https://www.mdpi.com/2076-393X/9/7/693/pdf
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 one inflicted by vaccination. Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy.
Conclusions
The present assessment raises the question whether it would be necessary to rethink policies and use COVID-19 vaccines more sparingly and with some discretion only in those that are willing to accept the risk because they feel more at risk from the true infection than the mock infection. Perhaps it might be necessary to dampen the enthusiasm by sober facts? In our view, the EMA and national authorities should instigate a safety review into the safety database of COVID-19 vaccines and governments should carefully consider their policies in light of these data. Ideally, independent scientists should carry out thorough case reviews of the very severe cases, so that there can be evidence-based recommendations on who is likely to benefit from a SARS-CoV2 vaccination and who is in danger of suffering from side effects. Currently, our estimates show that we have to accept four fatal and 16 serious side effects per 100,000 vaccinations in order to save the lives of 2–11 individuals per 100,000 vaccinations, placing risks and benefits on the same order of magnitude.
From Google Translation:
摘要:背景:COVID-19 疫苗在没有足够安全性的情况下进行了快速审查
数据。我们想比较风险和收益。方法:我们计算了需要的数量
从以色列的一项大型实地研究中接种疫苗 (NNTV) 以防止一人死亡。我们访问了 Adverse
欧洲药品管理局和荷兰国家药品管理局的药物反应 (ADR) 数据库
注册 (lareb.nl) 以提取报告严重副作用的病例数和病例数
具有致命的副作用。结果:NNTV 在 200-700 之间,以防止 1 例 COVID-19
辉瑞(Pfizer)上市的 mRNA 疫苗,而防止一人死亡的 NNTV 则在 9000 至 50,000 之间
(95% 置信区间),以 16,000 作为点估计值。经历不利的案件数量
据报道,每 100,000 次接种有 700 次反应。目前,我们看到 16 种严重的副作用
每 100,000 次接种,致命副作用的数量为 4.11/100,000 次接种。三个
接种疫苗预防死亡,我们必须接受接种疫苗造成的死亡。结论:这
缺乏明确的利益应导致政府重新考虑其疫苗接种政策
目前的评估提出了是否有必要重新考虑的问题
政策并更谨慎地使用 COVID-19 疫苗,仅在那些情况下有一定的酌处权
愿意接受风险,因为他们觉得真正感染的风险更大
比模拟感染。也许有必要通过清醒来抑制热情
事实?在我们看来,EMA 和国家当局应该发起安全审查
COVID-19 疫苗的安全数据库和政府应仔细考虑他们的
根据这些数据制定政策。理想情况下,独立科学家应该进行彻底的
对非常严重的病例进行病例审查,以便提出循证建议
谁有可能从 SARS-CoV2 疫苗接种中受益,谁有遭受痛苦的危险
从副作用。目前,我们的估计表明我们必须接受四个致命的和
为了挽救 2-11 个人的生命,每 100,000 次疫苗接种有 16 种严重的副作用
每 100,000 次疫苗接种,将风险和收益置于同一数量级。