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Coronavirus Update: FDA Puts Inovio Trial on 'Partial Clinical Hold'

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According to Johns Hopkins, There are over 33.1 million cases of the virus worldwide, with over 998,000 deaths.

The U.S. has surpassed 7.1 million cases with 204,000 deaths.

Per the COVID-19 Tracking Project, there were 35,289 new cases reported Sunday, which is lower than the 47,733 cases reported the day earlier. 806,258 new tests were reported. And 307 deaths were reported yesterday, which is lower than the 866 deaths reported the day prior.

And markets are sharply higher in trading on Monday as we prepare for the first presidential debate, which will take place tomorrow and the final jobs report before the election on Friday.

We also have some news around Inovio’s vaccine candidate and it’s not very positive. The Food and Drug Administration has halted the company’s coronavirus vaccine trial, placing it on “partial clinical hold.”

Inovio said the FDA raised questions about its Cellectra 2000 delivery device, which is being used in the trial, while adding that the request was "not due to the occurrence of any adverse events" related to the group's expanded Phase 1 study of INO-4800, a coronavirus vaccine candidate being explored with Thermo Fisher Scientific.

The company said, "Until the FDA's questions have been satisfactorily addressed, Inovio's Investigational New Drug Application (IND) for the Phase 2/3 trial is on partial clinical hold...The company is actively working to address the FDA's questions and plans to respond in October, after which the FDA will have up to 30 days to notify Inovio of its decision as to whether the trial may proceed. "

Moderna, Pfizer, Johnson & Johnson and AstraZeneca are commonly referred to as the front-runners in the race to get a COVID-19 vaccine.

You can follow Katherine Ross on Twitter at @byKatherineRoss.

Read more from Katherine Ross here.

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