FDA Eying Antimalarial Drug With COVID-19 Vaccine Testing Underway

WASHINGTON (CN) — Nearly two months since the U.S. confirmed its first case of the novel coronavirus, the White House said Thursday it is pushing to have a pre-existing antimalarial drug available broadly for treatment.

“It’s been around for a long time, so we know if things don’t go as planned, it’s not going to kill anybody,” President Donald Trump said this morning, discussing hydroxychloroquine at a briefing by the White House task force.

A surgical mask is placed on The “Fearless Girl” statue outside the New York Stock Exchange on Thursday. (AP Photo/Kevin Hagen)

Flanked by Vice President Mike Pence and other members of the task force including immunologist and task force coordinator Deborah Birx, Trump said the drug would be available by prescription.

“I think it could be a game changer and maybe not,” he said. “But it could be, based on what I see, a game changer. I want every American to know we’re doing what we can.”

Food and Drug Administration Commissioner Stephen Hahn emphasized at the same press conference, however, that the drug is still in the clinical trial phase.

Trump meanwhile said the administration has been urging the Food and Drug Administration to slash red tape, pointing to the first clinical trials for a COVID-19 vaccine that got underway in Washington state this week.

A spokesperson for the FDA said Thursday that hydroxychloroquine has not yet been approved for use in individuals with COVID-19.

As far as other vaccines or antiviral drugs go, Hahn sought to quell concerns that the FDA may be rushing safety-review periods.

“We need to expand different therapeutic options,” he said, noting that the FDA has also ramped up its exploration of experimental drugs for compassionate use.

This will be helpful, the commissioner explained, because through compassionate care, researchers and developers can gather data that informs safety and efficacy for broader treatment of the population.

The antiviral drug remdesivir was also discussed. Trump called the drug “essentially approved,” prompting Hahn to issue another clarification from the dais.

Because Remdesivir is not originally intended for the novel coronavirus, Hahn said the process now is about determining the “right drug, the right dosage and the right time” to administer it to patients.

In the U.S., the number of confirmed cases now exceeds 9,400, according to the Center for Systems Science and Engineering at Johns Hopkins University. For context, this time last week, that figure was closer to 1,600 confirmed cases. The case rate will continue to rise as testing becomes more prevalent and viable across the U.S. The U.S. death toll now hovers at 150, while China on Thursday reported its first day without any local transmission of the virus.

Vice President Pence, the leader of the White House task force, said Thursday that tests were being conducted by the tens of thousands across the U.S.

“State and private labs are now required by law to report all coronavirus testing directly to the CDC, which will give the American public and our research timely information,” Pence said.

Food and Drug Administration Commissioner Stephen Hahn speaks during a Thursday press briefing with the coronavirus task force at the White House, as President Donald Trump looks on. (AP Photo/Evan Vucci)

When compared against other widely used models like the one developed by Johns Hopkins University, however, testing figures from the Centers for Disease Control and Prevention have been unreliable or at times on a dayslong delay since the start of the U.S. outbreak.

The urgent need for broader testing capacity in the U.S. is matched only by the dire need for medical equipment at U.S. health care facilities and hospitals: Ventilators are needed to treat suffering patients, and N95 masks are needed by nurses and doctors working right on the frontlines.

The CDC has recently issued guidelines suggesting medical workers reuse masks or even bandanas in the interim.

Pence said Thursday that manufacturer Honeywell is “repurposing” its production facility to increase mask production up to 120 million masks per year. Other companies, like 3M, Pence said, will also increase their output to over 400 million masks per year.

But how quickly those companies can scale up is unclear. Representatives for both Honeywell and 3M did not immediately return request for comment. Pence said Thursday, however, that at least 35 million masks produced by 3M were on the assembly line back in January and are “available now” for sale now to hospitals.

It is the private sector that will buoy the medical supply chain, Pence said, going on to say the administration is “confident” the U.S. will soon have more ventilators at the ready.

A day earlier, companies like General Motors and Ford, which shuttered automotive production through the end of this month because of the outbreak, announced they are evaluating ways to build ventilators at their plants. The Department of Defense announced Tuesday it would donate 2,000 ventilators to the Department of Health and Human Services.

Pence credited help from “health care providers around the U.S.” in saying the administration has identified tens of thousands of ventilators that can be converted to treat the sick, but he did not offer specifics beyond that.

The White House did not return request for comment Thursday afternoon.

With layoffs unfolding around the nation and stock markets throttled daily, the push to provide relief to millions of Americans continues. Trump signed off Wednesday on a relief package covering sick leave and unemployment benefits as well as free testing for the virus. The administration is also angling for a $500 billion infusion to taxpayers and another separate package of $500 billion for small businesses. The first tranche includes is stimulus that Treasury Secretary Steve Mnuchin described on Fox News Thursday as a $1,000 check for each adult and a $500 additional check for each child.

The White House has suggested this week that those checks could be distributed within three weeks of finalization of the deal in the Senate. Mnuchin said Thursday that six weeks from that point, if necessary, another series of checks will be distributed. Those checks might total $3,000 per adult.

When faced with a question over fears of growing unemployment, Trump was dismissive of a recent prediction from Kevin Hassett, the Trump administration’s former chief economist. Hassett Thursday suggested on CNN that the coronavirus outbreak could trigger a million jobs lost in the U.S.

“I don’t think anyone believe that is going to happen,” Trump said.

But if the U.S. can see the virus “wrapped up” sooner than later, he said, he expects the economy to “rocket up” and work out “nicely.”

The State Department is also poised to announce tighter travel restrictions, including instruction to Americans not to travel abroad. Politico was the first to report the development. Americans who are already overseas but cannot return home will reportedly be encouraged to shelter in place.

Trump wouldn’t comment on the travel restrictions Thursday and was equally cagey when discussing when he thought Americans may be able to end social distancing and resume life as normal.

“I hope very soon,” Trump said, going on to call the current state of affairs uncharted territory.

Whether the social-distancing guidelines that the White House is promoting will be extended in two weeks, the president responded: “We’ll have to see.”

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