The Nuremberg Code and COVID-19 vaccines

Following the development and subsequent global rollout of successful COVID-19 vaccines one particular anti-vaccine trope has been delivered with increasing gusto. Namely that the administration of these vaccines is in breach of the Nuremberg Code.

This isn’t the first time the Nuremberg Code has been used by the anti-vaccination lobby in an attempt to argue against the legality of vaccination. It is however the most widespread use of this piece of disinformation to date. It also includes the threat that health professionals will be tried as war criminals. To arrive at the conviction that COVID-19 vaccination is in breach of the Nuremberg Code, a triumph of non-critical reasoning is necessary. Specifically that the vaccine rollout is an ongoing experiment and that recipients have not given informed consent.

The latter is a misguided application of the first point of the Code. Global, real time scrutiny of the COVID-19 vaccine rollout means recipients are better informed when giving consent than for any other vaccine in history. Whilst the first point of the Code includes the most lengthy accompanying explanation of all ten points in the Code, it opens with the requirement:

The voluntary consent of the human subject is absolutely essential.

Background

An early claim that vaccine recipients are denied informed consent can be found in a 1997 NBC interview with Barbara Loe Fisher and her related article on the NVIC website [Archive]. Loe Fisher provides five bullet points contending there is inadequate knowledge of injury, death, side effects, vaccine failure and that vaccination, “could reasonably be termed as experimental each time it is performed on a healthy individual”. The postulation at play here is that if such uncertainty exists then informed consent cannot be given. Another ambitious claim is that post-marketing surveillance of vaccines is “a de facto experiment”.

Further on in the article the Nuremberg Code itself is addressed and the deception immediately begins apace. Loe Fisher exploits the words of physician and ethicist Jay Katz. His work is included in Nazi Doctors and The Nuremberg Code – Human Rights in Human Experimentation. Loe Fisher selectively chose in part:

The rights of individuals to thoroughgoing self-determination and autonomy must come first. Scientific advances may be impeded, perhaps even become impossible at times, but this is a price worth paying.

As the tone indicates, this is a quote about human experimentation, not vaccination as Barbara Loe Fisher is suggesting. The article trots on to mislead readers that, “bioethicist Arthur Caplan concurred when he said”:

The Nuremberg Code explicitly rejects the moral argument that the creation of benefits for many justifies the sacrifice of the few. Every experiment, no matter how important or valuable, requires the express voluntary consent of the individual. The right of individuals to control their bodies trumps the interest of others in obtaining knowledge or benefits from them.

Jay Katz passed away in 2008. Arthur Caplan is a professor of bioethics at New York University and in June last year informed FactCheck.org that the NVIC use of his quote is “completely erroneous” and reflected “ignorance of history and ethics”. He also observed that it is:

… a gross disservice to the victims of brutal Nazi experiments to distort my words for lame anti-science that will kill people if this bilge is taken seriously.

The above quote is no doubt not lost on those familiar with the harm anti-vaccine activists ultimately achieve and the disrespect they so often reveal in doing so. It also brings to mind the reality surrounding the Nuremberg Code. It is the result of one of the Nuremberg trials that followed the Second World War. The Doctors’ Trial (USA vs Brandt) focused on 23 German doctors and administrators who performed unethical, inhumane experiments in concentration camps and 3.5 million sterilisations of German citizens.

The Nuremberg Code itself has a controversial history surrounding authorship and was largely ignored for 20 years following the Nuremberg trials. In The Nuremberg Code and the Nuremberg Trial: A Reappraisal, Jay Katz wrote that careful reading of the judgement indicates it was written:

…for the practice of human experimentation whenever it is being conducted.

The vaccine ‘experiment’

This helps us appreciate the importance of, and the rationale behind, insisting that the COVID-19 vaccine rollout is an experiment. In the last post I covered another reason as to why the anti-vaccine lobby pushes this line. Namely to wrongly claim that hospital cover for adverse events following immunisation will be withheld by insurance companies on the basis that the vaccine is an “experimental treatment”. The trial it is alleged runs until 2023.

Helped by a widely disseminated video from the UK (here), misinformation regarding the Pfizer Phase III clinical trial is sustaining the belief that a long term “experiment” involves all vaccine recipients. This is demonstrably false. In fact the clinical study description cited in the video refers to the original participants who will be followed on a post-marketing basis until 6 April 2023. In a comprehensive 10 December 2020 article Pfizer report under Adverse Events:

Safety monitoring will continue for 2 years after administration of the second dose of vaccine.

In Australia Meryl Dorey of the Australian Vaccination-risks Network has been quite vocal about Nuremberg Code breaches. She contends the “experiment” is admitted to by the TGA, FDA and European Medicines Agency. In fact the Australian TGA provisional approval of the AstraZeneca vaccine is valid until February 2023. This is almost certainly a source of added confidence regarding the false claim of an ongoing experiment.

On 13 March 2021 during Under The Wire (Source) Dorey spoke about, “crimes against humanity as determined by the Nuremberg Code” due to COVID-19 vaccine administration and the so-called ‘vaccine passport’. At one time she challenged, “if you even believe that COVID exists”. Download the MP3 here or listen below.

Meryl Dorey followed this with a firm message warning medical professionals. MP3 here or listen below.

War crimes

During the same episode Dorey presented a flyer (below) warning “all medical practitioners” involved in the COVID-19 vaccine rollout that they will be on trial for war crimes and held accountable. These flyers continue to be letter dropped, faxed and placed on car windscreens to reach doctors and nurses.

To suggest that medical practitioners will be subject to war crimes is as baffling as it is offensive. The claim is international and again hints at a massive break down in critical thinking. Only cursory reflection is needed to realise that administering a vaccine during peacetime cannot possibly constitute a war crime regardless of the human rights issues one may think apply. The Nuremberg Code reflects not only what happened during the Second World War but also the ethical standards that existed in Germany before the war.

Nuremberg Code and ‘No Jab No Pay’

Use of the Nuremberg Code as an argument against vaccination legislation was honed in Australia in response to the Social Services Legislation Amendment (No Jab, No Pay) Bill in 2015. The legislation ensures a childcare benefit, rebate and a tax benefit supplement will be withheld from parents of children under 20 years of age who are not fully immunised. This legislative amendment followed community concern in response to “conscientious objection” to immunisation.

Submissions to the Senate Standing Committee on Community Affairs arguing against the Bill focussed often on the argument that informed consent would be denied. There are a number of examples and the following are indicative. Submission 511 offers further insight into the first point of the Nuremberg Code. Namely that consent should be:

…without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion.

And:

By refusing welfare payments to family’s (sic), this is a clear form of financial duress and coercion (and also over-reaching by Government). Some families rely on welfare payments to enable or assist them to provide for their family. To deny access to welfare payments is coercion of parents to subject their children to a medical procedure. 

Submission 508 also refers to the first point of the Nuremberg Code and suggests that the Australian Immunisation Handbook, in its section on consent, reflects a hitherto unknown aspect of the Code. The author notes:

The Australian Immunisation Handbook reflects the Nuremberg Code is requiring valid consent as a pre-cursor to vaccination.

Another submission combined the My Will command with reference to the Nuremberg Code, the Australian constitution, the Immunisation Handbook and the 2005 Universal Declaration of Bioethics and Human Rights, Article 6, Section 1. Despite the use of so many references to rights and ethics (Submission 511 also cited the AMA code of ethics and the Victorian Charter of Human Rights) the submissions highlight a common flaw. No Jab No Pay is an incentive. Indeed to see it as active coercion and ignore the harm caused by vaccine preventable diseases is uniquely selfish.

As a testament to how the anti-vaccine lobby manage to keep alive the notion that vaccines constitute grave abuses of human rights we can see that Article 6 of the UDBHR has also been trotted out today for COVID-19 vaccines. A striking LTE in the Elko Daily alluded to the Pfizer clinicaltrials.gov information, the Nuremberg Code and the UDBHR. Article 6, section 1 states:

Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be expressed and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.

Despite the vocal insistence of an experiment being run without consent the main antagonists of the anti-vaccination lobby are aware this is a false claim. Enter the inane insistence that the COVID-19 vaccine is set to be mandatory in developed nations. The AVN still push the tired line that Scott Morrison aims to make it “as mandatory as possible”, despite his very clear walk back of that unfortunate statement. The next “march against mandatory vaccination” is set for 29 May 2021.

Nuremberg Code Today

As for the Nuremberg Code itself an adequate critique is beyond the scope of this post. Nonetheless, whilst it does reflect important ethical standards it is likely not legally enforceable. It has not been adopted by any government and the Universal Declaration of Human Rights is more readily recognised. Of major importance in this regard is the CIA post 9/11 experimental torture programme that utilised unwilling human subjects. Critiques of the Code raise justifiable concerns from its acceptance of animal experimentation to the arguably ridiculous item five which states:

No experiment should be conducted, where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

Today the recognised standard for medical ethics is the World Medical Association’s Helsinki Declaration. It may be considered superior to the Nuremberg Code for one simple reason. That of regular revision. It has been amended seven times since June 1964. The most recent occasion was in October 2013.

Conclusion

The claim that COVID-19 vaccination is in breach of the Nuremberg Code is the most recent manifestation of an anti-vaccine deception that is probably over 25 years old. It is a falsehood that relies on calculated disinformation. Namely that vaccine recipients are denied informed consent and that the COVID-19 vaccine rollout is an experiment. Social media has aided the dissemination of this claim and a genuine COVID-19 vaccine Phase III trial document is being misrepresented as confirmation of a global trial.

The Nuremberg Code was written at the time of the Nuremberg War Crime trials. As such, baseless threats that medical practitioners will be tried as war criminals are being circulated. The Nuremberg Code clearly refers to experimentation on human subjects and says nothing about vaccination. Submissions to state and federal parliament in Australia opposing the No Jab No Pay/Play Bill 2015 unsuccessfully tested the veracity of the Nuremberg Code in this respect.

As an ethical statement and historical document the Nuremberg Code is sullied by anti-vaccine disinformation. The claims are absurd, serving no purpose other than disruption of sound public health policy. The most recent incarnation targetting COVID-19 vaccines is rightly viewed as a conspiracy theory.


References

Nuremberg Code

Nuremberg Code – Experimentation not vaccines

AMA Code of ethics for doctors

Staff administering COVID vaccines are not war criminals

Do vaccinations violate human rights under the Nuremberg Code?

WMA Declaration of Helsinki

Nuremberg Betrayed: Human Experimentation & the CIA Torture Program

Last Update: 2 May 2021

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Why AVN supposedly quit Facebook

goodbye-facebook

On a rather recent January 13th the Australian Vaccination-risks Network announced its partial departure from Facebook. Only weekly videos of Meryl Dorey’s Under The Wire show and Facebook-live videos will continue.

By member email, and more fittingly by Facebook post, distraught followers and amused critics were confronted with this graphic and informed;

The AVN Committee has made the decision not to remain on Facebook where we are already shadow-banned and suppressed for sharing factual, referenced information on the harms and ineffectiveness inherent in our one-size-fits-all vaccination program. We cannot support a platform that is so blatant about silencing us and so many others.

Yes. There is a lot of wrong packed into that short paragraph. Perhaps the mid-section is the most compelling. This blog is one of many that counter so-called “factual, referenced information” from the AVN and the contention that vaccination programmes are harmful and ineffective. The “one-size-fits-all” anti-vaccine mantra has become standard in recent years, finding a place amongst CBS News’ 10 deadly myths about childhood vaccines. The US site Vaxopedia comprehensively addresses this claim.

This was pushed by Judy Wilyman in her 2015 PhD thesis. The term features on four pages and receives much attention as supposed support for her claim that genetic diversity renders immunisation programmes ineffective and dangerous. It also features on her website. This towering failure to grasp immunology rests upon her exploitation of a 70 year old quote from Sir Frank Macfarlane Burnet. I touched on this in 2012 and in the previous post referred to Wilyman’s most recent publication which again presents this contention. Australia’s National Immunisation Programme is not “one size fits all”. It is a diverse programme targetting specific needs.

Back to the paragraph of wrong. It finishes by stating the AVN can’t “support” Facebook because it is so blatant about “silencing” them and others. This is all very dramatic and as I will explore part of an attempt by the AVN to big-note themselves as a radical right wing threat to social media. One must remember that at no time in their history of “supporting” Facebook has the AVN page been temporarily suspended. It’s fascinating timing that whilst writing today I scrolled to a video announcing that Dorey has been suspended from the AVN Facebook page for 30 days. I’m unaware as to why and her most recent Under The Wire (UTW) videos remain on the page.

♦︎ Update 4 Feb. 2021 – see below.

AVN founder Meryl Dorey and president Aneeta Hafemeister have constantly peddled the line that they may be deplatformed at any time due to warnings from Facebook. In fact in a 31 May 2020 Facebook live video Hafemeister observed that Facebook got “snarky” because they had “shared about the [anti 5G] picnics”. So radical was this that she didn’t know if they’d get any more warnings. You may grab the MP3 here [300KB] or listen below.

Aneeta Hafemeister tells listeners AVN could be banned from Facebook, 7 1/2 months before they voluntarily leave… somewhat.

So this leaves us with the claim they were already “shadow banned and suppressed”. We can dispense with the claim of suppression immediately. The AVN has had nothing more than fact-checked posts to deal with. These are greyed out and state False Information: checked by independent fact-checkers, giving the reader pause before proceeding. The AVN once observed that such censoring revealed the importance of the information. Shadow banning involves quietly blocking posts or comments such that members aren’t aware of the ban. This hasn’t happened either. Although the claim being made seemed to be about notifications of posts. They claimed followers could not find them or see notifications.

I’m not sure how this was determined as some commenters confirmed they had the page marked and missed nothing. None agreed they were suddenly not being notified. The lie, as it turned out to be, was revealed the following Saturday when Dorey’s show attracted a larger than normal audience. To date there have been over 800 shares and over 500 comments. The next show managed 470 comments. A recent video by Hafemeister managed 300 shares and 424 comments. To top it off she talked about the spike in numbers visiting the AVN page. Topping that off is that live videos will include interviews from the Vaxxed II bus which can number several per day.

So. Why the pretence? Both Dorey and Hafemeister are unashamed conspiracy theorists and seemingly seek the attention presently given to right wing extremists. Having retained US citizenship, Dorey is a Trump devotee and proudly voted for him. I will stress they are not active extremists but do crave an anti-authoritarian image. In today’s social media environment that means wandering into areas of the far right. They are anti-government mainly in thought, sticking to large, safe gatherings and protesting against soft, even meaningless and imagined “suppression”. Like all anti-vaxxers COVID-19, 5G, lockdowns and then the COVID vaccines gave them the chance to play rebel and increase their following without facing up to the reality that they in turn were a means for others and not a solution.

They have both revelled in the thrill of being taken seriously whilst ignoring the inescapable adage that nothing is forever. From Hafemeister gushing about “We are not government property” painted on the Vaxxed II bus to Dorey’s frenetic rants about fascist dictators that I posted in The Hill We Die On, they have laid a rebellious veneer over the anti-vaccine reality. The opening slug of that post quoted Dorey as follows;

When the police were in Ballina and they were telling us we had to move… I called Aneeta who’s the president of the AVN and I explained to her what the situation was… and she said ‘this is the hill we die on’. And that’s what I think too. We can’t be pushed any further, we just can’t. [..] I did not move here to live in a dictatorship… I will live in a free country or I will die.

The audio of Dorey in the post contains far more intense pseudo-revolutionary, anti-government ranting than the above. Hafemeister’s live videos are filled with “we the people” rhetoric mocking government health policy. A rhetoric that consistently pushes the fallacy of a vaccine injury epidemic that the AVN works against “the system” to solve. In truth both these women are secure white upper middle class individuals with very comfortable, entitled, privileged lives. It’s this very privilege and comfort that allows them to invent and internalise huge problems that don’t exist. Their present lives are spent in elaborate role play.

This was confirmed a number of times during last year’s Vaxxed II bus tour. Despite promises to metaphorically storm the Bastille, and literally die or be free Dorey and Hafemeister meekly complied with requests to move their elaborate show elsewhere. Without exception. Without as much as a shaken fist. The promised revolution shrivelled to behind keyboard attacks on Lord Mayors, councillors and business owners who had dared “suppress” them. AVN members were and are constantly exploited in these endeavours. They are fed contact details of targets and often provided with a template response. Abusive tweets and sabotage of Facebook pages is the norm. Accepting that these responses are excessive is not something the AVN does.

All of this rhetoric, posturing and role playing helps us grasp why the AVN announced its departure from Facebook at the time they did and in the way they did. It was just over a week since the riot and breach of the US Capitol [Wikipedia]. Significant changes had occurred on Twitter and Facebook with Trump’s accounts being permanently suspended and his violent followers being banned. The right wing extremist and fascist hosting platform Parler had been dumped from app stores and deleted from Amazon. It has not yet returned. Much to their frustration the AVN was left happily unmolested. Even Dorey’s very pro Trump “they-stole-the-election” Twitter feed was untouched. When it comes to anti-authoritarianism they just ‘aint bad enough to be Zucked permanently. If they weren’t going to be pushed they could always jump. So they did.

It was the ideal time to leave. They could seize upon the energy following the banning of dangerous accounts and important identities. For bad ass anti-vax revolutionaries it isn’t just what you leave but where you go that matters. The AVN announcement offered a list of alternatives where they would set up shop. These were Telegram, Parler, Gab, MeWe, Brighteon Social and Twitter with videos being posted at YouTube, Brighteon, Bitchute and Rumble. Most of these groups will permit unchallenged falsehoods to be published as “news” and “fact” under the guise of “freedom of speech”. Compare this rubbish from AVN’s Gab page (vaccine kills 24) with the actual reports (COVID kills 24). One can plainly see why fact checking and mainstream media don’t fit their plans.

The AVN also mentioned in their email that Telegram was under threat of being deplatformed, but omitted the reason. Following Parler’s ban the encrypted messaging app had become the default platform for radical nationalists. Telegram channels had long been used by potentially violent elements. Telegram was under pressure to act and finally removed Neo-Nazi and extremist channels. The move was a no-brainer for Telegram which was gaining tens of millions of new users thanks to the confusion over WhatsApp’s upcoming changes to its privacy policy.

One wonders at the wisdom of six different social media platforms and four video sites. It’s excessive but these platforms offer the AVN more exposure, potentially more recruits and thus more members. They seem to be settling in to Telegram and Gab (using their past name Australian Vaccination Network), the latter accomodating large numbers of Trump supporters. Gab is similar to Parler in that it is a haven for right wing extremism and hate speech. It was dumped by GoDaddy in late October 2018 after a member was involved in a synagogue shooting. The domain was then registered by Epik. It has been reported that Gab now rents server hardware.

The AVN’s Twitter and Parler accounts are unique to the group whilst Meryl Dorey also has Parler, Twitter and Facebook accounts. These accounts provide insight into how genuine the move from Facebook may be. On 25 September 2020 on what is the AVN Twitter account they announced;

The AVN has just set up a page on [Brighteon]. If you can join us there, it means that we can actually leave Facebook and its censorship, far, far behind! Please share this link as widely as you can too. Show Zuckerberg hs is very replaceable! [Screenshot]

Dorey leaving Facebook for Parler

Then on 5 December 2020 Dorey announced (left) she was leaving her personal Facebook account for Parler. She was tired of “the censorship, the abuse from FaceBook itself and the constant fact-less checks”.

Meryl would no longer be posting or responding to anything on Facebook. However she was back in four weeks by 1 January 2021 – before Parler was deplatformed. Indeed a quick check confirms she was “responding” to another commenter on her page earlier today. The post to the left has been deleted.

Meryl Dorey is still the face of AVN and wears whatever colours seem to get the attention she desires. COVID-19 is a hoax, a ‘scamdemic’ perpetrated by governments to enable control of the population. Yet she is an adamant supporter of hydroxychloroquine as a treatment for COVID-19 and those right wing commentators who claim it is being suppressed. Her Twitter profile (@nocompulsoryvac) features a photo of Donald Trump and she tweets and retweets in support of the notion the US election was stolen. She supports COVID conspiracist, Dr. Simone Gold and posts common themes of COVID misinformation. Some of her tweets are in the slide show below. The same themes featured in Parler in December 2020 and continue on the AVN’s current Twitter account and Dorey’s personal Facebook page. The image from Gab would have been promptly fact-checked on Facebook.

  • covid misinformation
  • avn tweet brighteon
  • avn post on gab

By quitting Facebook with as much fanfare as possible the AVN can associate itself with genuine anti-government forces on social media. Aneeta Hafemeister and particularly Meryl Dorey can envelope themselves in a controversy that is not of their making and has zero to do with them. In time their narrative can bend to accomodate claims that they, and many others, were forced to leave Facebook at the time of the US Capitol riots. In the case of the AVN they will now claim they were forced to make the choice.

The reality is that the COVID-19 pandemic drew unforeseen attention and numbers to the anti-vax cause. Anti-vaccine media coverage increased by 900% from March to May 2020. It is highly unlikely anything like this will be repeated although it is also a wave with ongoing energy. The COVID-19 vaccine rollout, the Trump election fiasco and the US Capitol riot have continued to motivate a disparate conspiracy-loving demographic. Nonetheless the AVN had begun to witness a decrease in Facebook attendance which they blamed on supposed censorship.

Both Hafemeister and Dorey have easily embraced unrelated dynamics to fit their role play. The impetus for the changes in social media were unmistakably due to events that occurred in Washington D.C. and had the specific aim of restricting organised and potentially violent episodes on behalf of Donald Trump and his claim of election fraud. For Meryl Dorey however the issue was the need to be a source of vaccine and medical information. For both, it’s an opportunity to exploit AVN members and perhaps turn the events to their own profit.

In the audio outtakes below from UTW 16 January 2021 we hear Dorey open by telling viewers that;

Here in our bunker we are on a war footing and that is only a slight overstatement because actually the entire world of social media, most governments and certainly the medical community and the media are at war with the truth. So we are your home at the present time, while we’re allowed to be, for the truth about vaccines and medical practices that you need to be aware of.

Yes, indeed.

Nonetheless, it’s now time to say goodbye from the bunker. You can download the MP3 here [1.5MB] or listen below to farewell AVN’s Facebook days… sort of.

An unedited 5 1/2 min from the opening is available here [4.6MB] for those interested in the unblemished truth from which the outtakes above are taken. It does offer insight into how Meryl tries to convince members to cancel any Amazon subscriptions, as she did, because she can’t abide censorship. She’s not going to tell them what to do but if they’re Amazon subscribers they might want to consider doing the same sort of thing. Subtle.

One awaits further AVN social media developments with interest.

♦︎ 8:00 PM 4 February 2021: AVN publish newsletter stating the 30 day ban was due to the most recent UTW episode of 30 January 2021 which is still available on the Facebook page.


Latest update: 9 Feb. 2021

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AstraZeneca problems don’t confirm anti-vax theories

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.

Problems emerge

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.

Media coverage

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.

Back to Norman Swan of Coronacast;

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.

Anti-vaccination lobby

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.

AVN on AstraZeneca

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.

Reading information on the AstraZeneca board we see;

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.

t-shirt with anti-vax wording

AVN devotee wearing T-shirt demanding ‘inert saline placebo’ trials

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.

Conclusion

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%. 

 


References:

COVID-19 vaccines: where are the data? – BMJ

After admitting mistake AstraZeneca faces difficult questions about its vaccine – NYT

Oxford COVID vaccine: regulator asked to assess jab – BBC

Australia’s Oxford-AstraZeneca COVID-19 vaccine choice questioned as experts highlight ‘shaky’ science – ABC

Pfizer vaccine: what an efficacy rate above 90% really means – The Conversation

Moderna’s trial data shows its COVID-19 vaccine nears 95% efficacy – ABC

Placebo use in vaccine trials: Recommendations of a WHO expert panel – NCBI

There are no vaccines with saline placebo? – Vaccines Work blog

Last Update: 1 Dec. 2020

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Call to action on anti-vaccination bus tour

© Australian Skeptics Inc.

By Tim Mendham

July 19th 2020

Australian Skeptics has issued a warning and call to action to Australian media, medical professionals, and local councils regarding the current anti-vaccination ‘revival’ tour of rural and regional Australia:

VAXXED Bus
Delivers COVID-19 Conspiracies and Bad Advice

The so-called “VAXXED” bus is currently touring Australia, spreading misinformation about vaccination at local ‘revival-style’ meetings, often in regional venues owned or managed by local councils or schools. This big black bus carries the logo of the “Australian Vaccination-risks Network” (AVN), an organisation whose leaders have:
● Claimed COVID-19 is nothing more than a bad cold.(1)
● Encouraged people to take photos in hospitals to show COVID-19 is not serious.(2)
● Discouraged face masks for COVID-19 and stated temperature testing is crazy and stupid.(3)
● Likened vaccination to rape.(4)
● Claimed microchips could be injected into the population via vaccines.(5)
● Promoted the falsehood that contrails from aircraft – which they call “Chemtrails” – are used to poison the population.(6)
● Spread the discredited falsehood that vaccines lead to autism.(7)
● Propagated the myth that SIDS and the fatal injuries suffered by some babies who were shaken to death are really the results of vaccines.(8)

With the recent resurgence of COVID-19 in parts of the country, now is not the time to have anyone spread disinformation about the pandemic or vaccine preventable diseases. It is clear from their own statements that the organisers of this tour do not take the threat of COVID-19 seriously.

In 2014, the NSW Health Care Complaints Commission issued a public warning against this organisation, stating in part:

Warning – The Commission has established that AVN does not provide reliable information in relation to certain vaccines and vaccination more generally. The Commission considers that AVN’s dissemination of misleading, misrepresented and incorrect information about vaccination engenders fear and alarm and is likely to detrimentally affect the clinical management or care of its readers.(9)

MEDICAL PROFESSIONALS: Should be aware that the VAXXED Bus may be visiting their area. This will mean that current and potential patients may be exposed to dangerous misinformation that can have deleterious if not fatal consequences. Anti-vaccine messages should be actively resisted, and we encourage local medical professionals to take a stand on this issue, either via local media, social media or whatever public avenues exist in their area.

MEDIA: We advise the media to take great care when covering the VAXXED Bus and the Australian Vaccination-risks Network. They use the tactic of “tell both sides of the story”, also known as “False Balance”, a misrepresentation that the ABC’s Media Watch has covered with regard to this organisation in 2012(10). The media are advised to focus on the more bizarre conspiracy theories propagated, but are under no obligation to give this group the oxygen they seek.

LOCAL COUNCILS: Should consider very carefully the possible consequences of hiring out venues to this organisation. With parts of regional Australia recording a worrying low level of vaccination in a time of a global pandemic, encouraging parents not to vaccinate their children is irresponsible.

“We have one of the safest outcomes when it comes to preventable diseases in the world, because of our strong immunisation program, and anti-vaxxers should just butt out. Vaccination has saved lives, it’s safe, it’s effective and anyone that tried to create any other discussion against it is really trying to harm the Australian public”
– Australian Medical Association President Dr Tony Bartone (Radio 2GB 20/04/2020)

“…there has been somewhat of an upsurge in paranoid and sort of unhinged behaviours.”
– AMA state president (SA) Dr Chris Moy (ABC NEWS 21/05/2020)

“It is concerning that the reports that I have received are that some people believe that coronavirus is a conspiracy or that it won’t impact on them.”
– Victoria’s Health Minister Jenny Mikakos (7 News July 2020)

References

1. The Australian Vaccination-risks Network is one group which has moved to downplay the significance of coronavirus, with spokeswoman Meryl Dorey saying the virus “is just the common cold”. “The cold can kill anyone if they’re sick to begin with and coronavirus is no different,” she said on a Facebook video on Sunday. She said people have been “fooled” by a “fear campaign on the silly sheep media”.
https://7news.com.au/lifestyle/health-wellbeing/anti-vaxxers-downplay-common-cold-like-coronavirus-amid-fears-of-forced-vaccinations-c-725089

2. Dorey questioned the COVID-19 pandemic saying: “Are you being lied to?” Requesting that followers “take your phones and pop into the local hospital” and “Let us know how crowded it is — or is not. Is coronavirus really overwhelming our nation or is our nation overwhelming us with lies and killing our economy and us?”
Hansen, Jane (3 April 2020). “Anti-vaxxers deny COVID-19 pandemic, urge others to ignore isolation advice”. The Sunday Telegraph. Sydney NSW.

3. On Face Masks for COVID-19: “… a piece of cheese cloth… something with lots and lots of holes in it is the best to wear.”
On Temperature Testing for COVID-19: “…. temperature testing, that’s just crazy….” “It is so stupid. It just shows the extent of stupidity that our government, our medical community and our media are displaying.”
Meryl Dorey, Under the Wire – https://www.bitchute.com/video/K77QIp3HJQyP (49min 20sec mark)

4. A controversial anti-vaccination group has likened vaccines that prevent disease to rape, drawing condemnation even from some its own supporters.
https://www.smh.com.au/national/australian-vaccination-skeptics-network-compares-vaccines-to-rape-20150422-1mr0wk.html

5. “The next and most logical step is the use of microchips which will contain all of the same information contained on smart cards but which will be injected into us and read and updated from a distance.”
http://web.archive.org/web/20010406083421/avn.org.au/big.htm

6. “The number of chemtrails sprayed over the #CDCWhistleblower #VAXtruth rally was shocking! Many of the protesters were sickened. Stop it NOW!”
Twitter @nocompulsoryvac – 1:15am – 27 Oct 2016

7. Meryl Dorey: “All vaccinations in the medical literature have been linked with the possibility of causing autism, not just the measles/mumps/rubella vaccine.”
https://www.abc.net.au/mediawatch/episodes/false-balance-leads-to-confusion/9973912

8. Anti-vaxxers come up with their most abhorrent lie yet. – “So Shaken Baby Syndrome again, like SIDS, is a waste basket. It is a way of blaming the family for what may have been caused by the medical community.”
https://www.mamamia.com.au/avn

9. The NSW Health Care Complaints Commission – Public statement – warning about the Australian Vaccination-skeptics Network, Inc. (‘AVN’), formerly known as Australian Vaccination Network Inc.
https://tinyurl.com/p6o4yy8

10. False balance leads to confusion (Media Watch ABC October 2012) https://www.abc.net.au/mediawatch/episodes/false-balance-leads-to-confusion/9973912

For reliable information about COVID-19: https://www.health.gov.au
For reliable information about vaccination: https://www.health.gov.au/health-topics/immunisation


Once again please note this post is © Australian Skeptics and the original can be sourced here.

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No reason to not vaccinate but anti-vaxxers continue to resist sound health policy

On April 17th last year Paul Offit was interviewed by Christiane Amanpour of CNN on the fact that there is “no legitimate reason” for not vaccinating.

This video very recently accompanied a February 21st article by U.S. pediatrician Dr. Edith Brancho-Sanchez, entitled Several vaccines at once might be too much for parents, but kids are just fine. The article reinforced the fact that the misinformation regarding the safety and efficacy of vaccines causes variations of anxiety in parents who take their children to be vaccinated.

It was reported that a 2014 USA National Immunization Surveillance Survey indicated that;

… over a third of parents of children ages 19 to 35 months followed delayed immunization schedules. Of the parents surveyed, 23% followed an alternate schedule that either limited the number of shots per visit or skipped at least one vaccine series altogether. Another 14% followed an unknown or unclassifiable schedule that did not follow a pattern and was not in line with national recommendations. Children who followed an alternate pattern were four times as likely not to be up to date on their vaccines and those who followed an unclassifiable pattern were over twice as likely not to be up to date.

Regrettably pediatricians are in a Catch 22 situation. They need to build parental trust. A 2015 study published in Pediatrics indicated that 93% of 534 pediatricians had been asked by parents of children under 2 to spread out vaccines. 82% believed complying with the parent’s request would build trust, whilst 80% thought if they declined, this may lead to parents leaving their practice.

In Connecticut, USA state lawmakers “narrowly advanced a bill” this week that seeks to ban religious vaccine exemptions for children. Despite reports of a 25% increase in religious exemptions from last year anti-vaccine opposition to the bill was fierce including protests in Connecticut’s Legislative Office Building. One Democrat representative, who seemed to have abandoned any pretense of basing his decision on evidence, referred to vaccination as “injecting a witches brew of chemicals”.

Here in Australia the leading anti-vaccine disinformation group The Australian Vaccination-risks Network has called on members and fellow anti-vaxxers to heed another infamous Action Alert. They are targetting Victoria and South Australia. In Victoria the Health Services Amendment Bill 2020 seeks to provide for mandatory vaccination of healthcare and ambulance workers with specific immunisations. Ten days ago the Victorian Minister for Health published this media release outlining the logic behind the decision.

The vaccines included are the flu vaccine, whooping cough, measles, chicken pox and hepatitis B. It is astonishing, as we witness the evolving impact of COVID-19 in the absence of a vaccine, that groups such as the AVN seek to multiply these negative effects. They have teamed up with the anti-science, anti-medicine group, Health Freedom Victoria helping to disseminate their “generic letter” for anti-vaxxers to mail to “all Victorian politicians including your local member”. Of course one may pen ones own. Be sure to stress you “vehemently oppose this draconian overreach of the Andrews’ government”.

They also advise to follow up with phone calls. Following that, they basically suggest harassing Martin Foley who is Minister for Mental Health, Minister for Equality and Minister for Creative Industries. Martin Foley’s mental health portfolio sees him quite active in reducing discrimination for Victorians living with mental health challenges. Health Freedom Victoria want anti-vaxxers working in the health sector to email and call Mr. Foley to;

Tell him you are appalled that he would change the Discrimination Act to get away with forcing you to take an untested and unwanted medical procedure in order to keep your job

In the material they have disseminated to encourage targetting Martin Foley, Health Freedom Victoria refer to him as, “the Minister for amongst other things, Mental Health and Discrimination”.

South Australia introduced No Jab No Play legislation on September 30th 2019. Again there is a “generic letter” ready to go. In both cases the AVN seek to motivate loyal anti-vaccine followers to engage in pestering letter and/or email writing campaigns, asking those involved to follow up with a phone call, in this case “within half an hour but at least by the end of the day”. This is to confirm they have received your email and will be sending a Decision Regulatory Impact Statement (RIS). Of course one should inform the person you’ll call back in two weeks to chase up that RIS. And why?

In the words of the AVN themselves;

Phone calls increase their workload, so they’re more likely to do their job to avoid getting repeat calls.

Yep, you read that right. Wasting the time of your local members already busy and hard working staff is ensuring they “do their job”.

Now, it’s over to Paul Offit…