Informed Consent: ADE, waning antibody titres and negative efficacy
In this blog I set out to provide evidence from a range of sources that relate to, and link signs of waning and negative efficacy of the vaccines and Antibody Dependent Enhanced disease.
Prior to SARS CoV-2, research showed that some vaccines designed to prevent respiratory diseases led to Antibody Dependent Enhancement (known by several names – immune enhancement, disease enhancement, antibody-dependent cell-meditated cytotoxicity (ADCC), pathogenic priming).
Attention was brought to the potential side effect, ADCC, when designing vaccines (specifically respiratory, influenza, pandemic etc) with the publication of studies in 2017 and 2018 of mice models showing increased mortality in mice vaccinated and then exposed to the virus. [1, 2]
However, previous vaccine development (respiratory syncytial virus vaccines – discussed below) had exposed the problem as early as the 1960’s.
In this video Dr. Peter Hotez, Centre for Vaccine Development, Texas, is speaking at a senate hearing (House Science Committee Hearing, March 5th 2020). This indicates the US Senate was informed of the dangers of waning and ADE. (9.54 on segment on Highwire)
“One of the things that we’re not hearing a lot about is the unique potential safety problem of corona-virus vaccines. This was first found in the early 1960s with respiratory syncytial virus vaccines. And it was done here in Washington with the NIH and Children’s National Medical Center that some of those kids who got the vaccine actually did worse. And I believe there were two deaths in the consequence of that study, because what happens with certain types of respiratory virus vaccines you get immunized and then when you get actually exposed to the virus, you get this kind of paradoxical immune enhancement phenomenon. When we started developing corona-virus vaccines and our colleagues, we noticed in laboratory animals that they started to show some of the same immune pathology that resembled what had happened 50 years earlier. Since it we said, oh, my God, this is going to be problematic. These clinical trials, are not going to go quickly because of that immune enhancement. It’s going to take time.”
In September 2020, Nature Journal published ‘Antibody-dependent enhancement and SARS-CoV-2 vaccines and therapies.’ (written in May 2020) . This clinically detailed article provides a useful background for understanding current concerns.
The Abstract – “Antibody-based drugs and vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are being expedited through preclinical and clinical development. Data from the study of SARS-CoV and other respiratory viruses suggest that anti-SARS-CoV-2 antibodies could exacerbate COVID-19 through antibody-dependent enhancement (ADE). Previous respiratory syncytial virus and dengue virus vaccine studies revealed human clinical safety risks related to ADE, resulting in failed vaccine trials. Here, we describe key ADE mechanisms and discuss mitigation strategies for SARS-CoV-2 vaccines and therapies in development. We also outline recently published data to evaluate the risks and opportunities for antibody-based protection against SARS-CoV-2.” 
Did we hear about this in the news? No, all we heard is that it is safe and effective.
In December 2020, the USA Food and Drug Administration stated that exisiting data did not indicate a risk of vaccine-enhanced disease, but that risk remains unknown and needs to be evaluated further. 
Were doctors, nurses and other persons giving the vaccines explaining this possible side effect whilst gaining ‘informed consent’?
The lack of information given to obtain informed consent, especially the use of coercion, has been a major ethical dilemma for many health professionals. The following study (published December 2020) looks at the risk of ADE and the need for the significant risk to be explained.
“Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease”
‘Aims of the study: Patient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs. The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus.
Conclusions drawn from the study and clinical implications: The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.’ 
Concern about the risk of ADE occurring with the mRNA vaccines was high amongst virologists, pathologists and medical doctors, including Geert Vanden Bossche, Peter McCollough, Robert Malone and Ryan Cole, (I will quote and provide links to some of their work below but will need to write another paper to include the vastness of this medical experiment) but their voices became hard to hear through censorship by Big Tech and avoidance by main stream media of anything but the narrative that vaccines are safe and effective. Fact checker discredited them. However, as shown by a US court hearing Fact checkers are just journalists with opinions.
Surely the vaccine trials would have checked for ADE.
Unfortunately, the short Pfizer trial did not even follow their own advice, and regulatory bodies did not assess, or require the safety process of excluding immune waning and potential ADE. Pfizer only submitted up to 6 months of trial data to the FDA to get approved, and they didn’t retain the placebo group. The administers of the trial vaccinated most of the control group at or before 6 months of the trial. There are numerous concerns about the trials including manipulation of data, removing the injured from the trial data or minimising their injuries but in relation to this issue the absence of a control group beyond 6 months reduces the ability to analyse longer term effects caused by waning and potential ADE. Concerned medical specialists, scientists, data analysists etc have had to wait for the ‘unofficial global human trial’ to progress to assess what is happening.
Data from many countries (Singapore, Scotland, Israel, Qatar) are now showing low to negative efficacy.
“[In a trial] zero percent means that vaccinated people are at as much risk as people who got the placebo.” 
So negative means that the risk is higher in the vaccinated people, in most cases this is double jabbed or based on the time since vaccination. More infections (and/or severe illness & deaths) are occurring post vaccine than in the unvaccinated. At this stage the data reports from Health Departments accompanying the figures and graphs are not acknowledging ADE, but there are serious safety and efficacy issues that need to be discussed, not censored.(Links to each countries data below)
In the absence of a one specific, globally encompassing study, I have provided excerpts and quotes with links to studies but I am unable to include them all.
I acknowledge the Janzen report on the Highwire, medical investigative journalism, for many of the links. As the screenshots are hard to read I advise visiting the website to view their report. I have based some of my text on their transcripts.
Episode 226 “Ahead of the Curve, in June 2021, covers great material including video clips of top specialists explaining the types of immunity affected. For example:
David Bauer is a lead on a study that Janzen and Bigtree discuss. He heads up the RNA Virus Replication Laboratory at the Francis Crick Institute.
“And here’s what he had to say about immunity and vaccination.”
[00:10:44] Dr. David Bauer
“So the key message from our finding is that we found that recipients of the Pfizer vaccine, those who’ve had two doses, have about five to six fold lower amounts of neutralizing antibodies. Now, these are the sort of gold standard private security antibodies of your immune system which block the virus from getting into your cells in the first place. And so we found that that’s less for people with two doses. We’ve also found that for people with only one dose of the Pfizer job, that they are less likely to have high levels of these antibodies in their blood. And perhaps most importantly for all of us going forward, is that we see that the older you are, the lower your levels are likely to be. And the time since you’ve had your second job, as that time goes on, the lower your levels are also likely to be. So that’s telling us that we’re probably going to be needing to prioritize boosters for older and more vulnerable people coming up soon, especially if this new variant spreads.”
In Episode 230, October, 2021, segment “Serious Antibody Drop After Vaccine” Janzen and Bigtree look at news headlines and studies that indicate waning of antibody titres happening post vaccination.
What this Figure above shows:
Vaccine Effectiveness against Any SARS-CoV-2 Infection
Estimated BNT162b2 effectiveness against any SARS-CoV-2 infection was negligible for the first 2 weeks after the first dose, increased to 36.8% (95% confidence interval [CI], 33.2 to 40.2) in the third week after the first dose, and reached its peak at 77.5% (95% CI, 76.4 to 78.6) in the first month after the second dose (Table 2 and Figure 2A). However, effectiveness declined gradually, starting from the first month after the second dose. The decline accelerated after the fourth month, and effectiveness reached a low level of approximately 20% in months 5 through 7 after the second dose. A sensitivity analysis that adjusted for previous infection and health care worker status confirmed the main analysis results (Table 3). 
No, according to the article; “In either case, new vaccines will be created, and manufacturers will provide new measures of their efficacy.”
Once I started following references in studies I found numerous studies measuring or discussing the effectiveness, however, this one identified by Janzen, refers to ADE.
Journal of Infection: Infection-enhancing anti-SARS CoV-2 antibodies recognize both original Wuhan Strain and Delta variants of potential risk from mass vaccination? (Published online August 2021)
“Infection enhancing anti SARS CoV-2 antibodies recognize both original Wuhan Strain and Delta variants of potential risk from mass vaccination? … As they entered the NTD (N-terminal domain) is also targeted by neutralizing antibodies., our data suggest that the balance between neutralizing and facilitating antibodies in vaccinated individuals is in favour of neutralization for the original Wuhan/D614G strain ..However, in the case of the Delta variant, neutralizing antibodies have a decreased affinity for the spike protein, whereas facilitating antibodies display a strikingly increased affinity. Thus, ADE may be a concern for people receiving vaccines based on the original Wuhan Strain spike sequence. Under these circumstances, second generation vaccines would spike protein formulations lacking structurally conserved ADE related epitopes should be considered…the possibility of ADE should be further investigated as it may represent a potential risk for mass vaccination during the current Delta variant pandemic”.
More studies showing waning of the various vaccines can be found on the UCI virus watch page. Public Health officials see boosters as the answer.
Real World Data
Data recording varies from country to country and amongst states or counties. What constitutes fully vaccinated varies, and changes with time as boosters are added. This study used COVID-19 data provided by the Our World in Data for cross-country analysis, available as of September 3, 2021.
They investigated the relationship between the percentage of population fully vaccinated and new COVID-19 cases across 68 countries and across 2947 counties in the US.
There is no abstract but the .pdf provides useful Tables and graphs. I have provided two excerpts. (I advise visiting the paper). 
At the country-level, there appears to be no discernable relationship between percentage of population fully vaccinated and new COVID-19 cases in the last 7 days (Fig. 1). In fact, the trend line suggests a marginally positive association such that countries with higher percentage of population fully vaccinated have higher COVID-19 cases per 1 million people. Notably, Israel with over 60% of their population fully vaccinated had the highest COVID-19 cases per 1 million people in the last 7 days…
The sole reliance on vaccination as a primary strategy to mitigate COVID-19 and its adverse consequences needs to be re-examined, especially considering the Delta (B.1.617.2) variant and the likelihood of future variants. Other pharmacological and non-pharmacological interventions may need to be put in place alongside increasing vaccination rates. Such course correction, especially with regards to the policy narrative, becomes paramount with emerging scientific evidence on real world effectiveness of the vaccines…” 
The U.K., which posts the most comprehensive granular weekly data every Thursday, shows that COVID cases per capita are more common among the vaccinated than the unvaccinated in most age groups. News headlines state “It’s time to stop calling infections among the vaccinated “breakthrough cases.”
Using data from Public Health England, Don Wolt posted these clear graphs to show the vaccinated (blue colours) and unvaccinated (orange colours), in age groups and different degrees of vaccination with numbers per one hundred thousand.
Title – UK CoV2 Infections Per 100,000 by Vaccination Status (Oct1, 2021) Source PHE COVID-19 Vaccine Surveillance Reports: Weeks 36-39
In the green box it says – CoV2 infection rates are similar or higher among fully vaccinated in all age cohorts over 30 years old.
First age group is Under 18, 18-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80+. From the age group 40 to 49 it shows that the vaccinated peopler having more infections per 100,000 than the unvaccinated.
The blue colour – light to darker is the weeks from vaccination (2 doses) 32-35, wks 33-36, wks 34-37, wks 35-38 and in orange going from light to dark similarly for the unvaccinated.
He ‘pinned’ the post on the 3rd February, 2022 and has followed up with another graph using the next 4 weeks of data and says:
“Infection rate growth (Rept Wk 50 to Rept Wk 5) since Omicron became dominant is now higher in all boosted cohorts. In boosted adult cohorts ≥40, growth increases with age or time since boosting – whereas infection rate growth in the unvaxxed is fairly consistent across cohorts.” 
“UK vaxx surveillance data also suggests that the fully vaxxed (which includes the boosted) may be much more susceptible to Omicron infection than their unvaxxed peers.” Feb 3rd 2022.
The Jaxen report alerted me to news from Taiwan.“ Taiwan has a zero COVID policy like Australia, especially Western Australia, and New Zealand. The article quotes several news sources reporting that death from COVID-19 vaccination exceeded death from COVID-19.
“On October 7th, the death toll after vaccination in Taiwan reached eight hundred and fifty two, while the death toll after COVID-19 was diagnosed was eight hundred and forty four. The number of deaths after vaccination exceeded the number of confirmed deaths for the first time.” 
Western Australia is in a unique position as community spread has been minimal until the arrival of Omicron. Many people have welcomed our ‘hard border closure’ and the Zero Covid policy. Mandated vaccination for most workers and the introduction of a Vaccine Passport to access many venues and events has resulted in high vaccination. The Government has pushed the booster shot. However concerns remain about the safety, the treatment of the injured and the rights of people to chose their preferred defence against virus infections. Early treatment with pre-exisiting drugs and supplements requires a paper of its own. Injuries can be reported to the TGA, and numbers of reports are visible on their web site, but only myocarditis is broken down. My interaction with personal accounts of attempts to have injuries recorded has indicated a reluctance from health staff to do so.
Only time will tell how the long term effects on the declining immunity of the vaccinated, as reported in other countries, affects a population isolated from the original strain and now being exposed to the variant Omicron and any future variants. We really need a control group and I am sure there are thousands of people who have refused to be injected who would volunteer for this role. There is no scientific reason for stigmatisation, let alone segregation of the unvaccinated.
News in the main stream media is changing quickly with glimpses of questioning the narrative. In WAtoday, Feb 10th, 2022 (the day I initially published this article) an article titled “Experts call for WA’s border to reopen, with concerns immunity of frontline workers will wane” quotes the Shadow Minister for Health expressing concerns of health professionals and researchers from the University of Western Australia who have predicted waning immunity in health staff who were boosted two months ago. Professor George Milne’s Omicron modelling calculations indicate escalating death the longer W.A.’s hard border policy remains. Hollywood Hospital infectious diseases expert Clay Golledge agreed with the modelling but felt deaths would be far less due to the availability of new oral antivirals at the end fo the month. Meanwhile Premier McGowan repeated his reasons for making the decision to delay the border opening with this mantra:- “[the delay was] for the safety of the people of this state. It was about saving lives, saving jobs and saving our economy”. Ms Mettam, shadow minister, concluded
“The UWA infectious disease modelling confirms that the WA hard border has served its purpose and it could now be costing lives”. 
Is there any scientific data indicating that Vaccine Passports are useful, let alone ethical in segregating the population based on a medical procedure that does not stop transmission of the virus, or in the existence of waning immunity, even protect from severe disease?
Who will be responsible if it actually results in more severe disease for the vaccinated?
Who is listening to and helping the vaccinated injured?
Is the science we have been fed by our government and media propaganda and the studies that have not been ‘aired’, including the scientists who have been censored, the real truth? If so, which I believe to be true, where to from here?
References (and extra links not included in article)
- Ye ZW, Yuan S, Poon KM, Wen L, Yang D, Sun Z, Li C, Hu M, Shuai H, Zhou J, Zhang MY, Zheng BJ, Chu H, Yuen KY. Antibody-Dependent Cell-Mediated Cytotoxicity Epitopes on the Hemagglutinin Head Region of Pandemic H1N1 Influenza Virus Play Detrimental Roles in H1N1-Infected Mice. Front Immunol. 2017 Mar 21;8:317. doi: 10.3389/fimmu.2017.00317. PMID: 28377769; PMCID: PMC5359280. https://pubmed.ncbi.nlm.nih.gov/28377769/
- Wang J, Liu M, Ding N, Li Y, Shao J, Zhu M, Xie Z, Sun K. Vaccine based on antibody-dependent cell-mediated cytotoxicity epitope on the H1N1 influenza virus increases mortality in vaccinated mice. Biochem Biophys Res Commun. 2018 Sep 10;503(3):1874-1879. doi: 10.1016/j.bbrc.2018.07.129. Epub 2018 Jul 29. PMID: 30064910. https://pubmed.ncbi.nlm.nih.gov/30064910/
- Lee, W.S., Wheatley, A.K., Kent, S.J. et al.Antibody-dependent enhancement and SARS-CoV-2 vaccines and therapies. Nat Microbiol 5, 1185–1191 (2020). https://doi.org/10.1038/s41564-020-00789-5 https://www.nature.com/articles/s41564-020-00789-5#citeas
- Antibody levels decrease after two doses of Pfizer vaccine – study, The Jerusalem Post October 7 2021. https://www.jpost.com/health-and-wellness/coronavirus/antibody-levels-decrease-after-two-doses-of-pfizer-vaccine-study-681260
- Waning of BNT162b2 Vaccine Protection against SARS-CoV-2 Infection in Qatar, The New England journal of Medicine. https://pubmed.ncbi.nlm.nih.gov/34614327/
- Horowitz: The Country with the best data shows infection rates higher among vaccinated, Blaze Media October 04, 2021
- Subramanian SV, Kumar A. Increases in COVID-19 are unrelated to levels of vaccination across 68 countries and 2947 counties in the United States. Eur J Epidemiol. 2021 Dec;36(12):1237-1240. doi: 10.1007/s10654-021-00808-7. Epub 2021 Sep 30. PMID: 34591202; PMCID: PMC8481107. https://pubmed.ncbi.nlm.nih.gov/34591202/
- Taiwan Deaths from COVID-19 Vaccination Exceed Deaths from COVID-19, Medical trend, Global Research, Transcend Media Service. https://www.transcend.org/tms/2021/10/taiwan-deaths-from-covid-19-vaccination-exceed-deaths-from-covid-19/
- Video -House Science Committee Hearing March 2020. Dr Hotez. Vaccine Development Co-Director, Texas, Dean for the National School of Tropical Medicine, Baylor College of Medicne. https://thehighwire.com/videos/are-we-starting-to-see-a-d-e/
- Vaccines and Related Biological Products Advisory Committee Meeting Dec 10, 2020, FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine. https://www.fda.gov/media/144245/download
- Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease, Int J Clin Pract 2021 Mar
- UK scientists back Covid boosters as study finds post-jab falls in antibodies, The Guardian
- Infection-enhancing anti-SARS CoV-2 antibodies recognize both original Wuhan Strain and Delta variants of potential risk from mass vaccination?Yahi N, Chahinian H, Fantini J. Infection-enhancing anti-SARS-CoV-2 antibodies recognize both the original Wuhan/D614G strain and Delta variants. A potential risk for mass vaccination?. J Infect. 2021;83(5):607-635. doi:10.1016/j.jinf.2021.08.010 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8351274/
- Rochelle Walensky, Director, Centers for Disease Control & Prevention, USA. Press conference video followed by different message February 2022 https://www.c-span.org/video/?517851-1/white-house-covid-19-response-team-briefing
- Ryan Cole MD, pathologist, PhD immunology speaking on The Highwire (website -https://www.rcolemd.com/about)
- Geert Vanden Bossche, https://www.voiceforscienceandsolidarity.org/
- What do Vaccine Efficacy Numbers Actually Mean”, The New York Times, March 2021. https://www.nytimes.com/interactive/2021/03/03/science/vaccine-efficacy-coronavirus.html
- Don Wolt on Twitter https://twitter.com/tlowdon/status/1489255319460990986
- Prevalence and Durability of SARS-CoV-2 Antibodies Among Unvaccinated US Adults by History of COVID-19. https://jamanetwork.com/journals/jama/fullarticle/2788894
- Cardozo T, Veazey R. Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease. Int J Clin Pract. 2021 Mar;75(3):e13795. doi: 10.1111/ijcp.13795. Epub 2020 Dec 4. PMID: 33113270; PMCID: PMC7645850. https://pubmed.ncbi.nlm.nih.gov/33113270/
- Experts call for WA’s border to reopen, with concerns immunity of frontline workers will wane, WAtoday. https://www.watoday.com.au/national/western-australia/experts-call-for-wa-s-border-to-reopen-with-concerns-immunity-of-frontline-workers-will-wane-20220210-p59vcf.html
- Front Line COVID_19 Critical Care Alliance Dr Paul Marik & Dr Pierre Kory – Prevention and Treatment Protocols https://covid19.onedaymd.com/2021/11/math-protocol-for-covid-19-and-dr-paul.html
Published 10th February 2022. Edits in March – reformatting.