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US FDA may fast track COVID vax before Phase-3 trials complete

US FDA may fast track COVID vax before Phase-3 trials complete
August 31
10:02 2020

NEW YORK: 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 Sunday, FDA Commissioner Stephen Hahn said emergency authorisation of Covid-19 could be the right decision if the benefits outweigh the risks. The development comes barely a week after US President Donald Trump lashed out at the FDA for its approach to giving drug makers the approvals for testing vaccines and medicines.

Trump accused the FDA of trying to delay the approval process in a bid to harm his propspects in the November elections.

The FDA Commissioner, however, denied that such a move would be influenced by political consideration. “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. The Financial Times last week reported that the Trump administration was considering speeding up the availability of an experimental Convid-19 vaccine from the UK ahead of the presidential polls in November.

The vaccine candidate the Trump administration is targeting for fast tracking is being developed by thee Oxford University in partnership with AstraZeneca, said the report.

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.

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