Policy Review: Covid-19 Vaccines

The failed experiment

UPDATE NOVEMBER 2023: What we have learned in the past year has made us rethink nearly every single aspect of what was written in this document. Please see our revised stance here.

PANDA’s comprehensive multidisciplinary review has found that mass Covid-19 vaccination has been a failed experiment.

Mass public-health measures always involve a trade-off between expected benefits and known and potential risks or harms. Harms include both short-term and long-term or inter-generational harms (e.g. poverty). Separately, they must at all times comply with basic human rights requirements. These fundamental realities have been ignored in much of the public-health response to the Covid-19 event, including mass vaccination.

Vaccines, like all medications, have potential risks and benefits. When a new class of medication is introduced, risks of harm are of particular relevance as no predicates are available beyond the duration of existing studies. Such concerns apply particularly to children and pregnant women, in whom the impacts are less predictable and may affect development. The overall effectiveness of a medication should always be assessed through measuring its impact on all-cause morbidity and mortality, and reported as such when considered for mass use.

Where mass, population-wide medications are employed, the acceptable evidential bar for the assurance of benefit and the avoidance of risk becomes higher. For consent to be fully informed it must include full disclosure of all known risks, and make clear any areas with significant potential unknowns. Any coercion, anathema to basic principles of public-health and international norms on human rights, is unacceptable.

PANDA considers that the Covid-19 vaccines should be assessed in the same manner as any other mass intervention, and all implementation should be subject to these basic, widely-accepted principles.

In this document, PANDA refers to these products as “vaccines”, consistent with commonly-used terminology. However, this is not to be interpreted as endorsing the manner in which the classification of these products as vaccines was used to justify their regulatory treatment - especially in terms of the paucity of preclinical studies.

The novel nature of these products, in particular that they act as a pro-drug instructing the body to create the antigenic agent, ought to have mitigated against that approach, as should the knowledge that the lipid nanoparticles (in the case of the mRNA products) were designed to - and in fact do - become widely distributed throughout the body.

In this regard:

The risks from SARS-CoV-2 to the majority of the population have been hugely overstated.

• SARS-CoV-2 presents a negligible risk to the great majority of the world’s population. It primarily poses a risk to elderly, metabolically unhealthy and immunocompromised individuals.

• Many individuals already had a degree of immunity acquired through previous encounters with similar viruses. Moreover, those infected develop further natural immunity against severe disease, which appears to be more flexible and durable than any protection acquired through the Covid-19 vaccination. This is consistent with expectations based on prior immunological knowledge.

• As such, the novelty of the virus and its severity appear to have been overstated, and whilst the emergency and voluntary use of rapidly-developed products in the vulnerable may appear justifiable, mass administration of the entire population with products for which there is no long-term safety data was and remains an inappropriate strategy. 

The Covid-19 vaccines have not delivered in terms of preventing infection and transmission.

• These products clearly do not prevent transmission. They should never have been expected to, by virtue of their mechanism of action (i.e. the creation of blood-borne antibodies, when - as with other respiratory viruses - the primary immune defences reside in the mucous membranes lining the upper respiratory tract and lungs).

• It was entirely foreseeable that the extremely narrow immune response generated would render these products at best ineffective against a highly mutable virus, and at worst actually harmful at an individual or population level due to vaccine-mediated selection pressure on viral evolution.

• For many reasons, including the absence of properly controlled randomised clinical trials of sufficient size and duration, it is currently impossible to quantify the efficacy, if any, of the Covid-19 vaccines, especially against all-cause (rather than Covid-labelled) morbidity and mortality. Available studies alleging efficacy are weak, particularly because of the short duration of data collection. Real-world evidence that extends beyond 6 months of data collection is strongly consistent with zero or negative efficacy.

• An effective vaccine would be expected to result in a clear negative correlation between vaccination coverage and the burden of Covid.  In fact, the opposite is observed. In low and middle-income countries (e.g. India and African nations including South Africa) where take-up has been much lower than in the higher-income world, the pandemic appears completely "over". Neither of these observations is compatible with these products being either effective or necessary.

Safety signals are extremely concerning.

• The assumption by regulators that the mRNA products would behave similarly to more traditional vaccine products merely by virtue of having the label of “vaccine” applied to them - thereby permitting substantial tranches of pre-clinical research to be skipped - was deeply flawed. It has resulted in billions having been injected with multiple doses of a product about which there are an unacceptable number of significant unknowns.

• The US CDC VAERS database is a signalling system for adverse events in the US, which the CDC is legally obliged to maintain in good working order. It is a felony to input false records. This official database has indicated multiple signals of safety concern, orders of magnitude higher than any ever seen with previous vaccines.

• These concerns span every bodily system, most notably clotting abnormalities causing strokes, heart attacks and various other thrombo-embolic phenomena, myocarditis (especially in young males), reproductive system irregularities and autoimmune disorders. A period of immunosuppression after injection has been documented, and this gives rise to obvious concerns about the potential for increased risks of infection and malignancy.

• Whilst causal mechanisms are still being elucidated, it is clear that harm is being done. For many reasons, including the absence of properly controlled Level 1 Medical Evidence (controlled randomised clinical trials of sufficient size and duration), it is currently impossible to quantify the magnitude of harm. Even so, the early, available data suggests that overall harms are likely to be significantly outweighing benefits.

• In every major jurisdiction, the injured are prevented from seeking legal redress against the manufacturers who enjoy wide-ranging protection by way of indemnities in their contracts with governments. This is a particularly egregious state of affairs given the unknowns related to the product, and the extent of the coercion and mandates employed.

• It is difficult to estimate the extent of the harm based on population-level data, because any and all such harms have been ignored and obfuscated by countless compromised entities including the press, health agencies and medical journals. Furthermore, these harms are entangled with the vast public-health damage occasioned by the lockdowns and the deaths caused by unsound medical practices which were adopted during the panicked response to Covid-19.

• In evaluating harms it is essential to remain objective and it is as important to avoid over-stating harms as it is to avoid under-stating them. Notably, Sweden has vaccinated 87% of its adults with these products without  - apparently and so far at least -  seeing the same pronounced levels of excess death evident in many other countries, the reasons for which are as yet unclear. 

The responses of governments and their institutions appear to have been driven by political - rather than scientific - imperatives.

• Governments sought to impose an engineered response to the pandemic in the form of the mass-vaccination programme, which quickly followed the draconian and harmful lockdowns they imposed. To this end, they inappropriately pressurised regulators and coerced their populations using tactics which breached ethical norms and central tenets of public-health.

• Governments and regulators have not been transparent about the data they hold relating to the safety and efficacy of these products. By way of example, firstly, several acclaimed scientists spotted anomalies in the Pfizer trial data, yet the FDA refused to provide the data upon which they based their authorisation in any reasonable timeframe, including detailed data from the trials themselves. Secondly, despite repeated requests over a period of more than 400 days, the CDC also refused to release adverse event information gathered from over 10m vaccine recipients using its “V-Safe” smartphone app, and only did so in response to multiple lawsuits.

• When combined with the extensive conflicts of interest of the FDA’s approval panel and the paucity of biodistributional, pharmacodynamic and pharmacokinetic studies on this novel class of products, the data that has been released is clearly incompatible with the population-wide use of a vaccine even administered voluntarily, let alone on a mandated basis.

Conclusion

Whilst some make a case for the careful voluntary use of the Covid-19 vaccines with fully-informed consent in the most vulnerable groups, this should be based on solid evidence of overall health benefit for each individual.

These products should have been contra-indicated for the vast majority of the population for whom the overall net benefit-risk ratio is either zero, or limited and short-lived, with efficacy versus the risk of infection becoming negative after six months and an unknown longer-term safety profile.

The steps taken to mandate or coerce populations to receive the injections were completely unjustifiable from a public-health and human rights view-point, and suggest a politically-driven or profit-driven agenda.

There was insufficient justification for the emergency rollout of these products to the general population. This represents a massive failure of regulatory oversight and changes are needed to ensure this cannot happen again.