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 疫苗在沒有足夠安全性的情況下進行了快速審查
數據。我們想比較風險和收益。方法：我們計算了需要的數量
從以色列的一項大型實地研究中接種疫苗 (NNTV) 以防止一人死亡。我們訪問了 Adverse
歐洲藥品管理局和荷蘭國家藥品管理局的藥物反應 (ADR) 數據庫
注冊 (lareb.nl) 以提取報告嚴重副作用的病例數和病例數
具有致命的副作用。結果：NNTV 在 200-700 之間，以防止 1 例 COVID-19
輝瑞（Pfizer）上市的 mRNA 疫苗，而防止一人死亡的 NNTV 則在 9000 至 50,000 之間
（95% 置信區間），以 16,000 作為點估計值。經曆不利的案件數量
據報道，每 100,000 次接種有 700 次反應。目前，我們看到 16 種嚴重的副作用
每 100,000 次接種，致命副作用的數量為 4.11/100,000 次接種。三個
接種疫苗預防死亡，我們必須接受接種疫苗造成的死亡。結論：這
缺乏明確的利益應導致政府重新考慮其疫苗接種政策
目前的評估提出了是否有必要重新考慮的問題
政策並更謹慎地使用 COVID-19 疫苗，僅在那些情況下有一定的酌處權
願意接受風險，因為他們覺得真正感染的風險更大
比模擬感染。也許有必要通過清醒來抑製熱情
事實？在我們看來，EMA 和國家當局應該發起安全審查
COVID-19 疫苗的安全數據庫和政府應仔細考慮他們的
根據這些數據製定政策。理想情況下，獨立科學家應該進行徹底的
對非常嚴重的病例進行病例審查，以便提出循證建議
誰有可能從 SARS-CoV2 疫苗接種中受益，誰有遭受痛苦的危險
從副作用。目前，我們的估計表明我們必須接受四個致命的和
為了挽救 2-11 個人的生命，每 100,000 次疫苗接種有 16 種嚴重的副作用
每 100,000 次疫苗接種，將風險和收益置於同一數量級。
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