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 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.
Update: this study has now been "unpublished" by mdpi.com as of 5/7/21 .
We have managed to obtain a PDF copy which you can read on our Scientific Articles page.
In the course of the SARS-CoV2 pandemic, new regulatory frameworks were put in place that allowed for the expedited review of data and admission of new vaccines without safety data . Many of the new vaccines use completely new technologies that have never been used in humans before. The rationale for this action was that the pandemic was such a ubiquitous and dangerous threat that it warrants exceptional measures. In due course, the vaccination campaign against SARS-CoV2 has started. To date (18 June 2021), roughly 304.5 million vaccination doses have been administered in the EU (https://qap.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#distribution-tab (accessed on 18 June 2021)), mostly the vector vaccination product developed by the Oxford vaccination group and marketed by AstraZeneca, Vaxzevria  (approximately 25% coverage in the EU), the RNA vaccination product of BioNTec marketed by Pfizer, Comirnaty [3,4] (approximately 60%), and the mRNA vaccination product developed by Moderna  (approximately 10%). Others account for only around 5% of all vaccinations. As these vaccines have never been tested for their safety in prospective post-marketing surveillance studies, we thought it useful to determine the effectiveness of the vaccines and to compare them with the costs in terms of side effects.
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