US FDA may fast track COVID vaccine before Phase-3 trials co
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After Russia and China, the US drug regulator is now willing to consider giving emergency authorisation to a COVID-19 vaccine even before the end of crucial Phase-3 trials, according to the head of US Food and Drug Administration (FDA).

In an interview with the Financial Times published on 30 August, FDA Commissioner Stephen Hahn said emergency authorisation of COVID-19 could be the right decision if the benefits outweigh the risks.

"It is up to the (vaccine developer) to apply for authorisation or approval, and we make an adjudication of their application," Hahn told The Financial Times.

"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," he was quoted as saying.

China and Russia have both approved vaccines without waiting for the end of Phase Three trials, which are the largest and most rigorous of all the tests that a potential new drug. But they have been criticised by public health officials — including ones in the US — who have warned that doing so could be unsafe.

Public health officials have warned that giving approval to COVID-19 vaccine before completion of Phase-3 trials could amount to compromising on safety concerns.

Source: https://www.ft.com/content/f8ecf7b5-f8d2-4726-ba3f-233b8497b91a
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