Theranos Founder Elizabeth Holmes Faces Trial for Fraud. Heres What to Know About the Case8/25/2021 Theranos founder Elizabeth Holmes will stand trial later this month on charges of defrauding investors and patients of the blood-testing company. If convicted, 37-year-old Holmes—once named the world’s youngest female self-made billionaire—could face 20 years in prison for each of the ten counts of wire fraud and two counts of conspiracy to commit wire fraud she is accused of. The Theranos case has attracted worldwide attention, inspiring a bestselling book, an HBO documentary, a podcast, a limited series on Hulu and an upcoming film set to star Jennifer Lawrence. Who is Elizabeth Holmes?Holmes, who grew up in Washington D.C., aspired to change the world from a young age. “What I really want out of life is to discover something new,” she wrote in a letter to her father when she was nine. A top student throughout high school, Holmes dropped out of Stanford University at 19 to launch ambitious blood-testing startup Theranos. An admirer of Apple CEO Steve Jobs, Holmes became known for her distinctive black turtlenecks and baritone voice. Despite lacking medical qualifications, Holmes’ charisma and belief in her idea convinced wealthy and connected investors, from the DeVos family to Rupert Murdoch, to pour millions into Theranos. What was Theranos?Founded in 2003, Theranos developed a portable device that it claimed could test for hundreds of illnesses using a single drop of blood. Inspired by the aesthetics of Apple products, Holmes poached designers from the tech giant to work on the “Edison” machine. Theranos promoted its blood-testing device as cheaper and more portable than traditional intravenous blood tests. Influential figures including George Shultz, General Jim Mattis, and Henry Kissinger joined Theranos’ board of directors. Businessman Ramesh “Sunny” Balwani, 56, was first employed by the company in 2009, rising up the ranks to Chief Operating Officer. Balwani and Holmes had earlier begun a romantic relationship, which they didn’t disclose to investors. Before the Edison device had been rolled out for use on the general public, Holmes began making bold, unproven claims about its capabilities, saying the Edison machine would catch terminal illnesses early, creating “a world in which no one has to say goodbye too soon.” In September 2013, Theranos landed a lucrative deal with Walgreens Boots Alliance that included plans to install Edison machines in thousands of its stores across the U.S. to make testing available to customers. In their pitch to Walgreens, Holmes and Balwani claimed that the U.S. military used Theranos devices on the battlefield. Holmes later admitted under oath that this was untrue. What happened at Theranos?As Theranos began the roll out of their Wellness Centers in Walgreens stores, Theranos was valued at $9 billion. Holmes was on the front cover of Fortune, Bloomberg BusinessWeek, Forbes, Inc. Magazine, and named one of TIME’s 100 Most Influential People. Yet, the technology Theranos was depending on didn’t produce reliable results. Patients were given inaccurate results relating to serious conditions such as cancer, HIV and miscarriages, according to reporting by the Wall Street Journal. How did it fall apart?In October 2015, the Wall Street Journal ran a series of damning reports uncovering the company’s failings. Tyler Shultz, a grandson of Theranos director George Shultz, was the first employee to blow the whistle on the company’s malpractice. Walgreens sued Theranos for breach of contract in November 2016 for the full $140 million it invested in the company. In 2017, an agreement was reached to settle for less than $30 million. Facing multiple civil and criminal federal investigations, Theranos dissolved in 2018. Both the company and Holmes reached settlements with the Securities and Exchange Commission (SEC). The U.S. attorney’s office for the Northern District of California had also launched a two-year long investigation into the company, which culminated in the indictment of Holmes and Balwani in June 2018. The pair ended their professional and romantic relationship in the wake of the investigations. Who were Theranos’s investors?A star lineup of investors poured more than $600 million into the company. The family of former education secretary Betsy Devos lost $100 million, the Wall Street Journal reported. Other investors included the heirs of Walmart founder Sam Walton, media tycoon Rupert Murdoch, the Kraft family, the Cox family, and Mexican businessman Carlos Slim. “The Theranos story is an important lesson for Silicon Valley,” said Jina Choi, director of the SEC’s regional office in San Francisco, after charging Holmes with civil securities-fraud charges in March 2018. Read more: The Theranos Downfall Was Inevitable What is the trial about and when does it start?In July 2020, a superseding indictment charged Holmes and Balwani with two counts of conspiracy to commit wire fraud and ten counts of wire fraud. The pair are accused of defrauding investors of millions of dollars and patients who were sold inaccurate tests. Both Holmes and Balwani have pleaded not guilty. Holmes’ trial is expected to begin on Aug. 31. Balwani will be tried separately next year. If found guilty, the pair face prison time, possible fines and compensation payments to victims. from https://ift.tt/3gwESiO Check out https://takiaisfobia.blogspot.com/
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Welcome to COVID Questions, TIME’s advice column. We’re trying to make living through the pandemic a little easier, with expert-backed answers to your toughest coronavirus-related dilemmas. While we can’t and don’t offer medical advice—those questions should go to your doctor—we hope this column will help you sort through this stressful and confusing time. Got a question? Write to us at [email protected]. Today, A.S. in Wisconsin asks:
As I read your question, you’re asking two different things: First, there’s “what sacrifices should I make to protect my children from COVID-19?” Second, there’s “how do I navigate the social challenges of the pandemic?” Like so many other questions related to the pandemic, neither of these have easy or definitive solutions. But we spoke with a psychiatrist and several pediatric physicians to try and sort them out. For starters, it’s important to consider the scientific evidence about the spread of COVID-19. You’ve already made one important decision that reduces the risk to yourself and your children: getting vaccinated. However, vaccination can’t completely eliminate the risks facing you or your kids. Emerging evidence suggests that even fully vaccinated people can spread the virus—especially the now-dominant Delta variant—to others. Concerns about this possibility led the U.S. Centers for Disease Control and Prevention in July to once again recommend that even fully vaccinated people wear masks indoors in most areas of the country. So if your question is whether you could potentially go to this wedding, get infected with COVID-19, and bring it home to your kids, the answer is yes, there’s a chance that could happen. That would be true even if everyone there is vaccinated, though that would reduce the risk. That said, children have so far proven remarkably resilient in the face of this virus. As of Aug. 18, 430 U.S. children have died of the coronavirus, and while the death of any child is an unspeakable tragedy, that’s a small fraction of the nearly 630,000 overall U.S. deaths so far. Furthermore, children face lots of dangers whenever they go out into the world, whether it’s for school, daycare or playdates. How a parent weighs any potential danger to their children comes down to their risk tolerance, says Dr. Allison Messina, the chief of the infectious disease division at Johns Hopkins All Children’s Hospital. Messina advises parents who are nervous about their children getting COVID-19 to ask themselves a question: what are you really worried about? As she points out, the data suggest previously healthy kids are at low risk of severe disease from the virus. However, the Delta variant makes this calculation harder—pediatric ICUs in hard-hit states are hitting capacity, but it’s unclear if Delta is inherently more dangerous to kids or if more kids are falling ill simply because this strain is so transmissible and kids under 12 can’t yet be vaccinated. “When I answer these questions, I don’t really answer them as ‘you should’ or ‘you shouldn’t,'” Messina says. “I just say, these are the risks that you would face if you decided to do this.” If you decide to attend the wedding, there are other ways you could reduce your risk of bringing the virus home to your kids. You could wear a mask, for instance, though they are better at preventing infected people from spreading the virus, rather than helping the wearer avoid getting infected, so consider wearing one at home for a while after you get back (getting tested afterwards and self-isolating if you’re positive could be smart, too). Depending on your relationship, you could ask the couple getting married to require masks, even if just for unvaccinated guests. You could also decide to attend the ceremony but skip the reception to lessen your overall exposure, but given that you’re in the wedding party, that could be socially difficult. (Also consider the venue—outdoor, well-ventilated spaces are generally safer than indoor, poorly ventilated ones.) That brings us to the second part of your question: how to deal with the social side of your dilemma. The first step is having a conversation with your soon-to-be-wed friend, says Dr. Sophia Albott, a psychiatrist with the University of Minnesota Medical School and the practice University of Minnesota Physicians. Discuss your concerns, talk about potential solutions, and frame things around your children’s safety, she says. “These conversations are difficult to have, but there is potentially an opportunity even for some reaffirmation of their friendship or some sort of two-party empathy.” If you decide not to attend the wedding or minimize your participation, your friend could be angry or disappointed. Weddings are always stressful, but the upheaval of the pandemic has drawn up a lot of extreme emotions in many people. Albott suggests that you work to keep your conversation respectful, and be sure to acknowledge how your friend is feeling. That’s especially wise if, like so many other engaged couples, your friend had to delay or otherwise change their wedding plans because of the virus. Finally, while you’re worrying about your children and friends, Albott recommends showing yourself a little kindness, too. Problems like these aren’t easy to navigate, and it’s important to make sure that you’re getting enough sleep, exercise, and connection with other people. “The pandemic has just gone on so long, that I think everyone is tired,” says Albott. “As much as we can, [we should] take care of ourselves, give ourselves a break, and give other people a break.” from https://ift.tt/3B2Cbxo Check out https://takiaisfobia.blogspot.com/ Popular at-home COVID-19 tests from Abbott Laboratories and Quidel Corp., available without a prescription, were launched without a mechanism for reporting results to health officials, potentially leaving many cases uncounted by authorities as the delta variant spreads around the U.S. How many of the products have been sold in pharmacies and online and used isn’t clear. When Abbott’s BinaxNOW Self Test became available through retail stores in late April, the company said it planned to make at least tens of millions each month. The company last month said a group of COVID tests including BinaxNOW brought in $1 billion in global sales. While COVID testing sites and labs are required to report their findings, the Food and Drug Administration relaxed requirements for some at-home tests to speed their path to market. Abbott said customers are encouraged to report results of its tests, while Quidel didn’t respond to a request for comment. COVID cases are still one of the best indicators of the direction of the pandemic, and health officials are watching them as closely as ever for signs that the latest surge may be near a peak, at least in some parts of the U.S. Although new, accessible testing technologies have been helpful, data gaps can be dangerous, said Michael Mina, an epidemiologist at the Harvard T.H. Chan School of Public Health who studies diagnostics. “We should be doing a better job of keeping track,” he said in an interview. “We should be planning and creating ways that really allow us to capture that information, for no other reason than for monitoring and planning at the public health level.” Instead, once a person finds out they’re positive, “then their families are going out and buying the same kind of test. And nobody knows that there’s a little cluster of people that are infected right here,” he said. “The public health authorities don’t have any view into that.” Abbott and Quidel shares were little changed as of 3:45 p.m. Monday in New York. Testing has long been a key way to measure the spread of the coronavirus and risk posed in different parts of the country, although it has taken a back seat since vaccines became available late last year. With nearly 30% of adults still lacking even a single shot, the U.S. is again navigating a wave of COVID-19 cases that’s stretching hospital capacity and threatening plans to return to workplaces and schools. About 9% of U.S. virus tests over the last seven days returned positive results, according to Centers for Disease Control and Prevention data, well above a World Health Organization threshold of 5% or lower for reopening. About 1.2 million tests a day, on average, were performed and reported last week through Friday, according to data compiled by Bloomberg. Authorized by the FDA at the end of March, the Abbott BinaxNOW Self Test and Quidel QuickVue At-Home OTC COVID-19 test are user-friendly and don’t require prescriptions. They use a self-collected swab to seek out a specific viral marker, providing results in 10 to 15 minutes. The cost for a pack of two is $20 to $25. As demand for the rapid tests waned earlier this year, Abbott told workers to get rid of the products, laid off employees and shut down one of its factories, according to a New York Times report. In a response to the same article provided to Bloomberg, Abbott said that test cards were destroyed, not completed products, and that they were near the end of their shelf life and couldn’t have received approvals quickly enough to be provided to governments overseas. Abbott chose to store parts of those tests, such as reagent bottles, swabs and nitrocellulose strips “in the event that we needed to scale back up, which is exactly what’s happening now,” according to a statement. Demand RebuildsInterest has surged, with over-the-counter COVID tests becoming top sellers since mid-July at CVS Health Corp. stores that sell BinaxNOW and other products, according to a CVS spokesperson. On Friday, the BinaxNOW product was listed as the No. 1 seller on the Amazon.com Inc. website’s industrial & scientific category, ahead of face masks and toilet paper; the Quidel QuickVue at-Home OTC test ranked 10th. The BinaxNOW test was listed as usually shipping within one to three weeks, and the Quidel test was sold out. BinaxNOW has since become unavailable, too. While lack of a prescription requirement takes some of the red tape out of getting tested, health-care providers and laboratories aren’t involved, making results harder to track. Some other at-home testing companies require the use of an app to read a positive or negative result. The app automatically reports the result. Abbott said in a separate statement that it prioritized developing the test and making it available to people, and that users were encouraged to report results through their health-care providers. Under a recent update to the test’s emergency use authorization, test-takers will be able to report results using Abbott’s Navica website or phone application — but it’s optional. Self-Reporting Encouraged“We encourage all people to report their test results and Navica will now allow them to do this in an easier way, but it is reliant on the individual to report,” a spokeswoman said. “This development will help give better visibility to public health officials about the status of COVID in their communities.” When the FDA gave the Abbott and Quidel tests emergency authorizations, the regulator required them to develop reporting mechanisms “so as not to delay consumer access to at-home tests,” an agency spokesman said. “FDA’s approach to reporting mechanism requirements at the time of authorization provided maximum flexibility in working with test developers to help meet the needs of both individual consumers and populations in the context of a rapidly changing pandemic,” the spokesman said. Other virus tests, including another Quidel at-home product, the QuickVue At-Home COVID-19 Test, which requires a prescription, have also been cleared without a way to report results to public health officials, the FDA spokesman said. In those cases, the agency has asked companies to later develop a way to help with results reporting. from https://ift.tt/3jdyI9f Check out https://takiaisfobia.blogspot.com/ Across the U.S. children are heading back to school, despite spiking COVID-19 cases. The emergence of the more contagious Delta variant as the most prominent virus strain in the country is causing concern for parents. Not only are they worried about the health and safety of their kids, they have been dealing with a childcare crisis for the past year and a half and now that seems unlikely to end anytime soon. This will be the third school year affected by the pandemic, but despite the fact that children under 12 are not yet eligible for vaccination, many schools are not putting mitigation efforts into effect and several governors have banned mask mandates. It’s our responsibility as adults to protect our kids, but record hospitalization numbers for children suggest we are already failing in this task. Read more: Why I’m Mandating That Austin Schools Must Be Masked When Classes Start How Will Delta and COVID-19 Change This Back-to-School Season? Here’s What to Know These Mothers Wanted to Care for Their Kids and Keep Their Jobs. Now They’re Suing After Being Fired from https://ift.tt/3B4Pmhq Check out https://takiaisfobia.blogspot.com/ Pfizer-BioNTechs Vaccine Is the First COVID-19 Shot to Get Full Approval From the U.S. FDA8/23/2021 On Aug. 23, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine, one made by Pfizer-BioNTech, for anyone 16 years and older. The vaccine requires two doses and according to company studies, is 91% effective in protecting people from COVID-19 disease, including from severe illness. The vaccine received the FDA’s emergency use authorization (EUA) in December, which allowed the company to distribute and administer the shot due to the urgent public health threat of the pandemic. “I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity,” said Pfizer chairman and CEO Albert Bourla in a statement. With full approval, little in the way of how the vaccine is made will change, according to Pfizer. The two companies are discussing with the FDA how the labels on the approved vials will be revised to reflect the full licensure, but the manufacturing process will not change appreciably. What will change is the quality control requirements for each lot of vaccine. As with any approved vaccine, the FDA must now conduct its own analysis of each lot manufactured and give the green light to release those lots on to the market. Under the EUA, the companies sent samples from each lot they made to the FDA at least 48 hours before distributing, along with their own analysis of the doses’ safety and quality but did not have to wait for the FDA to release them. What may also change are vaccine mandates from both public and private agencies including governments, schools, and businesses. Having an approved vaccine may provide stronger support for such entities to require vaccination for employees, students and customers. While some already do have such mandates in place, the FDA approval may lead more organizations to adopt similar requirements. The full licensure may also help to sway those who have been reluctant to get vaccinated with a shot that was not approved. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” acting FDA Commissioner Dr. Janet Woodcock said in a statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” Pfizer and BioNTech submitted their request for approval in May, and the agency had eight months to review the 340,000 page package that included data from 44,000 people who participated in clinical trials. Those data showed that overall, the two doses of vaccine are 91% effective in protecting people from COVID-19 disease up to six months after the second dose. The FDA requires follow-up data of at least six months in order to qualify for approval. In the months since the vaccine has been administered around the world, the FDA has also added warnings about rare side effects that can occur among vaccinated people, including the risk of inflammation of the heart muscle and tissues surrounding the heart. With an approved vaccine, Pfizer-BioNTech can also start selling and distributing its shot through its own channels. However, Pfizer said it has an agreement with the U.S. government to provide doses through April 2022, at no cost to Americans, and expects the U.S. government to remain the sole distributor of its vaccine through that time. The vaccine will therefore continue to be offered at the same sites where it has been distributed until now—at federal or state mass vaccination sites, pharmacies, hospitals, doctors’ offices and other health care centers. Those sites would also be responsible for giving Americans an additional, booster dose of the vaccine which the FDA is currently considering as a way to bolster protection against the more infectious Delta variant. The agency is expected to announce its decision on whether a booster is needed in coming weeks; the FDA has already authorized a booster shot for people with compromised immune systems. from https://ift.tt/388EIJY Check out https://takiaisfobia.blogspot.com/ First Came an Earthquake. Then a Hurricane. Now Haiti is Bracing for an Outbreak of Disease.8/20/2021 On Aug. 14, a devastating 7.2-magnitude earthquake hit southwestern Haiti, leaving 2,189 people dead, 12,268 injured and at least 332 missing. Days later, Tropical Storm Grace swept over the ravaged landscape, hampering the complicated search and rescue mission. Yet aid groups say this is only the beginning of the crisis. The island country of nearly 12 million people has faced one disaster after another in the space of a few weeks. In July, President Jovenel Moïse was assassinated amid mounting allegations of corruption. The country has been struggling with poverty, disease and a fractured infrastructure since a catastrophic earthquake in 2010, which killed over 200,000 people. Now another quake, followed by a storm, has left Haiti in pieces. According to U.N. estimates, 40% of the total affected population are in need of emergency humanitarian assistance. In some areas, up to 15 inches of rain led to flash flooding and landslides, blocking roads to communities in urgent need of relief. “There’s a lot of death and a lot of destruction,” Ann Lee, the CEO of CORE, a community-oriented aid organization, tells TIME. “We’re slowly seeing the numbers come up and it’s a lot worse than what I feared.” In the most affected areas—the regions of Sud, Grand’Anse and Nippes—around 61,000 houses were destroyed. Flooding from the storm has forced people to shelter inside unstable buildings. Humanitarian workers are no less at risk. Wes Comfort, recovery and response lead at aid organization Heart to Heart International, told TIME his medical team chose to sleep on their car hoods. “Everyone is very wary of sleeping indoors. So last night we camped out and listened to the aftershock rattle the tin roof of the [mayor’s] office.” Aid organizations now fear the deadly combination of landslides, falling debris and flooding will heighten the risk of disease to the local population. The ongoing COVID-19 pandemic is also an immediate concern. Over the course of the pandemic, Haiti has reported 184 confirmed cases of COVID-19 per 100,000 people and 582 deaths. Yet, testing is very limited due to poor infrastructure; confirmed cases are likely higher. But this week’s natural disasters risk escalating the spread of coronavirus through a barely vaccinated population. Haiti was the last country in the western hemisphere to receive COVID-19 vaccines, and took receipt of its first batch of 500,000 Moderna doses on July 16. CORE had just opened several COVID-19 vaccine clinics when the earthquake hit. “They’re mostly in the western [part of the country],” Lee tells TIME. “We were spreading out to the south, and this happened. And this is going to cause a lot more difficulty being able to get out there as we had planned.” Muhamed Bizimana, Assistant Country Director in Haiti at CARE aid organization, told TIME his team is concerned by the potential for another wave of COVID-19. “We are concerned that the environment created by the whole devastation [is] creating conditions for a new outbreak,” he said. Aid organizations say they are encouraging people to shelter on their home ground rather than in crowded camps, which could further spread the virus. “This [the earthquake] only happened on Saturday. So now we are still in the incubation period,” Bizimana said. Poor sanitation and damage to water systems are also sparking concerns about waterborne diseases. In Pestel, Grand’Anse, nearly 1,800 tanks of clean water were cracked by the earthquake. Stagnant water from flooding also provides a breeding ground for mosquitoes. According to Dr. Maureen Birmingham, a representative in Haiti for the Pan American and World Health Organizations, the country had been making advances in malaria control before setbacks brought by COVID-19 and the political instability. Birmingham says medical teams are on high alert for “diarrhoeal disease, respiratory disease, […] and skin problems” due to poor sanitation, poor hygiene, and crowded conditions. “[It’s] hard to say which is the most worrying one.” Cholera is on everyone’s minds—the country’s first outbreak came after the 2010 earthquake, resulting in nearly 10,000 deaths. The waterborne disease continued to spread through the population, with a particularly significant increase after Hurricane Matthew in 2016. According to a UNICEF report, the last confirmed cholera cases in Haiti were reported in February 2019. The risk, says Birmingham, is “very much on the radar.” from https://ift.tt/3kb3dMr Check out https://takiaisfobia.blogspot.com/ (WASHINGTON) — President Joe Biden on Wednesday announced that his administration will require that nursing home staff be vaccinated against COVID-19 as a condition for those facilities to continue receiving federal Medicare and Medicaid funding. Biden unveiled the new policy Wednesday afternoon in a White House address as the administration continues to look for ways to use mandates to encourage vaccine holdouts to get shots. “If you visit, live or work in a nursing home, you should not be at a high risk for contracting COVID from unvaccinated employees,” Biden said. The new mandate, in the form of a forthcoming regulation to be issued by the Centers for Medicare & Medicaid Services, could take effect as soon as next month. Hundreds of thousands of nursing home workers are not vaccinated, according to federal data, despite those facilities bearing the brunt of the early COVID-19 outbreak and their workers being among the first in the country to be eligible for shots. It comes as the Biden administration seeks to raise the costs for those who have yet to get vaccinated, after months of incentives and giveaways proved to be insufficient to drive tens of millions of Americans to roll up their sleeves. In just the past three weeks, Biden has forced millions of federal workers to attest to their vaccination status or face onerous new requirements, with even stricter requirements for federal workers in frontline health roles, and his administration has moved toward mandating vaccines for the military as soon as next month. Biden has also celebrated businesses that have mandated vaccines for their own workforces and encouraged others to follow, and highlighted local vaccine mandates as a condition for daily activities, like indoor dining. The new effort seems to be paying off, as the nation’s rate of new vaccinations has nearly doubled over the past month. More than 200 million Americans have now received at least one dose of the vaccines, according to the White House, but about 80 million Americans are eligible but haven’t yet been vaccinated. Mark Parkinson, the president and CEO of the American Health Care Association and National Center for Assisted Living, praised the Biden decision, but called on him to go further. “Vaccination mandates for health care personnel should be applied to all health care settings,” he said. “Without this, nursing homes face a disastrous workforce challenge.” Last year CMS used similar regulatory authority to prohibit most visitors from nursing homes in an effort to protect residents. from https://ift.tt/3k6HNQn Check out https://takiaisfobia.blogspot.com/ Better to Stay Ahead of It. Why the White House COVID-19 Strategy Now Involves Vaccine Booster Shots8/18/2021 By now, many public health experts, and the public for that matter, have accepted that vaccinated people may need another dose of whichever COVID-19 shot they received in order to better protect against new variants of COVID-19. And on Aug. 18, the White House endorsed a third dose for those who received either the Pfizer-BioNTech or Moderna vaccines. People who received the single-shot Johnson & Johnson/Janssen vaccine may also need an additional dose, but the relevant studies are still ongoing. For now, the government plans on rolling out Pfizer and Moderna booster doses the week of Sept. 20, beginning with people who received their last dose eight months earlier. Booster shots still need to be authorized by the U.S. Food and Drug Administration (FDA). Only Pfizer-BioNTech has submitted relevant data to that agency so far; Moderna and Johnson & Johnson are still compiling safety and efficacy data on their additional dose and plan to submit their results to the FDA in coming weeks and months. Once the FDA authorizes boosters, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) needs to endorse the extra doses, and outline who should receive them and when. (The FDA and ACIP have already authorized a booster dose for certain people who are immunocompromised because they have received organ transplants or have other conditions that prevent their immune systems from responding adequately to the vaccines.) White House chief medical advisor Dr. Anthony Fauci and CDC Director Dr. Rochelle Walensky said during an Aug. 18 briefing that the White House’s decision to move forward with booster shots for all American adults was based on recent data from vaccine makers, state health registries and academic studies, all of which point to a concerning trend: a decline in the protection provided by vaccines and, according to Walensky, “worsening infection among vaccinated people over time.” For now, the data continue to show that two doses of the mRNA vaccines from Pfizer-BioNTech and Moderna provide good protection from severe illness, hospitalization and death. But Fauci and Walensky noted that if the early signs of waning immunity continue to develop, then worse COVID-19 outcomes could follow. To prevent that from happening, the Biden Administration laid out plans for distributing boosters in a tiered fashion, similar to the approach used in doling out the original shots. Residents of nursing homes, health care workers and first responders will be first to receive the extra doses if and when they are authorized. Whether booster shots can slow the spread of SARS-CoV-2, the virus that causes COVID-19, remains unclear. For now, health officials are going on indirect lines of evidence—some of which is strong, but inferential nonetheless. They’re working on the assumption that viral levels found in the nasal passages of infected vaccinated people are much lower than those in unvaccinated infected individuals, and that lower viral load should translate into lower transmissibility and therefore less contagiousness. “It’s entirely conceivable that [boosters] would be important in lowering the level of virus in the nasopharynx, which could impact transmission,” Fauci said, referring to the deeper part of the nasal respiratory system. “We certainly hope that’s the case. If it is, then we could really get multiple benefits from [boosting]—benefits in reducing severity of disease and ultimately transmission and infection. But the bottom line is that we don’t know that right now.” The FDA has yet to determine that booster shots are both safe and needed. But Fauci stressed that staying ahead of the virus and preparing for booster shots is the best way to tamp down the growing threat of the Delta variant. “If you wait for something bad to happen before you respond to it, then you find yourself considerably behind in the full capability of your response,” he said. “You don’t want to find yourself behind and playing catch up. Better to stay ahead of it than chasing after it.” The data on which health officials based their updated booster recommendation included results from a New York City study that showed the effectiveness of the COVID-19 vaccines in preventing infection with SARS-CoV-2 dropped from 91.7% in May to 79.8% by the end of July, by which time the Delta variant was the dominant strain in the area (most of the people studied received either the Pfizer-BioNTech or Moderna vaccines, with only about 9% receiving the single dose Johnson & Johnson/Janssen shot). In another national study of nursing home residents conducted by the National Healthcare Safety Network, researchers found that vaccine effectiveness in protecting people from getting infected with SARS-CoV-2 was 74.7% prior to the emergence of the Delta variant, but dropped to 53.1% by the end of July. In addition to the data generated within the U.S., health officials have also been poring over information from Israel, which has been serving as a vaccination bellwether for the world, since health officials there were able to quickly vaccinate a significant percentage of the population. Data from the Israeli health department shows that immunity (as measured primarily by antibody levels) waned among people who received two doses of the Pfizer-BioNTech vaccine after about eight months. After reaching a peak of 81% effectiveness against severe COVID-19 disease among Israelis in March 2021, the protection from two doses of the Pfizer-BioNTech shot against severe disease started to wane in April, sliding to 69.4%. And likely because of that, after dropping significantly, new infections have climbed again in Israel, primarily due to the emergence and quick spread of the Delta variant. That decline in effectiveness has contributed to breakthrough infections among vaccinated Israelis. According to the Israeli data, by early August, 341 out of 100,000 people who received two doses of the Pfizer-BioNTech shot by January had tested positive, 196 out of 100,000 who had been fully vaccinated by February tested positive, and so on throughout 2021, a trend that strongly suggests that the immunity provided by the vaccine is strongest soon after the second dose but starts to drop off months later. Indeed, it was a strong enough signal that on July 29, Israeli health officials approved a third dose of the vaccine for people 60 years or older as new infections continued to climb. Early data among the small percentage of older people getting a third dose suggest that their new infection rates are lower, but it’s too early to determine what impact the additional dose will really have. The idea of a booster dose is to bring people’s immune defenses—specifically antibodies—back up to the level generated soon after the last vaccine dose. It’s a well-established principle in immunology that antibodies tend to decline in number over time, whether it’s after people get vaccinated or get naturally infected with a virus. The vaccines were never designed to protect completely against getting infected with the virus, only from getting severely ill after getting infected. “These vaccines were never intended to be a force field,” says Dr. Kirsten Lyke, professor of medicine at University of Maryland who has led some of the vaccine studies. When antibody levels start to dip, however, they can be boosted. Reassuring data from people who were naturally infected with SARS-CoV-2 and then vaccinated suggest that immune boosts are indeed possible with COVID-19. The same phenomenon should mean that people who never had COVID-19 but were vaccinated and generated SARS-CoV-2 antibodies could also get a surge in these antibodies if they receive another dose of vaccine. “Once the immune system makes antibodies against something, re-exposure will boost those antibodies back up to high levels again,” says Dr. Otto Yang, professor of medicine and associate chief of the division of infectious diseases at University of California, Los Angeles. “There’s no reason that somebody whose antibodies dropped after vaccination shouldn’t also have a large jump in antibodies if they receive a booster dose.” The antibodies generated by the vaccine tend to provide a broad spectrum of protection against different types or variants of SARS-CoV-2, so the more antibodies a person develops in general, the more likely that a good proportion of them will be targeted against specific variants like Delta, which is now the dominant form of the virus in the U.S. and in many other parts of the world. With each vaccine boost, the immune system adapts to generate more targeted antibodies. And the immune system is just as clever as the virus: in the same way that SARS-CoV-2 can mutate to evade drug treatments or vaccine-induced immune cells, the antibody-producing cells in the body get selected for the effectiveness of their output. Cells making antibodies that bind more tightly to SARS-CoV-2 and disable it are rewarded by getting stimulated more frequently to make more of these virus-destroying antibodies. “The cell with the best advantage [for binding the virus] will over-grow compared to its peers,” says Yang. “Continued exposure with additional vaccination gives these cells more time to continue to evolve and make even better antibodies [against variants] like Delta.” That’s why boosting with another dose of the existing vaccines should prove effective in controlling SARS-CoV-2, even if the shots aren’t specifically targeted against the Delta variant. And that applies to not just the antibody response, but to another type of immune response generated by a different group of immune cells known as T cells, which tends to be a little more durable. Antibodies are shorter lived because they target only outer parts of the virus, but T cell responses can target any proteins made by a virus, even after it infects a healthy human cell. That means T cells focus on parts of the virus that don’t mutate and change as easily to evade immune cells. The fact that people who are vaccinated but still get infected with SARS-CoV-2 yet don’t tend to get as sick or need hospitalization, and rarely die from COVID-19, is likely thanks to this T cell response. Ideally, future vaccines would focus on boosting this T cell response against SARS-CoV-2 in an effort to trigger the longest-lasting immunity possible. Yang, who specializes in studying T cell-based immunity, says his group and others have already identified an attractive viral protein to target to accomplish this. Adding the genetic information for this protein into the genetically-based mRNA vaccines from Pfizer-BioNTech and Moderna could be “easily done,” he says. T cells may end up being more important later in the disease’s course, in protecting against severe illness and providing longer term protection against COVID-19. Therefore, finding ways to strengthen that response remains an important target for COVID-19 researchers. “No doubt T cells will play a role in very likely not preventing initial infection but in the progression of disease by eliminating or blocking against infected cells,” said Fauci. “We will continue to study the T cell response.” In the meantime, there’s reason to be confident that boosting people’s immune response with another dose of the existing vaccines would significantly improve their protection. But public health officials warned that variants like Delta are thriving where the virus can continue to reproduce, and at the moment, that’s in unvaccinated individuals, both in the U.S. and worldwide (only about 51% of Americans have been fully vaccinated so far, per TIME’s tracker). Vaccinating more people for the first time, as well as boosting those who are already immunized, are not mutually exclusive goals, and both need to be accomplished simultaneously in order to build an adequate wall of immunity that will finally slow COVID-19 down. from https://ift.tt/3yYrdIQ Check out https://takiaisfobia.blogspot.com/ The COVID-19 pandemic is now defined by its impact on two groups of people: the vaccinated and the unvaccinated. Lest we forget, all children under 12 years of age fall into the latter category. As pediatric pulmonologists, we care for children with chronic respiratory conditions whose lives are threatened by COVID-19, as well as previously healthy children who have suffered from COVID-19 infections. As of the most recent data, some 4.3 million children have tested positive for COVID-19. This number is likely an underestimate, as some children can become infected but show no or only milder symptoms and may not get tested. But, despite some claims to the contrary, not all children cope so well with infection. In the U.S., well over 17,000 children have been hospitalized with COVID-19, thousands have developed a severe, life-threatening post-COVID-19 illness that impacts the heart, and hundreds have died from this now vaccine-preventable disease. As the highly transmissible SARS-CoV-2 Delta variant triggers a steep incline in COVID-19 infections across the U.S., pediatric cases, too, are rising dramatically. We must protect our children. Vaccinations save lives, but our children cannot get themThe COVID-19 vaccines have dramatically changed the course of disease for people who are fully vaccinated. All of the authorized vaccines were, indeed, designed to prevent severe COVID-19 disease—and thus reduce hospitalizations. At this point in the pandemic, the who require intensive care from COVID-19 complications are unvaccinated. However, not all Americans have access to these life-saving vaccines. In particular, access for children under the age of 12 has been delayed for several reasons. First, as is typical for new drug and vaccine development, children were not enrolled in early vaccine trials. Second, ongoing vaccine trials for children were not as widely available for potential volunteers compared to adult studies, and some sites have reported slow enrollment. Finally, COVID-19 vaccines have faced extensive scrutiny for rare or delayed side effects—and one of these rare effects is vaccine myocarditis, or inflammation in the heart tissue, which has been reported in adolescents and young adults. Along with all pediatricians, we eagerly await clinical trial results showing that COVID-19 vaccines can be given to our younger patients safely and with efficacy. But time is short. With the rising wave of COVID-19 driven by the Delta variant, widespread relaxing of safety precautions, and the start of a new school year, unvaccinated children are not only increasingly at risk of infection and its complications but they are also more likely to spread the virus unknowingly, putting others at risk who might have a higher likelihood of developing severe disease.—While safety data are essential, especially for interventions involving children, the U.S. Centers for Disease Control and Prevention emphasizes that the risk of adolescents developing severe COVID-19 illness outweighs the risk of developing vaccine-related myocarditis, which is rare and usually resolves without the need for treatment. Because of the sharp increase in COVID-19 cases as children return to schools and after-school activities, the risks of COVID-19 infections for children, especially those living with chronic lung diseases, likely exceed the potential risks of the vaccine. We urge the FDA to act immediately to protect children from the looming threat of COVID-19. In the meanwhile, there are other actions we can take to protect our kids. Children under 12 are not yet eligible for vaccines—but their parents, grandparents, aunts, uncles, older siblings, teachers, and coaches are. The risk of severe COVID-19 for these older groups is higher, and if they become infected, they can transmit the virus to children under 12. There is no reason for those eligible to delay vaccination, particularly with rising numbers of positive COVID-19 tests throughout the country. Vaccines save lives. We implore parents and caretakers to get vaccinated themselves to protect vulnerable children from infection. Masks are a mustAs summer ends and schools reopen, many children will be restarting in-class learning—at facilities where mask usage is limited. In fact, several states have enacted laws that block mask requirements for schools, despite most parents preferring a mask requirement. Mask use is a simple and effective safety measure for preventing the spread this airborne illness. In schools that required masks during the previous academic year, viral transmission was minimal. The American Academy of Pediatrics, the most highly respected organization of pediatricians world-wide, recommends universal masking in schools to protect our children. States that enact policies that effectively decrease mask usage will put their children at higher risk of contracting COVID-19. Reports suggesting that masks are harmful or result in toxic levels of inhaled carbon dioxide are false—in fact, a recent publication claiming harm from masks has been retracted. On the contrary, extensive research has shown that face masks are safe and do not affect carbon dioxide levels at rest or with exercise—not just for SARS-CoV-2 but for the flu and other respiratory viruses. New SARS-CoV-2 variants will keep the COVID-19 pandemic unpredictableAs the COVID-19 virus replicates, its genetic makeup changes and mutates; this is a common trick of infectious pathogens. Mutations that are more contagious have a selective advantage that allows some strains of the virus to dominate. This is what we’ve seen with the Delta variant, now the predominant SARS-CoV-2 strain in the U.S., and in many other parts of the world. It is more contagious, and more people—including children—are now getting sick as this virus spreads more quickly than prior variants. We are in a sharp uptick of the Delta surge. New variants have the potential to challenge vaccine, monoclonal antibody, or anti-viral efficacy. The best way to prevent new, potentially more contagious or lethal variants is to contain the current virus; this can be done with higher rates of vaccination and wide-spread efforts to reduce transmission, including among children. Safety measures for children are needed now more than everNow is the time to take safety measures, vaccinate yourself if you are eligible, vaccinate your children as soon as allowed, wear your mask, and help your children wear their masks when you are in public. We’ve seen children who’ve lost parents to COVID-19; we’ve seen children who require ventilators and other advanced life support due to COVID infections; we’ve all seen the schools shut down, the mental health crisis, and how our children struggle when COVID-19 cases soar. Too many children have been harmed by COVID-19, a disease that is now nearly preventable. We all must take precautions, vaccinate, and encourage others to take these same measures by “normalizing” them. We must protect our children. from https://ift.tt/3ARgXmc Check out https://takiaisfobia.blogspot.com/ As the Superintendent of Austin, TX, schools I have mandated that our kids must be masked when they start school on Tuesday. Requiring masks is not and never has been about defying the Governor. This is about having local control to respond to the data about our local conditions, which have become dire. After the July 4th break, we began seeing the numbers of COVID-19 cases climbing in Austin as the Delta Variant took over. Recently, the situation began escalating quickly on a daily basis to the point that recently I was told that on some days we have had only one pediatric ICU bed available in the entire Austin region. That’s why, with around 75,000 children returning to school on Tuesday, I decided to temporarily return to requiring masks despite the governor’s prohibition. Anyone in public office must balance freedom with safety. And how we do that should be based solely on local data, not statewide politics. We must take into account what the local public health experts and hospital administrators have told us. Based on their advice and the clear data that masks prevent the spread of COVID-19 in schools—as well as our experience last school year when we were allowed to mandate masks—requiring masks this school year was absolutely necessary regardless of what the Governor may want. We have serious political divisions in this country when it comes to masking, but for me this was not a political decision but rather a deeply personal one. What if a child dies on my watch? How do I say to you, “I’m really sorry. We did everything we could except for masking because the governor’s executive order prohibited me from doing so.” What does that do for a parent? How does that bring them comfort or solace? If we err, we will err on the side of safety. I can live with someone saying that a mask mandate wasn’t necessary. Honestly, I can live with someone telling me, “I told you so.” I cannot live with a tragedy occurring because I was afraid of the possible consequences of defying part of the governor’s order. That is just not something I’m willing to take the chance on. I realize, of course, that the governor’s executive order may mean that we will be fined for requiring masks. I’d rather pay money than risk a child’s life. But let’s be clear that this is not meant as an act of political resistance or activism. I do not enjoy defying a governor’s order. As educators, we’re rule followers. That’s what we do as classroom teachers. We create expectations of behaviors and academic outcomes. But we are also critical thinkers, and we create critical thinkers. Anyone who knows me, knows that this was not something I wanted to do but it was something I needed to do. Overwhelmingly the Austin community has supported our decision to require masks at school. Even those who disagree start their emails to me, “It’s clear that you’re in an impossible situation, but…” before expressing their perspective. That gives me hope that we can work through this. To our students and families who disagree with this, we want to work with you individually. I do not want a one-size-fits-all. This is about our children. Ultimately, they must live with what we decide, and I’m confident we can work parent-by-parent, student-by-student to tailor our solutions rather than impose a blanket edict regardless of how broadly popular that may be with others. I think the Austin community will demonstrate in this moment that we can get through conflicts in a way that respects our different perspectives and teaches us how to balance personal freedoms with responsibility for each other. Vaccinations are still the best and safest way out of this pandemic, but they are not yet available for those under 12, which is why we also offered virtual K-6 instruction despite not getting state funding to do so. I know some people want to talk about how few deaths from COVID-19 there are for elementary school-aged children and to claim that those that did occur had comorbidities. As a mom, I could not be OK with saying to you that your child’s death was statistically unlikely. When it’s your child, your niece, your nephew, your sister, your brother, the statistics don’t mean a whole lot. And we have it in our power to reduce those statistical chances even further by mandating masking and other measures to help save kids lives. We look forward to welcoming children back into classrooms and are confident we will do so safely. Because of what we learned last year, we are confident that with masking, air purifiers and increased vaccinations among other precautions, we can keep our kids safe while giving them the rich and exciting instruction they deserve. After all, teaching children, and not “defying” the governor, is why we exist in the first place. from https://ift.tt/3g4Lm8A Check out https://takiaisfobia.blogspot.com/ |
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