Vaccine targets no use in Covid-19 policy

14/09/2021

Many areas of the world are now in a race to achieve high coverage of covid-19 vaccination. Some commentators in New Zealand are now criticising the government for not rolling out  fast enough. Given the high efficacy of many vaccines, this seems like a sensible strategy, but is it?

The government recently asked some of New Zealand’s epidemiology experts “Is an elimination strategy still viable as international travel resumes or are we going to need to accept a higher level of risk and more incidence of COVID in the community”. The specialists concluded that: “There is no doubt that this strategy has served us well”, comparing deaths in New Zealand attributed to covid-19 of 26 to 10,000 in Scotland. The way out was through high levels of vaccination. The document assumes that elimination is the ‘optimal’ strategy and further incursions, we are assured, will be ‘stamped out’ as we achieve high levels of vaccine induced immunity.

Will this really eventuate? In terms of rapid vaccine rollouts, Iceland is a counter example. Icelanders have now vaccinated 69 or 81% of their population, depending on whether you consider the whole population or only those eligible for vaccination (12 years and over). Almost all Iceland’s older generations are now vaccinated (99% coverage of 70 to 79 years), yet the younger generation has slightly lower coverage (78% of 30 to 39 years).  However, the vaccination records of covid-19 cases there tells another story: 73% of cases are fully vaccinated. This figure is inconsistent with the trial evidence of efficacy of the vaccine being 95% in reducing symptomatic infections (95% confidence interval: 90.3 to 97.6%). If this efficacy were correct, covid cases would be expected to only yield a small fraction of people with records of full-immunisation [(69% – 95% * 69%)/(1 – 69% * 95%) = 10%]. As almost three-quarters (73%) of recent cases in Iceland are fully vaccinated the efficacy obtained in the trial does not match the reality of the roll-out.

Others are noticing similar results: a recent case-series in the US also showed 74% of cases were vaccinated, with PCR cycle threshold values, roughly assumed to be equivalent to infectivity, similar in vaccinated and unvaccinated cases.

A case is being made for continuing vaccination since deaths may be prevented in those vaccinated. However, in the UK, a Public Health England recent report shows that of all dominant delta variant cases occurring from 2 February to 3 August 2021 (n = 300,010), 15.7% (47,008/300,010) were fully vaccinated compared to 50.3% (151,054/300,010)  unvaccinated. The remainder were either partially vaccinated or their status was unknown. A total of 741 deaths occurred in the delta cohort (0.25%; 741/300,010) within 28 days of testing PCR positive, with 90% of deaths (670/741) occurring in those aged over 50 years (figure; five unlinked cases are removed). The outer grey square represents the total cohort who tested positive for delta variant, with the blue rectangle the cases aged less than 50 years, the beige those who had been fully vaccinated, the dark green those who were hospitalised and the light green the deaths. One can immediately appreciate that deaths are few in the delta cohort and that most people do not need hospital treatment, even in the over 50 age group. This means that delta is hardly the “game changer” the Prime Minister has talked of.

Analysis of the delta cohort points to differential associations between exposure to the vaccine and death within a month. When the cohort is divided by age, deaths associated with covid-19 are 1.57 times (95% confidence interval (CI): 0.85 to 2.89, not significant) more likely in the vaccinated group under 50 years, compared to unvaccinated, whereas in the older bracket the vaccinated are 70% less likely to die from covid-19 compared to the unvaccinated (95% CI: 84 to 64%).  The vaccine’s ability to prevent covid-19 deaths in younger age groups among people with the delta variant is certainly questionable from these data. It must also be remembered that these calculations are crude in the sense that they do not account for comorbid status of delta ‘cases’.

Figure. Scaled rectangle diagram, illustrating the fatality proportion of the UK delta variant case cohort, by vaccination status, age and need for hospital care. Some counts of small cell values and those with uncertain vaccination status (n = 31,841) have been omitted. This includes 13 deaths occurring in the ‘fully vaccinated’ under 50 years, 56 in the ‘unvaccinated’ group under 50 and 7 were unlinked, making 741 total deaths.

The best evidence of overall effect on death comes from the latest update of the Pfizer trial which shows slightly more overall deaths (15/21,926) occurred in the vaccinated group than in controls (14/21,921). This is important, since the outcome doesn’t just count successes (reduced covid ‘cases’), but also includes the possibility of vaccine harm, evaluating the effect of the vaccine on overall survival. This means the best evidence thus far indicates a 7% increase in risk of death, comparing the vaccinated to the unvaccinated. Yes, the numbers are small, and these results are compatible with a wide range of vaccine effects, but it seems strange that this important information is relegated to the study appendices and is absent from the summary. Most of us are more interested in our overall longevity, rather than being solely focused on avoiding covid-19. The Prime Minister’s claim (52’:27”) that the vaccine is “saving lives” is sounding hollow, from the best possible epidemiological evidence: Pfizer’s own trial.

The policy response to the recent surge in cases in Iceland is to extend vaccination to pregnant women and impose further restrictions. The UK, in contrast, is dropping restrictions, despite a recent spike in overall case-numbers.  As New Zealand is once again thrown into costly lockdowns, we need to ask whether it is appropriate, given the evidence.

We now have a group of scientists advising the government that cannot see any other strategy apart from elimination as ‘viable’ or ‘optimal’. This is understandable, as they have committed the country to this course of action, one that has cost us at least NZ$50 billion. We must now recognize that other courses of action are viable. Sweden, Florida, and Texas demonstrate this. Analysis of excess mortality in Sweden for 2020 has shown a 3 to 8% increase from background which are attributable to past mild influenza seasons. The rush to vaccinate must now be balanced by the questionable efficacy of vaccines demonstrated in Iceland, the accumulating evidence of vaccine-related adverse effects, including the 350 serious reactions on government websites. The enthusiasm for more lockdowns must also be questioned, given evidence of  business closures, queues at food banks and the extra 43,000 kiwis on jobseeker support since March 2020.

As we said from early 2020, the path forward lies not in a medical intervention, but rather in a realistic assessment of the threat posed by the virus, based on such evidence as the distribution of age of death with covid-19 being similar to background mortality. Our efforts should be best focused on protecting the most vulnerable, implementing early treatment protocols, increasing capacity in our hospitals, while the majority of those of working age and younger people return to normal life. Overseas data clearly now show that vaccines are not a way out.

Protocol for re-opening New Zealand society

24/08/2021

Introduction

18 months on from the world’s fearful response to the arrival of SARS-CoV-2, we provide an alternative to New Zealand’s elimination strategy to one of ‘living with covid-19’. We are now back in level four lockdown indefinitely with escalating PCR positive ‘cases’. We urgently need to reassess New Zealand’s elimination strategy and whether it makes sense given the new information.

The revised strategy takes account of five major developments over the period:

  • The infection is far less threatening than originally forecast by authorities, including New Zealand, when they proposed lockdowns and other restrictions. Data from the WHO, CDC and other peer-reviewed studies show the median infection fatality ratio (IFR) is ~0.23%, not the projected 3.6%. The condition is therefore more akin to pandemics in 1957 and 1967 than influenza in 1918. Asymptomatic individuals do not spread the infection, removing the key idea underpinning lockdowns. Long-term health effects (“long covid”) have not proven any different to or more prevalent that those experienced in the recovery period from existing circulating pathogens.
  • Questions still remain about the accuracy of the polymerase chain reaction (PCR) test used to diagnose ‘covid-19 cases’. The virus remains yet to be isolated, the sequence of the virus was generated in silico (stitched together from computer databases) and many people who test positive are asymptomatic. In addition, the clinical symptoms associated with covid-19 are not unique.
  • It is clear that the average age of death with covid-19 is about the same as our life expectancy (~82 years). Older people are much more likely to die of covid than younger ones.
  • Very rapid development of vaccines and dissemination of these in New Zealand. The vaccines show some evidence of reducing PCR positive cases, but not of prolonging overall survival or reducing transmission. In many countries now with highly vaccinated populations, there are increasing numbers of breakthrough cases. It is now obvious that vaccines will not stop the spread of the condition long term. In addition, clear evidence shows a major increase in post-vaccination deaths and serious injuries.
  • Early treatment protocols are showing promise in the early treatment of cases otherwise destined to be hospitalised.
  • New Zealand’s very low incidence of covid-19, with the apparent absence of community transmission for many months, whereas covid-19 cases occur freely throughout the rest of the world. Now, we are faced with yet another lockdown and an increase in case numbers.

The vaunted elimination objective makes re-engagement impossible without an improved vaccine administered as often as necessary to most of the population.

New Zealand cannot sustain economically or socially the years of border closure, threat of lockdowns, social disruption and government debt, needed to reach this position, if it can be reached at all. We believe, frankly, this to be a utopian pipe dream, but necessitating dystopian government dictates. The fabric of our society will be rent – then restitched to what?

We propose an approach that slowly and carefully manages our entry back into a world where covid-19 exists, and where it can exist in New Zealand without causing unacceptable harm.

Guiding Principles

The risks of mortality following covid-19 infection have been grossly exaggerated. As observed in other pandemics, a high degree of ascertainment bias has occurred that has further exaggerated the importance of this condition in the minds of scientists, decision makers and politicians. This has led to an over prioritisation of the illness above many other health issues. In turn, this exaggerated threat has led to mortality and morbidity from other diseases due to the imposition of lockdowns and disruption of usual medical care.

The economic effects of lockdowns and border closures, leading to unemployment and poverty will lead to further health deterioration that is out of proportion to the threat of covid-19. Consistent evidence also highlights that lockdowns do not limit the spread of infection.

Now, it is important to note that hospital treatment for covid-19 patients has improved considerably during the course of the pandemic and that hospital mortality has declined. Potential treatments are also available to reduce morbidity and mortality include the use of both the micronutrient vitamin D and anti-parasitic and anti-viral drug ivermectin. It is also clear that metabolic disease is an important contributor to death with covid-19, and it also raises risk of death from other diseases. Addressing dietary risks related to metabolic disease is also worthwhile to reduce potential harm from covid-19, such as reducing sugar intake.

These guidelines were inspired from those produced by the group who published pandata.org.

Ongoing pursuit of elimination is risky

New Zealand is the only country in the world now continuing to attempt to eliminate cases. Many countries that were attempting to eliminate covid-19 have now given up, such as Singapore, UK and Australia. It is a dead-end strategy which will leave New Zealand isolated and vulnerable, in a (possibly) covid-free bubble. Even if elimination is possible and the reward warrants the financial and social cost, cases will still exist throughout the rest of the world – endemic for the foreseeable future (hundreds of years). To keep it out, New Zealand will need to retain covid-19 border testing indefinitely. Similarly, lockdowns and tracing and testing have no time limit.

There are three ends to the elimination strategy:

  1. A cataclysmic failure at the border, such as the beginnings of which we are now seeing, or a winter-resurgence within the country, in which infection sweeps quickly through the population. Lockdowns would, like the US and UK, not protect us.
  2. The infection becomes endemic with low levels of circulation and winter peaks, like the varieties of influenza and coronaviruses that circulate. This is likely to take many years. New Zealand would need to decide a point at which it could open.
  3. Future vaccines may be developed to completely interrupt transmission of covid-19. The development of the currently available partially effective vaccines has been the quickest ever, and faster than we imagined. We do not yet have evidence that the current vaccines reduce viral transmission through a population. Given performance to date, this evidence might one day eventuate. But the rest of the world is not trying to eliminate covid-19 and appears satisfied with the imperfect protection of the current vaccines. That makes it uncertain whether there will be a commercial incentive to ever invent such a comprehensively protective vaccine, since the existing ones are not as effective as required to maintain population elimination.

Our belief is that none of these exits from the elimination strategy are palatable.

Instead, New Zealand should prepare for, and carefully manage, the inevitable introduction of covid-19 to New Zealand.

Frequently asked questions

Do new variants and strains (lineage B 1.1.7 or delta) pose an increased risk of harm?

Every virus is thought to have thousands of variants. There are over 100,000 alleged variants for covid-19. The fact that there are new strains is not important. What’s important is their effect. With the UK strain, the claim is it transmits easier. We haven’t yet seen any convincing evidence that new strains are more dangerous.

Has there been increased overall mortality as a result of covid-19?

Yes, there has been increased overall mortality in some countries, but not all. Many countries, such as Malaysia, Cyprus, Costa Rica, Uruguay, Japan, Singapore, Denmark, Finland, Ireland, Luxembourg and Malta have not. Excess death is also statistically associated with the period after lockdowns in between country comparisons and between US states. Since the average age of death is close to our life expectancy in almost every country, much of the excess mortality is likely to be related to displaced mortality, and light influenza seasons in recent years, leaving a high number of people who are frail and elderly. It is also clear that some of the excess mortality was due to responses to covid-19, such as abandoning non-invasive ventilation for intubation and mechanical ventilation and prematurely sending infectious patients from hospital to rest homes. Hospital mortality in New York has now dropped by 70% since the beginning of the pandemic.

Does evidence support the wearing of masks to prevent infection?

The best evidence from a randomised controlled trial, the Danish mask study, couldn’t find any evidence to support mask use, particularly cloth ones, to protect the wearer. That also indicates that they are not preventing transmission. And asymptomatic people are unlikely to transmit the infection anyway.

What is the extent of the economic recession?

Globally, the World Bank is saying we are now facing the greatest recession since World War 2, demand in food banks in New Zealand has doubled or trebled and we have now thrown more than 50,000 adults in New Zealand into the dole queue, since March, when lockdowns and border closures began.

The health effects from the widespread panic over covid-19 has also produced many mental problems. For example, there has been an increase in children hospitalised for eating disorders both here in Auckland and in Melbourne. In the UK, mental health scores have deteriorated.

Does asymptomatic spread occur?

A mass testing study in Wuhan, a city of 10 million residents, identified 300 asymptomatic cases, with no evidence of spread of infection from them.

Are you just scientific outliers?

We might seem a minority in New Zealand, but our approach is the same as the Great Barrington Declaration, a view on covid-19 signed internationally by 15,000 medical and public health scientists and almost 44,000 medical practitioners.  The counter viewpoint signed by supporters of lockdowns only mustered ~4,200 signatories.

The Plan

Brief guide
  1. Offer enhanced protection and treatment for covid-19 to vulnerable people.
  2. End mass testing, contact tracing, quarantine and lockdowns.
  3. Vaccination should be voluntary and with informed consent and transparency of both efficacy and safety data.
Healthcare recommendations
  1. Since approximately half of fatalities worldwide with covid-19 have occurred in people living in rest homes, this should be the focus of protection. Effort should be given to protecting those who are at high risk of fatality from covid-19, which are individuals aged greater than seventy-five years, particularly those living in supported residential care, and those with metabolic health conditions, such as diabetes, obesity and cardiovascular disease. Measures to protect these people could include regular testing of health workers with respiratory symptoms, who have a high level of exposure to vulnerable people. Strong exclusion policies for workers with respiratory symptoms are important. Ensure people with covid-19 are not in contact with vulnerable people during their infectious period. Other measures include:
    1. Minimise the number of nursing home staff a resident is exposed to.
    2. Provide outdoor areas for socialisation of rest home residents where transmission of the infection is likely to be lower.
    3. Enforce strict exclusion policies related to workers or visitors with any respiratory symptoms.
    4. Encourage supplementation of vitamin D and sun exposure for vulnerable people, since trial evidence supports the use of this micronutrient to prevent intensive care admission in hospitalized patients.
  2. End mass testing for the infection and contact tracing. The test should be only used within a clinical context of a characteristic clinical picture, compatible with a lower respiratory infection within hospitalised individuals.
  3. Increase capacity in hospitals and intensive care units to cope with seasonal demands of respiratory illnesses, including covid-19. As stated, early treatment on diagnosis promises to reduce admissions
  4. Cases should only include those who test PCR positive, at a limited cycle threshold value, with compatible symptoms of a respiratory infection.
  5. Deaths from covid-19 should include only those who fulfil the criteria of being an active covid-19 case temporally related to their death, with no other likely competing cause.
  6. Eliminate mask wearing in the community, since evidence does not support their use to prevent infection in the community.
  7. Vaccination should be entirely voluntary with informed consent of the risks and benefits as more information about their efficacy and side effects come to hand. Vaccination for children of school age should be withdrawn since they are not at appreciable risk of covid fatality. Dangers of exposure to the vaccine, particularly to pregnant women, should be made clear and Ministry of Health information updated accordingly. Vaccination passports or any form of discrimination based on vaccination status should be abandoned, since the vaccines do not convincingly reduce SARS-CoV-2 transmission.
  8. Consider the routine use of vitamin D and ivermectin in the treatment of hospitalised covid-19 infection.
Societal recommendations
  1. Abandon the use of either regional or national lockdowns to contain viral spread, since they are unnecessary, economically disastrous and ineffective.
  2. Schools, childcare centres and universities should not be subject to restrictions and face-to-face learning should have no restriction since children are at extremely low risk for covid fatality.
  3. End all restrictions on businesses.
  4. Undergo a phased re-introduction of normal travel across New Zealand’s border. At first, a risk-based approach may be undertaken, as shown in the following web app and accompanying paper, which has been published in the New Zealand Medical Journal. This strategy indicates a method for opening NZ’s border, based on the estimated prevalence of covid-19 infection in the country of the traveller’s origin. This would enable travellers to come from several countries immediately who have a very low prevalence of covid-19. New Zealand should then aim to end travel restrictions completely, should this initial strategy be successfully enacted. In support of such a stance, the European CDC, for example, has now recommended the dropping of covid-19 testing and quarantine across borders.
  5. End the covid-19 elimination strategy in New Zealand. With cases widespread globally, it is clear that such a strategy is neither sustainable nor beneficial from a perspective which considers both the costs and benefits of such a strategy to New Zealand. Eventually, infection is likely to become endemic and part of the usual seasonal respiratory illnesses that affect New Zealanders every year.

Zero Covid is not a necessary or sustainable solution for New Zealand

Simon Thornley

6/7/2021

We have recently been told that “Life’s not going to go back to 2019 any time soon.” and that we need at least 83% of us vaccinated for measures such as lockdowns and quarantines to be a thing of the past. Other experts said these estimates were “plausible”. In fact, the figure might be as high as 97%. Before we abandon any dream of returning to normal, let us consider the broader issue of how much certainty we can place in these pronouncements, and whether we should now be putting our skeptical spectacles on.

These days it is easy to live under the illusion that specialists in any field have it all together. The other day my oven started burning food that I thought was put in to keep warm. I assumed the thermostat was broken, I ordered and installed another, but the problem persisted. I couldn’t work out what was wrong. I finally gave up and called a very good appliance repairer, who within ten minutes had found the short and the oven now works almost as good as new. The same generally happens when I bring my car in for a service. Whatever wasn’t working, now is and the problem is solved. Even I can now repair a computer that gives me the blue screen of death and fails to boot. The Windows recovery USB is a beautiful thing and is worth looking-up if you haven’t discovered it yet.

All of this creates the false impression that we live in a world of certainty and that experts can solve any problem. This assumption is safe when it comes to human designed machines and usually there is either an expert somewhere or a youtube™ video ready to give you advice about how to fix something that is broken. Such advice is often built on a profound and subtle understanding of how a machine normally works, how to distinguish normal from abnormal behaviour, and replace the faulty part in question.

The same is not true, however, for my chosen specialty. Epidemiology is fraught with uncertainty as we often have competing information from different areas and we need to decide which evidence is most important and most reliable. About covid, for example, we have seen this in action. We are still told to wear masks on public transport in New Zealand. Mask proponents will use this observational study to justify their use to prevent infection, whereas people opposed to their use may point to trials such as this one. Now both parties have evidence to fall back on and justify their viewpoints. The question is then now “which evidence is superior?” Conventionally, trials, such as the DANMASK one is generally considered better evidence than observational ones, since all other differences, other than the one under study (masks or no masks) are cancelled out by design. Instead, observational studies cancel out other factors through statistical means, which are clunky and we can only account for what we know, whereas the trial rather miraculously accounts for what we don’t know.

This is all old news. Science writer Gary Taubes pointed to this many years ago in a seminal article, asking the question of whether epidemiology had faced its limits? Taubes made the relatively straightforward observation that studies purporting to answer the same question in epidemiology often came to diametrically opposed conclusions, so it was hard to know where the true answer lay. Examples in the recent past include the questioning of the belief that saturated fat is the cause of heart disease. This has been dogma for many years, and now the lack of statistical evidence in support of the hypothesis is starting to more than raise eyebrows. Sugar intake, traditionally thought to be healthy, is now considered a prime suspect, taking the place of the formerly guilty animal fat.

This should now give us pause for thought as the country is given no letup in the torrent of bad news that seems to stream from authority on the covid-19 path. Although, I acknowledge there are different views of covid-19 and those who think it is terrible will point to scenes of overwhelmed hospitals in India and other places, there are also many reasons to be optimistic. We now have much data about the fatality ratio of the virus, and it is now in the region of 0.15%, not far off seasonal influenza (0.1%). The fear created by the spread of the latest ‘delta variant’ shows a case-fatality of only 0.1% in UK data. This is even with systematic exaggeration of death reporting which we are now only just appreciating. Deaths rates from covid-19 have dropped precipitously in many hospitals.

In perhaps the most sinister twist, we have our medical council stating that we may only discuss  evidence-based information about the COVID-19 vaccine if it aligns with government issued information, implying that any other information is anti-vaccine and not acceptable. This is despite new information leading to 18 countries withdrawing the AstraZeneca vaccine in order to protect their populations. The assertion that we are being told the “Whole Truth” is starting to now feel rather hollow. The recent case-series of cases of myocarditis and the rapid increase in reports of post-vaccine death in the US demands a cautious approach.

Te Pūnaha Matatini’s latest headline grabbing piece is based on another complex model that paints us all in a corner until we are all vaccinated. Even children, who have almost zero risk from covid-19 are targeted for the jab. Reading the document, I can’t help but yawn. The underlying assumptions are that we have no background immunity, it is only achieved through either infection or vaccination. It is also clear that the only goal is to defeat covid-19. Nothing else matters. There is not one mention of vaccine adverse effects – these are of no interest on the road to zero covid. It is almost as if this group is living in a parallel universe where the only concern is defeating the virus. This group who gave us visions of mass death that prompted lockdowns does not discuss the issue of pre-existing immunity from other coronaviruses that provide protection to SARS-CoV-2. Other modelers are drawing attention to this as a major reason for exaggerated death estimates early in the covid-19 saga.

The importance of the defeating covid-19 must be balanced against the growing evidence of harm from the vaccine and from restrictive measures. It is almost as if reports of vaccine harm don’t exist to the mathematical modellers. Physicians calling for the withdrawal of the vaccine stating there is “more than enough evidence on the Yellow Card system [UK vaccine side effects reporting system] to declare the COVID-19 vaccines unsafe for use in humans” must be deluded. The rate of 1/50,000 covid-19 vaccinees dying and the 1/70 having adverse effects reported after the vaccine must simply be co-incidence. These admonitions   along with the recent finding of strong cross-reactive immunity to SARS-CoV-2 in children hasn’t seemed to have dampened the Ministry of Health’s enthusiasm to vaccinate this age group.

In a recent telephone call from Professor Michael Baker, I was told that the average number of years of life lost from covid-19 was sixteen. I asked him what the average age of death from covid-19 was in this country? He couldn’t tell me. He asked me what that I thought that figure was. I responded that it was similar to our life expectancy: about 82 years. The same is true overseas. The combination of an average of 16 years of life lost and average age of death from covid-19 logically means somehow the virus is targeting people who would have otherwise lived to 98 years. This seemed implausible to me. Professor Baker agreed with me, however, Nevertheless, one week later he made the same claims about average life years lost. During that lecture he dismissed everything I’d said during the covid-19 saga as “misinformation” and accused me of “cherry picking” data. I had the same conversation with a stuff.co.nz reporter about one week later. Whatever else covid-19 is doing, we should not simply assume it be prioritised above all other concerns. We need to face the vaccine and the virus with our eyes open. From these data, it is not overall reducing our life expectancy.

It is a positive sign that Singapore, UK, and now Australia have recently announced that they have abandoned ‘zero covid’ as unsustainable, in favour of living with the virus and eventually returning to normality, albeit with vaccination. We urgently need to remember that the pretense of ‘one source of truth’ is anti-scientific, and that good science demands freedom to raise and debate uncomfortable evidence.

Analysis of NZ serology study

In the year since New Zealand closed its border and adopted an ‘elimination strategy’ against SARS-Cov-2, only one reliable serology test has been conducted. During this period at least 47 serology studies have been conducted throughout the world. Serology tests were banned from import or sale in NZ.

The result of the authorised study of 9806 blood samples taken in December 2020, was pre-print published (not peer reviewed) on April 19: https://www.medrxiv.org/content/10.1101/2021.04.12.21255282v1

The headline result is that it found antibodies to SARS-CoV-2 in 0.1% of samples.

This is lower than we expected – especially when compared to the prevalence found in other nations of studies conducted earlier in the pandemic (as high as 50% in India). It is also much lower than the NZ prevalence of H1N1 (30% positive antibodies), which triggered health authorities to abandon elimination plans.

The title and commentary of the paper suggests this low level is explained by elimination of the virus. It is directly explained by the estimated 3-month half-life of antibodies (S and RBD, compared to month long half-life of N protein). Our reference paper on seropositivity is https://www.medrxiv.org/content/10.1101/2020.07.16.20155663v2.full.pdf. That means ‘fresh’ infections have been falling. This undoubtedly means that border closure has cut off supply of renewed infection but tells us very little about how much infection existed in NZ at the time of the border closure.

Even if you would like to believe the result shows the elimination strategy has throttled infection rates, you cannot ignore that it simultaneously proves that elimination is impossible. The 0.1% prevalence is double the number of identified positive tests. For every identified case, there is at least one other person with covid-19 who has not been identified. That means there has been at least 5000 cases in NZ (5,000,000*0.001).

Worse still, community infection is higher than thought. The study shows the ratio of previously detected locally acquired cases to known cases is 6:8. The number of locally acquired cases from the Ministry of Health is 2600 – 865 in MIQ = 1,735. This indicates that there were 2313 (1,735*8/6) extra locally acquired cases that were not detected.

If we wanted to ascertain true cumulative exposure to infection, then 0.1% is certainly an underestimate, compared to influenza antibodies. The study makes no mention of the possibility of infection that can be found in T-cell levels e.g. from Karolinska. Those studies suggest that if the true infection rate could be, conservatively, 1.5 times the antibody prevalence.

We note that the eight undetected cases claimed in media coverage were widely geographically distributed, so could not have been from a localised cluster. Covid-19 was evidently widespread across NZ, breaking the fiction of being contained by lockdowns and tracking into ‘clusters’.

A big implication of the study is that we now have a more definitive infection fatality ratio (IFR) for NZ of 0.5% (26/~5000). Only a month or two before this serology survey Rod Jackson and the NZ Herald refused to retract articles that told New Zealanders the IFR was at least double that (over 1%). We trust they will now delete those articles. Most other NZ experts have been more recently citing the CDC’s IFR of 0.65% – which is now clearly too high in NZ.

Our search for an accurate IFR now has a more certain starting point. We know that about one quarter of the NZ deaths were attributed to covid without evidence of a positive test. We also know that given the half-life of antibodies, the real infection level must be higher than 5000.  A conservative level would be about 10,000 infections. So NZ’s IFR could be as low as 0.2% (20/10,000). This figure is concordant with median estimates from summaries of serology studies.

In summary, the study reveals a lower antibody level than we expected. It’s a surprise that indicates a likely waning of fresh transmission. But it reveals that we have had at least one undetected case for each detected case. This means:(a) the virus is not as deadly as first thought as these cases were not diagnosed since they didn’t come to clinical attention and(b) it is a fiction that New Zealand has detected each and every case of covid-19 and so can declare the virus ‘eliminated’.

Fact-checking Covid vaccine experts

Simon Thornley

18/04/2021

1014 words

In a recent interview with Radio New Zealand, a vaccine expert claimed that the risk of blood clot was 165,000 times higher after having covid-19, compared to the risk after having the AstraZeneca jab. This claim illuminates several misunderstandings of the nature of the SARS-CoV-2 virus, the true nature of the side effects that are worrying health officials overseas and the influence of misleading claims on social media.

Even though New Zealand is currently using a different vaccine, the emergence of blood clot reactions to some covid-19 vaccines has worried those who have been saying the vaccines are safe and effective.

In response they have tried to do something they refused to do with SARS-CoV-2; provide people with realistic data about the small risk posed.

To make the vaccine-related blood clots seem comparatively small, Dr Helen Petousis-Harris recently claimed that the risk of covid-19 blood clots was high.

She said the risk of clot from the AstraZeneca vaccine is about 1/1,000,000 against risk of clotting from covid-19 which is 165,000/1,000,000.

The frequencies of 165,000/1,000,000 are hard to understand until we start wiping off a few confusing zeros and end up with 16.5/100 or 16.5%.

Dr Petousis-Harris claims that 1/6 people who have covid-19 infection have a clot; not just any clot, but the rare brain vein clot being experienced by covid-19 vaccine takers.

All Helen’s words are taken verbatim from numbers on an infographic image doing the rounds on social media.

The statistic of 1/6 people suffering rare clots after being infected with the covid-19 virus comes from a summary study of hospitalised patients which evaluated the risk of pulmonary embolus and deep vein thrombosis in patients hospitalised for covid-19. Over half the studies included in the summary were from patients in intensive care. Some studies screened all patients for clots. The average of all studies showed a weighted proportion of 16.5% for both deep vein (leg) and lung clots.

Despite widely held belief, over 95% of people who test positive for covid-19 do not need a hospital, so would not have appeared in the denominator of the 16.5% figure. A study from Iceland, one of the most tested nations on earth, showed that 5% of positive patients for covid-19 were hospitalised, and only 1% went to intensive care. This means that the 16.5% figure is a very skewed proportion of all patients with covid-19. Since only 1-5% of cases make it to intensive care or hospital, that 16.5% chance should be less than 1%.

We know also that many more people have caught the virus than the positive genetic (PCR) tests say, as shown by serological tests and other immune studies. T-cell tests show that even more have been exposed to the virus, compared to antibody studies. The incidence of blood clots following covid-19 infection is simply not known, but it must be at least an order of magnitude lower than presented by our vaccine expert. So now the claimed 16.5% chance of blood clots across the population is not even 1%; it is closer to 0.1%.

Now comes the worst part of this attempt to mislead people about the vaccine risk; we’re not even talking about the same type of blood clot.

The blood clots experienced by some vaccine takers is cerebral venous sinus thrombosis, a deadly and rare condition.

The blood clots that threaten about 0.1% of us who catch covid-19 is deep venous thrombosis, a comparatively common condition found across all manner of hospitalised patients. It is so common that in one autopsy case-series, 10% of deaths in hospital patients who had the post-mortem procedure were caused by venous thromboembolism.

The background rate of cerebral sinus thrombosis is estimated to be 1.32 per 100,000 person years.

In contrast, the background rate of deep venous thrombosis is estimated at 50/100,000 person years, about 38 times higher than for cerebral sinus clots. The risk of leg clots is very strongly age-related, with older people more affected.

A direct comparison of the rate of cerebral sinus thrombosis in covid-19 patients compared to those who have had covid-19 vaccines has been carried out. The rate of cerebral venous thrombosis was higher in the covid-19 group compared to the vaccinated, but by a factor of 6 rather than 165,000-fold higher, as claimed in the Radio NZ interview. The cerebral sinus thrombosis group after covid-19 was more likely to have heart disease than those who had had the virus without the clot. The covid-19 group only counted PCR positive individuals, which as mentioned, underestimates the spread of the virus. The rate of venous thrombosis in the vaccinated groups (both Pfizer and AstraZeneca) was about 4-5 per million people in the two weeks following the vaccine. The risk of the vaccine is clearly higher than baseline which is an annual statistic, even if it is lower than for people who have had covid-19.

The administrative bodies of several nations are rightly concerned about the incidence of a rare type of blood clot from the AstraZeneca vaccine. Concern is justified when one particular risk of taking the vaccine is higher or worse than the risk of not taking it.

The image carrying the numbers quoted by Dr Petousis-Harris has been shared over social media by New Zealand doctors. I am sure they were well-intentioned, but it is never justified to allay fears using false information. It is always wrong to misinform people, particularly over the risk to their health of a medical intervention.

I am severely disappointed that our national broadcaster has not questioned these statements. It concerns a vaccine New Zealand is not using. But what happens when it does? What happens if rare reactions and deaths are attributed to treatments used here? We must be able to count on our media, and taxpayer funded experts to look at data impartially.

The conversation they held with Dr Petousis-Harris revealed a hopelessly exaggerated view of the severity of covid-19 in the minds of our “experts”, doctors, and the governing elite.

I call on Dr Petousis-Harris and Radio NZ to check the numbers, issue a retraction and an apology.

 

Govt policies must catch up with latest data on Covid19

Simon Thornley, Ananish Chaudhuri

1258 words.

António Egas Moniz was awarded the Nobel Prize in 1949 for frontal lobotomy, a supposed cure for mental illness. Ultimately, however, Moniz and the Nobel committee were wrong. The operation did irreparable harm to over fifty thousand patients and the results were far from the claimed ‘cure’.

Early in New Zealand’s Covid-19 story we were admonished with predictions of  80,000 covid-19 deaths by Professor Sean Hendy and his colleagues, even with stringent lockdowns in place. Recently, Professor John Gibson questioned the accuracy of these predictions as implausible because they would require our population to be almost 10-times larger, to square with the infection-fatality proportion reported by the WHO for countries like us. Yet Hendy doubled down on the predictions. Considering that New Zealand now has 26 official Covid-19 deaths, it seems at face value that Gibson is right. Hendy overshot the mark. By a lot.

What is remarkable now is the lack of insight into why these predictions were wrong. We have now learned so much more about Covid-19, we must update our ideas. The government’s own advice to its new Minister shows that Hendy’s exaggerated prediction will have enormous costs to New Zealand society. Crown debt is forecast to grow by 2.5 times to a level of NZ$200 billion in 2024, and the real value of output in 2020 is over five percent smaller than what had been forecast in 2019.

With so much at stake, it is essential that we take stock of what we have learned and why Hendy and his colleagues erred. After all, science is little more than the recalibration of our beliefs and predictions to match the stark reality of collected data. From what Hendy indicated in his response with revised predictions of 10,000 deaths he has learned little about the virus since the early forecasts. His response centred on explanations such as: vaccines arriving early, a modest change in the infection fatality rate (0.9% is the new value, compared to 1.0%), and the lack of capacity in intensive care.

What is most remarkable about these explanations is that none of them could possibly explain the discrepancy between Hendy’s original model and the observed deaths. Since the deaths are simply a proportion of the overall cases (infection fatality ratio), a 10% change can in no way explain the difference between models and reality, which differ by three orders of magnitude (3,076 times).

So, what have we learned about Covid-19 and why were Hendy’s models wrong? First, the models assumed the virus was totally new and that the entire New Zealand population was susceptible. Many studies now show that cross-reactivity and T cell responses to other coronaviruses protect us from Covid-19. Many of us will simply shake off the virus since our immune systems have already seen similar ones.

Hendy takes it as a given that Covid-19 is ten times more deadly than influenza, with no evidence cited. Calculating the ‘deadliness’ of a virus is a difficult issue, since it is dependent on accurately estimating cumulative numbers of infection – the denominator, as well as Covid-19 deaths – the numerator. Deaths are sensitive to definitions of what exactly constitutes a Covid-19 death, particularly in the frail elderly, who often have a range of other diseases.

To illustrate, Singapore has a strict definition of Covid-19 deaths, which requires a positive test and respiratory infection leading to death. The city state has registered only 30 deaths out of 60,019 cases (case fatality ratio: 0.05%). In contrast the UK, which has a comparatively loose definition, including all who died within a period of testing positive, has a case fatality ratio of 2.9%, 40 times higher than Singapore, from the same virus. The most comprehensive survey of infection fatality ratios, which account for positive serology, has yielded a corrected median of 0.23%, well under Hendy’s estimate. This figure does not account for T cell responses to the virus, and takes death recording at face value.

Evidence from wastewater in Barcelona and retrospective analysis of blood samples from a lung cancer screening study in Italy suggests that SARS-Cov-2 was circulating in Italy before its supposed discovery in Wuhan in December 2019. What do we learn from this? Since there was no excess death at that time, it cannot therefore be assumed that excess death that accompanied lockdowns is a direct consequence of the virus. Many of us have likely seen the virus and not known it, since it was circulating well before Wuhan, and health systems coped at that time.

It is remarkable also that Hendy’s doomsday predictions showed little appreciation of the age of deaths with Covid-19. Other authors predicted the magnitude of deaths in NZ from Covid-19 to those from World War 1, which averaged in the 20s of the soldiers who died. Spanish flu victims, similarly, had a median age of death in the twenties, but not those from Covid-19. The average age of deaths with Covid-19 are about the same as the life expectancy of that country. This means that the virus is certainly not as deadly as Hendy claims, since deaths from the virus will not lower the life expectancy of a population. Put another way, risk of death from the virus is no different to the background risks we face every day.

Hendy also fails to discuss the exaggeration in coding of Covid-19 deaths that has occurred during the pandemic. The fact that many deaths have been due to other illnesses and the usual process of recording death has been overturned. This panic induced exaggeration has also been a feature of many other historical epidemics of respiratory illnesses.

Another feature of the Covid-19 story is that much of the early high fatality was related to foregone opportunities for healthcare for other conditions. In the UK, emergency department visits halved during lockdown. To compound this, early mechanical ventilation in intensive care, which overloaded these units, inflated mortality from the virus. Statistical evidence now supports this policy as a cause of excess deaths in Covid-19 cases.

Hendy’s revised estimate that we must have saved at least 10,000 lives assumes lockdowns are effective. This is counter to the weight of statistical evidence on the subject. A between-country analysis showed no evidence that lockdowns save lives, either measured as a stringency index or from google mobility data.

We urgently need to return to the foundations of science which means a sober assessment of reality over failed forecasts. It seems Hendy is unlikely to champion such a cause, since his predictions have cost New Zealanders dearly. Wrong predictions are a routine part of science, but a stubborn adherence to them indicate a deviation from usual practise.

Our usual way of life, our ability to engage with the world, and much of our economy have been surrendered to erroneous predictions. Even with orders of magnitude differences from the reality of observed data, the author remains wedded to them.

The words of Nobel prize winner, Professor Richard Feynman are relevant:

“It doesn’t matter how beautiful your theory is, it doesn’t matter how smart you are. If it doesn’t agree with experiment, it’s wrong.”

Given what is at stake for New Zealand’s future, the last thing we now need is to cling to failed models. Rather, we must confront the frightening fact that much of what we initially thought we knew about Covid-19 was wrong. Dire predictions simply did not eventuate. The spectre of further lockdowns and strict border closures urgently need to be re-evaluated in this light. Feynman again:

“Reality must take precedence over public relations, for nature cannot be fooled.”

Ivermectin now a proven Covid treatment

A WHO-commissioned meta-analysis of Ivermectin shows that using this generic medicine in hospitals leads to a 83% reduction in covid mortality (95% CI 65%-92%). See: https://www.youtube.com/watch?v=yOAh7GtvcOs
The WHO is understood to be waiting for the results this month from three trials before issuing a recommendation.
The position of NZ’s Ministry of Health cautioning against using Ivermectin has not changed since April 2020, despite a consistent growth in studies showing effectiveness.
On the basis of the studies to date, Covid Plan B urges the Ministry of Health to immediately delete its nine-month old caution against using Ivermectin to treat Covid19. A new formal position can be release following advice from the WHO.
Internationally, front line doctors have been frustrated and even abused by authorities and politicians in their efforts trying to make people aware of the effectiveness of Ivermectin. https://www.hsgac.senate.gov/imo/media/doc/Testimony-Kory-2020-12-08.pdf
Covid Plan B contrasts the MOH warning against studies that emerged in favour of Ivermectin, with its decision to buy respirators at the start of the pandemic without clear evidence of their effectiveness. It now appears that respirators harmed some Covid19 patients.
Panic from politicians and policy makers has driven over-reactions and bad decisions. Acting without evidence has caused more harm than good.

NZ’s solo effort on elimination

A short piece from us published in NZ Journal of Primary Health Care.

https://www.publish.csiro.au/hc/Fulltext/HC20132

How many more lockdowns, billions of dollars and social and health harm is an acceptable price to pay before this misguided and expensive strategy is abandoned? We implore Prime Minister Jacinda Ardern, Director-General of Health Dr Ashley Bloomfield, and fellow health advisors to reflect on the points raised in this paper and to abandon elimination as a strategy and the use of lockdowns. We believe that future policy should return to the initial approach that was taken. That is to reduce transmission of COVID-19 through reasonable use of infection control, to maintain capacity in our hospitals and intensive care, while focusing public health and infection control efforts to protect the frail and elderly of our community.

Immunologist cautions on lead vaccines

17 November 2020

Byram Bridle, a viral immunologist at the University of Guelph, cautions New Zealanders that the lead vaccines against Covid19 may not be the solution they are expecting to end its isolation under the elimination strategy.

The main points of his caution are:

  1. NZ will have to wait at least two years before the Pfizer vaccine is available, because it is in strict isolation and low on the priority list for the 500m doses available in 2021.
  2. Not enough data has been released to know whether the vaccine prevents or weakens the symptoms of Covid19, or how long the protection will last.
  3. The safety data will be incomplete if it is approved for use next year, so monitoring will need to be carried out on vaccinated people for some years.
  4. The Pfizer data has not been rigorously peer-reviewed.
  5. There is no available data on the qualitative nature of the immune response. Vaccines like this can be misinterpreted by the immune system as an extracellular pathogen, which can cause them to respond poorly to natural infections with future coronaviruses.

“Pfizer’s vaccine is a RNA-vectored vaccine. This technology is relatively new and has not been approved for clinical use before. The company has been able to move surprisingly fast. If the recent data is indicative of what data from the rest of the trial will look like, there is a good chance the vaccine could receive emergency approval by early in 2021.

However, there are many nuances…”

Insufficient public data

“The study is only partially complete. There exists the possibility that the final data set will fail to secure regulatory approval (but it looks like they may be on track).

Data that accompanied the Pfizer press release was extremely superficial and, therefore, difficult to interpret. Data being collected for the Pfizer study cannot accurately be commented on until it undergoes rigorous peer review for publication in a good quality scientific journal.”

Effectiveness of protection

“90% effectiveness sounds surprisingly high. But we have no idea what the demographics look like. Although they opened the trial to high-risk people, we have no idea who contracted COVID-19. As an extreme example, if all the vaccinated volunteers that got COVID-19 were elderly and that number was not significantly different from the elderly among the non-vaccinated volunteers that got COVID-19, that would tell us that the vaccine does not work in those who need it most.

Most of the cases of COVID-19 in the study were presumably mild to moderate since no hospitalizations or deaths were reported, so we don’t know how protective the vaccine will be for those who are susceptible to severe cases.

There is no data regarding immunological memory, which is the entire point of a vaccine. If the memory response is weak or wanes too quickly, people will not be protected over the long term. This would be a fatal flaw because the global roll-out of a vaccine will take a very long time.

Pfizer hasn’t stated what the qualitative nature of the vaccine-induced immune response is. Sub-unit vaccines like theirs have been known to be misinterpreted by the immune system as being an extracellular pathogen. If that is the case, people who receive this vaccine might have a bias imprinted on their immune system that could cause them to respond to natural infections with future coronaviruses in a sub-par fashion.”

Two dose vaccine.

  • “It can be hard to get people back for a second dose. It is probably achievable in urban centres but could be hard to get the same people back 21 days later in remote and/or difficult-to-access places, especially in developing countries.
  • A vaccine that needs two doses is arguably a ‘weak’ vaccine. For this vaccine, it will take 28 days to build up sufficient protection. So there will be a one-month window during which people will remain susceptible. A better quality, single-dose vaccine could probably reduce this to 10-14 days.
  • Fewer than 500 million people could be vaccinated within a year of the vaccine being approved. The company is going to try to stockpile 50 million vaccines this year in anticipation of the vaccine being approved, and they optimistically predict that they can make 1.3 billion doses by the end of 2021. This sounds like a lot, but a two-dose regimen cuts the number of people that can be immunized in half. The person to get the 500 millionth dose will have to wait a year compared to the person who gets the first one. Some will wonder why some people get two doses while they get none. The vaccine won’t be protective unless two doses are given.”

Roll out internationally

“What about the rest of the population? As many of us have been predicting, it could take years to roll out these vaccines. Approval of a vaccine doesn’t help anyone; what matters is when it has been administered and sufficient time has passed for the immune system to respond. Of course, where in this very long timeline for the roll-out will countries that have used strict isolation to control their cases be (arguably, low on the priority list). Pfizer’s press release is essentially saying that everyone beyond the first half-million people will have to wait over 1 year. Presumably, it also means that people beyond the first billion or so may have to wait over 2 years.”

Long term safety

“Long-term safety in people is inferred based on animal models (such as rodents) that have shorter lifespans. Usually, clinical trials are done sequentially and span quite a few years. So acute and some long-term (i.e. 4 or more years) safety data would be in-hand. With the different trial stages overlapping and being run faster than normal, we will likely have less than a year’s-worth of safety data. Ultimately, the only way to be completely sure about long-term (i.e. beyond the duration of the clinical trial phase) safety in people is to monitor vaccinated people for a long period of time after the roll-out. Things like long-term kidney damage, etc. can often (but not always) be predicted/ruled out by things like blood chemistry within the acute stages.”

/ends

Covid19 elimination strategy almost abandoned

13 November 2020

Media Release

Covid Plan B has welcomed the Government’s decision not to over-react to cases of people testing positive to Covid-19 by starting another lockdown.

Simon Thornley, spokesperson for the group, says the Government appears to finally be adapting its strategy to new information about ineffectiveness of lockdowns and the low death and ill health effects of the virus.

“We support the Government’s inclination not to go back to lockdowns. Positive tests in Auckland, Christchurch and Wellington show the elimination strategy is fragile, futile and unnecessary.

“We urge the Government to be clear about why it is less fearful of Covid and more concerned by lockdowns. The public will understand and accept an admission that elimination attempts are over,” Thornley says.

Covid Plan B experts were this week published in the British Medical Journal showing the threat of Covid-19 is not what it was initially thought to be, in large part because of inaccurate recording of deaths.

Countries such as Singapore that use a strict definition of covid-19 death have very low fatality rates from the virus. Studies show that in past pandemics, coding of death certificates exaggerate fatality rates.

Estimates of covid-19 fatality are now extremely low; at 0.05% for people under seventy years old.

Statistical evidence now shows lockdowns do not reduce mortality from the virus, while causing much health and economic harm.

“Envoys from the World Health Organisation caution against the use of lockdowns since they “… have one consequence that you must never belittle and that is making poor people an awful lot poorer.

“This has happened in Auckland, where thousands turned to food banks to make ends meet. Over 50,000 people have started on the jobseeker benefit since March this year. The disproportionate economic costs of lockdown, relative to any benefits are also now apparent.

Heavily restricted borders will continue to devastate New Zealand’s tourist economy, and are leading to labour shortages, further reducing productivity. In contrast, many academics, doctors and the public are now urging their governments to focus on protection of the vulnerable, while allowing those at low risk from the virus to return to normal life.

/ends

Contact: Simon Thornley, 021 299 1752