米国の中国語サイトによると, ハーン, 米国食品医薬品局長官 (FDA), 新型コロナウイルスワクチンをできるだけ早く供給するために、連邦承認プロセス全体が回避される可能性があると述べた。. 彼は、もし利益がリスクを上回れば、と述べた。, 第III相臨床試験が完了する前に緊急許可を発行できる. He also said the move was not due to pressure from the government to develop vaccines quickly.
報道によると, Hahn told the Financial Times: “(Vaccine developers) have the right to apply for authorization or approval, and we will make a ruling on their application.” “If they do this before the end of the third phase (clinical trial), we may think it is appropriate; We may find it inappropriate and we will make a decision. ”
以前, although some health officials were worried that the data of clinical trials were too weak, FDA urgently approved the treatment of hospitalized COVID-19 patients with restorative plasma.
Hahn said he would not rush to approve the vaccine just to please US President Trump. Without any evidence, Trump accused the FDA of trying to delay the approval of novel coronavirus vaccines and therapies in order to politically disadvantage them.
“We are facing the combination of the COVID-19 pandemic and the political season, and we will have to overcome this and stick to our core principles.” Hahn said, “This will be a decision based on science, medicine and data.” “This will not be a political decision.”
He said that before clinical trials are completed, emergency authorization can be used to safely provide vaccines to certain groups. “Our emergency use authorization is different from full approval.” Hahn said, “The legal, medical and scientific standard is that in public health emergencies, the benefits outweigh the risks.”
先週, the Financial Times reported that the Trump administration was considering issuing emergency use authorization to an experimental novel coronavirus vaccine developed by Oxford University and AstraZeneca in Britain before the presidential election. その時, a spokesman for the US Department of Health said that any report on the emergency authorization of vaccines before the election was “absolutely wrong”. AstraZeneca said it had not discussed the move with the US government.
