RETRACTED: The Safety of COVID-19 Vaccinations-We Should Rethink the Policy (Publication with Expression of Concern. See vol. 9, 2021) (Retracted article. See vol. 9, 2021)

被引:26
作者
Walach, Harald [1 ,2 ,3 ]
Klement, Rainer J. [4 ]
Aukema, Wouter [5 ]
机构
[1] Poznan Univ Med Sci, Pediat Hosp, PL-60572 Poznan, Poland
[2] Univ Witten Herdecke, Dept Psychol, D-58448 Witten, Germany
[3] Change Hlth Sci Inst, D-10178 Berlin, Germany
[4] Leopoldina Hosp, Dept Radiat Oncol, D-97422 Schweinfurt, Germany
[5] Brinkenbergweg 1, NL-7351 BD Hoenderloo, Netherlands
关键词
SARS-CoV2; COVID-19; vaccination; mRNA-vaccine; number needed to vaccinate; safety; side effects; adverse drug reaction; fatal side effects; EMA;
D O I
10.3390/vaccines9070693
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
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.
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页数:8
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