health agencies such as the Centers for Disease Control and Prevention (CDC) remain determined to use vaccination to eradicate diseases and therefore argue that the overall value of vaccines to the community outweighs the risk to any single individual.
Diseases are no longer just diseases, we’re told they’re vaccine preventable diseases. Evidence in the medical literature of people who fail to respond to vaccination (primary failure) or of waning protection following vaccination (secondary failure) is simply ignored. The single greater good concept has provided the justification for mandatory vaccination and, in Covid times, for restricting the freedoms of those who exercise their right to bodily autonomy by refusing a medical procedure. Those unlucky enough to be injured or die from vaccine administration are what the American bioethicist Dr Leroy Walters has called ‘injured recruits in the war on infectious disease’.
Despite the rationale that society benefits from universal vaccination, the burden of vaccine injury is largely borne by individuals. It’s now standard practice for vaccine manufacturers to bear no liability for their products. The precedent of indemnification was set by the ill-fated 1976 US swine flu vaccination campaign when the US government stepped in because insurers balked. It paid out almost as much in compensation for vaccine injuries as it spent on the programme, thanks to an active surveillance reporting system for vaccine injuries. Active surveillance has never been repeated. Today only 27 countries have compensation programmes for vaccine injuries, a small improvement on the dozen that had them when GAVI was created in 1999. As for the rest, their injured citizens are collateral damage in the Rockefeller-conceived War on Microbes.
Google will be integrating digital ID cards and proof of vaccination cards into a new Google Wallet app that’s set to be released in a few weeks.
Google revealed the new digital wallet app at its Google I/O ‘22 keynote. Sameer Samat, Google’s Vice President of Product Management, said the tech giant is working with US states and governments around the world to bring digital IDs to Google Wallet and that driver’s licenses will be the first type of ID to be digitized in the app.
Samat noted that items with highly personal information, such as vaccine cards, are stored on device and “not shared with anyone, not even Google.”
When it started digitizing driver’s licenses, Apple insisted that users could present their ID without needing to unlock, show, or hand over their device. Samat made similar claims at Google I/O ‘22 and said users can share information from driver’s licenses that are stored in Google Wallet without having to give the phone to another person by either using near-field communication (NFC) or a quick response (QR code).
The blitzkrieg culminates with a “Future Framework” to automatically deem all reformulated Covid-19 shots as “safe and effective” WITHOUT further clinical trials
I. FDA goes full Shock & Awe in the attempt to get several toxic shots authorized in quick succession
In a little noticed article in theWashington Post, the FDA revealed that they are going to hold FIVE meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in June. FIVE! The meetings have not been officially announced on the FDA website yet but the best guess at this point is as follows:
June 7, Novavax in adults
June 8, Moderna in adolescents (delayed for a year because of myocarditis concerns)
June 21, Moderna in kids <6
June 22, Pfizer in kids <5
June 28, “Future Framework” for Covid-19 shots
This is very troubling. It means that the FDA is shifting into Shock & Awe military strategy to try to push through five authorizations in quick succession — so that the public does not have time to think and react. This is not the proper way to do science, it is an attack on democracy, and if they succeed, the FDA will kill and injure millions of American for years to come.
Let’s talk about what we know about each of these shots and then talk about what we can do to stop the FDA from destroying our country.
II. Novavax is terrible and useless
Novavax is a protein subunit vaccine. Fellow Substacker Robyn Chuter has done the best deep dive that I’ve seen on Novavax:
Robyn reviewed 3 Novavax clinical trials and the results are always terrible:
• No reductions in hospitalizations.
• No reductions in deaths.
• Tiny absolute risk reduction for a couple months (and then, after six months, the control group gets injected too so there is no long term data).
• Significant risk of adverse events in the vaccinated group.
This is not a surprise. The SARS-CoV-2 virus was never a good candidate for a vaccine (in the same way that HIV and the common cold have never had a successful vaccine in spite of decades of efforts). Recombinant proteins are not safer nor more effective than mRNA — they just fails in different ways. Novavax also uses a proprietary new adjuvant, “Matrix M”, that is not well studied.
III. Moderna mRNA shots in adolescents and kids are useless and terrible
A few days ago, I did a deep dive into the problems with the Moderna mRNA shot in kids. To summarize briefly:
• The Moderna application to inject adolescents has been held up since June 2021, because the Moderna shot increases the risk of myocarditis.
• Finland, Sweden, Denmark, and Norway have all suspended the use of the Moderna mRNA shot in teenagers because it leads to myocarditis. Finland and Sweden even suspended its use in men under 30 years old.
• We have no data from the Moderna clinical trial in kids younger than 12 other than selective leaks to the NY Times. But we know that even with Moderna rigging the trials, the shot made no difference on clinically significant outcomes including infection, hospitalization, ICU visits, or death.
However the Moderna shot did cause fevers in 15% to 17% of kids and fevers over 104 degrees in 0.2% of kids (which, if you multiply that by the 18 million kids they want to inject = 36,000 kids with potentially permanent neurological injury from a shot that provides no benefit).
IV. Pfizer mRNA shots in kids under 5 are useless and terrible
I’ve done severalarticles on the dangers of Pfizer mRNA shots in kids under 5. To summarize briefly:
• There is no Covid emergency for children under five years old. The CDC’s own research shows that 74.2% of kids 0-11 already had natural immunity. That was as of February 2022 — by now the number is probably closer to 100%.
• The Pfizer mRNA shot does not work very well in kids. The Pfizer clinical trial in kids 6 months to four years old failed in December 2021 and failed again in February 2022. A study by the NY State Department of Health shows that against the Omicron variant, after one month the Pfizer shot was only 12% effective in kids 5 to 11. After 6 weeks, vaccine effectiveness was a shocking MINUS 41% (vaccinated children were significantly more likely to catch Covid than the unvaccinated).
• The harms from the Pfizer mRNA shot in children are catastrophic. There are now 47,736 VAERS reports of adverse events in children following Covid-19 shots. These reports likely understate harms by a factor of 41 to 100. There are numerousreports of fatalities in children following Covid-19 shots (including reports that mysteriously disappear).
V. The FDA’s proposed “Future Framework” for Covid-19 Vaccines is the worst idea in the history of public health
The “Future Framework” is how the FDA plans to rig the process in perpetuity. The “Future Framework” will take the” “flu strain selection process” that is used every year — and apply it to future (reformulated) Covid-19 shots.
Manufacturers love this because then all future Covid-19 shots will be deemed automatically “safe and effective” WITHOUT FURTHER CLINICAL TRIALS because they are “biologically similar” to existing Covid-19 shots.
This approach does not work with the flu shot (last year the flu shot was somewhere between 0% and 14% effective) and it will not work with Covid-19 shots either.
Moderna is already signaling that they want to manufacture a Covid-19 shot with Wuhan and Beta strains — even though neither strain is still in widespread circulation.
If the “Future Framework” is approved, there will be no future clinical trial data submitted to the FDA in connection with Covid-19 shots in perpetuity.
VI. What is to be done. Talking points.
I imagine we are all tempted to just say/write:
• No Novavax in adults.
• No Moderna in adolescents.
• No Moderna in little kids.
• No Pfizer in little kids.
• No “Future Framework”.
The problem with that approach is that negating a frame reinforces a frame. So the more we just say NO, the more we reinforce the very thing we are trying to stop.
Furthermore, we do not want to leave the bougiecrats in an existential abyss because they are incapable of original thought. So if we just say no, they will not know what to do with themselves and will become panicked and vengeful and start lashing out.
So let’s find a way to reframe and give our country a path out of this valley of misery. My proposed talking points are as follows.
1. The FDA must revoke the existing authorizations for Moderna, Pfizer, and J&J Covid-19 shots and withdraw them from the market immediately. SARS-CoV-2 was never a good candidate for a vaccine. These shots do not stop infection, transmission, hospitalization, nor death. They appear to have negative efficacy and are driving the evolution of variants that evade vaccines. The pandemic will never stop as long as the FDA and CDC are promoting shots that lack sterilizing immunity.
2. The FDA and CDC must pivot to therapeutics. This was always the answer. The CDC’s own research showed that chloroquine is safe and effective for prophylaxis and early treatment of SARS coronaviruses (hydroxychloroquine is even safer than chloroquine). The best frontline doctors have found that ivermectin is a life saver if used early. About twenty off-the-shelf treatments are more effective than vaccines. Get these safe and effective medicines to people who need them and let doctors be doctors again and treat patients based on their own best clinical judgment.
3. Vaccine safety assessments must be based on actual science. That means:
• Large (50,000+ person) double blind randomized controlled trials with inert saline placebos conducted by an independent third party.
• Safety and efficacy studies for two years prior to any application followed by 20 years of follow up (with the control group intact).
• Greater than 90% efficacy with less than 1% Grade 3 Adverse Events.
• Proper monitoring for carcinogenesis, mutagenesis, and impairment of fertility.
VII. What is to be done. Whom to contact:
Please reach out and find a way to awaken the moral core of these 36 people:
You can use the talking points from above or share your own story and insights.
Robert Califf
FDA Commissioner
Food and Drug Administration
Mail stop: HF-1
10903 New Hampshire Ave.
Silver Spring MD 20993-0002
phone: (301) 796-5400
fax: (301) 847-8752 commissioner@fda.hhs.gov https://twitter.com/DrCaliff_FDA
Rochelle Walensky
Director, Centers for Disease Control and Prevention
Roybal Building 21, Rm 12000
1600 Clifton Rd
Atlanta, GA 30333
phone: (404) 639-7000 Aux7@cdc.gov https://twitter.com/CDCDirector
FDA staff:
Peter Marks
Director, Center for Biologics Evaluation and Research
FDA, Mail stop: HFM-2
10903 New Hampshire Ave., WO71-7232
Silver Spring MD 20993-0002
phone: (240) 402-8116
fax: (301) 595-1310 Peter.Marks@fda.hhs.gov
Hong Yang
Biologist, FDA/CBER/OBE
Building WO71, Room 5338
Mail stop: HFM-210
Silver Spring MD 20993-0002
phone: (240) 402-8836
fax: (301) 595-1240 Hong.Yang@fda.hhs.gov
Richard Forshee
Associate Director, FDA/CBER/OBE
Building, WO71, Room 5342
Silver Spring MD 20993-0002
phone: (240) 402-8631
fax: (301) 595-1240 Richard.Forshee@fda.hhs.gov
Hui-Lee Wong Associate Director for Innovation and Development,
Office of Biostatistics and Epidemiology,
Center for Biologics Evaluation and Research
White Oak Building 71, Room 5222
Silver Spring MD 20993-0002
phone: (240) 402-0473 Huilee.Wong@fda.hhs.gov
Leslie Ball Office of Vaccines Research and Review
Division of Vaccines and Related Products Applications,
Center for Biologics Evaluation and Research
Building WO22, Room 6156 Silver Spring MD 20993-0002
phone: (301) 796-3399 Leslie.Ball@fda.hhs.gov
Doran L. Fink Deputy Director – Clinical
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review, CBER
Mail stop HFM-475
Building WO71, Room 3314 Silver Spring MD 20993-0002
phone: (301) 796-1159 Doran.Fink@fda.hhs.gov
Hana El Sahly, M.D., Chair VRBPAC Associate Professor
Department of Molecular Virology and Microbiology
Department of Medicine
Section of Infectious Diseases
Baylor College of Medicine
Houston, TX 77030
713-798-2058 hanae@bcm.edu
Paula Annunziato, M.D.
Vice President and Therapeutic Area Head
Vaccines Clinical Research
Merck
North Wales, PA 19454 paula.annunziato@merck.com
Adam C. Berger, Ph.D.
Director, Division of Clinical and Healthcare Research Policy
Office of Science Policy
Office of the Director
National Instituters of Health
6705 Rockledge Drive, Suite 630
Bethesda, MD 20892
(301) 827-9676 adam.berger@nih.gov
Henry H. Bernstein, D.O.
Professor of Pediatrics
Zucker School of Medicine at Hofstra/Northwell
Department of Pediatrics
Cohen Children’s Medical Center
New Hyde Park, NY 11042
phone: (516) 838-6415 (office)
fax: (516) 465-5399 hbernstein@northwell.edu
Captain Amanda Cohn
Chief Medical Officer
National Center for Immunizations and Respiratory Diseases
Centers for Disease Control and Prevention
1600 Clifton Rd
Atlanta, GA 30333 MS C-09
phone: (404) 639-6039
fax: (404) 315-4679 acohn@cdc.gov anc0@cdc.gov
Holly Janes, Ph.D.
Fred Hutchinson Cancer Research Center •
Vaccine and Infectious Disease Division
1100 Fairview Avenue North,
M2-C200
P.O. Box 19024
Seattle, Washington 98109 U.S.A.
phone: (206) 667.6353 hjanes@fredhutch.org
Hayley Gans, M.D.
Professor of Pediatrics
Department of Pediatrics
Stanford University Medical Center
Stanford, CA 94305
phone: (650) 723-5682
fax: (650) 725-8040 hgans@stanford.edu
David Kim, M.D.
CAPT, U.S. Public Health Services
Office of Infectious Disease and HIV/AIDS Policy
Office of the Assistant Secretary for Health
U.S. Department of Health and Human Services
330 C Street SW, Suite L600
Washington, DC 20024
phone: (202) 795-7636 david.kim@hhs.gov
Arnold Monto, M.D. Professor Emeritus
Department of Epidemiology
University of Michigan School of Public Health
Ann Arbor, MI 48109
phone: (734) 764-5453
fax: (734) 764-3192 asmonto@umich.edu
Paul Offit, M.D.
Professor of Pediatrics
Division of Infectious Diseases
Abramson Research Building
The Children’s Hospital of Philadelphia
Philadelphia, PA 19104
phone: (215) 590-2020 offit@chop.edu https://twitter.com/DrPaulOffit
Jay Portnoy, M.D.
Director, Division of Allergy, Asthma & Immunology
Children’s Mercy Hospitals & Clinics
2401 Gillham Road
Kansas City, MO 64108
phone: (816) 960-8885
fax: (816) 960-8888 Jportnoy@cmh.edu
Eric Rubin, M.D., Ph.D. Editor-in-Chief
New England Journal of Medicine
Adjunct Professor
Harvard TH Chan School of Public Health
665 Huntington Ave
Building 1, Room 811
Boston, MA 02115
phone: (617) 432-3335 erubin@hsph.harvard.edu erubin@nejm.org
Andrea Shane, M.D.
Professor of Pediatrics
Emory University School of Medicine
2015 Uppergate Drive NE, Rm. 504A
Atlanta, GA 30322
phone: (404) 727-9880 (direct)
(404) 727-5642 (main)
fax: (404) 727-8249 ashane@emory.edu
Geeta K. Swamy, M.D.
Senior Associate Dean
Vice Chair for Research & Faculty Development
Associate Professor, Department of Obstetrics & Gynecology
Division of Maternal-Fetal Medicine
Duke University
Box 3967 Med Ctr,
Durham, NC 27710
phone: (919) 681-5220 swamy002@mc.duke.edu
Temporary VRBPAC members (but their votes count just the same):
A. Oveta Fuller, Ph.D.
Associate Professor of Microbiology and Immunology,
University of Michigan Medical School
Ann Arbor, MI 48109
phone: (734) 647-3830 fullerao@umich.edu
Randy Hawkins, M.D.
Charles Drew University
1731 E. 120th St.
Los Angeles, CA 90059
(323) 563-4800 RandyHawkins@cdrewu.edu
James Hildreth, Sr., Ph.D., M.D.
Professor
Department of Internal Medicine
School of Medicine
President and Chief Executive Officer
Meharry Medical College
Nashville, TN 37205 officeofthepresident@mmc.edu
Jeannette Lee, Ph.D.
Professor Department of Biostatistics
University of Arkansas for Medical Sciences
Little Rock, AR 72701
phone: (501) 526-6712 JYLee@uams.edu
Ofer Levy, M.D., Ph.D.
Staff Physician & Principal Investigator
Director, Precision Vaccines Program
Division of Infectious Diseases
Boston Children’s Hospital
Professor,
Harvard Medical School Associate Member
phone: (617) 919-2900
fax: (617) 730-0254 ofer.levy@childrens.harvard.edu
Wayne Marasco
Dana-Farber Cancer Institute
450 Brookline Avenue
Jimmy Fund 824
Boston, MA 02215
Phone: (617) 632-2153
fax: (617) 632-3889 wayne_marasco@dfci.harvard.edu
H. Cody Meissner, M.D.
Professor of Pediatrics
Tufts University School of Medicine
Director, Pediatric Infectious Disease
Tufts Medical Center
Boston, MA 02111
phone: (617) 636-5227
fax: (617) 636-4300 cmeissner@tuftsmedicalcenter.org
Michael Nelson, M.D., Ph.D.
Professor of Medicine
Asthma, Allergy and Immunology Division
UVA Division of Asthma, Allergy & Immunology
PO Box 801355
Charlottesville, VA 22908
phone: (434) 297-8399
fax: (434) 924-5779 mrn8d@virginia.edu
Stanley Perlman, M.D., Ph.D.
Professor of Pediatrics
University of Iowa
3-712 Bowen Science Building (BSB)
51 Newton Rd
Iowa City, IA 52242
phone: (319) 335-8549 stanley-perlman@uiowa.edu
Mark Sawyer, M.D.
Professor of Clinical Pediatrics
8110 Birmingham Way
Bldg. 28, 1st Floor
San Diego, CA 92123
phone: (858) 966-7785
fax: (858) 966-8658 mhsawyer@ucsd.edu
Melinda Wharton, M.D., MPH
Associate Director for Vaccine Policy
National Center for Immunization and Respiratory Diseases,
Centers for Disease Control and Prevention,
1600 Clifton Road, Mailstop E05,
Atlanta, GA 30333
phone: (404) 639.8755
fax: (404) 639.8626 mew2@cdc.gov
I know that we’re all weary. We’ve been battling Pharma fascism for the last two years and battling against the FDA every day for the last few months. I imagine it’ll take about an hour to call or write to all 36 people on this list. It’s a heavy lift. But that’s the price of liberty. This is what it’s going to take to save our Republic. So let’s fire up our computers and get out our phones and generate the largest response in the history of the movement. Let’s make history together!
THIS is the first of a special five-part investigation into the way in which, and why, winning ‘vaccine confidence’ became the primary goal of world health agencies, regardless of need, efficacy or risk.
Since the UK’s Covid-19 vaccine programme began in December 2020, 140million doses have been administered to 55million people, representing 73 per cent of the population.
The high level of acceptance of these vaccines, which were developed in one tenth of the normal time frame – and in the case of the mRNA vaccines using a novel technology never previously licensed for use in either humans or animals – is a remarkable testament to the level of public trust in vaccines.
It is arguably the end product of two decades of work, first by GAVI, the Global Alliance for Vaccines and Immunisations (now called The Vaccine Alliance) and recently by initiatives such as that of the London-based Vaccine Confidence Project, established to deliver the goal of universal childhood vaccination set 40 years ago by UNICEF, the United Nations children’s welfare organisation.
The Vaccine Alliance, a public-private partnership financed by vaccine manufacturers, the Bill and Melinda Gates Foundation and national governments, aimed to give impetus to the universal vaccination campaign and to revitalise the fortunes of a stagnating market for new vaccines. The UK government is currently is largest single donor, having made a five-year pledge in 2020 of £1.65billion.
When GAVI was launched, a UNICEF employee and anthropologist, Dr Heidi Larson – who would later found the Vaccine Confidence Project – was chosen to lead its vaccine communications and advocacy work.
She later explained how the nature of the advocacy was soon to evolve away from the initial focus on client governments.
‘There was a growing epidemic of individuals and communities and even some government officials questioning and refusing vaccines,’ she said. ‘I ended up getting the nickname “Director of UNICEF’s Fire Department,” because it turned out to be a crisis management position, because people weren’t taking vaccines.
‘I saw what seemed to be a trend: The northern Nigeria boycott of the polio program made it into the international press, but it wasn’t one place, it was everywhere.
‘I didn’t have time in my day job to investigate what was going on there, because there was not a quick fix. That’s when I put together a proposal and got some seed money and founded the Vaccine Confidence Project.’
These interim measures were necessary because matching the industrialised world’s standards of sanitation, clean water, nutrition and health care to reduce the disease burden was ‘prohibitively expensive’.
An RF trustee, James P Grant, had been appointed executive director of UNICEF in 1980, operating it as a rival to the vaccine-agnostic World Health Organisation of his era.
In 1980, in an article on the eradication of smallpox, WHO director-general Dr Halfdan Mahler did not even mention vaccines. Rather, he stressed: ‘Smallpox eradication is a sign, a token, of what can be achieved in breaking out of the cycle of ill-health, disease and poverty.’
But Grant engaged in what the New York Times called ‘tireless, peripatetic proselytising’, using his UNICEF pulpit to zealously promote vaccination.
With rearguard reinforcement from the US Centres for Disease Control (CDC), by 1984 he had brought the WHO, the agency meant to provide the technical lead, on board with ‘universal’ vaccination.
Today, UNICEF is a quasi-arm of the pharmaceutical industry. Figures in its most recent Immunisation Roadmap document show it is now responsible for distributing 40 per cent of vaccines in developing countries, while its 659 staff spend more than half their time managing immunisation programmes and supply chain logistics.
In Part 2 tomorrow, I will explain how GAVI’s ten-year strategic plan, the Decade of the Vaccine, set out to eliminate vaccine scepticism.
Have you read How to Prevent the Next Pandemic by Bill Gates yet? Well, I have, and let me tell you: it’s every bit as infuriating, nauseating, ridiculous, laughable and risible as you would expect. Here are the details.
The U.S. Food and Drug Administration’s (FDA) top vaccine official told a congressional committee on Friday that COVID-19 vaccines for kids under 6 will not have to meet the agency’s 50% efficacy threshold required to obtain Emergency Use Authorization (EUA).
The FDA is reviewing data from Moderna’s two-shot vaccine for infants and toddlers 6 months to 2 years old, and for children 2 to 6 years old.
The agency is awaiting data on Pfizer and BioNTech’s three-dose regimen for children under age 5 after two doses of its pediatric vaccine failed to trigger an immune response in 2-, 3- and 4-year-olds comparable to the response generated in teens and adults.
According to Endpoints News, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, told the House Select Subcommittee on the Coronavirus Crisis the agency would not withhold authorization of a pediatric vaccine if it fails to meet the agency’s 50% efficacy threshold for blocking symptomatic infections.
COVID-19 vaccines for adolescents, teens and adults had to meet the requirement.
“If these vaccines seem to be mirroring efficacy in adults and just seem to be less effective against Omicron like they are for adults, we will probably still authorize,” Marks said.
The FDA on June 30, 2020, issued guidance that in order for an experimental COVID-19 vaccine to obtain EUA, it must “prevent disease or decrease its severity in at least 50 percent of people who are vaccinated.”
The guidelines were issued during a briefing with the Senate Committee on Health, Education, Labor and Pensions, during which senators sought assurances from former FDA Commissioner Stephen Hahn, Dr. Anthony Fauci and other top health officials that the expedited speed of development of COVID-19 vaccines wouldn’t compromise the integrity of the final product.
All previously authorized COVID-19 vaccines and boosters for all age groups were required to meet the FDA’s 50% requirement prior to obtaining EUA.
Vinay Prasad, a hematologist-oncologist and associate professor of Epidemiology and Biostatistics at the University of California, San Francisco posted a video responding to the news the FDA would bypass its own standard to authorize pediatric COVID-19 vaccines for kids.
Prasad said:
“Peter Marks from the FDA — he’s the defacto regulator-in-chief when it comes to vaccines — is saying that kids’ vaccines don’t need to hit the target. They don’t need to hit the 50% vaccine efficacy against symptomatic SARS-CoV-2 target. That was the target that the FDA themselves came up with in the original pandemic.
“They came up with this target 50% point estimate above, and the lower bound to the 95% confidence interval has to be above 30%. That was their minimum efficacy standard for vaccination. That was the standard they themselves set and that was the standard initial vaccine trials did clear for adults.
“But the pediatric vaccine trials — both the Pfizer and Moderna — appear not to have cleared that bar, and Peter Marks is talking to congressional officials and he is saying that it’s okay, we’ll probably authorize it anyway.”
Vasad said it was “incredible” that Marks would sign off on a pediatric vaccine if it seems to be mirroring efficacy in adults but is less effective against Omicron.
“We have standards for a reason,” Vasad said. The standard chosen by the FDA was “arbitrary and if anything I’d argue it was on the low side — 50% isn’t as good as what we wanted,” Vasad said.
“Fifty percent is quite low, and if you have a very low vaccine efficacy […] you can have compensatory behavior that actually leads to a lot more viral spread,” he added.
Vasad said when it comes to kids, it’s “kind of a moot point” because estimates from the Centers for Disease Control and Prevention from a few months ago showed 75% of children had zero prevalence — and it’s “probably higher now.”
“Taking a child under the age of 5 who already had and recovered from COVID and trying to make them better off with a vaccine against the original Wuhan ancestral strain — that’s an uphill battle,” Vasad said.
“The absolute upper bound, absolute risk reduction, has got to be super super low because once kids have it and recover from it they generally do pretty well. If they get it again they do even better than the first time.”
Lowering the regulatory standards for vaccine products is not the direction FDA should go, Vasad said. “They need to be upholding the standards they’ve set and raising the standards.”
Vasad raised concerns over what the standard will be moving forward if the agency doesn’t abide by its own minimum requirement.
“At what point will vaccine efficacy arrive at something the agency doesn’t accept?” He asked.
Vasad said once the FDA does away with EUA, many preschools will immediately mandate COVID-19 vaccines, and they won’t make exceptions for natural immunity or provide any exceptions at all.
“And so what he’s talking about is authorizing a vaccine in a setting where you have 75% minimum zero prevalence and the vaccine efficacy could be less than 50%,” Vasad said. “How much less?”
Pointing to a Moderna press release stating one arm of its trial showed its pediatric vaccines were only 37% and 23% effective, Vasad asked, “How much lower can it go — 10%? How low before Peter Marks says that’s too low?”
Vasad said if the adult vaccine becomes less effective over time, “tell me why that means you should accept the less effective kids’ vaccine?”
Vasad explained:
“If a therapy loses efficacy over time, why does that mean the bar to be a therapy is lower? It should mean that we need new therapies. We need a new mRNA construct.
“You need to kind of aim at the thing that’s actually out there now and not the original thing from two years ago. Maybe you want to rejigger your process. Try something new but it doesn’t mean we keep lowering the bar. This is ridiculous.”
Moderna reports concerning efficacy data for pediatric COVID-19 vaccines
As The Defender reported, Moderna on April 28 asked the FDA to approve its COVID-19 mRNA-1273 vaccine for children 6 months to 6 years old, citing different efficacy numbers than it disclosed in March.
The company conducted separate trials for two versions of the vaccine, one for infants and toddlers aged 6 months to 2 years, and one for children 2 to 6 years, and claimed data showed “a robust neutralizing antibody response” and “a favorable safety profile.”
Yet, Moderna’s KidCOVE study showed the company’s COVID-19 vaccine failed to meet the FDA’s minimum efficacy requirements for EUA in the 2- to under-6 age group, and barely surpassed the agency’s 50% efficacy requirement in the 6-month to 2-year age group — even after the vaccine maker changed its analysis of the study to meet the threshold.
Moderna also did not follow trial participants beyond 28 days, so vaccine effectiveness after that time is unknown. Data from New York state show vaccine effectiveness for the 5-to-11 age group plummets within seven weeks to 12%.
“Here, we’re looking only at the first four weeks,” Dr. Madhava Setty told The Defender. “Although data from New York were in a different age group using a different mRNA vaccine, the effectiveness was remarkably similar after four weeks. Why wouldn’t we expect that the same thing is going to happen?”
The House Select Subcommittee on Coronavirus Crisis on April 26 asked the FDA for a status update on COVID-19 vaccines for children under 5.
The agency said it was considering holding off on reviewing Moderna’s request to authorize its COVID-19 vaccine for children under 5 until it has data from Pfizer and BioNTech on their vaccine for children, pushing the earliest possible authorization of a vaccine from May to June.
When asked on Friday whether the FDA’s vaccine advisors would slow-roll Moderna’s applications and wait to review Pfizer’s and Moderna’s applications together, Marks said the meetings set for next month could move up if necessary.
“Obviously if we get through reviews faster, then we will send them to committees sooner,” Marks said.
According to Rep. Jim Clyburn’s (D-S.C.) account of the meeting, Marks said the FDA’s vaccine advisory committee has reserved earlier dates, enabling the agency to potentially “move dates up even by a week for any of these reviews.”
“At the end of the day, we want people to have confidence in getting vaccinated,” Marks said. “We need to get more kids vaccinated, not just in the younger than 5 age range, but also older than 5.”
Megan Redshaw is a staff attorney for Children’s Health Defense and a reporter for The Defender.
I’ve mentioned previously that the roll out of a dose of vaccine has been associated with an increase in excess deaths (eg, here), and we seem to have seen the same effect in March.
At around the 21st March (week 12) England started to roll out the spring booster doses for those aged over 75 (and other vulnerable individuals). By the 7th April (week 14) the NHS had congratulated itself with the announcement that over 1 million doses had been given.
Here’s the data (from Euromomo) for excess deaths in England for those aged 75-85 since the start of the year:
I’ve highlighted the period where the million booster doses were delivered.
I note that we managed to get through the Omicron wave in the UK with normal levels of excess deaths in those aged 75-85, but as soon as the booster doses were rolled out we rapidly hit the threshold for a ‘substantial increase’.
Of course, it might be a coincidence — we have had rather a lot of coincidences over the last 15 months.
The U.S. Food and Drug Administration (FDA) on Thursday put strict limits on the use of the Johnson & Johnson (J&J) COVID-19 vaccine, citing the risk of a blood-clotting condition the agency described as “rare and potentially life-threatening.”
In a statement Thursday, the FDA said the risk of vaccine recipients developing thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine “warrants limiting the authorized use of the vaccine.”
The FDA said it has identified 60 cases of vaccine-induced thrombosis with thrombocytopenia syndrome, including nine deaths, out of about 18 million doses administered — although the condition is likely underreported.
Women 30 to 49 years old are at the highest risk of TTS from the J&J vaccine, with about eight cases per 1 million doses of vaccine administered, according to the FDA.
According to the latest data from the Vaccine Adverse Event Reporting System (VAERS), between Dec. 14, 2020, and April 29, 2022, there were 13,873 reports of blood-clotting disorders following COVID-19 vaccines in the U.S.
In the U.S., 575 million COVID-19 vaccine doses had been administered as of April 29, including 339 million doses of Pfizer, 217 million doses of Moderna and 19 million doses of J&J.
The agency said the “known and potential benefits” of the J&J vaccine for preventing COVID-19 outweigh the known and potential risks for individuals 18 and older “for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate,” or “who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.”
The agency described TTS as “a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen [J&J] COVID-19 vaccine.”
The updated restrictions to the Emergency Use Authorization (EUA) of the vaccine, marketed under the Janssen brand, also apply to booster doses, CNN reported.
People who can still get the Janssen vaccine include:
Those who had a severe allergic reaction to the Pfizer/BioNTech or Moderna mRNA vaccine.
Those with personal concerns about the mRNA vaccines who would remain unvaccinated unless they can choose the Janssen vaccine.
Those with limited access to mRNA COVID-19 vaccines.
Symptoms of TTS include shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms (like headaches or blurred vision) or red spots just under the skin called “petechiae” found beyond the site of injection.
Experts question timing, and why just J&J?
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said limiting the authorized use of the Janssen vaccine “demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions.”
Marks said:
“We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA.
“The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”
However, Brian Hooker, Ph.D., P.E., Children’s Health Defense chief scientific officer and professor of biology at Simpson University, had a different take on the news.
“It seems like the FDA pays lip service to the fact that the spike protein can cause clotting, and to the widespread reports of clotting, by punishing Janssen, who has become the ‘whipping boy’ of the COVID-19 vaccine manufacturers through the pandemic,” Hooker said.
“I believe this is partially because of the limited use of the Janssen vaccine in the U.S. as compared to Pfizer and Moderna,” he added.
Hooker said the FDA can limit the use of the J&J vaccine without significantly impacting vaccine distribution overall, “while having the appearance of addressing the myriad vaccine adverse events caused by all the types of COVID-19 vaccines.”
As of Thursday, CNN reported only 7.7% of those considered fully vaccinated received the J&J vaccine.
Dr. Pierre Kory, founder and president of Front Line COVID-19 Critical Care Alliance, told The Defender :
“My only hypothesis is this action is some attempt for the FDA to be able to claim that they took at least some action to protect the safety of the public, akin to ‘virtue signaling.’
“Having been a keen observer of their actions throughout the pandemic, I find this action to be completely insufficient and demonstrates a calculated attempt to ensure vaccinations with similarly dangerous vaccines continue.”
Dr. Meryl Nass questioned the timing of the FDA’s restriction of the EUA.
“Why did the FDA just throw the kill switch on the Janssen vaccine, when it knew of the thrombosis problems since the rollout?” Nass asked.
Nass told The Defender the FDA may have known about the thrombosis problem even before the Janssen vaccine rollout, “since the adenovirus vector platform is known to be associated with thrombosis” for “more than 15 years.”
Kory, who noted that all COVID-19 vaccines have had a high rate of adverse events, also questioned the timing of the new restrictions.
“I find the timing of this action to be both irrational and alarming given there is extensive data from around the world, much of it being censored from media and medical journals, that all the COVID-19 vaccines, not just Janssen, have long had unacceptable and diverse toxicity signals — beyond just clotting disorders from numerous pharmacovigilance databases and epidemiological and public health data reports,” Kory said.
As far back as April 2021, U.S. and European health officials were investigating whether the J&J COVID-19 vaccines were causing blood clots.
However, there was already mounting evidence the Pfizer and Moderna vaccines could cause similar adverse reactions. U.S. regulatory officials were alerted to this risk as far back as December 2020.
The Centers for Disease Control and Prevention (CDC) in December 2021 recommended the Pfizer and Moderna mRNA COVID vaccines over the J&J vaccine due to the risk of blood clots, despite data showing the Pfizer and Moderna shots also cause blood-clotting disorders.
In January 2021, shortly after the rollout of Pfizer’s vaccine in the U.S., The Defender reported on the death of a 56-year-old Florida doctor who developed a blood-clotting disorder after the Pfizer vaccine and died 12 days later.
The Defender also reported on numerous other deaths related to blood-clotting disorders that developed after the Moderna and J&J vaccines.
On April 13, 2021, the FDA and CDC paused use of the vaccine to investigate six reported cases of TTS.
The agencies lifted the pause only 10 days later, after confirming a total of 15 cases of TTS had been reported to VAERS, including the original six reported cases, out of approximately 8 million doses administered.
Acclaimed vaccinologist, Geert Vanden Bossche, sits down for his second groundbreaking interview with Del to explain why the intense pressure mass vaccination is putting on the Covid-19 virus will likely drive it to become catastrophically deadly.
This paper, published in the “peer-reviewed” Canadian Medical Association Journal, quite simply represents an amoral, unethical and utterly transparent attempt to use pseudoscientific modelling to fabricate a false narrative. The apparent objective seems to be sowing divisions in society by marginalising and vilifying the unvaccinated.
The paper describes a “study” which is nothing of the sort. It actually describes a model which the authors have constructed. This is an unnecessarily complex model — and suspiciously so. The model itself has been very expertly taken apart by Jessica Rose here and Drs Rancourt and Hickey for the Ontario Civil Liberties Association here.
The authors appear to have tested their model to death to find the optimal combination of inputs which results in the “narrative” they wish to promote.
The logical flaws in this approach have been brilliantly analysed by Dr Byram Bridle, including a critique of the assumptions made for the various input parameters. Among the more egregious examples are:
(1) the model assumes 80% effectiveness against infection for the Covid injections vs omicron, whereas real-world data suggests zero — at best.
(2) the model assumes very little pre-pandemic immunity present within the community (they assume just 20% when for some time the evidence has suggested much higher levels, especially against severe illness).
(3) the model assumes no waning of efficacy at all over time, a claim not even made by the most ardent promoters of the covid vaccines.
Many news outlets — including Forbes— appear to have been taken in by this sham science and are reporting it as a bone fide “study” with no critical analysis whatsoever, this being their key message:
“The findings counter the common argument that the decision to get vaccinated is a personal one, the researchers said, as the unvaccinated are ”likely to affect the health and safety of vaccinated people in a manner disproportionate to the fraction of unvaccinated people in the population.”
One commentator on Twitter acerbically — though rather accurately — summed up the Forbes article thus:
It is quite clear that the model and the entire article has been constructed to push a political agenda, namely to neutralise the growing realisation by the population that the story they were told in relation to the Covid 19 injections is entirely false. Contrary to the authorities’ official narrative, in the context of Omicron the injections don’t reduce infections or transmission, and actually probably even increase them. Far from being a selfish act, it was in fact entirely rational — and beneficial to one’s fellow man — to decline the injection.
To use Dr Bridle’s words, the paper is actually “Fiction Disguised as Science to Promote Hatred”.
We support and join the many voices calling for this paper to be retracted.
Postscript: When Denis Rancourt, one of the authors of the Ontario Civil Liberties Association’s statement, tweeted the essence of their complaint with it, the paper’s author — David Fisman — didn’t respond by way of any form of scientific justification — he threatened legal action.
By Kit Klarenberg and Wyatt Reed | The Grayzone | October 5, 2025
A roving reporter who covered Italy’s top politicians explains to The Grayzone how his country was reduced to a joint US-Israeli “aircraft carrier,” and raises troubling questions about an Israeli role in the killing of Prime Minister Aldo Moro.
For years, Israel’s Mossad monitored and secretly influenced a violent communist faction that carried out the March 16, 1978 kidnapping and murder of Italian statesman Aldo Moro, veteran investigative journalist Eric Salerno has documented.
Having worked closely alongside multiple Italian heads of state during his 30-year career as a correspondent, Salerno published an expose of their secret relationship with Israeli intelligence in 2010 called Mossad Base Italy. … continue
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