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Coronavirus update: outbreak has not disrupted drug supplies, vaccine development advancing

The 2019-nCoV outbreak has not adversely affected supplies of drugs or active pharmaceutical ingredients to the U.S., FDA Commissioner Stephen Hahn said Friday. “At this moment we have received no reports from manufacturers of disruptions to the pharmaceutical supply chain,” he said at a briefing by the Coronavirus Task Force.

Risks to the U.S. supply chain, public health measures, and the development of therapies and vaccines will be discussed at a Senate Homeland Security Committee roundtable on Feb. 12. Expected participants include Robert Kadlec, assistant secretary for preparedness and response (ASPR) at HHS; former FDA Commissioner Scott Gottlieb; and Luciana Borio, VP at IN-Q-Tel, a non-profit investment firm and former director for medical and biodefense preparedness at the White House National Security Council.

China has rebuffed U.S. offers to send scientific and medical experts to help mitigate the outbreak, HHS Secretary Alex Azar said at the task force briefing.

In contrast to the U.S. drug supply chain, there are global shortages of personal protective equipment (PPE), WHO Director General Tedros Adhanom Ghebreyesus said Friday in a press briefing. “Demand is up to 100 times higher than normal and prices are up to 20 times higher.”

Tedros said shortages have been “exacerbated by widespread, inappropriate use of PPE outside patient care” and that “global stocks of masks and respirators are now insufficient to meet the needs of WHO and our partners.”

WHO and the Global Research Collaboration for Infectious Disease Preparedness have scheduled a Feb. 11-12 global research and innovation forum to mobilize international action in response to the 2019-nCoV emergency.

At the U.S. Coronavirus Task Force briefing, Tony Fauci, director of NIH’s National Institute for Allergy and Infectious Diseases, said that two randomized, controlled trials of remdesivir are under way in China. Both are testing remdesivir, a nucleotide analog from Gilead Sciences Inc. (NASDAQ:GILD), plus standard of care versus SOC.

At least 31 clinical trials of 2019-nCoV therapies are under way in China (see “Clinical Trials for Coronavirus Have Begun”).

Fauci also updated the status of a 2019-nCoV RNA vaccine that Moderna Inc. (NASDAQ:MRNA) is developing in partnership with NIAID. The vaccine development program is being funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

There have been “no glitches so far” in the program, Fauci said. He reported that preclinical studies of a candidate vaccine have started and Moderna has started GMP manufacturing.

NIAID plans to start a Phase I trial of the vaccine candidate in two and a half months, Fauci said.

In addition to the Moderna vaccine program, at least 17 other 2019-nCoV vaccine development programs are under way.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus. The 2019n-CoV content is free to all who visit the site.

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