Reframing Risk. Company style.
(A) The God trick. Science lowers the bar for ID'ing pandemic risk; while science deflects tricky & 'controversial' questions on tech risk. Who would-a-thought !?
This is a 2 part paper. The first part considers how institutions change definitions in ways which shift understanding of risk. The second part, published in my next Substack, considers the role of provisional consent, the loophole par excellence for entry of mRNA gene therapy treatments onto the New Zealand market at scale.
The governance and regulatory environment is social. From what to value, what science is demanded or recognised, to the setting of guidelines and controls that estimate risk. The extent of contestation of values and guidelines can be observed through what Gieryn has described as boundary work - efforts undertaken by powerful (private and public) institutions, lobby groups, media, scientists and civil society which challenge or accept regulatory decisions. Most fundamentally the degree to which this boundary work is pulled in a direction is a function of power and the values enmeshed in that power. For where the rubber meets the road - the science concerning where biology meets technology - is never settled.
This is often existential stuff. No-one can articulate the intersectional crisis of science, democracy and health better than Sheila Jasanoff, Professor of Science and Technology Studies at the Harvard Kennedy School.
‘questions of what and how we should know go hand in hand with questions of how we should govern. These, therefore, were profoundly ideological, indeed constitutional, battles over the role of the state, the freedom of the market, people’s right to health, and the sorts of information and processes needed to ensure meaningful democratic participation. No wonder, then, that so many knowledge controversies of the past few decades have been both vicious and intractable. They are stand-ins for recurring, open-ended questions about the kinds of democratic futures Americans should aspire to. The rising stakes of defeat, coupled with intensifying demands for expertise and loss of trust in the institutions responsible for making public knowledge, provide needed context for understanding the current crisis of public credibility.
‘Truth in the public square has always been demonstrable truth. It is the insight that truth needs to be performed and accepted that marks STS from other disciplines that would separate truth, with its own norms, understandings and aspirations, from a politics and ethics that march to entirely different drummers. One of the hallmarks of modernity was to make truth and knowledge the foundations for exercising political power, as if fact-finding had to precede and direct political. That move had broad appeal because it seemed to take arbitrariness out of rulership. In the United States, a bastion of modern democracy, publics at opposing ends of the political spectrum could all agree on the importance of science for policy or, more simply, on the need for public facts. Yet, just as power is continually contested and forced to justify itself to democratic publics, so power’s knowledge came under continual questioning. Arguably, that long record of attack and counter-attack, and the associated appeals to truth as the ultimate arbiter, weakened the American state’s moral authority to produce ‘serviceable truths’ – that is, robust statements about the condition of the world, with adequate buy-in from both science and society to serve as a basis for collective decisions’[i]
Fifty years ago, Thomas Kuhn illustrated that what was taken for granted as an accepted scientific activity in any period, was merely an activity which conformed to the prevailing paradigm.[ii] Claims of objectivity, were, he demonstrated socially constructed according to the maxims, cultures and funding patters that surround what is selected for study, what is selected to be prioritised in the process of knowledge gathering, and what is not prioritised. In such an environment, the prevailing power, institutional and expert, could have a lot to do with how science, convention and practice were shaped, and along what rails, it sped.
The work of maintaining authority and ensuring that only ‘authoritative’ science is used is known as ‘boundary work’[iii]. Regulatory boundary work, undertaken by corporations, officials, media and lawyers not only encompasses what is known, but how it is known, it encompasses rule making which includes the changing nature of definitions which, in public health-related science, often revolve around how risk is understood and communicated to wider publics.
Legacy and social media institutions play a key role in censoring uncertainty that conflicts with policy. It can occur in surprising ways. During COVID-19, when regulators or published papers communicate uncomfortable or controversial new knowledges, their posts are likely to be flagged by Twitter or Facebook because they are inconsistent with ‘legitimate’ facts.
Science is in crisis, as evidence of fraud and deliberate manipulation of results (misconduct) through fabrication, falsification, or plagiarism, are outlined in media and brought to public attention. This human face of science dovetails with the replication crisis. It can be distinctly difficult to replicate results. This often occurs in the profoundly complex space when technology (medicine, environment) meets society, culture and biology.
In 1990, Jasanoff explained the tension between technocratic and democratic approaches in regulatory decision-making. For Jasanoff, the ‘technocratic’ view favoured by commercial and industrial interests, directed energies towards more and better scientific experts into decision, expanding expert communities in decision-making. By contrast, the ‘democratic’ perspective drew attention to the ‘failure of regulatory agencies to incorporate a full enough range of values into their decision-making. …
‘such critics emphasise the need for non-scientific modes of accountability; open decision-making procedures, advance publication of decision-making guidelines, and judicial review.’[iv]
These issues and challenges are in hyperdrive throughout the COVID-19 event, with the the mass deployment of a novel mRNA gene therapy at scale. Changes in the governance and regulatory public health environment have altered how risk is framed.
What can be observed, is a tightly wound regulatory-industrial complex that engages in boundary work to exclude science that might draw attention to risk and biological vulnerability from government interventions; while harnessing the power of global institutions, including media, to frame and communicate risk of infection and transmission from a coronavirus.
From early 2020 as I have discussed– risk throughout the COVID-19 event has been persistently framed around case rates - infection and transmission, rather than the potential for hospitalisation and mortality.
As more OIA requests are released, we can observe how, authorisation and risk assessment for the mRNA gene therapy technology has been based on data supplied directly by the industry with the financial interest in approval.
Rule changes and shifts have consistently - whether intrinsically and extrinsically - supporting the deployment of the novel mRNA gene therapy, have been at scale and over time. Classificatory terms have changed, for ‘pandemic’ and a pandemics’ ‘severity’; for ‘vaccine’; and for ‘immunity’. These shifts direct policy to vaccinate, but with lower bars, or hoops for industry to navigate in order to release their technology.
Rules around provisional consent (the way to get a drug onto market which lacks full clinical trial evidence) have been relaxed to deploy the mRNA gene therapy at scale across the New Zealand population.
And efficacy as a condition for provisional consent, which is central to approval, has somehow never been clarified in the murky, opaque space of Keeping the Show on the Road.
(And ever circling, are legislative committments where treaty compliance seems to be increasingly weighted (valued) more heavily in decision-making than local factors. A treaty, an agreement, a goal, an accord. What happens to democracy or sovereignty, when nation-state compliance with some remote and unaccountable offshore institution, over-rules human, social and health-based rights in the name of compliance? How does the rule of law as a democratic maxim, work in such a world? … and where do we go to appeal?)
It is inordinately difficult to build precaution (which is a value) and hesitancy concerning conflicts of interest from powerful industries into the regulatory narrative. Such discourse firstly, risks contradicting economic/economic-growth priorities, and it might unpick the myth that regulatory science is objective.
INDUSTRY IN CONTROL OF RISK ASSESSMENT
Yes the COVID-19 vaccine is a gene therapy technology.[v]
The gene therapy - a nucleoside-modified messenger RNA encoding the SARS-CoV-2 S-glycoprotein (the Pfizer product is referred to as BNT162b) is a relatively new technology for which there is no evidence of long term safety in the published literature.
Risk assessment, the basis for provisional consent, was carried out using safety data exclusively supplied by the industry, using the rationale (excuse) of commercial in confidence clauses to keep information outside the public sphere.
Industry is and was, in control of designing the clinical trial endpoints and therefore how ‘efficacy’ – effectiveness - is constructed and understood.
Industry controls the supply of data demonstrating risk for serious harm or death through disclosure of clinical trial data, and through post-market reporting procedures. Such processes, controlled by industry, demonstrate the possibility for harmful, unintended or off-target effects, and which age group and/or gender would be at risk. On the basis of that evidence, the tech would be released.
Industry has a demonstrable financial conflict of interest, but never mind.
In New Zealand, provisional consent was granted on February 2, and renewed on November 3, 2021. Renewal of provisional consent was granted based on the industry sponsor fulfilling the conditions listed in the original provisional consent agreement (which is discussed in the next Substack).
Throughout 2021 safety signal issues were arising in the peer reviewed literature. Was the product persistent, and/or bioaccumulative and/or toxic (PBT)?
Reviews could be undertaken by independent scientists, in the public interest, to grasp the complexities, uncertainties and nuances of what the published literature reveals. But – by convention - the regulators were not resourced or ‘mandated’ to require that this work is undertaken. It remains undone.
Regulators then, went hop-skipping back to the industry for evidence on safety. Or rather, the sponsor submitted the safety studies to ensure the technology wa renewed
Regulatory Capture
Over time, in the most human of ways, close relationships between regulators and the industry regulated (known as regulatory capture) arise. These relationships, plus the under-resourcing of regulatory scientists, the absence of technical expertise in the technology governed, works in concert to encourage the development of industry friendly guidelines. This includes tricks (such as a failure to update guidelines relating to risk after the science advances; or acknowledge different vulnerability over the life course), loopholes and techniques to avoid some of the trickier issues being dealt with.
I had an interesting experience recently, in a recent contract where institutional regulatory scientists (not in the medical arena) oversaw a paper that I undertook for an industry group (notice the relationships..). During the period of the contract, it was referred to a literature review, relating to a specific chemical class.
They were so apparently peeved by my insistence on drawing attention to issues of biological vulnerability and precaution (all drawn from the scholarly and scientific literature) that they called it a literature report instead of review. It must be technical. It must not reflect uncertainties. That’s how regulatory landscapes seem to work....
Back to mRNA technologies & their prediliction for positivistic discourse.
A simple example of how the narrative remains locked in, despite the knowledge in the scientific literature, is the CDC’s explanation of how mRNA COVID-19 vaccines work which remains online in August 2022,
As the CDC graphic states:
After vaccination, the mRNA will enter the muscle cells. Once inside, they use the cells’ machinery to produce a harmless piece of what is called the spike protein. The spike protein is found on the surface of the virus that causes COVID-19. After the protein piece is made, our cells break down the mRNA and remove it, leaving the body as waste.
It’s extraordinary. mRNA does not exclusively enter muscle cells and there are now over a thousand studies published in the peer reviewed literature drawing attention to the pathogenicity of the inflammatory spike protein. But due to governance and regulatory mechanisms and practices that ensure governments turn to industry for evidence of harm, such information is kept outside the regulatory sphere.
They don’t know. Such data is irrelevant and therefore impotent.
Yes, the process has been corrupted when scientific literature is persistently excluded. In times of controversy, people draw attention to the potential for fraud and bribery or embezzlement across the regulatory-industrial-pharmaceutical complex.
I suggest a greater, overarching, social and cultural corruption permeates the institutions that we trust to govern us, which are driven by power and influence. (See Merriam-Webster). Corrupt, in this sense, is
to degrade with unsound principles or moral values
The strength of democracy is its capacity to be guided by principles, and navigate uncertainty and doubt in the public interest.
‘Our regulatory system is the response to these market failures. The objectives of the new laws and the agencies empowered to enforce them is not only to stop the damage and prevent future harm; it is to maintain and strengthen the free market system. Although many advocates of free market economics refuse to acknowledge this dynamic, law and regulations are the underpinnings of our economic system. They define market structure and property rights while attempting to ensure that property rights don’t intrude on our civil liberties. Without the regulatory apparatus of the state, our modern economy could not exist. The state fosters a safe space for market growth.’ Professor David Michaels, The Triumph of Doubt.
Yet we may be losing this battle in the world of oligopolies.
Sergio Sismondo views the potential for pervasive industry power, especially pharmaceutical-paid science that has so much influence intertwined through the scientific literature and the experts who produce that knowledge, as epistemic corruption.[vi] Many of us are familiar with the pressure to publish, and the natural human reluctance to release and publish unfavourable results.
Epistemic corruption is more nuanced. It occurs in many ways. Through financial conflicts of interests on committees, historic relationships with industry scientists, industry influence (through expertise and resourcing) in the establishment of clinical practice guidelines, historic funding to the World Health Organization (WHO), medical boards and practitioners, and through the sponsorship of events and relationships.
‘Our’ public institutions have failed to put structural and ethical processes in place to ensure that we have knowledge systems that can counter, balance and where necessary, refute industry claims. They simply don’t have the principles or cultural values enshrined at high level, to build and protect these politically delicate knowledge systems which may directly or indirectly challenge political and financial power.
Resourcing is a function of power, and science is particularly vulnerable - as frankly, science is expensive. Expertise takes years to accrue, and scientists require laboratories, staff, instrumentation, time to undertake long-term research. Over time - where resources are directed, institutional knowledge grows. This is how we get centres of excellence, or expertise. The choice of what we resource is a function of power, influence, and institutional expertise.
But that’s also how rules and definitions are eroded, or don’t keep up with the production of technology and of risk. We simply lack cohorts of experts with the expertise, independence and culture that can counterbalance industry power.
RISK THAT CHANGES: THE REFRAMING OF RISK-BASED CLASSIFICATION TERMS
The 1918 Spanish Influenza infectious disease outbreak was devastating and severe. That is how the global population generally recognises as central to a pandemic, the event places the general population at risk of death.
But risk also arises from exposure to medicine, and vaccines are designed to, essentially, be toxic, and stimulate an immune response. Risk increases when a medication is available to all, rather than targeted, as the public, healthy and unwell, are then exposed to risk, and all medicines carry risk.
Risk can be economic, from the cost of hospitalisation and medical services in a catastrophic event; or from iatrogenic harm, as manufacturers have indemnity in the event of injuries, they will push claims of safety, while governments take on the cost of compensation to the victims.
In the past, drug manufacturers have worked diligently to avoid drugs being recognised as harmful. Historically, in the USA, five unexplained deaths from a medical treatment would result in a black-box warning, while 50 deaths would result in withdrawing a drug. Safety signals need not accrue before investigation, as the FDA has acknowledged, ‘it only takes a single well-documented adverse event to justify a safety signal investigation’.[viii]
Because of the privileged position, vaccines are conventionally required to undergo extensive clinical trials and must prevent transmission of an infection. As I have previously outlined, vaccines traditionally required 10-15 years of time-dependent testing protocols to ensure safety and efficacy with genetic vaccines having tighter controls.[vii]
The U.S. Patent Office has previously rejected patent applications for vaccines which have been merely protective (acting more like a conventional drug such as by suppressing symptoms), requiring instead, that infection is prevented.[ix]
However, definitions and classification terms are not locked in. They can be contested and altered. Regulatory environments are political.
‘A key function of classifications, particularly in the context of risk, is to erase uncertainty.’[x]
We see a term or classification that is established by regulators such as the WHO as a normal or taken for granted ‘fact’. However, where the categories are presumed to be ‘natural’ or ‘true’ they may still be subject to erosion or change.
WORLD HEALTH ORGANISATION (WHO)
The pivotal moment when institutions, regulatory authorities and media shifted to conflate risk from an infectious disease with infection and transmission rather than severity of disease was most likely in 2009, when the WHO updated its guidance on pandemic risk phases, or alerts which communicate risk regarding pandemic severity.
The WHO Pandemic Influenza Preparedness and Response 2009 document changed the definition of pandemic, changed the definition of severity, failed to discuss the role of natural immunity in achieving herd immunity, and introduced the prospect of global vaccination at scale.[xi]
This was how ‘severe’ as a signal of risk in a pandemic, became broader, decoupled from case fatality rate:
‘Influenza pandemics are unpredictable but recurring events that can have severe consequences on societies worldwide.’ [xii]
The 2009 updated phased process (p.29/64) focused on outbreaks from an animal influenza virus, but have, in the years since. been interpreted to include broader respiratory viruses. The phases exclusively concerned the degree to which community level outbreaks were occurring.
There was no focus on severity relating to hospitalisation and death risk. Nor was there, in this 60 page document, any reference to the role of natural immunity in shifting past the early phases. Vaccines, however, were mentioned over 80 times.
This realigned pandemic risk to focus on risk based on societal and economic effects. In doing so, it strategically lowered the bar regarding when governments would declare a pandemic, and it also lowered the bar on the burden of evidence required to set in place regulatory triggers that could place obligations, potentially rights limiting obligations, on the wider population.
This decoupled ‘pandemic’ from the interpretation of pandemic understood by the global public, derived from the example of the Spanish Influenza Pandemic, the ‘prototypical example of severe and unpredictable pandemic’, that the health impact, following infection would be severe and devastating.[xiii]
The 2009 version of the WHO’s Pandemic Alert Phases as Abeysinghe (2013) explained:
‘did not fulfil the implicitly assumed characteristic that a pandemic would cause severe disease (born from the experience of the Spanish Influenza Pandemic) since the effect of the virus was different from the previous experience of such events. This fact uncovered fundamental flaws in the WHO’s construction of the Pandemic Phases, where more readily measurable criteria (spread and mode and mechanism of transmission) were emphasized, while other criteria (severity) were neglected. Given that both the manifest and implicit tasks of the Phases revolved around the concept of risk – in helping member states evaluate and manage the risk posed by the virus, and in producing an aura of certainty around the uncertain risk – this was a fundamental flaw. A high-risk event – one which would result in a higher burden on public health institutions – was not distinguished from the spread of mild disease. As part of this, several key classificatory distinctions were also missing: a distinction between pandemic and seasonal influenza and the definitions of the start and end of pandemic events. This meant that the links between Phase changes, changes in the status of risk posed, and therefore necessary public health actions, were not adequately produced.’
A year earlier, in January 2008, the influenza virus A(H1N1) had been detected in Norway. While pathogenic, it was less virulent than other viruses ‘such as highly pathogenic avian influenza (H5N1), upon which many national influenza pandemic preparation plans were based.’ [xiv] By 2010 any global risk had passed.
I turn back to conventional WHO Health indicators of severity (p.25/64):
· case fatality rate
· unusually severe morbidity
· unexpected mortality patterns
· unusual complications. [xv]
Such indicators of severity, case fatality rate and mortality at the population level, for generally healthy people, have never been articulated to New Zealanders, throughout 2019-2022. While the case fatality rate from the Spanish Influenza was estimated at 2-3%, the mortality risk in 2019-2022 (i.e. the 21st century) was always understood to be highly variable, depending on age, socio-economic and health status and access to targeted medical and nutritional early treatment.
Over the 2009 H5N1, the case definition shifted to focus on not only symptoms, but to use real time reverse-transcription polymerase (rRT-PCR) testing to identify cases.[xvi] The indicator of risk shifted away from the case fatality rate, mortality, - to the results of a testing device. Noting that seroprevalence, which might identify population level immunity, was never incorporated into testing and informational protocols.
The reputational integrity of the WHO, as steward of global health, particularly in relation to its advice function for democratic states, has historically been associated with institutional independence. This historically enabled the WHO to reflect an institutional morality, and promoted trust in the WHO’s decision-making.
However, this independence has eroded in recent decades, as corporate (including NGO actors with pharmaceutical industry relationships) has grown to overshadow government sector funding and shift the foci of influence. Private interests often earmark donations to the WHO, directing the WHO down a path of medical deployment rather than addressing utmost public health need.[xvii]
These ‘investment’ shifts may have been behind that 2009 WHO Pandemic Influenza Preparedness and Response paper.
VACCINE DEFINITION SHIFTS. DICTIONARIES & REGULATORS
The definition of a vaccine has changed. Dr Peter Doshi, during a panel discussion held by U.S. Senator Ron Johnson explained the phenomenon of definition changes in the Merriam Webster dictionary (outlined also by Professor Eric Baković):
“I found it fascinating to learn that Merriam Webster changed its definition of ‘vaccine’ earlier this year. mRNA products did not meet the definition of ‘vaccine’ that has been in place for 15 years at Merriam Webster, but the definition was expanded such that mRNA products are now ‘vaccines’.”
In September 2021 the U.S. Centre for Disease Control (CDC) altered the definition of vaccine:
Vaccine: A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease. Vaccines are usually administered through needle injections, but can also be administered by mouth or sprayed into the nose.
Vaccination: The act of introducing a vaccine into the body to produce immunity to a specific disease.
To a new definition:
Vaccine: A preparation that is used to stimulate the body’s immune response against diseases.
Vaccines are usually administered through needle injections, but some can be administered by mouth or sprayed into the nose.
Vaccination: The act of introducing a vaccine into the body to produce protection from a specific disease.
DISCOUNTING OF NATURAL IMMUNITY
Alongside this shift is the remarkable discounting and downplaying of the role of natural immunity in shifting the population to herd immunity, as could be seen in the 2009 WHO paper. Very early in the New Zealand pandemic, natural immunity was ignored, with an overarching focus instead, on infection, or case rates. Sir David Skegg considered in June 2021 that the mRNA provided better immunity than from natural infection. The Skegg review also presumed the mRNA vaccines were safe.[xviii]
As I have discussed in an April 2022, Emergency Powers discussion document:
From the earliest, most of the population were not at risk of hospitalisation and death, but the case rate rhetoric did not provide a safe space for people to question whether a case was a ‘good’ thing. In line with longstanding principles of epidemiology, each case would shift the population (or herd) closer to immunity, and as natural immunity increased, the virus would become less harmful. According to established principles of epidemiology, most of the population could safely become infected, and therefore the most important tactics were to protect the vulnerable. However, this was never a conversation that was undertaken in a public forum. This strategy of case alarm, or case fear, promoted ignorance in the population.
Earlier studies clearly articulated the broad overarching structural response that arose from exposure to the complete virus, rather than a single spike protein.[xxi] [xxii] Later studies demonstrate the protective effect of natural immunity.[xxiii], without focussing on the temporality of boosters.[xxiv] [xxv]
An important variable in claimed ‘hybrid’ immunity, from exposure to both the natural infection and the gene therapy, is the potential for collateral damage from constant exposure to the mRNA gene therapy. This is a little studied variable.
What level of seroprevalence, or herd immunity to SARS-CoV-2 in the New Zealand population, at different age categories, right now, in August 2022?
The reason you don’t know, is because the assessment of natural immunity, or herd immunity has not been prioritised or valued by the COVID-19 campaign team.
Ignoring herd immunity directly favours, and shepherds the public consciousness towards so-called vaccine induced immunity. The 2009 WHO document, which completely ignored herd immunity, focused intensively on the role of vaccination in pandemic outbreaks. Yet throughout the current COVID-19 event, the goal of vaccine immunity is plagued by problems from adverse reactions, risk of vaccine-associated enhanced disease (VAED) and ongoing waning, particularly for the most at risk groups.
Public health is interwoven and complex.
Balanced against infection risk and the role of herd immunity, are questions of how risk might scale following prolonged exposure to boosters.
For example, if myocarditis risk doubles or triples with the second dose[xix] [xx] – where is the risk-benefit analysis? Across all age groups, particularly for ongoing mandated professions?
The New Zealand government understood adverse events were common in November 2020. New Zealand’s Clinical Evaluation released January 2021 (OIA request H202106950) noted that 21% of BNT162b recipients experienced an adverse event (p.95/162).
(Note: The H202106950 link to the Health.govt.nz, described in this OIA request, has since been removed by the Ministry. This document included New Zealand’s clinical evaluation of the Pfizer/BioNTech product, TT No. TT50-10853, Application ID 109400. This document does not appear to be anywhere on public facing sites.)
By that time it was distinctly evident that risk for COVID-19 was stratified to age and health status.
This is - excuse me - an ethical clusterf*ck. It doesn’t merely impair trust in the Ministry of Health. It creates doubt in the machinery of government, and the capacity of officials to act in the public interest.
‘Most of the measures employed to counter the pandemic aren’t prompted or supported by data, and those measures carry grave physical, ethical and political consequences.’ Prof. Julie Ponesse, bioethicist, 2022.
So, alongside the evidence of risk in the peer reviewed literature that has been ignored by conventions, we can observe the shifting of relevant rules and definitions relating to the degree of risk and severity required to announce a ‘pandemic’. This can and has result in lockdowns and human rights violations for a respiratory virus that was of equivalent risk to a bad cold, or influenza to most of the population.
Such manoeuvres set a chilling precedent for future ‘pandemics’.
[i] Jasanoff, S. No funeral bells: Public reason in a ‘post-truth’ age. Social Studies of Science. 47(5) 751-770
[ii] Kuhn, T. (1970). The Structure of Scientific Revolutions (4th ed.). University of Chicago Press (2012).
[iii] Gieryn TF. 1983. Boundary-Work and the Demarcation of Science from Non-Science: Strains and Interests in Professional Ideologies of Scientists. American Sociological Review 48(6) 781-795.
[iv] Jasanoff S. The Fifth Branch. Science Advisers as Policymakers. Harvard University Press. 1990.
[v] Nakagami, H. (2021). Development of COVID-19 vaccines utilizing gene therapy technology. International Immunology, 33(10)521-527. https://doi.org/10.1093/intimm/dxab013
[vi] Sismondo S (2021) Epistemic Corruption, the Pharmaceutical Industry, and the Body of Medical Science. Front. Res. Metr. Anal. 6:614013. doi: 10.3389/frma.2021.614013
[vii] Rose J. (2021). Critical Appraisal of VAERS Pharmacovigilance: Is the U.S. Vaccine Adverse Events Reporting System (VAERS) a Functioning Pharmacovigilance System? Sci, Pub Health Pol, & Law. 3, 100-129 https://cf5e727d-d02d-4d71-89ff-9fe2d3ad957f.filesusr.com/ugd/adf864_0490c898f7514df4b6fbc5935da07322.pdf
[viii] Gortler D. (2022, February 10). Former Senior FDA Official: Manufacturers, FDA Negligent In Not Investigating Covid-19 Vaccine Risks To Heart Health. The Federalist. https://thefederalist.com/2022/02/10/former-senior-fda-official-manufacturers-fda- negligent-in-not-investigating-covid-19-vaccine-risks-to-heart-health/
[ix] Kostoff et al. (2021) Why are we vaccinating children against COVID-19? Toxicology Reports 8:1665–1684
[x] Abeysinghe, S. 2013. When the spread of disease becomes a global event: The classification of pandemics. Social Studies of Science. DOI: 10.1177/0306312713492559
[xi] WHO (2009). Pandemic Influenza Preparedness and Response: A WHO Document. Geneva: Global Influenza Programme, Health Security and Environment Cluster, WHO. https://apps.who.int/iris/bitstream/handle/10665/44123/9789241547680_eng.pdf?sequence=1&isAllowed=y
[xii] Pandemic Influenza Preparedness and Response: A WHO Document. Geneva: Global Influenza Programme, Health Security and Environment Cluster, WHO.
[xiii] Abeysinghe, S. 2013. When the spread of disease becomes a global event: The classification of pandemics. Social Studies of Science. DOI: 10.1177/0306312713492559
[xiv] Al Hajjar S & McIntosh K. 2010. The first influenza pandemic of the 21st century. Ann Saudi Med.30(1) 1-10
[xv] Pandemic Influenza Preparedness and Response: A WHO Document. Geneva: Global Influenza Programme, Health Security and Environment Cluster, WHO. p.12/64
[xvi] Al Hajjar S & McIntosh K. 2010. The first influenza pandemic of the 21st century. Ann Saudi Med.30(1) 1-10
[xvii] Reddy, SK., et al (2018). The financial sustainability of the World Health Organization and the political economy of global health governance: a review of funding proposals. Globalization and Health. 14, 119
[xviii] Skegg Review (2021). Letter to Hon Ayesha Verrall. Strategic COVID-19 Public Health Advisory Group. https://covid19.govt.nz/assets/reports/Independent-Advisory-Groups/Strategic-COVID-19-Public-Health-Advisory-Group-Advice-to-Minister-Verrall-June-2021.pdf
[xix] Chua, G.T. et al, (2021). Epidemiology of Acute Myocarditis/Pericarditis in Hong Kong Adolescents Following Comirnaty Vaccination. Clinical Infectious Diseases, ciab989 https://doi.org/10.1093/cid/ciab989
[xx] Mansanguan, S.et al.Cardiovascular Effects of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents. Preprints 2022, 2022080151 (doi: 10.20944/preprints202208.0151.v1).
[xxi] Gazit et al. Comparing SARS-CoV-2 natural immunity to vaccine-induced immunity: reinfections versus breakthrough infections. medRxiv preprint. 10.1101/2021.08.24.21262415
[xxii] Brouqui et al 2021. COVID-19 re-infection. Eur J Clin Invest. 2021;51:e13537.
[xxiii] Altarawneh HN. Et al. Protection of SARS-CoV-2 natural infection against reinfection with the Omicron BA.4 or BA.5 subvariants. July 12, 2022 medRxiv preprint https://doi.org/10.1101/2022.07.11.22277448; t
[xxiv] Goldberg Y. et al. Protection and Waning of Natural and Hybrid Immunity to SARS-CoV-2. N Engl J Med 2022; 386:2201-2212 DOI: 10.1056/NEJMoa2118946
[xxv] Supplement to: Goldberg Y, Mandel M, Bar-On YM, et al. Protection and waning of natural and hybrid immunity to SARS-CoV-2. N Engl J Med 2022;386:2201-12. DOI: 10.1056/NEJMoa2118946. https://www.nejm.org/doi/suppl/10.1056/NEJMoa2118946/suppl_file/nejmoa2118946_appendix.pdf