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| Coronavirus US live: FDA approves experimental drug remdesivir for emergency use | Coronavirus US live: FDA approves experimental drug remdesivir for emergency use |
| (32 minutes later) | |
| Emergency approval comes days after Dr Anthony Fauci expressed cautious optimism about results of drug trial | Emergency approval comes days after Dr Anthony Fauci expressed cautious optimism about results of drug trial |
| Michigan Governor Gretchen Whitmer said Friday that Michigan will remain under stay-at-home orders through 15 May, despite Republican lawmaker in the states refusing to extend her emergency declaration, the AP reports. | |
| The order will allow for some outdoor work, such as forestry, power equipment maintenance and construction, to resume next Thursday. | |
| Earlier today, Donald Trump tweeted that Whitmer should “give a little” and “make a deal” with a small group of protesters, some of them armed, who have held demonstrations at the state capital urging a reopening of the state. | |
| “The governor of Michigan should give a little, and put out the fire,” Trump said in a tweet on Friday morning. “These are very good people, but they are angry. They want their lives back again, safely! See them, talk to them, make a deal.” | |
| Whitmer called the protests “disturbing” and said that the presence of swastikas, Confederate flags, nooses and assault weapons “do not represent who we are as Michiganders”. | |
| “We’re not in a political crisis where we should just negotiate and find some common ground here. We’re in a public health crisis,” she said. “We’re in the midst of a global pandemic that has already killed almost 4,000 people in our state.” | |
| The Food and Drug Administration (FDA) has released additional information about its emergency use authorization (EUA) for remdesivir, the anti-viral drug that has shown some promise as a treatment for patients with Covid-19. Donald Trump announced the EUA earlier today. | |
| Use of the drug will be authorized for adults or children who are hospitalized with suspected or confirmed Covid-19 and whose condition is “severe”, meaning they have low blood oxygen levels, need oxygen therapy, or are on a mechanical ventilator, the FDA said. | |
| “Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use,” the FDA said in its statement. | |
| The EUA also includes information about possible side effects, which include “increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering”. It also notes that there may be other serious side effects that have not been discovered yet. | |
| The EUA requires hospitals to monitor patients’ liver enzymes through blood tests before the treatment is started and every day that treatment is ongoing. | |
| Patients who receive the drug will be provided with a fact sheet, which is available here. The drug is administered through an IV once a day for up to 10 days. | |
| Donald Trump appears to have revised upward to 100,000 his expectations for the number of Americans who will die of Covid-19. | Donald Trump appears to have revised upward to 100,000 his expectations for the number of Americans who will die of Covid-19. |
| “Hopefully we’re going to come in below that 100,000 lives lost, which is a horrible number nevertheless,” Trump said at a White House event to honor people who are doing work related to the coronavirus pandemic, according to Reuters. | “Hopefully we’re going to come in below that 100,000 lives lost, which is a horrible number nevertheless,” Trump said at a White House event to honor people who are doing work related to the coronavirus pandemic, according to Reuters. |
| On Monday, Trump had said that the death toll would likely be between 60,000 and 70,000. As of Friday, it stand at 64,198. | On Monday, Trump had said that the death toll would likely be between 60,000 and 70,000. As of Friday, it stand at 64,198. |
| Trump has changed his predictions over time. On Friday, he claimed that the White House’s actions had saved “maybe millions of lives”. | Trump has changed his predictions over time. On Friday, he claimed that the White House’s actions had saved “maybe millions of lives”. |
| The last patient has left the field hospital that was erected in New York City’s Javits convention center, the AP reports. | The last patient has left the field hospital that was erected in New York City’s Javits convention center, the AP reports. |
| The emergency facility was erected by the members of the US military to alleviate strain on the city’s hospital system at the height of the outbreak. It ultimately treated 1,095 patients, the last 8 of whom left the hospital today. | The emergency facility was erected by the members of the US military to alleviate strain on the city’s hospital system at the height of the outbreak. It ultimately treated 1,095 patients, the last 8 of whom left the hospital today. |
| The closure of the emergency hospital is another hopeful sign that conditions in New York are improving, though the crisis is by no means over. On Friday, New York governor Andrew Cuomo reported a daily death toll of 289. | The closure of the emergency hospital is another hopeful sign that conditions in New York are improving, though the crisis is by no means over. On Friday, New York governor Andrew Cuomo reported a daily death toll of 289. |
| Hello everyone, this is Julia Carrie Wong in Oakland, California, picking up the blog for the rest of the day. | Hello everyone, this is Julia Carrie Wong in Oakland, California, picking up the blog for the rest of the day. |
| As we head into the weekend, and with the weather improving around the country, the question of whether people should be allowed to go to beach is inspiring debate and protest. | As we head into the weekend, and with the weather improving around the country, the question of whether people should be allowed to go to beach is inspiring debate and protest. |
| In California, where Governor Gavin Newsom ordered the closure of beaches in Orange County, hundreds of people staged a protest in Huntington Beach. | In California, where Governor Gavin Newsom ordered the closure of beaches in Orange County, hundreds of people staged a protest in Huntington Beach. |
| Meanwhile, in Florida, the beaches have been opened, and not everyone is happy about it. | Meanwhile, in Florida, the beaches have been opened, and not everyone is happy about it. |
| This local lawyer, who dressed as the Grim Reaper, granted an interview to a local TV reporter, and argued that it is simply too soon for the beaches to be open. | This local lawyer, who dressed as the Grim Reaper, granted an interview to a local TV reporter, and argued that it is simply too soon for the beaches to be open. |
| My colleague Sam Levin spoke to several experts about the potential risks and rewards of allowing people to go to beaches during this pandemic. You can read his full report here: | My colleague Sam Levin spoke to several experts about the potential risks and rewards of allowing people to go to beaches during this pandemic. You can read his full report here: |
| That’s it from me today. My west coast colleague, Julia Carrie Wong, will take over the blog for the next few hours. | That’s it from me today. My west coast colleague, Julia Carrie Wong, will take over the blog for the next few hours. |
| Here’s where the day stands so far: | Here’s where the day stands so far: |
| The FDA has approved remdesivir for emergency use on hospitalized coronavirus patients. A drug trial of remdesivir showed a positive effect on coronavirus patients’ recovery time and survival rate. Dr Anthony Fauci said earlier this week, “The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery. ... What it has proven is that a drug can block this virus.” | The FDA has approved remdesivir for emergency use on hospitalized coronavirus patients. A drug trial of remdesivir showed a positive effect on coronavirus patients’ recovery time and survival rate. Dr Anthony Fauci said earlier this week, “The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery. ... What it has proven is that a drug can block this virus.” |
| White House press secretary Kayleigh McEnany held her first daily briefing. It was the first time in more than a year that a White House press secretary had held a formal briefing. McEnany promised to never lie from the White House podium, but she went on to share several false or misleading statements about sexual misconduct allegations against Trump and the FBI investigation of former national security adviser Michael Flynn, among other things. | White House press secretary Kayleigh McEnany held her first daily briefing. It was the first time in more than a year that a White House press secretary had held a formal briefing. McEnany promised to never lie from the White House podium, but she went on to share several false or misleading statements about sexual misconduct allegations against Trump and the FBI investigation of former national security adviser Michael Flynn, among other things. |
| Joe Biden denied Tara Reade’s allegation of sexual assault. The presumptive Democratic presidential nominee said in an MSNBC interview, “I’m saying unequivocally, it never, never happened.” | Joe Biden denied Tara Reade’s allegation of sexual assault. The presumptive Democratic presidential nominee said in an MSNBC interview, “I’m saying unequivocally, it never, never happened.” |
| New York schools will remain closed for the rest of the academic year, governor Andrew Cuomo announced. The news was unsurprising considering the state reported another 1,000 new coronavirus hospitalizations yesterday, but the daily death toll has fallen slightly to 289. | New York schools will remain closed for the rest of the academic year, governor Andrew Cuomo announced. The news was unsurprising considering the state reported another 1,000 new coronavirus hospitalizations yesterday, but the daily death toll has fallen slightly to 289. |
| Trump said Michigan governor Gretchen Whitmer should “make a deal” with anti-stay-at-home protesters. The president’s suggestion came one day after demonstrators, some of them carrying assault rifles, swarmed the Michigan state capitol to protest Whitmer’s stay-at-home order. | Trump said Michigan governor Gretchen Whitmer should “make a deal” with anti-stay-at-home protesters. The president’s suggestion came one day after demonstrators, some of them carrying assault rifles, swarmed the Michigan state capitol to protest Whitmer’s stay-at-home order. |
| Julia will have more coming up, so stay tuned. | Julia will have more coming up, so stay tuned. |
| FDA commissioner Stephen Hahn was careful to note that remdesivir has not received FDA approval as a coronavirus treatment and has only been approved for emergency use on severely ill coronavirus patients who have been hospitalized. | FDA commissioner Stephen Hahn was careful to note that remdesivir has not received FDA approval as a coronavirus treatment and has only been approved for emergency use on severely ill coronavirus patients who have been hospitalized. |
| FDA approval requires a much more lengthy review process, while an emergency use authorization is issued more quickly after the agency weighs the potential risks and potential benefits of a treatment option to help address an emergency situation. | FDA approval requires a much more lengthy review process, while an emergency use authorization is issued more quickly after the agency weighs the potential risks and potential benefits of a treatment option to help address an emergency situation. |
| “Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” Hahn said in a statement. | “Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” Hahn said in a statement. |
| “There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts.” | “There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts.” |
| The Guardian’s Lois Beckett reports on the latest from California: | The Guardian’s Lois Beckett reports on the latest from California: |
| As many as 1000 people rallied against California governor Gavin Newsom’s stay-at-home measures in Sacramento, the state’s capitol, as hundreds more protested in conservative Huntington Beach. | As many as 1000 people rallied against California governor Gavin Newsom’s stay-at-home measures in Sacramento, the state’s capitol, as hundreds more protested in conservative Huntington Beach. |
| In his Friday news conference, Newsom said he empathized with the protesters’ “frustration and concern and deeply understandable anxiety about the economy and the fate and future of their families.” | In his Friday news conference, Newsom said he empathized with the protesters’ “frustration and concern and deeply understandable anxiety about the economy and the fate and future of their families.” |
| Asked about his response to protesters calling him a tyrant and a fasicst, Newsom was gentle. “All I ask for is: Take care of yourself,” he said. “Wear a face covering. Do justice to physical distancing. You don’t want to contract this disease.” | Asked about his response to protesters calling him a tyrant and a fasicst, Newsom was gentle. “All I ask for is: Take care of yourself,” he said. “Wear a face covering. Do justice to physical distancing. You don’t want to contract this disease.” |
| The governor said that law enforcement officials were responsible for deciding how to respond to protesters violating social distancing orders, and that he could not possibly monitor every protest happening across the state. | The governor said that law enforcement officials were responsible for deciding how to respond to protesters violating social distancing orders, and that he could not possibly monitor every protest happening across the state. |
| “I have confidence in local law enforcement, incredible confidence,” Newsom said, passing on responsibility for the fraught question of whether people violating social distancing guidelines at protests should be arrested. | “I have confidence in local law enforcement, incredible confidence,” Newsom said, passing on responsibility for the fraught question of whether people violating social distancing guidelines at protests should be arrested. |
| In Sacramento, where many protesters were flouting social distancing guidelines, at least one person had been arrested, according to a Sacramento Bee reporter. | In Sacramento, where many protesters were flouting social distancing guidelines, at least one person had been arrested, according to a Sacramento Bee reporter. |
| The Guardian’s Lois Beckett reports on the latest from California: | The Guardian’s Lois Beckett reports on the latest from California: |
| California governor Gavin Newsom promised “meaningful” adjustments to the state’s stay-at-home order in “many days, not weeks,” as small rallies to reopen the economy attracted hundreds of people in the state’s capital and in Huntington Beach, a more conservative city south of Los Angeles. | California governor Gavin Newsom promised “meaningful” adjustments to the state’s stay-at-home order in “many days, not weeks,” as small rallies to reopen the economy attracted hundreds of people in the state’s capital and in Huntington Beach, a more conservative city south of Los Angeles. |
| Newsom said that the state was “getting very close” to making changes that would affect how businesses, including restaurants, could operate, and urged residents to be patient. | Newsom said that the state was “getting very close” to making changes that would affect how businesses, including restaurants, could operate, and urged residents to be patient. |
| More than 2,000 people have died of coronavirus in California so far, including 91 people in the previous day, but the number of patients in intensive care units stayed flat, and the total number of hospitalizations had fallen slightly, both signs of progress, Newsom said in his Friday press conference. | More than 2,000 people have died of coronavirus in California so far, including 91 people in the previous day, but the number of patients in intensive care units stayed flat, and the total number of hospitalizations had fallen slightly, both signs of progress, Newsom said in his Friday press conference. |
| But, Newsom said, “We can screw all that up and set all that back by making bad decisions.” | But, Newsom said, “We can screw all that up and set all that back by making bad decisions.” |
| The positive signs in the number of hospitalizations and ICU patients was only possible “because people have done an incredible job in their physical distancing.” | The positive signs in the number of hospitalizations and ICU patients was only possible “because people have done an incredible job in their physical distancing.” |
| “Thousands of people congregating together, not practicing social distancing or physical distancing,” could undermine the current progress in preventing the spread of the virus, Newsom said. | “Thousands of people congregating together, not practicing social distancing or physical distancing,” could undermine the current progress in preventing the spread of the virus, Newsom said. |
| “If we can avoid that, we can get to the other side with modifications a lot quicker,” the governor added. | “If we can avoid that, we can get to the other side with modifications a lot quicker,” the governor added. |
| Gilead, the company that makes remdesivir, said it would donate 1.5 million doses of the drug to the US now that it has been approved for emergency use on hospitalized coronavirus patients. | Gilead, the company that makes remdesivir, said it would donate 1.5 million doses of the drug to the US now that it has been approved for emergency use on hospitalized coronavirus patients. |
| FDA commissioner Stephen Hahn said the drug’s approval for emergency use represented “an important clinical advance” in the fight against coronavirus. | FDA commissioner Stephen Hahn said the drug’s approval for emergency use represented “an important clinical advance” in the fight against coronavirus. |
| Gilead CEO Daniel O’Day said earlier today that his company has already ramped up production of the drug and hopes to make millions of treatment courses available by the end of the year. | Gilead CEO Daniel O’Day said earlier today that his company has already ramped up production of the drug and hopes to make millions of treatment courses available by the end of the year. |
| “I think it’s important to note that this is a medicine for the most severe patients,” O’Day told the “Today” show. “What we see here is really, of course, not a cure but a very, very significant and important treatment for patients.” | “I think it’s important to note that this is a medicine for the most severe patients,” O’Day told the “Today” show. “What we see here is really, of course, not a cure but a very, very significant and important treatment for patients.” |
| Trump told reporters that the drug remedesivir has been approved for emergency use to treat coronavirus patients. | Trump told reporters that the drug remedesivir has been approved for emergency use to treat coronavirus patients. |
| FDA commissioner Stephen Hahn clarified that the drug had specifically been cleared for emergency use on hospitalized coronavirus patients. | FDA commissioner Stephen Hahn clarified that the drug had specifically been cleared for emergency use on hospitalized coronavirus patients. |
| The president said the approval represented a “very promising situation” in the country’s fight against coronavirus, and Dr Deborah Birx added, “I think this really illustrates what can happen in such a short time.” | The president said the approval represented a “very promising situation” in the country’s fight against coronavirus, and Dr Deborah Birx added, “I think this really illustrates what can happen in such a short time.” |
| The emergency approval comes days after Dr Anthony Fauci, the government’s top infectious disease expert, expressed cautious optimism about the results of a remdesivir drug trial. | The emergency approval comes days after Dr Anthony Fauci, the government’s top infectious disease expert, expressed cautious optimism about the results of a remdesivir drug trial. |
| “The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” Fauci said earlier this week. “What it has proven is that a drug can block this virus.” | “The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” Fauci said earlier this week. “What it has proven is that a drug can block this virus.” |