WASHINGTON (AP) — A panel of U.S. health advisers on Tuesday narrowly backed a closely watched COVID-19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the coronavirus. A Food and Drug Administration (FDA) panel voted 13-10 that the drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy. The recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Experts backing the treatment stressed that it should not be used by anyone who is pregnant and called on FDA to recommend extra precautions before the drug is prescribed, including pregnancy tests for women of child-bearing age. The vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including older people and those with conditions like obesity and asthma. Most experts also said the drug shouldn’t be used in vaccinated patients, who weren’t part of the study and haven’t been shown to benefit. The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision before year’s end. The pill is already authorized in the U.K. The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes case counts higher and U.S. officials brace for the arrival of the new omicron variant. Merck hasn’t specifically tested its drug against the new variant but said it should have some potency based on its effectiveness against other strains of coronavirus. But that uncertainty frustrated many panelists as they grappled with whether to back the treatment for millions of Americans. “With no data saying it works with new variants I really think we need to be careful about saying that this is the way to go,” said Dr. David Hardy of Charles Drew University School of Medicine and Science, who ultimately voted to back the drug. The panel’s narrow-but-positive recommendation came despite new data from Merck that paint a less compelling picture of the drug’s effectiveness than just a few weeks earlier. Last week, Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, when compared with adults taking a placebo. That effect was significantly less than the 50% reduction it first announced based on incomplete results. That smaller-than-expected benefit amplified experts’ concerns about the drug’s toxicity for fetuses. FDA scientists told the panelists earlier Tuesday that company studies in rats showed the drug caused toxicity and birth defects when given at very high doses. Taken together, FDA staffers concluded the data “suggest that molnupiravir may cause fetal harm when administered to pregnant individuals.” FDA is weighing a blanket restriction against any use in pregnant women or allowing it in rare cases. Some panelists said the option should be left open for pregnant mothers who have high-risk COVID-19 and may have few other treatment options. Dr. Janet Cragan, who backed the drug, said that even with tight restrictions some pregnant women would inevitably take the drug. “I don’t think you can ethically tell a woman with COVID-19 that she can’t have the drug if she’s decided that’s what she needs,” a panel member and staffer with the Centers for Disease Control and Prevention. “I think the final decision has to come down to the individual woman and her provider.” Merck’s drug uses a novel approach to fight COVID-19: It inserts tiny errors into the coronavirus’ genetic code to stop it from reproducing. That genetic effect has raised concerns that the drug could spur more virulent strains of the virus. But FDA regulators said Tuesday that risk is theoretical and seems unlikely. While Merck and its partner Ridgeback Biotherapeutics were the first to submit their COVID-19 pill to the FDA, rival drugmaker Pfizer is close behind with its own pill under review. Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns raised with Merck’s drug. Pfizer said this week that its drug shouldn’t be affected by the omicron variant’s mutations. The U.S. government has agreed to purchase 10 million treatment courses of Pfizer’s drug, if it’s authorized. That’s more than three times the government’s purchase agreement with Merck for 3.1 million courses of molnupiravir. Both drugs require patients to take multiple pills, twice a day for five days. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. from https://ift.tt/3d3jVu3 Check out https://takiaisfobia.blogspot.com/
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While no cases of the new coronavirus variant, Omicron, have been reported in the U.S. yet, it’s only a matter of time. In fact, Dr. Anthony Fauci, chief medical advisor on COVID-19 to President Biden, says it’s likely the virus is already in the country, given how much travel is occurring between countries as pandemic restrictions have started to lift in recent months. Even if the variant were here, could existing tests tell if someone were infected by it? Testing experts say yes and no. The majority of tests used by commercial and public health labs can detect SARS-CoV-2, but they can’t confirm which version of the virus is present. That’s because the tests intentionally target parts of the virus that don’t change much. Variants are designated based on differences in mutations—in Omicron’s case, especially those in spike protein, a part of the virus that changes frequently to bypass drugs and immune cells, and thus are difficult to test for. So the majority of the tests available will show if a person is carrying the virus—but there’s no way to tell whether that virus is Omicron. For that, a doctor would have to send your sample to a lab that can then sequence genetically to look for the genetic signatures unique to Omicron. There is one commercial test, from Thermo Fisher Scientific, that can perform the two-fer: both detect the presence of the virus and give testers an inkling that what they’re dealing with might be the Omicron variant. The company’s test targets three different parts of SARS-CoV-2: two relatively stable regions, and the more variable spike protein. It turns out that Omicron will show positive matches on the two more stable regions, a pattern similar to the one from the Alpha variant, but will show a mismatch on the spike protein portion. The Delta variant, which is now responsible for nearly 99% of new cases around the world, does not share this omission, and produces a three-for-three match on all three regions targeted by Thermo Fisher’s PCR test. That means, given Delta’s dominance, if a sample produces all three matches, it’s likely Delta; if it results in only two positive matches, it’s likely to be Omicron. To confirm, researchers can then send those samples in for sequencing to definitively look for Omicron’s genetic profile. “This happens to be good fortune that this pattern can flag the presence of Omicron,” says Mark Stevenson, executive vice president and chief operating officer at Thermo Fisher. “It’s a good early warning system.” Clients using the company’s test in South Africa alerted Thermo Fisher last Wednesday that they were seeing those unusual patterns, even before the country’s health officials announced the spurt of new cases. Stevenson expects public health labs in Europe and the U.S. are now also using the test to look for the first cases of the Omicron variant. At Qiagen, a global testing company that makes assays for both diagnostic testing and research purposes, the team immediately evaluated their test against the samples of genetic sequences of Omicron uploaded by public health experts into the public GISAID database. “We’ve seen no drop in performance in our products,” says Dr. Davide Manissero, chief medical officer at Qiagen. Similarly, the research team at diagnostic testing company BD ran tests of its COVID-19 assays using the Omicron sequences in GISAID. “We are confident that our rapid antigen and PCR tests for COVID-19 will detect the novel variant,” Dave Hickey, president of BD Life Sciences, said in a statement. If you prefer to rely on the at-home tests available over-the-counter at pharmacies that can provide results in a few minutes, those are also still useful, at least for letting you know if you might be positive. Like most PCR tests, the at-home kits cannot determine if someone is infected with the Omicron variant specifically, but they will turn positive for anyone infected with any version of the virus. from https://ift.tt/3DavoTd Check out https://takiaisfobia.blogspot.com/ As businesses across the country start imposing strict COVID-19 vaccine and testing requirements, some employees are claiming religious exemptions to avoid getting vaccinated—putting human resources departments on the frontlines of a fraught political issue that has already proven fertile ground for lawsuits. The task before HR leaders is tricky: they have to figure out whether employees are applying for an exemption based on authentic religious beliefs or whether it’s a cover for their political views. “There are people who are going to have a sincerely held religious belief, but there’s a lot of folks out there who just object to the vaccine, and this will be their avenue to not get it,” says Ed Enoch, an attorney in Augusta, Ga., who has been fielding calls from clients at small and mid-size local businesses about everything from handling religious exemptions to vaccine mandates. Every request for a religious exemption from the COVID-19 vaccine has to be considered individually. The requester can be part of a minority sect or small religious community, but you can’t just make a religion up. More importantly, what employers assess is not so much whether perceived leaders of an organized religion endorse vaccines but whether an individual’s religious belief is authentic and informs other aspects of their life beyond getting out of a COVID-19 vaccination. “You can’t just say in a blanket manner that the Pope says it’s okay to get vaccines so we’re not giving religious exemptions to Catholics,” Enoch says. “It doesn’t have to be part of the doctrine of the faith that you attend, so it’s a really squishy standard; it’s really hard to put a finger on that.” Federal employees are already subject to a COVID-19 vaccine mandate, and 92% have received at least one dose, the White House said on Nov. 24. There is currently no such rule in effect for private employers in the U.S., despite the Biden Administration’s repeated attempts to establish one. An Occupational Safety and Health Administration (OSHA) rule issued on Nov. 4 that would require businesses with 100 or more employees to ensure their workforce is fully vaccinated or tests negative for COVID-19 at least weekly has been stayed. Last week, the Biden Administration asked a federal court to intervene and lift the stay. In the meantime, the White House is urging businesses to proceed with adopting the rules. While the fate of the OSHA rule plays out in the courts, many businesses have already imposed or are considering imposing strict vaccine and testing rules. Many large companies and government entities around the U.S. that have instituted vaccine mandates have been successful in getting employees inoculated. For example, New York City Schools’ vaccine mandate resulted in 96% of teachers getting a shot, the city’s mayor said in October. And United Airlines, which was the first U.S. airline to adopt a vaccine mandate, announced in late September that following the requirement, 99.5% of employees were vaccinated. These new requirements have sparked some lawsuits, too. On Monday, a federal judge blocked the Biden Administration from imposing a vaccine mandate for health care workers in 10 states. A circuit court ruled the same day that 15 New York City public school teachers and administrators must have their COVID-19 religious exemption requests reconsidered because of a potential violation to their First Amendment rights. Enoch, for his part, has been encouraging many of his clients—including businesses that either have no HR department or rely on one or two people—to avoid imposing a vaccine mandate. That’s not because he thinks employees shouldn’t be vaccinated. Rather, he believes incentives, such as bonuses, are a more productive way to get a majority of workers inoculated. He also worries that employers don’t “have the time, resources or knowledge to properly vet (religious exemption) claims” and will likely end up saying: “Well, I’ll just grant it to anyone that asked for it.” “Once you do that, then you really don’t have a mandate. All you’ve done is created a bunch of paperwork for yourself that you could have avoided by not having the mandate,” Enoch says. On social media, thousands of people are sharing tips with each other on how to successfully secure religious exemptions. Nico Rocco, who was the admin of a Facebook group called “Writing Religious Exemptions for Vaccine Mandates Private Public Employers,” which has 5,300 members and is dedicated to navigating religious exemptions in the workplace, runs a website called Essential Liberties that offers workshops on “How to Answer the Hardest Questions on Religious Exemption Forms” for $25. The questions include describing the conflict between one’s religious belief and a COVID-19 vaccine requirement, as well as probing whether an employee also avoids using medication such as Tylenol and Pepto-Bismol, which were researched and developed in a similar manner to the COVID-19 vaccines (which relied partly on fetal cell lines). He offers to provide “real examples … to use from letters that have gotten accepted” and a free comprehensive guide to answering questions from employers. Rocco, who collects donations from those who feel the information has benefitted them, did not respond to a request for comment from TIME. After TIME sent a Facebook message to the group’s admins requesting an interview, the group was set to private. Sharing advice on how to tailor responses to employer questions about religious exemptions could be a way to game the religious exemptions system, some experts say. Relying on templates instead of one’s own articulation of their specific beliefs undercuts the question of sincerity, which employers are trying to gauge. “It’s legitimate for an employer to say, ‘Well, are these your words?’” says Katherine Franke, a law professor at Columbia University and faculty director of the Law, Rights and Religion Project. “If it looks like the person is just parroting something that they copied off the internet, the employer can say no; we won’t give you an exemption.” But in reality, it’s unclear how much time labor companies’ HR departments will be able to dedicate to scrutinizing these claims. “Many small businesses”—a majority of the businesses in the U.S.—”have an HR department of one,” says Emily M. Dickens, chief of staff and head of government affairs at the Society for Human Resource Management (SHRM). Vetting each exemption claim can be time consuming. “There will be employers who just don’t want to get in the business of evaluating religious exemptions, and so they will just do a box check,” Franke says. Employees have long been able to request religious exemptions to policies such as dress codes or being required to work on certain days, but these can be approved more easily because they don’t affect other employees. “[If companies] have outbreaks of COVID in their workforce because they’ve been overly generous in granting exemptions,” says Franke, employers could face litigation and complaints from other employees who get sick because they were exposed at work. With the new omicron variant, the need for a rigorous test for religious exemptions is even more urgent, experts say. “This is serious business. This is not a theoretical exercise. People are going to die,” Franke says. “If all the rest of us have to bear the weight, the public health risk of overly broad religious exemptions—that’s a public health catastrophe.” A Nov. 4 survey from SHRM found that 64% of employers are concerned about how to handle requests for religious or medical exemptions to a potential vaccine mandate. Many HR professionals are already overwhelmed as it is, with budget cuts and a significant labor shortage. Now they’re faced with questioning the sincerity of employee’s religious beliefs, and potentially getting sued no matter how they decide. “We have companies that weren’t prepared for this,” Dickens says. “This wasn’t in the job description.” from https://ift.tt/3E980Xx Check out https://takiaisfobia.blogspot.com/ It’s the news that the HIV community has been waiting four long decades for: the hint that maybe, just maybe, HIV can be cured. Dr. Xu Yu, a principal investigator at the Ragon Institute of Massachusetts General Hospital, MIT and Harvard, as well as an associate professor of medicine at Harvard Medical School, had to check and recheck her results to be sure. In one of her patients, test after test to detect evidence of HIV in the woman’s blood came up empty. In addition to her lab’s results, “We had complementary assays in labs in Australia, D.C. and Argentina, where the patient is from, all trying to see if they find any evidence of active virus at all, and there was absolutely nothing,” says Yu. All told, the international team analyzed more than 1.5 billion cells from the patient, who’s from Esperanza, Argentina, and none of the labs found intact traces of HIV’s whole genome in her samples. The woman tested positive for HIV after becoming infected from her partner, but soon after, her body’s immune system was somehow able to control the virus and prevent it from spilling more copies of itself into her body and, more importantly, block it from establishing reservoirs of latent virus in places like the lymph nodes—all without being on the powerful anti-HIV drugs that are normally needed to suppress the virus. This is what sets the Esperanza patient apart. Unlike the handful of other patients who have been able to control the virus, she does not show evidence of these reservoirs, while the others do. “There is no way to ever say we have proof that there is not a single virus in this patient,” says Yu, who reported the latest case in the Annals of Internal Medicine. “The only thing we can say is that after analyzing a large number of cells from the patient, with the technology in our lab we cannot reject the hypothesis that the patient probably reached a sterilizing cure by natural immunity.” If that’s indeed the case, she would be only the second case of a patient curing themselves of HIV. Yu also described the first patient, from San Francisco, in 2020, and the fact that she has now found another means researchers can start studying these patients to better understand how these people are able to achieve such a remarkable feat. There have been previous reports of patients who stopped taking anti-HIV medications and achieved undetectable virus levels for years: Timothy Ray Brown, who’s also known as “the Berlin patient,” and most recently Adam Castillejo, “the London patient.” Both, however, had been diagnosed with cancer and benefited from having a stem cell transplant to treat it, which replaced their immune cells with ones from donors that included cells that could block HIV infection. And they likely continued to harbor latent reservoirs of HIV, which means they haven’t been entirely cured, but what scientists call functionally cured. That doesn’t appear to be the case with the Esperanza patient. Yu and her team have analyzed 1.5 billion blood and tissue cells from the woman since 2017, and they did not find any evidence of intact genetic virus material that would indicate a potentially viable virus. They did, however, find fragments of viral genes, which indicated that the patient was indeed infected with HIV at one point. They found similar clues in the San Francisco patient. “This person’s body did this itself,” says Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a long-time HIV expert on the Esperanza patient. “It just happened. That means we have got to try to measure every possible parameter and everything in that patient to see if we can find some hint that could possibly be generalized to the public.” The patient continues to work with Yu’s team to provide blood samples for ongoing research studies. She is currently pregnant with her second child, and Yu and the patient’s doctors are discussing whether her remarkable, apparently virus-free condition means she won’t need to take anti-HIV drugs before and during delivery, as guidelines currently recommend for pregnant women who are HIV positive. She had taken these drugs for six months during her first pregnancy to ensure any virus she might have didn’t get passed on to her child during delivery. The Esperanza patient is also planning to provide the team with samples of her breastmilk once her baby is born so the scientists can determine if it contains any virus. While these two recent cases are encouraging, Yu cautions that the findings may not be generalizable to most HIV patients. Both of her patients belonged to a group known as elite controllers, or people who are able to suppress HIV at very low, often undetectable levels, with their immune systems without the help of anti-HIV drugs. Researchers don’t understand what it is about these people’s immune systems that allow them to control the virus so well, but they are studying these people intensively, looking at everything from the antibodies they make to the highway that immune cells use that includes lymphocytes. “I continue to be cautious,” says Fauci. “You can never really tell if the virus has completely left sanctuaries in the body or are just not coming out for any number of reasons until the right set of circumstances, but this proof of concept in my mind is much more relevant than the cases of the stem cell transplant. Because nobody manipulated this person. It just happened. To me, a) that’s rare. And b) I don’t know for sure if she has really eliminated the virus, but even if she hasn’t, she is controlling it in a very powerful way. If we can get a handle on that, it would be helpful for us going forward in our quest to develop a cure for people affected by HIV.” Yu is similarly hopeful that these patients, and others like them who might now come forward, will help answer critical questions such as whether tweaking current combinations of anti-HIV drugs could help others mirror the response her two patients have had. One thing she is hoping to do, for example, is compare the immune response among these two patients to that produced by people who are taking anti-HIV drugs. It’s possible that the drug cocktails produce an immune response weaker than what’s generated by these two patients, and scientists could find ways to bolster that response. “We are actively studying the durability and strength of their responses and comparing them to people who are treated with combination therapy,” says Yu. “I’m hoping that as more people are aware of these cases, they will approach us so we can understand their immune systems better.”
from https://ift.tt/3I9yI4s Check out https://takiaisfobia.blogspot.com/ New Findings Show the Omicron Variant Spread Widely At a Faster Pace Than Initially Thought11/30/2021 BRUSSELS (AP) — New findings about the coronavirus’s omicron variant made it clear Tuesday that the emerging threat slipped into countries well before their defenses were up, as two distant nations announced their first cases and a third reported its presence before South African officials sounded the alarm. The Netherlands’ RIVM health institute found omicron in samples dating from Nov. 19 and 23. The World Health Organization said South Africa first reported the variant to the U.N. health agency on Nov. 24. Meanwhile, Japan and France reported their first cases of the new variant that has forced the world once again to pinball between hopes of returning to normal and fears that the worst is yet to come. It remains unclear where or when the variant first emerged or how contagious it might be—but that hasn’t stopped wary nations from rushing to impose travel restrictions, especially on visitors coming from southern Africa. Those moves have been criticized by South Africa and the WHO has urged against them, noting their limited effect. The latest news though made it increasingly clear that travel bans would struggle to stop the spread of the variant. German authorities said they had an omicron infection in a man who had neither been abroad nor had contact with anyone who was. The WHO warned Monday that the global risk from omicron is “very high” and that early evidence suggests it may be more contagious. Others sent more reassuring messages, like European Medicines Agency chief Emer Cooke, who insisted that the 27-nation European Union was well prepared for the variant. While it is not known how effective current vaccines are against omicron, Cooke said the shots could be adapted within three or four months if need be. But nearly two years after the virus first held the world in its grip, the current response echoed in many ways the chaos of the early days, including haphazard travel bans and a poor understanding of who was at risk and where. Many officials tried to calm fears, insisting vaccines remain the best defense and that the world must redouble its efforts to get the shots to every part of the globe. The latest variant makes those efforts even more important, U.S. Secretary of State Antony Blinken said, noting as many have before that “as long as the virus is replicating somewhere, it could be mutating.” In the face of the new variant, some introduced new measures aimed at mitigating the spread. England made face coverings mandatory again on public transport and in shops, banks and hairdressers. And one month ahead of Christmas, the head of the U.K,’s Health Security Agency, Jenny Harries, urged people not to socialize if they don’t need to. And after COVID-19 already led to a one-year postponement of the Summer Games, Olympic organizers were beginning to worry about the February Winter Games in Beijing. Chinese Foreign Ministry spokesperson Zhao Lijian said omicron would “certainly bring some challenges in terms of prevention and control.” Japan had announced that it would ban all foreign visitors beginning Tuesday—but that turned out to be too late. It confirmed its first case that day, a Namibian diplomat who recently arrived from his country. World markets continued to seesaw on every piece of medical news, either worrisome or reassuring. Global shares mostly slipped Tuesday as investors cautiously weighed how much damage omicron may unleash on the global economy. Some analysts think a serious economic downturn, like what happened last year, likely will be averted because many people have been vaccinated. But they also think a return to pre-pandemic levels of economic activity, especially in tourism, has been dramatically delayed. In a world is already unnerved by the more contagious delta variant that filled hospitals again in many places, even in some highly vaccinated nations, the latest developments underscored the need for the whole globe to get their hands on vaccines. “We have vaccination rates in the United States, in Europe of 50, 60, 70 %, depending on exactly who you’re counting. And in Africa, it’s more like 14, 15 % or less,” Blinken said. “We know, we know, we know that none of us will be fully safe until everyone is.” AP journalists from around the world contributed. from https://ift.tt/3rnAvNt Check out https://takiaisfobia.blogspot.com/ On Nov. 26, the World Health Organization declared Omicron the latest COVID-19 variant of concern, and vaccine makers jumped on the news. Moderna quickly announced that it was developing an Omicron-specific vaccine, while continuing to study both a higher dose of its currently authorized shot, and a combination vaccine that protects against one of the previous SARS-CoV-2 variants. BioNTech, which developed its vaccine with pharmaceutical giant Pfizer, began studying whether its existing two-dose shot continues to protect against Omicron, and a company spokesperson said those results could be available in about two weeks. In the meantime, Pfizer-BioNTech are also preparing an Omicron-targeted vaccine that could take six weeks to develop, plus another several months to test—which means if needed, that vaccine could be available next spring. Both Moderna and Pfizer-BioNTech developed their COVID-19 vaccines using mRNA technology, which allowed them to quickly move from getting the right genetic sequence of the SARS-CoV-2 virus and inserting it into their shots to generate a robust immune response. The technology is highly adaptable and means that additional vaccines, directed against new genetic targets on the virus, such as Omicron, will take weeks rather than years. Whether a vaccine targeted directly against Omicron will be necessary, however, depends on the results of studies that pit existing vaccine-induced antibodies and immune cells against the variant in a lab. If the current protection from vaccines continues to control Omicron, then it will be even more critical for people to get a booster shot of the existing authorized or approved vaccines. That additional dose will enhance protection and likely keep people who are infected with Omicron from getting severely ill with COVID-19. If, on the other hand, the studies show that the existing vaccine protection against Omicron is weak, public health officials and vaccine makers will have to decide two things: first, whether people need to be re-vaccinated against Omicron with two doses of a a new, variant-specific mRNA vaccine; or if a booster with an Omicron-targeted dose will be enough. Vaccine makers using other technology, such as Johnson&Johnson-Janssen and AstraZeneca, are also testing how their shots fare against Omicron. Their vaccines introduce snippets of genetic material in the form of DNA to the body, so cells can then produce viral proteins that the immune system targets. AstraZeneca launched studies in Botswana and Eswatini, two of the nations where Omicron cases have been reported. The latest variant isn’t a surprise to vaccine and public health experts, who warn that other variants like it are inevitable if vaccination rates remain low around the world. Viruses mutate when they copy their genetic material to duplicate themselves—basically, when they infect someone. The more infections and the more copying the virus squeezes in, the more opportunities it has to generate mutations and variants like Omicron. Vaccines dampen the virus’ ability to replicate, so creating some vaccine-based defense by getting good vaccine coverage in as much of the population as possible is the best weapon against any new, potentially more contagious and dangerous variants. from https://ift.tt/3rqspDX Check out https://takiaisfobia.blogspot.com/ There are still more questions about the Omicron variant than answers. While the mutations identified suggest it has the potential to be more resistant to vaccines, invade cells more efficiently and be more transmissible than other variants, it may also turn out to cause less severe disease or it could just simply fizzle out. However, what it does tell us is that so long as there are large populations of unvaccinated people enabling the virus to spread and mutate unabated, worrying new variants of concern like this will continue to emerge. Once again, as borders close and stock markets tumble, it tells us that this crisis is far from over, and without dramatic course correction, will go on for some time. Given the rising levels of infection, the global shortage in ICU beds, the resumption of lockdowns and the riots, that much should already be obvious. And yet there is a growing perception – particularly in countries with high vaccine coverage where life appears to be returning to something close to normal – that COVID-19 has somehow become or is close to becoming endemic. That in itself is a concern, but a bigger worry now is that Omicron will trigger a knee-jerk response and a repeat of past mistakes. If the priority becomes to provide variant-specific boosters for people who are already protected, diverting efforts and resources from getting first doses to the 3.6 billion people who are still unvaccinated, then we could face a seemingly endless cycle of resurgences and new variants. Read More: Is a Fifth Wave Coming? Ahead of Holidays, COVID-19 Cases Are Still Below 2020 Levels—For Now If, as now seems likely, we won’t be able to eliminate this virus entirely, then the COVID-19 endgame will indeed mean that it eventually does become endemic – ever present, but with stabler and much lower levels of transmission and infection, much like flu. When that does happen, regular boosters will no doubt become the norm. But we are not anywhere near that stage yet. So, while it is encouraging and important that manufacturers are already working on Omicron-specific boosters, this cannot come at the expense of protecting those still most at risk, particularly those at highest risk, namely people who are still not vaccinated. At this stage in the pandemic, COVID-19 has effectively become a disease of the unvaccinated. Because up until now vaccines have been incredibly effective at preventing severe disease and death, even against variants that have shown some resistance to vaccines like Delta. With Omicron it’s possible that that effectiveness could be reduced with existing vaccines, while boosters may offer some enhanced protection. But even if that is the case, what is likely to have the most impact on the pandemic: providing additional protection through third or fourth shots to people who are already at an extremely low risk or pouring efforts into reaching the billions of people who have still not had their first shot? Read More: The Childhood Vaccine Debate Ignores a Crucial Point: Kids Aren’t Supposed to Die This really is a no-brainer. The only qualifier is if Omicron really does significantly reduce the ability of existing vaccines to keep people out of ICUs, and that seems unlikely. While its mutations suggest it may be better at evading antibodies, even if this proves to be the case, vaccine immunity offers other lines of defense, which are often more resilient to such mutations. So, while Omicron is a big concern, we need to be smart about how we respond. It’s nearly a year since the COVID-19 vaccines were first made available, during which time the vast majority of doses have been hoarded by the wealthiest countries. Had that not happened, had access been made more equitably available across the globe, with people most at risk prioritized, such as health care workers and vulnerable groups, then transmission could have been significantly reduced and it’s quite possible that variants like Omicron would not have been given the opportunity to emerge. Read More: What Happens When the World’s Most Popular COVID-19 Dashboard Can’t Get Data? Instead, as things stand nearly half the world’s population have not yet been vaccinated, and in the poorest counties only about 5.7% of people have had their first shot. This not only puts people needlessly at risk, but it allows the virus to continue to spread and mutate. With 1.5 billion doses now being produced a month, global vaccine supply challenges are finally easing and the race is on to protect the world, with COVAX aiming to deliver 800 million to 1 billion doses by the end of the year. Even if this variant outcompetes Delta, as we fear it may, unless there is firm evidence that existing vaccines are no longer protecting people and saving lives, the focus of governments and manufacturers must be to support this global effort, because that is the only way to break the cycle and alter the course of this pandemic. Given that it looks like it’s already too late to contain Omicron, what we now need most is answers. The fact that we already know so much about it so quickly is largely thanks to the excellent science carried out in South Africa and the speed with which they shared that work with the world. If the fruit of that labor and spirit of partnership only benefits people in wealthy countries, in the form third or fourth boosters for protected people, while countries like South Africa are left on their own, then what motivation will they – or other countries – have to be so transparent the next time a variant emerges? from https://ift.tt/3xBJdc3 Check out https://takiaisfobia.blogspot.com/ Harnessing the immune system to target cancer has long resided on doctors’ wish lists, with very little promise of becoming reality. Because cancer cells are normal cells that mutate to grow out of control, directing the body to destroy these cells is a risky endeavor with potentially dangerous outcomes. Advances in immunotherapy, however, have led to powerful drugs that can help immune cells better distinguish between cancer cells and healthy ones, and researchers are now testing the idea of whether the immune system can be trained to recognize and destroy breast cancer cells in the same way that it dispatches viruses or bacteria. Dr. G. Thomas Budd, staff physician at the Cleveland Clinic Taussig Cancer Center, is leading a potentially ground-breaking study of a breast cancer vaccine that could help women produce antibodies and other immune cells that protect them from getting cancer. The vaccine is designed to target a particularly aggressive form of the disease, known as triple negative, that currently has very few treatment options. Triple negative cancer lacks the molecular flags—for estrogen, progesterone or HER2—that common breast cancer drugs target. The first phase of the study will focus on safety and include 18 to 24 women who have already been diagnosed with triple negative breast cancer and treated with standard therapies, which include chemotherapy, surgery and DNA-interfering drugs that inhibit cancer cells’ ability to copy their genes and grow. They will receive three doses of the experimental vaccine, two weeks apart, and Budd and his team will look for side effects and determine whether the participants produce any immune response directed against the cancer targets. Budd’s team will also see if the women’s cancer returns. Ultimately, he says, if this early phase indicates the vaccine is safe and shows promise in triggering an anti-cancer immune response, the study will expand to include women at high risk of developing triple negative cancer, but who haven’t been diagnosed yet, to see if immunizing them could help prevent the cancer from occurring in the first place. Women with BRCA1 mutations as well as Black and Hispanic women are more likely to develop triple negative cancers, so including these women in the study will help demonstrate how effective the vaccine might be. “I would say this could be game changing,” says Budd of the approach. While others have tried to develop breast cancer vaccines, targeted against some of the more common features of breast cancer cells like the HER2 receptor, those efforts haven’t led to dramatic success yet. That may have to do with the fact that the vaccine targets things on the breast cancer cells that also appear on healthy cells, which makes them more toxic and less efficient in blocking tumors from growing. The vaccine Budd is testing was based on work by his Cleveland Clinic colleague and immunologist Vincent Tuohy. It targets a never-before-tried breast cancer protein called alpha lactalbumin, which breast cells actively express only when a woman is lactating. If she’s no longer lactating, the gene for the protein goes silent, and the protein isn’t produced. It turns out, however, that 70% of triple negative breast cancers actively produce this protein, which makes it a reasonable target for the immune system. Tuohy showed in studies with mice that training the immune system to recognize this protein with a vaccine effectively preventing tumors from forming, and also slowed growth of existing breast tumors in the animals. That data convinced the Food and Drug Administration to support the first studies in humans, which Budd is leading. With funding from the Department of Defense, his team is now recruiting women with triple negative breast cancer who are in remission and treating them to see if the vaccine is safe, and, hopefully, if it can prevent recurrence of their disease. From the animal studies, Budd believes that the vaccine will be most effective in preventing disease, or preventing recurrence, and is hopeful that once this first trial shows the vaccine is safe, his team can start vaccinating healthy women at high risk for triple negative breast cancer. “I do think the [target] we are using makes a difference, and the major lesson from previous vaccine trials shows that ultimately we ought to move more to the prevention setting than the treatment setting,” he says. The trial could be a milestone in establishing the usefulness of immune-based approaches in treating breast cancer, including its most intractable forms. Some immunotherapy drugs that manipulate the immune system and make it easier for immune cells to target breast tumors have demonstrated some anti-cancer activity, but it’s not enough. “Those showed us the bear can dance, and we’d like to teach it new steps,” says Budd about the vaccine strategy. from https://ift.tt/3xBEmHR Check out https://takiaisfobia.blogspot.com/ The World Health Organization warned that the new coronavirus variant could fuel surges with “severe consequences” amid signs that it makes Covid-19 more transmissible. Scientists in South Africa, where omicron was first detected, said it appears to spread more easily but existing vaccines are still likely to protect against severe illness. The Geneva-based WHO assessed the variant’s risk as “extremely high” and called on member states to test widely. Understanding the new strain will take several days or weeks, the agency said. “We don’t have enough data to determine vaccine effectiveness against omicron or disease severity, so any claims about either at this stage are not evidence-based,” said Raina MacIntyre, professor of global biosecurity at the University of New South Wales in Sydney. “So far, the virus has not mutated to become less severe — in fact the opposite.” Governments around the world are banning travelers from South Africa and nearby countries amid fears omicron could evade vaccines, exacerbate Covid surges and frustrate efforts to reopen economies. While news of the new variant wreaked havoc in global financial markets on Friday, trading in Asia Monday indicated investors were waiting for more clarity as scientists work to better understand omicron. Omicron’s mutations may make it easier for the virus to evade existing immunity, the WHO said in a technical briefing document for its members. It warned of “future surges of Covid-19, which could have severe consequences.” The variant was first detected earlier this month. It’s characterized by some 30 or more genetic changes, half of which are in the part of the spike protein used to bind to human ACE-2, which is the enzyme the coronavirus targets to enter cells and cause an infection. Mutations there can make the spike protein less recognizable to the antibodies produced in response to vaccination or a natural infection. Urgent MeetingThe U.K. government will convene an urgent meeting of Group of Seven health ministers Monday to discuss the latest developments, according to the country’s Department of Health. In the U.S., President Joe Biden will also give an update on Monday, the White House said. Angelique Coetzee, chair of the South African Medical Association, called symptoms associated with the variant at this point “different and so mild” compared with others she’s treated in recent months. Coetzee, who first spotted what turned out to be the new variant, told the U.K.’s Telegraph newspaper that a number of healthy young men turned up at her clinic “feeling so tired.” About half were unvaccinated. “What we are seeing clinically in South Africa and remember, I’m at the epicenter, that’s where I’m practicing, is extremely mild,” she said Sunday on the BBC’s “Andrew Marr Show.”
Asked if authorities around the world were panicking unnecessarily, Coetzee said, “Yes, at this stage I would say definitely. Two weeks from now on maybe we will say something different.” Experts elsewhere, however, followed the WHO in urging caution. Richard Lessells, an infectious-diseases physician at the University of KwaZulu-Natal in Durban, said a rapid understanding of disease severity caused by omicron is critical, but it’s too early for reliable data. The time it takes for infections to progress to severe disease or hospitalization means omicron’s impact may not be apparent for a few more weeks. ‘Be Cautious’“Observations from clinicians on the ground are always important, and we lean heavily on them, but we need to be cautious about jumping on early reports that all cases with this variant are mild,” Lessells said in a Twitter post Sunday. The variant’s genome contains “some concerning elements,” said Stephen Goldstein, an evolutionary virologist at the University of Utah in Salt Lake City. Their effect on vaccine effectiveness should be better known in the next couple of weeks, he said. Omicron also has some mutations near the so-called furin cleavage site of the spike protein that are associated with the increased transmissibility of both the alpha and delta variants. “We’re starting to see cases pop up in other parts of the world, so it appears to be spreading quite quickly, which leads to concerns that it may be even more transmissible than delta, but it really is too soon to say,” Goldstein said in a Zoom interview. Any advantage omicron has may become clearer if it starts spreading in the U.S. and parts of Europe already battling delta-fueled epidemics, he said.
The average number of daily cases in South Africa jumped to about 1,600 last week from about 500 the previous week and 275 infections in the week before that, President Cyril Ramaphosa said Sunday. The proportion of Covid tests coming back positive jumped to 9% from about 2% in less than a week. No unusual symptoms have been reported following infection with omicron and, as with other variants, some individuals are asymptomatic, South Africa’s National Institute for Communicable Diseases said Friday. Only 36% of adults in South Africa are fully vaccinated. Asymptomatic CasesTwo omicron cases detected in Australia and an initial one in Hong Kong occurred in vaccinated people who developed no apparent sign of illness. A 62-year-old man who was infected in a quarantine hotel in Hong Kong did develop symptoms. Both places require negative Covid tests for travelers to enter, however, indicating these infections may have been at an early stage. The WHO said there was preliminary data showing a higher number of hospitalizations, “but this may be due to increasing overall numbers of people becoming infected, rather than a result of specific infection with omicron.” —With assistance from Stuart Biggs, Ainslie Chandler, Jinshan Hong and S’thembile Cele. from https://ift.tt/3163MBc Check out https://takiaisfobia.blogspot.com/ A new variant of SARS-CoV-2 first reported in South Africa is raising alarms for health officials around the world, leading to fresh travel restrictions amid fears it could be resistant to existing vaccines. Researchers in South Africa conducting genetic analysis of COVID-19 virus cases determined that a new variant, B.1.1.529, had been found in cases in South Africa, Botswana, and a traveler who had traveled from South Africa to Hong Kong, the country’s health minister announced on Nov. 25. The following day, Belgian health officials reported the first case of the new variant discovered in Europe. Dr. Anthony Fauci, chief medical advisor on COVID-19 to the White House and director of the National Institute of Allergy and Infectious Diseases, told CNN U.S. researchers will be speaking with their South African colleagues “to find out scientist to scientist to exactly what is going on.” Why this variant is worryingWhat makes the variant especially concerning is the number of mutations, up to 30, that South African scientists reported in the spike protein, which is the main target for currently available vaccines and drug therapies. The changes make the protein look different enough from the original that scientists are worried about whether existing vaccines can still protect against disease. Researchers will now be rushing to determine how easily the new variant spreads, and whether it can indeed escape vaccine protection. So far, scientists have said that the existing vaccines continue to protect against severe disease, and the shots have helped to lower hospitalizations and deaths from COVID-19 in areas where coverage is high. But large numbers of people around the world still aren’t vaccinated, either because they can’t access doses, or are hesitant to get immunized. That contributes to a steady stream of new infections, which provide the virus new opportunities to mutate, and public health experts have been wary of new variants that could escape vaccine-protection. How the world is reactingUntil researchers learn more about the latest variant, health officials and political leaders aren’t taking any chances, as the world prepares for a busy holiday travel season. The U.K. immediately banned flights from six African countries — South Africa, Namibia, Lesotho, Botswana, Eswatini and Zimbabwe — and instituted a mandatory 10-day quarantine for any travelers entering the U.K. from those countries. U.K. health minister Sajid Javid said the variant is of “huge international concern.” Belgian health authorities said one case of the new variant, in an unvaccinated traveler who had returned from abroad, had appeared in the country. As a precaution, the European Commission President Ursula von der Leyden said in a statement that flights from South African nations “should be suspended until we have a clear understanding about the danger posed by this new variant.” Cases in the bloc have been spiking in recent weeks due to low vaccination rates and greater density of people in public areas. In the U.S., among the first priorities for researchers will be getting more details about the molecular features of the virus that will allow them to develop a test to start looking for the variant in this country, as well as challenge the variant in the lab with antibodies made by vaccinated people or those who recovered from COVID-19 to determine if those antibodies continue to neutralize the virus. A World Health Organization working group is scheduled to meet on Nov 26 to assess the variant, which it currently designates as a “variant under monitoring.” The group will determine if the new version of the virus is concerning enough to re-categorize it, in which case it would be labelled with a Greek letter designation as previous variants of concern have been.
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