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開発元が安全性有効性データ無しって
名言している以上それが答え


【1次ソース】ビオンテック社、重大な副作用、安全性と有効性に関するデータなしと認める

SEC Filing | BioNTech
https://investors.biontech.de/node/11931/html#ic5e06a05a31d4c4491031d3208cef8c2_2840
【抜粋】
•We may not be able to demonstrate sufficient efficacy or safety of our COVID-19 vaccine and/or variant-specific formulations to obtain permanent regulatory approval in the United States, the United Kingdom, the European Union, or other countries where it has been authorized for emergency use or granted conditional marketing approval.
•Significant adverse events may occur during our clinical trials or even after receiving regulatory approval, which could delay or terminate clinical trials, delay or prevent regulatory approval or market acceptance of any of our product candidates.
•Our operating results may fluctuate significantly, which makes our future operating results difficult to predict.
•Clinical development involves a lengthy and expensive process with an uncertain outcome, and delays can occur for a variety