The Safety of COVID-19 Vaccinations—We Should Rethink the Policy
Open Access
- 24 June 2021
- Vol. 9 (7), 693
- https://doi.org/10.3390/vaccines9070693
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.This publication has 27 references indexed in Scilit:
- Seroprevalence of Antibodies to SARS-CoV-2 in 10 Sites in the United States, March 23-May 12, 2020JAMA Internal Medicine, 2020
- Selective and cross-reactive SARS-CoV-2 T cell epitopes in unexposed humansScience, 2020
- Seasonal coronavirus protective immunity is short-lastingNature Medicine, 2020
- The Epistemology of a Positive SARS-CoV-2 TestActa Biotheoretica, 2020
- Nicotinic Cholinergic System and COVID-19: In Silico Identification of an Interaction between SARS-CoV-2 and Nicotinic Receptors with Potential Therapeutic Targeting ImplicationsInternational Journal of Molecular Sciences, 2020
- Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trialThe Lancet, 2020
- Population-level COVID-19 mortality risk for non-elderly individuals overall and for non-elderly individuals without underlying diseases in pandemic epicentersEnvironmental Research, 2020
- Empirical estimation of under-reporting in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS)Expert Opinion on Drug Safety, 2017
- Underreporting of Hemorrhagic and Thrombotic Complications of Pharmaceuticals to the U.S. Food and Drug Administration: Empirical Findings for Warfarin, Clopidogrel, Ticlopidine, and Thalidomide from the Southern Network on Adverse Reactions (SONAR)Seminars in Thrombosis and Hemostasis, 2012
- Under-Reporting of Adverse Drug ReactionsDrug Safety, 2006