Drug Regulators Failed the Public on Covid-19

Rasmussen is among the most respected public opinion pollsters in America. In findings of a poll conducted between 27–29 March and published on 31 March, 11% of respondents said a member of their household had died with Covid, and 10% said someone had died from a vaccine side-effect. This is a remarkably even breakdown of deaths with Covid and from vaccine-related injuries. Earlier, on 21 February, Norwegian scientists Jarle Aarstad and Olav Andreas Kvitastein published a preprint of their findings that vaccination rollouts across 31 countries in 2021 were associated with rising all-cause mortality in the first nine months of 2022. A one percentage point increase in vaccination uptake in 2021 was associated with a 0.105% increase in monthly mortality in 2022. The association remained robust even after controlling for alternative non-vaccine-related explanations for the increased mortality rate.

This follows a March analysis from the Vaccine Damage Project which concluded that among 16–64 year old, employed Americans, 82% of people did not suffer any vaccine injuries. The next largest group of 18% suffered mild injuries, but 0.93% (1.36mn) suffered disabilities and there were 310,000 (0.05-0.1%) vaccine-related excess deaths in the two years of 2021–22. 

If we were to add to the total those who have died from the enduring consequences of lockdowns (canceled cancer and cardiovascular screenings, delays of scheduled operations, added difficulties in accessing healthcare, reduced beds and staff in hospitals from isolation and social distancing rules), it would be clear that the scale of non-Covid excess deaths was substantial. 

Yet, unlike the breathless daily press briefings in 2020–21 on Covid cases and death counts as this disease was the only one that governments, health bureaucrats and the media seemed interested in, there are no urgent efforts to investigate just what is going on with these vaccine/lockdown-related deaths and how best to address the problem. The lack of curiosity from the press and parliamentarians adds to the institutionalized indifference to lockdown and vaccine harms that amounts to outright contempt of the public. And isn’t it remarkable that we still don’t have all the necessary details and raw data from the Pfizer and Moderna vaccine trials whose claimed efficacy results continue to be seriously disputed by reputable scientists? Not to mention allegations of fraud in Pfizer’s clinical trials, as reported by Germany’s Die Welt. 

Disturbing Data from Australia 

On 8 February, the Australian Technical Advisory Group on Immunization quietly published updated advice on boosters. In this, ATAGI finally acknowledged that the harm-benefit equation for boosters doesn’t compute for young people: ‘Adolescents and younger adults [especially males] have a lower age-related risk of severe Covid-19, and a comparatively higher risk of myocarditis following vaccination’. It declined to recommend booster doses for under-18 year olds; recommended it for over-65 year olds and 18–64 year olds with comorbidities; and advised the bulk of the healthy 18–64 year olds to ‘consider a 2023 booster dose ... based on an individual risk benefit assessment with their immunization provider’.

A January 2021 (sic) ‘Nonclinical Evaluation Report’ from Australia’s Therapeutic Goods Administration was also published recently, following a Freedom of Inquiry request (which is a scandal in itself). The TGA states: 

•  The microscopic lung inflammation in monkeys after infection was ‘almost similar’ in immunized and control groups; 
•  Long-term immunity after a second dose was questionable because the antibody and T cell responses ‘declined quickly over 5 weeks’. 
• Data was not available on: 

o Distribution and degradation of ‘the S antigen-encoding mRNA’, so the half-life and pattern of distribution was unknown; 

o Medium- and long-term protection against serious illness, hospitalization, and death; 

o Toxicity of the repeat dose; 

o Potential for autoimmune diseases and other long-term effects. 

• Concentration of radioactive tracer (incorporated into the lipid nanoparticles) was detectable in tissue and blood as soon as 25 minutes after the initial dose and up to as long as 48 hours later in several parts of the body, including heart (peak total lipid concentration of 1.40 microgram of lipid equivalent/gram (or mL) after 2 hours), kidneys (2.05μg after 2 hours) and liver (26.54μg after 8 hours). 

In other words, the TGA knew, back in January 2021, that we lacked full efficacy and safety data for both the short and the long term, there was evidence already of rapid waning of efficacy, and there was evidence of lack of effectiveness (the first bullet point above). And, if the TGA knew, then so must its counterparts across the Western world have known. 

These are serious and egregious omissions. They suggest that the authorities should have been less emphatic and more guarded with the ‘safe and effective’ messaging. They would not then have experienced the drip-drip erosion of public trust that has occurred. 

This also raises another issue of medical ethics. Western medicine has been predicated on the norm that the doctor’s primary responsibility in assessing benefits against the risk of harms of treatment options is the welfare of the individual patient, and only secondarily with community welfare. The messaging on ‘My mask/vaccine protects you and your mask/vaccine protects me’ turned this long-standing principle of Western medicine on its head. It is also a violation of Articles 3 (“The interests and welfare of the individual should have priority over the sole interest of science or society”), 5 (The autonomy of persons to make decisions, while taking responsibility for those decisions and respecting the autonomy of others, is to be respected), and 6 (Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information) of the Universal Declaration on Bioethics and Human Rights (2005). 

This is centrally relevant, for example, to the benefit-harm equation of vaccines by age groups: it violates core medical ethics to recommend them to healthy children, adolescents and young people up to 50, and to pregnant women and women of child-bearing age, on the reasoning that doing so helps to protect the whole community. This is further reinforced by the Convention on the Rights of the Child (1989: “the most widely ratified human rights treaty in history,” says UNICEF), Article 3.1 of which affirms: “In all actions concerning children ... the best interests of the child shall be a primary consideration.” 

The primary consideration should always have been: 

1. The risk exposure to the Covid disease to the individual; 

2. The efficacy of the vaccine for them against infection, hospitalization, ICU admission, and death; 

3. The number within their age group that would need to be vaccinated (NNV) to prevent one hospitalization, ICU admission, and death; and 

4. The corresponding numbers of serious adverse events for that NNV. 

The potential for protecting the wider community should not have entered the discussion unless the patient raised it with regard, for example, to a parent or grandparent. 

The TGA report validates the early vaccine skepticism from the top British medical and scientific advisers. On 29 February 2020, responding to a report that Israeli scientists were weeks away from developing a Covid vaccine and the question of if this was credible, Chief Scientist Sir Patrick Vallance replied “Short answer is no.” Chief Medical Officer Chris Whitty explained: “For a disease with a low ... mortality a vaccine has to be very safe so the safety studies can’t be shortcut.” 

Raising Questions in Parliament

On 17 March, a Member of Parliament in the UK, Andrew Bridgen, presented figures on the net benefit-harm equation of vaccines. Among healthy people, he claimed, for every one hospital or ICU admission averted by a booster, the number at risk of serious adverse events that would put them in hospital was 55, 116, and 263 for 50–59, 40–49, and 30–39 year olds, respectively. The corresponding numbers at risk of ICU admission were 321, 1,165, and not known. 

For healthy people, therefore, the probability of being harmed by the vaccine is much higher than the risk of serious harm from Covid. Bridgen concluded: “in the light of the Government’s own data, Covid vaccinations and boosters are not effective. From the evidence of the yellow card system, they are not safe, and for the UK taxpayer, they are not value for money.”

Pericles declared that “Your empire is now like a tyranny: it may have been wrong to take it; it is certainly dangerous to let it go.” That is certainly proving true of the empire of Covid tyranny. The MPs in the House appeared to stage a mass walkout as Bridgen began his speech, unwilling to contemplate the harms they had failed to check in the name of keeping the people safe. 

Continuing their habit of questioning critics of official policy rather than their journalistic duty to investigate official claims with a genuinely open mind, the media have smeared Bridgen as a conspiracy theorist and criticized him for spreading dangerous misinformation. BBC Radio 4 broadcasted an hour-long program on his speech on 23 March, for which they declined his offer to join in the discussion. 

Subsequently five experts mounted a robust defense of Bridgen in The Daily Sceptic and took apart the criticisms of his speech that was aired on Radio 4. There is a growing body of studies that support Bridgen’s skepticism as, for the first time, there is genuinely open debate among experts. For example on 27 March The Telegraph reported that young women in England aged 12–29 faced a risk of death from heart issues that was 3.5 times higher after an AstraZeneca Covid vaccine. 

The Slippage between Vaccine Efficacy and Effectiveness 

There’s a technical distinction between vaccine “efficacy” in controlled clinical trials and vaccine “effectiveness” in the real world. The famed 95% efficacy claimed in trials has produced empirical outcomes of 77% of all infections and 85% of all Covid deaths in New South Wales being among people vaccinated at least once, from 22 May–31 December 2022 (the period for which data separated by vaccination status is available). 

Non-sterilizing Covid vaccines could and should never have been expected to significantly reduce infection or transmission. The real world data show that with rapidly waning effectiveness and requirement for boosters every four months, they are closer to a treatment than a vaccine as traditionally understood. Tetanus and polio vaccines do not require multiple annual shots. For all the eye-watering amounts of money expended, Covid vaccines bear little causal relationship to mortality outcomes. 

If we look at groups of countries by income levels, the difference in Covid mortality rates is shockingly stark, even accounting for their respective age differentials. And it correlates positively with vaccination rates. According to Our World in Data, the number of vaccine doses administered per 100 people as of 31 March went down from 224 in high, to 214 in upper middle, 142 in lower middle and 38 in low income countries. The number of Covid deaths per million people also went down, from 2,274 to 1,050, 390 and 65, respectively. Not exactly a stunning demonstration of vaccine success in reducing Covid mortality.

The number of Covid deaths in Australia was just over 900 in the first year of the pandemic. With vaccines not yet developed, the low toll was due to geographical isolation of the island continent from the Covid hotspots, border closures, favourable climate conditions and housing patterns, etc. In 2021, the year of the vaccine rollout, the number of Covid deaths was just under 1,500. In 2020, Covid was the 38th leading cause of death (0.56% of total). In 2021, it was the 34th leading cause (0.65% of total deaths). By now (31 March) the Covid-related death toll has climbed steeply to 19,511, despite adult vaccine coverage of over 90% by the end of 2021. 

The vast majority of Covid deaths in many countries by now are among the vaccinated and boosted. The number of vaccine doses administered in Australia was 43 million in 2021 and another 21 million in 2022. By the end of 2021, 92% of over-16 year olds had been fully vaccinated. According to the Department of Health, almost 100% of Australians aged 75–89 are at least double vaccinated by now and over 80% have received four or more doses. Despite this very impressive success in the vaccination drive, in 2022 Australia recorded over 16,000 Covid deaths and by 31 March this year its total stood at 19,511. Thus despite 92% adult vaccination, 18 times as many Australians died with Covid in 2022 as in pre-vaccine 2020. 

On the harms side, a CDC report on 16 March showed US maternal mortality jumped by 40% from 861 in 2020 to 1,205 in 2021. The 2021 rate of 32.9 maternal deaths per 100,000 live births is the highest maternal mortality rate since 1965 and coincides with the year of the vaccine rollout. 

Similarly, lagged temporal correlations are clearly visible in several European countries between vaccine uptakes and falling births nine months later.

Dr. Ros Jones, a retired consultant pediatrician from the Health Advisory and Recovery Team (HART) guides us soberly through a discussion of how this could be explained by a combination of societal (choice, restricted opportunities due to lockdown effects) and medical causes (exacerbated problems with male/female fertility and conception, miscarriages, terminations, stillbirths). Her conclusion is the key message. As the public and the specialists have not been given access to the raw data, “when is the Government going to order a proper investigation to put an end to speculation over whether correlation does or does not reflect causation”?

According to the latest data from the Australian Bureau of Statistics that was published on 31 March, there were 190,394 deaths from 1 January to 31 December 2022. This is 25,235 or 15.3% more than the five-year historical average (2015–19). Of these, the number of Covid-related deaths was 10,095 or 40% of the total excess deaths. Thus 60% of the excess deaths could be the after-effects of the disastrous lockdowns and vaccine injuries. We don’t know and, infuriatingly, the government refuses to order a proper investigation of what should be an urgent preoccupation for the public health clergy.

The tragic case of 24-year old Amy Sedgwick whose death came after painful side-effects following two doses of the Pfizer vaccine was featured in The Weekend Australian on 25 March. The Australian kept the story going with another feature article on 1 April about the manifold failings of the compensation scheme for the vaccine-injured. Adam Creighton pointed out that this story would have been disappeared from the Internet in 2021 owing to the censorship collusion between Big Pharma, Big Tech and public health authorities.

Even truth was no defence with accounts of vaccine injuries, if their effect was to promote narrative skepticism. The social media Big Tech censored, suppressed, shadow banned and slapped labels of “false,” “misleading,” “lacking context” etc. to content at variance with the single source ministries of truth. “Fact checking” was weaponized using fresh young graduates—with no training, skills or capacity to sift between authentic and junk science—to put such judgmental stamps on pronouncements from world-leading experts in their field. 

Like Bridgen’s figures on the net vaccine harms-benefits equation in the UK, we too urgently require the same age-stratified data for Australia on numbers needed to vaccinate to prevent one hospitalization, ICU admission and death. This should be accompanied by the corresponding numbers put at risk of hospitalization, ICU admission and death by the vaccine. 

It is an outrageous and ongoing scandal that the public has not been given this information. How can anyone provide “informed consent” absent that vital data? 

Journalists attending the ritual of daily press briefings by the health ministers and chief medical officers were “all graduates from the Uriah Heep school of obsequiousness,” to borrow a phrase from Angus Dalgleish. The professor of oncology at St George’s Hospital Medical School in London adds that the boosters are against the Omicron variants. These “not only fail to protect from new variants but actively encourage them by Antibody Dependent Enhancement (ADE) which explains why boosted patients are 50% more likely to catch Covid after their vaccination than those who refuse.” In addition, it “induces T-cell suppression and antibody class switching,” causing cancer relapses. 

India refused demands from Pfizer and Moderna for fully indemnified emergency use authorization based on overseas trial results. Consequently the main vaccine administered in India is a virus-vector type, not mRNA. And, unlike many other countries that administered mRNA vaccines, India has not seen a surge in infections and mortality following rising vaccination coverage.

India’s contra example poses some difficult questions for Australia’s drug regulators. Why were local clinical trials not required before granting emergency use authorization to these experimental vaccines with no established long term safety profiles? Have the regulators been captured by the very industry they are meant to regulate in order to protect public health? Do they understand why there is public cynicism that they might have morphed from guardians of public health into vaccine enablers, accelerating the approval process by short-circuiting safety trials, yet being noticeably tardy in responding to safety signals and investigating vaccine injuries? 

Something else that several Indian states deployed but the TGA banned in Australia was ivermectin repurposed as a preventative and early outpatient treatment for Covid. With around four billion pills sold around the world over several decades, its safety profile is well established. Large scale observational data from India and Africa offers some evidence for its effectiveness. As an off-patent drug, it is incredibly inexpensive. This might explain Big Pharma’s hostility but does not excuse the TGA’s failure to fund more reliable randomized control trials, particularly in light of some convictions and a long list of out of court settlements by Pfizer. 

No one has as yet explained why, if the manufacturers were so convinced that their vaccines were safe and effective, they required legal indemnity against vaccine injuries. Did the ban cost Australian lives, as asked by Kara Thomas and Andrew McIntyre in Spectator Australia, by preventing doctors from recommending it to patients based on their best professional judgment of each individual case? 

Some of the fiercest vaccine promoters are starting to turn somewhat skeptical and hesitant, as reported in this article from Apoorva Mandavilli, herself an enthusiastic vaxmonger, in the New York Times on 24 March. It’s when they go back to blaming President Donald Trump for the vaccines and its assorted failings and injuries, that we will know the circle has been closed.