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Coronavirus Pandemic

Coronavirus Live: US FDA may fast track Covid vaccine before Phase 3 trials complete

IANS/New York
Filed on August 31, 2020
us, covid-19, vaccine, coronavirus, fda

(Reuters file)

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

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 vaccine 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 prospects 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.

31,000 volunteers vaccinated in UAE Covid vaccine phase 3 trials

The first Phase lll trials of an inactivated vaccine for Covid-19 in the UAE are among the largest in the world in volunteer recruitment having reached 31,000 vaccinated volunteers from more than 120 nationalities in only six weeks.

The speed and efficiency of volunteer registration, screening and vaccination is setting new global benchmarks for the 4Humanity trials of the inactivated vaccine developed by Sinopharm CNBG.

Reaching this volunteer milestone means that the vaccine centres at ADNEC and Al Qarain Center in Sharjah are now closed to new volunteers but remain open for individuals taking their second shot of the vaccine and for other health check-ups required as part of the programme per the approved protocols and timelines set for individual volunteers who are participating.

The Department of Health, Abu Dhabi has confirmed that there are now sufficient numbers of volunteers required to complete the clinical trial so no new registrations will be accepted effective from Sunday, August 30.

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