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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We Are Coming… but with whom?

Monica Smit loves being the centre of attention.

The present pandemic Australia is experiencing, and successfully managing to the envy of much of the world, has given attention seekers like Smit a spotlight they could previously only dream of. She clearly has no problem denying the scientific evidence and the necessary reality of COVID-19. Rather, Smit sees it as a tool to manipulate the gullible and those already tuned to conspiracy theories to further her own aims.

The COVID opportunity wasn’t lost on other conspiracy theorists around the world, particularly anti-vaccination lobbyists. As Vaxxed producer and CEO of the Informed Consent Action Network, Del Bigtree boasted last year the pandemic was “a dream come true”. It was to be capitalised upon. It was an opportunity to “get people to wake up”. In practice what this really means is convincing people that they have been asleep. A task that became easier when COVID lockdowns and restrictions yielded an attentive social media audience.

Smit’s attention-seeking includes an attempt to get a spot on Australian Survivor in 2017. The audition video is an interesting clip and Smit tells us that, “my willpower will definitely put up a very good fight” to scenes of her balancing on one leg (see below). Monica Smit has demonstrated her will power through the establishment of Reignite Democracy Australia (RDA), a $1 company of which she is the only director and sole shareholder. RDA has over 50,000 supporters with strong wellness, anti-vaccine and conspiracy beliefs.

Smit has also displayed unique energy in her willingness to jump onto any conspiracy theory that is popular amongst anti-lockdown protesters. Her website tells visitors that RDA is a political movement*, not a political party. It’s a clever line. Particularly if hiding your allegiance to political connections. The site also offers a discredited study disputing the efficacy of masks and the now worn out anti-vaccine trope that PCR tests are oversensitive and thus COVID-19 cases are false positives. She would reject conspiracy theory labels and does reject being anti-vaccine.

smit balances to impress judges

Smit is attempting a unique balancing act in protesting the anti-vaccine label. In a video on her RDA website today she offered a “recap” of yesterday’s protest at the office of Federal Health Minister, Greg Hunt.

Despite the presence of anti-vaccine protestors, signage and rhetoric Smit rejected media reports of an anti-vaxxer presence and maintained she was “about informed consent”, the standard anti-vaxxer catch cry.

Monica Smit is, unsurprisingly, hard to get a handle on. She can be found online as a freelance journalist, although as we’ll see, this is a role she has apparently abandoned. That site is now focused on attacking Dan Andrews and massaging the fears that link COVID public health measures to an impending death of democracy. The site hosts Smit’s articles covering a range of topics from around the world. Despite claiming she will “only work with positive endings” she manages to find negative subject matter. Caps lock and repeated exclamation marks abound.

She also describes herself as a “Catholic pilgrim”. Following the Journalism menu to Catholic one finds a Regina Coeli Report in PDF featuring an interview with Smit on pilgrimages. Smit talks about God, the devil and evil. She references the fight for the Catholic faith and getting a “clear response from God to my efforts” for which she “wept out loud with joy”. Asked what she would say to convince someone to go on a pilgrimage she answered.

You won’t regret it I promise! Just turn up and God will do the rest! You’ll see!

She would be just perfect for the emerging far right in the Victorian (and Australian) Liberal Party. As she bellowed at a rapturous crowd in Melbourne last weekend the fight she is leading against Bill Gates, Anthony Fauci, Scott Morrison and Dan Andrews is one, “between good and evil and we are the good and good always prevails”. Smit maintains she is independent. Not affiliated with any political party.

Smit’s involvement in attacks on Victorian premier Dan Andrews goes back at least to working for online group Victoria Forward. The group hides its allegiance to the Victorian Liberals claiming to be “bipartisan”. The main identity is Facebook-friendly teen Edward Bourke. As reported by Gizmodo Australia Bourke started work as Male Vice-Chair at the Sunbury branch of Victorian Liberals in December 2019. It was one month before Victoria Forward emerged. Bourke is a firm Trump supporter who is proud of his plan to “import US political culture” starting with the launch of Victoria Forward.

In May last year Monica Smit worked with another apparent freelance journalist Stephanie Bastiaan in video production for Victoria Forward. Bastiaan, a member of the Victorian Liberal Party, is co-administrator of Victoria Forward’s Facebook page. Bastiaan is an integral part of the party’s conservative faction associated with branch stacking last year. She is the wife of Marcus Bastiaan who resigned from the Victorian Liberal Party in August last year due to the same branch stacking revelations.

Victoria Forward is anti-Dan Andrews and has capitalised on political sore spots for the Andrews’ government. Anti-lockdown sentiment, the Belt and Road agreement with China, volunteer firefighters and the unfortunate but necessary brumby cull. Opposing the last issue found support from another anti-Dan Andrews group Project Rural which has close links to Victoria Forward. Another website has put time and energy into fighting the Andrews’ government’s planned brumby cull. That of Monica Smit “freelance journalist”, which includes images and the article Racing to save last descendants of WWI ‘waler’ brumbies. Smit and Stephanie Bastiaan were praised for their efforts defending the brumby by member for Western Victoria, Bev McArthur of the Victorian Liberal Party.

Monica Smit is also a darling of Sky News. She was interviewed in October last year during her stint on the Let Us Work bus with the “Sack Andrews” hashtag. With what would become a tactic of Smits during arguments with police at anti-lockdown protests she used her apparent status as a journalist to shirk social distancing restrictions. The bus was the idea of Laurie Pincini, of Rockleigh Tours and the sign was courtesy of another small businessman. Both had lost their businesses to the lockdown impact on movement and Smit used their situation to her advantage. Alan Jones on Sky interviewed Smit after the Stop the sale of Victoria rally last November.

Smit kept drawing attention over 2020 and into 2021. She would attend protests and have herself filmed arguing with police over her right not to wear a mask, because she was a journalist. As noted above yesterday she was vocal at a protest outside the office of Federal Health Minister Greg Hunt. Channel 7 reported on the event. In one bizarre post on the RDA site today is a screenshot of her message that, “It WASN’T and (sic) anti-vax protest just FYI”. In the shot is an image of a woman holding a sign that reads, “It’s a DNA altering poison to change who you are!”.

Her most compelling performance was last Saturday February 20th in the Botanic Gardens Melbourne. The much promoted Millions March Against Mandatory Vaccination. Immediately before she spoke, some organisers appeared to be trying to get the crowd to stay in groups and maintain some semblance of social distancing. Smit jumped onto the podium, grabbed the microphone from the speaker and yelled, “Do what ya want, awright!”, to rousing cheers. [Video: see 1min 15]

Then Smit almost screams, “We are coming!”. More cheers. She puts on a pair of gloves promising it will make sense. She went on to yell that the door that closed was Gates, Fauci, Morrison and Andrews. The window that opened was them. Cheers. The people around are fighting for your future, your children’s future the crowd was told. They would die for this country. Louder cheers. They had tried to do the right thing. Wrote petitions. Nobody opened the email. She stamps her foot, not for the first time. “Guess what? We’re coming for all the marginal seats”, Smit managed to loudly sneer leaning forward jutting out her chin.

She was in her element. Attention, glorious attention. Stuff Australian Survivor. They would never get cheers like this. She goes on firing up the crowd with promised threats to governments, Federal and State. A monster has been awakened and the fire in its belly is so bright it can’t be put out, she yells. “Guess what? We have God on our side… this is a battle between good and evil…”. She continued on leaving no doubt that her plan is revenge through political victory. Anyone who knows her, the crowd was told, would know she has been towing the line, she’s been a reporter (self-appointed freelance journalist), doing everything right. “Well guess what? The gloves are coming off”. She pulls her gloves off and throws them down. Then finishes with another, “We are coming!”. Chants of “Moni-Ka, Moni-Ka” followed.

You can also check Monica Smit’s performance by audio here [MP3 5MB] or listen below. After Smit is a few seconds of the angry crowd chanting at police, “Free Australia, freedom, freedom”. There were twenty arrests.

It was a well planned speech. Monica Smit has no doubt what her next move is. Exactly who she may have offering or even giving support is not clear. Past form would suggest conservative factions of the Victorian Liberal Party. Yet Smit’s conduct would almost convince that she is striving to be an independent liberal. Reality says she will be a conservative. Her attacks on the Morrison government serve to create the impression she has no time for a coalition government and perhaps the Liberal Party.

But impressions can be deceiving. Monica Smit can be deceiving and is likely deceiving her supporters. Time will tell if she has truly abandoned Victorian Liberals. At one point Smit yelled that the most dangerous thing was a person with nothing left to lose. She blamed the government/s for this. The scale of selfishness and recklessness at play in exploiting public health measures necessary in a pandemic, can’t be overestimated. Little wonder there were twenty arrests.

A pressing issue in this light is the growing protest movement and the rise in anti-vaccination traffic on social media. It is concerning that there is little doubt such protests will continue. I recently mused in a comment about this so-called mandatory vaccination march. What fascinates me is that this is going on in the wake of the severe oppression and jailing of Hong Kong protestors who dared publicly say, “Independence for Hong Kong”. At the same time as Myanmar is experiencing a military coup and suppression of democracy. The same time as the actual dictator (not Dan Andrews) Alexandar Lukashenko, crushes anyone who dares object to him stealing the most recent Belarusian presidential election. At the same time as Putin jails many who gather to vocally support opposition leader Alexei Navalny. Who himself was jailed in a penal camp for breaching conditions of a suspended sentence.

It goes to show what a secure and fair democracy Australia is when the utter vacuum of any need to protest leads to the invention of faux suppression. So the privileged bored can role play. COVID-19 vaccines are not mandatory. Nor are they ‘experimental’. But more so, we know much of the anti-vaccine, anti-COVID measures and conspiracy theories have been generated by Russian trolls and bots [BMJ]. So how does Australia treat ex-pat Putin loyalists who regard us as a USA puppet and Western “enemy”? It lets them protest and say whatever they like. To even counter-rally against Ukrainians who are also rallying for their own cause to be independent from Putin’s Russia. Because that’s what this county allows. Democracy.

I imagine protestors will continue to enjoy this game. To pretend their rights are being taken away. To act as if they can’t refuse the vaccine. Pretend vaccines don’t work but instead cause widespread injury. Gather absurd information from social media and accept it as truth. Become hysterical about the Nuremberg code and argue their rights are breached, which they aren’t. Praise the scam artists profiting from their gullibility. Never question how full-time anti-vaxxers – white, financially comfortable and safe, support themselves. Pay no attention to the genuinely oppressed in the world, unless they want to liken their pretend oppression to real suffering.

Australia and its democracy may not be perfect but it has given rise to the bizarre symptom that is faux suppression – the pathetic, selfish obsession with fantasy. These protestors are without a doubt a malignancy born from democratic values. If they can not only invent suppression but afford (financially and socially) to role play as if it were real, no matter what the health cost to the society that props them up, then they certainly live in one of the greatest nations on the planet.

Australia has flaws of course, and our government is far from perfect. But the purported reignited democracy from the likes of Monica Smit who has inane support from the likes of Bernie Finn and Craig Kelly would be truly horrifying.

Well guess what? Reignite Democracy Australia is not coming with anything Australia needs.


* 4 September 2021 – The site now describes RDA as “An advocacy group and aspiring media outlet.”.

Last update: 2 March 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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Coronavirus pandemic prompts increased transparency of drug companies

The unprecedented nature of the SARS-CoV-2 coronavirus pandemic has begun to influence the transparency of drug company trials of potential COVID-19 vaccines.

On September 17th The New York Times reported that Moderna and Pfizer were releasing the protocols that describe the trial process to test a potential COVID-19 vaccine. On September 19th they reported that AstraZeneca had done the same. This heralds a significant change on the part of drug companies. Although in practice complex vaccine trial protocols would need to be interpreted by say, science journalists, in order to be understood by the wider public particularly given the multicultural nature of today’s communities in developed nations.  [See references below for protocols]

As trials have progressed to Phase III in which data on the safety and efficacy of vaccines are collated, the interest of the public has grown significantly. Intense media attention surrounded the recent pause of the Phase III trial of the vaccine being developed by AstraZeneca in partnership with scientists from Oxford University. Not surprisingly public interest has turned to pressure for more transparency as to how trials are conducted.

From July 24th to August 7th Ipsos surveyed respondents from 27 countries [PDF] on attitudes toward a COVID-19 vaccine. 74% of respondents said they would have a vaccine if it was available. The most common reason for rejecting the vaccine was concern over side effects (56%). This was followed by doubt of its effectiveness (29%). The importance of transparency surrounding Phase III trials is confirmed by the weight of these two reasons for rejecting the vaccine.

These vaccines are being developed rapidly under the gaze of a public that expects at some time to be given such a vaccine. It’s understandable that anxiety surrounding both efficacy and safety of COVID-19 vaccines existed long before the specifics of Phase III trials became public. That those specifics have become better understood due to an issue with safety does raise matters of trust within the public.

Of course the increased attention over safety and efficacy would never have arisen during development of the many so-called “alternatives” to regulated vaccines. Alternative products are not subject to reliable scrutiny and as such the acute and chronic effects are in fact undocumented or unknown. The safety and efficacy of such listed (as opposed to regulated) therapeutic products is almost always merely assumed.

Establishing trust between the public and the government and health authorities is important. Increased transparency of vaccine trials will help promote trust. Sustaining trust is significantly reliant on clear information and explanation of complicated issues that raise public concern. This is particularly true in the present environment where changing evidence may come across as inconsistency and if left unacknowledged may lead to suspicion. The proper interpretation and presentation of available information is essential.

Normally data gathered during a trial are published after the trial. However the dynamic nature of COVID-19 vaccine development and the global impact of this pandemic have already changed what may be considered normal. Added to this is information that is leaking out. The Oxford trial has recommenced on the advice of an independent safety committee. AstraZeneca announced that they “had not confirmed a diagnosis” of transverse myelitis in the study volunteer.

What has also recently become apparent is that the study was paused in July after a male volunteer who had received one dose of the vaccine developed transverse myelitis. See page 10 of this participant information sheet. There was a review by independent experts. The trial resumed after it was determined that the individual had a previously undiagnosed case of multiple sclerosis unrelated to the vaccine. Still, there was a persistent concern that AstraZeneca had not revealed in detail what had happened to the woman whose significant neurological symptoms led to the most recent trial pause.

On the September 14th edition of The Health Report Dr. Norman Swan interviewed Professor Bruce Neal, Executive Director of the George Institute Australia. The occasion was to discuss the launch of a project called Join Us. A challenging issue about Phase III trials is that drug or vaccine development may stall or fail due to lack of suitable participants. This isn’t due to drop out or resistance. Rather the cost and administrative difficulty of finding suitable participants is significant. Join Us aims to secure pre-consent to trials of a certain nature.

Whilst that’s interesting information about trials, Swan also asked Professor Neal about his thoughts on the reluctance of AstraZeneca to reveal details about the woman responsible for the second pause of the Phase III trial. Neal considered reasons to release more information. It would give a heads up to other researchers around the globe allowing them to “provide input and information into it”. However he also noted that releasing such information midway through a trial may have negative consequences.

There may be confidentiality issues as such a “severe unusual event” might lead to patient identity being leaked. Perhaps most interestingly was the observation that the trial may well end with a conclusion that the event was not an issue related to the vaccine. By then the damage is done. The public have already internalised the notion of a negative side effect. The media effort to reverse that belief is not likely to be successful.

Professor Neal stated;

And so the media surrounding the announcement of something like that is going to retain much more prominence probably than the media that tries to reel that back in and say, look, actually it wasn’t an issue. And that could have ramifications down the track when you try to get people to take the vaccine.

It’s important to note that the FDA has not allowed the AstraZeneca trial to resume in the US. The National Institutes of Health stated that it remains to be seen if the illnesses are coincidental and that, “pausing to allow for further evaluation is consistent with standard practice”.

Understandably some health professionals in the US remain concerned. Whilst investors were told of the second problem it has become clear that the company did not immediately alert the F.D.A. and advise them of the independent safety board’s recommendation to pause the trial. Virologist Dr. Peter Jay Hotez based at Houston’s Baylor college of Medicine has not been impressed. He claimed communication has been “horrible and unacceptable” citing the failure of UK regulators to provide rationale for resumption of the trial.

The New York Times also reported;

Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the F.D.A.’s advisory committee on vaccines, said that it’s unclear how the company — or the U.K. government — determined that the second case was not related to the vaccine.

Offit has also noted that the rarity of transverse myelitis in the general public has not been reflected in the UK trial population. The extra caution we are seeing in the US is reason for the public to have increased confidence in the influence regulators have over the safety of vaccine trials. Consequently there is reason for the public to be less anxious about the safety of COVID-19 vaccines that are eventually marketed. Given that independent safety experts in the UK have advised it is safe for the Oxford trial to resume it will be very interesting to see what further evaluation by US authorities concludes.

There has been research into immunisation and the likelihood of subsequent development of transverse myelitis (TM) and acute disseminated encephalomyelitis (ADEM). Key points from the 2016 paper Acute Demyelinating Events Following Vaccines: A Case-Centered Analysis are as follows;

Results: Following nearly 64 million vaccine doses, only 7 cases of TM and 8 cases of ADEM were vaccinated during the primary exposure window 5-28 days prior to onset. For TM, there was no statistically significant increased risk of immunization. For ADEM, there was no statistically significant increased risk following any vaccine except for Tdap (adolescent and adult tetanus, reduced diphtheria, acellular pertussis) vaccine. […]

Conclusions: We found no association between TM and prior immunization. There was a possible association of ADEM with Tdap vaccine, but the excess risk is not likely to be more than 1.16 cases of ADEM per million vaccines administered.

Acknowledging vaccine safety concerns as a cause of vaccine hesitancy, in July this year Nicola Principi and Susanna Esposito published a narrative review, Do Vaccines Have a Role as a Cause Of Autoimmune Neurological Syndromes?

The authors wrote in part in their abstract;

Only well-conducted epidemiological studies with adequate evaluation of results can clarify whether a true association between vaccines and adverse event development truly exists. Autoimmune neurological syndromes that follow vaccine use are among these. […]

Literature analysis showed that most of the associations between vaccines and nervous system autoimmune syndromes that have been reported as severe adverse events following immunization are no longer evidenced when well-conducted epidemiological studies are carried out. Although the rarity of autoimmune diseases makes it difficult to strictly exclude that, albeit exceptionally, some vaccines may induce an autoimmune neurological disease, no definitive demonstration of a potential role of vaccines in causing autoimmune neurological syndromes is presently available. Consequently, the fear of neurological autoimmune disease cannot limit the use of the most important preventive measure presently available against infectious diseases.

The Institute for Vaccine Safety at Johns Hopkins University logically argues that a number of vaccines “may prevent transverse myelitis”. The institute published Do Vaccines Cause Transverse Myelitis? Last updated September 18th 2020 the article opens with the conclusion;

Natural viral infections with influenza, hepatitis A, measles, mumps and rubella and varicella have all been associated with myelitis, albeit rarely. Thus, these viral vaccines may prevent transverse myelitis by protecting against natural infection. Vaccines currently routinely recommended to the general population in the U.S. have not been shown to cause transverse myelitis.

Ultimately this research in conjunction with the cautious US approach at present does not support a contention of general recklessness in the production of this vaccine or of other potential COVID-19 vaccines.

This dynamic provides yet another blow to anti-vaccination conspiracies. Namely the contention that there is collusion between drug companies and health regulators to suppress the supposedly inherent dangers of vaccines that anti-vaxxers wrongly insist lead to an abundance of vaccine injuries. More so Dr. Paul Offit has been derided, verbally attacked and threatened by the global anti-vaccine lobby for many years as a callous profiteer of vaccines. Yet he has constantly raised a voice of caution to ensure safe COVID-19 vaccine development.

It is certain that placing the AstraZeneca trial on hold following advice from the F.D.A. is not a unique event. Rather the fact that measures employed to control the current pandemic are being played out before the public in real time has provided insight into events that are usually ignored. In the previous post I listed some other aspects of anti-vaccine conspiracy that simply cannot be sustained following media reports of the AstraZeneca/Oxford Phase III trial pause. Even cursory attention to the details of this trial has exposed the dishonesty of anti-vaxxer claims.

Well before the trial pause led to media attention, public anxiety and now transparency of drug companies, the importance of trust in accepting a COVID-19 vaccine had been raised in Australia. Prime Minister Scott Morrison made a significant mistake with respect to public confidence in vaccine development and uptake. In August he announced that Australia had signed a deal to produce the vaccine being developed at Oxford University if Phase III trials were successful.

His mistake was to add that it would be “as mandatory as you can possibly make it”. Morrison realised the mistake and in under a day had produced the anticipated walk back. Nonetheless the many anti-science and anti-reason groups that are feverishly misrepresenting the motives of governments and health authorities during this pandemic were delighted. Within hours of Morrison’s announcement the AVN published a video mocking the notion of “safe and effective” vaccines whilst contending they “had always known this was coming”.

There were of course no “walk backs” from the AVN when Morrison corrected his position. Pushing fear of mandatory vaccination has always translated to profit for this group and Scott Morrison had done them a favour. Say no to mandatory vaccination read the back of a T-Shirt weeks later in Perth during Australia-wide “solidarity” rallies. Messages on social media continue in the same vein. Still, the reality is that messages and memes on mandatory vaccination would be common had Scott Morrison made no such statement.

Any harm done to the uptake of a COVID-19 vaccine in Australia is likely negligible. A survey conducted in April found that just under 86% of Australians aged over 18 would get a COVID-19 vaccine. 4.9% would not whilst 9.4% were indifferent. These figures are promising but were collated before the widely publicised pause in the AstraZeneca trial and increased public reflection on the safety of a COVID-19 vaccine. Survey responses were to the statement, If a COVID-19 vaccine becomes available, I will get it.

Ipsos published their global attitudes results on September 1st, indicating an 88% uptake of a COVID-19 vaccine in Australia. 59% strongly agree and 28% somewhat agree with the statement, If a vaccine for COVID-19 were available, I would get it. Only China and Brazil were more likely to accept a vaccine. These figures were also collated before the pause in the AstraZeneca trial. Follow this link to read Key Findings for Australia.

Another area that’s causing anxiety is the posturing of Donald Trump toward authorising a COVID-19 vaccine before the upcoming election. Consider the measure of Trump for a moment. He will tempt the voters with the promise of a vaccine in weeks. However it is more realistic to expect a safe and effective COVID-19 vaccine in months. These promises demand a disregard for vaccine safety. Yet in March 2014 Trump was tweeting in support of the mythical vaccine/autism link, a bogus view that bemoans a lack of vaccine safety. After the last election, research fraud and vaccine/autism profiteer Andrew Wakefield attended an inaugural ball from which he posted a social media video calling for an overhaul of the CDC.

Others have long ago considered the measure of Trump in regard to the election and a COVID-19 vaccine promise. In early June University of Pennsylvania professors Dr. Paul Offit and Dr. Ezekiel Emanuel wrote an opinion piece in The New York Times entitled Could Trump turn a vaccine into a campaign stunt?

It included;

In a desperate search for a boost, he could release a coronavirus vaccine that has not been shown to be safe and effective as an October surprise. […]

Given how this president has behaved, this incredibly dangerous scenario is not far-fetched. In a desperate search for a political boost, he could release a coronavirus vaccine before it had been thoroughly tested and shown to be safe and effective. […]

Thousands of Americans have already died as Donald Trump has perpetually postponed effective public health interventions and made poor therapeutic recommendations. We must be on alert to prevent him from corrupting the rigorous assessment of safety and effectiveness of Covid-19 vaccines in order to pull an October vaccine surprise to try to win re-election.

At the beginning of the second week of September the CEOs of nine drug companies, arguably competing in the development of a COVID-19 vaccine, signed a pledge to stand with science and not launch such a vaccine until it met “high ethical standards and sound scientific principles”. The pledge statement as it appears on Pfizers website is in references below. It came at a time when public health specialists and scientists expressed concern that the Trump administration was pressuring regulators to authorise a vaccine before the November 3rd election.

The New York Times reported;

The joint statement by competitors was seen as an effort to restore public trust as President Trump has pushed for a vaccine before the presidential election.

An out-take from the pledge from Pfizer’s website is as follows;

Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:

  • Always make the safety and well-being of vaccinated individuals our top priority.
  • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
  • Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
  • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.

Yes to the cynical eye this may seem to present the pharmaceutical CEOs as really great guys. However I recommend reading the entire Biopharma Leaders Unite pledge. More to the point with increased transparency the public and the media have an invested interest to see a suitable outcome here. This pledge is certainly a step up from Fauci saying he has “confidence and some faith” that the COVID-19 vaccine approval won’t be political.

Earlier in the year it was reported that a significant number of Americans are likely to refuse a COVID-19 vaccine. A robust anti-vaccination lobby and rising numbers of the vaccine hesitant mean that the number of Americans who accept the vaccine may be insufficient to sustain herd immunity, which may require between 50 – 70% of the population to be immune. The more recent Ipsos survey found 67% of US citizens would have the vaccine.

Exactly how many must be vaccinated to achieve herd immunity is still uncertain. The WHO suggest 95%. Mathematical modelling reflecting age and social activity level produces a herd immunity “illustration” as low as 43%. Other reports suggest a vaccine uptake of over 70% is needed. The Mayo clinic point out that reaching this level of immunity through infection and not vaccination would overwhelm the health system and cause millions of deaths.

Thus there is ample reason to hope greater transparency of vaccine trials leads to justified improved confidence in the safety and efficacy of COVID-19 vaccines and increased uptake. Of course given the speed of current COVID-19 vaccine trials let us also hope that the vaccines that make it to market are extremely safe and splendidly effective. The fewer challenges that accompany immunisation on a global scale the better.

Another area that is getting more scrutiny if not exactly transparency is that of vaccine nationalism. This term refers to agreements between governments and vaccine manufacturers that ensure developed nations have secure access to vaccines for their entire population before they are available for other nations. With COVID-19 this may result in a delay in vaccinating health workers in developing nations, individuals at high risk of severe disease or death and those living in a region of a sudden dangerous cluster.

COVID-19 is a global pandemic. Yet we are faced with a situation where wealthy nations will be able to vaccinate their populations whilst countries that rely on aid organisations will be unable to vaccinate health workers and at-risk populations without organised help. A recent Science Friction podcast looks at the ways in which this problem can be combated. Australia’s Friends of Science in Medicine actively support equitable access to “COVID-19 vaccines and related health technologies”.

No doubt the anti-vaccine lobby will use information in the trial protocols in the same way they use vaccine package inserts. Thanks to exceptional cognitive dissonance they will list reasons as to why information from vaccine manufacturers can’t be trusted whilst using that same information to defend these reasons. The good news is that as we’ve seen, increased transparency and media attention has exposed tenets of anti-vaccine conspiracy and beliefs as vacuous and fallacious. On these points it’s a case of watch this space.

In conclusion it can be seen that the increase in transparency of COVID-19 vaccine development should indeed serve to increase public trust and confidence in the quality of eligible vaccines. I cannot finish without stressing again that the safety and efficacy elements of Phase III trials do not apply to the raft of concoctions marketed as alternatives to medicine. All consumers should seek reputable sources of information and beware of the many hoax “cures” of COVID-19. Discuss any novel plans to manage or prevent COVID-19 with a registered medical practitioner.

Finally whilst the importance of transparency with respect to vaccine trials has become clear, it was also confirmed by the Ipsos global survey on attitudes to a COVID-19 vaccine. The most common reasons for intending to refuse a vaccine are safety followed by efficacy. The establishment of which is the very aim of Phase III trials.


REFERENCES

Phase 3 clinical trial of investigational vaccine for COVID-19 begins

Moderna Clinical Trial Protocol – SARS-CoV-2 vaccine

Pfizer Clinical Trial Protocol – SARS-CoV-2 RNA vaccine

AstraZeneca Clinical Trial Protocol – COVID-19 vaccine

Oxford Vaccine Trials – Participant Information Sheet: COV002 (July 2020)

Oxford Vaccine Trials – Participant Information Sheet: COV002 (Sept. 2020)

Willingness to vaccinate against COVID-19 in Australia

9 in 10 Australians say they would get vaccinated for COVID-19 – Ipsos

Global attitudes on a COVID-19 vaccine – Ipsos [PDF]

A future vaccination campaign against COVID-19 at risk of vaccine hesitancy and politicisation

Biopharma Leaders Unite To Stand With Science – Pfizer

Moderna and Pfizer reveal secret blueprints for coronavirus vaccine trials – NYT

AstraZeneca under fire for vaccine safety releases trial blueprints – NYT

Do Vaccines Cause Transverse Myelitis? – Institute for Vaccine Safety, John Hopkins University Dept. of International Health

Acute demyelinating events following vaccines: a case-centered analysis
– DOI: 10.1093/cid/ciw607

Do vaccines have a role as a cause of autoimmune neurological syndromes?
– DOI: 10.3389/fpubh.2020.00361

FSM supports equitable access to COVID-19 vaccines

Vaccine nationalism threatens global plan to distribute COVID-19 shots fairly

The rise of vaccine nationalism – should we be worried? – ABC Podcast

Herd Immunity: Understanding COVID-19 – DOI: 10.1016/j.immuni.2020.04.012

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How the Oxford trial pause challenges anti-vaccine conspiracies

Recently the Oxford COVID-19 vaccine trial was paused due to a possible case of transverse myelitis in one of the subjects. Today (Saturday UK time) it was announced that the trial would resume following advice from from safety experts.

Confirmation Update: Transverse myelitis has not been diagnosed in the subject [1], [2], [3], [4].

The news of the pause had the anti-vaccine lobby reacting with as much composure as dozing picnickers who have awoken to find they are laying atop a large nest of very active fire ants.

There is the urge to proclaim we told you so. Yet this includes the realisation that forfeiture of key pegs in anti-vaccine conspiracy is required. What has followed as we see below appears to be confusion, the inability to comprehend events, fabrication of fallacy and bogus reinforcement of elements of the Big Pharma conspiracy.

It’s important not to underestimate how disturbing genuine challenges to an individuals world view can be. In the case of the Oxford trial announcement, the anti-vaccine conspiratorial view of the world is threatened by a distressing reality. For the dedicated anti-vaxxer this leads to uncomfortable cognitive dissonance. In fact anti-vaccine conspiracies must exist in the first place to resolve the cognitive dissonance that arises when scientific evidence and epidemiology overwhelmingly refute the myth of dangerous vaccines and manufactured claims of vaccine injury and death.

In this case there are three main challenges to current anti-vaccine beliefs.

  1. The MSM (mainstream media) presented a transparent account of the Oxford trial pause.
  2. The pause in the trial itself shows that the safety aspect of Phase III clinical trials is working well.
  3. Cursory reading of the situation confirms the efficacy component of Phase III clinical trials and the use of a placebo.

The anti-vaccine lobby contend that mainstream media are biased against the “truth” of vaccine horror because what is reported is not anti-vaccine. If the mistake of giving anti-vaccine identities air-time to push unsubstantiated disinformation is made, criticism swiftly follows. Yet primarily it is the industry requirement to fact check that keeps anti-vaccination views from being presented unchallenged.

It’s more likely that their antics make tabloid or news segments because they are dishonest and at times vindictive. This attracts regular criticism of the Australian Vaccination-risks Network. A scheme by anti-vaxxer Kyia Clayton to interview AVN president Aneeta Hafemeister on ABC Hobart was met with outrage. It was justly criticised on Media Watch which yet again led to Meryl Dorey urging members to bombard the ABC and ACMA with complaints.

Rather than rise to the occasion and present evidence that meets the standard of scientific consensus the AVN has instead accused the media of being part of the larger conspiracy. Attacking mainstream media and articles that are based on vaccine fact is a substantial activity for Australian anti-vaxxers.

A constant claim of anti-vaxxers is that vaccines are never tested adequately for safety. This is partly due to the erroneous belief that vaccines are so full of dangerous chemicals and biological matter that they cannot possibly be safe. Ergo, any genuine monitoring for adverse reactions in large samples would reveal that a high percentage present with such reactions. As this is not the case their only conclusion is the biased testing conspiracy.

Another claim is that vaccines are never tested for efficacy. They don’t work and we have all been deceived. Herd immunity is a fake concept. Vaccines were introduced after improved sanitation and hygiene eliminated most disease and thus deserve no credit. This claim is made with the help of deceitfully crafted graphs plotting mortality, not morbidity, in such small numbers it appears that vaccines had no impact. The two claims specific to Phase III clinical trials are often made together.

This was clear when the AVN responded to an August 2019 SMH article by Liam Mannix, Anti-vaxxers live in an online bubble this scientist wants to burst. Their response is a strange collection of “propositions” the author angrily contends must exist, whilst citing pseudoscience and articles relating to medication, not vaccines.

The AVN piece included this under “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.

Oh my. This persists despite accessible evidence to the contrary and available WHO recommendations. More so, in line with all anti-vaxxers the AVN argue their definition of a placebo (such as saline) is what should be used in vaccine trials. In fact it is used in many trials but the AVN choose to ignore this. This may include shifting the goal posts. Virology Down Under discuss this no true Scotsman anti-vax fallacy related to placebos.

In some vaccine trials a saline placebo is not ethically suitable and the placebo used is not inert. With respect to the urgency COVID-19 presents this article argues that placebos aren’t needed for vaccine challenge trials. In the Oxford trial a non-saline placebo functions as a more effective control as Dr. Norman Swan explains below. The AVN have always objected to Gardasil studies which used AAHS (the amorphous aluminium hydroxyphosphate sulphate adjuvant) as a placebo.

Without citing any reference the AVN offer their definition of a vaccine trial placebo;

By definition, a placebo must be a totally inert substance which will never provoke a response.

In a recent Coronacast episodeThe Oxford vaccine’s troubles. Why it’s not doomed (yet) Norman Swan talked about efficacy and safety in this vaccine trial. Whilst the USA are using a saline placebo, the other participant countries are not. Swan explains;

A few weeks ago, phase 2, phase 3 studies, that’s dose finding and whether or not the vaccine works in large numbers of people and whether it safe, started in Brazil, South Africa and the UK, and they were aiming to recruit 17,000 people. There was also a phase 3 study just beginning in the United States in about 80 sites, trying to recruit about 30,000-odd people. The aim is to have a trial of about 50,000 people.

And interestingly it’s a placebo-controlled trial but the placebo is not saline. It is in the United States, but in Brazil, South Africa and the UK it’s actually not a dummy drug, it’s not saline, it’s a meningococcal vaccine, and they are doing that so that people don’t recognise whether or not they’ve had a placebo. It’s very important in a placebo-controlled trial that you don’t know that you are in the placebo arm. And if you get a shot in your arm and nothing happens and it’s pretty mild you think, well, maybe I’m in the placebo group.

The presenters talk about the seriousness of transverse myelitis and Norman Swan offers this context;

However, there was a study not so long ago which looked at 64 million vaccine doses and really found very little evidence, if any, that transverse myelitis is caused by immunisation. Out of 64 million doses they found seven cases or eight cases that may be associated with it. And they look really widely. They didn’t just look at the week after you’ve had the immunisation or the month after, they looked at almost any time after you’ve had the immunisation, and they conclude that transverse myelitis, unless in very rare circumstances, is not caused by a vaccine. […]

So what they’ve got to find out with this person is are they in the placebo arm, are they in the active arm, is it really transverse myelitis, what are the antibodies that have actually been shown? Are there any other symptoms? And did the person actually get infected with real COVID-19 after the trial had started…

I recommend reading the transcript or listening to this episode of Coronacast. Tegan Taylor and Swan talk more on Phase III trials and discuss the specifics of the Oxford vaccine. It’s an adenovirus carrying genetic material into cells to instruct the cells to produce fragments of COVID-19 virus. It is these fragments that induce an immune response. With respect to the use of placebos in vaccine trials a July 27th episode examines the ethics associated with the fact that subjects in the placebo arm of Phase III trials are not receiving a vaccine.

By the time the Oxford podcast was published on Thursday the AVN was already suggesting on Facebook that there may be more adverse reactions hidden from the public.

AVN Facebook post

Dubious message on AVN Facebook

“It does raise questions”? The problem with the above post is the apparent interpretation by an AVN Facebook administrator that one of the “close friend daughters” who took part in the Oxford trial “is in the Royal” [London Hospital], “diagnosed with Transverse Mylytis” (sic). There is an unverified claim that, “they have asked to keep this quite (sic) as they don’t want the public to know”. The AVN admit the information may not be true.

Yet is this really evidence of a covert case of transverse myelitis? Perhaps Karen McNab is referring to a) her friend’s daughter and also b) the “volunteer” mentioned in the WhatsApp message. The trial subject who had the presumed adverse reaction is a woman who is in hospital.

Of course my interpretation could be wrong. There is however no clear statement that one of the friend’s daughters has transverse myelitis.

Some AVN members were justifiably suspicious.

AVN FB members question source

Rixta Francis, a long term AVN member prone to simply inventing disinformation published her predictably outrageous fallacy of the Oxford trial. This is an excellent example of an immediate, and  feverish attempt to slap at the fire ants of cognitive dissonance. Fellow members are supportive.

Facebook: Rixta Francis misleads over Oxford COVID vaccine trial
Self published author of The Fiction of Science Rixta is prone to reinterpret reality in the manner above. To appreciate this we need to explore her approach more fully. In an interesting example of how things come round in circles Francis is infamous for her abuse of the memory and parents of baby Riley Hughes, who featured in the SMH article I mentioned above.

Riley died from pertussis in March 2015 before he was old enough to be vaccinated. Feeling a need to educate parents about immunisation Catherine Hughes began the Light For Riley campaign. She now runs the Immunisation Foundation of Australia. Ten months after the death of Riley, Francis falsely claimed Catherine was a member of Stop the AVN, suggested Riley and his pertussis had never existed or that the parents killed infant Riley themselves.

The post below suggests the Oxford adverse reaction has been staged. It includes dismissal of genuine media intention, dismissal of safety and dismissal of efficacy helped by quoting Australia’s CSIRO. Again this is textbook management and minimisation of cognitive dissonance.

AVN Facebook post

Other comments in the thread follow a similar theme and manage to reveal quite ridiculous thought processes. The reason people placed themselves at such risk is because they were offered “a small fortune… it all comes down to money”. Vaccines always cause “horrific injuries”. We “can’t cure cancer but we can make a vaccine in six months for a disease we don’t understand?”.

It will be interesting, but not surprising, to see how this group reacts to the news that the trial has resumed.


Further reading:

Oxford Vaccine Group

Oxford vaccine trial – University of Oxford

How Vaccine hesitancy could undermine Australia’s COVID response – The Guardian, September 12th 2020

Fact Check: Mastercard partnership on vaccination records is unrelated to finances – USA Today, September 9th 2020

Halting the Oxford vaccine trial doesn’t mean it’s not safe – The Conversation, September 9th 2020

Vaccine testing and approval process – CDC

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