Coronavirus government response updates: FDA authorizes emergency use of remdesivir

Roughly 25 states are lifting some form of restriction over the weekend.

May 1, 2020, 5:42 PM

Though the White House has not held an official coronavirus task force briefing all week, President Donald Trump has taken the opportunity at other scheduled appearances to take questions and applaud his administration's response to the coronavirus pandemic as a "spectacular job."

At the tail-end of a response to a question Thursday about the president's senior adviser and son-in-law Jared Kushner declaring the government's response to COVID-19 a "success story," Trump touted the U.S. death total, which has climbed past 60,000, as "very strong."

"Our death totals, our numbers per million people, are really very, very strong. We are very proud of the job we have done," he said in the East Room event on "protecting America's seniors."

PHOTO: President Donald Trump listens during an event with Gilead Sciences on their work on HIV and Hepatitis C, in the Oval Office at the White House in Washington, May 1, 2020.
President Donald Trump listens during an event with Gilead Sciences on their work on HIV and Hepatitis C, in the Oval Office at the White House in Washington, May 1, 2020.
Carlos Barria/Reuters

Trump's push to reopen comes as the country's economy sees its largest decline since the Great Recession, unemployment claims break records and as a November presidential election approaches.

Here are Friday's most significant developments in Washington:

  • The White House social distancing guidelines have expired
  • Trump delivers afternoon remarks, travels to Camp David
  • White House press secretary Kayleigh McEnany completes her first official press briefing
  • Fauci confirms project to speed up vaccination development
  • McConnell faces criticism for decision to bring Senate back Monday after House lawmakers suspend their return

Trump, Hahn say FDA has authorized emergency use of remdesivir

In an unannounced event, Trump called reporters into the Oval Office Friday afternoon and announced the Food and Drug Administration has authorized Gilead for emergency use of remdesivir to treat COVID-19.

"I'm pleased to announce that Gilead now has a EUA (emergency use authorization) from the FDA for remdesivir -- and you know what that is, because that's been the hot thing also in the papers and in the media for the last little while," the president said.

FDA Commissioner Stephen Hahn confirmed the authorization "was issued today."

PHOTO: Daniel O'Day, CEO of Gillead Sciences Inc., speaks during a meeting with President Donald Trump in the Oval Office of the White House, May 1, 2020, in Washington, as Vice President Mike Pence and Adam Boehler watch.
Daniel O'Day, CEO of Gillead Sciences Inc., speaks during a meeting with President Donald Trump in the Oval Office of the White House, May 1, 2020, in Washington, as Vice President Mike Pence and Adam Boehler watch.
Alex Brandon/AP

Vice President Mike Pence, coronavirus response coordinator Dr. Deborah Birx, Health and Human Services Sec. Alex Azar, and Gilead CEO Daniel O'Day were also in attendance.

O'Day said Gilead is working to ramp up production so there will be a greater supply the second half of the year. He also they'll be donating "about 1.5 million vials" of the drug to hospitalized patients and will work with the federal government to determine how to best distribute the supply

"Because there are patients out there that can benefit from this medicine today that are hospitalized. We don't want any time to waste for that," the CEO said.

Birx took a moment to thank patients in the randomized trial that led them to conclude remdesivir might be an efficient treatment.

"To the patients who were willing to be randomized and to the doctors who did the trials and the nurses who took care of them, we're very grateful, because this clinical research is critical for these breakthroughs," Birx said. "But obviously, there's someone getting the agent and there's others that aren't. And so that's really been extraordinary."

PHOTO: Dr. Deborah Birx, White House coronavirus response coordinator, speaks during a meeting with Daniel O'Day, CEO of Gillead Sciences Inc., and President Donald Trump in the Oval Office of the White House, May 1, 2020, in Washington.
Dr. Deborah Birx, White House coronavirus response coordinator, speaks during a meeting with Daniel O'Day, CEO of Gillead Sciences Inc., and President Donald Trump in the Oval Office of the White House, May 1, 2020, in Washington.
Alex Brandon/AP

The emergency use authorization allows for remdesivir to be distributed and administered intravenously by health care providers, as appropriate, to treat severe cases of COVID-19 in adults and children hospitalized with the disease.

The FDA officially confirmed the move in a statement: "While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients."

It also cautioned "the issuance of an EUA is different than FDA approval" -- but in the absence of any "approved" treatments, doctors are allowed to use it with patients now.

This is the first FDA authorized therapy for COVID-19 treatment.

Trump says US will 'hopefully' come in below 100,000 deaths from coronavirus

After previously saying he predicted the U.S. death toll to be roughly 60,000 from the novel coronavirus, Trump said the U.S. will "hopefully" remain below 100,000 deaths -- but that it could have been worse.

PHOTO: President Donald Trump speaks during a coronavirus response event in the Blue Room at the White House in Washington, May 1, 2020.
President Donald Trump speaks during a coronavirus response event in the Blue Room at the White House in Washington, May 1, 2020.
Carlos Barria/Reuters

"People were thinking in terms of 1.5 million lives lost to 2.2 without the mitigation, and hopefully we're going to come in below that 100,000 lives lost, which is a horrible number nevertheless. It's a horrible thing. Could have been stopped. Should have been stopped at the source, but it wasn't," the president said.

"Think of it, we could save anywhere from a million to even 1,000,005m and guess if you think about it, we could save 2.1, 2.5 million lives, depending on what happens with this invisible enemy," Trump added. "As we said, nobody knows what really happens, but we've learned a lot in the last two months."

PHOTO: President Donald Trump presents a "Presidential Message of Appreciation" to Kyle West of Cincinnati for his actions delivering essential supplies requested by the elderly people living along his mail route, at the White House, May 1, 2020.
President Donald Trump presents a "Presidential Message of Appreciation" to mail carrier Kyle West, 23, of Cincinnati for his actions delivering essential supplies requested by the elderly people living along his mail route, at the White House in Washington, May 1, 2020.
Carlos Barria/Reuters

Trump made the remarks in the afternoon event in the Blue Room, the White House said, "to recognize a handful of individuals who have gone above and beyond to assist their fellow Americans during this challenging time."

The president said the day's honorees would be "the first of a number of individuals we will honor in the coming weeks," before handing out certificates.

New White House press secretary Kayleigh McEnany delivers first briefing: 'I will never lie to you'

President Donald Trump's new press secretary, Kayleigh McEnany, held her first official briefing from the White House Briefing Room, something her predecessor never did, and vowed from the podium: "I will never lie to you."

"I will never lie to you. You have my word on that. As to the timing of the briefings, we do plan to do them. I will announce the timing of that forthcoming, but we do plan to continue these," McEnany said, breaking an extended draught of no White House press briefings.

At the top of the briefing, McEnany announced that $12 billion in aid will be distributed to 395 hospitals that were hardest hit by the coronavirus pandemic. She said New York, New Jersey and Illinois would receive the most money.

Tune into ABC at 1 p.m. ET and ABC News Live at 4 p.m. ET every weekday for special coverage of the novel coronavirus with the full ABC News team, including the latest news, context and analysis.

She went on to express the president's continued displeasure with China and said Trump is deciding how to handle what she called the country's "slow-walking."

"I won't get ahead of the president's decision or the timing of that decision, but he takes this very seriously because the decisions of China that I referenced, slow-walking some of that information, put American lives at risk," she said, after reading a timeline of how, she said, China and the World Health Organization were slow to respond.

PHOTO: White House press secretary Kayleigh McEnany arrives to speak during a press briefing at the White House, May 1, 2020, in Washington.
White House press secretary Kayleigh McEnany arrives to speak during a press briefing at the White House, May 1, 2020, in Washington.
Evan Vucci/AP

She was also asked whether the president supports armed protesters in Michigan, after he tweeted for the state's Democratic governor to "make a deal" with her residents Friday morning, to which McEnany said, he was making a general reference.

"The president was referencing generally that in this country you have a First Amendment right to protest," she said. "He encourages everyone to protest lawfully, and then also to engage in our social distancing guidelines, which we think all Americans should engage in."

Notably, the White House social distancing guidelines have expired, but McEnany could have been referring to social distancing guidelines suggested by the Centers for Disease Control and Prevention or those imposed by states.

PHOTO: White House Press Secretary Kayleigh McEnany holds her first on-camera news conference in the James Brady Press Briefing Room at the White House, May 01, 2020, in Washington.
White House Press Secretary Kayleigh McEnany holds her first on-camera news conference in the James Brady Press Briefing Room at the White House, May 01, 2020, in Washington.
Chip Somodevilla/Getty Images

When ABC News' Chief White House Correspondent Jonathan Karl sought details about "Operation Warp Speed," the administration's effort to fast-track vaccine development, McEnany didn't offer many details but said the president will be the "day-to-day point person" on the project.

"Rest assured we're on an accelerated pace to a vaccine at least for this phase one portion of clinical trial," McEnany said.

Asked about the return of the president's mega rallies, which Trump said this week he "hopes" to have again soon, she said she would defer the question to the Trump campaign.

Trump to travel to Mount Rushmore for Fourth of July

The White House has confirmed that President Trump will travel to South Dakota to visit Mount Rushmore for fireworks and to see the iconic presidential sculpture as part of a Fourth of July celebration.

The visit will actually take place on July 3, a White House official said, as the president has also said he still intends to have his July 4th Salute to America event on the National Mall, even as he's admitted it may be downsized somewhat this year due to the coronavirus.

-- ABC News' Jordyn Phelps

Most states easing restrictions Friday not yet meeting White house 'gating criteria' for reopening guidelines

Most states that are relaxing some restrictions Friday do not appear to be satisfying the "gating criteria" the White House suggested "before proceeding to phased comeback," as part of the guidelines for "Opening Up America Again."

The criteria says states and regions should achieve the following before moving on to phase one: A "downward trajectory" of reported "influenza-like illnesses," "COVID-like syndromic cases" and "documented cases" or "positive tests as a percent of total tests" within a 14-day period, as well as the ability for hospitals to "treat all patients without crisis care" and have a "robust testing program in place for at-risk healthcare workers, including emerging antibody testing."

The University of Washington's Institute for Health Metrics and Evaluation (IHME) model, a key forecasting tool used by the White House, shows states meeting the criteria for hospital capacity -- but all states reopening in some form Friday, except for Hawaii, do not appear to have a "downward trajectory" of cases for 14 days.

The government's top expert on infectious diseases, Dr. Anthony Fauci, said at a CNN event Thursday that governors should have "wiggle room" on reopening their states but offered a suggestion: "Don't wiggle too much."

-- ABC News' Brian Hartman

Dept. of Housing and Urban Development allocates second wave of relief funds for public housing residents

The Department of Housing and Urban Development (HUD) on Friday announced the allocation of $685 million from the CARES Act to go to "low-income Americans residing in public housing" as part of COVID-19 relief efforts.

The funds will be allocated through the Public Housing Operating Fund, according to HUD, and Public Housing Authorities may use them for: "Childcare costs for residents so that they can continue to work, and childcare costs for staff performing essential functions," "costs of protecting residents (particularly high-risk residents) from exposure from interaction with PHA (Public Housing Authority) staff and vice versa," and "expenses to safely transport residents/staff in need of medical attention," among other options.

"HUD has worked hard to ensure that these funds will reach Public Housing Authorities quickly and efficiently, so they are well equipped to protect their residents and staff as we all work together as a Nation to combat this invisible enemy," said Housing and Urban Development Secretary Dr. Ben Carson in a statement.

The department's first wave of funding of over $3 billion was allocated on April 2 "to assist communities and non-profits, help protect the homeless and Americans with compromised immune systems, and assist Tribal communities in their COVID-19 response efforts."

-- ABC News' Sophie Tatum

Trump tweets support for Michigan protesters, suggests Whitmer 'make a deal'

President Donald Trump is tweeting support once again for protesters in Michigan after Democratic Gov. Gretchen Whitmer extended the state's stay-at-home order and protesters, some who were armed, spilled into the state Capitol Thursday. The president suggested the governor "give a little" and "make a deal."

He had previously tweeted to "LIBERATE" protesters in Michigan, Minnesota and Virginia -- 2020 election battleground states with Democratic governors -- appearing to try to take advantage of public restlessness amid the coronavirus pandemic.

Trump set to travel to Camp David

With the White House social distancing guidelines officially expired, President Donald Trump is traveling to his vacation home of Camp David for the weekend following his Friday afternoon remarks on "Presidential Recognition Ceremony: Hard Work, Heroism, and Hope."

PHOTO: President Donald Trump speaks on protecting Americas seniors from the COVID-19 pandemic in the East Room of the White House in Washington, April 30, 2020.
President Donald Trump speaks on protecting Americas seniors from the COVID-19 pandemic in the East Room of the White House in Washington, April 30, 2020.
Mandel Ngan/AFP via Getty Images

It'll be the first time Trump has left the White House since March 28, when he went on a day trip to Norfolk, Virginia, to send off the USNS Comfort.

He briefly visited the Federal Emergency Management Agency headquarters in Washington, D.C., on March 19.

Before that, he was in Florida the first weekend of March, and prior to that Florida trip, he maintained a regular travel schedule of rallies and other events, such as a rally in Charleston, South Carolina, on Feb. 28.

-- ABC News' Ben Gittleson

What to know about the coronavirus:

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