COVID-19 vaccines have had expedited reviews without sufficient safety data. We wanted to compare risks and benefits.
Method: We calculated the number needed to vaccinate (NNTV) from a large Israeli field study to prevent one death. We accessed the Adverse Drug Reactions (ADR) database of the European Medicines Agency and of the Dutch National Register (lareb.nl) to extract the number of cases reporting severe side effects and the number of cases
with fatal side effects.
Result: The NNTV is between 200–700 to prevent one case of COVID-19 for the mRNA vaccine marketed by Pfizer, while the NNTV to prevent one death is between 9000 and 50,000 (95% confidence interval), with 16,000 as a point estimate. The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 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.
Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy.
In my post, I pointed out that the analysis was deeply flawed and its conclusion ridiculous. Many other observers agreed, and several editorial board members of the journal, Vaccines, that unbelievably had published this junk resigned. Yesterday, the journal reacted by retracting the paper. Here is their statement:
The journal retracts the article, The Safety of COVID-19 Vaccinations—We Should Rethink the Policy.
Serious concerns were brought to the attention of the publisher regarding misinterpretation of data, leading to incorrect and distorted conclusions.
The article was evaluated by the Editor-in-Chief with the support of several Editorial Board Members. They found that the article contained several errors that fundamentally affect the interpretation of the findings.
These include, but are not limited to:
The data from the Lareb report (https://www.lareb.nl/coronameldingen) in The Netherlands were used to calculate the number of severe and fatal side effects per 100,000 vaccinations. Unfortunately, in the manuscript by Harald Walach et al. these data were incorrectly interpreted which led to erroneous conclusions. The data was presented as being causally related to adverse events by the authors. This is inaccurate. In The Netherlands, healthcare professionals and patients are invited to report suspicions of adverse events that may be associated with vaccination. For this type of reporting a causal relation between the event and the vaccine is not needed, therefore a reported event that occurred after vaccination is not necessarily attributable to vaccination. Thus, reporting of a death following vaccination does not imply that this is a vaccine-related event. There are several other inaccuracies in the paper by Harald Walach et al. one of which is that fatal cases were certified by medical specialists. It should be known that even this false claim does not imply causation, which the authors imply. Further, the authors have called the events ‘effects’ and ‘reactions’ when this is not established, and until causality is established they are ‘events’ that may or may not be caused by exposure to a vaccine. It does not matter what statistics one may apply, this is incorrect and misleading.
The authors were asked to respond to the claims, but were not able to do so satisfactorily. The authors were notified of the retraction and did not agree.
Two questions still remain to be answered:
- Were Walach et al just incompetent or did they wilfully try to mislead us?
- How much nonsense is Walach allowed to publish before he is finally stopped?