2020-10-01@16:32:48 GMT
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emergency use:

    Washington Emergency Management Division The Starlink satellite internet network that SpaceX is developing has been used in the field by Washington state emergency responders in recent weeks, the first early application of the company's service to be disclosed. Washington's state military, which includes its emergency response division, began employing Starlink user terminals in early August to bring internet service to areas devastated by wildfires. User terminals are the small devices on the ground that connect to the satellites. The emergency division has seven Starlink user terminals, which it is deploying with early success. "I have never set up any tactical satellite equipment that has been as quick to set up, and anywhere near as reliable" as Starlink, Richard Hall, the emergency telecommunications...
    BEIJING — After the first shot, he had no reaction. But Kan Chai felt woozy following the second dose of a COVID-19 vaccine approved for emergency use in China. “When I was driving on the road, I suddenly felt a bit dizzy, as if I was driving drunk,” the popular writer and columnist recounted in a webinar earlier this month. “So I specially found a place to stop the car, rest a bit and then I felt better.” His is a rare account from the hundreds of thousands of people who have been given Chinese vaccines, before final regulatory approval for general use. It’s an unusual move that raises ethical and safety questions, as companies and governments worldwide race to develop...
    Hundreds of thousands of Chinese have been given experimental, emergency-use COVID-19 vaccines by the government since July, despite concerns over their safety and efficacy. China was initially criticized for for giving the vaccine to their top executives and leading researchers before human test trials. But in recent months, according to The Associated Press, they’ve given the jab to many more citizens under an emergency-use designation approved in June. Chinese health officials say they’ve almost wiped out the coronavirus but want to ensure that it never comes back. Zheng Zhongwei, of China’s National Health Commission, claimed that China gained the “understanding and support” of the World Health Organization before starting to administer the vaccines. Zheng has said that some people...
    Hundreds of thousands of Chinese have been given experimental, emergency-use COVID-19 vaccines by the government since July, despite concerns over their safety and efficacy. China was initially criticized for for giving the vaccine to their top executives and leading researchers before human test trials. But in recent months, according to The Associated Press, they’ve given the jab to many more citizens under an emergency-use designation approved in June. Chinese health officials say they’ve almost wiped out the coronavirus but want to ensure that it never comes back. Zheng Zhongwei, of China’s National Health Commission, claimed that China gained the “understanding and support” of the World Health Organization before starting to administer the vaccines. Zheng has said that some people in...
    China, which has largely eradicated the disease, should take action to prevent it from recurring, a Chinese health official said on Friday. But an external expert questioned the need for emergency use when the virus was not spreading in the country where it was first detected. So far it is not clear who or how many were vaccinated, but Chinese vaccine makers have provided some clues. CNPG, a state-owned Sinoform subsidiary, has given the vaccine to 350,000 people outside its clinical trials, of which about 40,000 have been registered, a senior CNPG executive recently said. Another company, Sinovac Biotech, has injected 90 percent or about 3,000 of its employees and family members, most of them under emergency use arrangement, CEO...
    (CNN)China gained the "understanding and support" from the World Health Organization before starting a controversial emergency use program for its Covid-19 vaccine candidates, a Chinese health official said Friday.China has been administering experimental coronavirus vaccines to hundreds of thousands of people since July under an emergency use program approved by the Chinese government, before their safety and efficacy have been fully proven by clinical trials.Some experts and vaccine developers in the West have warned against the premature authorization of coronavirus vaccines before last-stage trials are completed.Zheng Zhongwei, an official with China's National Health Commission, said Friday that China's cabinet, the State Council, approved a trial plan for the emergency use of Covid-19 vaccines at the end of June."After the approval,...
    BEIJING (Reuters) - The World Health Organization gave China its support and understanding to start administering experimental coronavirus vaccines to people while clinical trials were still underway, a Chinese health official said on Friday. China launched its emergency programme in July, having communicated with the WHO in late June, according to Zheng Zhongwei, a National Health Commission official. Hundreds of thousands essential workers and other limited groups of people considered at high risk of infection have been given the vaccine, even though its efficacy and safety had not been fully established as Phase 3 clinical trials were incomplete. "At end-June, China's State Council approved a plan of COVID-19 vaccine emergency use program," Zheng told a news conference. "After the approval,...
    Sign up for our COVID-19 newsletter to stay up-to-date on the latest coronavirus news throughout New York City BY JULIE STEENHUYSEN The scientific head of the U.S. government program designed to speed development of COVID-19 vaccines said on Thursday he supports stricter rules to grant emergency use of new inoculations against the novel coronavirus. Speaking at a meeting with Black physicians and community leaders, Operation Warp Speed scientific lead Dr. Moncef Slaoui said he supports recommendations being drafted by the U.S. Food and Drug Administration that companies wait two months after the last administration of their vaccine before seeking emergency use authorization (EUA) of their products. Operation Warp Speed already has recommended the vaccine candidates it is supporting observe...
    The Food and Drug Administration (FDA) granted Assure Tech emergency use authorization for a point-of-care test capable of detecting past COVID-19 infections through blood samples. In July, the Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by some labs to identify individuals with antibodies to SARS-CoV-2, indicating a recent or prior infection to COVID-19. LARGE ANTIBODY STUDY OFFERS HOPE FOR VIRUS VACCINE EFFORTS As of Wednesday, the test is now authorized for point-of-care use using a blood sample from the fingertip. This means it can be tested in settings like "doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing," the FDA announced. FDA Commissioner Stephen Hahn said the point-of-care serology tests...
    Johnson & Johnson announced Wednesday that it has launched its final trial for a coronavirus vaccine that would require only one dose. [ SEE: The Latest News on the Coronavirus Outbreak ]The trial is expected to enroll up to 60,000 volunteers at more than 200 clinical research sites in the U.S. and other countries. The development means four coronavirus vaccines have reached phase three trials in the U.S. Leading infectious disease expert Anthony Fauci called the news "an unprecedented feat for the scientific community made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia." Preclinical trials have shown the vaccine to have promising results in nonhuman primates and hamsters. The vaccine was developed...
    The US Food and Drug Administration (FDA) is expected to issue new, tougher requirements for its approval of a coronavirus vaccine, a move that could obliterate the chances of a shot getting emergency use authorization before Election Day, according to the Washington Post.  Regulators could publish the new approval standards as early as this week, and will do so publicly in an effort to bolster Americans' eroded trust in the US to ensure the safety a COVID-19 vaccine.  President Trump and his Operation Warp Speed initiative have been pushing for months to have a coronavirus vaccine approved ahead of the November 3.  But according to a new Axios poll, less that less than 40 percent of Americans now say they...
    By Julie Steenhuysen CHICAGO (Reuters) - If Moderna Inc's COVID-19 vaccine proves to be at least 70 percent effective, the company plans to seek emergency authorization for its use in high-risk groups, the company's chief executive told Reuters. Moderna's vaccine candidate - mRNA-1273 - is nearing the finish line in its push to enroll 30,000 individuals in a late-stage trial of a novel coronavirus vaccine. But the company may be able to declare victory early if it is able to show that people who got the vaccine fared much better in its trial that people who didn't. Vaccines must demonstrate they are at least 50% moreeffective than a placebo to be considered for approval. To provethat, government officials have said,...
    China is treating tens of thousands of its citizens with experimental coronavirus vaccines that have not had completed standard testing — raising concerns about safety. In July, China launched a vaccine emergency use program offering three experimental shots developed by a unit of state pharmaceutical giant China National Pharmaceutical Group (Sinopharm) and biopharmaceutical company Sinovac Biotech. The vaccines were aimed to protect essential workers, including those in the medical field, transportation industry and grocery store workers. But now, China National Biotec Group — the Sinopharm unit developing two of the emergency use vaccines — and Sinovac Biotech have confirmed that at least tens of thousands of people have been jabbed with the untested inoculations. Among those who received an...
    By David Stanway and Miyoung Kim SHANGHAI/SINGAPORE (Reuters) - China is inoculating tens of thousands of its citizens with experimental coronavirus vaccines and attracting international interest in their development, despite expert concerns over the safety of drugs that have not completed standard testing. China launched a vaccine emergency use programme in July, offering three experimental shots developed by a unit of state pharmaceutical giant China National Pharmaceutical Group (Sinopharm) and U.S.-listed Sinovac Biotech. A fourth COVID-19 vaccine being developed by CanSino Biologics was approved for use by the Chinese military in June. Aiming to protect essential workers and reduce the likelihood of a resurgence, the vaccines are also grabbing attention in the global scramble by governments to secure supplies, potentially...
    Berlin (CNN)Pfizer and BioNTech are confident they can have a vaccine against the novel coronavirus ready for regulatory approval by the middle of October or early November, BioNTech CEO and co-founder Ugur Sahin told CNN Tuesday."It has an excellent profile and I consider this vaccine ... near perfect, and which has a near perfect profile," Sahin said in an exclusive interview with CNN.US drug giant Pfizer and German firm BioNTech say they plan to provide 100 million doses of their vaccine candidate, BNT162, by the end of the year, and up to 1.3 billion doses in 2021.In July, the US Department of Health and Human Services and Department of Defense announced a $1.95 billion agreement with Pfizer to produce 100...
    SACRAMENTO (CBS SF) — The California Independent System Operator (ISO) issued a Stage 2 Grid Emergency early Saturday evening due to high temperatures and power grid loads, as well as fires causing the loss of about 1,600 megawatts of generation. Consumers are urged to conserve energy to reduce overall demand on the system to avoid any further emergencies and/or rolling outages, according to Cal ISO officials. If a large enough number of consumers conserve even in small ways, they can help grid operators avoid more serious system emergencies. Until 9 p.m. tonight, the ISO is urging consumers to: Set air conditioning thermostats to 78 degrees, if health permits Defer use of major appliances Turn off unnecessary lights Unplug unused...
    Program aims to protect Asian youth from COVID-19 bullying You can be both social and safe during the pandemic Savvy Americans do this to earn an extra $1,394 per month in retirement Ad Microsoft New Car Gadget Magically Removes Scratches & Dents Ad Microsoft 23 Gadgets That Could Sell Out Before the Holidays Ad Microsoft Full screen 1/17 SLIDES © fstop123/istockphoto Weather the Storm It’s essential to be prepared a hurricane threatens, including the possibility of evacuation and...
    During the 2009 H1N1 pandemic, Sandra Quinn asked hundreds of Americans if they’d be willing to take a hypothetical vaccine that was authorized for emergency use but wasn’t formally approved by the Food and Drug Administration. Most were hesitant: Quinn, the senior associate director of the Maryland Center for Health Equity at the University of Maryland, found that only around 8 percent of people said that they’d definitely take the vaccine. An emergency H1N1 vaccine never came to be, but the questions Quinn asked 10 years ago are back in the spotlight today, as pharmaceutical companies in the US and around the world fight to produce a coronavirus vaccine as quickly as possible. It’s a real possibility that the...
    ‘These are the same voices who . . . wish failure on [every] breakthrough.’ Trump-haters are so determined to defeat the president that they are opposing emergency authorization of a COVID-19 vaccine. What callous disregard for human life. Without a vaccine, another 100,000 fatalities are expected by year’s end, according to Washington University epidemiologists. On Friday, Food and Drug Commissioner Stephen Hahn ignited a firestorm when he said the FDA might grant emergency-use authorization to one of the COVID-19 vaccines this fall, if results rolling in from a clinical trial indicate it’s safe and effective. Emergency-use authorization would allow the vaccine to be rushed to front-line health workers, cancer patients and the elderly, among other groups. But only those who want it....
    VIDEO1:2901:29Scott Gottlieb reacts to report that the FDA is willing to fast track vaccine trialSquawk Box Dr. Scott Gottlieb told CNBC on Monday the late-stage coronavirus vaccine trials underway in the U.S. are unlikely to have gathered enough evidence to receive emergency approval ahead of the November presidential election.  "I think it's very unlikely. I think it's more likely you're going to get a top-line result some point in November and maybe be able to make a decision about an emergency use authorization after that," the former Food and Drug Administration commissioner said on "Squawk Box." Gottlieb — who sits on the board of Pfizer, which is developing a vaccine to prevent Covid-19 — said the more effective the vaccine is, the sooner...
    Food and Drug Administration (FDA) Commissioner Stephen Hahn said in a new interview that he is willing to fast-track a coronavirus vaccine before clinical trials are complete if it is determined to be “appropriate.” Hahn stressed politics would play no part in such a move, telling the Financial Times “this is going to be a science, medicine, data decision.” “It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn told the newspaper while discussing scenarios in which the FDA grants vaccine approval. “If they do that before the end of Phase Three, we may find that appropriate. We may find that inappropriate, we will make a determination.” The...
    Sign up for our COVID-19 newsletter to stay up-to-date on the latest coronavirus news throughout New York City The head of the U.S. Food and Drug Administration (FDA) is willing to fast-track a COVID-19 vaccine as quickly as possible, the Financial Times reported him as saying in an interview published on Sunday. Dr. Stephen Hahn, the FDA Commissioner, said his agency was prepared to authorize a vaccine before Phase Three clinical trials were complete, as long as officials are convinced that the benefits outweigh the risks, the newspaper reported. Without providing evidence, U.S. President Donald Trump last Saturday accused members of a so-called “deep state” working within the FDA of complicating efforts to test COVID-19 vaccines in order to...
    LONDON (AP) — Britain is preparing to revise its laws to allow the emergency use of any effective coronavirus vaccine before it is fully licensed — but only if the shots meet required safety and quality standards. In a statement Friday, Prime Minister Boris Johnson’s Conservative government said it was adopting “reinforced safeguards” to allow the country’s medicines regulatory agency to grant temporary authorization of a COVID-19 vaccine, provided it meets safety and quality standards. The proposed regulations would allow coronavirus vaccines to receive an emergency approval allowing people to be immunized while the full licensing process is being finished. Typically, vaccines are only used after the licensing review has been completed, a process which can take several months....
    NEW YORK (CBSNewYork) — A new, inexpensive coronavirus test has just been given emergency use authorization by the FDA. Most public health experts agree that fast, widespread and affordable coronavirus testing is essential to bring the pandemic under control. That’s why numerous companies and labs have developed nasal swab tests, blood tests, even saliva tests for COVID-19. But most of these tests are either expensive, take a long time to get results back or are not widely available. That may be about to change. CORONAVIRUS PANDEMIC Tri-State Coronavirus Travel Advisory Quarantine List Resources, Hotlines, Unemployment & Covering Bills Remote Learning Tools For Parents Teaching At Home CBS2’s Dr. Max Answers Your Health Questions What To Do If Someone Isn’t...
    By: KDKA-TV News Staff WASHINGTON (KDKA) – The Food & Drug Administration has granted a rapid COVID-19 test emergency-use authorization. The test is an antigen “card” test, made by Abbott, and it can detect the virus in 15 minutes. Studies have shown the test can correctly identify positive cases 97% of the time and has an accurate-negative reading 98% of the time. According to Abbott, the test is the size of a credit card and will cost only $5.
    On Wednesday, Abbott Laboratories announced that the U.S. Food and Drug Administration (FDA) had approved Emergency Use Authorization (EUA) for its new rapid test for detection of COVID-19; Abbot will sell the test for $5. The test will be available for use by authorized laboratories and in patient care settings. “It is highly portable (about the size of a credit card), affordable and provides results in 15 minutes,” Abbott wrote. “BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don’t spread the disease to others.” “Abbott...
    President Donald Trump announced the Food and Drug Administration approved "emergency use" of blood plasma from COVID-19 survivors to treat other patients.However, the World Health Organization is cautioning that it is still considered experimental therapy.In the early days of the coronavirus pandemic, convalescent plasma was one of the first treatments to give people hope. It involves extracting plasma from the blood of people previously infected with the coronavirus."This plasma is particularly antibody-rich," said Dr. Michael Daignault, emergency medicine specialist with Providence St. Joseph Medical Center.The hope is that injecting the amber-colored liquid into COVID-19 patients will help them recover, but the data is limited. A Mayo Clinic study suggests if patients receive convalescent plasma within three days of diagnosis, they...
    The top doctor at the US Food and Drug Administration (FDA) has apologised for overstating the benefits of plasma for treating Covid-19 patients. FDA Commissioner Stephen Hahn came under fire after his agency on Sunday gave emergency authorisation to use convalescent plasma on Covid patients. Echoing President Donald Trump, Mr Hahn touted the treatment as life-saving. Scientists quickly questioned the data provided by Mr Hahn, who suggested plasma could reduce deaths by 35%. This claim grossly exaggerated preliminary findings from a clinic at the Mayo Clinic. "I personally could have done a better job and should have done a better job at that press conference explaining what the data show regarding convalescent plasma," Mr Hahn told CBS News...
    The head of the US Food and Drug Administration has clarified his remarks about a new COVID-19 treatment — and insisted politics had nothing to do with his agency’s decision to authorize its emergency use. “I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified,” FDA Commissioner Stephen Hahn tweeted. “What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.” Hahn also said the decision to authorize emergency use of convalescent plasma — which is derived from the blood of people who recovered from the coronavirus — “was made entirely by FDA scientists.” “We at FDA do not...
    The head of the US Food and Drug Administration has clarified his remarks about a new COVID-19 treatment — and insisted politics had nothing to do with his agency’s decision to authorize its emergency use. “I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified,” FDA Commissioner Stephen Hahn tweeted. “What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.” Hahn also said the decision to authorize emergency use of convalescent plasma — which is derived from the blood of people who recovered from the coronavirus — “was made entirely by FDA scientists.” “We at FDA do not permit...
    Commissioner of U.S. Food and Drug Administration Dr. Stephen M. Hahn speaks during a news conference about the latest coronavirus disease (COVID-19) developments, in the Brady Press Briefing Room of the White House in Washington, U.S. August 23, 2020.Erin Scott | Reuters FDA Commissioner Stephen Hahn is walking back comments on the benefits of convalescent plasma, saying he could have done a better job of explaining the data on its effectiveness against the coronavirus after authorizing it for emergency use over the weekend. Hahn came under intense criticism from the scientific community after he said at a White House press briefing Sunday that a Mayo Clinic study found the treatment resulted in a 35% improvement in survival. While the data suggested...
    Pharmaceutical company AstraZeneca might be granted an emergency use authorization by the Food and Drug Administration (FDA) for a COVID-19 vaccine, according to a new report. The vaccine, being developed by AstraZeneca and Oxford University, could receive authorization as early as October, the Financial Times (FT) reported. “The Trump administration is considering bypassing normal US regulatory standards to fast-track an experimental coronavirus vaccine from the UK for use in America ahead of the presidential election, according to three people briefed on the plan,” FT reported. “One option being explored to speed up the availability of a vaccine would involve the US Food and Drug Administration awarding “emergency use authorisation” (EUA) in October to a vaccine being developed in a partnership between...
    President Donald Trump has mulled skirting regulatory procedures in order to fast-track the authorization of a coronavirus vaccine before Election Day, according to The Financial Times. The administration has considered speeding up the availability of an experimental coronavirus vaccine being developed in the U.K. by Oxford University and the pharmaceutical giant AstraZeneca via an “emergency use authorization” from the Food and Drug Administration, three people briefed on the plan told The Times. The AstraZeneca vaccine is undergoing testing in a trial with 10,000 volunteers, though U.S. health agencies have said a vaccine must be studied on at least 30,000 people to meet authorization standards. “Each vaccine needs to be tested on about 30,000 volunteers,” Dr. Francis Collins, the director of the National Institutes of Health, told CNN in...
    LONDON (Reuters) - An experimental COVID-19 vaccine being developed by the University of Oxford and AstraZeneca could be put before regulators this year if scientists are able to gather enough data, the director of the Oxford Vaccine Group said on Tuesday. "It is just possible that if the cases accrue rapidly in the clinical trials, that we could have that data before regulators this year, and then there would be a process that they go through in order to make a full assessment of the data," Andrew Pollard told BBC Radio. The Oxford vaccine showed early promise in the first human trial when it produced an immune response, underlining its position as one of the leading candidates in the race...
    NEW YORK (CBSNewYork) – In a surprise move, the U.S. Food and Drug Administration reversed course over the weekend and gave emergency use authorization to an antibody treatment for COVID-19. It’s called convalescent plasma, which is taken from recovered COVID patients. In Monday’s Max Minute, CBS2’s Dr. Max Gomez explains what the treatment entails and why many experts are unsure about its safety and efficacy. CORONAVIRUS PANDEMIC Tri-State Coronavirus Travel Advisory Quarantine List Resources, Hotlines, Unemployment & Covering Bills Remote Learning Tools For Parents Teaching At Home CBS2’s Dr. Max Answers Your Health Questions What To Do If Someone Isn’t Social Distancing Or Wearing A Mask? Expert: Parents Be Mindful Of Children’s Stress After Months Of Isolation Chopper 2...
    MIAMI (CBSMiami) – For 87 days, Dr. Vladimir Laroche was in a coma and on a ventilator suffering from COVID-19. In April, his family made sure he got convalescent plasma as part of his larger treatment to help battle the virus. “I put my trust in God, I say God will do whatever need to be done,” said Dr. Laroche. “So when I received the plasma, I think somehow the plasma helped.” Paul Laroche is Vladimir’s brother. “It was really looking grim at that point in time and the plasma, within 24 hours, showed a little sign of improvement, which gave the doctors a window of opportunity,” Paul said. He said the family is pleased the FDA issued “emergency use...
    China has been administering a potential COVID-19 vaccine to employees who work in high-risk situations for contracting the virus, a top health official said. Zheng Zhongwei, director of the Science and Technology Development Center of the National Health Commission, said that frontline healthcare workers and border patrol officers are among those who have been able to receive the vaccine candidate since July 22, CNN reported. Developed by Sinopharm’s China National Biotec Group Company, the potential vaccine has been approved for “emergency use,” Zheng said. “We’ve drawn up a series of plan packages, medical consent forms, side effect monitoring plans, rescuing plans, compensation plans, to make sure the emergency use is well regulated and monitored,” Zheng told state media, according to...
    Phlebotomist Jenee Wilson talks with Melissa Cruz, an ER technician for Valley Medical Center who has recovered from the coronavirus disease (COVID-19) she contracted from a patient, as she finishes donating convalescent plasma at the Central Seattle Donor Center of Bloodworks Northwest during the outbreak in Seattle, Washington, U.S. April 17, 2020.Lindsey Wasson | Reuters Scientists and public health officials said Monday they are skeptical convalescent plasma is an effective treatment for patients hospitalized with Covid-19, even after the Food and Drug Administration issued an emergency use authorization for the treatment and President Donald Trump touted it as a "breakthrough." There are no formally approved drugs or vaccines for the coronavirus. Convalescent plasma is one of several therapies being tested as...
    CHICAGO (Reuters) - American Airlines said it is preparing to begin spraying its airplane cabins with a disinfectant proven to fight COVID-19 on surfaces for up to seven days that has been granted emergency approval by the U.S. Environmental Protection Agency for use in Texas. The announcement came at a press briefing hosted by the EPA, which called the product, SurfaceWise2 by Allied BioScience Inc, a game-changing step to battle the spread of COVID-19 which could eventually be used in facilities including schools once it receives full approval. Reuters first reported emergency approval of the product for use by American in Texas, its home base, on Sunday. (Reporting by Tracy Rucinski; Editing by Chizu Nomiyama) Copyright 2020 Thomson Reuters.
    Dr. Scott Gottlieb told CNBC on Monday that the blood plasma treatment for coronavirus patients recently granted emergency approval by the Trump administration may be effective.  "I think that this could be beneficial. It might be weakly beneficial," Gottlieb said on "Squawk Box." "It doesn't look like a home run, but right now we're looking for singles and doubles. There aren't really going to be any home runs on the horizon until we can get the other therapeutic antibodies on the market and hopefully eventually vaccines and better therapeutics."   The Food and Drug Administration on Sunday announced the emergency use authorization for using convalescent plasma to treat coronavirus patients. President Donald Trump touted it as a "a breakthrough," just a few days after suggesting, without providing evidence, that...
    Sign up for our COVID-19 newsletter to stay up-to-date on the latest coronavirus news throughout New York City The World Health Organization on Monday was cautious about endorsing the use of recovered COVID-19 patients’ plasma to treat people who are ill, saying evidence it works remains “low quality” even as the United States issued emergency authorization for such therapies. “There are a number of clinical trials going on around the world looking at convalescent plasma compared to the standard of care,” said Soumya Swaminathan, WHO chief scientist. “Only a few of them have actually reported interim results…and at the moment, it’s still very low-quality evidence,” she told a news conference. President Donald Trump on Sunday hailed FDA authorization of...
    The Trump administration is weighing a fast-tracked process that would allow AstraZeneca’s coronavirus vaccine to be used in the US before November’s presidential election, a new report says. One plan under consideration would see the Food and Drug Administration issue an “emergency use authorization” for the British drugmaker’s vaccine candidate in October, the Financial Times reported Sunday, citing three people briefed on the plan. The authorization, known as an EUA, would be based on forthcoming results from a study involving 10,000 people in the UK — even though federal agencies have said a study of 30,000 people would be needed to win such an approval, according to the paper. White House Chief of Staff Mark Meadows and Treasury Secretary Steven...
    Washington — The Food and Drug Administration announced Sunday that it had authorized an emergency use declaration for convalescent plasma to treat the coronavirus. FDA commissioner Dr. Stephen Hahn said that early trials indicate a 35% better chance of survival when convalescent plasma is used in "optimal patients." President Trump held a news conference with Hahn at the White House shortly after the FDA announced the emergency authorization. The two left as multiple reporters shouted "was there pressure on you to authorize this?" CBS News' Weijia Jiang reported last week that National Institute of Health director Dr. Francis Collins, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci and others at the NIH have warned Hahn...
    (CNN) — The US Food and Drug Administration issued an emergency use authorization for the use of convalescent plasma to treat Covid-19 on Sunday, saying the “known and potential benefits of the product outweigh the known and potential risks of the product.” The FDA said more than 70,000 patients had been treated convalescent plasma, made using the blood of people who have recovered from coronavirus infections. “Today I am pleased to make a truly historic announcement in our battle against the China virus that will save countless lives,” President Trump said at a White House briefing. “Today’s action will dramatically increase access to this treatment.” Last week, Trump accused some health officials of playing politics regarding an EUA for convalescent...
    The US Food and Drug Administration (FDA) has given emergency authorisation for the use of plasma to treat coronavirus patients. The technique uses antibody-rich blood plasma from people who've recovered from the disease, and has already been used on over 70,000 people in the US. President Donald Trump said the treatment could reduce deaths by 35%. It comes a day after he accused the FDA of impeding the rollout of vaccines and therapeutics for political reasons. The announcement comes on the eve of the Republican National Convention, where Mr Trump will launch his campaign to win a second term in the White House. Does the US have the world's worst coronavirus death rate? "This is what I've been...
    In a hastily-called press conference Sunday evening, President Donald Trump and the heads of the Food and Drug Administration and Department of Health and Human Services announced what the president had touted as a “breakthrough” in treating the pandemic disease Covid-19. That breakthrough turned out to be a change in the bureaucratic status of convalescent plasma, a treatment made from the blood of people who have recovered from the disease—one that most people can already get, that at least 70,000 people have already received (and probably more like 100,000), and that despite the president’s assurances currently lacks solid evidence for its effectiveness. “It is proven to reduce mortality by 35 percent. It’s a tremendous number,” President Trump said at the...
    WHITE HOUSE - Calling it “a truly historic announcement,” U.S. President Donald Trump on Sunday hailed a federal government emergency authorization for use of convalescent blood plasma that he declared would “save countless lives” of coronavirus patients.   Trump and his health secretary, Alex Azar, at a briefing for reporters, noted a 35% decrease in mortality among those younger than 80 who were not on a respirator, a month after receiving the treatment early in the course of their disease. “We dream in drug development of something like a 35% mortality reduction,” Azar, the secretary of Health and Human Services, said alongside the president. “This is a major advance in the treatment of patients.” White House: ‘Breakthrough’ Coming for...
    President Donald Trump announced late on Sunday that the FDA has issued an “emergency use authorization” for convalescent plasma as a potential treatment for the coronavirus. “This is a powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection,” Trump said. “It’s had an incredible rate of success. Today’s action will dramatically expand access to this treatment.” BREAKING: U.S. FDA issues emergency use authorization for convalescent plasma as potential treatment for COVID-19, President Trump announces. pic.twitter.com/8xneaZW8m7 — NBC News (@NBCNews) August 23, 2020 The FDA “issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the...
    WHITE HOUSE - Calling it “a truly historic announcement,” U.S. President Donald Trump on Sunday hailed a federal government emergency authorization for use of convalescent blood plasma that he declared would “save countless lives” of coronavirus patients.   Trump and his health secretary, Alex Azar, at a briefing for reporters, noted a 35% decrease in mortality among those younger than 80 who were not on a respirator, a month after receiving the treatment early in the course of their disease. “We dream in drug development of something like a 35% mortality reduction,” Azar, the secretary of Health and Human Services, said alongside the president. “This is a major advance in the treatment of patients.” White House: ‘Breakthrough’ Coming for...
    NEW YORK (CBSNewYork) — There is a new development in the fight against COVID-19. The Food and Drug Administration has issued an emergency authorization for convalescent plasma treatment, CBS2’s Ali Bauman reported Sunday. The White House is heralding this as major therapeutic breakthrough, but it comes just days after the FDA held off on issuing an emergency use authorization at the urging of top health experts. MORE: Max Minute: Convalescent Plasma Getting More Attention As Search Continues For COVID-19 Treatment President Donald Trump’s emergency authorization will allow the use of blood plasma from patients who have recovered from COVID-19 as a treatment for the virus. Convalescent plasma is created from blood of recovered patients. It contains what doctors call “neutralizing antibodies,”...
    President Donald Trump on Sunday announced an emergency use authorization from the Food and Drug Administration for convalescent plasma to treat COVID-19, calling it a "historic breakthrough." "It's had an incredible rate of success," Trump told reporters at a White House briefing.Cartoons on President Donald TrumpView All 914 ImagesThe treatment is already widely available and has been given to more than 70,000 patients, according to the FDA. The authorization could make it easier to get for patients, but it is far from a full approval, which requires rigorous clinical trials. The FDA said in a press release that "this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known...
    President Donald Trump announced Sunday that the Food and Drug Administration (FDA) has issued an emergency use authorization for convalescent plasma in treating patients with coronavirus, expanding access to a potentially lifesaving therapy. OLD FORGE, PENNSYLVANIA – AUGUST 20: U.S. President Donald J. Trump speaks at his campaign rally on August 20, 2020 in Old Forge, Pennsylvania. President Trump is campaigning in the battleground state of Pennsylvania near the hometown of former Vice President Joe Biden, hours before Biden will accept the Democratic Presidential nomination on the last day of the Democratic National Convention. (Photo by Michael M. Santiago/Getty Images) “Today I’m pleased to make a truly historic announcement in our battle against the China virus that will save countless...
    Bradley Cortright August 23, 2020 0 Comments President Donald Trump says the Food and Drug Administration has issued an emergency-use authorization for convalescent plasma to help patients diagnosed with the coronavirus. In a press conference on Sunday night, Trump said, “The FDA has issued an emergency-use authorization — and that’s such a powerful term emergency-use authorization — for a treatment known as convalescent plasma.” “This is a powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection,” he added. He said the treatment has had “incredible rate success,” and the new emergency-use authorization will “dramatically expand access to this treatment.”Watch the video below: JUST IN: President Trump...
    Reuters August 23, 2020 0 Comments The Trump administration plans emergency approval of a new coronavirus therapeutic treatment and is considering fast-tracking a vaccine developed in Britain, according to media reports on Sunday, the day before the start of the Republican National Convention. President Donald Trump later on Sunday will announce the emergency authorization of convalescent plasma for COVID-19, a treatment that already has been given to more than 70,000 patients, the Washington Post reported, citing officials familiar with the decision. The action will be highlighted at a news conference scheduled for 5:30 p.m. EDT (2130 GMT), the newspaper said. A White House spokesman declined to comment on the Post story. But White House Press Secretary Kayleigh McEnany tweeted...
    A series of treatments "aggressively" being studied amid the global coronavirus pandemic include synthetic antibodies, stem cells, and a steroid spray, and Dr. Marc Siegel speculates it might be an upcoming development for American healthcare. "I dont know for sure thats what the president is going to discuss, but its on the table," Siegel told Fox News "Fox & Friends." The U.S. Food and Drug Administrations hesitance to approve emergency-use authorizations amid the pandemic, particularly on the antibody testing is "eyebrow-raising," according to Siegel, and perhaps President Donalds concern the FDA is becoming "too political" might be justified. "The FDA delayed an emergency use authorization on convalescent plasma," Siegel said. "Now, thats the plasma or the antibodies you get when youre getting over COVID-19....
    President Trump was expected to use a press conference on Sunday to announce emergency use authorization from the Food and Drug Administration for convalescent blood plasma to treat COVID-19, according to media reports. The treatment, which hinges on the general concept of antibodies from the recovered being injected into people currently facing their own coronavirus infections, has been widely used but only produced middling data to support it. The announcement was expected just days after the FDA reportedly pulled back from issuing the same authorization over concerns about the effectiveness of the treatment. This is a developing story and will be updated.Madeline CharbonneauCheat Sheet Intern@maddicharbGot a tip? Send it to The Daily Beast here.
    A White House briefing Sunday on a “major therapeutic breakthrough” is expected to be about an emergency use authorization for the use of convalescent plasma to treat COVID-19, according to two sources with knowledge of the situation. Last week, President Trump accused some health officials of playing politics regarding an EUA for convalescent plasma. When asked about the US Food and Drug Administration not having granted an EUA, Trump said the reason was political. Today, one of the sources, who is close to the White House Coronavirus Task Force, says the FDA has reviewed additional data to inform its impending EUA decision. This official has not personally reviewed the data. They added the FDA is under no obligation to consult...
    A Michigan appeals court on Friday ruled in favor of Gov. Gretchen Whitmer, finding that her emergency declarations and orders in response to the coronavirus were legal. Whitmer implemented strict lockdown measures during the crisis, and has since extended the state of emergency to keep gyms and movie theaters closed. Masks are required in many parts of the state. GRETCHEN WHITMER CRITICIZES TRUMP'S CORONAVIRUS RESPONSE DURING CONVENTION SPEECH  Republicans in the state’s Legislature argued that she had overstepped her authority, and can unilaterally extend emergencies only if they are local, not statewide, under the 1945 Emergency Powers of the Governor Act (EPGA). They said a separate 1976 law means statewide emergencies need the Legislature’s approval after 28 days. The appeals court, in...
    President Trump on Saturday accused the “deep state” at the Food and Drug Administration of making it hard for drug companies to test coronavirus treatments -- and suggested the agency is trying to delay them until after Election Day. “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” he tweeted. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!” FDA PAUSES EMERGENCY AUTHORIZATION FOR BLOOD PLASMA AS CORONAVIRUS TREATEMENT: REPORT   He also tagged FDA Commissioner Stephen Hahn in the tweet. Trump later re-tweeted a Twitter Moments story from June that reported on...
    Reuters August 19, 2020 0 Comments U.S. President Donald Trump on Wednesday touted the use of convalescent plasma as a treatment for COVID-19 and suggested a reported decision by regulators to put on hold an emergency authorization for its use could be politically motivated. “I’ve heard fantastic things about convalescent plasma,” Trump told a briefing. An emergency approval by the Food and Drug Administration for the use of blood plasma as a coronavirus treatment has been put on hold over concerns the data backing it was too weak, the New York Times reported on Wednesday. “It could be a political decision,” Trump said. “You have a lot of people over there that don’t want to rush things because they...
    President Donald Trump alleged that U.S. health regulators may be delaying the emergency authorization of blood plasma to treat coronavirus patients until after the election to hurt him politically, offering no substantiation for the charge. “I hear great things about it, that’s all I can tell you,” Trump said at a White House news conference Wednesday. “It could be a political decision because you have a lot of people over there that don’t want to rush things because they want to do it after November 3rd,” the date of the election. The use of plasma drawn from people who have survived Covid-19 as a virus treatment has been embraced by some doctors. While seen as safe, clinical trials haven’t yet...
    Last week, the U.S. Food and Drug Administration (FDA) was planning to release an emergency use authorization (EUA) for blood plasma as a treatment against COVID-19. But the authorization is now on pause after top experts, namely Dr. Anthony Fauci and Dr. Francis Collins, reportedly stepped in saying the evidence was not strong enough to do so at this time, according to a new report. Dr. H. Clifford Lane, deputy clinical director at the National Institute of Allergy and Infectious Disease, said the authorization was put "on hold for now" while more data is under review. However, emergency approval is still possible; Lane noted that it "could still be issued in the near future," according to the report from The New York Times....
    PHILADELPHIA (CBS) — COVID-19 is now the No. 3 cause of death in the United States. The Food and Drug Administration has issued an emergency use authorization for a saliva test that can easily detect COVID-19. The technology is being described as a potential game-changer. This is what many have been waiting for — a quick, non-invasive and inexpensive way to find out if they’ve been infected with the coronavirus. The newest saliva COVID-19 test to get the nod from the FDA was developed by researchers at Yale University and funded by the National Basketball Association, which also uses the test that’s called SalivaDirect. “It doesn’t need the same re-agents and swabs that have been the limiting steps to create...
    California suffered power outages on Friday, Saturday and Sunday and the heat wave continues this week according to Governor Gavin Newsom The state worked over the weekend to increase power generation capacity. Photo: BAY ISMOYO / . / . During a press conference the governor of California, Gavin Newsom, made reference to the power failures that the state presented during the weekend in the heat wave that hit the west of the country. In his speech, the president advocated an investigation to determine the causes of these service interruptions to prevent it from happening again. “We cannot control the weather, but we can prepare for these weather events. Not having a plan and failing...
    Reuters August 16, 2020 0 Comments  The U.S. Food and Drug Administration on Saturday granted emergency use authorization to Yale School of Public Health’s saliva test to detect COVID-19, after a trial on National Basketball Association players and staff. SalivaDirect, the fifth saliva test approved by the FDA for the disease, requires no swab or collection device and uses spit from people suspected of having the coronavirus, the agency said. FDA Commissioner Stephen Hahn called the test “groundbreaking” in its efficiency and in being unaffected by crucial component shortages. SalivaDirect is seen as a cheap, simpler and less invasive testing method that requires no extraction of nucleic acid and can use several readily available reagents. The NBA has used...
    A new saliva-based laboratory diagnostic test for the novel coronavirus developed by researchers at Yale University's School of Public Health has been granted an emergency use authorization by the Food and Drug Administration. ARIZONA TEACHERS 'SICK OUT' FORCES SCHOOL DISTRICT TO DELAY PLANNED IN-PERSON REOPENING SalivaDirect is a simple, affordable, and less invasive testing method that has been found to yield similar outcomes to the traditional nasal swab test. “This is a huge step forward to make testing more accessible,” said Chantal Vogels, a Yale postdoctoral fellow, who led the laboratory development and validation along with Doug Brackney, an adjunct assistant clinical professor. “This started off as an idea in our lab soon after we found saliva to be a promising sample type of the...
    Sign up for our COVID-19 newsletter to stay up-to-date on the latest coronavirus news throughout New York City The U.S. Food and Drug Administration on Saturday granted emergency use authorization to Yale School of Public Health’s saliva test to detect COVID-19, after a trial on National Basketball Association players and staff. SalivaDirect, the fifth saliva test approved by the FDA for the disease, requires no swab or collection device and uses spit from people suspected of having the coronavirus, the agency said. FDA Commissioner Stephen Hahn called the test “groundbreaking” in its efficiency and in being unaffected by crucial component shortages. SalivaDirect is seen as a cheap, simpler and less invasive testing method that requires no extraction of nucleic...
    The Food and Drug Administration granted emergency use authorization for a saliva-based testing system that can return accurate results in less than three hours. The SalivaDirect test is conducted using saliva collected in a container without a swab and has a sensitivity of results similar to nasal swabs, which have been used to test for COVID-19 since the start of the pandemic. The FDA announced its emergency use authorization on Saturday, according to CNN. Another major advantage is that up to 92 samples can be tested at once. The price of the test is also relatively low, with the cost largely confined to the reagents used. Researchers have estimated a cost of about $10 per sample. White...
    SACRAMENTO (CBS13) — The California Independent System Operator (ISO) declared a statewide Stage 2 emergency Friday afternoon due to the excessive heat. The agency said the heat is driving electricity use and putting a strain on the power grid, and if systems do not improve, there may be rotating power outages. Earlier Friday, ISO issued a Flex Alert, a voluntary call to conserve energy, from 3 p.m. to 10 p.m. They urge consumers to set their thermostats to 78 degrees or higher, turn off unnecessary lights, and not use major appliances. California #ISO has declared a statewide Stage 2 emergency, due to excessive heat driving up energy use. If system conditions dont improve, the ISO will call a Stage 3...
    When you buy through our links, we may earn money from our affiliate partners. Learn more. Amazon LifeStraw's popular water filter is a boon for anyone who spends time outdoors, allowing access to clean, drinkable water almost anywhere. Operation is a no brainer, too, as the straw design eliminates the risk of wrong-use and is easy enough to be used by kids or first-timers. At $20, this water filter isn't hard on the wallet and can be used to stock emergency kits like a bugout bag, a hurricane kit, or even a car kit. A sure-fire way to ruin any camping trip is to contract with a water-borne illness like Salmonella, E. coli, or even Giardia...
    Appearing Wednesday on TMZ, House Majority Whip James Clyburn (D-SC) claimed, without evidence, that President Donald Trump intends to use his “emergency powers” to install himself as “president for life” if he is elected to a second term. A partial transcript is as follows:  CHARLES LATIBEAUDIERE: Your comment this week that the American people need to wake up because President Trump is, in your eyes– HARVEY LEVIN: A Hitler-wannabe. LATIBEAUDIERE:  –He’s Mussolini and Putin is Hitler. Harking back to the axis of power. That’s definitely going to draw people’s attention. REP. JAMES CLYBURN: Well, I think it’s real. I wouldn’t say it if I didn’t believe it. The facts are very clear. He says he was on the phone seven or eight times with...
    During an interview with TMZ on Wednesday, House Majority Whip James Clyburn claimed that Donald Trump plans to use “emergency powers” to extend his presidency indefinitely, Breitbart reported. The Democratic lawmaker, who has endorsed Joe Biden for president, made the comments in response to questions about his recent CNN interview in which he compared the real estate mogul to Italian fascist dictator Benito Mussolini. “Well, I think it’s real. I wouldn’t say it if I didn’t believe it,” Clyburn said. The lawmaker also used his CNN interview to liken Russian leader Vladimir Putin to Hitler. While speaking to TMZ, the lawmaker noted Trump’s recent phone calls with Putin and the secrecy surrounding the content of the conversations. The 80-year-old politician...
    (Reuters) - Medical device maker Abiomed Inc said on Tuesday the U.S. Food and Drug Administration granted its left-sided heart pumps emergency use authorization to help patients suffering from COVID-19-related heart and lung failures. COVID-19, the respiratory disease caused by the new coronavirus, causes widespread inflammation which could impair or damage the left ventricle of the heart and lead to heart failure or excess fluids in the lungs. Impella, part of a family of invasive heart pump devices manufactured by Abiomed, provides circulatory support to patients who develop left side ventricular failure and is authorized to be used by healthcare providers in the hospital setting. It was approved for use in the United States in 2015. This is the...
    Treasury Secretary Steve Mnuchin said Monday the United States will “make sure” a Covid-19 vaccine will be ready for “emergency use” by the end of 2020. “The focus is kids and jobs and vaccines,” Mnuchin told reporters in the Oval Office during a session with GOP leaders. “We are going to make sure we have a vaccine by the end of the year for emergency use.” Under section 564 of the Federal Food, Drug, and Cosmetic Act, the FDA may “allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved,...
    Jody Serrano54 minutes ago•Filed to:coronaviruscoronaviruscovid-19healthSaveThe Food and Drug Administration will allow up to four coronavirus tests to be analyzed in one batch.Photo: Andrew Milligan/Pool/AFP (Getty Images) Faced with the biggest coronavirus outbreak in the world and long wait times for test results, the Food and Drug Administration on Saturday issued the first emergency use authorization for covid-19 pool testing, a form of testing that allows up to four samples to be tested at once using the same test. Latest Coronavirus Science: Hopeful Evidence for Longer-Lasting ImmunityIn this roundup of the latest research into the covid-19 pandemic, we cover encouraging evidence…Read moreThe real-time PCR pool test belongs to Quest Diagnostics, the largest private medical testing company in the U.S., which recently...
    (CNN) — The US Food and Drug Administration on Saturday announced it has issued an emergency use authorization that allows the laboratory Quest Diagnostics to pool samples from up to four individuals to test for COVID-19. This is the first COVID-19 diagnostic test in the United States to be authorized for use with pooled samples, the agency said in a statement. “This EUA for sample pooling is an important step forward in getting more COVID-19 tests to more Americans more quickly while preserving testing supplies,” FDA Commissioner Dr. Stephen Hahn said in the statement. “Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population.” Sample pooling allows multiple people to be tested...
    (CNN)The US Food and Drug Administration on Saturday announced it has issued an emergency use authorization that allows the laboratory Quest Diagnostics to pool samples from up to four individuals to test for Covid-19. This is the first Covid-19 diagnostic test in the United States to be authorized for use with pooled samples, the agency said in a statement.Heres what pooled testing is and how it can be used for the coronavirus"This EUA for sample pooling is an important step forward in getting more Covid-19 tests to more Americans more quickly while preserving testing supplies," FDA Commissioner Dr. Stephen Hahn said in the statement. "Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of...
    Angelo Mascia, DO, and Daniel G. Murphy, MD, work in the Department of Emergency Medicine at St. Barnabas Hospital in The Bronx. They write to The Post about the latest increase in business — electric scooters:  The growing use of private and pay-per-use bicycles in New York City is a worthy and convenient transportation solution that is environmentally friendly. The prevention of injuries and deaths among bicyclists requires ongoing innovation and civil-engineering solutions. Bicyclists, pedestrians and vehicles should safely coexist. Our emergency department has noticed a concerning and dangerous transportation trend in The Bronx, however, with the introduction of p ay-per-use motorized scooters and mopeds. The rapidly expanding use of the Revel scooter, a two-person electric scooter with maximum...
    White House trade advisor Peter Navarro reiterated the Trump administration's calls for the FDA to authorize use of hydroxychloroquine, the antimalarial drug touted publicly by President TrumpDonald John TrumpCNN's Anderson Cooper: Trump's Bubba Wallace tweet was 'racist, just plain and simple' Beats by Dre announces deal with Bubba Wallace, defends him after Trump remarks Overnight Defense: DOD reportedly eyeing Confederate flag ban | House military spending bill blocks wall funding MORE, to tread COVID-19 patients during comments to reporters Tuesday. Navarro told pool reporters that the FDA should approve a request from several Detroit doctors to grant emergency use authorization to the drug, which it granted and then rescinded earlier this year after several studies pointed to the drug not...
    New Jersey pharmaceutical firm Becton, Dickinson and Company has won approval from the U.S. Food and Drug Administration for a fast, easy-to-use test for novel coronavirus infections. At first glance, the Veritor test system from BD, as the company is widely known, might seem like exactly the thing public-health officials have been clamoring for since SARS-CoV-2 first reached the United States early this year. But a closer look at BD’s data reveals limits to the new test’s effectiveness. And that underscores how difficult it can be to quickly develop a coronavirus test that’s both fast and accurate. The FDA approved BD’s testing system for emergency use in a July 2 letter. The approval expires when the federal government ends its...
    PRAGUE — Tomas Kapler knew nothing about ventilators — he’s an online business consultant, not an engineer or a medical technician. But when he saw that shortages of the vital machines had imperiled critically ill COVID-19 patients in northern Italy, he was moved to action. “It was a disturbing feeling for me that because of a lack of equipment the doctors had to decide whether a person gets a chance to live,” Kapler said. “That seemed so horrific to me that it was an impulse to do something.” And so he did. “I just said to myself: ‘Can we simply make the ventilators?’” he said. Working around the clock, he brought together a team of 30 Czechs to develop...
    PRAGUE (AP) — Tomas Kapler knew nothing about ventilators — he’s an online business consultant, not an engineer or a medical technician. But when he saw that shortages of the vital machines had imperiled critically ill COVID-19 patients in northern Italy, he was moved to action. “It was a disturbing feeling for me that because of a lack of equipment the doctors had to decide whether a person gets a chance to live,” Kapler said. “That seemed so horrific to me that it was an impulse to do something.” And so he did. “I just said to myself: ‘Can we simply make the ventilators?’” he said. Working around the clock, he brought together a team of 30 Czechs to develop...
    MIAMI BEACH (CBSMiami) – Mask up on Miami Beach. The city has amended its emergency measures and effective immediately, everyone in public spaces, both indoors and outside, must wear a facial covering. This new mandate falls in line with the county’s emergency order. Any person not wearing a facial covering is subject to a $50 civil fine. There are some exceptions. Download The New CBS4 News App Here Facial coverings are not required inside private residences, cars, or inside hotel guests’ rooms. Children under two years of age are exempt as are people who have trouble breathing due to an existing medical condition. Also exempt are people who are hearing-impaired or people communicating with an...
    FORT WORTH (CBSDFW.COM) – The Fort Worth Fire Department is warning residents that using fireworks is illegal in the city, following an accident last July 4 that killed a teenager. The department said any residents or visitors who are found selling, possessing or using fireworks can be punished with a fine and/or confiscation. According to the department, it saw one death, four “significant trauma events,” five structure fires and 37 outdoor/grass fires on July 4, 2019. Maneno Juma, 19, was killed after a firework exploded on him in a Fort Worth neighborhood, fire officials said. Officials said the explosion severely injured his hand, arm and chest and that he was in cardiac arrest when first responders arrived. The teenager was...
    A woman gives blood for a coronavirus antibody test.Marijan Murat | picture alliance | Getty Images Medical device maker Danaher said on Monday its Covid-19 blood test for detecting if a person had ever been infected with the new coronavirus received emergency use clearance from the U.S. Food and Drug Administration. The company's unit Beckman Coulter said it had shipped the antibody tests to nearly 400 U.S. hospitals and laboratories, and has ramped up production to deliver more than 30 million tests a month. Antibody tests, which can indicate a certain degree of immunity in those who have had the virus, are seen as crucial in safely reopening economies after weeks of lockdowns. High demand for the test has led...
    As the coronavirus spread across the US this spring, authorities warned people not to purchase N95 respirator masks, lest they contribute to a shortage of the masks for medical personnel. The N95 respirators are considered the most effective masks to filter out droplets in the air that may transmit the virus. Sites like Amazon suspended sales of N95 masks to the general public and cracked down on sellers who tried to sell counterfeit versions. But a ProPublica investigation uncovered an operation in Texas that was repackaging masks marked as “prohibited” for medical use into unlabeled bags. A man who answered an ad for a TaskRabbit gig told ProPublica what he witnessed: …five or six other “Taskers” earning about $20...
    After months of debate and intense research concerning hydroxychloroquine, on Monday FDA officials revoked their Emergency Use Authorization (EUA) for the anti-malarial drug that President Donald Trump has promoted in the fight against Covid-19. When the EUA was issued in late March, no high-quality studies of the drug’s ability to prevent and treat Covid-19 were yet available. Now, a handful of randomized trials have failed to find any benefit associated with hydroxychloroquine use. Everything You Need to Know About the CoronavirusHeres all the WIRED coverage in one place, from how to keep your children entertained to how this outbreak is affecting the economy. On the basis of the current research, hydroxychloroquine “may not be effective to treat COVID-19,” and its “potential...
    The U.S. Food and Drug Administration on Monday revoked its emergency use authorization for hydroxychloroquine to treat COVID-19, but quickly came under fire from President Donald Trump, who said only U.S. agencies have failed to grasp its benefit in fighting the coronavirus. Based on new evidence, the FDA said it was no longer reasonable to believe that hydroxychloroquine and the related drug chloroquine may be effective in treating the illness caused by the novel coronavirus. The FDA also warned that the drugs have been shown in lab studies to interfere with Gilead Sciences Inc’s antiviral drug remdesivir – the only medicine so far to show a benefit against COVID-19 in formal clinical trials. The move comes after several studies of...
    SAN FRANCISCO (KGO) -- The Food and Drug Administration is revoking the emergency use of hydroxychloroquine to treat the novel coronavirus, the agency announced Monday.RELATED: FDA revokes emergency use of malaria drugs to treat coronavirusIn ABC7 News' live interactive newscast at 3 p.m., UCSF Infectious Disease Specialist Dr. Peter Chin-Hong joined ABC7 News Anchor Liz Kreutz to explain what the drug was and why it was revoked.Doctor Chin-Hong said the malaria drug is not an antiviral drug, which is probably not likely to work."We've never had a virus is treated by something that's not an anti-virus drug," Chin-Hong said. "For example, if you're taking Tamiflu, it's an antiviral drug that actually targets the lifecycle of the virus with influenza. When...
    Emergency use of the anti-malaria drug hydroxychloroquine as a treatment for coronavirus has been withdrawn by the US Food and Drug Administration (FDA). The FDA said that new evidence from clinical trials meant that it was no longer reasonable to believe that the drug would produce an antiviral effect. President Donald Trump later defended promoting the use of hydroxychloroquine as a treatment of Covid-19. In March, the FDA granted the emergency use of the drug for some serious cases. But on Monday, the agency said clinical studies had suggested that hydroxychloroquine was ineffective in treating the deadly virus and failed to prevent infection among those exposed to it. Hydroxychloroquine 'does not save lives'Responding to the FDA's decision, Mr Trump...
    By MATTHEW PERRONE WASHINGTON (AP) — U.S. regulators on Monday revoked emergency authorization for malaria drugs promoted by President Donald Trump for treating COVID-19 amid growing evidence they don’t work and could cause serious side effects. The Food and Drug Administration said the drugs hydroxychloroquine and chloroquine are unlikely to be effective in treating the coronavirus. Citing reports of heart complications, the FDA said the drugs’ unproven benefits “do not outweigh the known and potential risks.” The decades-old drugs, also prescribed for lupus and rheumatoid arthritis, can cause heart rhythm problems, severely low blood pressure and muscle or nerve damage. The agency reported Monday that it had received nearly 390 reports of complications with the drugs, including more than 100...