A statistical fallacy: unvaccinated excess mortality in Italy and at Nivel

Who Kaplan-Meier voor Dummies understands what the "belly" of a Kaplan-Meier graph says. Recently I was shown an Italian study in which a similar graph was shown. Here too, as with Nivel, the conclusion was that the vaccines had not caused mortality and that the excess mortality was among the unvaccinated. We first look at the Italian approach and then compare the findings with the Nivel report.

Kaplan-Meier 1: Italy

Italian study: COVID-19 vaccination not associated with an increase in mortality or selected PVR-SAEs incidence.

Are we worried about nothing? Are vaccines absolutely safe? According to experts, this is evident from everything: the situation in New Zealand, for example (which I here with ChatGPT) and a thorough, peer-reviewed, academic research from Italy would be decisive. The data comes from the Italian demographic databases and databases of hospital admissions for the period from January 2, 2021 to July 31, 2022.

The researchers of that peer-reviewed article in Vaccines | Like Nivel, came to the conclusion that mortality among vaccinated people was no greater than among unvaccinated people. ¹did not show an increased risk of all-cause death, non-COVID death, or any PVR-SAEs, as compared to the unvaccinated A glance at the Kaplan-Meier graph makes it clear that there may be something to be bargained for.

They have made corrections to a number of comorbidities, including Covid-19, but write at the end of the strengths and weaknesses:

“… there may be disruption from the Healthy Vaccinee Effect, where vaccinated people are expected to engage in less risky behaviours."²there may be confounding due to the healthy vaccinee effect, wherein vaccinated people may be expected to adopt less risky behaviors It's really like this, see dangerous. That didn't seem like a good explanation to me and my well-read friend confirmed that. And despite that, we are just presented with this graph:

It is striking that this graph is shown in a report that aims to show that vaccination does not lead to mortality or serious side effects. Apparently, this cannot be achieved without leaning on the difference with the less healthy unvaccinated. That difference is interpreted as positive for vaccinations.

Only after about 7 months do we see a stable ratio in straight lines. And they run parallel to each other: no difference at all! But the first 7 months, that "HVE belly", count in the calculations because only the totals after a year and a half are compared. Then you get Nivel-like outcomes. The conclusion of the Italians is therefore obvious:

"In conclusion, COVID-19 vaccination was not associated with an increase in mortality or selected PVR-SAEs incidence. Further research is needed to evaluate the long-term safety of COVID-19 vaccines."

Quite a lot if you include the "Unhealthy Non-Vaccinee Effect". Then the vaccinated always come out better.

This study exploits the Unhealthy Non-vaccinee effect to prove the safety of vaccines. Something that the literature (e.g. in the excess mortality report by Meester/Jacobs) explicitly warns against.

"Further research in the coming years will be required to evaluate the long-term safety of COVID-19 vaccines."

You can say that again...!

Kaplan-Meier 1I: The Netherlands

Nivel report: Excess mortality during the COVID-19 pandemic – Study of people with and without COVID-19 vaccination

In the much-discussed Nivel report, there are two measurement points: the first at 3 months and the second at 12 months after vaccination. The development per day or per week does not appear in the study. Forget? Not important?

However, the first quarter is analysed separately. Could they be expecting more deadly side effects in the first three months? Then you shouldn't have to correct them away with increased expectations. You'd like to find something like that right.

In most age groups, the Nivel researchers expect a slightly higher mortality in the first 3 months than in the reference period. In the vaccinated only a little higher and why that is we do not read, it will have to do with corrections and weighings.

For the unvaccinated, the mortality expectation is therefore higher than the reference period. This looks like an attempt to correct for the Healthy Vaccine Effect: removing the expected excess mortality in people who did not receive the jab, for example because their date of death was approaching. After three months, that period will be over, they may have thought. But is that so? They could have seen that in their data. And even then, instead of months 1-3 and 1-12, they might have been better off reporting month 4-12. Otherwise, they will unjustly take the HVE with them in favor of the safety of the vaccinations.

If you expect an HVE, you cannot detect possible mortality due to vaccination by comparing with unvaccinated people. This is only possible if the study population is carefully composed, which is simply not the case with observational research.

For the passage over time, we look at one of the Kaplan-Meier graphs (71-81 years) by Bram Bakker, chapter 6 in the Master Jacobs report.

With the dotted lines I have indicated where the lines are straight. In the first few weeks, actually on the first day, the difference is really huge, like Herman Steigstra has calculated here.

Only after about 1 year (second vertical dotted line) does the situation remain stable. This is where a continuous mortality risk begins to emerge that you might be able to find something about. But that's also where the research period of the Nivel report ends...

Nivel has looked at two snapshots: at 3 months and at 12 months (indicated by the dotted lines). It is only after 12 months that there is a continuous trend. Up to 12 months, the differences per day become smaller and that cannot have been caused by the vaccinations. The differences are also not in line with Covid mortality trends.

The gray dotted line is the upwardly pushed purple dotted line. Here, the purple dotted lines do not coincide after shifting as they do in Italy. The unvaccinated continue to die more here. This will have to do with the age cohort, because this is the case with people in their fifties, as we saw in the previous article.

Even more striking is that Nivel's 'belly' is much deeper than that in Italy. In Italy, they didn't seem to be bothered by waiting times, non-consenters and other data pollution. So that could be 'pure' HVE there. On the basis of that graph, we may be able to say something more about the composition of those bellies in the Dutch data, which led to the amazing results of the Nivel report. If we subtract the 'pure' HVE, what is left in terms of data pollution, especially due to the waiting time problem? That, too, has Herman further elaborated.

In summary, the only thing Nivel has measured is what the Italian study is also based on: the Healthy Vaccine Effect that they had wanted to correct and on top of that the administrative chaos. This is how they come to similar conclusions.

Is there anything in the report about the HVE? Sure:

• On average, the vaccinated group is healthier than the unvaccinated group, for example because seriously ill people, who are about to die, no longer get vaccinated.
• This implies that the reason for not vaccinating may be related to a higher risk of death. However, even after correction for certain characteristics, we saw that excess mortality among the unvaccinated/unregistered was much higher than among vaccinated people. There are still many features that we have not taken into account.

As Maurice pointed out: for Obesity and smoking for example, has not been corrected.

And then just keep at it...

What do we think?

Dat er wetenschappers zijn die in door de overheid gesubsidieerde studies met dit soort gegevens en deze methodologie door blijven werken om vaccin-veiligheid te bewijzen, is zorgelijk. Het is een statistische drogredenering: een onmiskenbaar HVE wordt omgekat naar vaccinveiligheid en de wetenschappelijke elite kijkt toe.

Mensen die tegen hun levenseinde het vaccin niet meer kregen en ongevaccineerd overleden, worden meegerekend om een lagere sterftekans voor gevaccineerden aan te tonen, nog los van andere gezondheidskwesties bij niet-gevaccineerden. Dit levert niet alleen desinformatie op maar het beschadigt alles wat met wetenschap, instituten en overheden te maken heeft (en met de zorg).

P.S.

Nivel's expectations, as they have been reported, are exasperatingly sloppy. They are rounded to 2 decimal places. For example, a 3-month expectation for unvaccinated people (18-35 years) of 0.01% mortality is calculated. On the face of it, this corresponds exactly to the reference period on which this expectation is based: also 0.01%. But that is the rounded percentage of 15 deaths among 223,552 young people. That's 0.0067%. By presenting this percentage as 0.01%, they set the standard 50% higher than what has been observed. I couldn't find the justification for that. Could it really be carelessness? When it comes to such small numbers, you report per 100,000, not per hundred, right? We just have to hope that those roundings didn't end up in the calculations...

Of course, these are only small numbers... 0.01% would mean 22 deaths, not 15 deaths of students and young parents in this study. A difference of 7. But calculated for the entire Dutch population, this is a difference of more than 100 young people. I can't imagine that medicine has gotten away with that in the past. Careless, after Honesty the second core concept in the Guidelines for scientific integrity.

References

• 1
  did not show an increased risk of all-cause death, non-COVID death, or any PVR-SAEs, as compared to the unvaccinated
• 2
  there may be confounding due to the healthy vaccinee effect, wherein vaccinated people may be expected to adopt less risky behaviors