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

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

 

 

Wearing masks does not cause staphylococcus infection or CO2 toxicity

On August 20th I was passing through AVN Facebook territory and noticed the image below had been posted in the comments section of a post citing a Daily Telegraph news article. The article was about the likelihood of a free COVID-19 vaccine in Australia.

It included this shin kick for anti-vaxxers;

Can there be anything more satisfying than the dangerous, hypocritical and unspeakably cruel anti-vaxxer mob in full self-combust mode at news that the rest of us — the sensible Australians — are delighted to hear?
The only national glimmer of hope in this coronavirus war on our bodies, livelihoods and mental health has been the promise of a free vaccine available eventually to all Australians, writes Louise Roberts

The post urged readers to include their thoughts. One of which was this image;

image falsely linking skin conditions to mask wearing

Fake “Mask Induced Staphylococcus” scam

Firstly the claim of lung infections and loss of consciousness due to restricted airflow from masks has been debunked. This claim as pushed on social media relies on the belief that masks cause CO2 toxicity, known as hypercapnia.

In very, very rare cases with an open wound and a dirty mask contaminated with staph bacteria one may develop a staphylococcus infection from masks. Nonetheless, what’s important is dealing with the claim in the context of the images above. Simply put the claim is that these are examples of “staphylococcus from masks”.

This claim of staphylococcus infection from masks is as offensive as it is bogus. It is a textbook example of what goes wrong when one trusts social media as a source of news or facts. Particularly social media outlets of groups that use the term “fake news” to describe genuine media presenting facts they disagree with. Yes indeed, verily this describes the Australian Vaccination-risks Network.

Staphylococcus infection is described by the Mayo Clinic in these opening paragraphs as follows;

Staph infections are caused by staphylococcus bacteria, types of germs commonly found on the skin or in the nose of even healthy individuals. Most of the time, these bacteria cause no problems or result in relatively minor skin infections.

But staph infections can turn deadly if the bacteria invade deeper into your body, entering your bloodstream, joints, bones, lungs or heart. A growing number of otherwise healthy people are developing life-threatening staph infections.

The article continues to list symptoms, types of infections, causes, invasive devices and treatment.

Merck Manual also has an excellent article by Larry Bush M.D. which was updated just over a year ago. The important point here is that consulting articles on staph infection reveals facts specific to the diseases that result and the lack of any information confirming that the wearing of surgical masks is responsible. So this nonsense is predetermined disinformation designed to sabotage public health measures.

When it comes to challenging an image “collage” like the above taking a screenshot of each image and doing a reverse image search via Google or TinEye yields ample insight into the mind of COVID-19 conspiracy promoters. Taking the middle right image we find pages of results devoted to articles on exhausted doctors wearing PPE and working long hours during the height of Italy’s struggle with COVID-19. The initial post of Italian nurse Valeria Zedde was made by her on Instagram. Other photos capturing the impact of long term PPE use can be found online including these on Twitter.
italian doctor after long shift with covid patients

Italian nurse after hours wearing PPE

The face above the hard working nurse is from a Wikipedia post on Eczema herpeticum. This infection may be caused by a herpes simplex virus, coxsackievirus or vaccinia virus. The image file was uploaded on April 11th 2018 as is clear on this Wikimedia commons page. The image is cropped in the scam staphylococcus collage above to give the appearance of a mask infliction but more importantly to hide the eyes which help confirm this child is certainly under five years of age.

The WHO have published a Q&A on children and mask wearing due to COVID-19. They clearly state;

In general, children aged 5 years and under should not be required to wear masks.

Ah well, nice try. Still, no amount of cropping can hide the fact this image was uploaded 18 months before the first case of COVID-19 in Wuhan in December 2019.

Eczema herpeticum on childs face

Eczema Herpeticum

On the subject of cropped images we can trace the image at bottom right to an article in Medical News Today describing Malar rash. In the case of this subject the rash is caused by a condition known as rosacea. More so the lady appears in a large number of Alamy stock photos with a caption plainly stating her condition is rosacea characterised by facial redness, small and superficial dilated blood vessels.

Whilst determining the exact origin of Malar rash is difficult due to a large number of candidate causes, turning into a strange looking case of staphylococcus due to wearing a surgical mask is not one.

case of malar rash

Malar Rash – Source Medical News Today

The condition in the image at bottom left may well have been determined by you as the case of varicella (chicken pox) that it is. The Getty images iStock photo also appears on Pinterest with no watermark where anyone with an account can take a screenshot of the image at not cost.

It’s interesting that with this image the cropped version used in the scam collage also removes any helpful identifying features to help one conclude this is a young child.

child with chicken pox pimples/varicella

Chicken Pox / Varicella pimples on female child

The final image is the one at top left. In fact this image is the only one that may have substance. The French teenager in the image claims to have had an allergic reaction to wearing a sheet mask for a prolonged period of time.

With help from Google Translate we see that Le Monde newspaper reported;

According to the mother, the 12-year-old wore a sheet mask for several hours on vacation: “This is the first time she has worn this mask provided by her college for so long. We went on a camping holiday for a week, and the mask was mandatory in closed areas, so she had to put it on every day”. […]

Beware of hasty conclusions, however. “There may be intolerance reactions to the mask that are not allergic reactions. The mere fact that it is red is not enough to say that a mask contains an allergenic substance”, tempers Brigitte Milpied, dermatologist at Bordeaux University Hospital and member of the French Dermatology Society (SFD). “Whenever something goes wrong, people tend to call it an allergy. However, the allergy remains exceptional. To be sure, you have to do a test” she adds.

Doctor Hervé Masson, allergist in Bordeaux, shares this opinion: “In the image, it looks more like a burn than an allergic reaction, but as long as the child has not been examined, we cannot tell”. […]

allergic reaction to wearing the same surgical mask for extended time

Claimed allergic reaction – prolonged mask wearing

The importance of wearing a proper, clean mask and discarding of disposable masks when they are moist or soiled can’t be understated. If a genuine allergic reaction, the image above raises questions about just how well informed this teenager and her parents were about hygienic mask wearing, maintenance and disposal.

It’s important to wash cotton masks before wearing them and to not exceed recommended duration of wear. Individuals prone to allergies may have to test materials and take extra precautions. Information as to how to avoid allergic reactions from wearing masks should be clearly conveyed by health authorities in all languages used in the release of other COVID-19 information.

The good news is that this particular effort to scare the unsuspecting into believing masks cause staph infections or CO2 toxicity has been thoroughly debunked. Either through sourcing the images or combining this with facts about CO2 toxicity and mask wearing. Please check the excellent sources below

No doubt COVID-19 related scams and disinformation will continue in the foreseen future.


True colours: Australian Vaccination-risks Network ponder the rights of others

A Current Affair recently reported on the Australian Vaccination-risks Network after they used the cover of late night to sneak their Vaxxed bus into the BIG4 Caloundra Holiday Park.

This bus is used to film anti-vaccine testimonials, sow fear about any possible COVID-19 vaccine and promote COVID-19 disinformation and COVID conspiracies. The CEO of the park Angus Booker quite rightly asked the group to leave. His reason was that he has a policy of not allowing anyone to “conduct their business in our park, especially without our consent”. He explained that this would apply to a political party, to activists or a radio station.

However Meryl Dorey states;

They really don’t care whether your children are killed or injured by vaccines.

This is an unverified claim in an attempt to imply callousness. As there have been no fatalities attributed to vaccines in Australia this is dangerously misleading and highly offensive. The facts help explain why the group, despite advertising for fans to give on-camera accounts of “vaccine deaths” for weeks, still haven’t produced an evidenced backed testimonial. The harm done by this group is seen in the video as a young man contends that his father recently passed away “as a result of a flu vaccination”.

Yet there are no recorded cases of anyone dying as a result of a flu vaccination. It is a bizarre alternative reality they inhabit. One in which according to Meryl Dorey, Italian COVID-19 fatalities were apparently all people who “were going to die anyway” and vaccines, not illness or disease, kill.

In actual reality modern medicine employs a vast arsenal of medication and procedures when managing disease and keeping very ill patients alive. The influenza vaccine is one such tool. It may be given to a patient who is very ill and who later dies from an existing condition or a condition of comorbidity. The vaccine may be given to someone who at a later time passes away from a chronic or acute condition. In both cases however, the flu vaccine has not caused a death. That the AVN revel in this tragic deception, promote it and profit from it is very telling indeed.

Asked to leave the park, Meryl, who raves day and night about the erosion of her rights, reacted in her standard fashion to someone else exercising their rights. She urged Facebook followers to leave “reviews” on the park’s Facebook page. The flying monkeys complied and dutifully threw dirt on both Angus Booker and the BIG4 Holiday park in question. This included the defacing of Angus’ profile picture and reposting it back onto the Big4 business Facebook page. AVN Facebook comments show that others called the caravan park to complain. One loyal devotee to Dorey’s cult urged members to repost the attacks that were removed.

Again, this is tragic. A number of these angry members wrongly believe they have a vaccine-injured child after digesting disinformation peddled for profit by this group. Or believe vaccines can only harm and actively reject life saving interventions for their children and themselves.

So how would the AVN profit from this? Knowing full well that the CEO is within his rights Dorey and AVN president Aneeta Hafemeister still teased that they had “spoken with a lawyer… and are considering taking action… about the discrimination”. Below are just a couple of eager responses.


Fortunately I haven’t seen an active attempt to raise funds for legal costs but the tone of these comments is concerning. In the past there have been donation campaigns for similar costs in which no action eventuates.

In any case asking Facebook flying monkeys to now focus on the press council with complaints about A Current Affair was a predictable response from the AVN.

Presently the Vaxxed bus is in hiatus with the AVN assuring they will be back on the road in due course.

 


14/08/2020: Updated to add ‘complain to press council’ screenshot.

Meryl Dorey suddenly believes viruses can only be transmitted by injection

The driving force behind the Australian Vaccination-risks Network is Meryl Dorey who is tagged on this blog, and was highly active at the time of the HCCC Public Health Warning about this group.

Thanks to a tweet by a highly effective critic of the AVN my attention was drawn to a post Meryl made on her Facebook page during a live video broadcast on April 11th this year. What I found compelling was that suddenly – and I do mean suddenly as Dorey had never made this claim before – she announced that her “personal opinion is that viruses can only be transmitted by injection”. As we’ll see this causes problems for one particular anti-vaccine position Meryl has promoted.

The comment below was posted in the context of discussing viral testing and the strange notion of buying “a private test”, presumably to avoid the COVID conspiracy pitfalls. The last sentence contains Meryl’s view about viral transmission by injection. This pattern of adopting stand out themes of conspiracy theories is one Meryl Dorey has followed for years.

Meryl Dorey: viruses only transmitted by injection

Source: Comment 32

The compelling aspect to Dorey’s sudden revelation is that this claim had already been made 12 days earlier by anti-vaxxer and erstwhile Involuntary Medication Objectors Party candidate, Tom Barnett. The video in which he made his claims was removed from Facebook and YouTube.

Barnett claimed in the video;

You can’t catch a virus; it’s impossible. The only way you can catch a virus is by having it injected into your bloodstream.

I say. Meryl apparently decided this sounded pretty good to however she is planning to profit from the COVID-19 crisis. Feel free to search her online material prior to Tom Barnett’s comments for a statement suggesting Meryl Dorey believes viruses can only be transmitted by injection. I for one am having trouble finding such a reference.

Claiming to hold such a position enables one to reject the need for immunisation and to argue that vaccination against viral disease may in fact be the cause of the disease.

Meryl is clearly spinning more plates than is wise with this latest addition of evidence denial. To be specific, her claim that viruses can only be transmitted by injection is a form of germ theory denial |Wikipedia|. Denial of germ theory |Wikipedia| is as old as germ theory itself. Thanks to germ theory significant advances in personal hygiene and public sanitation have brought about improvements in health and reduction in the spread of disease.

Which brings us to a real problem for Meryl Dorey. She claims that vaccinations have done almost nothing, if not absolutely nothing, to prevent disease. She has fallaciously argued before that the documented fall in vaccine-preventable disease is in fact due to better hygiene, diet and sanitation and occurred before the introduction of vaccines. This is very common misinformation pushed by anti-vaxxers usually with heavily doctored graphs that chart disease mortality as opposed to morbidity and are falsely attributed to official sources.

It fails utterly to explain the success of vaccines introduced in the later half of the 20th century such as measles (1963) and haemophilus influenzae type b (1993). The WHO do a good job of dispelling this misinformation here. At the beginning of 2012 I looked at the AVN’s use of this myth and included an explanatory video with audio from both Meryl Dorey and Judy Wilyman.

In it we hear Dorey during a radio interview with Helen Lobato on Melbourne’s 3CR in December 2011 make the familiar claim;

Meryl Dorey: A lot of the credit that’s been given to vaccines for the decline in deaths and infectious diseases has nothing to do with vaccines. Because it all happened before the shots were even introduced.

Helen Lobato: Mmmm… and it was more the diet and the sanitation?

Meryl Dorey: That’s right. Engineers did more to improve the health of Australians than doctors ever have.

You might like to listen to Meryl on the audio player below;

 

Looking back at Dorey’s frequent promotion of this misinformation on the AVN website, social media and other media it is impossible to find any clarification specific to viral infection being only possible by injection. Nor is there any delineation between bacterial infection and viral infection being controlled by sanitation.

Thus in one foul swoop Dorey has removed the logic behind her claim that sanitation, not vaccination, brought about the control of specific viral infections. If viruses can only be transmitted by injection then improved sanitation must only be responsible for reducing infectious diseases caused by bacteria.

This also removes her concerns over “vaccine shedding” [1], [2] with respect to vaccines designed to prevent viral infection. This is highly significant concerning Dorey’s new claim as material presented to defend the notion of unbridled “vaccine shedding” refers exclusively to viral shedding in stools or in the case of LAIV nasal spray, in nostrils.

As Meryl Dorey and the AVN have challenged health ministers and authorities to accept being injected with a body weight adjusted equivalent of the entire childhood vaccine schedule, I do hope there is no intent to demonstrate strength of conviction by ingesting or inhaling any viral material associated with disease.

Therefore as it now stands I would be fascinated to know how Meryl Dorey intends to justify believing that sanitation, not vaccination, reduced the spread of viral disease given her claim that viruses can only be transmitted by injection.