>>807 https://www.mdpi.com/2076-393X/9/7/693/htmExpression of Concern published on 28 June 2021, see Vaccines 2021, 9(7), 705.
Retraction published on 2 July 2021, see Vaccines 2021, 9(7), 729.
The Safety of COVID-19 Vaccinations—We Should Rethink the Policy
by Harald Walach
1,2,3,*, Rainer J. Klement
4 [OrcID] and Wouter Aukema
5 [OrcID]
1
Poznan University of the Medical Sciences, Pediatric Hospital, 60-572 Poznan, Poland
2
Department of Psychology, University of Witten/Herdecke, 58448 Witten, Germany
3
Change Health Science Institute, 10178 Berlin, Germany
4
Department of Radiation Oncology, Leopoldina Hospital, 97422 Schweinfurt, Germany
5
Independent Data and Pattern Scientist, Brinkenbergweg 1, 7351 BD Hoenderloo, The Netherlands
*
Author to whom correspondence should be addressed.
Academic Editor: Ralph J. DiClemente
Vaccines 2021, 9(7), 693;
https://doi.org/10.3390/vaccines9070693Received: 2 June 2021 / Revised: 19 June 2021 / Accepted: 21 June 2021 / Published: 24 June 2021
(This article belongs to the Section COVID-19 Vaccines and Vaccination)
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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 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.
Keywords: SARS-CoV2; COVID-19; vaccination; mRNA-vaccine; number needed to vaccinate; safety; side effects; adverse drug reaction; fatal side effects; EMA