Reacting to a surprising and growing monkeypox outbreak, U.S. health officials on Tuesday expanded the group of people recommended to get vaccinated against the monkeypox virus. They also said they are providing more monkeypox vaccine, working to expand testing, and taking other steps to try to get ahead of the outbreak. “We will continue to take aggressive action against this virus,” said Dr. Ashish Jha, White House COVID-19 response coordinator, who has also been playing a role in how the government deals with monkeypox. The administration said it was expanding the pool of people who are advised to get vaccinated to include those who may realize on their own that they could have been infected. Most monkeypox patients experience only fever, body aches, chills and fatigue. People with more serious illness may develop a rash and lesions on the face and hands that can spread to other parts of the body. The disease is endemic in parts of Africa, where people have been infected through bites from rodents or small animals. It does not usually spread easily among people. Last month, cases began emerging in Europe and the United States. Many—but not all—of those who contracted the virus had traveled internationally. Most were men who have sex with men, but health officials stress that anyone can get monkeypox. Case counts have continued to grow. As of Tuesday, the U.S. had identified 306 cases in 27 states and the District of Columbia. More than 4,700 cases have been found in more than 40 other countries outside the areas of Africa where the virus is endemic. There have been no U.S. deaths and officials say the risk to the American public is low. But they are taking steps to assure people that medical measures are in place to deal with the growing problem. One of the steps was to expand who is recommended to get vaccinated. Vaccines customarily are given to build immunity in people before they are ever infected. But if given within days or even a few weeks of first becoming infected, some vaccines can reduce severity of symptoms. A two-dose vaccine, Jynneos, is approved for monkeypox in the U.S. And it is that vaccine that officials have been trying to use as a primary weapon against the outbreak. U.S. officials on Tuesday said said they are increasing the amount of Jynneos vaccine they are making available, allocating 56,000 doses immediately and about 240,000 more over the coming weeks. They promised more than 1 million more over the coming months. Another change: Until now, the Centers for Disease Control and Prevention has advised that vaccines be given after exposure to people whom health officials identify as close personal contacts of cases. But on Tuesday, CDC officials say they are expanding the recommendation to people who were never identified but may realize on their own that they may have been infected. That can include men who have sex with men who have recently had multiple sex partners in a venue where there was known to be monkeypox or in an area where monkeypox is spreading. “It’s almost like we’re expanding the definition of who a contact might be,” said the CDC’s Jennifer McQuiston. If people have been to a party or other place where monkeypox has been known to spread “we recommend they come in for a vaccine,” she said. from https://ift.tt/3JehV6D Check out https://takiaisfobia.blogspot.com/
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On June 28, a panel of experts convened by the U.S. Food and Drug Administration (FDA) voted 19 to 2 to change the vaccines that have been used since December 2020 to protect against COVID-19. The change, which will apply only to booster doses for people who are already vaccinated, involves including a strain that targets the Omicron variant, which is now responsible for nearly all infections of COVID-19 in the U.S. and around the world. But the committee stopped short of deciding exactly which Omicron strain; Omicron has produced many different subvariants, starting with BA.1 and now BA.4 and BA.5, the latter two which now account for 50% of COVID-19 cases in the U.S. Including an Omicron strain in the next booster is similar to the way flu viruses are swapped out every year to give people the strongest immunity against whichever version of influenza is circulating at the time. The committee’s decision is based on several lines of evidence, including the fact that Omicron is different from the original version of the virus in the currently approved vaccines. The original COVID-19 vaccines, as well as the booster doses that have been authorized in the U.S., have all targeted an earlier strain of the virus known as D614G, which public health experts call the ancestral strain. The experts also heard from scientists at the U.S. Centers for Disease Control and Prevention (CDC) who provided data showing that these original vaccines are no longer as effective at protecting people from getting infected with the Omicron variant and its subvariants as they were against the ancestral strain. The vaccines continue to provide good protection against getting seriously ill with COVID-19, and from getting hospitalized or dying from the disease, but public health experts provided compelling evidence that such protection could be even stronger if the next booster shots come from a new version of the vaccine that specifically targets Omicron. Why is a new vaccine necessary now?The FDA committee decided that it’s time to update the COVID-19 vaccine and that continuing to boost with the existing shot will not provide the durable protection that people need. The experts reviewed data on the dominance of the Omicron variant, which has circulated in the U.S. since December 2021, and has already spawned several different subvariants, including BA.1, BA.2.12.1, BA.4, and BA.5. The same FDA committee had met in April to discuss the criteria for changing the COVID-19 vaccine and concluded that it would take into consideration the advice of the World Health Organization’s Technical Advisory Group on COVID-19 Vaccine Composition (TAG-Co-VAC), which analyzes data on COVID-19 vaccine effectiveness and makes recommendations about when to change vaccines if that effectiveness shows signs of waning, just as a similar WHO group does for the flu vaccine each year. That group concluded in June that while the currently available vaccines made by Moderna and Pfizer-BioNTech continue to protect against severe COVID-19 disease—even if people are infected with Omicron variants—stronger immunity against Omicron could come with a booster dose with a new Omicron-containing vaccine. Dr. Kanta Subbarao, director of the WHO Collaborating Center for Reference and Research on Influenza, explained to the committee the reasoning behind the group’s advice, noting that adding an Omicron-specific component to the next booster would increase the breadth of protection people might receive from immunization. “It’s not so much matching what [virus strain] is likely to circulate, but more about achieving broader immunity [against the existing variants],” she told the committee. Subbarao presented data showing that people who were vaccinated and then infected with Omicron generated a wider range of antibodies that could neutralize more SARS-CoV-2 variants, including the original strain and Omicron, than people who were unvaccinated and were infected with Omicron, who primarily generated immune responses specific to Omicron only. The WHO did not, however, recommend switching to an Omicron-specific vaccine to immunize people who have not been vaccinated yet, since there isn’t data yet to support whether that immunity would be robust enough. The FDA committee also considered several other pieces of evidence, including the fact that currently circulating versions of SARS-CoV-2, mostly from the Omicron strain, are different enough from the original virus that the vaccines target, and that available vaccines are less effective in protecting against Omicron infections than they are in protecting against other variants. The committee reviewed data showing that while the current vaccines continue to protect against severe disease, the level of virus-fighting antibodies in vaccinated people, including those who have received a booster shot, wanes over time. Taking into account all of the available data, the FDA panel decided that there was enough evidence to justify changing the COVID-19 vaccine booster to better target the Omicron variant currently responsible for nearly all infections. Which version of Omicron will the next vaccine target?This question led to the most division among the invited speakers and the committee members. While Subbarao from WHO suggested including BA.1 in the next vaccine, because of its genetic difference from the original SARS-CoV-2 strain in current vaccines, Dr. Peter Marks from the FDA disagreed, preferring instead to focus on BA.4 and BA.5. “The current vaccines appear to be the least effective against them,” he said. Both Moderna and Pfizer-BioNTech provided data on new vaccines they developed that contain two strains of SARS-CoV-2: the original, and one that targets the first Omicron variant, BA.1, in so-called bivalent vaccines. This approach is similar to that used in the flu shot, which typically targets three different influenza strains. The companies also developed and studied vaccines aimed at just the BA.1 Omicron variant, but found that combining the Omicron and original strains provided a broader immune response against more than just the Omicron strain. The committee was not tasked with deciding which version of Omicron should be included in the new booster shot, although the committee members leaned toward targeting BA.4 and BA.5, since those are increasing in prevalence in the U.S. But there is little data involving the efficacy of BA.4 and BA.5-containing vaccines, and the committee members urged the companies to continue studying those versions, which both Moderna and Pfizer-BioNTech are doing. Will the new vaccine provide better protection against Omicron?That’s the hope, although there is still limited data from the real world on how much stronger the protection against Omicron will actually be. The companies tested their bivalent vaccines for their ability to produce virus-fighting antibodies, in the lab, against Omicron, and the committee extrapolated from those studies that the level of antibodies would be sufficient to provide protection against infection and disease. It’s not clear whether people vaccinated with the bivalent vaccine targeting BA.1 will produce the same levels of antibodies against the newer Omicron subvariants, including BA.4 and BA.5, as against BA.1. Moderna is studying how the immune response to BA.4 and BA.5 generated by its BA.1 bivalent vaccine compares to that against BA.1, and Pfizer-BioNTech provided early data from a mouse study. That data showed that its bivalent vaccine did produce antibodies against BA.4 and BA.5 strains, albeit at lower levels than against BA.1 or the original virus strain. Both companies are continuing to study their new vaccines against the newer Omicron subvariants that will likely become more prevalent in coming months. Are the vaccines safe?Some committee members raised questions about whether the bivalent vaccines, which would target two different SARS-CoV-2 strains, would generate more side effects, including myocarditis, an inflammation of heart tissues that affects mostly adolescent males. In short-term data provided by Moderna and Pfizer-BioNTech and reviewed by the FDA, side effects and adverse reactions to the new vaccines measured about one months after vaccination occurred at similar rates as those to the original doses, but longer term follow-up is needed. Will other new vaccines come later this year?The committee also saw data from Novavax, which makes a COVID-19 vaccine using a different technology from the mRNA platform behind Moderna and Pfizer-BioNTech’s vaccines. The FDA is still reviewing the company’s request for emergency use authorization and has not yet made a decision. But many committee members were impressed with the data from the Novavax’s original vaccine candidate, which targets the original SARS-CoV-2 strain but generated strong immune responses to a variety of variants, including against Omicron. Dr. Glenn Gregory, the company’s president of research and development, argued that the data made a good case for deploying Novavax’s vaccine, with at two doses, to better fight the current Omicron cases. But because that vaccine isn’t authorized, and the data haven’t been reviewed by the FDA yet, it’s not clear how valid that evidence is. When could the new booster doses be available?Both Moderna and Pfizer-BioNTech have begun manufacturing bivalent vaccines aimed at BA.1, and Moderna said if the U.S. government decided to boost with that shot, it could have hundreds of millions of doses available by July or August. If regulators decide on a bivalent vaccine containing BA.4 or BA.5 strains, however, both companies would need about three months to manufacture those shots and go through FDA review, so those vaccines would not be available until October or November if the FDA and CDC authorizes them. Now that the FDA’s advisory committee recommends including some version of Omicron in the next booster shot, it’s up to the FDA to review the available data, or ask for additional data from the vaccine makers, to decide which Omicron strains to include and when people should be boosted. The panel’s decision is only the first in a long series of steps—and more studies—that are required before anyone receives a new COVID-19 vaccine in the fall. “What I’d like to see are additional data, and better understanding of the clinical meaningfulness on the impact on severe outcomes and disease,” said Adam Berger, director of clinical and healthcare research policy at the National Institutes of Health. “I’d like further data on the long-term durability of any type of change to the actual vaccine composition.” from https://ift.tt/13sUO2b Check out https://takiaisfobia.blogspot.com/ Chronic Traumatic Encephalopathy Is Diagnosed in a Major League Soccer Player for the First Time6/28/2022 BOSTON — Researchers have diagnosed chronic traumatic encephalopathy in a Major League Soccer player for the first time, saying Tuesday that former Sporting Kansas City defender Scott Vermillion suffered from the degenerative brain disease. The Boston University CTE Center said Vermillion, who died of an accidental drug overdose in December 2020 at the age of 44, had CTE. Although it is not possible to connect any individual case to a cause, the disease has been linked to repeated blows to the head. CTE has been found in more than 100 former NFL players as well as semi-pro and high school soccer players. Vermillion is the first from MLS. “Mr. Vermillion has shown us that soccer players are at risk for CTE,” said Dr. Ann McKee, director of the BU CTE Center. “We need to make every effort to identify players who are suffering and provide them compassionate care and appropriate medical support.” Vermillion began playing soccer at the age of 5 and continued for 22 years, culminating in four MLS seasons for D.C. United, the Colorado Rapids and Sporting KC. He also played for the United States at the 1993 Under-17 World Championship and made some appearances for the Under-20 team in 1996. After retiring in 2001 with an ankle injury, his family said, he became depressed and had problems with impulse control and aggression. Eventually, he suffered from memory loss and developed a substance abuse problem. All have been associated with CTE, which has been linked to concussions or subconcussive blows in athletes, combat veterans and others who sustain repeated head trauma. “This disease destroys families, and not just football families,” said Vermillion’s father, Dave Vermillion. “We hope this will be a wake-up call to the soccer community to support former players and get them the help they need, so some good can come from this tragedy.” The MLS Players Association called upon the league to break with the sport’s international governing bodies and adopt a rule expanding substitutions to allow for players with concussions. “We must not sit by and wait for them to do the right thing. MLS should unilaterally adopt a full concussion substitution rule immediately,” the union said in a statement. “Current substitution rules do not give medical professionals sufficient time to properly diagnose potential concussions without putting a team at a substantial competitive disadvantage.” The Concussion Legacy Foundation has called for rules that would limit tackle football and heading in soccer to children over 14. CLF co-founder Chris Nowinski said dementia has already been linked to repetitive heading by pro soccer players in Britain. “It is time for the global soccer community to have a real conversation about heading, especially in the youth game,” Nowinski said. “We urgently need to investigate how far this crisis extends into amateur soccer and immediately put in place reforms to prevent CTE in the next generation.” from https://ift.tt/BPZgGQj Check out https://takiaisfobia.blogspot.com/ It took a long time for Rachel Bean to fully accept that she has Long COVID. Bean, 35, caught the virus in May 2020, when most experts were still saying that COVID-19 either causes life-threatening illness or milder symptoms that resolve within a few weeks. Bean’s acute case was asymptomatic—so as time passed and she felt unwell, with a rapid heart rate and unrelenting fatigue, she figured there had to be another explanation. Then, in August 2020, she joined an online Long COVID support group and found that plenty of other people hadn’t fully recovered from COVID-19, either. But many of their symptoms seemed different than hers, so she kept pushing through. Finally, in late 2020—shortly before her illness forced her to leave her job as a social worker—Bean asked her doctor to refer her to a Long COVID treatment clinic. Today, Bean is struck by how many people still don’t realize that their health issues could be signs of Long COVID. She’s talked to people who insist they’ve fully recovered from COVID-19, but also complain of classic Long COVID symptoms like fatigue and cognitive dysfunction. “People aren’t necessarily connecting the dots,” Bean says. Experts say that lack of recognition could be causing some Long COVID cases to go undiagnosed. “People are bad at correlation if they’re not thinking about it all the time,” says Hannah Davis, a machine learning expert who is part of the Long COVID Patient-Led Research Collaborative. “When you had COVID…and then two months later you stop being able to drive, you’re not necessarily going to tie it to that.” Not every health issue is a sign of Long COVID. Thousands of people around the world are diagnosed with COVID-19 every day, and many recover without lingering issues. Others experience health problems following but unrelated to their infections, because all the things that made people sick before the pandemic haven’t gone away. But Long COVID affects more people than many realize. In the U.S. alone, roughly one in five adults with a known previous case of COVID-19 currently has Long COVID symptoms, according to recent data from the National Center for Health Statistics. Others could be living with the condition without realizing it. Testing for COVID-19 is now as easy as swabbing your nose at home. Diagnosing Long COVID is more complicated, as no single test can detect it. Public-health groups define the condition slightly differently, but their criteria usually boil down to having symptoms that didn’t exist prior to a confirmed or suspected SARS-CoV-2 infection, last at least a couple months after infection, and can’t be explained by anything else. In the summer of 2020, an estimated half of cases weren’t formally diagnosed, according to an article co-authored by U.K. researcher Trish Greenhalgh. It’s hard to say exactly what that percentage is today, but it’s probably still significant. There are an estimated 2 million people with Long COVID in the U.K., which by Greenhalgh’s estimate means each full-time general practitioner there cares for about 65 long-haulers. But fewer are properly diagnosed, due to factors like patients not seeking care, doctors missing the condition, or doctors entering it into patient records as something else, she explains. Elisa Perego, an honorary research fellow in archaeology at University College London who is credited with coining the term “Long Covid” to describe her own condition, says there’s another problem: many people genuinely have no idea they might have Long COVID. Policymakers, public-health officials, and the media “have often portrayed covid as a short, flu-like disease, especially in the young,” Perego wrote in an email. As a result, people might not make the connection between a case of COVID-19 and health issues months later, especially if they had a mild initial illness or are fully vaccinated; other people may have been asymptomatically infected or got a false-negative test result, so they don’t know they had COVID-19 at all. Long COVID also isn’t always a linear condition. Some people catch COVID-19 and never fully recover, while others seem to get better and then relapse—sometimes multiple times. There’s also a common misconception that Long COVID symptoms are a continuation of the issues people experience right after getting sick, like coughing or fever. That’s the case for some people, but many others develop new symptoms, including fatigue, chronic pain, and neurological or cognitive issues. “It is commonly more than one symptom and commonly more than one system in the body,” says Nisreen Alwan, an associate professor in public health at the U.K.’s University of Southampton who has had Long COVID herself. These symptoms are also often oversimplified. Labels like “fatigue” or “brain fog” don’t always capture the more distinctive experiences of long-haulers—like crashing after physical activity (known as post-exertional malaise) or experiencing cognitive dysfunction such as memory loss. Plus, media coverage doesn’t always reflect the range of severity associated with Long COVID, focusing on only the most dire cases. If people don’t see their experiences reflected in news articles or lists of symptoms, they might assume something else is going on, Alwan says. Research shows that more people are found to have post-COVID fatigue and cognitive impairment when studies screen for these symptoms using objective, as opposed to subjective or self-reported, measures. That finding suggests some people either miss or minimize their own symptoms, Davis says. People of color seem most likely to be missed, says Dr. Zeina Chemali, director of neuropsychiatry clinics at Massachusetts General Hospital and co-author of a recent study on Long COVID symptoms. Three-quarters of the people in her study were white, educated women, which “speaks volumes about the disparities in care and access,” she says. While some people don’t realize they could have Long COVID, others refuse to accept it—and ableism plays a part in that, Perego says. “Discrimination of disabled people in society and the fear of being permanently ill may render it more difficult to accept prolonged disease and the risk of never recovering,” she wrote. Almost all long-haulers experience stigma at some point, according to a study Alwan co-authored that has yet to be peer-reviewed. That could mean stigma from others—like loved ones being uncomfortable with or not believing a Long COVID diagnosis—or internalized stigma, like being embarrassed about one’s illness or physical limitations. The medical establishment often doesn’t make matters easier, as some patients still face disbelief or a lack of knowledge from their doctors. “This is an area where you really have to be on top of research,” Davis says. “Your average clinician just doesn’t seem to be doing that,” which leads to cases being missed, dismissed, or misunderstood. Even people who are correctly diagnosed with Long COVID don’t have great treatment options; there is no known cure for the condition, though some of its associated symptoms can be managed. But Alwan says getting a diagnosis is important for other reasons. It could make people eligible for disability benefits and sick pay, and a diagnosis might prompt a patient’s physicians to do more thorough physical exams that could uncover treatable issues. Better recognition, diagnosis, and public education about Long COVID could help people who might currently be suffering in silence. “The fear is that you might be missing those most in need of support,” Alwan says. “It might be that people recognizing they’ve got Long COVID are not the only people who really need access to care.” from https://ift.tt/TmwFqlv Check out https://takiaisfobia.blogspot.com/ Most Americans are in favor of policies that protect people who identify as transgender from discrimination. Most Americans also believe that trans individuals should be allowed to use the bathroom that reflects their gender identity. But a growing majority of Americans believe that whether a person is a man or woman is determined by the sex they were assigned at birth, according to a new survey. Attitudes towards gender are at a curious crossroads. Essentially, at the same time that most Americans surveyed by the Pew Research Center support a range of policies to protect the rights of trans people, a full 60% do not believe that a person’s gender can be different from their sex assigned at birth, according to the May 2022 poll of 10,188 U.S. adults. And that opinion is growing in popularity, up from 56% when the same question was asked in a survey last year. The authors of the study at Pew, a non-partisan, non-advocacy polling and social science research firm, say that the increase in the number of people who believe gender is the same as sex given at birth was not led by any particular group. “Certainly Republicans are more likely to say that than Democrats,” says Anna Brown, a research associate at Pew and one of the co-authors of the study. “But it’s increased among both Republicans and Democrats.” The respondents more likely to believe that gender and sex were indivisible included those older than 50, and those with a high school education or less. When broken down by race, Black respondents were also more likely than other races to agree that gender and sex were the same. However, even among those who hold that view, there’s a diversity of opinion about what rights transgender people should be accorded. “There’s a lot of different nuanced views within that group,” says Brown. “Half of adults in this group say they would favor laws that would protect trans people from discrimination. About one in four say forms and online profiles should include options other than male or female.” The report suggests that America’s views about policies that affect trans people are also complex. More than half of the respondents support rules that require trans athletes to compete on teams that align with the sex they were assigned at birth. But a majority also believe public elementary schools should be allowed to teach lessons about gender identity. Nearly half of American adults say it’s important to use the new name of a person who has transitioned but only about a third say the same about using their new pronouns. The study also suggests that public opinion on trans rights may be becoming less progressive—at least for the moment. “The share [of people] saying that society has gone too far in accepting trans people has grown since 2017,” notes Brown. On the other hand, young people are more likely believe gender and sex at birth are not intrinsically linked; half of those under 30 hold this view. “Adults aged 65 and older are the most likely to say that views on these issues are changing too quickly,” says Brown, “while those younger than 30 are the most willing to say they’re actually not changing quickly enough.” Younger Democrats are more accepting of a range of gender identities than older Democrats, but age makes less difference among Republicans. There was some unity in the opinions, however. Both groups, no matter what they believed about the link between the sex they were assigned at birth and gender, said the most important factor influencing their views was science. from https://ift.tt/H1NPlJT Check out https://takiaisfobia.blogspot.com/ COVID-19 vaccines for some of the youngest children in the U.S. are now rolling out, and parents are faced with a new question: Moderna or Pfizer-BioNTech? Both of the mRNA shots—which are now authorized for kids ages 6 months and up—are effective at preventing severe illness, and they both help prevent symptomatic infections. They offer vital protection in this age group, even for kids who have already recovered from COVID-19. The vaccines “provide protection against a broader variety of variants than [a previous] infection, which generally provides protection mostly against the variant that you had,” says Dr. Alissa Kahn, a pediatric hematologist and oncologist in Paterson, N.J. That’s particularly important as the virus evolves to overcome prior immunity. Each time an unvaccinated child is exposed to SARS-CoV-2, “you’re sort of rolling the dice—and most kids will do well, but sometimes they don’t.” Since the start of the pandemic, more than 440 children under 5 in the U.S. have died. But unlike with the adult shots—where the best shot was the one you could get quickly—there are some key differences between the two under-5 vaccines. “The science behind how they work is the same,” says Dr. Mona Amin, a pediatrician in Fort Lauderdale, Fla. “The difference is the schedule and the dose.” Moderna’s vaccine for kids ages 6 months through 5 years is 25 micrograms (mcg)—one-quarter of the dose that adults get. Pfizer’s shot for kids 6 months through 4 years is 3 mcg—one-tenth the adult dose. Likely because of the higher dose, mild side effects (such as a fever) are more common with the Moderna shot, according to trial data. The timeline for vaccination is also different. Moderna’s vaccine involves two shots four weeks apart, while Pfizer’s requires three shots over 11 weeks. So while Pfizer has a lower dose and possibly fewer side effects, it takes one more shot than Moderna and several more weeks until kids are fully vaccinated. If parents want kids to be protected as soon as possible—a particular concern with most schools starting in a couple of months—they might want to go with Moderna. That’s what Kahn is choosing for her 4-year old son. The faster Moderna timeline “is really going to allow parents to be able to send their kids to school in the fall fully vaccinated, which is important for a lot of families,” she says. Moderna is also the “pretty clear” choice for Dr. Alpa P. Shah, a pediatrician in Milwaukee. Her 2-year-old daughter attends preschool at a school with elementary-aged kids, and Shah is worried about increased chances of exposure this fall as more children return to the classroom. “The timeline is much more friendly for the fall with Moderna,” she says. Moderna might also be more appealing for families who prefer two initial shots over three because of transportation issues or time spent away from work. But if parents are concerned about side effects, and they’re not in a particular hurry, Pfizer might be a better option. Having the option for a lower dose with a decreased risk for side effects could also help some families overcome hesitancy about getting vaccinated. The third Pfizer shot also seems to elicit broader antibody responses, which likely help against Omicron. That’s what Amin is choosing for her 2-year-old son. He already had COVID-19 twice, and while that doesn’t offer complete protection against reinfection, it means his existing immune response could be strong even before he gets a third shot. Amin also likes the fact that the Pfizer vaccine has already been given to millions of children ages 5 and up, while Moderna was only available for U.S. adults until June 24, when the U.S. Centers for Disease Control and Prevention recommended its use in kids. That means there are more real-world data on Pfizer’s side effects among older children, including very rare side effects like myocarditis. Dr. Roby Bhattacharyya, an infectious disease doctor at Massachusetts General Hospital, went back and forth on which vaccine to schedule for his 4-year-old son. “The data for either one looks great, far above my threshold for where the expected benefits exceed the risks,” he writes in an email. “If only one or the other were available, I’d take either in a heartbeat for my kid.” Ultimately, he decided the most important thing was to get a vaccine quickly. “Our kids are starting camp, and I think the cost of waiting another 10 days where they’re hanging out in close quarters with a bunch of kids at a time when there’s still a decent amount of circulating virus is more risk than any difference I see between these two, both of which I see as good options,” Bhattacharyya writes. A few hours later, his son received the first vaccine they could schedule: Pfizer’s. That’s fairly typical right now; some pediatricians and health systems are only carrying the Pfizer shot, at least at first, because they already have a system set up for giving Pfizer to older kids. As of mid-June, providers had ordered 2.5 million doses of Pfizer and 1.3 million doses of Moderna. But if you only have access to one type of vaccine, even if it’s not your preference, you shouldn’t feel like you’re getting an inferior vaccine, the experts agreed. And, more generally, the under-5 vaccines are not available in as many places as vaccines for other ages, which were often administered at mass vaccination sites or schools. Instead, most families are going to their pediatrician or general practitioner, pharmacies (which by law can only give COVID-19 vaccines to kids ages 3 and up), state or local health departments, and federally qualified health centers. (If you’re looking to set up an appointment, you can search by vaccine type at vaccines.gov.) “I would just love to see both vaccines available in all states and distributed in an equitable fashion,” Shah says, “so families can really choose what makes sense to them.” from https://ift.tt/Cl5hsOA Check out https://takiaisfobia.blogspot.com/ After the U.S. Food and Drug Administration (FDA) announced last week that it would order e-cigarette giant Juul Labs to stop selling its products in the U.S., my inbox flooded with emails from public-health groups applauding the decision. The CEO of the American Lung Association called it “long overdue and most welcome.” The CEO of the Truth Initiative, an anti-smoking group, called it a “huge public health victory.” These celebratory statements center around Juul’s starring role in what federal regulators have called an epidemic of teenage nicotine addiction, one that many experts feared could undo decades of progress on smoking prevention. In that sense, its ordered exit from the U.S. market was a victory: finally, regulators were holding the company accountable and protecting kids. It took less than 48 hours for a federal court to issue an emergency stay, allowing Juul to keep selling its e-cigarettes while its lawyers prepare a full appeal. In court filings, Juul’s lawyers called the FDA’s ruling—which the agency said was based on inadequacies in Juul’s toxicology data—”arbitrary and capricious” and argued that Juul can benefit public health by helping adult smokers switch to a less-dangerous product. That’s a point that has often gotten lost over the past few years. Juuling isn’t only something that happens in high school bathrooms. Adult smokers also use Juul to ditch cigarettes—and for them, last week’s decision was not a victory. “Juul is the most thoroughly researched #ecig in history,” Jonathan Foulds, a professor of public health sciences at Pennsylvania State University, tweeted after the FDA’s decision came out. “Banning this lifesaving escape route from smoking because some ‘potentially harmful chemicals’ may leach from some pods is a bit like locking the door to the fire escape because the steps may be slippery.” Like any tobacco product, e-cigarettes are not not full-stop safe. Experts widely agree that no one who is not currently smoking should start vaping. But for those who already smoke, current studies suggest e-cigarettes can be a less-dangerous way to consume nicotine, potentially providing a bridge between lethal cigarettes and quitting nicotine entirely. Not long ago, the country’s top tobacco regulators were cautiously optimistic about that promise. In 2017, Dr. Scott Gottlieb, who was then FDA commissioner, and Mitch Zeller, who until April was director of the FDA’s Center for Tobacco Products, described a framework for reducing tobacco-related death and disease in the U.S., including promoting e-cigarettes as an off-ramp for adults who want to stop smoking, along with nicotine gums and patches. Then vaping took off among teenagers, with Juul, especially, spreading like wildfire in certain U.S. middle and high schools. An understandable concern for kids began to eclipse all else. As the teen vaping problem snowballed and influential lawmakers, parent groups, and public-health organizations started speaking out against Juul, the FDA had little choice but to act aggressively. To be clear, Juul has made more mistakes than I have space to list here. (I wrote a whole book about them and have covered them extensively for this magazine.) Its first marketing campaign—which the company has repeatedly denied was meant to attract kids--was, at the very least, ill-advised. It was too easy, for too long, for underage customers to buy Juul products online and in stores. Juul executives sent company representatives into schools to educate kids about the dangers of vaping, despite the sordid history of tobacco companies doing the same. They then accepted almost $13 billion from tobacco giant Altria, raising significant conflict of interest concerns. Though Juul has behaved more responsibly in recent years, it’s not hard to understand why it earned so much public scrutiny. The FDA’s denial didn’t focus on any of those very public mistakes. Instead, the agency ordered Juul off the market because “insufficient and conflicting data” raised concerns about genetic damage and chemicals leaching out of Juul’s e-liquid pods. The FDA said it does not have “information to suggest an immediate hazard” linked to Juul products, but any concern about health risks needs to be taken seriously. Still, some public-health experts wondered aloud whether politics also played a role. “Given the political pressure brought to bear by tobacco-control groups, parent groups, and members of Congress to ban Juul, one wonders whether this decision was solely based on safety,” Clifford Douglas, director of the University of Michigan’s Tobacco Research Network, told the Washington Post. A former Juul employee with knowledge of the company’s FDA application put it to me more bluntly: “Many of these decisions are political,” they said. “They’re not necessarily based on the evidence.” Zeller categorically denies that politics influenced the FDA’s decision. “I know that a lot of people who are pro-harm-reduction and pro-e-cigarette were very disappointed in this,” he says. “I understand how others have reacted, but this is the way the system is supposed to work. This was a science-based decision by subject-matter experts.” The question is what the effects of that decision will be. The impact among teenagers might be smaller than Juul’s history would suggest. In the latest federal study on teen vaping, about 6% of high school vapers listed Juul as their preferred brand, while 26% said their go-to brand was Puff Bar—which makes flavored, disposable vaporizers that are still for sale. If Juul doesn’t win its appeal and must remove its products from the market, many adult users will probably switch to another e-cigarette, either one that has been authorized by the FDA or remains for sale as it waits in regulatory limbo. But if I’ve learned anything in reporting on vaping, it’s that vapers are passionate about and loyal to whatever product helps them stop smoking. So potentially taking one of the biggest brands off the market is not trivial. When I was reporting my book on Juul, multiple people—some who had worked at Juul and some who had watched the vaping industry evolve from outside the company—said Juul’s story was one of missed opportunities. If Juul, the company, had acted more responsibly—if it hadn’t been so popular with teenagers, if it hadn’t angered regulators, if it hadn’t lit the match that started a political firestorm—perhaps Juul, the product, could have made a real difference for public health. Would it have been “one of the greatest opportunities for public health in the history of mankind,” as co-founder James Monsees once said? That’s probably an overstatement. A major research review published last year concluded that e-cigarettes could help about three additional smokers out of 100 ditch cigarettes, compared to traditional nicotine-replacement therapies like gums and patches. That’s not a massive difference—but it is still a difference, both for public health and for those three hypothetical smokers. That’s not to say the FDA had an easy choice on its hands, only that there is more nuance to the vaping debate than is sometimes expressed. Zeller, for his part, wishes the tobacco-control community was more willing to look for common ground when it comes to vaping. “I wish that the pro-e-cigarette people were not completely dismissive of the concerns the other side has about unintended consequences” like youth use and addiction, Zeller says. “But in the same breath, I wish that the anti-e-cigarette people were more open-minded on the potential upside of a properly regulated marketplace.” The FDA’s decision on Juul lives in that gray area. Even if it was ultimately the right choice, based on troubling toxicology data or concerns about underage use, to cast Juul’s potential removal from the market as an unmitigated win for public health feels overly simplistic. There is some loss tied up with it, too. from https://ift.tt/kJFneS4 Check out https://takiaisfobia.blogspot.com/ (London) — The World Health Organization (WHO) said the escalating monkeypox outbreak in more than 50 countries should be closely monitored but does not warrant being declared a global health emergency. In a statement Saturday, a WHO emergency committee said many aspects of the outbreak were “unusual” and acknowledged that monkeypox—which is endemic in some African countries—has been neglected for years. “While a few members expressed differing views, the committee resolved by consensus to advise the WHO director-general that at this stage the outbreak should be determined to not constitute” a global health emergency, WHO said in a statement. WHO nevertheless pointed to the “emergency nature” of the outbreak and said controlling its spread requires an “intense” response. The committee said the outbreak should be “closely monitored and reviewed after a few weeks.” But it would recommend a re-assessment before then if certain new developments emerge — such as cases among sex workers; spread to other countries or within countries that have already had cases; increased severity of cases; or an increasing rate of spread. WHO Director-General Tedros Adhanom Ghebreysus convened the emergency committee on Thursday after expressing concern about the epidemic of monkeypox in countries that haven’t previously reported the disease. “What makes the current outbreak especially concerning is the rapid, continuing spread into new countries and regions and the risk of further, sustained transmission into vulnerable populations including people that are immunocompromised, pregnant women and children,” the WHO chief said. Monkeypox has sickened people for decades in central and west Africa, but until last month, the disease had not been known to cause significant outbreaks in multiple countries at the same time and involving people with no travel links to the continent. Declaring a global health emergency means that a health crisis is an “extraordinary” event requiring a globally-managed response and that a disease is at high risk of spilling across borders. WHO previously made similar declarations for diseases including COVID-19, Ebola in Congo and West Africa, Zika in Brazil, and the ongoing effort to wipe out polio. The emergency declaration mostly serves as a plea to draw more global resources and attention to an outbreak. Past announcements have had mixed impact, given that WHO is largely powerless when trying to convince countries to act. WHO said this week it has confirmed more than 3,200 monkeypox infections in about 40 countries that haven’t previously reported the disease. The vast majority of cases are in men who are gay, bisexual or have sex with other men and more than 80% of the cases are in Europe. A leading WHO adviser said last month the spike in cases in Europe was likely tied to sexual activity by men at two raves in Spain and Belgium, speculating that its appearance in the gay and bisexual community was a “random event.” British officials have said most cases in the U.K. involve men who reported having sex with other men in venues such as saunas and sex clubs. Scientists warn that anyone in close, physical contact with someone infected with monkeypox or their clothing or bedsheets is at risk of catching the disease, regardless of their sexual orientation. People with monkeypox often experience symptoms like fever, body aches and a rash; most recover within weeks without needing medical care. Monkeypox in Africa mostly affects people who come into contact with infected wild animals, like rodents or primates. There has been about 1,500 reported cases of monkeypox, including 70 deaths, in Congo, Cameroon and the Central African Republic. To date, scientists haven’t found any mutations in the monkeypox virus that suggest it’s more transmissible or lethal, although the number of changes detected show the virus has likely been spreading undetected for years. The version of the disease transmitting beyond Africa typically has a fatality rate of less than 1%, while the version seen in Africa can kill up to 10% of people affected. WHO is also creating a vaccine-sharing mechanism for monkeypox, which could see vaccines go to rich countries like Britain, which currently has the biggest outbreak beyond Africa. Some experts warned that could entrench the deep inequities seen between rich and poor countries during the coronavirus pandemic. “France, Germany, the U.S. and U.K. already have a lot of resources and plenty of vaccines to deal with this and they don’t need vaccines from WHO,” said Dr. Irwin Redlener, an expert in disaster preparedness and response at Columbia University. “What we should be doing is trying to help the countries in Africa where monkeypox has been endemic and largely neglected,” he said. “Monkeypox is not COVID, but our attention should not be so distorted that it only becomes a problem when it is seen in rich countries.”
from https://ift.tt/rEes5Px Check out https://takiaisfobia.blogspot.com/ Pfizer announced Saturday that tweaking its COVID-19 vaccine to better target the omicron variant is safe and works — just days before regulators debate whether to offer Americans updated booster shots this fall. The vaccines currently used in the U.S. still offer strong protection against severe COVID-19 disease and death — especially if people have gotten a booster dose. But those vaccines target the original coronavirus strain and their effectiveness against any infection dropped markedly when the super-contagious omicron mutant emerged. Now with omicron’s even more transmissible relatives spreading widely, the Food and Drug Administration is considering ordering a recipe change for the vaccines made by both Pfizer and rival Moderna in hopes that modified boosters could better protect against another COVID-19 surge expected this fall and winter. Pfizer and its partner BioNTech studied two different ways of updating their shots — targeting just omicron, or a combination booster that adds omicron protection to the original vaccine. They also tested whether to keep today’s standard dosage — 30 micrograms — or to double the shots’ strength. In a study of more than 1,200 middle-aged and older adults who’d already had three vaccine doses, Pfizer said both booster approaches spurred a substantial jump in omicron-fighting antibodies. “Based on these data, we believe we have two very strong omicron-adapted candidates,” Pfizer CEO Albert Bourla said in a statement. Pfizer’s omicron-only booster sparked the strongest immune response against that variant. But many experts say combination shots may be the best approach because they would retain the proven benefits of the original COVID-19 vaccine while adding new protection against omicron. And Pfizer said a month after people received its combo shot, they had a 9 to 11-fold increase in omicron-fighting antibodies. That’s more than 1.5 times better than another dose of the original vaccine. And importantly, preliminary lab studies show the tweaked shots also produce antibodies capable of fighting omicron’s genetically distinct relatives named BA.4 and BA.5, although those levels weren’t nearly as high. Moderna recently announced similar results from tests of its combination shot, what scientists call a “bivalent” vaccine. The studies weren’t designed to track how well updated boosters prevented COVID-19 cases. Nor is it clear how long any added protection would last. But the FDA’s scientific advisers will publicly debate the data on Tuesday, as they grapple with whether to recommend a change to the vaccines’ recipes — ahead of similar decisions by other countries. from https://ift.tt/SbK4Hgk Check out https://takiaisfobia.blogspot.com/ On June 24, the U.S. Supreme Court overturned Roe v. Wade, undoing the constitutional right to abortion that has been in place for nearly 50 years. The reversal paves the way for states to ban or limit abortions, and many are expected to do so soon. Four abortion providers who live in states that severely restrict or are likely to soon criminalize abortion spoke with TIME about what they plan to do now. Some say they’ll shift care across state borders, while others resolve to amp up their activism in a post-Roe America. Yet all four providers say they dread the way new laws will endanger pregnant people seeking abortions. Their interviews have been lightly edited for length and clarity. Dr. DeShawn TaylorOb-gyn in PhoenixTaylor founded her Phoenix clinic, Desert Star Family Planning, in 2013. Earlier this year, Arizona enacted a 15-week abortion ban that was going to take effect later this summer, but it’s now possible that the state may pass an even stricter ban. Arizona also has a “pre-Roe” ban on the books—a law enacted before Roe and never removed—but whether or it will be enforced is unclear. Those moments when I tell somebody that they’re too far along—the wailing and the emotion—are so heart-wrenching. I don’t want people to experience that if I can help it. Having my hands tied is hard. I made up my mind some time ago that I was going to stay in Arizona and be a resource to the community. My clinic provides general gynecology, well-woman sexual health, gender-affirming care, and miscarriage management. The idea that once abortion is illegal in the state—that abortion providers potentially will leave the state—that doesn’t sit well with me, and it’s not in alignment with my values. Read More: The Fight Over Abortion Has Only Just Begun I intend to be a resource for my community, a safe space. A place for the community as they’re mobilizing to help each other get what they need, where they can get accurate information. I also anticipate that the people of Arizona are going to need a safe place to receive miscarriage care, without being interrogated about whether they self-induced or not. People are going to be afraid to help. Post-Roe does not look the same as pre-Roe. People are safely self-managing their abortions already. What concerns me is people are going to attempt self-managed abortion later in pregnancy. I’m concerned about bleeding complications and incomplete processes not being identified and treated, potentially causing infections. We may see people die. Right now, I’m just really in a mode of determination. I’m a problem solver. The biggest issue is the criminalization piece. And what my limits are—what level of risk I’m comfortable taking, considering that most people who get criminalized in this country around these things are people of color. The pre-Roe law has an exception for the life of the pregnant person. The biggest question for me is, at what point can you intervene? Does the person have to literally be dying? If someone presents to me with a miscarriage, I’m not going to be interrogating people about how they got to this place. I’m just going to provide the care. And I suspect that those types of instances will be scrutinized closely as well. I am a very spiritual person, and I consider my practice my ministry. It’s deeply gratifying, and I know I am changing people’s lives for the better. I’m just trying to stay open, to continue to provide as long as possible. Making sure I have staff, and that I’m resourced to provide abortion care all the way up until I can’t. I believe that the pendulum will swing back, which is why keeping my clinic open is very important. We’ve seen over the course of the years that once independent abortion clinics close, they generally don’t open back up again. Dr. Colleen McNicholasChief medical officer for Planned Parenthood of the St. Louis Region and Southwest MissouriUntil Roe v. Wade was overturned, McNicholas saw abortion patients in both Missouri and Illinois. But a “trigger” ban—a law that will take effect nearly automatically now that Roe is overturned—in Missouri means that abortions in the state will likely soon be outlawed (with an exception for pregnant people whose lives are in danger). McNicholas plans to split her work between Illinois, where the legality of abortion is not directly affected by the recent Supreme Court decision, and Missouri. Missouri has long been the leader in eliminating abortion access. It’s passed nearly every single restriction and law that other states have, and did so a long time ago. Illinois will serve as an oasis and will be the nearest location for tens of thousands of people who will be seeking care. Now that Roe is repealed, we have two enormous responsibilities: to step up and fill gaps for states that have lost or will lose access, while simultaneously working within Missouri to fight back and build back some access. We can’t abandon places. We know that over time, it will change, but we need the people here who are committed to that change to stay here and work for it. Read More: What It’s Like to Be an Abortion Clinic Escort Abortion is an act of love and an act of humanity for people who are pregnant and their families. It provides some hope and the opportunity to meet their potential, to get out of poverty. I think the elimination of abortion says to people: we don’t care about you. We don’t care that you’re struggling. The real, on-the-ground implication for patients is that life gets harder. But people should know that there are lots of folks out there trying to make a difference, to address this, and to eliminate the barriers. The reason why I continue this work is that I get to sit with patients every single day and see the impact of a very simple procedure. Sometimes it’s as simple as me handing you a medication. There are very few medical services that, with such little time and education and skill, can make such a profound impact on somebody’s life. Dr. Carol WannaOb-gyn in Macon, Ga.Wanna has provided abortions part-time at Planned Parenthood for about two years. The reversal of Roe v. Wade will likely clear the way for Georgia to begin outlawing abortions after about six weeks of pregnancy. Most of us have accepted what would happen this summer. You pretty much could see what was coming. But the cruelty of the decision still makes me feel sadness and depression. Atlanta, Augusta, and Savannah are the only places in Georgia that abortions are provided, so there’s really nothing around where I live. I commute almost two hours to Atlanta and almost three to Savannah to be able to work with Planned Parenthood. I just so strongly believe in the right for women to choose their destiny. All of my patients are making a very difficult decision, but they’re deciding what’s right for their life at that time. The thought that women cannot have power over their destiny and be forced to continue a pregnancy they don’t want just horrifies me. Medically, abortion is extremely low risk; it’s lower risk than continuing the pregnancy. Read More: Inside the Small Group of Doctors Who Risked Everything to Provide Abortions in Texas I’ll definitely stay in Georgia, just because it’s my home. I will probably continue to work at Planned Parenthood, at least doing family planning and other services. I’m not ready to uproot my whole life, but if there are opportunities to go to states where abortions are legal, I would certainly consider traveling to provide services. We’re going to have to change our services to try to enable women to get into clinic as quickly as possible, so that it can be done early. I worry that women are going to have to jump into having the abortion even though they’re not completely comfortable with their decision. That seems horrible. It might become a situation where even if a woman’s not completely sure, they know it’s now or never. Tammi KromenakerClinic owner and director of Red River Women’s Clinic in North DakotaNorth Dakota has a “trigger” ban in effect that clears the way for the state to outlaw abortion soon after Roe v. Wade is overturned. Kromenaker is in the process of moving the clinic from North Dakota to Minnesota. We’re very fortunate that we are on a border with Minnesota, which is considered a politically protected state for abortion. After the Supreme Court leak, we looked at what it would take to relocate the clinic over to Minnesota, because it was important for us to not change access. We already have patients who drive four, five, six hours just one way to get to our clinic. Read More: What to Know About Abortion Pills Post-Roe We don’t want to have to move. We’ve established amazing community connections, and it’s going to be like starting over. North Dakota law and Minnesota law are also very different. I’m going to have to learn the court system there and learn what judges are favorable and which ones might be hostile—all of those things that in North Dakota, we’ve got down. We have a huge target on our back; we have for a very long time. We’ve basically been in litigation with the state of North Dakota pretty much continuously for over a decade. They tried everything with us, and we have met the challenge and worked really hard to be able to provide this care. It’s been challenge after challenge after challenge here, whether it’s the legislature or litigation or the protesters. So we’re ready to take on this next challenge. from https://ift.tt/BSKxjuh Check out https://takiaisfobia.blogspot.com/ |
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