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FDA willing to fast track COVID-19 vaccine, as U.S. nears 6 million cases

FDA willing to fast track COVID-19 vaccine, as U.S. nears 6 million cases
Food and Drug Administration Commissioner Stephen Hahn on Sunday said the agency would consider issuing an emergency use authorization for a COVID-19 vaccine ahead of stage three clinical trials. File Photo by Kevin Dietsch/UPI | License Photo

Aug. 30 (UPI) -- Food and Drug Administration Commissioner Stephen Hahn said the agency would be willing to fast track a COVID-19 vaccine as the United States nears 6 million cases.

In an interview with Financial Times, Hahn said the FDA would consider an emergency authorization of a vaccine for the coronavirus before the completion of phase three clinical trials if it found it appropriate to do so.

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"It is up to the [vaccine developer] to apply for authorization or approval and we make an adjudication of their application," he 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."

Hahn said the decision would not be politically influenced and would rather be based on science, medicine and data.

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"We have a convergence of the COVID-19 pandemic with the political season, and we're just going to have to get through that and stick to our core principles," said Hahn.

He added that an emergency use authorization, like the one the agency issued last week for convalescent plasma treatments following criticism by President Donald Trump, is not the same as full approval.

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"The legal, medical and scientific standard for that is that the benefit outweighs the risk in a public health emergency," Hahn said.

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Hahn's comments come as the United States nears 6 million total COVID-19 cases, with a world-leading 5,969,916 reported as of Sunday afternoon, according to data collected by Johns' Hopkins University. The United States has also reported more deaths than any other nation since the start of the pandemic with a death toll of 182,909.

California reported 6,070 new cases on Sunday for a total of 699,909, as it leads the nation in total cases. The state also reported 71 new deaths for a death toll of 12,905 in third place behind New York and New Jersey.

Florida on Sunday reported 2,583 new COVID-19 cases, its lowest total since June after reporting a record high of 15,299 on July 12. The state is second in the nation with a total of 621,586 reported cases. Florida also reported 14 new resident deaths for a total of 11,119, also the lowest since 12 in June, and fifth overall.

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Texas is third in the nation in total COVID-19 cases, reporting 3,759 new positives for a total of 610,354 and fourth in deaths at 12,510 after reporting 90 new fatalities.

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New York Gov. Andrew Cuomo announced the state reported 698 new COVID-19 cases and eight new deaths on Sunday, as the state also set a record-high with 100,022 test results. The state leads the nation in deaths with 32,944 confirmed fatalities and is fourth in cases with a total of 434,100 after having been the U.S. epicenter of the virus.

SUNY Oneonta, a public college in central New York, announced Sunday it would suspend in-person classes for two weeks after they began on Monday.

The university has reported 105 positive cases since the start of the semester as of Sunday, while 36 students have been quarantined on campus and seven are in isolation. State University of New York Chancellor Jim Malatras is set to visit the university on Sunday after reports of "a number of large gatherings and parties" reported on campus.

Georgia reported 1,298 new cases for the fifth highest total in the nation at 268,973 and 28 new deaths for a total of 5,604. It's the first time cases fell under 1,300 since late June.

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