Absolute Risk Reduction of the COVID-19 Vaccines. Part 2

Addendum October 7, 2021

A reader brought to my attention that the study in this article, The Safety of COVID-19 Vaccinations—We Should Rethink the Policy, was withdrawn by MDPI.

Just the news reported that two of MDPI resigned in protest of the retraction. Virologist Florian Krammer and immunologist Katie Ewer, publicly announced their resignations on Twitter within three days of publication.

Science magazine reported four more resignations from Vaccines by July 1, including the journal’s founding editor in chief. Ewer made the same correlation-versus-causation argument and complained that the paper was “being used by anti-vaxxers and COVID-19-deniers as evidence that COVID-19 vaccines are not safe.”

Just the news reached out for a third party opinion,

Brown University epidemiologist Andrew Bostom wasn’t impressed by the journal’s “baloney” explanation for the retraction, either. “The [vaccine] deaths are as causally related as C19 deaths which allow for any positive test within 30-60 days of a death from any cause to be tallied as a C19 death,” he wrote in a Twitter message to Just the News.

MDPI contends that the authors were establishing a cause-and-effect relationship between the vaccines and the adverse effects and deaths. The authors respond that the data in LAREB is the only data they have and that this study should prompt a closer look at the safety of the vaccines.

The results of this study counter the official narrative that COVI-19 vaccines are safe. The way to disprove their study is to present another well-done and unbiased study and not to retract the study. This retraction is a manifestation of the cancel culture we are now in.

I agree with the authors’ response, and that is why this article stays on this website.

The following is the complete response of the authors. I separated some sentences for easier readability and added highlights.

Response to “Incorrect use of data..” by Prof. Dr. Eugène van Puijenbroek”

Harald Walach, Rainer J. Klement & Wouter Aukema

We are grateful to Prof. van Puijenbroek for raising his concerns. This starts a
long-overdue debate on how to gauge the safety of COVID-19 vaccines. We would like to remind Prof. van Puijenbroek and all readers: These vaccines have had an emergency approval without the necessary safety data.

Although we would agree with Prof. van Puijenbroek that the self-reporting system of side effects for vaccines and other drugs is far from foolproof, it is the only data we have. So why should it not be put to use? It is interesting to note that Prof. Puijenbroek, in his concern, describes the Lareb-ADR data as “spontaneous reporting.” In a statement in Regulatory Science 2021
(https://www.regulatoryscience.nl/editions/2021/12/prof.-dr.-eugene-van-puijenbroek-on -the-nature-of-signals; accessed 29th June 2021) he says:

“The Netherlands Pharmacovigilance Centre Lareb collected 34.000
reports of adverse drug reactions in 2019, of which 14.000 reports are submitted directly to Lareb by healthcare professionals and patients and more than 20.000 were forwarded by the marketing authorisation holders. These reports are assessed and analysed, which may lead to safety signals about adverse drug reactions.

These are reported to and reviewed by the Medicines Evaluation Board (MEB), supporting the MEB in its decisions in pharmacovigilance in the Netherlands and Europe.” (typos and grammatical errors removed, else identical with webquote at the end of the article)

So, what is really true and what should we go by: Is it true that roughly 60% of the
adverse drug reaction (ADR)-data come from market authorization holders, who, by law, are required to report, and is it true that the data are reviewed, as stated on the website and in this article, or are this information only true in all other cases but not in the case of COVID-19 vaccines? It would be good to have clarity on this point.

We assumed that what Lareb says about all other ADR reports is also true of COVID-19 ADR reports. If we were mistaken in this assumption, perhaps Lareb should clearly state: “ADR reports are reviewed and evaluated in all cases of ADR reports, but not with COVID-19 vaccines.” And, ideally, it should also give a reason why this is so if it is so. Ideally, the consequence of this debate is that someone sets up a systematic observational post-marketing surveillance study in a large number of vaccinated persons under public scrutiny to really document the side-effects that can be causally related to the vaccine.

Currently, we only have an association, we agree, and we never said anything
else. But the same is true with fatalities as consequences of SARS-CoV2-infections. The cases that are counted here as deaths are rarely vetted by autopsy or second opinion, but still counted as deaths due to COVID-19.

And it is exactly this allegedly high number of COVID-19 related deaths that gave rise to an unprecedented sloppy regulation process that allowed new types of vaccines using a mechanism never before tested in humans to be widely distributed in the population.

Prof. Puijenbroek basically argues that the largest vaccination experiment in the history of medicine cannot be assessed for safety and unforeseeable toxicities because we should not use the ADR data for such inferences.

In contrast, we argue that it is mandatory that those data which are at hand are used to gauge the safety, and this is what we have done.

We are happy to admit that these data are far from perfect. But we repeat: they are the only ones that are available. We quoted LAREB itself which states on its website at the time we checked the data:

“All reports received are checked for completeness and possible ambiguities. If necessary, additional information is requested from the reporting party and/or the treating doctor. If necessary, additional information is requested from the reporting party and/or the treating doctor. The report is entered into the database with all the necessary information. Side effects are coded according to the applicable (international) standards. Subsequently, an individual assessment of the report is made. The reports are forwarded to the European database (Eudravigilance) and the database of the WHO Collaborating Centre for International Drug Monitoring in Uppsala. The registration holders are informed about the reports concerning their product.”).

We took this statement to mean that those reports that are obviously without any
foundation are taken out such that the final database is at least reliable to some degree. Would it not be like that, why else would one want to collect these data and make them public in the first place?

We are happy to concede that the data we used – the large Israeli field study to
gauge the number needed to vaccinate and the LAREB data to estimate side-effects and harms – are far from perfect, and we said so in our paper. But we did not use them incorrectly. We used imperfect data correctly. We are not responsible for the validity and correctness of the data but for the correctness of the analysis. We contend that our analysis was correct. We agree with LAREB that their data is not good enough. But this is not our fault, nor can one deduce incorrect use of data or incorrect analysis.

And we hope that this stimulates governments or university consortia to collect
valid data to prove us wrong. We would be the first to be happy about that. But the challenge is out: Prove that the vaccines are safe! No one has done so. We say they are not, and we used the best data currently at hand. Our usage was correct. If the data were not, whose fault is this?

The original article follows.

A new study published in the journal, Vaccines looked at the number of people who will have severe adverse effects, including deaths, and how many people will be protected by the COVID vaccines.

The data came from a large Israeli study and the data from the Adverse
Drug Reactions (ADR) database of the European Medicines Agency and the Dutch National Register.

The Number Needed to Vaccinate or NNTV is the number of people that have to be vaccinated before an outcome is produced. That outcome may be prevention of the disease, adverse reaction, or death.

NNTV is calculated as the inverse of the absolute risk reduction or the absolute risk difference.

The Results:

The NNTV for the Sputnik vaccine is 22,000 to prevent one death.
The NNTV for the Moderna vaccine is 3050 people to prevent one death.
The NNTV is between 200–700 to prevent one case of COVID-19 for the mRNA vaccine marketed by Pfizer.
The NNTV to prevent one death is between 9000 and 50,000.
The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations.
16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations.
For three deaths prevented by vaccination, we have to accept two inflicted by vaccination.

The authors end their report with,

Currently, our estimates show that we have to accept four fatal and 16 serious side effects per 100,000 vaccinations in order to save the lives of 2–11 individuals per 100,000 vaccinations, placing risks and benefits on the same order of magnitude.

Knowledge about Covid-19 is rapidly evolving. Information may update as new studies are made. Stay current by subscribing. Feel free to share.

Don’t Get Sick!

Related readings:

Reference:

Walach, H.; Klement, R.J.; Aukema, W. The Safety of COVID-19 Vaccinations—We Should Rethink the Policy. Vaccines 2021, 9, 693. https://doi.org/10.3390/vaccines9070693

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Addendum October 7, 2021

Response to “Incorrect use of data..” by Prof. Dr. Eugène van Puijenbroek”

The Results:

Reference:

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