Fact check: benefit-risk assessment for corona vaccination overestimated?

The Austria Press Agency (APA) subjected the study to a fact check:

Vaccination-critical circles (1) currently often refer to a scientific publication (2). “For three deaths prevented by vaccination, we have to accept two deaths caused by vaccination,” the article is quoted as saying. This is highly controversial among scientists.

Assessment: The publication really exists. In terms of method, however, it has considerable shortcomings. Scientists criticize the authors.

Verification:

The study was published on the website of the Multidisciplinary Publishing Institute (MDPI). In reality, there are only three individual scientists behind the alleged publication by five universities.

Harald Walach is a German psychologist and worked as director of the Institute for Transcultural Health Sciences at the Frankfurt European University Viadrina (3). In the publication he lists three chairs, including the Medical University in Posen, the University of Witten / Heidecke and the Change Health Science Institute in Berlin, an institute founded by Walach himself. In Witten / Heidecke, Walach claims to be a visiting professor (4), in Posen he appears with the professors (5). According to the Berliner Zeitung, Walach was already criticized during his work in Frankfurt for his pseudo-scientific approaches (6).

In addition to Walach, a physicist from radiation oncology at the Leopoldina Hospital in Schweinfurt is named as a co-author, as is an independent data scientist who is not assigned to any scientific institute. Of five claimed universities, two remain, including a visiting professorship. There are no virologists, epidemiologists or vaccinologists among the authors.

MDPI warns readers

The study is controversial among scientists. The MDPI has already published an “Expression of Concern”, a kind of notice to readers that there are concerns about the publication (7). The “serious concerns” mainly concern a misinterpretation of the data or the conclusion of the authors. The deaths assigned by the authors to vaccines are incorrect and distorted.

The Austrian virologist Florian Krammer, a co-editor at the MDPI (8), even announced his resignation from his role at the MDPI (9) in response to the publication of the study. In his tweets, Krammer expresses approval of comments that believe the article is wrong (10). British immunologist Katie Ewers also left the editorial team (11).

The number used for vaccination deaths is not reliable

In terms of content, the criticism primarily concerns the number of alleged vaccine deaths used. The authors of the study use the database of the European Medicines Agency (EMA), in which side effects after vaccinations can be documented. However, the deaths recorded there are only close in time to a corona vaccination and in no way automatically have a causal relationship. This topic has already been dealt with in another APA fact check (12) and it was pointed out that the figures in the EMA database do not provide any reliable information about side effects or deaths possibly caused by vaccinations.

The authors of the study themselves noticed that the EMA database is not necessarily reliable, as they point out that different countries have different rates of reported side effects. They then limited themselves to the data from the Netherlands, where most of the side effects were reported. In the study, this is referred to as the “most thorough” set of data. This brings them to four deaths per 100,000 inhabitants.

For Austria this would mean that around 300 people have died from vaccinations so far. According to the latest report (13) by the Federal Office for Safety in Health Care (BASG), only 132 deaths were reported in Austria close to a vaccination by mid-June. In four of these, a connection with the vaccination could be ruled out, in 34 others there were presumably secondary diseases that caused death, in 20 people the vaccination fell during the incubation period of a Covid disease, during which they died. The protective effect was not achieved in 14 people. 59 cases are still being reviewed; a connection with the vaccination is currently only seen in one death.

Limited time study with only one dose of vaccine

The authors also try to calculate how many vaccinations are necessary to prevent a corona death. To do this, they refer to an Israeli vaccination study (14), which certified the corona vaccination to be highly effective. However, data on preventing deaths can only be found there for people with a vaccination.

In addition, the study only lasted around 40 days, so the full protective effect of the second vaccination cannot be determined with this data set. Thus, the conclusion of the controversial publication that vaccination policy has to be reconsidered because of this publication is very questionable.