According to the US Chinese website, Hahn, director of the US Food and Drug Administration (อย.), said that the entire federal approval process may be bypassed in order to supply novel coronavirus vaccine as soon as possible. He said that if the benefits outweigh the risks, emergency authorization can be issued before the completion of Phase III clinical trials. He also said the move was not due to pressure from the government to develop vaccines quickly.
ตามรายงาน, 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. ”
ก่อนหน้านี้, 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.”
Last week, 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. At that time, 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.
