A review of efficacy and safety data for the COVID-19 vaccines by three scientists has been published in the peer-reviewed journal Vaccines and comes to the disturbing conclusion that for every three deaths the vaccines prevent, two people die from an adverse reaction, while another four suffer serious side effects. The authors conclude: “This lack of clear benefit should cause governments to rethink their vaccination policy.”
Here is the abstract:
Background: 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 9,000 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 per 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.
The authors note this conclusion is based on the reported adverse reactions, whereas the true number of adverse reactions may be considerably more.
Finally, we note that from experience with reporting side effects from other drugs, only a small fraction of side effects is reported to adverse events databases. The median underreporting can be as high as 95%. Given this fact and the high number of serious side effects already reported, the current political trend to vaccinate children who are at very low risk of suffering from COVID-19 in the first place must be reconsidered.
They note that the “risks and benefits” of the vaccines are “on the same order of magnitude” and suggest: “Perhaps it might be necessary to dampen the enthusiasm by sober facts?”
The present assessment raises the question whether it would be necessary to rethink policies and use COVID-19 vaccines more sparingly and with some discretion only in those that are willing to accept the risk because they feel more at risk from the true infection than the mock infection. Perhaps it might be necessary to dampen the enthusiasm by sober facts? In our view, the EMA and national authorities should instigate a safety review into the safety database of COVID-19 vaccines and governments should carefully consider their policies in light of these data. Ideally, independent scientists should carry out thorough case reviews of the very severe cases, so that there can be evidence-based recommendations on who is likely to benefit from a SARS-CoV-2 vaccination and who is in danger of suffering from side effects. 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.
The full study can be found here.
UPDATE: The study has been updated. It originally stated that: “For three deaths prevented by vaccination, we have to accept one inflicted by vaccination.” This has been amended to say “we have to accept two inflicted by vaccination”. This article has been updated accordingly.
UPDATE 2: The study has been retracted by the journal. The retraction notice reads:
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 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.
The focus on the events not being established as reactions appears to miss the point that they are reported because they are suspected of being reactions. It may be a fair criticism that the authors should have been more cautious in how they characterised the events. However, they did acknowledge the issue of causality and address it. They argue that in the Dutch system the fatal adverse events are “certified by a medical specialist”. This is not true in every case, as the editors point out. However, the official guidance the authors quote from in the paper does indicate a system of verification in which doctors are involved in some cases:
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. 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.
Note that the guidance also refers to the events as “side effects”, underlining that this is the working assumption of the reporting system. The authors also note that the proportion of reported adverse events is similar in America, and that studies have shown that adverse events are typically under-reported rather than over-reported.
The paper is by no means perfect, and perhaps would benefit from revision to tidy up some unclear or inaccurate claims and incautious language (this is what the peer-review process is supposed to achieve). But retraction feels a little too convenient as a way of burying one of the few peer-reviewed papers that raises questions about the safety profile of the vaccines in light of the unprecedented number of adverse event reports lodged in connection with them.