There’s Something About VAERS

Since the inception of VAERS, anti-vaccination activists have misused reports as a cornerstone in their campaign to misinform and mislead. Vaccination against COVID-19 has led to that misuse exploding.

What is VAERS?

VAERS is the U.S. based Vaccine Adverse Event Reporting System managed by the Department of Health and Human Services (HHS) and co-managed by the Centers for Disease Control (CDC). It is an early warning system that collates reports of suspected adverse events following immunisation. A full explanation is here. Reports may be submitted by anyone who has received a vaccine authorised in the United States. Doctors, health workers, family members and associates can also submit reports. It is an open passive reporting system that allows reports from anyone who is aware of an adverse event they perceive as related to a vaccine.

It follows that the reports are just that; reports. Reports that contain no information about causality or indeed accuracy. This is not to say they are inaccurate. Rather that their true meaning, and indeed impact, can only be borne out in the context of further evaluation. Evaluation will assess any pattern of events, related health problems, any identifiable mechanism of causality and the time frame between vaccination and adverse event. Suspect vaccines would be suspended and emergency investigations employed to assess the scale and seriousness of adverse reaction(s). If the adverse event is confirmed to be more significant than in pre-licencing trials, the vaccine is removed from market.

Research and peer reviewed publication would follow, describing these findings. This information is of enormous benefit to the design, manufacture and trial of future vaccines. What stands out immediately is that determining adverse events due to vaccination requires significant input seperate from VAERS. The most important and irrefutable element about VAERS reports is that they do not represent cause and effect.

The VAERS site includes a Guide to Interpreting VAERS Data.

Under Evaluating VAERS Data:

When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. […]

VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.

Under VAERS Data Limitations:

Reports vary in quality and completeness. They often lack details and sometimes can have information that contains errors. […]

No proof that the event was caused by the vaccine is required in order for VAERS to accept the report. VAERS accepts all reports without judging whether the event was caused by the vaccine.

The above is a small selection from the guide. Yet it is enough to inform readers seeking definitive information on adverse events linked to vaccines, that it will not be found there. Exploiting the reports to provide an accurate picture of potential or existing problems takes resources. Resources that individuals don’t have. Consider the case of RotaShield. This rotavirus vaccine was taken off the U.S. market in 1999 because of an association between the vaccine and intussusception. The U.S. Advisory Committee on Immunisation Practices (ACIP) voted for its removal after an in depth review of available data. RotaShield was available for just months.

Paul Offit is well schooled in how VAERS is misused. He is also a firm supporter of civilian reporting because, as intended, unanticipated side effects can be caught this way. He has referred to VAERS as a “hypothesis-generating mechanism”, and observed about RotaShield:

There were a number of VAERS reports that patients within a week developed an intestinal blockage. A study was done and it was shown to be a causal association. VAERS was the tipoff. There’s value in it.

Medscape provide detail on the scale of the study:

The suspected association between RRV-TV and intussusception based on a review of VAERS data led CDC, in conjunction with state and local health departments, to implement a case-control study [in 19 U.S. states among 429 infants and 1,763 matched controls] and case-series analysis and a retrospective cohort study [among 463,277 children].

So yes. If it’s confirmation of adverse events due to vaccination one seeks, merely perusing VAERS isn’t enough. This doesn’t stop antivaxxers from abusing the VAERS database to create the illusion of wide scale “vaccine injury”. As we’ve seen time and again during the COVID-19 vaccine rollout, screenshots and memes reach a large audience. Discredited Australian Instagram influencer and anti-vaccine advocate, Taylor Winterstein, has misused VAERS data to attack “mainstream mentality”. These tactics have the added advantage of side-stepping the guide to interpreting what is limited data on VAERS. The same approach is used by right wing cable news outlets. There are numerous techniques used to avoid the reality that there is only a temporal, and not a causal, relationship between vaccine and adverse reaction. Presenting government data carries a certain authority. Stripping it of context ensures it is inaccurate.

OpenVAERS

Post hoc ergo propter hoc: After this therefore because of this. This fallacy is the fuel driving the VAERS misinformation empire. Without it, outright claims cannot stand. Nor could the inference and extrapolation that comes from accepting widespread vaccine injury and death. The Vaxxed II bus in Australia is a typical example. It began last year, collecting dubious testimonials on “the vaccine-killed and injured”. Last month it began targeting the COVID-19 vaccine. Removing context from VAERS data ensures post hoc fallacy. This is exactly what the OpenVAERS project does. Launched in September 2019, it was initially run from archivist.net as confirmed on the Facebook page of The Archivist. In January 2021 the domain switched to openvaers.com and focused on COVID-19 vaccination data. Unsurprisingly OpenVAERS is a favourite of antivaxxers. Until recently, the index page offered:

The OpenVAERS Project allows browsing and searching of the reports without the need to compose an advanced search (more advanced searches can be done at medalerts.org or vaers.hhs.gov).

That’s what we find on the archived index page as at 1 August 2021. The next capture is 23 August 2021. At some time between these captures, OpenVAERS included a link to its own copy of the VAERS disclaimer both on the index page and its impactful VAERS COVID Vaccine Data page. The change on the vaccine data page was minor. Compare the 23 July and 20 August pages below. Keep in mind this is what readers see when they land on the data page. To appreciate the importance of context I’ve included a screenshot of the government VAERS data page.

Prior to this, users of OpenVAERS would have to navigate to the About page and follow the link to the VAERS About page. The change came just prior to the publication by Logically, a misinformation tracking group, of an article on 12 August which revealed the name and face behind the site. Logically had posed questions and a request for comment, which may have prompted the design change. Lizabeth Pearl Willner (below) better known as Liz Willner believes her daughter was injured by vaccination and began posting anti-vaccine content on social media in April 2019. She insists the site exists to provide easy access to official data.

There were significantly more visits to OpenVAERS (1.23 million) than to VAERS (796.63k) between February and July this year. Logically discovered that 30 percent of referrals to OpenVAERS are from the right wing, fake news site, Gateway Pundit. 10 percent are from conspiracy theorist Vernon Coleman (old man in a chair). These sites promote COVID conspiracies, pseudoscience and anti-vaccination rhetoric. Willner’s now deleted Facebook account and recently deactivated Twitter handle @1pissedoffmom1, amplified the reach and impact of OpenVAERS.

Until April 2021 OpenVAERS included a dedicated and searchable vaccine excipients table. The OpenVAERS blog now returns a 404 page. Indeed those behind OpenVAERS seem intent on having their deleted content also removed from archive.org. When running, the blog provided a one stop antivax shop for COVID-19 misinformation for “warrior moms, dads and grandparents”.

Call For Action posts contained alarming inaccuracies about the COVID-19 pandemic and the safety of the COVID-19 vaccine. The posts linked to ready-made PDFs to be printed out and mailed to “friends, family, and elected officials”. The drill, as they called it, was “10 copies, 10 stamps, 10 envelopes, 10 chances to wake someone up”.

As recently as 2 August this year we find:

Unfortunately, coronavirus vaccines excel at producing iatrogenic injury. Since their rushed introduction in December, these shots have produced four times more fatalities than the terrorist attacks on 9/11.

A link to that particular post, along with the 9/11 reference was shared on The Defender. That’s the “news and views” site of Robert F. Kennedy Jr.’s Children’s Health Defense. The potential for harm by encouraging vaccine hesitancy in the midst of a pandemic is significant. Willner has ignored requests for comment from VICE News. The OpenVAERS blog also claims to be getting around “the criminal censorship of essential vaccine information on social media”.

Successful misuse of data this way relies upon the base rate fallacy. When vast sections of the population are involved, background mortality and morbidity become significant. Adverse events and deaths are reported in such numbers not because the vaccine is responsible, but because so many people are being vaccinated on any given day. Each person is given literature on how to report adverse reactions to VAERS. The V-Safe initiative includes regular text messages asking about any symptoms or changes to health. Attention given COVID-19 vaccination is unparalleled and this is reflected in data. Reports to VAERS (CSV VAERS Data accessed 3 September 2021) for all of 2020 totalled 63,544. To date, reports for 2021 ending 20 August, total 674,382. Not only are these reports unconfirmed but the safety of the COVID-19 vaccine is regularly affirmed.

Kolina Koltai is a Postdoctoral Fellow at the Center for an Informed Public based at the University of Washington. She describes OpenVAERS as “misinformation 101” and stresses that such decontextualisation is common to misinformation. Koltai uses such examples in classes that she teaches. In responses to questions posed by Logically, Liz Willner accused them of misrepresenting both VAERS and OpenVAERS. She cited data collected between 1990 – 2010 to argue, misleadingly, that “83% of reports are health care workers and Pharma”. Despite all evidence pointing to her, she insists OpenVAERS is a team effort. This is reflected on the site.

From the FAQ. Why is OpenVAERS necessary?

We built openVAERS because we found the HHS site difficult to navigate and get information from. We wanted a way to browse reports. Once we had that we decided to make it public.

How generous. Who is behind OpenVAERS?

OpenVAERS is a project developed by a small team of people with vaccine injuries or have children with vaccine injuries. We do not accept donations or solicit fees. There is zero monetization of this site. It is purely created in order to help others browse the VAERS records and to identify the reported signals that may otherwise get missed.

Here Willner misuses the term “signals”, specifically in how they relate to establishing risk. According to the CDC under How VAERS works:

Patterns of adverse events, or an unusually high number of adverse events reported after a particular vaccine, are called “signals.” If a signal is identified through VAERS, scientists may conduct further studies to find out if the signal represents an actual risk.

The design of OpenVAERS allows immediate access to VAERS reports. These, in conjunction with tabulated figures, can be easily screenshot and spread via social media. Misleading commentary on these platforms aims to encourage vaccine hesitancy. One claim is that COVID-19 vaccines cause serious cardiac events and heart attack. In addressing this topic the indefatigable Orac picks apart flawed manipulation of data from Robert F. Kennedy Jr. and Children’s Health Defense. Back in May the energetic David Gorski addressed the “vaccine holocaust” based on VAERS data that Mike Adams bravely announced. Examples abound. The one constant, and undoubtedly something to be factored into public education, is that misuse of unverified reports is a key driver of vaccine hesitancy.

Despite long standing problems, VAERS works. RotaShield is a case in point. Twenty years of research preceded its approval by the FDA. Four months after ACIP recommended a three dose schedule for all infants it was suspended to allow for a CDC investigation. There had been twelve reports to VAERS of intussusception. Dorit Reiss, a law professor at UC Hastings and pro-vaccination activist, shares Paul Offit’s view that submitting reports to VAERS should be easy for members of the public. Reiss has suggested withholding reports that are “clearly not credible”.

One imagines this would include suicides, drownings, car accidents, homicides, and so on. To appreciate the less credible, or in this case incredible, consider the case of James Laidler M.D. He submitted a report to the effect that the influenza vaccine turned him into The Incredible Hulk. It was accepted. To reinforce this flaw Kevin Leitch of Left Brain Right Brain, submitted a report to VAERS that his daughter had turned into Wonder Woman following vaccination. This too was accepted. The ease of submitting dubious reports has been raised with antivaxxers. The unanimous reply is that submitting a false report to VAERS is a felony. This was also argued by Liz Willner when defending her conduct to Logically. The Hulk and Wonder Woman however, remain felony free.

It is clear though, that VAERS as it presently exists is of benefit to U.S. public health. Given that so much of the anti-vaccination response to the COVID-19 vaccine rollout was anticipated it is unfortunate that the abuse of VAERS was not proactively met. The outlay of resources to say, educate, or at least inform the public would not be prohibitive. The probable cost of managing the harm that exploitation of the system has, and will continue to cause is significant. Of course that’s an easy observation to make in hindsight. Nonetheless, any measures taken now to manage misinformation adversely effecting vaccine uptake would likely be justified.

VAERS Underreporting

The misuse of VAERS data is rarely complete without also misrepresenting the fact that adverse events following vaccination go largely unreported. In other words VAERS data represents underreporting. Given that the majority of events are minor, such as injection site soreness and redness or involve headaches, fever, aches, nausea, itching and so on, this is to be expected. For the anti-vaccination lobby the aim has always been to create the illusion of large scale death and serious injury, then compound this by claiming it represents only a small fraction of actual cases. Judy Wilyman favoured this tactic to smear successful HPV immunisation campaigns and indeed all vaccines. Liz Willner doesn’t disappoint.

VAERS is the Vaccine Adverse Event Reporting System put in place in 1990. It is a voluntary reporting system that has been estimated to account for only 1% (see the Lazarus Report) of vaccine injuries. OpenVAERS is built from the HHS data available for download at vaers.hhs.gov.

From the OpenVAERS blog post of 2 August 2021:

The 518,769 injury reports are just the tip of the iceberg as a government-funded study concluded that “fewer than 1% of vaccine adverse events are reported.”

This is more decontextualisation. It is unlikely visitors will read the report or indeed search for definitive reviews of the one percent finding. Also, as data are from a government authority, and underreporting is represented on government sites, an appeal to authority is in constant play. Antivaxxers have thus quite confidently used this two pronged approach for over a decade. Adapting to the rollout of the COVID-19 vaccine while obfuscating increased reporting of symptoms and the role of V-Link, has proven seamless for established lobbyists.

The figure of 1% comes from a report from Harvard Pilgrim Health Care, Inc., authored by Ross Lazarus. Data examined are from 1 December 2007 to 30 September 2010. These data include all possible adverse events. Prior evaluation of the reporting rates of various events confirms that minor events are rarely reported and more serious events routinely reported. A 2014 report on surveillance of adverse events following immunisation in NSW, Australia noted that:

Only 11% of the reported adverse events were categorised as serious

Reuters report the case of an antivaxxer reiterating falsely that only one percent of deaths and injuries following the COVID-19 vaccine are reported. The article includes this comment from a CDC spokesperson:

Mild events, like a rash, tend to be reported less frequently than severe events (like a seizure). We have data to show that serious adverse events that occur after vaccination are more likely to be reported than non-serious adverse events. Events such as a sore arm at the injection site might not get reported since they are expected and therefore people don’t feel the need to report them.

A December 1995 study of passive surveillance sensitivity in The American Journal of Public Health reported 72% for poliomyelitis after the oral polio vaccine and less than 1% for rash and thrombocytopenia after MMR. A 2020 study of VAERS sensitivity published in Vaccine noted in Background, a similar rate of 68% capture for poliomyelitis after oral polio vaccine and 47% capture of intussusception cases after rotavirus vaccine. The target objective of anaphylaxis and GBS following various vaccines revealed a range from 12% to 76%. As early as 2003 a study found that serious events are rare.

What antivaxxers won’t tell you

The evident paucity inherent in the misuse of VAERS data becomes apparent when examining another appeal to authority employed by antivaxxers. Namely the amount of money awarded to “victims of vaccine injury” via the Vaccine Injury Compensation Program (VICP). Total compensation paid out over the life of the VICP, since 1988, is in the area of $4.6 billion US. Members of the anti-vaccine lobby often cite various approximations of this figure to underscore their claim that vaccine damage occurs on a huge scale. In fact a simple analysis of VICP figures reveals the opposite to be true.

The report states that for every 1 million vaccine doses, “approximately 1 individual was compensated”. This is a familiar figure. The table below contains the monthly VICP statistics update report for 1 September 2021. It may be found on page three of the data and adjudication statistics report from Health Resources and Services Administration. It is headed Adjudication Categories, by Alleged Vaccine for Petitions Filed Since the Inclusion of Influenza as an Eligible Vaccine for Filings. NB: Influenza doses = 45% of total doses since 2006.

From 1 January 2006 to 31 December 2019 the number of vaccine doses distributed, as sourced from the CDC, totals 4,092,757,049. The total number of compensable cases is 5,983. Or 0.00015% of distributed doses. The Influenza vaccine accounts for 71.6% of compensable doses. Total settlements, including dismissed cases and non-compensable cases to date, have reached 8,438. Or 0.00020% of distributed doses. This represents a striking absence of vaccine injury. Unsurprisingly you will not hear these figures from the anti-vaccination lobby.

TABLE: Petitions Filed Since the Inclusion of Influenza as an Eligible Vaccine for Filing

Since January 1988, 24,335 petitions have been filed [page 5]. 8,278 or 34% of petitions were compensated. More so, as the HRSA report states, “Being awarded compensation for a petition does not necessarily mean that the vaccine caused the alleged injury”.

And:

Approximately 60 percent of all compensation awarded by the VICP comes as a result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury.

Before moving on it’s worth reflecting on the fact that both VAERS and the VICP exist thanks to the efforts of established anti-vaccine campaigners such as Barbara Loe Fisher. Their campaigning led to the creation of the 1986 National Childhood Vaccine Injury Act, which is itself the subject of Andrew Wakefield’s most recent film claiming widespread vaccine injury. As we can plainly see not only are compensated cases exceedingly rare, but only 40% of those demonstrate a causal link to any vaccine. One expects it is not rash to expect that in time we will see similar figures pertaining to COVID-19 vaccines.

Antivax Winning Formula

Misrepresenting VAERS data is a simple winning formula for antivaxxers. It follows that it can be applied to any adverse event reporting system, particularly those employing passive surveillance. The COVID-19 vaccine rollout is unprecedented and subject to significant scrutiny. Governments support the reporting of adverse events and deaths post COVID-19 vaccination. The winning formula thus ensures the anti-vaccination lobby has a significant advantage in spreading its message. Data from the U.K., the E.U. and Australia have also been misused this way. The exploitation of coincidental deaths following COVID-19 vaccination was met quickly and comprehensively by Australia’s Therapeutic Goods Administration. Not surprisingly this had no effect on those opposed to vaccination against COVID-19.

Analysis of application of the winning formula to other government reporting systems is beyond the scope of this post. However, Australians have made good use of the tactic both before and during the COVID-19 pandemic. Underreporting of adverse events was mentioned in a May 2019 press release from the Informed Medical Options Party. They promise a “more accurate” system if elected. More recently, misused data from the U.K. Yellow Card voluntary reporting system was retweeted by Australian senator Malcom Roberts. United Australia Party leader, Craig Kelly, randomly texts Australians with a link to screenshots of reports to the TGA Database of Adverse Event Notifications. In April 2021 Judy Wilyman cited conspiracy theory website accounts of unverified reports to smear COVID-19 vaccine. A flyer packed with false and unverified deaths and injuries from four different reporting systems was tweeted by Meryl Dorey in mid June 2021. Watch this space.

Conclusion

The U.S. Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system open to the public that has, since its inception, been exploited by the anti-vaccination lobby. The absence of any causal relationship between vaccine and report is ignored by antivaxxers. The introduction of the COVID-19 vaccine has accompanied unprecedented reporting due to increased vaccination with active encouragement of recipients to use the VAERS system. The rise in reports was to be expected. This clinical reality has been obfuscated by players in the anti-vaccination community who have skilfully used social media to present background mortality and morbidity as causally linked to COVID-19 vaccination.

The website OpenVAERS, dedicated to misrepresenting VAERS data has focused exclusively on COVID-19 vaccination since January 2021. An investigation by Logically found Lizabeth Pearl Willner from California is the force behind the site. A frenetic antivaxxer, Liz Willner attempted to dismiss her activity as provision of easy access to data. Since the investigation she has been actively removing her anti-vaccination footprint on social media whilst keeping the site active.

Payouts from the Vaccine Injury Compensation Program to date total $4.6 billion. Often cited by antivaxxers as further evidence of widespread vaccine related harm, VICP settlements from 2006 – 2019 equate to 0.00015% of vaccine doses given in that period. The Influenza vaccine accounts for 71.6% of this total.

Misrepresenting VAERS data to convince others that vaccines cause significant harm has proven to be both durable and successful. Combined with the misleading claim that only one percent of all events are reported, the result has almost certainly been an as yet unknown increase in vaccine hesitancy. Familiarising the public with the manner in which such data are misused may alleviate some amount of vaccine hesitancy.

COVID-19 vaccines are safe and effective.


References and reading

Vaccine Adverse Event Reporting System – HHS

Guide to interpreting VAERS data – HHS

CDC: VAERS

Surveillance for Adverse Events Following Immunization Using VAERS – CDC

Selected Adverse Events Reported After COVID-19 Vaccination – CDC

Anti-vaccine activists use a government database to scare the publicScience

Anti-Vaxxers Misuse Federal Data to Falsely Claim COVID Vaccines Are Dangerous – VICE

California Woman Behind Antivax Site Outperforming Government DatabaseLogically

The Woman Who Secretly Runs One of the World’s Biggest Anti-Vax Websites From Her House – VICE

Hugely Popular Antivax Site Is Just Some Lady In Piedmont

Unverified reports of vaccine side effects in VAERS aren’t the smoking guns portrayed by right-wing media outlets – they can offer insight into vaccine hesitancy – The Conversation

Reports of adverse effects in US database aren’t confirmed to be linked to vaccination – Fact check

Large real-world study: Pfizer’s COVID vaccine is safe

Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS) – PDF

Underreporting and Post-Vaccine Deaths in VAERS Explained

The reporting sensitivity of VAERS for anaphylaxis and for Guillain-Barré syndrome

Last update: 7 September 2021

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Monica Smit: COVID-19 charlatan given ABC air time

It seems longer, but it has been only two and a half months, since we dropped in on Monica Smit and her self-appointed government-in-waiting, absurdly named Reignite Democracy Australia (RDA).

The occasion was their attendance during COVID-19 lockdown at a meal held at Moda Kitchen and Bar in Seddon, in breach of the Victorian Public Health and Wellbeing Act 2008. It was all a bit of a chuckle, given that the group effectively outed themselves and the restaurant by boasting about it on social media. The amusement was short lived for Moda however. On 6 August they announced their imminent closure on Instagram and Facebook. Their last meal was 14 August, just 11 weeks after hosting RDA. A representative told Star Weekly that the closure was unrelated to that event.

The representative claimed that mask-wearing mandates and lockdowns had not effected the business, insisting, “To be honest, we’ve never been so busy”. Although the attitude of the establishment to public health regulations was echoed in the observation:

Running a business is hard work and with or without the unlawful restrictions we were ready for a change.

Speaking of unlawful, it should be noted that Moda Kitchen and Bar had made the RDA business listing. The listing provides details of businesses, prepared to exploit loopholes in public health regulations that keep us safe during the COVID-19 pandemic. Most specifically, this relates to mask-wearing and QR code check-in. There are exemptions to the requirement to wear a face mask. These include breathing difficulties, facial skins problems, intellectual disability, mental illness and having experienced trauma. The Privacy Act 1998, The Disability Discrimination Act 1992 and The Equal Opportunity Act ensure that no-one, should they not be wearing a mask, can be asked to provide evidence of such a disability unless their prior consent has been given.

It is thus quite easy for the dishonest to venture out without a mask. This is something we’ve seen as mask-less RDA disciples with phone cameras taunt police. The business listing idea is fluffed up through RDA concern that businesses might not be aware of the risks of discriminating. When it comes to QR code compliance, a business may simply trust patrons to do the right thing. Or perhaps trust them to do what Monica advises; choose to check in with pen and paper and be trusted to leave genuine details. If you happen to be a business that regard essential public health initiatives as “unlawful restrictions”, as Moda did, your RDA business listing is this.

RDA business listing – Moda Kitchen and Bar

ABC Radio Nth QLD

Monica Smit offers unregulated “advice” about public health and wellbeing mandates. On 12 August 2021, Monica was interviewed by Adam Stephens during the Drive programme on ABC North Queensland. The reason for this was RDA “You Can Say No” pamphlet-dropping in Cairns. Dave, a small business owner, was interviewed prior to Smit. He wasn’t impressed and wasn’t fooled.

The flyer tactic backfired, as the only change in his behaviour was to place a sign outside his shop, reinforcing that no mask or no QR code check-in, meant no entry. That Drive programme is archived and Dave and Adam begin their chat at the 45:00 min mark. Next comes Monica Smit, introduced by Adam as Monica Schmitt. Text messages, read out after a news break, were unanimously negative. If you’d prefer the highlights package, grab this mp3 here or listen below.

  • Cairns resident objects to RDA flyers, Monica Smit (4min), Adam reads text messages (9:40)

RDA recently made the Daily Telegraph’s top ten list of COVID misinformation spreaders in Australia. You may thus wonder why the ABC would give them air time. I would rush to add that the Daily Telegraph (DT) is not equivalent to the US based Centre for Countering Digital Hate. The latter spent significant time and resources, collating information on those they ultimately termed the disinformation dozen. Nonetheless, the central thesis remains intact. Despite clearly fallacious claims that place the community at risk, well-financed groups and individuals manipulate Facebook to their advantage. The DT reported that RDA subscribe to the belief no COVID-19 vaccine has been properly tested, and in fact weaken the immune system.

They also allow their name to back the conspiracy theorist standard that the vaccines are “manufactured by people who openly want population control”. Professor Mary-Louise McLaws specialises in infection prevention and control. She rightly observed those claims were “completely fallacious” and “wickedly inaccurate”. In a welcome development since the DT piece on 6 August, RDA had their page, and shortly after their backup page, unpublished from Facebook. That came on the heels of their aggressive campaign to boycott SPC, after the fruit packing giant mandated COVID-19 vaccination for employees. The boycott campaign resulted in product tampering and threats that presently continue.

Editorial standards?

Adam Stephens did give his reasons for interviewing Smit. He observed that it’s interesting that there are people that hold this view. That there are people in regional QLD who are active members of RDA, as evidenced by pamphlet distribution in Cairns. He continued;

Whether you wanted to hear from Monica or not there are people that are listening to her message, and sometimes it’s… I think worthwhile in actually learning about the motivations of some of these groups in our community, and some of the people that feel strongly enough to actually join groups like this and distribute their information.

I’m aware that listeners took the trouble to contact the ABC to voice concern. Before we examine Monica Smit’s claims, let’s consider the following. Smit was not introduced with sufficient context to advise listeners that they may be misled. It was not stressed that Monica Smit and RDA are not medical or pandemic specialists or that they are not advised by medical experts. It was not explained that their website provides no reputable or evidence-based information. Indeed, it was not stressed that the group has no relevant qualifications specific to the management of COVID-19, or any illness, at all. Finally, there was no public health representative on hand to address the claims made by Smit.

One might then ask, were ABC standards for editorial accuracy satisfactorily met? Granted, a context of sorts was laid down during Stephens’ chat with business owner Dave. Whether this was enough to reinforce that Smit and RDA act in dissonance to both government guidelines and evidence-based health policy, is not merely unclear, but unlikely. Monica Smit brings a firm, if utterly misguided, confidence to her stints behind any microphone. It came to the fore as she insisted that masks were not only useless and causing harm but there is, “so much science out there” to support this.

“Because it’s the truth”

When asked why she is informing people that they don’t have to follow mask mandates or QR code check-ins if they choose, Smit replied, “Well because it’s the truth”. With QR codes she advises to manually sign-in or shop somewhere else.

In effect this would mean finding a shop that has adopted Smit’s loophole advice. As we’ve come to expect from RDA on evading mask wearing, she mentions PTSD, anxiety, depression – the “huge list of exemptions”.

She blames, “the coercion and the scare tactics of the police and the government”, for forcing those with legitimate reasons for exemption, into wearing masks. At no time did Smit offer a legitimate reason as to why Australians without a health condition can refuse mask wearing. Unless of course, you are willing to feign one (I’m not suggesting she advised this). She followed on by claiming long term mask wearing is “really dangerous”.

That word brings to mind the long debunked claim that oxygen is restricted and CO2 intake rises to poisonous levels. Smit gushes that “People have, you know, passed out at work”. A fan of Tucker Carlsen, Smit is likely influenced by the research letter pushed by him about six weeks ago, and now retracted from JAMA Pediatrics. Smit goes one better, claiming there is, “[A] lot of science to say that they cause cognitive issues with teenage children as well, and they’re wearing them eight hours a day”.

Smit might get that notion from an isolated German survey, looking at “complaints from adolescents and children caused by wearing a mask”. This is not “a lot of science”, and comes with an editorial note stressing the absence of a causal link. There is also the genuine concern related to the importance of non verbal facial cues, to children who are learning. These are minimised by face masks. Particularly in the classroom. As fate would have it, or rather, as science would have it, this has been studied pre-pandemic and during the pandemic. CNN published a handy summary here. If you land on the conservative City Journal, you will find arguably emotive material to support Smit’s contention.

Adam Stephens questioned Smit on whether she really did have substantial supporting science, given the evidence-based source material that advises government policy. Smit was glad he asked because in March and April of last year the media, “were saying that a healthy person wearing a mask is an absolute waste of a mask”. She wondered “why the narrative has changed”. In fact that was because of a WHO-funded systematic review and meta-analysis, published in June of 2020 in The Lancet. More so this was clearly conveyed in “the narrative” presented by the media. Consider this non-ambiguous heading in The Guardian: Victorians may be now be told to wear face masks to halt COVID-19 – what’s changed? Then Smit confidently offered another disingenuous and factually wrong line.

The ‘Brett Sutton’ lie

Smit claimed:

I know that Brett Sutton, he’s the Victorian CHO (Chief Health Officer) here, he actually did a full study paper on how useless masks are to stop the spread of disease. So basically the narrative has just changed but the science has not changed and that is that masks are dangerous.

A “full study paper”? Sounds impressive. Also, I happen to agree with Monica here. The science has not changed. Nor has the old tactic of cherry picking and manipulating facts to support disinformation. What we find on checking Sutton’s authorship of research, is a 2001 literature review in Anaesthesia and Intensive Care, that he co-authored. At the time Sutton was based at North West Regional Hospital in Burnie, Tasmania. Both he and his co-author worked in the Department of Anaesthesia. The title of the literature review was Do Anaesthetists Need to Wear Surgical Masks in the Operating Theatre? A Literature Review with Evidence-Based Recommendations.

The review text could not be more clear. It was undertaken due to the absence of published data on the unmasking of the anaesthetist alone. In the modern operating theatre, exactly how this would impact post operative wound infection, if at all, needed elucidation. It was noted that surgical masks offer incomplete protection from bacteria and viruses. More so, plastic face shields provide better protection from infection for the anaesthetist. Three compelling studies, led the authors to conclude in part;

These studies provide sound scientifically-based evidence that, in the setting of a modern operating theatre with laminar flow/steriflow systems, surgical masks should no longer be considered mandatory for anaesthetists and non-scrub staff during most surgical procedures.

There is a reason for the extra detail on this review. This claim about Brett Sutton’s past authorship is not just misinformation, already tossed about like a Frisbee at a church picnic. This is hot-off-the-tongue disinformation. A nice fresh lie still in its packaging, delivered over the airwaves for the gullible to snatch up, unwrap and distribute. It has the added connotation that Victoria’s CHO is not only aware that masks are ineffective, but had produced “a full study paper” to this effect. Listeners may wrongly assume this is both recent, and in response to the COVID-19 pandemic. Smit studiously avoids admitting the paper is nineteen years old, and that it examines only anaesthetists and non-scrub staff, in operating theatres. Whilst cherry picking, she missed the one that suggested plastic face shields offer better protection.

In July 2020 Brett Sutton presented advice on wearing face masks, in areas experiencing stage three restrictions. At the same time the reasons for the mandating of mask wearing were being thoroughly discussed in mainstream media. It was impossible to miss. To suggest there was just a sudden change in “narrative” is wrong. Adam Stephen put it to Smit that her advice could place people at risk of COVID-19.

Deep breath

Without drawing breath, she responds;

Well I just totally disagree with that because, um, you know I think the government is putting people at risk of serious problems ah, with lockdowns and things like that so, it’s proven around the world that lockdowns don’t work. Australia has the worst lockdowns actually, I think, in the world. We’re being laughed at overseas because of how harsh our lockdowns are. Some, some, some countries have hundreds of thousands of cases daily and they’re still living about their lives, and we get one case and we close borders.

So ah, I would say the government is being a lot more dangerous than we are, and we’re actually empowering people to have critical thinking, which the government doesn’t want. They don’t… the government’s not giving people all the information. And that’s… and we get censored. I just got taken off Facebook. I had sixty six thousand followers and I get censored because my science is apparently not true, but I can back it up. But a lot of the science that’s said on mainstream media can’t be backed up but there’s no censorship for them so it’s really difficult.

It has not been “proven around the world” that lockdowns are ineffective. They remain one of the most effective non-pharmaceutical interventions. Healthy discussion continues about how this effects economies and communities. What is doubly strange about Smit’s approach here is that if masks are as useless as she claims, there is one clear alternative. The very lockdowns she also insists are useless. I doubt she is aware of this. Her approach is to attack all options, and encourage us to abandon them. She has no alternative to offer Victoria.

Stephens raises the question of people who accept the claims on the You Can Say No flyer, being fined. Smit comes back with a prompt that all the resources are on the website, and that;

If you get the flyer you really need to take that extra step to actually do the research because if, you know… know the law and you know your rights, then actually that fine is null and void and it’s actually um… it won’t mean anything.

Adam lets Monica know they’ll leave it there. Smit responds with an eager “No worries!”. Those familiar with Monica Smit might have noticed the big grin-tone in her final words. She had reason to feel smug, as Australians have every right to expect better from our national broadcaster. Smit usually only gets this much air time on Sky News. The reaction on Telegram, the favoured social media platform of COVID conspiracy theorists, was predictable. Discussion was kicked off thirty minutes later by RDA on their Telegram channel, with an announcement headed by a customised graphic.

Telegram

The first post I wrote on Monica Smit and RDA, opened with Monica Smit loves being the centre of attention. That entire topic requires a post on its own. Suffice it to say however, that certain personalities only take. They surround themselves with givers, and ruthlessly ban, delete and expunge those who challenge their bogus view of reality. The result is the unfettered pseudo-worship you see in the small sample above.

Note the suggestion from one, to “destroy those imbeciles”, in reference to Dave the shop keeper. It’s further worth noting RDA didn’t provide Adam Stephens’ interview with Dave, or the dissenting text messages. All that was known is that a shop owner was “appalled” by the flyer. Sophie, who unwittingly outed herself as a Cairns local, and likely a distributer of the flyers, decided that was enough for the destruction of “those imbeciles”.

Still no evidence

The bulk of RDA members on social media, continue to behave as if enjoying a sustained muck up day. This, however, gives an inaccurate view of the groups resources. Their recent advertising truck, growing range of merchandise, and increasingly slick video production suggests donations remain healthy. This has enabled the group to curate their campaign of alienation through misinformation. Their message is for those who prefer to be told what to think, rather than make their own conclusions. Yet this group is convinced they have discovered a unique truth that “sheeple” cannot see.

Although Smit talks of access to science that confirms the RDA position, there is none on their site. The well examined Danish study on mask wearing and transmission of SARS-CoV-2, can be accessed in favourable format. Rather than finding masks do not prevent transmission, the study failed to find, “at least a 50% protection against a SARS-CoV-2 infection given by mask wearing”, as it was designed to do. Fact Check also addressed this nine months ago. In targeting COVID-19 vaccine safety and efficacy, RDA direct readers to the tired example of the estimated study completion date, for the AstraZeneca vaccine. The actual study completion date was 5 March 2021.

Other material is presented in misleading context. Despite Smit’s claim of enabling critical thinking, visitors to the site are shown bias. There are no opportunities to compare contentious information in a critical fashion. The elephant in the room here is that all reputable evidence is against the position held by RDA. The use of “critical thinking” as a buzz term, has become almost commonplace in conspiracy theory circles. It is seemingly confused with contrariness. This is underscored by the fact that constant cries of suppressed freedom, and the exploitation of loopholes, is possible only because of our democratic rights and the legislation that protects them.

Conclusion

There’s little point rambling on much more dear reader. I’m certain the RDA site would be worthy of content analysis. A work similar to the excellent approach employed by Thomas Aechtner, in assessing the Australian Vaccination-risks Network, would be welcome.

Monica Smit is more than just dishonest. In taking advantage of a global pandemic to raise her profile and profits she has proven to be a malignant influencer. What has been demonstrated above, is that everything Monica Smit said during the interview with Adam Stephens, is demonstrably false. More to the point it has long been clear what she stands for.

The Australian Broadcasting Corporation needs to be out in front of such people.


References

ABC North QLD Drive – Thursday 12 August 2021

The Lancet VOLUME 395, ISSUE 10242, P1973-1987, JUNE 27, 2020. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis.

Anaesthesia and Intensive Care 2001; 29: 331-338: Do Anaesthetists Need to Wear Surgical Masks in the Operating Theatre? A Literature Review with Evidence-Based Recommendations. M.W.Skinner, B.A. Sutton.

Mask Mythbusters: Common questions about kids and masks

Corona children studies “Co-Ki”: First results of a Germany-wide registry on mouth and nose covering (mask) in children – DOI: 10.21203/rs.3.rs-124394/v3

The impact of face masks on children-A mini review: PMID: 33533522 PMCID: PMC8014099 DOI: 10.1111/apa.15784

BMJ Rapid Response – Conclusions from the Danish study

Danish study doesn’t prove face masks don’t work

Why nobody will ever agree on whether COVID lockdowns were worth it – The Conversation

Reignite Democracy Australia – You Can Say No

Reignite Democracy Australia – Informed Consent

Reignite Democracy Australia – Face mask Exemptions

Updated: 19 August 2021

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COVID-19 vaccination: an uninsurable experimental medical procedure?

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;

The Therapeutic Goods Administration (TGA) has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine, making it the second COVID-19 vaccine to receive regulatory approval in Australia.

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

Dear [redacted]

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.

Yours sincerely

[signature]

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:

The truth is out there.


Last update: 8 April 2021

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Losers, loss and denying evidence in 2020

Losers. 2020 has seen a lot of them.

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 [2] 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 paper Dealing 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.

Of course, there’s always next year.

  • Video: A Song for Anti-vaxxers by Flo & Joan

Last update: 1 Jan. 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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