Just days before a momentous and unpredictable Presidential election, the United States has reached a new record high in the number of daily COVID-19 infections, surpassing the peak in mid-July during the second wave of the coronavirus pandemic’s domestic toll. As of Oct. 23, there was a weekly average of 21.2 infections per 100,000 residents, up from 20.5 on July 19 and ticking rapidly upward. The country also set a new single-day record on Oct. 23 with 83,757 new cases. There have been clear signs for weeks of a third wave of the pandemic in the U.S. as the weather gets colder and the virus has migrated from metropolitan regions to more rural settings. But it was far from certain, at the beginning of October, that the resurgence would surpass that of the summer, even though the figures were climbing far sooner than the timeline of the most promising vaccine trials, one of which was temporarily halted after a volunteer became ill but is set to resume soon. We know now that the third wave will be worse than the second, which was far worse than the first, when cases peaked at 9.7 per 100,000 on April 7. The twin threads of the COVID-19 pandemic and the 2020 Presidential Election that have cornered the headline market all year were perhaps destined to converge, but the timing couldn’t have come any more conspicuously, as deadlines for requesting and submitting mail-in ballots loom or have passed in many states and polling locations scramble to enact safety measures for those who vote in person. The COVID-19 pandemic has ground many sectors of life to a complete halt or, at best, a crawl. Even after the election results are clear, which is unlikely to be next Tuesday evening, all signs suggest the winner will take the oath of office on Jan. 20, 2021 at a generous distance from Chief Justice John Roberts--if not by Zoom. from https://ift.tt/35zD16z Check out https://takiaisfobia.blogspot.com/
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Researchers in India report that COVID-10 patients who received convalescent plasma from recovered patients did not see a lower risk of dying from the disease. The study, published in BMJ, included 464 people with moderate COVID-19 disease, meaning they had oxygen saturation levels of 93% or less when breathing room air, the criterion that most doctors use to determine if they should hospitalize people who are infected with SARS-CoV-2, the virus that causes the illness. Study co-author Aparna Mukherjee, a scientist in epidemiology and communicable diseases at the Indian Council of Medical Research, notes that patients in her study would likely be considered severely ill in other countries, since definitions of illness vary considerably around the world. Once in the hospital, some patients in the study received two doses of convalescent plasma from those who had recovered from the disease and donated their immune cell-rich blood. These patients were compared to those treated with standard of care, who acted as a control group (but did not receive a placebo infusion). Both groups had similar mortality rates after 28 days. “This study had a large sample size and it showed that when plasma is infused in patients who have moderate COVID-19 (similar to severe in other countries), it did not reduce mortality or progression to more critical COVID-19,” Aparna Mukherjee, a scientist in epidemiology and communicable diseases at the Indian Council of Medical Research and one of the co-authors of the study, said in an email response to questions. The results add to the continued debate over how useful convalescent plasma might be as a treatment for COVID-19. Convalescent plasma is one of the oldest therapies that doctors have used in treating infectious diseases, based on the idea that people who are naturally infected and recover will have a ready supply of the proper immune cells needed to fight off the virus or bacteria in question. But because people’s immune systems vary widely, their volume of disease-fighting cells is also unpredictable, and may range from barely adequate levels to extremely rich sources of immune cells. That variability has led to conflicting results on the effectiveness of the therapy, including in this study, which used donated plasma from people who were sick for an average of six days with what the authors describe as mild disease. Two other international studies also failed to find a benefit of convalescent plasma, but those were stopped early because too few eligible patients were enrolled. Other, smaller studies were more encouraging, so in the U.S. the Food and Drug Administration issued an emergency use authorization for the therapy in August that allows doctors to treat patients with plasma. Key public health leaders including Dr. Francis Collins, director of the National Institutes of Health, and Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, however, have noted that researchers are still studying convalescent plasma’s role in COVID-19. Those ongoing studies are comparing people who receive the plasma to those receiving a placebo, and may provide more convincing data on whether plasma can help COVID-19 patients or not. It’s also possible that because convalescent plasma serves as a stand-in for immune cells that an infected person might not have generated yet (or won’t generate at robust levels), it’s best used not in hospitalized patients who are already sick but in those who are more recently infected. The ongoing studies are looking at this possibility as well, and Mukherjee agrees that it’s worth investigating. Her study’s findings might even suggest that the plasma was used in patients who were too sick to benefit. “The main cause of mortality in COVID-19 is inflammation in the body that causes pneumonia and other organ failures,” she says. “While the body’s response to virus infection initiates the inflammation, it is not regulated by the virus. So even when the virus is neutralized, the inflammation continues. That is why it is being hypothesized in the upcoming studies on convalescent plasma that it may work in the very early phases of the disease … and may prevent the initiation of the inflammation cascade.” from https://ift.tt/3kBEWxK Check out https://takiaisfobia.blogspot.com/ Shalyse Olson knows there are risks associated with sending her children back to school during the coronavirus pandemic, but the mother of four in Salem, Oregon says virtual learning “has been nothing but frustrating and sad.” That’s why she is among parents in several school districts around the country who are demanding a return to in-person, the latest escalation in the polarizing debate over how to educate children as it becomes clear that the pandemic is not subsiding. Olson, whose children are enrolled in kindergarten through 10th grade in Salem-Keizer Public Schools, says she understood the need for remote learning initially, when the pandemic closed schools abruptly and forced teachers, students and parents to find ad-hoc workarounds from home. “All of a sudden it was like, ‘This will have to be good enough for now.’ And it was for a few weeks at the end of the year,’” says Olson. “But now, others are finding ways to do this safely. And we need to get on board and catch up, or it’s going to be a hard one to recover from.” A recent analysis of 106 school district plans by the Center on Reinventing Public Education found that just 10% were in-person at the beginning of September, but 55% of those districts are planning to be in-person by November. A recent Washington Post survey of the country’s 50 largest school districts found that 24 have resumed in-person learning for large groups of students, and 11 others plan to in the coming weeks. Chicago Public Schools, for example, announced a phased plan for returning to school, which drew pushback from the Chicago Teachers Union, which called the plan “reckless” as cases surge in the city. But district CEO Janice Jackson said she was “not throwing in the towel on in-person instruction.” San Francisco Mayor London Breed urged the city’s school district on Oct. 16 “to do what needs to be done to get our kids back in school.” “The achievement gap is widening as our public school kids are falling further behind every single day,” Breed said, noting that “parents are frustrated and looking for answers.” <strong>“We’ve seen around the country, and in almost every state, that cases are going up right now.”</strong> But on Tuesday, the district’s superintendent said the schools would not reopen until 2021, citing limited COVID-19 testing capacity, the San Francisco Examiner reported. Such disputes are playing out across the country as parents realize that remote learning is likely to last far longer than they imagined. Some express frustration that they can go to restaurants and into shops, yet their children cannot go to classes. Others see remote learning as the necessary response to a virus that has not been brought under control. As the Trump administration plays down the pandemic’s gravity, school districts have largely been left to figure things out on their own. (Education Secretary Betsy DeVos said Tuesday that it’s not up to the federal government to track school districts and their coronavirus infection rates.) Parents have resorted to citing individual anecdotes as evidence of the success or failure of reopening schools. One thing they all agree on is that remote learning is filled with challenges, as students struggle to learn over computer screens and parents try to balance work with helping their children navigate online learning. Some families who can afford it have opted for private schools or homeschooling, and experts have predicted this year will only exacerbate educational inequities as rising coronavirus cases hamper efforts to get children back on campus. “We’ve seen around the country, and in almost every state, that cases are going up right now, that we’re not quite at the peak where we were this summer, but we’re heading that way,” says Tara Smith, a professor of epidemiology at Kent State University College of Public Health, who chose remote learning for her own son, a first grader. “So to open up schools again right now, I think, is the wrong choice.” People under 18 represent 10.9% of COVID-19 cases in the U.S., according to the American Academy of Pediatrics and the Children’s Hospital Association. Children, especially the youngest, seem to be less likely than adults to get seriously sick or die from the virus. And there is still debate over how frequently children spread the virus; recent studies and case reports provide evidence that transmission from children is possible. Teenagers are more likely than young children to be infected, according to the Centers for Disease Control and Prevention, which is why many schools have prioritized in-person instruction for the youngest learners first. While COVID-19 cases have risen among children in recent months, it’s not clear that those infections stemmed from schools, but the uptick could reflect spread of the virus in the community at large. An unofficial dataset crowdsourced by Brown University economist Emily Oster suggests that schools tend to reflect the community rate of infection. Information, and tracking, still lackingDuring a recent briefing on school reopenings by the Infectious Diseases Society of America, Dr. Wendy Armstrong, an infectious disease expert at the Emory University School of Medicine, said that was “encouraging.” But Armstrong noted the dataset is based on schools that voluntarily reported data, not a representative sample, meaning the results could be skewed toward schools that have strong mitigation strategies in place and are carefully tracking coronavirus cases. “Without really broad national surveillance that incorporates all schools and all school systems, with the appropriate tracking in those schools — and that is lacking in a number of places — I would say we can’t know for sure,” Armstrong said. “But certainly, we have not seen a massive super-spreading event that has been obvious in the school systems.” Olson, the mother in Oregon, started a petition last month, calling on state and district leaders to provide “an in-classroom learning option for those educators and families who are ready, willing and wanting to be in the classroom.” She organized rallies at the state capitol, where parents held signs that read, “School is essential,” and, “Our kids deserve an education.” “We do not discount the virus. It’s absolutely real, and it needs to be taken seriously,” she says. “But we can’t discount education.” Christy Perry, the superintendent of Salem-Keizer Public Schools, which serves about 42,000 students, understands why parents are frustrated, and she notes that school districts—like parents— aren’t used to dealing with such a sustained disruption to education either. “Usually an emergency is a hurricane, tornadoes, wildfires. They come, you clean up, and they go. In this case, the emergency has come and stayed,” she says. On Oct. 13, Perry announced that the district would continue remote learning for fourth- through 12th-grade students until February 2021 because the two counties in which the district falls had not met state guidelines for reopening, with a test positivity rate of 7.6% in Polk County and 9.9% in Marion County as of Oct. 11. She’s hoping that students from kindergarten through third grade, for whom guidelines are less stringent, will be able to return to classes earlier. “I think we do have a responsibility to get more kids back,” Perry says. “We just have to do it when it’s safe.” Some parents are arguing that should be sooner rather than later. Jennifer Dale, in Lake Oswego, Oregon, has held rallies calling for in-person learning because her 8-year-old daughter, who has Down syndrome, has felt isolated and has struggled to participate in lessons. She recently began going to school for two hours, twice a week, as part of the district’s expansion of limited in-person instruction. “The importance of in-person, general education classrooms in my daughter’s life could not be more critical,” Dale wrote in an email to the director of Oregon’s Department of Education, adding: “Lizzie asks me each morning – I want to go to ‘far away school. No more computer school.'” The problems with remote learning are especially acute for children with special education needs. “We really feel that our kids deserve better,” says Amy Medling, who is part of a group of parents calling for in-person instruction in Nashua, New Hampshire. Her 11-year-old daughter, a sixth grader in Nashua Public Schools, has an auditory processing disorder that makes it more difficult to follow along on Zoom and decipher who is speaking, especially when multiple people are chiming in. “Pretty much we end up in tears every day at the end of remote learning,” Medling says. <strong>“Pretty much we end up in tears every day at the end of remote learning.”</strong>Nashua School District Superintendent Jahmal Mosley says he wants to be “safe and methodical” about reopening in a city with rising transmission levels. The district has started welcoming some students back for hybrid learning in phases, starting with some special education and preschool students this month and prioritizing the youngest grades in the coming weeks. High school students would begin hybrid learning in January “if everything goes well.” Mosley agrees with parents who say remote learning is no replacement for the classroom experience, but it’s one way to keep kids learning during the pandemic. “It’s not perfect. It never will be,” he says. “But it’s a weapon against COVID-19.” Many teachers’ unions agree and have advocated for continued remote learning, raising safety concerns about conditions within school buildings and noting that school employees, because of their ages, would be at higher risk of becoming seriously ill from the coronavirus than children. The issue is pitting parental groups against each other in some cases. Soon after Leslie Hofmeister, who has two children in the San Diego Unified School District, and others began protesting outside the district’s Board of Education office to demand in-person learning, other parents launched a petition urging the district not to fully reopen classes until “it can be safely done using an informed, science-based approach.” San Diego County is now seeing 7 daily new coronavirus cases per 100,000 residents, nearing the level at which the state prohibits most in-person instruction. The district is currently allowing some students with the most needs to come into schools for limited in-person instruction and is working on a plan to expand hybrid learning to all students. “I am heartbroken for this generation of kids,” Hofmeister says, calling remote learning “an absolute disaster.” Dawniel Carlock Stewart, who has three children in San Diego schools, disagrees. “While it’s not ideal, we have certainly adjusted to the hard situation and understand that this is what’s best for everyone right now,” she says. Carlock Stewart worries about how her children would feel if they were allowed back at school and brought the virus home to her husband, whose compromised immune system puts him at high risk of illness. “It would be more detrimental to my children and our family, ultimately, than whether or not they do well in math,” she says. ‘These families are in a bind’Experts say the lack of national data and clear guidance on school reopenings has made it harder for parents and for schools trying to figure out the best way forward. President Trump, in his final debate with Democratic nominee Joe Biden, insisted Thursday that the virus “will go away.” “We are rounding the turn, we are rounding the corner,” he said, as daily cases continued to rise in the U.S., insisting again that “we have to open our schools.” The result, for many parents and educators, is mass confusion. “I think in many places, there’s probably a way to make the schools safe, but often, people don’t even agree on what safe means,” says Whitney Robinson, an associate professor of epidemiology at the University of North Carolina Gillings School of Global Public Health. “And another thing is that there has not been the federal funding to do things that would make all places safe.” Smith, the Kent State epidemiologist, says the lack of sufficient testing and contact tracing still makes it difficult to determine if outbreaks are directly related to in-school transmission. And just as Black and Latino communities have been hit hardest by COVID-19, and by its economic impact, they also have the most at stake in the schools dispute. Students of color are more likely to attend high-poverty schools, which have faced the biggest challenges getting buildings ready for safe in-person instruction or supplying students with the computers and internet access needed for remote classes. Parents of color have also been among the most hesitant to send their children back to school, in part because they have been disproportionately affected by the pandemic. “I think there’s a lot of families, particularly in Black communities, Latino communities, where parents are essential workers and need to work, and not having in-person school can be a hardship,” says Robinson, who studies health disparities by race and ethnicity. “But also, these communities have seen first-hand how awful the coronavirus is.” “So these families are in a bind,” she says. Robinson says Congress needs to pass a relief bill that will provide more funding to school districts so they can invest in protective equipment, ventilation systems and testing to enable more schools to open in person. “It’s doable,” she says. “We just need political will.” from https://ift.tt/2IYuGSy Check out https://takiaisfobia.blogspot.com/ The COVID-19 pandemic continues to have a devastating impact on the health and economic well-being of families and communities across the country, and this virus will remain a significant threat until a safe and effective vaccine can be made available to all. While we all hope to get potential vaccines reviewed, produced and distributed as quickly as possible, we can’t sacrifice safety and efficacy for speed. It is also critically important that the public has confidence in the federal government’s vaccine review process, which includes assurances that the Food and Drug Administration (FDA) has followed the necessary protocols to ensure vaccine safety and effectiveness. Together, we’ve introduced the Safe Authorization for Vaccines during Emergencies (SAVE) Act to ensure that the FDA and the Centers for Disease Control and Prevention (CDC) follow well-established measures so that COVID-19 vaccines meet rigorous standards that the public can rely on. The FDA and CDC have existing vaccine review processes that are considered the gold standard by public-health experts around the world. During the normal vaccine approval process, the CDC and FDA each have advisory committees that meet and issue findings and recommendations on the safety and effectiveness of vaccines before they enter the market, including whether specific vaccines are safe for certain populations such as children or seniors. For the COVID-19 vaccine, however, an expedited review process called an emergency use authorization is being used. There’s never been an emergency use authorization for a new vaccine before, and it is important to ensure that any expedited review process does not come at the expense of safety and efficacy. Keep up to date with our daily coronavirus newsletter by clicking here. By taking key oversight measures, we can ensure the safety and effectiveness of a potential vaccine and promote transparency, even during an expedited process. By extension, we can also help bolster public confidence in the vaccine review process, as well as any vaccine product that enters the market. However, we have a lot of work ahead of us. Public trust in the vaccine approval process is critical to achieving widespread use, and right now, the public is skeptical. A CBS poll released in September found that two-thirds of Americans would think the process had been rushed if a vaccine enters the market this year, and only one in five plan to get vaccinated as soon as possible. Another poll from the Kaiser Family Foundation showed that 62% of Americans worry that political pressure will lead to premature approval of a vaccine. If a majority of Americans are unwilling to take a vaccine, that vaccine will not be able to provide our communities with the protection that we need to return to normal life. We must make sure that doctors and public-health experts are evaluating each vaccine as it is being reviewed and are providing feedback in a public, transparent manner that is free from political influence. Doing so will help strengthen the safety of a vaccine and bolster the American people’s confidence in it. At a recent Health, Education, Labor, and Pensions Committee hearing, FDA commissioner Dr. Stephen Hahn and CDC director Dr. Robert Redfield committed that their respective agencies would conduct oversight measures, including allowing their independent advisory committees to meet, review data and issue public findings as part of the expedited COVID-19 vaccine review process. In addition, in September leading COVID-19 vaccine manufacturers took an unprecedented step of jointly releasing a public pledge committing to an evidence-based vaccine review process focused solely on safety and efficacy. We need to enshrine these commitments into law. That’s what the SAVE Act does. Our bipartisan bill codifies into law that these FDA and CDC advisory committee meetings must meet and report findings, even if a COVID-19 vaccine goes through the expedited emergency use authorization process. And if these meetings do not occur, the Secretary of Health and Human Services must publicly explain why. Our bill will help ensure that a vaccine review process can take place in a transparent way, free from political influence, without slowing down its development. A safe and effective COVID-19 vaccine is the only way we will be able to fully reopen our economy and get back to our normal lives. Through this bipartisan legislation, we can help reassure Americans when a vaccine is available, that it is safe. Please send any tips, leads, and stories to [email protected]. from https://ift.tt/31wrdRu Check out https://takiaisfobia.blogspot.com/ As part of its routine review process, the U.S. Food and Drug Administration (FDA), the agency responsible for evaluating and deciding if the handful of COVID-19 vaccines currently being studied are safe and effective enough to use by people around the world, convened a committee on Oct. 22 to allow experts and the public to learn about and comment on the review process. The FDA’s Vaccines and Related Biological Products Advisory Committee is responsible for reviewing any applications by manufacturers hoping to get vaccines to market. The 18-member committee includes scientists and doctors with infectious disease, virology, and epidemiology expertise from academia, industry and government. Over a period of four and a half hours, the committee, which met virtually, heard from invited speakers from the government agencies responsible for developing testing and distributing COVID-19 vaccines about the latest plans for evaluating how safe and effective the vaccines are. Experts provided updates from the National Institutes of Health (which provided basic research that led to many of the vaccine candidates), the Centers for Disease Control and Prevention (which is responsible for working with state and local health departments to lay out plans for distributing the vaccines if and when they are authorized), the FDA (which provides criteria for what makes a vaccine safe and effective), BARDA (a Department of Health and Human Services office overseeing research and development of treatments against public health threats) and the inter-agency Operation Warp Speed (which is coordinating development, testing and distribution efforts). Marion Gruber, director of the office of vaccines research and review at the FDA’s Center for Biologics Evaluation and Research (CBER), opened the meeting by saying “I want to take a minute to assure the American public that facilitating the development of safe, effective COVID-19 vaccines is the highest priority of my office, CBER and the agency. Today’s discussion provides transparency about the data we will request and evaluate in support of the safety and effectiveness of vaccines.” The FDA confirmed it will consider a COVID-19 vaccine effective if it achieves 50% effectiveness in protecting against the illness. The members and speakers debated about what this protection means, and raised the possibility that it could indicate that immunized people would still get infected, but then not progress on to serious disease. Another key question centered around what type of green light the FDA would give vaccines developed and tested on an accelerated timeline. The traditional approval process can take years from development to market, but the leading COVID-19 vaccine candidates sped from development to human testing in a matter of months. Emergency use authorization, or EUA, would further shorten the review process, as it requires shorter follow-up of people in the studies for effectiveness of the vaccines and their potential side effects (EUAs are allowed during public health crises, such as the pandemic, when the urgency of the need for treatments justifies the shorter research and development time). The FDA guidelines for COVID-19 vaccines currently require at least two months of follow up, although some experts questioned whether that was long enough to truly get a sense of a vaccine’s efficacy. That’s especially true since the coronavirus is so new to the world that the vaccine makers aren’t yet sure what immune reactions are needed to constitute a “strong” or Another unresolved issue centers around what will happen to ongoing placebo controlled studies if one or more of the vaccines are given EUA ahead of others. Given that the virus is still spreading in parts of the U.S., participants in ongoing trials may want to drop out of their studies and get vaccinated with an authorized shot, once available. But because the trials are all blinded, neither they, nor their doctors, will know if they received the experimental vaccine or a placebo. Those studies would have be unblinded if volunteers will be allowed to drop out, but that would mean researchers will not get the same high quality data on vaccines still being studied if those trials are stopped. “Once a decision is made to unblind it can’t be walked back,” said Doran Fink, deputy director in division of vaccines and related products applications at FDA. “That control [group] is lost forever.” Many speakers also stressed the need to continue to follow trial participants in order to collect more data on the vaccines’ effectiveness and side effects. The FDA noted that all of the participants will be followed for two years even after the trials end. During the public comment period, patient advocates and other infectious disease experts argued that the FDA should consider at least a six month follow-up period before allowing any manufacturer to request authorization or approval. That’s in stark contrast to the Trump Administration’s view; the White House initially opposed even the two month window. Members and speakers also raised the importance of addressing vaccine hesitancy, and the need to understand and address the many reasons why people have expressed reluctance to get vaccinated if and when COVID-19 shots become available. These range from general vaccine skepticism, to mistrust of the government and science, and more specific concerns about COVID-19 immunizations that have been developed in record time and seem to be rushing through the testing process. Some people may also intentionally wait to get vaccinated because they are skeptical of the first shots to come off the assembly line, which could keep infections percolating for longer. “People may be waiting to see what the first candidates are, and even waiting for a more ‘favorable’ candidate,” said Dr. Janell Rough, medical officer and program lead in the division of viral diseases at the CDC. “That’s not a message we want to convey.” Shifting those views may be one of the bigger challenges facing a massive COVID-19 immunization effort. Federal and state pubic health officials are taking this into consideration as they formulate plans for distributing the vaccines when they become available. All 64 state and local health groups in the country have submitted their plans for ordering and distributing vaccines. The CDC is now reviewing those plans and will work with local officials to refine them and provide resources necessary to educate the public about the vaccines themselves as well as the need for getting vaccinated more broadly. from https://ift.tt/2FXtZI4 Check out https://takiaisfobia.blogspot.com/ On Oct. 22, the Food and Drug Administration (FDA) approved the first drug for treating COVID-19. Remdesivir, an antiviral medication given intravenously, is now approved for anyone hospitalized with COVID-19. It works by blocking the virus’s ability to make more copies of itself. Earlier this year, the drug had received emergency use authorization (EUA), which falls short of approval but is granted during a public health crisis if there is encouraging data supporting its potential benefits. Approval means the drug’s maker, Gilead, provided more information to the FDA on the medication’s effectiveness and safety than was used to issue the EUA. “This decision by the FDA is a milestone in the treatment of hospitalized patients with COVID-19,” says Dr. Andre Kalil, professor of internal medicine at University of Nebraska Medical Center who was among the first to treat patients from the Diamond Princess Cruise ship with remdesivir and runs one of the drug’s clinical trials. “Remdesivir shortens the recovery time by 5-7 days, provides 50% faster clinical improvement, prevents patients’ progression to mechanical ventilation, and is associated with a 45% mortality reduction in the first two weeks of disease. These are real and meaningful benefits to our patients.” The FDA decision is based on three randomized controlled trials that found that people receiving remdesivir shortened their recovery time. While the data did not find a statistically significant benefit in reducing mortality, doctors involved in one of the studies, published in the New England Journal of Medicine (NEJM), reported a trend toward reduced mortality after about a month, especially among people who received the drug early in their infection, as Kalil notes. Patients receiving the drug also needed less additional oxygen and were less likely to progress to severe disease compared to those receiving placebo. The NEJM study was placebo-controlled and supported by the U.S. National Institute of Allergy and Infectious Diseases. The other two studies, sponsored by Gilead, did not include placebo controls, but compared patients receiving the drug and standard of care to those getting standard of care alone. The drug was effective, and those receiving five days of remdesivir treatment improved as much as those receiving a 10-day course. The National Institutes of Health now includes remdesivir as part of its recommended treatment strategy for hospitalized COVID-19 patients, and doctors treating patients have said that the drug is one of the reasons that death rates from the disease may have started to drop since the beginning of the pandemic. Other medications and treatment strategies, such as anti-inflammatories and keeping patients on their stomachs to prevent worsening respiratory symptoms, are other likely contributors to the decline in death rates. The FDA approval comes days after a study from India of nearly 3,000 COVID-19 patients found that the drug had no benefit on reducing early death or in preventing progression to serious disease. Those findings are controversial, however; the study did not include a placebo control and compared outcomes to standard of care. It’s also not clear how sick the patients were and therefore how to evaluate the contribution of remdesivir. The NEJM study included hints that people who receive the drug earlier in their disease may benefit more, and doctors are already studying whether people with mild symptoms but who don’t need to be hospitalized can be treated with remdesivir on an outpatient basis. from https://ift.tt/3ohOwbz Check out https://takiaisfobia.blogspot.com/ Li Shurui didn’t hesitate. Faced with putting his life on hold indefinitely or the risk of catching COVID-19 by returning to university in the U.K., the 22-year-old business student decided to roll up his sleeve and receive an experimental coronavirus vaccine. Two injections made by Beijing Kexing Biological cost 2,000 rmb ($300) at the private Taihe Hospital in the Chinese capital. The treatment still hasn’t passed final (Stage 3) clinical trials but is already being offered to the public on a first come, first served basis. Anyone can turn up, pay their money and get the jab. Li says hundreds were queuing to get immunized at the same time as him. “I’m a little worried about side effects but more worried catching the virus overseas,” Li tells TIME. “But I haven’t had any problems from the jabs so far.” It’s not just the Kexing vaccine on offer in China. An unofficial vaccine rollout is gathering pace despite the warnings of international public health experts. In September, state-owned SinoPharm revealed that hundreds of thousands of Chinese had already taken its experimental COVID-19 vaccines as part of a state initiative to protect frontline health workers and officials traveling to high-risk nations. In the eastern manufacturing hub of Yiwu this week, hundreds of people queued for a $60 dose of the CoronaVac vaccine made by private firm SinoVac. “This is insane,” Adam Kamradt-Scott, associate professor specializing in global health security at the University of Sydney, says of China’s gung-ho vaccine rollout. “It is just unsound public health practice. We have previous examples of where vaccines that have not gone through sufficient clinical trials have demonstrated adverse reactions with long-term health consequences.” As the coronavirus pandemic approaches its 11th month, with over 40 million cases and 1.1 million deaths globally, longing for a miracle cure becomes more desperate. But the consequences of a vaccine misstep could also be dire. In 1976, a rushed campaign to immunize millions of Americans against swine flu subsequently resulted in a small proportion developing chronic fatigue syndrome and helped spark the modern anti-vaxxer movement. Handing out a pre-approval vaccine without sufficient monitoring of efficacy and health of participants risks stoking public misinformation. Read more: How an Election-Year Vaccine Rollout in 1976 Backfired What’s more, since COVID-19 cases are so low in China, Stage 3 trials—when the vaccine is given thousands to see how many become infected, compared with volunteers who received a placebo—can only be conducted overseas. There have also not been any “challenge” trials where scientists deliberately expose vaccinated volunteers to the virus to test immunity. (Although controversial, such trials are about to go ahead in the U.K.) But it’s not just China that’s getting ahead of itself. U.S. President Donald Trump has put enormous public pressure on regulators and pharmaceutical companies to make a vaccine available in time for the American election. On Oct. 16, Pfizer revealed it may begin rolling out its vaccine for emergency use in the U.S. by late November. Moderna has a similar timeline for emergency use, though cautions widespread vaccine distribution may not happen until the spring. The difference in China, however, is that the virus has been largely contained domestically. The country reported only 14 cases on Wednesday, all imported. “It seems there is no need to get a vaccine in China,” says the student Li. “After all, the pandemic has little impact on life in China now; even masks are not mandatory here anymore.” So why is China so aggressively rolling out vaccines? For the Beijing government, the fight against the pandemic has become a PR battle to drown out international criticism about its early mishandling, coverup and silencing of whistleblowers. Instead, China wants to rebrand itself as a source of vital PPE and, ultimately, a solution the crisis. China’s National Health Authority projected China’s COVID-19 vaccine production capacity will reach 610 million doses annually by the end of 2020. SinoPharm’s boss says his firm alone may be able to produce more than 1 billion doses next year. Read more: Inside the Unprecedented Scramble to Immunize the World Against COVID-19 Sinovac has promised to supply 40 million CoronaVac doses to Indonesia by March 2021. São Paulo Governor João Doria said Brazil’s federal government had also agreed to buy 46 million doses of CoronaVac, one of at least five vaccines undergoing stage 3 trials in the country, which has the world’s third highest infection tally. “The first results of the clinical study conducted in Brazil prove that among all the vaccines tested in the country, CoronaVac is the safest, the one with the best and most promising rates,” Doria told reporters Monday. Of course, China is not alone in craving the PR benefits. On Aug. 11, Russian President Vladimir Putin unveiled what was ostensibly the world’s first COVID-19 vaccine, which he said had already been administered to his daughter. The trade name—Sputnik 5, after the groundbreaking Soviet satellite—leaves no doubt at the national pride wrapped in its development. But it was tested on only 76 people—38 in Phase I and 38 in Phase II trials—and hadn’t even entered phrase 3 trials. The vaccine hasn’t stopped COVID-19 from spiking to record levels in the country this month. “My gut reaction is that this is China’s attempt to claim international prestige by being first to rollout a widespread vaccination program,” says Kamradt-Scott, the Australian global health expert. “Unfortunately, I just see politics at play here rather than public health.” from https://ift.tt/2ThZKyl Check out https://takiaisfobia.blogspot.com/ COVID-19 Vaccines Should Be Available to the General Public by April 2021 Health Officials Say10/21/2020 COVID-19 vaccines are projected to be available to the entire American public by April 2021, U.S. Department of Health and Human Services Secretary Alex Azar said at an Oct. 21 press briefing. That timeline is in keeping with estimates made by other public-health officials, but is among the strongest and most specific statements made about the widespread availability of a coronavirus vaccine in the U.S. Two vaccine candidates—those made by Pfizer and Moderna—are nearing the end of the clinical trial process, and the pharmaceutical companies are already building up sizable stockpiles. Assuming these (and possibly other) vaccines meet safety and efficacy standards and are granted emergency-use authorization from the U.S. Food and Drug Administration, Azar said he expects to have enough doses to immunize the U.S.’ “most vulnerable individuals” by the end of 2020. By the end of January 2021, he said, he expects to have enough doses to immunize seniors, health care workers and first responders. And “by the end of March to early April, [there should be] enough vaccine for all Americans who would want to take a vaccine,” Azar said. (It’s not clear how many people that will be; recent polls suggest the majority of U.S. adults have some concerns about the safety and development of these vaccines.) At the same press briefing, U.S. Centers for Disease Control and Prevention (CDC) Director Dr. Robert Redfield addressed a subtle change to the agency’s definition of who is at high risk of contracting COVID-19 and should quarantine after exposure to a sick person. Previously, the CDC defined a “close contact” as someone who’d been within six feet of an infectious person for at least 15 minutes. Now, the agency has broadened that definition to include people who have had multiple brief interactions with an infectious person, totaling 15 minutes or more in the span of 24 hours. “It’s based on data that one didn’t have four months ago, but it is data now that we have,” Redfield said at the briefing, alluding to a new case report of a correctional officer who contracted COVID-19 after “multiple brief encounters with six incarcerated or detained persons” awaiting COVID-19 test results that ultimately came back positive. Redfield also appeared to push back against recent reports that suggest the CDC has been muzzled or used for political gain by President Donald Trump’s administration during the pandemic, calling the agency a “science-based, data-driven service organization.” He defended the agency’s right to change its recommendations based on new data, following recent criticism over its sometimes erratic guidelines. “We’re not an opinion organization,” Redfield said. “If we get data that supports a change in our recommendations, then those recommendations will be changed.” Azar also maintained the CDC’s importance in responding to the pandemic—as part of a larger governmental system. “This is a crown jewel of American and global public health. We revere it,” Azar said. “The CDC plays a very important, vital role. But in a pandemic of this scope, size and magnitude, it plays a role not just the role.” from https://ift.tt/34gb8RQ Check out https://takiaisfobia.blogspot.com/ On Oct. 20, researchers at the Imperial College of London announced plans for the first human challenge study of COVID-19, which involves deliberately infecting volunteers with the virus that causes the disease, in order to test the effectiveness of vaccines. The strategy is controversial, as researchers have to weigh the risks of infection against the benefits of learning how well the various vaccine candidates can fight that infection. The strongest argument in favor of the studies has to do with time. If cases of COVID-19 are waning, then the likelihood that people who are vaccinated would get exposed to and potentially infected with the virus naturally declines as well, and it takes researchers longer to accumulate enough data to tell if a vaccine is effective or not. By intentionally exposing people to the virus after they have been vaccinated, researchers can shrink this timeline significantly. Scientists have used the model to test vaccines against a number of different diseases, including the very first one against smallpox—Edward Jenner infected his son with cowpox, and then exposed his son to smallpox as a way to test his theory that exposure to the former would protect his son from infection by the latter. Scientists tested an H1N1 influenza vaccine by exposing people to the flu, and did the same with a cholera vaccine and the bacterium that causes it. But the strategy requires a solid base of information about both the disease and the vaccine in order to justify the risks. More recently, for example, scientists considered intentionally infecting volunteers with the Zika virus to test vaccines against that disease, but ultimately decided they didn’t have enough data to justify the risk. Adair Richards, honorary associate professor at the University of Warwick who last May published guidelines on how to ethically conduct human challenge studies, notes that during a pandemic, the risk of delays in developing treatments should be considered alongside the risks to volunteers who are intentionally exposed to disease. “There is a moral weight to inaction as well as action,” he says. “There is an unseen risk if we don’t do [these studies]. We send a lot of doctors, nurses and care workers to work every day, and some will get really sick and die of COVID-19 in the next few weeks. [Those] few weeks count—that’s the unseen risk.” More than 38,000 people in the U.S. agree, and have registered their intention to volunteer for challenge studies on 1DaySooner.org, an online recruiting group—despite the fact that no such studies have been planned in the country yet. The London-based scientists still need to submit a detailed proposal to regulatory agencies on how they could conduct their study. If the proposal is approved, the team won’t start exposing any volunteers until January. Before that, they will first need to determine what dose of SARS-CoV-2, the virus that causes COVID-19, is safe to give to people but can still produce enough disease to test a vaccine. They will start with the smallest possible dose and work up to one that balances safety with the ability to trigger a proper immune response. The participants will remain under quarantine at a designated facility in London until they test negative for the virus, the researchers said. From a scientific perspective, infecting people with a known dose of the virus can help researchers be more precise about evaluating and comparing people’s immune responses to different vaccines. It will also provide those answers faster than waiting for people to be exposed naturally infected with the disease. “These could almost take the place of phase 3 trials or at least go alongside them,” says Richards. That speed is one reason why the 1DaySooner.org volunteers have supported human challenge trials. “We could know already if some of the major vaccines in phase 3 trials are actually effective,” says the movement’s founder Josh Morrison, who also co-founded Waitlist Zero, and advocacy group for living organ donors. “It’s not to say that we wouldn’t still need phase 3 studies, but we would obviously be in a much better position if we could say that when we vaccinate healthy young people with this vaccine and then challenge them with virus, it’s 80% effective or 60% effective or 20% effective or not effective at all. It’s useful information we could have now but don’t have.” Exposing people deliberately to a disease-causing virus, however, would only make sense if the chances of naturally being infected is low, and would delay results of vaccine trials. That’s one issue regulators in the UK will likely consider before approving the plan, as daily case numbers there continue to climb. That’s also the case in the U.S., where new infections continue to emerge at high rates in many parts of the country. That’s one of the main reasons that Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and member of the White House Coronavirus Task Force, said earlier this year that the studies are not ethically justified—at the time, mid-July, daily case numbers were peaking. In an Oct. 20 statement to TIME, NIAID officials said the agency is “currently prioritizing randomized controlled clinical trials to evaluate the safety and efficacy of SARS-CoV-2 vaccine candidates. Should there be a need for human challenge studies to fully assess candidate vaccines or therapeutics for SARS-CoV-2, NIAID has begun efforts to manufacture a virus strain that could be used to develop a human challenge model, if needed, although human challenge trials would not replace Phase 3 trials.” Any human challenge study has to be done with extreme caution, says Richards. His guidelines include giving people a mandatory period of time to think about their decision to ensure they are making the choice freely and without any duress, and that the risks of infection are conveyed in a straightforward and easily understandable way. Any financial payment should be minimal to cover time away from work and any expenses related to being quarantined for the study, but not large enough to bias people’s decisions. “We also want participants to be screened for mental health conditions and cognitive capacity,” he says, to ensure that they are making their decision to join the study autonomously. The Imperial College of London team has yet to detail how its study volunteers will be managed, and what type of informed consent they will provide, but the announcement could change the discussion about the feasibility and utility of human challenge studies. Having studies that compare people’s immune responses to different vaccines could be useful in prioritizing which vaccines are manufactured in greater quantities. “Even if every vaccine currently in phase 3 trials works very well, we won’t be able to produce enough doses to vaccinate the whole world in 2021,” says Morrison. “It’s important that we are getting better vaccines and learning from the science and challenge studies are going to be quite useful for that.” from https://ift.tt/2HjVmMP Check out https://takiaisfobia.blogspot.com/ As COVID-19 began spreading around the world several months ago, sporting events from little league games to elite competitions were cancelled—and for good reason, as close contact among athletes and spectators can foster the spread of the novel coronavirus. A February soccer game in Italy, for example, helped fuel that country’s outbreak, while the U.S. Centers for Disease Control and Prevention last week said a recreational hockey game in Tampa, Fla. in June was a dreader “superspreader” event. The pandemic also forced the postponement of what was supposed to be year’s signature international athletic gathering—the 2020 Tokyo Olympics—lest athletes carry the virus back into their home countries. While sports have since returned, with measures like bubbles and daily testing and restrictions on spectators, a potential new surge of infections during the winter again threatens events on all levels. While COVID-19 is particularly dangerous for the elderly and other vulnerable populations, it can still kill otherwise healthy individuals, like elite athletes. Moreover, researchers are worried that COVID-19 may pose long-term risks to heart and lung health, consequences that could derail an athlete’s career. The sports stoppage, however, came with steep costs for those who’ve dedicated their lives in pursuit of victory. According to a study released Tuesday from Stanford University and Strava, a social network of exercise enthusiasts, 22.5% of professional athletes reported feeling down or depressed on more than half of the days of the week in the period between mid-March and August of this year, while COVID-19 restrictions on athletic training and competition were in place, compared to 3.9% of athletes reporting the same struggles earlier this year before the pandemic hit. That’s an increase of 477%. Researchers also found that those surveyed—who were endurance athletes like cyclists, runners, and triathletes—were 5.9 times more likely to report feeling nervous or anxious for more than half the days of the week during the pandemic period than beforehand; they were 7.1 times more likely to report little interest in doing things. The pandemic is also taking a mental health toll on pretty much everyone else, of course. But these numbers are startling given that exercise has been shown to help mitigate issues like depression and anxiety. “It’s pretty obvious that people right now, given everything that’s been going on in 2020, the calamity across the board, that people are going to have mental health struggles and difficulty exercising and a lot of these symptoms,” says Dr. Megan Roche, clinical researcher at Stanford and a lead author on the study. “What was most shocking was the magnitude of that. It’s very rare, in these sorts of studies, to see things like ‘six times increase’ and ‘seven times increase’ and just to see the staggering numbers we were seeing.” ‘I was in such a rut’While this study was limited to 131 professional endurance athletes, the data has implications across all sports. Considering that runners and cyclists still had relatively easy access to training during the shutdown—you could still go on a long run or bike ride while gyms and pools and other sports facilities were closed—the pandemic’s mental health effects could be worse for other athletes who were locked out of courts, rinks, and so on. The pandemic is also creating financial anxiety for these pros: 71% of them reported worrying about compensation during the pandemic, and of the athletes surveyed who received compensation from sponsors, nearly half--47%—saw a reduction in paid opportunities during COVID-19 restrictions. Rebecca Mehra, a U.S. middle distance runner who was preparing for the Olympic trials when the pandemic shut down sports, felt some relief when she saw the study results, as they showed she wasn’t the only one feeling anxious and unmotivated. “It makes you feel more normal to know other athletes have been frustrated and having a tough time,” says Mehra, who was surveyed for the study. The cancellation of the Olympics—and of her race schedule—crushed her. “I was just in such a rut,” says Mehra. “I didn’t want to get up and go to practice. I barely felt like running.” Mehra also lost a part-time job working in the athletic department at Stanford, her alma mater. Triathlete Pedro Gomes, an Ironman competitor, felt confused after pools near his Scottsdale, Ariz. home were shut down. “Mentally, I was definitely lost,” says Gomes, another study participant. “I just did not know how long the pool was going to be closed for. The uncertainty of not knowing when this is going to end and being completely out of my control, it was something scary.” How athletes can bounce backThe good news: athletes like Gomes and Mehra proved resilient. Data from Strava showed that overall, athletes wound up actually increasing their physical exertion during the period of COVID-19 restrictions: they exercised for an average of 103 minutes per day during the shutdown period, compared to 92 minutes a day beforehand. They seemed acutely aware that even if the fruits of running and biking wouldn’t show up in competitions, they’d at least help their mental health. “Right now,” says Roche, “it’s all about finding magic in the mundane.” Gomes started waking up at 2 am in Arizona to race virtually against his friends in his native Portugal on an indoor bike trainer; on Oct. 19, he finished second in his first competitive Ironman race since the pandemic. Mehra, meanwhile, hit reset. “I was eating Nutella and ice cream whenever,” she says. After the shock of the cancellations wore off, she returned to running for the sake of running and pursued other interests; she’s now serving as a campaign manager in a city council race in Bend, Ore, where she lives. And in August, she competed in a makeshift meet at a high school track in Los Angeles. There were no screaming fans or prize money. This 800-m race could not have been farther from Mehra’s Olympic dream. She ran a personal best. from https://ift.tt/35wasav Check out https://takiaisfobia.blogspot.com/ |
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