The COVID-19 vaccine is in fact an experimental medical procedure and because of this insurance companies have made void any claims relating to this “vaccine”.
The experimental trial in Australia runs until 2023 and thus it is only available due to an emergency use clause. Insurance companies are linking adverse reactions and deaths to this trial. As companies won’t pay out for injury and death due to experimental treatment it follows that such events following COVID-19 vaccination are not covered by hospital or life insurance.
Not a word of the above is true. Yet this notion is circulating on social media in the usual and predictable places. Despite it being demonstrably false and something one can refute for themselves in a few minutes, it is a notion with active supporters. Many others go further and contend that consent has not been given to be part of this experiment. Thus a breach of the Nuremberg Code is happening right before us.
Ethically relevant but not legally enforceable the Nuremberg Code remains semantically powerful. As such it is regrettably abused by anti-vaccine activists who have for years peddled the false claim that vaccines are not tested for safety and efficacy. It just so happens that global scrutiny of the development of COVID-19 vaccines also provided firm evidence of Phase III trials. This again refutes the anti-vaccine position and I touched on this last September. Yet as antivaccinationists are apt to do the facts have been twisted into falsehoods to support ongoing attacks on the COVID-19 vaccine rollout and to boost claims of further breaches of the Nuremberg Code.
Now, whilst this post isn’t focusing on Meryl Dorey and the Australian Vaccination-risks Network, it just so happens that she can assist us. On March 13th during an error-packed Under The Wire, Dorey presented a detailed performance outlining the absurdities that constitute the Nuremberg Code fallacy specific to COVID-19 immunisation. You may download the MP3 here, or listen below.
All of the points above popped up today in a thread on a COVID freedom fighter’s Facebook page. Elle Salzone is a feverishly active defender of anti-science beliefs. Elle moves from business to business, scheme to scheme and presently pushes ClearPHONE. Salzone and buddies sell the phone, claiming it provides the privacy necessary for today’s freedom fighters. How reliable a service it provides is uncertain. Elle fights with and also films police over her refusal to wear masks or remain in quarantine when necessary. But that’s okay if you decide to be a Sovereign Citizen. Elle is anti-COVID related responsibility. You can peruse her page for details on these pursuits.
Today one of her posts [Update: quietly deleted on 8 April] was screenshot by a tireless defender of reason, and thus came to my attention. It turned out to be an obvious forgery from this Allianz Product Disclosure Statement (PDS) and could be promptly demonstrated as such. The slideshow below is of the Allianz forgery and the two original parts of the document that were used in making it.
Salzone posts the forgery and states;
THIS IS EXTREMELY CONCERNING!!!!
Imagine getting the experimental shot thinking you’re protecting your health, then getting seriously injured and having no private health cover to help you and not being to sue because all vaccine manufacturers have been indemnified…
All to maybe protect you for a virus with a 99% Survival rate..
You literally can’t make this shit up..
“You literally can’t make this shit up”. In fact you can and in this case someone literally did. A quick search yielded the document in question. Even before presenting the original, un-cropped and pre-defaced, pages the text itself was screaming forgery. Insurance companies do not tend to torment font in that fashion. Apart from the caps lock, no policy section is referenced. Then there is the sneer at “vaccine” and the impossible consent self-infliction. Ouch! Finally at risk of boring you there’s that nagging bit about posting this most important development in the glossary.
Suffice it to say the above points were mentioned and a discussion took place.
Verified by multiple sources eh? The original source was “easily found” (comment now deleted) but Elle couldn’t find it. So screenshots of the original source were provided along with a link.
This resulted in an admission that it was posted in the knowledge it was a fake. Apparently however the information it conveyed is not only true but would be confirmed by Allianz if I checked;
For the record this forgery consists of four different screenshots from the original document pasted in a sequence that creates a misleading ‘preamble’ aiming to justify the bogus claims made beneath in added red font. The added text further presents existing terms from the Allianz PDS to construct a fraudulent disclosure statement. A significant amount of time and forethought has gone into this. It is a calculated work of disinformation that has succeeded in misleading vulnerable recipients of its message. The preparation date of the current Allianz Life Plan PDS is 5 march 2021. The date in the forgery is 31 July 2020, suggesting it could have been in circulation for some time.
Perhaps the most important aspect to look at is the claim that COVID-19 vaccines are part of an experimental “medical procedure”. This is frequently peddled by anti-vaccine activists and was also pushed by Meryl Dorey in the audio above. It is linked to other claims that the vaccine is not actually a vaccine. One contention is that mRNA vaccines are DNA modifying agents. Another is that viral vector vaccines [CDC] are completely experimental and also alter DNA. Despite available data on the molecular action, development, safety and efficacy of Pfizer, Moderna and AstraZeneca vaccines, antivaccinationists ignore this in favour of a conspiracy theory.
Viral vector vaccines are well understood due to decades of research and do not alter DNA. mRNA vaccines are also well understood and are incapable of altering DNA. The claim that COVID-19 vaccination is an experiment is often presented with the contention that the experiment will go on until 2023. Like all persistent falsehoods this has an element of fact to it. The reality is that in Australia both Pfizer and AstraZeneca vaccines have provisional approval from the TGA. The approval is valid for two years and the AstraZeneca vaccine will require review in February 2023. On 16 February 2021 the TGA stated;
COVID-19 Vaccine AstraZeneca is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for the active immunisation of individuals 18 years and older for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. […]
Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia. The approval is subject to certain strict conditions, such as the requirement for AstraZeneca to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment.
Reading the final paragraph above we can see also how the claim that data is still being collected for the experimental trial is peddled around with such confidence. Yet post-market assessment is a vital part to better understand all drugs and vaccines. There’s no trial, no experiment. It’s worth noting this fallacy is at times linked to another false claim. That of emergency use provision for the vaccine. This was a contention made by one Clive Palmer, deconstructed handsomely here by ABC corona check. Palmer has not alleged the COVID-19 vaccine rollout is an experimental medical procedure. Although he has pushed fear over the absence of one, three and five year safety data.
When it comes to hospital cover, insurance companies will not cover treatments for which no Medicare Benefits are payable. This includes cosmetic surgery, experimental treatments or experimental pharmaceuticals. Medicare will cover certain clinical research studies. For insurers if the device, trial or treatment is not recognised by Medicare or the Medical Services Advisory Committee it will be excluded from standard hospital cover. Still, there is insurance and indemnity available for clinical trials. This helps us understand why the term being used to misrepresent the COVID-19 vaccine is “experimental”.
Allianz also have a strong supportive position on the COVID-19 vaccine and like Bupa offer a comprehensive series of answers to possible questions. In a May 2020 article Allianz cover in depth the importance of research in developing a COVID-19 vaccine and the role of insurance for subjects in clinical trials. This is not what we would expect from a company that would deny insurance cover for adverse reactions post COVID-19 vaccine. Thus the claim by Salzone that refusal to cover is “verified by multiple sources”, in conjunction with the initial and consequent screenshot, appears to be disinformation. Insurance companies across Australia cover illnesses requiring hospitalisation following vaccination.
This leaves the obsession with claiming a 99% recovery rate as some type of stamp of insignificance. It is a rather tired trope having emerged about a year ago. This may also be linked to the frankly appalling claim that people die “with COVID, not of COVID”. Thus fatalities are incorrectly labelled an overestimation. Given this is pushed often by those who falsely insist vaccines kill and injure on a large scale it reflects a rather bizarre lack of compassion. As pointed out by USA Today the COVID-19 fatality rate is ten times that of influenza. More so it may be a serious diagnosis depending on age and health. To this we must add the emerging problems of ‘long haul’ symptoms perhaps in as many as 32% of those who have recovered from COVID-19.
In an interesting twist it was another wannabe COVID conspiracy-freedom-fighter who provided confirmation from Bupa that adverse reactions requiring hospitalisation are covered if their policy covers the treatment provided. It’s a bit of a story so another slide show is needed.
In the first image we see Bupa’s reply to anti-vaccine activist and COVID conspiracy theorist Matt Lawson, on social media. It outlines quite clearly that treatment covered by policy is available for adverse reactions post COVID-19 vaccination. In the next we see Lawson has engaged in a chat with ‘Cheryl’ from Bupa and presented this to Bupa on Instagram to challenge the prior response. The last screenshot was uploaded by Elle Salzone in the thread we’re discussing as another example of an insurance company denying cover to injury or reaction after COVID-19 vaccination.
Yet viewed in context we can see that during the chat Lawson supplied his policy number (image 3). So ‘Cheryl’ was answering in a specific sense, relative to his policy. This is absolutely in line with the claim made by Bupa in image 1 and also with feedback I’ve received from Bupa Australia. Still, image 2 reveals Lawson’s ill-informed, provocative reaction. The theme of acting with aggressive predetermined agendas is ingrained in the new age COVID conspiracy theorists. Matt Lawson reveals his conspiracy theory thinking when he writes;
Do you cover injuries caused by the convid19 experimental biological injection or not?
This comprehensive article reveals Bupa’s support for the COVID-19 vaccine and is in line with the position of global health authorities. There is no suggestion Bupa view the vaccine as experimental. Quite the opposite.
The letter mentioned in Lawson’s Instagram chat with Bupa Australia is circulating in social media within Australia. Within the Elle Salzone’s Facebook thread the image was uploaded twice, in support of the Allianz forgery. One commenter stated, “Another example shared of a void policy”. The second observed, “I think Bupa were one of the first…”. The image is below.
The text is as follows;
23 March 2021
Thank you for speaking to me.
I confirm that side effects arising from the COVID-19 vaccine are not covered under our exclusion for: Complications from excluded or restricted conditions/treatment and experimental treatment exclusion.
If you are injured whilst doing COVID-19 swab yourself, cover would be available towards the injury.
I hope this information is helpful. If there is anything else we can help you with, please call our team on the above helpline number.
Even if genuine, this letter has no impact on Australians. Peering at the Bupa letterhead we can confirm it is from Bupa Place in Salford Quays, Manchester U.K. Anti-vaccination activists will contend that the first paragraph confirms that side effects and complications from the COVID-19 vaccine are excluded from cover because it is an experimental treatment. The second paragraph conveys that insurance cover is available if one is injured, “whilst doing COVID-19 swab yourself”. In the U.K. home test kits are available.
Australians can also dismiss this as here it is illegal to advertise testing kits for serious infectious diseases. The TGA have a very clear warning to consumers and advertisers on their website. Thus there is no reason for Bupa to even consider such cover in Australia and Bupa members can disregard the letter and its claims.
Still, anti-vaccine claims are global in their reach, as is social media. If we take a cautious and in depth look into the origins of this letter there are different possible conclusions. It is a poorly written fake or a badly written follow up with a customer. Neither confirm the claim of an uninsurable experimental vaccine.
Bupa U.K. explain excluded and restricted cover in this Bupa Membership Guide [Archived]. This document provides a likely source for the information that the author presents with notably poor grammar. The opening paragraph is difficult to grasp. It may be that English is not the author’s first language.
With respect to the terminology used in the letter, on page 35 of the U.K. Bupa Membership Guide we find;
Exclusion 7 Complications from excluded conditions, treatment and experimental treatment
We do not pay any treatment costs, including any increased treatment costs, you incur because of complications caused by a disease, illness, injury or treatment for which cover has been excluded or restricted from your membership. […]
We do not pay any treatment costs you incur because of any complications arising or resulting from experimental treatment that you receive or for any subsequent treatment you may need as a result of you undergoing any experimental treatment.
On page 38 we find under Exclusion 16 Experimental Drugs and Treatment, this paragraph;
Please also see ‘Complications from excluded conditions/treatment and experimental treatment’ […]
There we have it. The text could have been copied and pasted in an extremely poor customer follow up, and that’s it above. Or copied and cobbled together in a dodgy forgery. The antivaccinationist lie of an uninsurable experimental vaccine is quite vocal on social media in the U.K. Yet under the glare of fact it is a demonstrably pointless effort.
In the U.K. COVID-19 vaccine side effects are covered under the Vaccine Damage Payments Scheme, established in 1979. This provides no-fault compensation for Adverse Events Following Immunisation. It is possible that offering cover is not an option for insurance companies. Either way, side effects are not covered by Bupa U.K. So it may well be that treatment of complications is classified as restricted and/or excluded regarding hospital cover.
The most important point here is that the COVID-19 vaccine is not an experimental treatment. Yet this letter is being pushed in Australian anti-vaccine circles to contend insurance companies are of the view it is experimental. Whilst a bogus claim, the overall forgery scam is reinforcing that claim in COVID conspiracy circles.
Bupa Australia are aware of this letter and have taken the chance to assure those who ask (such as the argumentative Matt Lawson) that cover is certainly available. When I raised this specific issue I was informed by Bupa Australia;
Private health care in the UK and Australia can vary greatly. But rest assured that our members will be covered for any hospital admission following an adverse reaction to the COVID vaccine, as long as the service is included in their cover, and any waits have been served.
Ultimately all the anti-vaccine points put forward by Elle Salzone and others on her Facebook page are demonstrably false. A search for insurance cover and COVID-19 vaccine adverse events yields results from around the world, not just Australia. For example cover for AEFI after the COVID-19 vaccine is available in Singapore whilst there’s a WHO compensation fund for people in developing nations suffering side effects. In general, insurance companies are involved in many areas specific to the COVID-19 vaccines, including in China where they are looking to cover adverse reactions.
Sadly some Facebook visitors to Elle Salzone’s page, who take her word on trust, are absolutely convinced of the dark side as this reply to me, packed with five pieces of misinformation, confirms. [Note – this is not from Salzone but a vulnerable visitor].
Sigh. Still all hope is not lost. As the well-known phrase from the X Files reminds us:
Whether genuine loss, disadvantage through the actions of others or continuing a failing streak, this year has served up a global platter. The COVID-19 pandemic has dictated that when it comes to denial of evidence SARS-CoV-2, its spread and how we managed the fallout were topics of choice. Conspiracies ran wild and we were even confronted with an infodemic. As usual so many who gain entry to these troubled pages are full throttle in a failing streak but convinced they have a winning strategy.
Denial of evidence may effect one in a small way. Such as rejecting the scientific consensus on the necessity of multi-vitamins and continuing to pay for expensive urine. Using vitamins or herbs to manage or “cure” an illness or injury can carry more serious implications. Not least being the shift in critical thinking that permits one to embrace an anti-science ideology, perhaps without initially realising this. Continuing to reject the scientific consensus on alternatives to medicine, one may ultimately delay seeking genuine medicine for a serious and ultimately terminal condition. Or refuse vaccination to prevent a nasty, harmful and potentially lethal condition.
Losers who believe they are on a winning streak inevitably ensure loss and disadvantage for the gullible who believe what they say or sadly for the innocents who rely on their judgement for health and wellbeing. The anti-vaccination movement continued unabated this year and swelled into a truly awful beast once it fed on COVID-19 disinformation. Necessary restrictions on crowd size and movement provided the ideal template for those already peddling terms like “health fascism” to insist the entire pandemic was a plot to control the population.
Of course this was a first world trend. Thanks to the positive impact of effective public health policies, education, medicine, law, public order and available media, quality of life is high. So high in fact we can invent faux abuses of our rights. Long before Karen from Brighton ignored travel restrictions because she had “walked all the streets” of that upper class suburb the notion of enduring lockdown to control the spread of COVID-19 was too much for self appointed freedom warriors. Social media losers vented their manufactured angst. Yet with our quality of life so good, a government that failed most frequently in climate policy and a P.M. who crept off to Hawaii during Australia’s bushfire crisis, it took months before ‘freedom day’ protestors gained attention. Even then it was for being deceptive in the making of their crisis.
Speaking of pretending life is tough, one term that kept popping up in anti-vaccine member emails was a favourite from AVN president Aneeta Hafemeister. “Show up. Speak up. Be brave.” The email linked to above was sent to members in mid January and peddled disinformation that the WHO had questioned vaccine safety. This calculated move involved the use of the WHO logo in the AVN press release. In fact Prof. Heidi Larson, Ph.D., Professor of Anthropology, Director of the Vaccine Confidence Project had spoken at the global vaccine summit in December 2019. The AVN selectively misrepresented what she said to convey a false impression.
On February 3rd the WHO legal counsel wrote to the AVN warning them to stop using the logo and to make it clear the press release was not approved by the WHO. In what would become a signature move for the AVN over 2020 they cowered into submission removing the press release and posting the WHO letter on their site. This was accompanied by standard antivax rhetoric and the claim that they had “responded” to the WHO. Members would be kept informed of “all correspondence”. But of course the WHO would never reply to their delirious mandates. Nor, later in the year, did any of the councils, parks or a business that banned their bus.
Hafemeister’s quote on being brave hadn’t really hit home at AVN Central it seems although it continued in member emails. Hafemeister would take her quotes to bizarre levels. In a May Facebook video promoting the AVN Vaxxed bus she went so far as to voice the worn out anti-vaxxer quote from Margaret Mead. Hit the audio button below or delight in the MP3 file.
“So never doubt that a small group of people can change the world because indeed it is the only thing that ever has”. AVN president Aneeta Hafemeister May 31st 2020.
There’s little point restating the AVN’s exploitation of those who have lost a loved one to death or injury and are vulnerable to the ‘vaccine injury’ profit machine. You can delve into the reality behind the scheme here and marvel at the scope of the delusion on sale here. Meryl Dorey scored extra points for claiming in April that her personal opinion was that viruses could only be transmitted by injection, then deleting the comment once it was made public.
The politicisation of hydroxychloroquine began on the back of Donald Trump’s endorsement of the drug. Despite a number of studies demonstrating cardiac problems linked to the drug shortly after and ultimately refuting its worth  the “triumph of hope over facts” continues on Twitter and elsewhere. It seems to be linked to denial of evidence supporting lockdowns and the use of PCR. A strong supporter of Trump and hydroxychloroquine is Chris Kenny of Sky News. Kenny is a stand out loser in our apparently lucky country. He has spent an inordinate amount of time this year launching attack after attack on Paul Barry, Media Watch and the ABC.
I covered this back in May and had a good look at Kenny’s flawed defence of hydroxychloroquine. His argument was simple. There are studies not yet finished. Thus Paul Barry who, Kenny repeats ad nauseam, hosts the most expensive 15 minutes of TV in Australia should apologise to his audience who, he also repeats ad nauseam, pay for the show. Kenny wrongly kept referring to a QLD study. The study however is looking into a very specific application of hydroxychloroquine for healthy young health professionals as a preventive measure. It is not studying the impact of treating COVID-19 with hydroxychloroquine. Kenny should be the one apologising.
In May he claimed “Barry and Media Watch preach global warming alarmism, promote leftist climate policies [and] defend the ABC”. Well. That does sound a lot like presenting the evidence News Corp tends to suppress. All this was part of an attempt to accuse Paul Barry of holding a biased opinion against George Pell despite his successful appeal. At the time I pointed out that Barry was the only journalist to argue that claiming Pell had simply been found “not guilty” was flawed. Barry argued that as one is innocent until proven guilty Pell was in fact innocent. Kenny however had taken a statement of Barry’s out of context and informed Sky viewers, “How about that for fairness and courage? What a whimp“.
It was a low point for Kenny who promotes himself as an arbiter of the ABC and Media Watch. As I covered back in May, Paul Barry had not only defended Pell but had soundly criticised the ABC for biased reporting on the topic in certain areas on certain shows. Well surprise! On 18 December Kenny presented his latest episode attacking the ABC. It included unsubstantiated comments about ABC bias toward Pell. One of the clips Kenny used to support this was the part of the Media Watch segment I’d cited in which Barry highlights the failure of Louise Milligan and Four Corners to report on Pell’s defence. This again shows Kenny to be biased in selection of material and deceptive in its omission.
Episodes of The Kenny Report (2020) devoted to attacking the ABC and Paul Barry have reached twenty that I know of since April. One included citing Alan Jones’ praise for hydroxychloroquine. That’s a handy introduction as Jones deserves a mention for appearing on Pete Evans’ podcast for a lengthy interview. You may subject yourself to the podcast here. It perhaps goes without saying that there’s enough on Pete Evans being an enemy of reason this year to satisfy the greatest of curiosities. There’s nothing I can add to it.
Judy Wilyman however. Well that’s a different story. She featured quite a lot supporting pretty much every COVID conspiracy going. Hosting service of her newsletters, Mailchimp, had clearly had enough. They closed her account and deleted all of her archived newsletters. Judy was not happy. Many others were delighted schadenfreude style. Wilyman claims COVID is a hoax and for years knew such a scam was coming. Perhaps most bizarre was the Natural and Common Law Tribunal for Public Health and Justice on which she sat as a judge. Using the International Criminal Code this group indicted most world leaders, international banks and entertainment companies, developers, inventors, etc, etc.
The 108 page indictment is too long for this post but some observations on Wilyman are crucial. On page 100 we learn that Prince Charles, Bill Gates, Elon Musk, Google and Ray Kurzweil are involved in creating a;
5G/AI artificial intelligence Coronavirus as a nanoparticle energy weapon [delivering] remote energy virus, virus, bacteria or other form of artificial intelligence induced remote directed energy weapon as part of a 5G/AI Coronavirus Genocide….
And that they;
…are entrained by and in criminal co-conspiracy with PPAI, a sentient Off-planet, predatory, pathogenic, invading Inorganic AI Artificial Intelligence, and are “entrained AI proxies, AI hosts, and AI sponsors” in creating and maintaining the 5G/AI Coronavirus Genocide that is causing imminent and irreparable harm to all human beings similarly situated.
Also these villains;
…appear to be among the key PPAI-entrained AI proxies, AI hosts, and AI sponsors for the sentient Off- planet, predatory, pathogenic, invading Inorganic AI Artificial Intelligence.
And I thought Musk’s greatest crime was naming his child.
Prince Charles also apparently covered up the invading alien intelligence and had the British Royal Society investigate potential problems with nanotechnology. This led to some media chatter about gray goo. The British Royal Society concluded in 2004 that such technology was too far in the future to be a problem worthy of present concern. Ergo, we were duped and horror awaits us.
Wilyman actually published this article about the tribunal on her site at the time. It was later deleted. It’s worth speculating as to why. Perhaps Brian Martin who has published two papers defending her from accusations of conspiracy theory thinking advised her to think it over. Also one James Lyons-Weiler who publishes antivax articles is keen to promote a scholarly face with antivax ’studies’. He endorsed Wilyman’s work in December last year and was the praise-singing, reviewing editor of her most recent publication, ‘Misapplication of the Precautionary Principle has Misplaced the Burden of Proof of Vaccine Safety’.
US resident Lyons-Weiler deserves a mention for his November 2020 paper contending that vaccinated children are less healthy than unvaccinated. Manifest flaws with key methodology are presented here. The AVN donated US $5,000 to this project. The money had come from donations for previous projects such as a promised High Court challenge to the No Jab No Pay legislation. The remaining float was just under AU $80,000. In a February 2019 email they urged members to donate to a GoFundMe page to help fund the study. It’s worth noting that funds raised for a purported challenge to Australian legislation were ultimately given to a US anti-vaxxer to help fund his US based project.
Brian Martin must surely be mentioned for evidence denial in 2020 thanks to publication of his paperDealing with Conspiracy Theory Attributions in April this year. It focuses on defending both Judy Wilyman and the AVN from having conspiracy theories “attributed” to them. Granted these are very specific conspiracy theories and his publication is, shall we say, unique. However Brian still fails to grasp the larger issues of academic veracity and intellectual honesty involved here. Issues of public health sabotage aren’t quite ready for semi-philosophical musing.
Judy Mikovits and her appalling Plandemic scam must of course be mentioned. Not least because despite heroic efforts to convince critics of the validity of her claims so many were able to be deemed fake as soon as she spoke. For example her reliance on the study of Greg Wolfe was tacky. Claiming his research supported her contention was demonstrably fallacious. His research sample was during the 2017-2018 winter. Long before COVID-19 was detected. He later wrote a Letter to the Editor stressing the error of anti-vaccine claims. Of her claims.
A special mention must go to all those who have misrepresented the risk of COVID-19 vaccines before distribution but particularly after. Cases of anaphylaxis were rare given the total number of vaccinations. One wonders how the anti-vaccine lobby would react if peanut butter sandwiches were rolled out to the same population. The mysterious-cannot-be-found Khalilah Mitchell, RN with Bell’s Palsy was so clearly suspicious I wondered at why it was picked up so quickly.
There are so many I would like to mention but time does not permit. Do visit the many fact checking publications and sites that are available.
Last week AstraZeneca announced demonstrated varying efficacy in two different dosing regimens of its candidate COVID-19 vaccine, AZD1222 (ChAdOx1 nCOV-19).
In a November 23rd press release [PDF] the company announced efficacy of 90% when AZD1222 was given as a half dose and followed by a full dose at least one month later. This sample group had 2,741 subjects. Vaccine efficacy of 62% was evident when two full doses of AZD1222 were given at least one month apart. This was observed in a sample group of 8,895. They also announced a “combined efficacy” averaging 70% in a sample of 11,636.
Whilst this sounded like a positive outcome it soon became apparent that the Oxford-AstraZeneca team still had hurdles to clear. It emerged later that the dose regimen yielding efficacy of 90% was given by mistake. This wasn’t made clear in the press release. The first dose should have been a full dose but due to a “manufacturing issue” only half of the expected dose was given. Regulators were told at the time and agreed the trial could continue with the immunisation of more volunteers. It is problematic that the trial wasn’t designed to test this regimen and less than 3,000 subjects aged 55 or less were involved. In order to validate the results another study examining the efficacy of the regimen will take place.
The other problem was the notion of “combined efficacy”. These data come from two different trials with different dosing regimens. One trial arm in the UK began in May. The Brazilian trial arm began in late June. So this information has not come from a single large Phase III trial as was the case with Pfizer and Moderna. Averaging efficacy from two different trials to yield “combined efficacy” of 70% is not acceptable. This doesn’t provide a sound assessment of what level of efficacy, or regimen, the public can expect. So again, further trials are needed. Also press release is not the vehicle to present scientific information and the AstraZeneca issue is an example of how problematic this can be. Study specifics that have been peer reviewed carry far more weight.
Which raises a point made by Norman Swan on today’s Coronacast that rumours are circulating, apparently with very little confirmation, that suggest Oxford-AstraZeneca are rushing to publish. He referred to a Financial times article which reported on Saturday;
Regulators and the rest of the world will soon have the full data. The Oxford academics who developed the vaccine have submitted a paper setting out their full Phase 3 results to The Lancet medical journal. They will be working over the weekend to answer questions from the journal and its referees and the article could be published as early as Thursday [UK time].
Concern and criticism about transparency and trust has been raised, particularly in the USA. Natalie E. Dean, assistant professor of biostatistics at the University of Florida posted a series of tweets on November 25th. Apart from transparency, concern about scientific rigour was raised. Her tweets included;
AstraZeneca/Oxford get a poor grade for transparency and rigor when it comes to the vaccine trial results they have reported. This is not like Pfizer or Moderna where we had the protocols in advance and a pre-specified primary analysis was reported.
The point about protocols in advance, along with the fact that AstraZeneca was one of nine vaccine makers to sign a scientific rigour pledge in September was raised in a highly critical article by Hilda Bastian writing in Wired. The article goes into the Phase III trial arms in depth and the manner in which Oxford-AstraZeneca has deviated from their trial protocol. Comparisons are made to the BioNTech-Pfizer vaccine at 90% efficacy and the Moderna vaccine at almost 95% efficacy. Bastian certainly casts them in a positive light. These two companies use messenger-RNA as the vector in their COVID-19 vaccines. Oxford-AstraZeneca use an adenovirus vector in their vaccine. How variously each approach effects COVID-19 vaccine efficacy is presently unknown. The Moderna and Pfizer vaccine results were also made public by press release.
It’s important to note that the FDA has argued a vaccine must be at least 50% effective to be useful in combating the pandemic. Whilst concern has been raised about the AstraZeneca situation it is over efficacy and not safety. The fact that regulators will accept an efficacy of at least 50% was noted by Mene Pangalos, AstraZeneca’s executive vice president for research, who dismissed concerns. AstraZeneca also want to alter the specifics of the US trial under the auspices of Operation Warp Speed. The aim is to change the two full dose regimen to a half dose, full dose regimen.
Certainly further successful trials are well within AstraZenecas grasp. The BMJ recently published COVID-19 vaccines: where are the data? The article examines the position of the three recent candidate vaccines and what is expected through peer-reviewed publication. The UK government has asked the Medicines and Healthcare products Regulatory Agency to evaluate authorising supply of the Oxford-AstraZeneca vaccine.
The cold chain needs of each vaccine vary. The Pfizer candidate requires storage at -70 degrees Celsius. This alone provides a challenge difficult to meet in developed nations and impossible in nations without significant infrastructure. Moderna’s candidate vaccine can be stored at -20 degrees Celsius meeting most pharmacy and hospital freezer temperatures but providing transport challenges for developing nations. Moderna claims that after thawing the vaccine will remain stable for up to 30 days at 2 – 8 degrees Celsius. AstraZenecas candidate can be stored in a normal refrigerator at 2 – 8 degrees Celsius and thus meets conditions in present healthcare settings and realistic options in developing nations. A successful outcome for Oxford-AstraZeneca is significant for the management of a global pandemic.
And remember, this is a vaccine that they promised not to make profits out of, that is cheap and they are committed to giving very large doses, I think something enormous like a third of the world’s doses of vaccines are relying on AstraZeneca. So there’s a lot riding on this vaccine.
The anti-vaccination community have taken the challenges faced by AstraZeneca as more evidence Big Pharma is always up to no good. A recent AVN Facebook post observed that maybe it wasn’t a good idea to let drug companies release their own study information without independent oversight.
So again we might consult the press release. It includes (para 3);
An independent Data Safety Monitoring Board determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine. No serious safety events related to the vaccine have been confirmed. AZD1222 was well tolerated across both dosing regimens.
Our Directors are collectively responsible for the success of AstraZeneca. In addition, the Non-Executive Directors are responsible for exercising independent and objective judgement and for scrutinising and challenging management.
Quickly scattering the seeds of disinformation in this manner is what the AVN always do. One expects this manipulation of their members. What I’m more interested in is the inability of the group to acknowledge that the focus on COVID-19 vaccine development has revealed a number of long standing claims to be false. In September I posted on how the Oxford-AstraZeneca trial pause alone refuted long standing anti-vaccine claims. Namely transparent mainstream media coverage and the documented process of Phase III trials. Despite the ample criticism of AstraZeneca’s handling of data the AVN are even further from defending their claims than they were in September.
As a quick reminder it is the claim that vaccine manufacturers do not assess the safety or efficacy of vaccines. Ever. Added to this is the strange insistence that a placebo must always be inert. Let’s revisit quotes promoting these errors. Given that the COVID-19 candidates are new vaccines the following quote published in a response to a journalist is particularly relevant. See Proposition 4;
…there have never been double-blind, placebo-controlled prospective studies done on either the safety or efficacy of vaccines, not even when a new vaccine is introduced.
This piece on HPV is highly misleading. Yet it’s the claim in the second paragraph under Safety In Question I find compelling;
By definition, a placebo must be a totally inert substance which will never provoke a response.
That definition might be fine for the “sugar pill” placebo. As in when we think of the “placebo effect”. Yet in vaccine trials it is more important to sustain the double blind nature of the trial. Simply put a subject must not know what group they are in. The AVN are anti-HPV vaccination. Gardasil trials have used the amorphous aluminium hydroxyphosphate sulphate adjuvant, or AAHS as placebo. This, unlike saline, produces an injection site effect like a genuine vaccine. Thus members of the placebo group and those administering the dose are unaware they have received or given the placebo. The randomised double blind nature of the trial is preserved.
Double blind randomised control trials are what Meryl Dorey, founder of the AVN calls “the gold standard” insisting they are ignored in vaccine research. The claim is part of the AVN Did You Know? leaflet. In this case demanding only inert placebos be used helps to both refute the value of trials and contend a heavy metal neurological injury is potentially caused by adjuvant placebos. The impact of this rhetoric can be seen below in an image of an interviewee on the Vaxxed II bus (27 Nov. 2020). Her T-Shirt has the words “gold standard science” and “inert saline placebos” amongst others written on it in Texta.
Finally as discussed in this article, by contending that no vaccine trials using saline placebos have ever been conducted the insistence that vaccines are primed to harm persists. It’s a simple no true Scotsman anti-vaccine fallacy. Also when saline is used as the placebo in an HPV vaccine trial, there really is nowhere to hide. Vaccine studies using saline placebos abound. Period.
As it happens saline has been used in the USA arm of the AstraZeneca Phase III trials. In other groups a meningococcal vaccine is given as placebo. This won’t only create an injection site effect but a general feeling in line with being vaccinated. Not being aware they are receiving a placebo ensures subjects don’t introduce an unexpected variable to the trial. This fact, and the ethical nature of the approach is discussed in a well written article here. Finally in establishing the safety of vaccines a more convincing and in depth picture is gained through the application of more than just placebo controlled studies.
The more we see of Phase III trials for COVID-19 candidates, whether they be immediately accepted or controversial, the greater the refutation of the above anti-vaccine tropes. Senior members of the AVN are reading material that describes Phase III trials and their testing of both safety and efficacy. The above claim that double blind, placebo controlled trials don’t exist, “even when a new vaccine is introduced” still exists on the AVN website and in discussion. In the bright light of facts this is a true measure of the group.
The Oxford-AstraZeneca AZD1222 results have been met, understandably, with specific criticism. This relates to efficacy only. Safety is not being questioned. Some media reports have hinted that AstraZeneca will have difficulty getting the vaccine regulated for emergency use in the USA based on present data. Further, larger studies are needed to establish the veracity of the 90% efficacy finding in the smaller sample given a half dose followed by a full dose. This is entirely within reach of AstraZeneca.
Given the unscientific notion of a “combined efficacy” of 70% it is within AstraZeneca’s interests to pursue further research. Indeed everything being equal one may hope that the “combined efficacy” rate is not reinforced with further research. As STAT reported;
If it’s 70%, then we’ve got a dilemma,” said Fauci. “Because what are you going to do with the 70% when you’ve got two [vaccines] that are 95%? Who are you going to give a vaccine like that to?
AstraZeneca’s AZD1222 vaccine has enormous potential. The low cost, cold chain specifics and the company’s offer to not profit from the vaccine meets a global imperative for pandemic recovery. What the scientific community and the public need to see is a large robust Phase III trial that reproduces efficacy in the region of 90%.
During the Vaxxed II bus tour in Australia the AVN has been extremely vocal about the tour’s aim to realise the rights of individuals and families “killed or injured by vaccines”. To give them a platform on which to exercise free speech. In the last post we heard Meryl Dorey accusing Australia’s “fascist dictatorship” of suppressing the voices of the vaccine injured. In the midst of Dorey’s vocal insistence of selfless goals we must remind ourselves of other goals. An email to members on 8th July 2020 described the noble aims of the Vaxxed II bus and included;
Parents will be filmed for an up-coming Australian documentary as well as having their stories livestreamed to hundreds of thousands around the world.
We are the media now… We have to get the best footage we can, make the best job of this and make our own documentary. This will be the Australian version of Vaxxed II I assume.
As we will see below involvement with Vaxxed films can prove quite lucrative. However the claims of a vaccine injury epidemic (or VIE) are not backed by evidence. The science supporting public health policies demonstrates a different reality. Protection of public health must, in an age of social media, also address the abuse of free speech. It causes demonstrable, long lasting harm of significant individual, social and financial cost. Such harms were addressed when the Vaxxed II bus was banned from local council land by Sydney City Council in a unanimous decision on October 26th. You can access Facebook entries, read related council material, hear audio of the motion being passed and the AVN reaction via this link.
Four days after the council took action the bus was again told to move on. As noted in the last post the Vaxxed II bus had chosen to set up in Centennial Park NSW on October 30th. The park is itself a suburb split between the local government area of the City of Sydney and the City of Randwick. One presumes that being banned from Sydney, the bus team has chosen a park area of the Randwick local government. Nonetheless they were asked to move on. After receiving legal advice Meryl Dorey came to a very amicable agreement with police and left.
Shortly before this however park rangers had raised Meryl’s ire, leading to a video request for help and the promise that she would be arrested before conceding to “these petty dictators”. The full audio of that video is here [4.9MB]. A shorter version of highlights can be listened to below.
“We are here to ensure their voice is never silenced” – Meryl Dorey [2min 16]
It is interesting that Dorey wants Polly Tommey to be notified. As we’ll see Tommey is a senior identity in the Vaxxed movement having turned the role into full time employment. Regarding the Vaxxed II bus one conclusion is certain. A large database of Australian anti-vaccination and unverified vaccine injury testimonial is being created. Every time the Vaxxed II bus is banned or asked to move on the database is threatened. Under the Vaxxed brand such material has already proven to be both lucrative and an ideal vehicle for the promotion of individual anti-vaccination identities. The rewards from co-producing a Vaxxed III film would be significant. As the AVN is using the Vaxxed brand there are likely contractural obligations, increasing the need to inform Tommey of interference.
The first Vaxxed film led to a Vaxxed bus travelling the USA, promoting the film and recording identical unsubstantiated testimonials of vaccine injury and vaccine fatality. The most compelling of these accounts formed the basis of Vaxxed II: The People’s Truth. Now a year after the release of Vaxxed II the AVN is four months into the Vaxxed II bus tour. Meryl Dorey and AVN president Aneeta Hafemeister have already established a narrative of struggle against tyrannical state and federal governments actively suppressing accounts of vaccine injury and death. This is happening during the COVID “scamdemic” and vocal AVN opposition to a mandatory or dangerous COVID-19 vaccine. Footage of these unsubstantiated accounts would be used in the production of an Australian version of Vaxxed. Dorey has a long established history of presenting photos of children purportedly injured or killed by vaccines. Stories are hosted on the AVN website. A closer look at the Vaxxed timeline allows greater insight into long term aims.
The making of Vaxxed
We should revisit the history of the pseudoscientific films under the title Vaxxed to understand how such film making and busses are related. First was the 2016 film Vaxxed: From Cover-up to Catastrophe directed by Andrew Wakefield whose elaborate fraud launched the global scare over the MMR vaccine and autism. It was produced by the Informed Consent Action Network of which Del Bigtree is CEO. Bigtree’s background in filmography included a small stint with Dr. Phil and the production of 30 episodes of an entertainment advice show The Doctors. The latter carried an FDA disclaimer. Vaxxed was co-produced by Polly Tommey who is a director of the Autism Media Channel (previously also run by Wakefield) and presently hosts We Are Vaxxed (Vaxxed TV).
A full time vaccine-autism theorist and frenetic anti-vaxxer, Tommey is presented by Hachette Australia as a film producer and journalist, and also, “[F]ounder and Editor-in-Chief of The Autism File magazine and founder of The Autism Trust”. Vaxxed’s entire narrative is built from the audio of phone calls between CDC employee William Thompson and anti-vaccination theorist Brian Hooker. Part of the audio was even spliced together. You can read in detail, and listen, about how the audio was manipulated here. There are a host of references debunking the film here.
Thompson was unaware that the calls were being recorded or that his name and voice would be used. He had referred to a correlation between African-American boys with autism and the MMR vaccine that was omitted from a 2004 CDC paper. The sample was omitted because the boys were diagnosed with autism before they were vaccinated. MMR is just one vaccine that secures eligibility for autism services. Brian Hooker published a reanalysis of the data in 2014 which purportedly found that the sample of boys were at significantly higher risk of autism after MMR. The paper was later retracted due to “serious concerns about the validity of its conclusions” . In 2015 the CDC concluded on further examination that the correlation did not exist. William Thompson unwittingly became the CDC whistleblower. Despite hours of recorded phone calls none of that audio supports the film’s central claim of “cover up”. Nor does Thompson appear in the film.
At no time did Thompson argue that data had been suppressed or destroyed or that it demonstrated a link between MMR and autism. Yet the narrative of data destruction, nefarious suppression of a causal link between MMR and autism and the contention Wakefield is the victim of a conspiracy is the central message of the film. In reality the data remain on the CDC website for researchers to analyse. Thompson had released a statement through his lawyers in August 2014 in which he stressed his support for immunisation and his belief that “vaccines have saved and continue to save countless lives”. All of this, and the retraction of Hooker’s paper was omitted from the film. I recommend reading this deconstruction of the claims in Vaxxed which expands on the details that are misrepresented in the film.
In an October 9, 2016 Vaxxed TV video Del Bigtree stood in front of the Vaxxed bus and claimed;
The story that Vaxxed is about which is the CDC whistleblower, top scientist from the Center for Disease Control, has come forward and said that vaccines are causing autism.
Memorably, Vaxxedwas dumped from the New York based Tribeca film festival which Robert De Niro co-founded. Award winning documentary director Penny Lane had written an open letter to the festival about Vaxxed. It is devastating to the credibility of Vaxxed. It included;
While it is true that we documentary filmmakers constantly debate vexing questions about the perceived and real differences between our work and the work of traditional journalism, I assure you that we are not debating whether it is okay to knowingly spread dangerous lies.
Issues around truth and ethics in documentary can get thorny. But this one is easy. This film is not some sort of disinterested investigation into the ‘vaccines cause autism’ hoax; this film is directed by the person who perpetuated the hoax.
On July 10 this year AVN founder Meryl Dorey interviewed Wakefield for an episode of Under The Wire (UTW). They discussed his latest film 1986 The Act, Vaxxed, the COVID pandemic and Wakefield’s research fraud. His contention is that he was deregistered in an attempt to silence revelation of MMR causing autism. “[I]t was all made up. I’ve never committed research fraud in my life”, he told Dorey. Wakefield mentions that Australian paediatric gastroenterologist John Walker-Smith was part of his research team. In fact Walker-Smith had told Wakefield about possible compromise of the research a year before publication because parents of research subjects were engaged in litigation against pharmaceutical companies.
As the world now knows Wakefield was well aware of the litigation, as he was secretly funded by the plaintiff’s lawyers to conduct the research. His research paper was eventually retracted fromThe Lancet. He was ultimately found guilty of more than 30 charges. Articles here tagged “Wakefield” are under this link. The full audio of Dorey’s UTW interview with Wakefield is available here [28 MB]. Interestingly he tells Dorey that the key to 1986 The Act was is not the “dense” content, but in making it entertaining by having a couple act to a script (10.20). Wakefield’s response to Dorey’s question is available below.
“How can I help?”: Andrew Wakefield’s account of his deregistration and research fraud [3min 59].
When members of the USA Vaxxed team visited Australia and toured with the AVN from July to August 2017 to screen the film and collect vaccine injury stories, early criticism and problems eventuated. Most notably that on leaving Australia, co-producer Polly Tommey was banned from entering the country for three years over visa breaches. Fairfax reported she had told her Australian audience that “doctors were murderers”.
The involvement of Tommey continued. In October 2017 Tommey announced the Australian Vaxxed team on the We Are Vaxxed Facebook page. It would include Taylor Winterstein, her sister Stevie Nupier and Deveraux David, daughter of (then) AVN president Tasha David. The three had travelled about on the Vaxxed bus in the USA with Tommey, learning how to conduct vaccine injury interviews. For further insight please see the comprehensive coverage at Diluted Thinking in Australian Vaxxed Team Announced.
Tommey’s supporters and the AVN insisted she was banned for her views on vaccination. Tommy appealed against the suspension and on July 15th 2019 the AVN reported in a “media release” that Judge Barnes of the Federal Circuit Court of Australia overturned the ban, reinstated the visa and awarded costs to Tommey. The following day the Informed Medical Options Party (IMOP) reported the same information on their Facebook page. It must be noted that no other media reports of the overturned ban exist. Neither group provided a link to, screenshot or image of relevant documentation despite publishing quotes from Judge Barnes’ finding. Under the heading A victory for truth and justice in Australia each publication included;
The AVN assisted Ms Tommey in fighting against this unconscionable ban. The Minister for Immigration tried to claim that Ms Tommey, a mother of 3 children, one of whom has been seriously injured by vaccination, was somehow a terrorist and needed to be kept out of Australia.
The importance of this can’t be underestimated in light of the language used by the AVN. The overturning of Tommey’s ban is a mark of a fair democracy in action. The suppression of rights in a so-called “fascist dictatorship” is then far from accurate.
It was reported at the time that another member of the 2017 visiting AVN Vaxxed team Dr. Suzanne Humphries was also banned from entry for three years. SBS updated an article to this effect in August last year. In late August 2017 anti-vaxxer Kent Heckenlively was denied entry into Australia because of his “dangerous” views. He was planning a tour to urge parents to stop vaccinating their children. The ban was not surprising. Just over two weeks earlier the Australian Government had launched a $5.5 million immunisation education campaign in response to the anti-vaccination message and falling vaccination rates. Nonetheless, Tommey and Heckenlively hosted Q&A sessions at AVN Vaxxed events via Skype.
The AVN Australian promotion of Vaxxed was further criticised. Prior to the Bundaberg QLD visit the Fraser Coast Chronicle published a piece in which (then) QLD Health Minister Cameron Dick called on the public to boycott the film. On October 22nd The Chronicle published a piece in which doctors warned of the film’s risk to children’s lives. The chair of AMA QLD was concerned parents could be “duped” into believing the anti-vaccination message. There was further criticism and coverage. An in-depth overview of the tour events is available at Diluted Thinking.
The use of Vaxxed busses
After the film’s release the 2016 Vaxxed Nation Bus Tour in the USA rolled out to promote and screen the film to paying audiences. Dorey and then president of the AVN, Tasha David, attended a CDC rally as part of an elaborate trip to the USA presumably at expense to AVN donors. During the tour unsubstantiated claims of vaccine injury and death were recorded on film forming the purpose of the We Are Vaxxed movement. Over the weekend of October 15-16th 2016, Tasha David appeared as an interviewee for We Are Vaxxed. Her fallacious contribution included claims there is no freedom of speech in Australia, the public can be “force vaccinated” for something as minor as a cold under the Australian biosecurity act, No Jab No Pay has left women living in cars and forced to have abortions and the AVN cannot choose their own name. This article published at the time looks more closely at these claims which can be heard below.
Past AVN president Tasha David interviewed in the USA Vaxxed bus [1min 50].
The bus continued its tour of the USA collecting unfounded stories of vaccine injury, death or apparent abuse and bullying at the hands of medical professionals. Popular targets were vaccination against HPV, hepatitis B, pertussis (DTaP), influenza, varicella, Hib, rotavirus, or any childhood vaccine. SIDS was blamed as a vaccine induced death often post DTaP. Horrific stories about the effect of autism brought on by MMR or other childhood vaccines were common. The bus is covered with the signatures of individuals who contributed a story.
This material provided the basis for Vaxxed II: The People’s Truth which was released in November 2019. It was produced by Robert F Kennedy Jr and co-produced by Polly Tommey. The Guardian previewed the film and reported that it;
[I]s slickly produced and carries considerable dramatic punch – making its message all the more potent.
Footage includes a gallery of photographs of dead babies, without evidence to back suggestions their deaths were linked to vaccines.
The Australian Vaxxed II Bus
So now we turn our attention to the Vaxxed II bus tour of Australia. An identical bus wrapped in an identical Vaxxed logo, serving an identical purpose. The bus is a 34 foot 2005 Coachmen Miranda registered in NSW as VAXXD2. Market availability suggests a quality 2005 model may sell for between $100,000 – $135,000 and similar models have varying prices. The interior of the AVN Vaxxed II Miranda is well appointed. The new paint finish with an AVN logo, personalised plates and even a logo’d spare wheel cover has delivered a quality, eye catching vehicle for the Australian tour. It too is being signed by everyone who contributes to a story. It has been registered, insured, made road worthy and prepared in the manner a Coachmen Miranda must be. It was certainly not a cheap venture and according to the AVN “a massive undertaking”.
Donation requests for the bus began on 16th February 2020 – the same day sales of Vaxxed II: The People’s Truth DVD’s were announced via email. Shortly after, the AVN shop provided a formal bus donation page. The set request was $50 and the range was from $5 to $500. 82 days after provision on the AVN site for donations to the Australian Vaxxed II Bus the announcement of bus ownership was made. If we accept a conservative total cost of $150,000 donations must equal $1,830 per day. Once rolling there are costs for accomodation and meals for volunteers along with the necessary $400 plus to fill the tank. Donations had been generous indeed.
It’s important to note the AVN have a history of accumulating member donations [PDF] for many purposes and not investing them. Misappropriating a minimum of $136,270 for the sale of a magazine that was not supplied and simple theft. More than once. In 2010 the NSW OLGR confirmed multiple breaches of the Charitable Fundraising Act 1991 and the Charitable Trusts Act 1993 . In December 2016 the AVN announced that their planned High Court challenge to the No Jab No Pay legislation was unsuccessful. Of $152,203.73 raised $72,526.37 was spent on legal advice, leaving just over $79,677. The AVN offered to refund 52 cents for each dollar donated (email) and then 66 cents (website). The money was kept for other campaigns. No follow up announcements were made. Of interest is that in September of that year members were advised over $160,000 had been raised for the High Court challenge but over twice that was needed. So please keep donating.
Regular income is from donations, memberships, AVN shop sales and sales at seminar events. Fair trading documents show annual income is declared as “less than $250,000”. The point being made is that the AVN may have a substantial balance of which financial supporters know nothing. The AVN may have financed the bus themselves. Anti-vaccination media coverage increased 900% over March – May this year. This equates to increased profit for the AVN and may assist in keeping the bus on the road.
The AVN team is very excited to announce that WE HAVE PURCHASED A BUS! Things have been very busy behind the scenes to make this vision a reality and we can’t wait for the next steps in this process. We can’t wait to bring you more updates as things progress. The AVN is extremely thankful to all the AVN members who have contributed to this project and made it a reality.
A media release on 8th June 2020 was equally noncommittal with respect to the entire funding of the purchase;
Thanks to the help and support of members of the Australian Vaccination-risks Network Inc. (AVN), Australia has become the first country outside of the United States to have its own Vaxxed Bus. […]
The AVN owes a huge debt of gratitude to our members, without whose help, love, encouragement and financial support, this dream never would have been realised. We also want to take this opportunity to sincerely thank Polly and Jon Tommey, Dr Andrew Wakefield, Del Bigtree and the entire US Vaxxed team whose dedication and energy has birthed a worldwide movement of informed vaccination choice for all.
That final statement of gratitude leaves one wondering just how much of the new bus venture members of the AVN were truly supporting. Perhaps it is cynical to link the bus to a long term goal of financial profit and self promotion for Meryl Dorey. After all, according to the first AVN email to announce the need for a bus readers were told, “Our members have demanded it, so it’s going to happen”. A lot of time and money would be involved, yes. “But due to the current climate of censorship on the issue of vaccine injury we feel the time is now!”.
Since the bus appeared urgent requests for donation campaigns have stopped. It is not unreasonable to conclude that this present incarnation of the Vaxxed brand has included some funding from outside the AVN. Nor does the AVN own the Vaxxed brand. Thus, all profit from a third film will not go to the AVN.
Financial backing of the Vaxxed movement
Thoughts of money bring us back to the Informed Consent Action Network (ICAN) who we met above as the producers of Vaxxed: From Cover-Up to Catastrophe. Also we can better understand why involvement with Vaxxed films is lucrative. The Washington Post published an in-depth investigative article in June 2019. Meet the New York couple donating millions to the anti-vax movement examined hedge fund manager and philanthropist Bernard Selz and his wife Lisa, who is president of ICAN. Amongst other anti-vax groups, the Selz’s donated handsomely to ICAN through the Selz Foundation.
When Vaxxed was released in 2016 Bigtree founded ICAN. US tax records show that in its first year the Selz’s donated 83% of ICAN’s income, or $100,000. As Bigtree’s status grew so did Selz Foundation donations. Records show ICAN spent $600,000 on legal fees in 2017. The following year, according to The Washington Post, the charity launched FOI Act lawsuits against the FDA, NIH and the US DHHS. The aim was, “to compel the release of data and documents related to vaccine safety”. If ICAN had any success accessing documents, their silence on the matter speaks volumes.
In 2017 the Selz couple donated $1 million of ICAN’s $1.4 million income. CEO Del Bigtree earned a salary of $146,000. Bigtree travels the country speaking at rallies against bills designed to increase childhood immunisation, lobbying legislators against passing such bills or attending wellness conferences. ICAN spent $148,000 on travel in 2017.
The Selz’s began supporting the anti-vaccination movement in 2012 with a $200,000 donation to the Dr. Wakefield Justice Fund. After Wakefield moved to Texas this fund was set up by supporters with the aim of “responding” to apparent false claims made against Wakefield. This would “protect his work from both profit- and politically-motivated censorship and retribution”. Despite the semantics it’s now documented that as many as four lawsuits brought against Brian Deer and media organisations were fruitless. Anti-SLAPP legislation demanded Wakefield provide evidence for his libel claim which was impossible as the case against him was demonstrably true.
Wakefield launched two nonprofit organisations in 2014. Over years the Selz’s donated $1.6 million. One group, the AMC Foundation, “was registered as a charity to fund documentaries about public health issues”. The money was used to help produce Vaxxed. The Vaxxed website states that the film was funded by a small group of philanthropists and “brave parents”.
In 2018 Wakefield dissolved the nonprofit organisations. Whilst active the AMC Foundation had directed grants to Wakefield and Tommey’s Autism Media Channel which claims on YouTube to “make informative and educational videos” for individuals with autism. In the article The Washington Post report;
Attorney Marc Owens, a former head of the IRS division responsible for monitoring tax-exempt organizations, said the arrangement is “a very suspicious transaction.”
“They transferred all of their income, it appears — with the exception of a small amount — to, basically, themselves,” Owens said. “It is extremely unusual to see this sort of expenditure from a public charity.”
Bigtree meanwhile continues his weekly online production of The Highwire, which was recently banned from YouTube. It has attracted supporters with deep pockets. New York City real estate executive Stephen Benjamin and his wife, Elizabeth donated $20,000 in 2017. They feel that the vaccine issue is not well managed by industry or political leaders and that opinion and discussion is being censored. Bigtree has landed on his feet and like Wakefield, has found the shift to anti-vaccination conspiracies a shortcut to a type of fame and fortune.
Without ranging through every avenue of profit that anti-vaxxers pursue one may conclude the very public attention that follows a Vaxxed bus creates an avenue of profit itself. Becomming a Vaxxed identity, particularly now, is as good for the bank balance as it is the ego. The initial Vaxxed film only generated a worldwide box office income of $1,215,647 with the vast majority being USA sales, according to The Numbers website. The DVD sells for around $25 AU, $15 US. Sales are impossible to calculate but Vaxxed TV has almost 88 thousand subscribers, the Autism Media Channel 7.3 thousand. The income from other sources, donations and control of charities appears significant. Polly Tommey’s Autism Media Channelfeatures in Snap Charity‘s business directory.
Possible script items for Vaxxed III
The involvement of the Vaxxed team and movie in Australia in 2017 has already produced published footage of vaccine injury and death accounts. The AVN YouTube channel now mimics Vaxxed TV and the Autism Media Channel in content and appearance. So without a doubt the promised “documentary” will feature identical accounts of vaccine injury and death recorded on the Vaxxed II bus and may well include the footage from 2017. As noted above there are accounts of vaccine injury on the AVN site. It is unlikely this fits with the Vaxxed brand however.
The most common themes will be the most familiar. SIDS caused by DTaP. Injury and death following influenza vaccination. A raft of neurological problems and death following HPV vaccination. Infant injury after hepatitis B immunisation. Autism following MMR and other vaccines. Images similar to those used in this attack on Sydney City Council, which were requested on Facebook by an AVN member will be used. People are bullied into vaccination whilst doctors who share these views are fearful of speaking out and deregistered if they do. Other topics may be included to shape an Australian identity to the film.
The threat of mandatory vaccination in Australia may fill part of any vaccine injury film Meryl Dorey and Aneeta Hafemeister are involved with. To understand some of the primary tactics Dorey has used for years follow this link. The requirement for healthcare workers to be vaccinated in some instances leads to injury, unemployment, ruin and death contend the AVN. No Jab No Pay legislation is often referred to as a means to mandatory vaccination or results in homelessness and poverty.
Protection of the Vaxxed brand should dictate not referencing Dorey’s claim of mandatory vaccination lobbyists. Not because the idea is poor. Rather because her approach is bogus, bitter and brutal. It includes attacking parents who have lost a child to vaccine preventable disease. On its Get The Facts page the Department of Health publishes these personal stories in which grieving parents contribute to public awareness of vaccine necessity. Together with Judy Wilyman the AVN wrongly insist these accounts are merely anecdotal, therefore unreliable. A criticism selectively omitted from assessing vaccine injury accounts.
A constant narrative of a cruel and tyrannical government at state and federal levels suppressing accounts of vaccine injury is a feature of the Vaxxed II tour. Council bans and orders to move on are likely to be covered with the approach that The People can’t be silenced. Another theme around mandatory vaccination is that the COVID-19 vaccine will be mandatory and dangerous.
In July Dorey informed Andrew Wakefield that this, “man-made situation is not really a pandemic… we are in the middle of a government take-over of human rights in this country”. In fact Dorey presented aspects of vaccine legislation and the COVID-19 situation in Australia with such dishonesty it was impressive. Such misleading accounts may feature in the film. The audio below is from the same episode of Under The Wire as Wakefield’s claim to innocence above.
Doctors are being “Wakefielded” (a new verb Dorey contends) and deregistered for even asking questions about vaccines or reporting adverse events. As are physiotherapists, nurses… anyone who’s registered with AHPRA. The film mentioned is 1986 The Act. Daniel Andrews is power mad and if Australians watch the film,“there will be an uprising”. The audio is a sequence of out-takes. Please listen below.
Meryl Dorey informs Andrew Wakefield about suppression of rights in Australia [4min 45]
Other topics might include the need for “vaxxed vs unvaxxed” studies funded by the Australian government and the lack of vaccine safety trials. The AVN insist in using suspect studies to show that vaccinated children are less healthy that unvaccinated. Despite the fact that efficacy and safety testing in Phase III trials of COVID-19 vaccine candidates has been widely reported the AVN still deny it. In a recent post looking at how increased transparency of the Oxford COVID-19 vaccine trial has exposed anti-vaccine conspiracies we saw that the AVN still have this dishonest claim on their site. See Proposition 4;
…there have never been double-blind, placebo-controlled prospective studies done on either the safety or efficacy of vaccines, not even when a new vaccine is introduced.
There may be input from Wakefield, who also denies proper safety studies are conducted. In the UTW interview with Dorey he chose to ignore the necessity for non-sterile placebos in trials. Without evidence he attacked the use of aluminium adjuvants as placebos. He is critical of COVID-19 candidate vaccine phase III trials because he can twist facts to fit his narrative. Some trials use a meningococcal vaccine as placebo so recipients will not know they have received a placebo. In essence, this is excellent methodology.
The two Vaxxed films produced to date are demonstrably false accounts of a vaccine link to autism and a vaccine injury epidemic (VIE). The involvement of disgraced ex-doctor Andrew Wakefield and his account of being the victim of conspiracy has ensured a level of interest and popularity for the Vaxxed brand. This has increased financial backing from his supporters who believe he is a victim with important work to do. Contributions from wealthy benefactors ensure donations to Wakefield are lucrative. Never the talented success his fans portray him as, wealth gained from anti-vaccine conspiracy promotion and his current lifestyle are well documented.
The key Vaxxed identities are Wakefield and producers Polly Tommey and Del Bigtree. The latter two are also fervent anti-vaccine campaigners. Bigtree is well paid with travel funded in his role as CEO of Informed Consent Action Network which produced the Vaxxed films. Tax documents confirm Wakefield and Tommey profited significantly from nonprofit tax-exempt organisations established to fund anti-vaccine media. The first Vaxxed bus significantly increased the profiles of Wakefield, Tommey and Bigtree. Media is continuously published on YouTube.
AVN founder and supporter of Andrew Wakefield, Meryl Dorey has battled controversy to promote both Vaxxed films in Australia. Her support of a VIE has been vocal for over 25 years and she has overseen the raising of significant funds through unmet promises and deception. The AVN have launched an identical Vaxxed bus in Australia. The full source of funding is unclear. Its purpose is to promote the second Vaxxed film and collect footage of Australians who believe they or a loved one are victims of vaccine injury or death. Meryl Dorey and current AVN president Aneeta Hafemeister acknowledge they intend to make a third Vaxxed film.
The AVN have clearly met more resistance from health authorities and local councils than expected. Supporters are constantly told the intention is to give the vaccine injured a voice. However given the involvement of Vaxxed the AVN must have contractural obligations. Despite professing noble intentions the show, it would seem, must go on. Exactly what arrangement Meryl Dorey and the AVN have with the Vaxxed brand is unknown. By not investing supporter donations into promised campaigns the AVN have accumulated significant monies, the extent of which is kept secret.
Income from film screenings and video sales is quite modest but not insignificant. Overall profit from the production of these films is helped by using volunteers. Here they staff the Vaxxed II bus, conduct filming, run the promotion and sales stall at events, collect, edit and post material on social media and address the multiple administrative details that senior AVN identities do not. Constant requests for donations via email and social media ensure income. Presenting a constant narrative that politicians and health authorities have a vested interest in silencing the vaccine injured encourages further support.
Despite justified opposition Meryl Dorey and the AVN will continue as they have. The aim is to mimic the USA Vaxxed bus and cover the nation. This will be costly. The more noise made and attention gained the more likely donations will increase. Australia may not have the wealthy benefactors of the anti-vaccination lobby in the USA but this doesn’t mean the AVN have not been well funded. Nor does it mean they have. The group has a history of accumulating significant finances for purposes unmet. Promised investment in campaigns never eventuates. The Vaxxed II bus has increased income. The sooner the Vaxxed III film can be produced the sooner the AVN will be taken seriously by potential benefactors.
Meryl Dorey has always craved success and legitimacy. She is presently in a good position to be co-producer of the Vaxxed III film. Her problem is that the AVN and Vaxxed are quite rightly regarded as a threat to public health in Australia. The COVID pandemic has increased exposure, support and donations for the AVN. Yet by embracing COVID conspiracies they have come under closer scrutiny from health and government authorities.
They will continue to meet resistance. They will respond dramatically. Dorey and Hafemeister will continue to rave about the suppression of rights and their fight to provide a voice for the vaccine injured. It will at least be entertaining. As Wakefield told Dorey, without entertainment you don’t have a film.
The prize for Meryl Dorey is to become Australia’s Vaxxed representative and if one conclusion is clear it’s that being a Vaxxed intimate is lucrative.
NB: The first and fourth audio files are made up of out-takes from the original file which is available. The out-takes are added in chronological order.
24 Nov. 2020: Updated details of misappropriated income from undelivered magazines and “member donations” spreadsheet at The Australian Vaxxed II bus.
The unprecedented nature of the SARS-CoV-2 coronavirus pandemic has begun to influence the transparency of drug company trials of potential COVID-19 vaccines.
On September 17th The New York Times reported that Moderna and Pfizer were releasing the protocols that describe the trial process to test a potential COVID-19 vaccine. On September 19th they reported that AstraZeneca had done the same. This heralds a significant change on the part of drug companies. Although in practice complex vaccine trial protocols would need to be interpreted by say, science journalists, in order to be understood by the wider public particularly given the multicultural nature of today’s communities in developed nations. [See references below for protocols]
As trials have progressed to Phase III in which data on the safety and efficacy of vaccines are collated, the interest of the public has grown significantly. Intense media attention surrounded the recent pause of the Phase III trial of the vaccine being developed by AstraZeneca in partnership with scientists from Oxford University. Not surprisingly public interest has turned to pressure for more transparency as to how trials are conducted.
From July 24th to August 7th Ipsossurveyed respondents from 27 countries [PDF] on attitudes toward a COVID-19 vaccine. 74% of respondents said they would have a vaccine if it was available. The most common reason for rejecting the vaccine was concern over side effects (56%). This was followed by doubt of its effectiveness (29%). The importance of transparency surrounding Phase III trials is confirmed by the weight of these two reasons for rejecting the vaccine.
These vaccines are being developed rapidly under the gaze of a public that expects at some time to be given such a vaccine. It’s understandable that anxiety surrounding both efficacy and safety of COVID-19 vaccines existed long before the specifics of Phase III trials became public. That those specifics have become better understood due to an issue with safety does raise matters of trust within the public.
Of course the increased attention over safety and efficacy would never have arisen during development of the many so-called “alternatives” to regulated vaccines. Alternative products are not subject to reliable scrutiny and as such the acute and chronic effects are in fact undocumented or unknown. The safety and efficacy of such listed (as opposed to regulated) therapeutic products is almost always merely assumed.
Establishing trust between the public and the government and health authorities is important. Increased transparency of vaccine trials will help promote trust. Sustaining trust is significantly reliant on clear information and explanation of complicated issues that raise public concern. This is particularly true in the present environment where changing evidence may come across as inconsistency and if left unacknowledged may lead to suspicion. The proper interpretation and presentation of available information is essential.
Normally data gathered during a trial are published after the trial. However the dynamic nature of COVID-19 vaccine development and the global impact of this pandemic have already changed what may be considered normal. Added to this is information that is leaking out. The Oxford trial has recommenced on the advice of an independent safety committee. AstraZeneca announced that they “had not confirmed a diagnosis” of transverse myelitis in the study volunteer.
What has also recently become apparent is that the study was paused in July after a male volunteer who had received one dose of the vaccine developed transverse myelitis. See page 10 of this participant information sheet. There was a review by independent experts. The trial resumed after it was determined that the individual had a previously undiagnosed case of multiple sclerosis unrelated to the vaccine. Still, there was a persistent concern that AstraZeneca had not revealed in detail what had happened to the woman whose significant neurological symptoms led to the most recent trial pause.
On the September 14th edition of The Health Report Dr. Norman Swan interviewed Professor Bruce Neal, Executive Director of the George Institute Australia. The occasion was to discuss the launch of a project called Join Us. A challenging issue about Phase III trials is that drug or vaccine development may stall or fail due to lack of suitable participants. This isn’t due to drop out or resistance. Rather the cost and administrative difficulty of finding suitable participants is significant. Join Us aims to secure pre-consent to trials of a certain nature.
Whilst that’s interesting information about trials, Swan also asked Professor Neal about his thoughts on the reluctance of AstraZeneca to reveal details about the woman responsible for the second pause of the Phase III trial. Neal considered reasons to release more information. It would give a heads up to other researchers around the globe allowing them to “provide input and information into it”. However he also noted that releasing such information midway through a trial may have negative consequences.
There may be confidentiality issues as such a “severe unusual event” might lead to patient identity being leaked. Perhaps most interestingly was the observation that the trial may well end with a conclusion that the event was not an issue related to the vaccine. By then the damage is done. The public have already internalised the notion of a negative side effect. The media effort to reverse that belief is not likely to be successful.
Professor Neal stated;
And so the media surrounding the announcement of something like that is going to retain much more prominence probably than the media that tries to reel that back in and say, look, actually it wasn’t an issue. And that could have ramifications down the track when you try to get people to take the vaccine.
It’s important to note that the FDA has not allowed the AstraZeneca trial to resume in the US. The National Institutes of Health stated that it remains to be seen if the illnesses are coincidental and that, “pausing to allow for further evaluation is consistent with standard practice”.
Understandably some health professionals in the US remain concerned. Whilst investors were told of the second problem it has become clear that the company did not immediately alert the F.D.A. and advise them of the independent safety board’s recommendation to pause the trial. Virologist Dr. Peter Jay Hotez based at Houston’s Baylor college of Medicine has not been impressed. He claimed communication has been “horrible and unacceptable” citing the failure of UK regulators to provide rationale for resumption of the trial.
Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the F.D.A.’s advisory committee on vaccines, said that it’s unclear how the company — or the U.K. government — determined that the second case was not related to the vaccine.
Offit has also noted that the rarity of transverse myelitis in the general public has not been reflected in the UK trial population. The extra caution we are seeing in the US is reason for the public to have increased confidence in the influence regulators have over the safety of vaccine trials. Consequently there is reason for the public to be less anxious about the safety of COVID-19 vaccines that are eventually marketed. Given that independent safety experts in the UK have advised it is safe for the Oxford trial to resume it will be very interesting to see what further evaluation by US authorities concludes.
Results: Following nearly 64 million vaccine doses, only 7 cases of TM and 8 cases of ADEM were vaccinated during the primary exposure window 5-28 days prior to onset. For TM, there was no statistically significant increased risk of immunization. For ADEM, there was no statistically significant increased risk following any vaccine except for Tdap (adolescent and adult tetanus, reduced diphtheria, acellular pertussis) vaccine. […]
Conclusions: We found no association between TM and prior immunization. There was a possible association of ADEM with Tdap vaccine, but the excess risk is not likely to be more than 1.16 cases of ADEM per million vaccines administered.
Only well-conducted epidemiological studies with adequate evaluation of results can clarify whether a true association between vaccines and adverse event development truly exists. Autoimmune neurological syndromes that follow vaccine use are among these. […]
Literature analysis showed that most of the associations between vaccines and nervous system autoimmune syndromes that have been reported as severe adverse events following immunization are no longer evidenced when well-conducted epidemiological studies are carried out. Although the rarity of autoimmune diseases makes it difficult to strictly exclude that, albeit exceptionally, some vaccines may induce an autoimmune neurological disease, no definitive demonstration of a potential role of vaccines in causing autoimmune neurological syndromes is presently available. Consequently, the fear of neurological autoimmune disease cannot limit the use of the most important preventive measure presently available against infectious diseases.
The Institute for Vaccine Safety at Johns Hopkins University logically argues that a number of vaccines “may prevent transverse myelitis”. The institute published Do Vaccines Cause Transverse Myelitis? Last updated September 18th 2020 the article opens with the conclusion;
Natural viral infections with influenza, hepatitis A, measles, mumps and rubella and varicella have all been associated with myelitis, albeit rarely. Thus, these viral vaccines may prevent transverse myelitis by protecting against natural infection. Vaccines currently routinely recommended to the general population in the U.S. have not been shown to cause transverse myelitis.
Ultimately this research in conjunction with the cautious US approach at present does not support a contention of general recklessness in the production of this vaccine or of other potential COVID-19 vaccines.
This dynamic provides yet another blow to anti-vaccination conspiracies. Namely the contention that there is collusion between drug companies and health regulators to suppress the supposedly inherent dangers of vaccines that anti-vaxxers wrongly insist lead to an abundance of vaccine injuries. More so Dr. Paul Offit has been derided, verbally attacked and threatened by the global anti-vaccine lobby for many years as a callous profiteer of vaccines. Yet he has constantly raised a voice of caution to ensure safe COVID-19 vaccine development.
It is certain that placing the AstraZeneca trial on hold following advice from the F.D.A. is not a unique event. Rather the fact that measures employed to control the current pandemic are being played out before the public in real time has provided insight into events that are usually ignored. In the previous post I listed some other aspects of anti-vaccine conspiracy that simply cannot be sustained following media reports of the AstraZeneca/Oxford Phase III trial pause. Even cursory attention to the details of this trial has exposed the dishonesty of anti-vaxxer claims.
Well before the trial pause led to media attention, public anxiety and now transparency of drug companies, the importance of trust in accepting a COVID-19 vaccine had been raised in Australia. Prime Minister Scott Morrison made a significant mistake with respect to public confidence in vaccine development and uptake. In August he announced that Australia had signed a deal to produce the vaccine being developed at Oxford University if Phase III trials were successful.
His mistake was to add that it would be“as mandatory as you can possibly make it”. Morrison realised the mistake and in under a day had produced the anticipated walk back. Nonetheless the many anti-science and anti-reason groups that are feverishly misrepresenting the motives of governments and health authorities during this pandemic were delighted. Within hours of Morrison’s announcement the AVN published a video mocking the notion of “safe and effective” vaccines whilst contending they “had always known this was coming”.
There were of course no “walk backs” from the AVN when Morrison corrected his position. Pushing fear of mandatory vaccination has always translated to profit for this group and Scott Morrison had done them a favour. Say no to mandatory vaccinationread the back of a T-Shirt weeks later in Perth during Australia-wide “solidarity” rallies. Messages on social media continue in the same vein. Still, the reality is that messages and memes on mandatory vaccination would be common had Scott Morrison made no such statement.
Any harm done to the uptake of a COVID-19 vaccine in Australia is likely negligible. A survey conducted in April found that just under 86% of Australians aged over 18 would get a COVID-19 vaccine. 4.9% would not whilst 9.4% were indifferent. These figures are promising but were collated before the widely publicised pause in the AstraZeneca trial and increased public reflection on the safety of a COVID-19 vaccine. Survey responses were to the statement, If a COVID-19 vaccine becomes available, I will get it.
Ipsos published their global attitudes results on September 1st, indicating an 88% uptake of a COVID-19 vaccine in Australia. 59% strongly agree and 28% somewhat agree with the statement, If a vaccine for COVID-19 were available, I would get it. Only China and Brazil were more likely to accept a vaccine. These figures were also collated before the pause in the AstraZeneca trial. Follow this link to readKey Findings for Australia.
Another area that’s causing anxiety is the posturing of Donald Trump toward authorising a COVID-19 vaccine before the upcoming election. Consider the measure of Trump for a moment. He will tempt the voters with the promise of a vaccine in weeks. However it is more realistic to expect a safe and effective COVID-19 vaccine in months. These promises demand a disregard for vaccine safety. Yet in March 2014 Trump was tweeting in support of the mythical vaccine/autism link, a bogus view that bemoans a lack of vaccine safety. After the last election, research fraud and vaccine/autism profiteer Andrew Wakefield attended an inaugural ball from which he posted a social media video calling for an overhaul of the CDC.
Others have long ago considered the measure of Trump in regard to the election and a COVID-19 vaccine promise. In early June University of Pennsylvania professors Dr. Paul Offit and Dr. Ezekiel Emanuel wrote an opinion piece in The New York Times entitled Could Trump turn a vaccine into a campaign stunt?
In a desperate search for a boost, he could release a coronavirus vaccine that has not been shown to be safe and effective as an October surprise. […]
Given how this president has behaved, this incredibly dangerous scenario is not far-fetched. In a desperate search for a political boost, he could release a coronavirus vaccine before it had been thoroughly tested and shown to be safe and effective. […]
Thousands of Americans have already died as Donald Trump has perpetually postponed effective public health interventions and made poor therapeutic recommendations. We must be on alert to prevent him from corrupting the rigorous assessment of safety and effectiveness of Covid-19 vaccines in order to pull an October vaccine surprise to try to win re-election.
At the beginning of the second week of September the CEOs of nine drug companies, arguably competing in the development of a COVID-19 vaccine, signed a pledge to stand with science and not launch such a vaccine until it met “high ethical standards and sound scientific principles”. The pledge statement as it appears on Pfizers website is in references below. It came at a time when public health specialists and scientists expressed concern that the Trump administration was pressuring regulators to authorise a vaccine before the November 3rd election.
The New York Times reported;
The joint statement by competitors was seen as an effort to restore public trust as President Trump has pushed for a vaccine before the presidential election.
Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:
Always make the safety and well-being of vaccinated individuals our top priority.
Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.
Yes to the cynical eye this may seem to present the pharmaceutical CEOs as really great guys. However I recommend reading the entire Biopharma Leaders Unite pledge. More to the point with increased transparency the public and the media have an invested interest to see a suitable outcome here. This pledge is certainly a step up from Fauci saying he has “confidence and some faith” that the COVID-19 vaccine approval won’t be political.
Earlier in the year it was reported that a significant number of Americans are likely to refuse a COVID-19 vaccine. A robust anti-vaccination lobby and rising numbers of the vaccine hesitant mean that the number of Americans who accept the vaccine may be insufficient to sustain herd immunity, which may require between 50 – 70% of the population to be immune. The more recent Ipsos survey found 67% of US citizens would have the vaccine.
Exactly how many must be vaccinated to achieve herd immunity is still uncertain. The WHO suggest 95%. Mathematical modelling reflecting age and social activity level produces a herd immunity “illustration” as low as 43%. Other reports suggest a vaccine uptake of over 70% is needed. The Mayo clinic point out that reaching this level of immunity through infection and not vaccination would overwhelm the health system and cause millions of deaths.
Thus there is ample reason to hope greater transparency of vaccine trials leads to justified improved confidence in the safety and efficacy of COVID-19 vaccines and increased uptake. Of course given the speed of current COVID-19 vaccine trials let us also hope that the vaccines that make it to market are extremely safe and splendidly effective. The fewer challenges that accompany immunisation on a global scale the better.
Another area that is getting more scrutiny if not exactly transparency is that of vaccine nationalism. This term refers to agreements between governments and vaccine manufacturers that ensure developed nations have secure access to vaccines for their entire population before they are available for other nations. With COVID-19 this may result in a delay in vaccinating health workers in developing nations, individuals at high risk of severe disease or death and those living in a region of a sudden dangerous cluster.
COVID-19 is a global pandemic. Yet we are faced with a situation where wealthy nations will be able to vaccinate their populations whilst countries that rely on aid organisations will be unable to vaccinate health workers and at-risk populations without organised help. A recent Science Friction podcast looks at the ways in which this problem can be combated. Australia’s Friends of Science in Medicine actively support equitable access to “COVID-19 vaccines and related health technologies”.
No doubt the anti-vaccine lobby will use information in the trial protocols in the same way they use vaccine package inserts. Thanks to exceptional cognitive dissonance they will list reasons as to why information from vaccine manufacturers can’t be trusted whilst using that same information to defend these reasons. The good news is that as we’ve seen, increased transparency and media attention has exposed tenets of anti-vaccine conspiracy and beliefs as vacuous and fallacious. On these points it’s a case of watch this space.
In conclusion it can be seen that the increase in transparency of COVID-19 vaccine development should indeed serve to increase public trust and confidence in the quality of eligible vaccines. I cannot finish without stressing again that the safety and efficacy elements of Phase III trials do not apply to the raft of concoctions marketed as alternatives to medicine. All consumers should seek reputable sources of information and beware of the many hoax “cures” of COVID-19. Discuss any novel plans to manage or prevent COVID-19 with a registered medical practitioner.
Finally whilst the importance of transparency with respect to vaccine trials has become clear, it was also confirmed by the Ipsos global survey on attitudes to a COVID-19 vaccine. The most common reasons for intending to refuse a vaccine are safety followed by efficacy. The establishment of which is the very aim of Phase III trials.