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The FDA's Vaccines and Related Biological Products Advisory Committee panel has endorsed a second COVID-19 vaccine in the United States.Now the FDA is expected to act quickly to authorize the Moderna vaccine for emergency use and keep it on schedule to be distributed to patients across the country as early next week.The panel voted 20 yeses and one abstain.WATCH RECAP:With the panel recommending EUA, the FDA as a whole would then need to file its own EUA approval. The final step would be a formal recommendation from the Centers for Disease Control and Prevention that Americans should receive the vaccine.Last Thursday, the committee voted in favor of granting EUA to Pfizer's COVID-19 vaccine. By Monday, it was being administered across the country.The panel's meeting comes days after a key FDA report upheld the safety and efficacy results of the Moderna vaccine's Phase III trials. Those statistics showed that the vaccine was 95% effective with no severe side-effects."FDA has determined that the Sponsor has provided adequate information to ensure the vaccine's quality and consistency for authorization of the product under an EUA," the report said.An approval of Moderna's vaccine would immediately boost the supply levels of COVID-19 vaccines in the U.S. Millions of doses are ready to be shipped across the country as soon as approval is granted.The arrival of COVID-19 vaccines comes amid the bleakest stretch to date in the COVID-19 pandemic. The U.S. is currently seeing the highest level of new cases (213.000) and deaths (2,500) each day, according to seven-day rolling averages totaled by the COVID Tracking Project. More Americans than ever are also battling the virus in a hospital (113,000). 1725
The budget-priced Motel 6 chain is well known for the enduring tagline: "We'll leave the light on for you."But some Phoenix immigration attorneys said employees of the motel chain also have been shining a light on undocumented guests, providing guest information directly to US Immigration and Customs Enforcement agents.Motel 6, in response to a report this week in the Phoenix New Times, said employees will no longer work with immigration agents.The weekly newspaper reported that federal immigration agents arrested at least 20 people at two Motel 6 locations in the Phoenix area between February and August. Motel employees told the New Times they regularly delivered guest lists to ICE."This was implemented at the local level without the knowledge of senior management," the hospitality company tweeted Wednesday night. "When we became aware of it last week, it was discontinued."A Motel 6 statement on Thursday confirmed "certain local Motel 6 properties in the Phoenix area were voluntarily providing daily guest lists to Immigration and Customs Enforcement.""To help ensure that this does not occur again, we will be issuing a directive to every one of our more than 1,400 locations nationwide, making clear that they are prohibited from voluntarily providing daily guest lists to ICE."The company was reviewing practices to "help ensure that our broader engagement with law enforcement is done in a manner that is respectful of our guests' rights," the statement said."Protecting the privacy and security of our guests are core values of our company," the statement said."Motel 6 apologizes for this incident and will continue to work to earn the trust and patronage of our millions of loyal guests."Phoenix immigration attorney Ray Ybarra Maldonado said one of his clients, Alfonso Gutierrez Tovar, was taken into custody by ICE agents at a Motel 6 in May. Gutierrez had returned to the United States illegally from Mexico after a previous deportation. He was deported again last month."One of the obvious questions to me was, 'You didn't commit a new crime, so how did ICE know you were at this Motel 6?" Ybarra said.Ybarra said ICE agents knocked on the motel room door one day after Gutierrez had checked in. They asked for him by name, handcuffed him and put him in the back of a car."Then he saw them knock on four other doors and get people as well," the attorney said. "At that point it's kind of like, OK something fishy is going on here."Another attorney, Robert McWhirter, said a client named Jose Eduardo Renteria Galaviz, an undocumented immigrant from Mexico, was picked up at a Phoenix Motel 6 and is awaiting deportation. He, too, had been previously deported."I won't stay at a Motel 6 again," McWhirter said. "Here's the thing -- you don't have a right of privacy on your signature on a register ... Motel 6 is in the business of renting hotel rooms. They (shouldn't) care about immigration status."Yasmeen Pitts O'Keefe, a spokeswoman for ICE's Phoenix division, declined to reveal specifics about enforcement leads. She said those sources include other law enforcement agencies, relevant databases, crime victims, and leads from the public via agency tip lines."It's worth noting that hotels and motels, including those in the Phoenix area, have frequently been exploited by criminal organizations engaged in highly dangerous illegal enterprises, including human trafficking and human smuggling," she said in a statement.Phoenix Police spokesman Sgt. Jonathan Howard said the department sometimes gets hotel and motel guest lists through "informal contacts."Civil liberties groups criticized the Motel 6 practice.The American Civil Liberties Union of Arizona tweeted: "Will new policy reflect this "discontinued" practice, @motel6? We look forward to reading it."Cecillia Wang, deputy legal director of National ACLU, said on Twitter, "@motel6: They'll leave the light on -- for ICE and police. Turning over guest info regularly?"Tom Bodett, the longtime Motel 6 brand spokesman and the voice behind the popular slogan, said via Twitter that he believed the Phoenix motel employees acted on their own."It is troubling for sure and not at all the values that me or anybody at Motel 6 management shares," Bodett told CNN."It's just troubling as can be and I'm sorry it happened."Ybarra, the attorney, suggested a new Motel 6 tag line: "They'll shine the light on you. That's what they're doing." 4432

The forensic pathology industry is facing a workforce shortage. These are the men and women who determine how and why a death happens. They are being overwhelmed, and the pandemic has only made things worse.“What you’re seeing now is part of our autopsy examination room,” said Francisco Diaz as he walked around the Office of the Chief Medical Examiner in Washington D.C. He is the deputy chief medical examiner.“The purpose of the medical examiner is to do two things, to determine why people die and to classify the manor of death,” he said.Diaz and his team have their hands full. Here, bodies are brought in, x-rayed, and analyzed every day. Most of them are bodies of those who have died of unnatural causes, like homicide, suicide, and certain accidents.They’re brought here, where seven forensic pathologists work.“As medical examiners and forensic pathologists you are dealing with death and tragedy every single day,” he said.This year the volume has been higher than usual, in large part because of the COVID-19 outbreak. “The peak of our pandemic was April, May. At that time we had that emergency morgue off campus,” Diaz explained. “We handled approximately 400 descendants or dead bodies.”The increase in autopsies needed is not only due to COVID-19 directly, but other ripple effects.“What I see as a consequence of the pandemic is a lot of people are dying at home because they choose not to seek medical attention because they may have concerns that they may get contaminated at hospitals,” Diaz said.If they die at home, they’re sent straight to D.C.’s Medical Examiner’s Office. Most people who die in a hospital are handled by the hospital, except for in certain jurisdictions like D.C. where they will help out with the hospital's cases as well.Regardless of where the cases are coming from, jurisdictions are strapped for resources. It’s a problem across the industry right now -- one that’s been facing a workforce shortage for years.“A lot of the policy makers think that it's a waste of money. You're just spending money on the dead, but everything we do is for the living,” said Victor Weedn, Forensic Science Professor at George Washington University. He’s an expert in the forensic pathology industry.“We are terribly undermanned, under served these days. It is thought we have 500 to 600 board certified forensic pathologists working in the field across the United States and that's simply not enough. It’s estimated we really ought to have 1,200 to 1,500 forensic pathologists.”The lack of workers has become more evident due to the pandemic, and also a growing epidemic. “And then the opioid crisis hit. That immediately caused 10% to 30% more cases because of all the overdose deaths,” Weedn said. “On top of that you have the COVID pandemic. The overdose cases have not declined, in fact they've continued to increase. And now we’re seeing a wave of homicides increasing our caseload still further. We are facing a true workforce shortage.”Weedn also talked about how some of their investigations on COVID-19 patients who passed helped answer some questions we had early on in the pandemic.Increasing a workers caseload is not a great option, according to Weedn. The National Association of Medical Examiners has accreditation standards.“A forensic pathologist really isn't supposed to do more than 250 autopsies a year. If you have more than that it’s considered an infraction of the standard,” he said. “When you start doing more than that, things get lost. Details get lost.”This puts many offices in a bind. “In the face of such a severe workforce shortage you find that people have changed the criteria for what deaths they will investigate and that means there are certain deaths that will go uninvestigated. A murderer could get away with murder. That’s certainly a possibility,” Weedn explained.As the workload remains heavy for many jurisdictions, Diaz said education and exposure for the industry might be their best bet in getting more interest.“I think every crisis brings an opportunity. And I think this is an opportunity for forensic pathology to be on the forefront and let the public at large know what we do, how we do it, and to encourage young people to pursue a career in forensic pathology,” Diaz said. 4266
The Food and Drug Administration on Wednesday authorized the first rapid coronavirus test that doesn’t need any special computer equipment to get results.The 15-minute test from Abbott Laboratories will sell for , giving it a competitive edge over similar tests that need to be popped into a small machine. The size of a credit card, the self-contained test is based on the same technology used to test for the flu, strep throat and other infections.It’s the latest cheaper, simpler test to hit the U.S. market, providing new options to expand testing as schools and businesses struggle to reopen and flu season approaches. The FDA also recently greenlighted a saliva test from Yale University that bypasses some of the supplies that have led to testing bottlenecks.Both tests have limitations and neither can be done at home. Several companies are developing rapid, at-home tests, but none have yet won approval. Abbott’s new test still requires a nasal swab by a health worker, like most older coronavirus tests. The Yale saliva test eliminates the need for a swab, but can only be run at high-grade laboratories.And in general, rapid tests like Abbott’s are less accurate than lab-developed tests. The FDA said in a statement announcing the decision that negative results with Abbott’s test may need to be confirmed with a lab test in some cases. The agency granted Abbott’s test an emergency use authorization late Wednesday for patients with suspected COVID-19.The two additions should help expand the number of available tests. The U.S. is now testing about 690,000 people per day, down from a peak of 850,000 daily tests late last month. Many public health experts believe the country will soon need to test vastly more people to find those who are infected, isolate them and contain the virus.The FDA noted that Abbott’s test could be used in a doctor’s office, emergency room or some schools. “Given the simple nature of this test, it is likely that these tests could be made broadly available,” the FDA said.Since the start of the pandemic, nasal swab tests that are sent to a lab have been the standard for COVID-19 screening. While considered highly accurate, the tests rely on expensive, specialized machines and chemicals. Shortages of those supplies have led to repeated delays in reporting results, especially during a spike in cases last month.Government and health experts view rapid tests that can be run outside the laboratory system as key to boosting capacity.“Those screening tests are what we need in schools, workplaces and nursing homes in order to catch asymptomatic spreaders,” said Dr. Jonathan Quick of the Rockefeller Foundation, in an interview earlier this month. The nonprofit group has called for the U.S. to conduct about 4 millions per day by October, mostly rapid, point-of-care tests.Abbott’s BinaxNOW is the fourth rapid test that detects COVID-19 antigens, proteins found on the surface of the coronavirus, rather than the virus itself. It’s considered a faster, though sometimes less precise, screening method. The other tests need to be inserted into a small machine.Inside the Abbott test is a specially coated strip that interacts with COVID-19 antigens. The patient’s nasal swab is inserted into the card and a few drops of a chemical solution are added. Markings appear on the card to indicate whether the sample is positive or negative — much like a pregnancy test.Two other makers of antigen tests — Quidel and Becton Dickinson have said they haven’t been able to meet demand for the tests. A third, LumiraDx, plans to begin shipping its recently approved antigen tests by the end of this month. Abbott expects to begin shipping tests in September, reaching 50 million tests a month in October.The influx of antigen tests will go a long way toward meeting the Trump administration’s projection that 90 million COVID-19 tests a month will be available by September if needed. But U.S. “testing czar” Adm. Brett Giroir has stressed that the U.S. can contain the outbreak with far fewer tests.“That’s the capacity ... we do not need that many tests to safely and sensibly reopen,” Giroir told reporters on a recent call. He pointed to several key indicators that have been falling, including new infections and hospitalizations, even as testing has slowed.Earlier this month, the FDA authorized Yale’s saliva-based test, which is expected to cut the time and cost compared with similar tests. It’s the fifth COVID-19 saliva tests OK’d by regulators. All require lab processing.Developed by Yale’s School of Public Health, SalivaDirect can use any sterile container to collect a sample, not the special tube needed with earlier tests, and requires less chemicals. Outside experts welcomed the new approach but noted its limitations.“It’s not a rapid test, it’s a laboratory-based test that will still be prone to the same massive delays as any other test,” said Dr. Michael Mina of Harvard University.___Follow Matthew Perrone on Twitter: @ AP_FDAwriter.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. 5201
The death toll from a series of wildfires in western states rose sharply Thursday evening, and officials expect more casualties and damage in the coming days.A total of 17 people have been killed in wildfires in California, Oregon and Washington in recent days. More than 100 fires are currently burning throughout 13 western states.On Thursday evening, officials with the Butte County Sheriff's Office in California announced that seven more people had died in what is now known as the North Complex Fire, according to ABC News. That brings the death toll from that particular fire up to 10, with 16 people still missing.ABC News also reports that one other person died Thursday in the Slater Fire, which is currently burning in Siskiyou County, California.A total of four people have been killed in a series of wildfires in Oregon in recent days. One person died Thursday in the Almeda Fire in the southern part of the state, bringing the total death toll to two. Two others died in a wildfire near Salem on Wednesday.In Washington, a 1-year-old boy was killed by the Cold Springs Fire, which is currently burning in the northeast part of the state.USA Today reports that more than 500,000 people in Oregon have been forced to evacuate due to the wildfires — more than 10% of the state's population. Many of the fires burning in Oregon are currently 0% contained — further threatening forest, 900,000 acres of which have already been burned in the state. That's more than double what typically burns in an entire year.“We have never seen this amount of uncontained fire across the state,” Oregon Gov. Kate Brown said Thursday.The New York Times reports that officials in California, Oregon and Washington are struggling to find the manpower for fighting the fires, as nearby states deal with their own outbreaks of wildfires.On Thursday evening, President Donald Trump approved an emergency declaration for the wildfires in Oregon, which allows FEMA and the Department of Homeland Security to coordinate disaster relief efforts. 2038
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