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The striking findings by Alami et al., published in The BMJ, that their “meta-analysis indicates that within 30-day follow-up period, vaccinated individuals were twice as likely to develop myo/pericarditis in the absence of SARS-CoV-2 infection compared to unvaccinated individuals, with a rate ratio of 2.05 (95% CI 1.49–2.82)” adds to the recent spate of evidence on the not-so-insignificant risk of COVID-19 vaccine-induced myocarditis.1 For example, Cho et al., publishing in the European Heart Journal, found a COVID vaccine-induced myocarditis incidence rate of around 1 in 100,000, and around 1 in 19,000 for males between the ages of 12 and 17 years; also finding that a significant number of vaccine-induced myocarditis sufferers (around 5%) end up dying soon afterwards.2
Contrast this with the UK government’s determination of numbers needed to vaccinate to prevent a severe COVID hospitalisation being in the hundreds of thousands for young ‘no risk’ groups.3 It would appear to be an unacceptable risk, at least for certain groups, for this one adverse effect alone. The risk of vaccine-induced myocarditis may indeed be very small, but the risk of serious COVID in the young and healthy is smaller still.
There are also increasing questions over the vaccines’ effectiveness, such as those concerning statistical biases in observational studies raised in the Journal of Evaluation in Clinical Practice by Fung, Jones, and Doshi;4 and by myself.5 Should we now adm...
There are also increasing questions over the vaccines’ effectiveness, such as those concerning statistical biases in observational studies raised in the Journal of Evaluation in Clinical Practice by Fung, Jones, and Doshi;4 and by myself.5 Should we now admit that, at least at this point in time, the benefits of the COVID-19 vaccines do not outweigh the risks?
1. Alami A, Krewski D, Farhat N, et al. Risk of myocarditis and pericarditis in mRNA COVID-19-vaccinated and unvaccinated populations: a systematic review and meta-analysis. BMJ Open. 2023;13:e065687. https://bmjopen.bmj.com/content/13/6/e065687.
2. Cho JY, Kim KH, Lee N, et al. COVID-19 vaccination-related myocarditis: a Korean nationwide study. European Heart Journal. 2023;44: 2234-43. https://doi.org/10.1093/eurheartj/ehad339.
3. Department of Health & Social Care. Appendix 1: estimation of number needed to vaccinate to prevent a COVID-19 hospitalisation for primary vaccination, booster vaccination (3rd dose), autumn 2022 and spring 2023 booster for those newly in a risk group. 2023. https://assets.publishing.service.gov.uk/government/uploads/system/uploa....
4. Fung K, Jones M, Doshi P. Sources of bias in observational studies of covid-19 vaccine effectiveness. Journal of Evaluation in Clinical Practice. 2023;1-7. https://doi.org/10.1111/jep.13839.
5. Lataster R. Reply to Fung et al. on COVID-19 vaccine case-counting window biases overstating vaccine effectiveness. Journal of Evaluation in Clinical Practice. 2023;1-4. https://doi.org/10.1111/jep.13892.