US FDA willing to give EUA for COVID-19 vaccines before Phase III trials
FDA Commissioner also said that it is not a blanket approval and will be subject to benefits outweighing the risks
Dr Stephen Hahn, Commissioner, US Food and Drug Administration (FDA) is willing to fast-track a COVID-19 vaccine as quickly as possible, the Financial Times reported him as saying in an interview published on Sunday.
Dr Hahn said his agency was prepared to authorise a vaccine before Phase Three clinical trials were complete, as long as officials are convinced that the benefits outweigh the risks, the newspaper reported
“Our emergency use authorisation is not the same as a full approval,” Hahn told the FT. “This is going to be a science, medicine, data decision. This is not going to be a political decision,” Hahn said.
He said the safest way for the vaccine to be available for use before the end of Phase Three trials, which involve thousands of patients and can take years, would be by issuing an emergency authorisation for use by certain groups rather than a blanket approval, the FT reported.
(Edits by EP News Bureau)
- Advertisement -