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FDA head says he is willing to fast-track Covid-19 vaccine


The head of the US Food and Drug Administration has said he is willing to bypass the normal approval process to authorise a Covid-19 vaccine as soon as possible — but has insisted he will not do so to please President Donald Trump. In an interview with the Financial Times, Stephen Hahn said his agency was prepared to authorise a vaccine before Phase Three clinical trials were complete, as long as officials believed the benefits outweighed the risks. But he defended his embattled organisation against accusations that it was rushing the process to boost Mr Trump’s re-election prospects. “It is up to the sponsor [vaccine developer] to apply for authorisation or approval, and we make an adjudication of their application,” Dr Hahn said. “If they do that before the end of Phase Three, we may find that appropriate. We may find that inappropriate, we will make a determination.”

Financial Times - August 30, 2020

View the full story here: https://www.ft.com/content/f8ecf7b5-f8d2-4726-ba3f-233b8497b91a