Covid-19 statistics are routinely exaggerated, and too few people care

A feature of the covid-19 pandemic has been the relentless highlighting of cases, hospitalisations and deaths of covid-19 with very little context to help interpret the statistics. No matter what the mitigating factors, the story of a deathly and fearful virus is maintained by authorities, media and others protecting  the concept of a Covid-catastrophe. This, to our knowledge, has never occurred with any other disease in living memory.

The phenomena has even exaggerated the threat of the virus in the minds of academics and health specialists, who you would expect to remain sober. As an example, Professor Rod Jackson, a professor of epidemiology, in a NZ Herald article published August 18 2020. In the article, he claimed “Learning to live with Covid-19 is not a viable option.

Jackson made several exaggerated claims of the severity of covid-19 that have gone unchallenged for 17 months. He stated that the infection fatality rate of the virus was between 0.5% and 1.5%, or about 1%. He stated that covid-19 is 20 to 40 times worse than the seasonal flu and that one in five infections (20%) would be hospitalised, and that one in five who were hospitalised would require intensive care. That means 4% of hospitalised cases will require intensive care (1/5 * 1/5 = 1/25 = 4%).

In reality, the proportion of cases requiring hospitalisation in New Zealand, at the time of writing (25/11/2021) is ~57/5213 cases = 1%. This is a 20-fold difference in risk of hospitalisation after testing positive for covid-19, comparing Jackson’s estimate to Ministry of Health reports. Rather than a 4% risk of need for intensive care, the risk is now 7 in intensive care/5,213 current cases = 1.3/1,000 or 0.13%.

The difference in severity of covid-19 conveyed by Professor Jackson compared to observed data may be displayed in Euler diagrams consisting of concentric circles whose areas represent numbers in each category of severity below (figure 1 for Jackson’s estimates, figure 2 for current government figures and figure 3 for pre-vaccine era figures). In each figure, the area of the outer circle is proportional to the total count of covid cases, the grey indicate those who needed hospital treatment, the light blue intensive care and the red deaths (taken as 1% case-fatality for Professor Jackson, and estimated by using 5,213 current cases * 41 deaths/10,789 cumulative cases in New Zealand (11/November/2021)).

These diagrams demonstrate the distorted perspective portrayed by experts and health authorities, compared to the official reported reality. The difference is stark.

Figure 1. Professor Jackson’s estimated proportions of cases needing hospitalisation, intensive care and who would ultimately die with covid-19 in the New Zealand media, August 2020.

Notional 10,000 cases used for illustration.

Figure 2. Actual severity of covid-19 cases in New Zealand, 25/Nov/2021.

One possible explanation for this discrepancy is that covid-19 cases in New Zealand now are mitigated by the widespread use of the vaccine. However, figure 3 below is based on an earlier description of the epidemiology of New Zealand covid cases from February to May 2020, before the vaccine era. This indicates only 4%, rather than Jackson’s 20% of cases needed treatment in hospital. Reality was already five times lower than Jackson’s figure. The admissions to intensive care were 0.67% of all cases, six times lower than Jackson’s estimate. Also, one can see (figure 2) that the many of the apparent deaths with covid-19 did not qualify for intensive care treatment, due to age and comorbidity. The figures given by Jackson have never been questioned for accuracy or corrected. Jackson also talked of infections rather than ‘cases’, on which the Lancet paper he drew from was based. This means the reality departs even further than Jackson’s depiction indicates.

Figure 3. Severity of covid-19 cases in New Zealand, February to May 2020.

To make sound policy, supported by a well-informed public, health authorities, and the media must convey an accurate sense of the severity of covid-19.

The threat needs to be estimated from true counts, rather than conjured-up figures. The diagrams convey how far reality has been warped.

It is clear now that many predictions, models, estimates and beliefs did not come to pass. The investment in the famed ‘elimination strategy’ is now not worth the paper it was written on. The lack of scrutiny on doomsday predictions has adversely affected our perception of the reality of covid-19 and our collective ability to respond to it appropriately.

We’ve been wondering why this distortion is occurring, and why so few people seem to care. The factor that stands out to us, and that the case of Professor Jackson illustrates, is that no one loses by highlighting the worst and downplaying the best. There are no questions, no re-assessments, and no penalties for being wrong, if you follow and contribute to the story of a deadly virus.

Fact checking the RNZ fact check

17/11/2021

Radio New Zealand has recently criticized a Facebook live conversation between former National MP Matt King and epidemiologist Dr Simon Thornley. While people should undertake their own research, we provide some comments related to the media’s critique. The evidence related to covid-19 policy continues to change and be updated.

In the interview, Professor Rod Jackson made several claims, decrying Thornley personally during the interview. Let’s examine them in turn.

  1. There is no trial evidence that ivermectin [an anti-parasitic drug used as early treatment for covid-19 in some parts of the world] works in people with Covid – it doesn’t exist.

Trials do exist. In fact a meta-analysis or summary study of six such trials exist. The pooled effect of these trials is a 79% decline in all-cause mortality (95% confidence interval: 89% to 58%). These trials are from Iraq, Iran, Bangladesh, Egypt, Turkey and India, places less reticent about its use. But they are trials, and the reduction in all-cause mortality is stark, an endpoint which is generally considered clinically important and free of error and bias. Another trial points to effective treatment, such as from vitamin D supplementation, which reduced intensive care admissions to 1/50 (2%) in the treated from 13/26 (50%) in the untreated in Spanish covid-19 patients.

We’re not advocating ivermectin at all. But we are prepared to look at the evidence. The fact that Jackson didn’t know there were trials invalidates his point.

  1. Professor Jackson also said claiming Covid-19 was no worse than the flu was nonsense”.

In the interview, Thornley claimed the infection fatality rate of covid-19 was as bad as a ‘severe flu’. A summary study of many countries indicates that the average global infection fatality rate of covid-19 is 0.15% or 1/667 people.

The fatality rate for H1N1 influenza is variable, but this figure from covid-19 is well within the range of estimates presented from a similar summary study.

The comparison between covid-19 and flu is therefore fair and accurate. Jackson’s claim is misinformation.

We should note that many fatality studies take the definition of a covid-19 death at face value but it does not mean the individual died exclusively from the virus. This was exemplified by the counting a recent covid-19 death in a man who was actually shot and killed, yet tested positive for SARS-CoV-2 during the autopsy. This was defended by the Ministry of Health, as it conformed with World Health Organization policy.

We are able to test the accuracy of Jackson’s claimed fatality risk. In May 2020, Jackson admonished Sweden for its lax approach. He said the fatality rate of covid-19 was 1/100 people infected, so predicted 56,000 deaths from covid-19 in the country, assuming 60% of the population would be infected. To date, there have been about 15,000 covid-19 deaths, with an age distribution similar to that of background deaths (figure). In fact, by all accounts, Sweden has fared through the epidemic particularly well compared to other European countries.

Figure. Deaths with covid-19 in Sweden, by age at November 3, 2021.

Source: statistica.com

  1. This is a severe disease and we have a evidence-based treatment [the vaccine] where there is definitive evidence that it reduces the risk of severe disease and death by 95 percent, in that order.

This is an extraordinary claim for several reasons. First, the original Pfizer trial reported about the same number of overall deaths in the treated and the untreated groups (14 in the treated and 13 in the untreated). In the six-month trial results, only three covid-19 deaths occurred, one in the treated and two in the untreated group. This is not consistent with Jackson’s assertion of a 95% reduction in risk of severe disease and death.

Given the numbers of deaths in the original trial, it is possible to work out whether the trial would have picked up a 95% reduction as Jackson claims. The trial would have been expected to have only one death in the treated group, and would have detected a difference more than expected by chance with 96% certainty.

There is observational evidence from Sweden of reduced covid-19 hospitalisations and deaths (not from all-causes), however, the vaccine effect diminished to zero for all three outcomes eight months after the date that the vaccine was administered.

To compound the confusion about the effect of the vaccine, the original Pfizer trial now is marred by whistle-blowers who have given the British Medical Journal evidence of fraud occurring during its conduct. Sixteen Swedish doctors have now called for the injection to be suspended as a result of these revelations.

Both Jackson and RNZ use extensive use of ad hominem attacks, which are considered an invalid, and lowest, form of argument.

Examples include:

  • “anti-vax”
  • “discredited academic”
  • “And we have someone who is questioning that evidence, who doesn’t know what they’re talking about, talking to an epidemiologist who doesn’t know what he’s talking about.”
  • “outlier in his field”.

The purveyors and writers of such ‘argument’ appear to have no embarrassment at the anti-intellectualism and inhumanity of their conduct.

We’ll stick to the contest of ideas by again considering Jackson’s accuracy. Back in August 2020, Jackson and his colleagues claimed that elimination was still the best strategy for New Zealand to tackle covid-19. That article has not dated well, yet the personalised tirade and arguments are familiar.

“He [Thornley] is the only dissenter in the epidemiological community,”

“It’s not like this is a discussion like a boxing match with two equal partners. What you’ve got is every experienced epidemiologist in the country supporting the Government’s elimination approach.”

“We are all advising the Government, and we speak with one voice. And you have got a junior epidemiologist who is presenting a different case.”

Jackson has made increasingly inaccurate claims during the pandemic, claiming, unchallenged that one in five infected people will be hospitalised after infection with covid-19. No media have ever fact checked this.

New Zealand’s own government data shows Jackson  overestimated by at least a factor of ten, since the proportion of cases (rather than infections) hospitalised is 2% (table).

Table. Counts of cases of covid-19 in New Zealand (16 November 2021).

Count %
Self-isolation 2058 56%
Isolation Complete 969 26%
Managed Isolation 396 11%
Hospital 73 2%
Other 198 5%

 

As sailing great Russell Coutts has recently pointed out, it is questionable how “media entities can maintain objectivity when they have accepted a government grant that is conditional on them promoting certain government policies”.

It is prudent to check all sources of information, not only those who dare to question the what is coming from the Beehive.

Should caution be exercised in the rollout of covid-19 vaccines to NZ children from 5 years old? History indicates rushed decisions lead to regret.

Should caution be exercised in the rollout of covid-19 vaccines to NZ children from 5 years old? History indicates rushed decisions lead to regret.

Gerhard Sundborn,1* Simon Thornley,2 Rupert Scott,3 René de Monchy,4 Matt Shelton,5 Byram Bridle6 

 

Epidemiologist, University of Auckland, Department of Pacific Health, New Zealand 1

Epidemiologist/Public Health Physician, University of Auckland, Section of Epidemiology and Biostatistics, New Zealand 2

General Practitioner, Whangarei, New Zealand 3

General Practitioner and Psychiatrist, Tauranga, New Zealand 4

General Practitioner, Wellington, New Zealand 5

Professor of Viral Immunology, University of Guelph, Canada6

Corresponding author * email: g.sundborn@auckland.ac.nz

 

The New Zealand Ministry of Health have indicated that they are now actively considering the Pfizer covid-19 vaccine for New Zealand Children age from 5 to 11 years old.1 This follows its approval for use in New Zealand children aged 12 to 15 years on Monday 21st June, by ‘Medsafe’, New Zealand’s drug regulator.2 Other countries including USA, Canada, China and the European Commission who have also approved the vaccine for children aged 12 to 15 years old. China has authorised vaccination for children from three years of age. However, the World Health Organization (WHO) advise that children and adolescents have milder disease than adults and therefore more evidence is needed on different covid-19 vaccines for this age group, which has prevented them from making general recommendations for their use.3 In the UK  the Joint Committee on Vaccination and Immunisation (JVCI) concluded that the health benefits gained by vaccination of 12 – 15 year old children are only marginally greater than the potential and known harms. And that this margin of benefit was too small to support universal vaccination of healthy 12 to 15 year old children.4 Since covid-19 itself poses little risk of fatality to children, and the exposure to a vaccine entails risks which are now poorly understood, we examine them in more detail here. Recently, an Auckland Professor of Epidemiology, regarding covid-19 vaccination stated:

The Government has introduced (vaccine) mandates in health – total no-brainer. They’ve also introduced one in education for all the staff – total no-brainer. They need to introduce the same mandate for 12-and-over children”.5

To date, a decision to rollout the vaccine to children aged 5 – 11 years has not been made. We question the idea that vaccine mandates are a “no-brainer” particularly for children. Specifically, we believe that for children, emerging data indicates that such a policy will lead to more harm than good. We urge a precautionary approach be taken and that any plans for the vaccination of children be delayed for three important reasons.

Long-term safety and efficacy of the covid-19 vaccine is unknown: The first and most crucial point is that the long-term safety and efficacy data from the trial will not be available until 2023. Although short-term safety and efficacy data looks promising, this has only been tested in a small cohort of children, with 1,131 children receiving the vaccine at the time of writing.6 This means that detected adverse effects would only be those which are relatively common, and side effects, such as excess clotting that have led to the withdrawal of the AstraZeneca vaccine, for example, from many countries would not have been detected.7 This vaccine is one of the fastest to ever be developed and rolled out, taking less than one calendar year. Before this, the fastest approval was four years. Most take an average of ten to fifteen years from development to approval for clinical use.8

When we reflect on the 2009 swine flu pandemic a similar scenario occurred where the hastened development and approval of a vaccine took an astonishing 5-6 months once the new virus was identified.9 The vaccine was then administered widely, until 2011-12 when long term safety and efficacy data were available – from which studies indicated that the vaccine caused unacceptable rates of narcolepsy.10 This resulted in over a billion-dollars’ worth of these vaccines being destroyed.11-13

Another more distressing example occurred in the 1976 swine flu outbreak at the US Fort Dix military base. The infection caused one death and 230 soldiers to become ill. This led to a hastily developed vaccine that was rolled out to approximately 22% of the US population. The resulting vaccine caused over 500 cases of paralysis and 25 deaths. The vaccine was far worse than the virus itself and observers thought that the government response was too fast, with important safety considerations overlooked.14

In the US there has been a dramatic increase observed in US government vaccine injury reports as evidence of vaccine harm. The 100-fold increase in post-vaccine deaths reported in temporal association to the rollout of the Covid-19 vaccines in late 2020 is perhaps best shown in the plot below.

Figure 1. Time series of monthly reports of post-vaccine deaths to the US VAERS monitoring system.

Such a rapid increase in reports should be cause for concern, particularly when the development and clinical testing of the vaccines has been so truncated, and adverse effects from wide scale vaccination are unknown.15  Conventional epidemiological knowledge confirms that medical adverse event databases generally under-report safety signals. In a United States study that compared augmented electronic monitoring of health records in the thirty days post-vaccination, with prompting of clinicians to report likely vaccine-related events to usual practice, the augmented system resulted in a 30-fold increase in vaccine-related incident reporting, compared to historical periods. 16 When considering whether the spike in adverse event reporting is related to increased rates of vaccination or harm due to the vaccine, statistical tests carried out by Rose et. al. indicate clearly that the deaths are clustered around the time immediately after the event, in a manner which is incompatible with what would be expected if such deaths were occurring due to background mortality risks (P < 0.001).17

Efficacy of the Pfizer covid-19 vaccine is reported to be 52% after the initial dose and 95% after the second dose which has been taken from interim data.18 However, these claims have been questioned by researchers in Israel who have seen a far lower than expected decline in cases following vaccination of over 75% of their elderly population. Rather than a 52% decline in cases they have seen a significantly lower reduction in cases by 33%.19 Further, the protection against new variants of the virus remains unknown. A study recently published in the Lancet has found being fully vaccinated does not reduce any transmissibility once infected with the virus, compared to unvaccinated infected people.20

 

Very recently published evidence from overseas, where the vaccine rollout has occurred earlier than in New Zealand shows that vaccines are not resulting in enduring and lasting protection from the virus. A preprint Swedish cohort study (1.6 million people) which compares the risk of Covid-19 infection in vaccinated and unvaccinated people throughout the Covid-19 vaccination roll-out in the country from the 4th of January to the 4th of October 2021.21  Analysis of those who had taken the Pfizer vaccine showed that the effectiveness at preventing symptomatic infection waned from initial high levels to 47% in the period 121-180 days after the vaccine to no convincing effect beyond day 211 post-vaccination (23% reduction; 95% confidence interval, -2 to 41, P = 0·07), compared to unvaccinated people. This modelled decline in vaccine effectiveness is illustrated in the figure below. Such an effect was observed for all Covid-19 vaccinations used in the country, and observed for more severe health outcomes such as prevention of Covid-19 hospitalisation and death.

Figure 2. Estimated adjusted effect of vaccine to prevent Covid-19 infection after vaccination in Sweden.21 Solid line represents point estimate and shading represents 95% confidence interval. Overall, no beneficial effect is observed after 240 days (8 months) since vaccination.

The risk covid presents to children is negligible: The second reason against vaccinating children is the very small risk that the virus poses to this group.22 There is a 1,000-fold difference in mortality risk between comparing children with frail elderly people after testing positive for covid-19. It is extraordinarily rare for a child to suffer any significant illness from covid-19 and orders of magnitude more rare for them to die from this virus.23 A prominent US epidemiologist likened the risk of a person less than 65 years old dying from covid-19 as remarkably uncommon and about the same as dying during a car journey from between 21 – 162 km each day.24 This comparison shows that there is little personal risk posed by covid-19 to children and thus no reason to expose them to an experimental vaccine. Other arguments for vaccinating children are related to the threat of ‘asymptomatic transmission’. Up-to-date evidence, however, shows little evidence of this phenomenon in Wuhan, after 10 million people were screened by PCR for infection, whether or not they had symptoms.25

Vaccine-associated risks that need further investigation: To date 18 countries including Canada, Sweden, Latvia, Germany, Italy, France, Spain, Denmark, Norway, and The Netherlands, have halted the roll-out of the AstraZeneca covid-19 vaccine due to concerns that it has caused blood clots in some recipients.6 There are similar concerns that the Pfizer vaccine may also cause clots. In Norway, 23 deaths of frail elderly people occurred shortly after receiving the Pfizer vaccine – with an investigation concluding that the vaccine was responsible for at least 10 of these deaths.26 In Australia two middle-aged women also died after receiving the AstraZeneca vaccine, caused by rare blood clots in the brain.27

Another risk from the vaccine for young people that have received the Pfizer or Moderna vaccine is myocarditis or pericarditis. In the US, more than 1,200 such cases have been identified in people younger than thirty years according to the Centres for Disease Control. A study in the United States showed that the risk of myocarditis after vaccination was 3.7 to 6.1 times higher than the risk of hospitalisation due to covid-19, even under conditions of moderate and high covid-19 incidence.28     A more recent study shows a 13.6-fold (1,260%) increase in new cases of myocarditis after the second vaccine in 16 to 19 year old males, compared to background rates of the disease in the same demographic group between 2017 and 2019.29 Other authors have questioned the use of vaccines in anyone less than the age of 65 years, since deaths attributable to the vaccine are likely to outnumber those saved by a factor of five.30 For younger children, this calculation is even less favourable. These events have generally occurred within a week following receiving the second dose of the vaccine.31

Under-reporting into vaccine safety databases is common. In a United States study that compared augmented electronic monitoring of health records in the thirty days post-vaccination, with prompting of clinicians to report likely vaccine-related events to usual practice, the augmented system resulted in a 30-fold increase in vaccine-related incident reporting,32 compared to historical periods. This means that analyses based on such reporting systems are likely to be gross underestimates of the true burden of adverse events.

Other academics overseas have expressed concerns at the high rate of post-vaccine adverse effects reported in vaccine safety databases. In the UK ‘Yellow card’ system, for example, between 4 Jan and 26 May 2021, a total of 1,253 deaths and 888,196 adverse reactions post covid-19 vaccine were recorded, with 63 million people receiving at least one dose, and 24 million having had two doses.  This is roughly a 1/50,000 risk of death and 1/70 risk of adverse reaction after vaccination, assuming these reports are all caused by the vaccine. The author of the document, Dr Tess Lawrie, stated that based on these figures there was: “more than enough evidence … to declare the COVID-19 vaccines unsafe for use in humans”.33

Table 1. Adverse Events for Covid-19 Pfizer vaccine verses influenza vaccine in NZ

  Covid-19

Vaccine

2021

Influenza Vaccine 2019
Adverse Events Following Vaccination

(AEFI)

27,651 229
AEFI Rate 477/100,000 15.2/100,000
Adverse Events of Special Interest 982
Death following vaccination 91
Doses administered 5,792,114 1,505,268

Reviewing the latest Covid-19 vaccine safety report from Medsafe (New Zealand Medicines and Medical Devices Safety Authority) published on 9 October 202134 – a total of 27,651 Adverse Events following Vaccination (AEFI) have occurred. With 982 of these being Adverse Events of Special Interest (AESI) which are paid greater attention due to their seriousness. Most concerning is the number of deaths that have occurred following vaccination which now totals 91. When comparing the number of adverse events from the covid-19 vaccine to those reported to Medsafe for the influenza vaccine in 2019, 35 we calculate that the Covid-19 vaccine adverse events rate is more than 31-fold greater. Further the influenza vaccine has no reports of Adverse Events of Special Interest, nor death following vaccination. From these data the covid-19 vaccine exposes those who receive it to far higher rate of adverse health consequences than that for influenza.

Summary: The Pfizer covid-19 vaccine remains experimental and is only provisionally approved for use in New Zealand. Long-term safety and efficacy data will not be known until 2023, and children are largely unaffected by the virus. Like the swine flu vaccine, a true understanding of the long-term side-effects of the vaccine remain unknown until these trials are complete. There are several serious side effects caused by current covid-19 vaccines whose risks are not fully understood. Basic safety biodistribution studies are missing,36 with data from rodent models showing high uptake of nanoparticle delivery substrate in the ovaries of these animals.37 Basic safety studies, that are a routine part of vaccine development were not carried out for this vaccine.

When considering whether to vaccinate children against covid-19, one must weigh the therapeutic benefits against the risks. With such little to gain, all children can possibly experience are the risks of the product, such as myocarditis. True estimates of risks from the vaccine are now not fully understood, although there are already several identified now including blood clots, myocarditis, and death. 38, 39, 34

On balance, we believe that the known and unknown risks from the vaccine outweigh any benefits for children. Historical examples should lead us to pause and make a sober assessment of the risks, given the lack of benefit to children. We believe that it is best to wait at least two years for the long-term safety and efficacy results to enable a more informed decision to be made about whether to vaccinate children against SARS-CoV-2. Whatever else can be said about the decision to vaccinate children, it cannot and must not be considered a “no brainer”. No sober analysis would come to that conclusion.

 

This research did not receive any specific funding.

The authors declare no conflicts of interest.

  

References

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2. Neilson M and Cheng D. Covid 19 coronavirus: Medsafe approves Pfizer vaccine for New Zealand 12-15 year olds. [Internet] New Zealand Herald. 21 June 2021. [cited 9 July 2021] Available from: https://www.nzherald.co.nz/nz/covid-19-coronavirus-medsafe-approves-pfizer-vaccine-for-new-zealand-12-15-year-olds/3D2OPZZLOPOOMXY6LJT43Z4F2A/

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24. Ioannidis JPA, Axfors C, Contopoulos-Ioannidis DG. Population-level COVID-19 mortality risk for non-elderly individuals overall and for non-elderly individuals without underlying diseases in pandemic epicenters. Environ Res. 2020 Sep;188:109890. doi: 10.1016/j.envres.2020.109890. Epub 2020 Jul 1. PMID: 32846654; PMCID: PMC7327471.

25. Cao, S., Gan, Y., Wang, C. et al. Post-lockdown SARS-CoV-2 nucleic acid screening in nearly ten million residents of Wuhan, China. Nat Commun 11, 5917 (2020). https://doi.org/10.1038/s41467-020-19802-w

26. Torjesen I. Covid-19: Pfiver-BioNTech vaccine is “likely” responsible for deaths of some elderly patients, Norwegian review finds BMJ 2021; 373 :n1372 doi10.1136/bmj.n1372

27. Davey M. ‘Extremely rare’: Australia records second death ‘likely linked’ to AstraZeneca vaccine blood clots. [Internet] The Guardian. 10 June 2021. [cited 9 July 2021] Available from: https://www.theguardian.com/australia-news/2021/jun/10/extremely-rare-australia-records-second-death-likely-linked-to-astrazeneca-vaccine-blood-clots

28. Hoeg T, Krug A, Stevenson J, Mandrola J. SARS-CoV-2 mRNA Vaccination-Associated Myocarditis in Children Ages 12-17: A Stratified National Database Analysis. medRxiv preprint posted 8 September 2021. https://www.medrxiv.org/content/10.1101/2021.08.30.21262866v1.full.pdf

29. Mevorach D, Anis E, Cedar N, Bromberg M, Haas EJ, Nadir E, Olsha-Castell S, Arad D, Hasin T, Levi N, Asleh R, Amir O, Meir K, Cohen D, Dichtiar R, Novick D, Hershkovitz Y, Dagan R, Leitersdorf I, Ben-Ami R, Miskin I, Saliba W, Muhsen K, Levi Y, Green MS, Keinan-Boker L, Alroy-Preis S. Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. N Engl J Med. 2021 Oct 6:NEJMoa2109730. doi: 10.1056/NEJMoa2109730. Epub ahead of print. PMID: 34614328; PMCID: PMC8531987.

30. Kostoff RN, Calina D, Kanduc D, Briggs MB, Vlachoyiannopoulos P, Svistunov AA, Tsatsakis A. Why are we vaccinating children against COVID-19? Toxicol Rep. 2021;8:1665-1684. doi: 10.1016/j.toxrep.2021.08.010. Epub 2021 Sep 14. Erratum in: Toxicol Rep. 2021 Oct 7;: PMID: 34540594; PMCID: PMC8437699. https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8437699/pdf/main.pdf

31. Lovelace B. CDC safety group says there’s a likely link between rare heart inflammation in young people after Covid shot. [Internet] CNBC. 23 June 2021. [cited 9 July 2021] Available from: https://www.cnbc.com/2021/06/23/cdc-reports-more-than-1200-cases-of-rare-heart-inflammation-after-covid-vaccine-shots.html

32. Meghan A. Baker, David C. Kaelber, David S. Bar-Shain, Pedro L. Moro, Bob Zambarano, Megan Mazza, Crystal Garcia, Adam Henry, Richard Platt, Michael Klompas, Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting, Clinical Infectious Diseases, Volume 61, Issue 6, 15 September 2015, Pages 864–870, https://doi.org/10.1093/cid/civ430

33. Trialsite staff. Look into UK Yellow Card System Reveals Large Numbers of Adverse Events and Deaths Associated with COVID-19 Vaccine. [Internet] Trial Site News. 10 June 2021. [cited 9 July 2021] Available from:

34. https://trialsitenews.com/wp-content/uploads/2021/06/Yellow-Card-Letter.pdf

35. Medsafe. Adverse events following immunization with COVID-19 vaccines: Safety Report #32 – 9 October 2021. Published  9 October 2021. Accessed 31 October, 2020.  https://www.medsafe.govt.nz/COVID-19/safety-report-32.asp

36. Medsafe. Spontaneous reports: Seasonal influenza vaccination 2020. Revised1 April 2021. Accessed 4 October, 2020. https://www.medsafe.govt.nz/safety/reports-and-promotion/Spontaneous-Reports-Influenza-Vaccination-2020.asp#More

37. Doshi P. Covid-19 vaccines: In the rush for regulatory approval, do we need more data? BMJ 2021; 373 :n1244 doi: 10. 1136/bmj.n1244 Available from: https://www.bmj.com/content/373/bmj.n1244

38. Joan-Ramon Laporte, Ermengol Coma, Francesc Fina, Luís García-Eroles, Xavier Vidal, Manuel Medina.  Vaccines against Covid-19, venous thromboembolism, and thrombocytopenia. A population-based retrospective cohort study. MedRxiv preprint; this version posted September 5, 2021. Date accessed: 4 October 2021. doi: https://doi.org/10.1101/2021.07.23.21261036

39. Marshall M, Ferguson ID, Lewis P, et al. Symptomatic acute myocarditis in seven adolescents following Pfizer-BioNTech COVID- 19 vaccination. Pediatrics. 2021; doi: 10.1542/peds.2021-052478

Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November 2021) Cite this as: BMJ 2021;375:n2635
  1. Paul D Thacker, investigative journalist

Author affiliations

Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Poor laboratory management

On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”

Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”

Worries over FDA inspection

Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.

At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated.

Box 1

A history of lax oversight

When it comes to the FDA and clinical trials, Elizabeth Woeckner, president of Citizens for Responsible Care and Research Incorporated (CIRCARE),3 says the agency’s oversight capacity is severely under-resourced. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. And sometimes oversight occurs too late.

In one example CIRCARE and the US consumer advocacy organisation Public Citizen, along with dozens of public health experts, filed a detailed complaint in July 2018 with the FDA about a clinical trial that failed to comply with regulations for the protection of human participants.4 Nine months later, in April 2019, an FDA investigator inspected the clinical site. In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. It said, “[I]t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.”5

“There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials.

Ventavia and the FDA

A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial.

“People working in clinical research are terrified of FDA audits,” Jill Fisher told The BMJ, but added that the agency rarely does anything other than inspect paperwork, usually months after a trial has ended. “I don’t know why they’re so afraid of them,” she said. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. “You would think if there’s a specific and credible complaint that they would have to investigate that,” Fisher said.

In 2007 the Department of Health and Human Services’ Office of the Inspector General released a report on FDA’s oversight of clinical trials conducted between 2000 and 2005. The report found that the FDA inspected only 1% of clinical trial sites.6 Inspections carried out by the FDA’s vaccines and biologics branch have been decreasing in recent years, with just 50 conducted in the 2020 fiscal year.7

RETURN TO TEXT

The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizer’s clinical trial at Ventavia. She then reported her concerns in an email to the agency. In the afternoon Ventavia fired Jackson—deemed “not a good fit,” according to her separation letter.

Jackson told The BMJ it was the first time she had been fired in her 20 year career in research.

Concerns raised

In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. She then listed a dozen concerns she had witnessed, including:

  • Participants placed in a hallway after injection and not being monitored by clinical staff

  • Lack of timely follow-up of patients who experienced adverse events

  • Protocol deviations not being reported

  • Vaccines not being stored at proper temperatures

  • Mislabelled laboratory specimens, and

  • Targeting of Ventavia staff for reporting these types of problems.

Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. She heard nothing further in relation to her report.

In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8

In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”

Other employees’ accounts

In recent months Jackson has reconnected with several former Ventavia employees who all left or were fired from the company. One of them was one of the officials who had taken part in the late September meeting. In a text message sent in June the former official apologised, saying that “everything that you complained about was spot on.”

Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. Both confirmed broad aspects of Jackson’s complaint. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a “helter skelter” work environment as with Ventavia on Pfizer’s trial.

“I’ve never had to do what they were asking me to do, ever,” she told The BMJ. “It just seemed like something a little different from normal—the things that were allowed and expected.”

She added that during her time at Ventavia the company expected a federal audit but that this never came.

After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)

“I don’t think it was good clean data,” the employee said of the data Ventavia generated for the Pfizer trial. “It’s a crazy mess.”

A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place.

Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.

Footnotes

  • Provenance and peer review: commissioned; externally peer reviewed.

  • Competing interests: PDT has been doubly vaccinated with Pfizer’s vaccine.

This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

References

 

View Abstract

What about Novavax in NZ?

We are very supportive of vaccines in general and principle. Covid19 vaccines do not have the efficacy experienced in  previous vaccines, and have far more adverse reactions.
New Zealand has taken an unusual step (October 2021) of trying to achieve 90% uptake of the Pfizer vaccine alone. To achieve that aim it is making it mandatory to have the Pfizer vaccination if you work in some fields (health, teaching and hospitality) and after 90% is achieved, to participate in civil life (events, hospitality).
Many public and private institutions and businesses are enthusiastically complying with this project, championed by media (NZ Herald), requesting their staff are vaccinated.
Those in NZ hesitant about Pfizer have looked at other vaccine options, such as Novavax. The Government has previously said it bought enough doses for over 5 million people, and was considering using it as the ‘booster’ vaccine.
Despite that, the Government health helpline won’t talk to callers about the option of using Novavax (first hand experience, 28 Oct 2021).
Novavax, from a biological perspective, seems safer and seems to have milder adverse events than the Pfizer Covid19 vaccine, although we’d like to see some independent data on this.
It is still the spike protein, but in recombinant form (rather than mRNA), which the body then makes.

Waning of Covid19 vaccine effectiveness

A preprint Swedish cohort study (1.6 million people)[1] compares the risk of Covid-19 infection in vaccinated and unvaccinated people throughout the Covid-19 vaccination roll-out in the country from the 4th of January to the 4th of October 2021.

The study is based on government vaccination and health record linkage, which are generally considered reliable, due to high levels of health data capture by the government in Nordic countries.

Analysis of those who had taken the Pfizer vaccine showed that the effectiveness at preventing symptomatic infection waned from initial high levels to 47% in the period 121-180 days after the vaccine to no convincing effect beyond day 211 post-vaccination (23% reduction; 95% confidence interval, -2 to 41, P = 0·07).

This modeled decline in vaccine effectiveness is illustrated in the figure below. Such an effect was observed for all Covid-19 vaccinations used in the country, and observed for more severe health outcomes such as prevention of Covid-19 hospitalisation and death.

[1] Nordström, Peter and Ballin, Marcel and Nordström, Anna, Effectiveness of Covid-19 Vaccination Against Risk of Symptomatic Infection, Hospitalization, and Death Up to 9 Months: A Swedish Total-Population Cohort Study. Available at SSRN: https://ssrn.com/abstract=3949410  or http://dx.doi.org/10.2139/ssrn.3949410

 

Select Committee presentation Sept 2021

Evidence of Simon Thornley, to New Zealand Parliamentary Select Committee, on the Public Health Amendment Bill. September 2021.

The covid-19 response as exaggerated and profoundly harmful. Instead of mandating experimental vaccines and ongoing lockdowns, our group advocates for returning to protection of the elderly, increased capacity in hospitals and early treatment of covid-19.

There will be legal experts who will address the mechanics of the bill, however,  our focus will be on the scientific evidence that relates to the need for extended far reaching powers entailed in the proposed amendments to the Act.

I wish to draw your attention to epidemiological evidence that the threat of covid-19 is exaggerated in the minds of the government and media. This is relevant to the nature of the proposed far reaching powers. One such example is that the distribution of age at death with covid-19 is almost identical to the distribution of age at death in earlier years when the virus was absent.

Professor John Ioannidis, one of the world’s most eminent epidemiologists wrote:

“Median age of death with COVID-19 typically tracks average life expectancy in high-income countries.”

Many people are not aware that the average age of death with covid is about the same as our life expectancy – about 82 years. This information contradicts  that which  is often portrayed in the media, and by other academics that the average number of years of life lost from Covid-19 is 16. It is simply implausible that this is true, since Covid-19 would then be causing the demise of patients who would have otherwise lived to the age of 98.

One of the reasons that covid-19 has become exaggerated in the minds of the public, politicians and scientists is that the definition of a covid-19 death is loose. Yet such deaths are paraded in the media as tragedies due to the virus. From an OIA request in June, it was found that even a positive PCR test was not required to count as a death from covid. The definition in New Zealand or overseas do not indicate that the person would have otherwise survived were they not infected with the virus.

Other reasons to suppose the pandemic is severe is that there is excess mortality in some countries. However, closer inspection of this data shows that this excess death occurs in close proximity to restrictions in mobility of citizens in that country. This indicates that it is the response to covid, rather than the virus itself that is the primary problem. Other evidence points to the excessive use of invasive ventilation and restriction in access to usual healthcare that were the primary drivers of this excess death.

The PCR test itself has faced intensive scrutiny and has been not recommended for widespread use in the community. The diagnostic accuracy, which has been tested in a large German study indicates that the assay does not reliably even distinguish between people with or without symptoms of a chest infection.

What is more, evidence indicates that the restrictive actions of the government so far have already caused substantial harm. This includes at least a 50% increase in children attempting suicide and presenting to hospital. Unemployment has increased since March 2020 in New Zealand with a 30% increase in eligible adults requiring the jobseeker benefit over the period inwhich covid restrictions have been imposed. Special needs grants also spike over lockdown periods, indicating that these policies come down most severely on our poor communities. Severe lockdowns have cost the country at least $1B/week, a figure that is well outside the amount usually thought to be reasonable for such health spending.

In summary, our objection to the amendments in the act are related to the proposed legislation of disproportionate powers to contain a health threat that we believe has been grossly exaggerated. The powers contained within the act infringe many of our fundamental freedoms and rights and are now causing severe harm to the economy and health of our children. Our group wishes to advise the government that this act should be repealed rather than extended. Thank you to the committee again for the opportunity to present.

 

Vaccine mandates twist Covid-19 saga

12/10/2021

The most recent twist in the covid-19 saga is forcing hard-working New Zealanders to believe in the story of the ‘deadly virus’ and ‘saviour’ vaccine. This will inevitably mean many will now be forced to choose between their jobs and their sense of autonomy over their own body and health. The death of the elimination strategy has meant that the accelerator has been applied to the vaccine pedal. Hang on a minute, where is the evidence to back this up such a policy?

Most recently, leading scientists advising the government have put their irrationality on show. They argue that we simply cannot live with endemic covid-19 and that we will all get SARS-CoV-2 under the reign of delta. The march to stamp out the virus “must” continue as there is no other way. Professor Rod Jackson has stated “”I’m freaking out in a major way Auckland, we just have to suppress it until we all get vaccinatedI mean we need everyone vaccinated before December, and if we got 95 per cent of the population vaccinated by [then]… yeah, then you can have a holiday.

According to Professor Jackson, the virus is extremely deadly and the only way out is vaccination and mandates which are all logical responses to the threat. First teachers, then doctors, nurses, and everyone else with a chance of spreading the virus. Where will it end? One could be forgiven for advocating such a strategy if we hadn’t been able to observe what is happening in other countries. But we have:  the experience of Israel, Iceland and others show the virus will continue despite vaccination. Singapore is the most extreme example, now with 85% vaccination, yet their covid-19 cases are higher than ever. Vaccines are clearly not the end of covid-19 and mandates will not change this.

A recent between-country epidemiological study has confirmed this. The epidemiologists found no relationship between the percentage of population fully vaccinated and new COVID-19 cases in the last 7 days. Counter-intuitively, the trend suggests that countries with higher percentage of population fully vaccinated have higher COVID-19 cases per 1 million people.

Politicians and most of the public are clinging to the hope of vaccinations. I conclude it is based entirely on unsubstantiated fear. Despite all evidence to the contrary, the idea that Covid-19 is deadly has taken even stronger hold. No questioning of this is allowed. The protagonists argue that on average sixteen years of life are lost from the virus.

A couple of pieces of information sum up the lack of real threat from Covid.

  1. Covid-19 deaths in New Zealand occur at about the same age (red line) as background (black line: figure 1). In fact, the two age distributions are statistically indistinguishable (P = 0.998). This could be a freak of the low covid-19 numbers in New Zealand, except that it is found again in almost every other country you care to look, no matter how many cases they’ve had. A German researcher found a very similar pattern in a country with 4.3 million cases and 94,000 deaths. It is very difficult, even, impossible to reconcile the 16 years of life lost per covid-19 death with age-at-death comparison. Doing so would mean that covid-19 is selectively targeting people who would otherwise live to the age of 98 years. This is simply implausible. It is hard to see how scientists could be so pessimistic, when the data on covid-19 deaths are shouting for optimism.

Figure 1. Background death in New Zealand 2019 to September (black) and national covid-19 deaths March to September 2020.

  1. No one is discussing is the downsides of the vaccine. In the following figure (not made by an official source) we see a summary of the highest level of evidence known about the Pfizer vaccine which is currently on offer in New Zealand. It summarizes the participants, covid-19 cases and overall deaths. I didn’t make this diagram, but I wish I had. When reading the Pfizer 6-month update, we see that 21 people died in the group vaccinated or eventually vaccinated, compared to 15 in the placebo group. This result does not fill me with confidence, even though the reduction in covid-19 cases was so dramatic in the vaccinated group compared to placebo.

Why do the excess fatalities in the treated group sap my confidence in the vaccine? Well, most of us who are thinking clearly, want to live longer, not just avoid Covid-19. This trial clearly signals that you are better off with the placebo if your objective is long life. The end-point of overall death is an important outcome in epidemiology, since it is easy to measure, and weighs both benefits of the intervention along with risks. Another author has tallied serious medical events in all covid-19 vaccine trials used in the United States, and all such analyses question vaccine use.

Figure 2. Study flow for the 6 month Pfizer trial follow-up.

Another concern is not being addressed is the 100-fold increase in reported deaths after covid-19 vaccine in the United States, indicating poorer safety than initially indicated in the trial. To support this interpretation, case-series of myocarditis, unusual clotting and haematological abnormalities have been reported in close proximity to having received the vaccine.

Children are at almost zero risk of death from covid-19 and so the risk-benefit in this group is severely questionable.

To sum up, when assessing the point of a vaccine, especially mandated ones, it is vital to;

  • Realistically appraise the threat, and the threat of Covid-19 is negligible.
  • Consider the overall benefit and harm associated with the vaccine, and even on Pfizer’s own trial results, the harm is at least equal to the benefit (deaths vs much reduced illness).

There is a heavy price for mandating vaccines. We put lives directly at risk from the medical intervention. We embed a culture of fear and intense community discord. We give up hard-won human rights and autonomy.

The time for slogans, gut reactions and freaking out is over. We are traveling a dangerous and hysterical path.

A sober look at facts is our only hope for a return to reasoned assessment of the best path forward. The Nordic countries are leading the way and are now abandoning almost all covid-19 restrictions. It can be done; it hasn’t led to catastrophe. We can live with the virus. All it takes is a little courage and clarity of thought.

Dissection of Prof Hendy model presented at Ardern conference 23/9/21

We do not hold this type of modelling in high regard.

First of all, it is myopically focused on reducing harm from Covid-19. It is hard to understand the utility of presenting such results without context.

There is no mention that the average age of death of those predicted to die will be about the same as our life expectancy. To put it slightly differently, most of those forecast 7,000 deaths were on average likely to die that year with or without SARS-CoV2. About 35,000 people die each year in New Zealand and half of them are over 80 years old. https://figure.nz/chart/SOBvdb4q1OXAaoLM-H9S6kQLicMFxLijb

There is not a single mention in any of the Matatini documents of deaths among Covid-vaccinated people. Even Pfizer’s latest trial shows more deaths in the vaccinated group compared to the unvaccinated. https://www.nejm.org/doi/full/10.1056/NEJMoa2110345.

It is misinformation to build a model that generates a result used to promote vaccination without mentioning that up to half of the predicted deaths will be among vaccinated people.

A quote from the study:

During the blinded, placebo-controlled period, 15 participants in the BNT162b2 group and 14 in the placebo group died; during the open-label period, 3 participants in the BNT162b2 group and 2 in the original placebo group who received BNT162b2 after unblinding died.

There is a very concerning issue in this Pfizer trial – that the vaccine itself might be responsible for some of the deaths in the trial, not Covid.  It is not very convincing that there was a 40% (20/14) increased overall death rate in the vaccinated and eventually vaccinated group compared to controls.  While the Pfizer paper asserts that the deaths in vaccinated people had nothing to with the vaccine, it does not provide evidence.

This is a consistent trend across all covid-19 vaccine studies

https://newsrescue.com/wp-content/uploads/2021/08/us-covid19-vaccines-proven-to-cause-more-harm-than-good-based-on-pivotal-clinical-trial-data-analyzed-using-the-proper-scientific-1811.pdf

The predictions from the study that high vaccination uptake will result in reduced harm from covid-19 are not borne out by real world experience, such as from Israel: https://www.timesofisrael.com/health-ministry-chief-says-coronavirus-spread-reaching-record-heights/

It is clear that high levels of vaccination coverage have not lived up to the hope indicated from the results of the trials.

The Covid policy responses modeled in the work are conventional ones already proven ineffective over the past 18 months in other countries. The model does not attempt to work out results of using other strategies, some now being attempted in countries such as India. https://www.thegatewaypundit.com/2021/09/huge-uttar-pradesh-india-announces-state-covid-19-free-proving-effectiveness-deworming-drug-ivermectin/

For example, meta-analysis of trials (conventionally considered high level evidence) support the use of Ivermectin to reduce covid-19 mortality. https://lnkd.in/g3eMbaGU

The use of models without comparing or contrasting with actual trials, amounts to misinformation. Trials are conventionally considered stronger evidence than modelling studies.

It is deeply worrying that the government is using models to justify responses, when we have actual evidence and trials from the past 18 months of experience in other countries. It feels disturbingly reminiscent of the now widely discredited models used by other Western Governments very early in the pandemic.

What Prof Hendy gets wrong

COMMENTS ON THE VIEWS OF PROFESSOR HENDY

Dr Martin Lally

Director, Capital Financial Consultants Ltd

lallym@xtra.co.nz

Professor Shaun Hendy is another prominent adviser to the New Zealand government on covid-19 issues.  Like Professor Baker, he combines frequent commentary via popular media in support of lockdowns with papers written (with numerous co-authors) in the academic style.  However, unlike Professor Baker, he does not seem to have done any prior research in epidemiology (he is a Professor of Physics).  His epidemiological work starts with his first covid paper, which was posted to a website on 25 March 2020:

https://www.tepunahamatatini.ac.nz/2020/03/26/suppression-and-mitigation-strategies-for-control-of-covid-19-in-new-zealand/

Table 2 of the paper presents predictions of the death tolls in New Zealand from a range of possible control strategies.  No control yields predicted deaths of 83,000 (1.67% of the population).  Case isolation and quarantining of members of their households reduces this to 62,500 (1.25% of the population).  Adding population-wide social distancing reduces this to 3,000 (0.06% of the population), and adding school and university closures reduces it further to 20.  On page 7, they consider a strategy they describe as “mitigation”, with a predicted death toll of 25,000 (0.508% of the population), and involving a combination of periods of low control (case isolation plus household quarantining) with periods of high control (add population-wide social distancing and school and university closures) as required to keep the number of cases within the capacity of the hospital system.  None of these strategies correspond to mitigation as defined in the 23 March published paper by Professors Baker, Wilson and Blakely (isolation of the over 60s). The most interesting features of the Hendy paper are:

1. The worst case scenario (in which no control measures are instituted) was 83,000 dead (1.67% population mortality rate, as per their Table 2).  By contrast, the worst case death toll (with no control measures) in the many papers of Professors Baker and Wilson (who were the most significant advisers to the government at this time) was 30,600 (in the Baker et al paper of 23 March).  Hendy et al do not even cite this paper, which predates theirs, let alone explain why their worst case figure is almost three times that of Baker et al.  The usual practice in academic work is to cite relevant existing work, and explain why your approach is better.  The need for this is amplified by the fact that none of the Hendy et al co-authors is an epidemiologist, while all co-authors of the Baker et al paper are.

2. The set of control strategies examined did not include lockdown (closing down all but essential businesses as well as all the restrictions described by Hendy), and yet Hendy et al concluded that deaths could be limited to 20 in the highest control state examined by them.  The only places of work that are closed down in any of the control states in Hendy’s Table 2 are schools and universities.  Since it took lockdowns on repeated occasions to achieve New Zealand’s covid death toll to date of 27, Hendy’s belief that this could be achieved without lockdowns would seem to have been far too optimistic. Interestingly, in Baker et al’s paper of 23 March, the authors do not define the restrictions involved in their high control scenario (which they call “eradication”) but the lack of specification of the restrictions at least allows for the possibility that it involved lockdowns.

3. None of the control strategies examined by Hendy et al corresponds to Level 3 or Level 4, despite these levels having been defined by the government on 21 March 2020, which was four days before the Hendy paper was released.  So, by the time the paper was released, it was already superseded by the events of 21 March.

4. The costs of adopting different control strategies are not even mentioned, let alone quantified.  Nor was there any conversion of predicted deaths to life years lost, nor valuation of this in accordance with standard methodology in the medical literature.  Again this contrasts with the Baker et al paper.

The next significant paper by Hendy et al was on 21 October 2020 and was concerned with the economic costs of the Level 3 August 2020 Auckland lockdown relative to those of an alternative Level 4 lockdown:

https://www.tepunahamatatini.ac.nz/2020/11/16/economic-comparison-of-the-use-of-alert-levels-3-and-4-for-aucklands-august-outbreak/

The paper assumes adoption of the government’s elimination strategy and is only concerned with the question of whether Level 4 restrictions would have been more or less costly (in lost GDP) than the Level 3 restrictions actually adopted in Auckland (Level 4 restrictions cost more per day than Level 3 restrictions but are likely to end sooner).   They find a modest such advantage to Level 4, because the expected time in lockdown to reach their epidemiological target is shorter in Level 4, which more than compensates for the higher costs per day.  This seems to be the first paper from Hendy et al that considers the costs of competing policies, but none of the co-authors appears to have any expertise in economics. The most interesting features of the paper are:

1. Despite considering the costs of these two options, the paper does not accord with the standard methodology in the medical literature of assessing the comparative deaths of the two options and converting this to a cost per QALY saved.

2. The data in their Tables 1 and 2 does not reconcile.  For example, Table 1 states that the cost per day in Level 3 is $57m, Table 2 gives expected days under Level 3 restrictions as 23, implying a cost of $1.3b, but Table 2 gives a cost of $1.8b instead.  The same problem applies to the Level 4 restrictions.  I raised this point with the lead author (Rachel Binny) on 17 November and received a reply from Professor Hendy but he did not address this issue over the course of several emails (in which I reminded him about the point).  I therefore presume that Table 2 is in error.

3. Page 8 of the paper says “Figure 2B shows the economic cost of the outbreak for a particular probability of elimination in the cases where the elimination was successful.”  This is not correct. The Figure is premised on exiting lockdown when cases have fallen to a level at which the probability of elimination has fallen to a particular level, and shows the economic cost for the expected lockdown period for a particular probability of elimination. Whether elimination was subsequently achieved is irrelevant to this calculation.  I also raised this point with the lead author (Rachel Binny) on 17 November and received a reply from Professor Hendy but he did not address this issue over the course of several emails (in which I reminded him about the point).

4. The authors acknowledge that their analysis does not consider the “..longer term economic costs of the measures..” (Executive Summary) and that “These factors may take the analysis to a different conclusion.” (page 10).  What then is the usefulness of the analysis?

5. Despite limiting themselves to the question examined, they note in passing that cost benefit analyses such as those performed by Heatley (2020) and Lally (2020) “…might be useful for informing a mitigation strategy but are not useful for a decision maker considering or following an elimination strategy” (pp. 4-5).  This seems to be accepting that cost-benefit analysis might be appropriate for choosing between mitigation and elimination strategies, as was the focus of Lally (2020), whilst denying its usefulness in choosing between Level 3 and 4 restrictions.  However, even if one has decided on an elimination strategy, for whatever reasons, there are competing variants of it, as Hendy et al recognises in comparing a Level 3 and Level 4 response to the Auckland outbreak, and cost-benefit analysis should also be used to choose between them, as Heatley does and Hendy et al do not.

6. Hendy et al refer again later to the cost-benefit analyses of Heatley and Lally, and state that “Combining our approach….with these more in-depth economic analyses may be useful in informing future responses.” (page 10). This seems to be accepting that cost-benefit analysis may be useful for choosing between Level 3 and 4 restrictions, thereby undercutting the contrary claim quoted in the previous point.

7. The equivocal comments by Hendy et al quoted in the last two points (“may” or “might”) suggest a lack of confidence on the part of the authors about basic economic issues that anyone offering policy advice ought to be confident about. This is understandable in view of none of the authors having any apparent expertise in economics, but it is harder to understand why they would offer policy advice about matters that they are so uncertain about.