Like many parents, Jason Newland, a pediatrician at Washington University in St. Louis and a dad to three teens ages 19, 17, and 15, now lives in a mixed-vaccination household. His 19-year-old got vaccinated with Johnson & Johnson’s shot two weeks ago and the 17-year-old with Pfizer’s, which is available to teens as young as 16. The 15-year-old is still waiting for her shot, though—a bit impatiently now. “She’s like, ‘Dude, look at me here,’” Newland told me. “‘Why don’t you just tell them I’m 16?’” But because certain pharmaceutical companies set certain age cutoffs for their clinical trial, she alone in her family can’t get a COVID-19 shot. She’s the only one who remains vulnerable. She’s the only one who has to quarantine from all her friends if she gets exposed. In America, adults are racing headlong into a post-vaccination summer while kids are being left in vaccine limbo. Pfizer’s shot is likely to be authorized for ages 12 to 15 in several weeks’ time, but younger kids may have to wait until the fall or even early 2022 as clinical trials run their course. This “age de-escalation” strategy is typical for clinical trials, but it means this confusing period of vaccinated adults and unvaccinated kids will not be over soon. And the pandemic will start to look quite different. How different? Vaccination is already changing the landscape of COVID-19 risk by age. In the U.S., hospital admissions have fallen dramatically for adults over 70 who were prioritized for vaccines, but they have remained steady—or have even risen slightly—in younger groups that became eligible more recently. This trend is likely to continue as vaccines reach younger and younger adults. Over the summer, the absolute number of cases may drop as mass vaccination dampens transmission while the relative share of cases among the unvaccinated rises, simply because they are the ones still susceptible. The unvaccinated group will, of course, be disproportionately children. By dint of our vaccine order, COVID-19 will start looking like a disease of the young. This means vaccines are working, but it also means many Americans are flipping how they think about COVID-19 risk. Adults who spent the past year worrying about their elderly parents are now worrying about their kids instead. The risks are not equivalent, of course: Kids are 8,700 times less likely to die of COVID-19 compared with those older than 85. But “even if the risk is not particularly high, you’re still going to be extra protective of your kids,” says Sandra Albrecht, an epidemiologist at Columbia. “It’s just human nature.” In coming months, parents may find themselves going back to normal while their kids still have to wear masks indoors. “It’s a very strange relationship to feel protected when your kids are still not,” Jennifer Nuzzo, an epidemiologist at Johns Hopkins, told me. But some 30 million households have children still too young to be vaccinated; in these families, parents and caretakers, especially of the youngest children, will have to keep navigating this incongruous world. The biggest risk factor to consider for unvaccinated kids, experts told me, is simply how much COVID-19 is spreading in the community. The U.S. is currently vaccinating at a good clip, and even partial herd immunity will slow transmission of the coronavirus. Seasonal effects may drive case numbers even lower in the summer. “If there’s very little virus circulating, that’s a pretty low-risk situation,” says Sean O’Leary, a pediatrician at Children’s Hospital Colorado. Experts have pegged the threshold where general restrictions can relax at 5,000 to 10,000 cases per day—the point at which risk of COVID-19 is roughly comparable to risk of the flu. (For context, the seven-day average of daily COVID-19 cases in the U.S. reached a low point of 20,000 last summer and peaked at 250,000 during the winter surge; that number has since plateaued at 70,000.) Not everyone will feel comfortable with the same level of risk though. Even before the pandemic, O’Leary points out, parents with children who have high-risk medical conditions were very careful about, say, traveling during flu season. COVID-19 might be another reason for these families to be vigilant. But already, momentum in the country is shifting toward reopening. States are ending their mask mandates and COVID-19 restrictions. How low cases go in the U.S. later this year will depend on the speed at which we inoculate harder-to-reach populations, as well as continued vigilance among the still-unvaccinated. Letting up after a year of social distancing is tempting, but as my colleague Katherine Wu writes, our vaccine cheat days add up. Variants may also influence case levels, but it’s not entirely clear how much. Early on, scientists in the U.K. thought the B.1.1.7 strain might be disproportionately more contagious among children than among adults, but the pattern has not held up. That may be because the variant was first detected after schools in the U.K. opened in the fall, explains Oliver Ratmann, a statistician at Imperial College London who has modeled the implications of the variant for kids. Then schools closed and mobility patterns changed over the holidays, which complicated the preliminary trends. The earlier pattern of B.1.1.7 in kids might just have reflected who had a chance to spread the virus at the time, especially because U.K. schools took fewer precautions, such as mask wearing, compared with many in the U.S. The evidence on whether this variant causes more severe illness is also mixed. [Read: Your body is far from helpless against coronavirus variants] What is clear, though, is that B.1.1.7 is more transmissible than the original virus among all age groups. In some places, that could tip the balance toward rising cases, but other factors are clearly at play too. For example, Michigan has a lot of B.1.1.7 cases and is experiencing a terrible COVID-19 surge, but Florida, which also has high numbers of B.1.1.7, is not. “The variants don’t help, but they’re not fully to blame,” Nuzzo said. The same precautions that worked before—including good ventilation, masking, and social distancing—still work against B.1.1.7. All of these concerns could come to a head in schools, which are one of the main places where unvaccinated people—e.g., kids—will congregate. As the U.S. is already seeing, school outbreaks do happen, but they can be contained with precautions in place. This means younger kids, who likely won’t get vaccinated before the fall, may have to continue to wear masks indoors. But the benefits of in-person schooling are significant enough, experts told me, that schools should open even if kids can’t get shots yet. The trickier question is what kids can do outside of school when it comes to playdates, sports, and extracurricular activities. In Michigan, officials have suggested that high-school athletics and the socializing around sports—rather than classes themselves—are driving the uptick in cases among teens. Parents and kids will have to decide together which risks are worth taking. Newland told me his 15-year-old daughter sees her core group of friends and plays sports. But she’s decided to keep taking virtual classes, even though her risk of contracting COVID-19 at school is low, because exposure to any cases at school could trigger a quarantine that keeps her from playing sports, which is important to her. That’s the tradeoff they’ve decided to make, but they’d of course prefer not having to make it. As Newland said, “I feel much better about my other daughter, who got vaccinated at 17.” At least 15-year-olds have an end in sight; they are likely to be eligible for Pfizer’s vaccine soon. Parents of younger kids may have to keep making these split decisions a lot longer. In their strange world, a dinner party with their adult friends is fine, but a birthday party for their 5-year-old could still spread the virus. When I asked several experts about a hypothetical party for unvaccinated preschoolers in the fall, they told me they would continue to think about ways to reduce risk, such as keeping the gathering small and outdoors. These assessments are hard to make in advance: We don’t know exactly what the situation will look like and how much the virus will still be circulating. Perhaps COVID-19 will have faded enough that people won’t be spending every waking minute thinking about the virus anymore. Perhaps not. [Read: The mRNA vaccines are looking better and better] To make these decisions more difficult, the situation probably won’t be the same everywhere in America. Already, rural residents report less interest in getting the shots than people living in cities and suburbs. Whether because of vaccine hesitancy or unequal access, “I think there’s going to be a huge amount of variation geographically,” says Whitney Robinson, an epidemiologist at UNC Gillings School of Global Public Health. The virus may continue to circulate in pockets of the country where not enough eligible adults are vaccinated. These adults plus still-ineligible kids could add up to a pretty large pool of susceptible people. Ultimately, the risk to unvaccinated kids later this year depends on the actions we take now. The faster we vaccinate and the better we suppress cases through other measures, the safer the situation will be for anyone who remains uninoculated in the fall. Then, finally, parents can stop telling kids to do things that they themselves are not doing—which, as former kids I think can agree, is literally the worst. from https://ift.tt/3dFkUBM Check out http://natthash.tumblr.com
0 Comments
In January, The New York Times published an alarming article about teen suicides during the pandemic. The story featured heartbreaking quotes from parents who had lost children, and was illustrated with photos of an empty classroom and a teenager sitting alone on his bed. The school district of Clark County, Nevada, the story said, had recorded the deaths of 18 students from suicide from mid-March 2020 to the end of December—twice as many as the district had in all of 2019. “There’s a sense of urgency,” the superintendent told NPR, when the same local crisis made national news again in February. “You know, we have a problem.” The prospect of a wave of suicides has loomed over the national debate about COVID-19 restrictions from their very beginning. Just days after the first stay-at-home orders were put in place, Donald Trump predicted “suicides by the thousands,” and reports emerged of increases in calls to suicide hotlines and emergency-room psychiatric visits. Fears about the mental-health toll on kids were particularly acute: What would happen if they couldn’t go to school, or play sports, or hang out with their friends? While the coronavirus appeared far more worrisome for adults, the harm that the shutdowns posed was another story: Teenagers seemed to be at the greatest risk. A year later, we’re starting to see signs of what actually occurred. Many parents say in surveys that the teenagers in their home have developed new or worsening symptoms of depression and anxiety since the start of the pandemic; a new report from the Department of Education states that, as schools begin to reopen, students will need “supports to address the isolation, anxiety, and trauma they have experienced.” Even just watching their kids sleepwalk through months of scholastic gloom and Zoom has given parents reason enough to be concerned. Youth suicide is already the second-leading cause of death among those ages 15 to 19, and the numbers have been inching upward for more than a decade. The reasons for that rise are much debated among suicide researchers, though they believe that a hard-to-unravel combination of factors is at play in each death. The recent testimony of parents and school officials suggests that the pandemic has, at least in certain cases, added new elements to that lethal mix. [Read: The millennial mental-health crisis] Deeply painful stories, combined with unsettling survey data, have made the connection between shutdowns and suicide seem like common knowledge at this point. President Joe Biden asserted not long ago that “suicides are up.” You'll hear the same presented as fact by news anchors, politicians on both sides of the aisle, and (as I did recently) on your neighborhood listserv. But the evidence supporting a broad, pandemic-driven suicide crisis among teens—or adults, for that matter—was always a narrative in search of data. For the record, there was no spike in teen suicides in Clark County last year. The county’s school district serves approximately 320,000 students in and around Las Vegas. You would expect, in a population of that size, to see minor year-to-year fluctuations in the number of suicides, as you would in the number of pregnancies, drug overdoses, or accidental deaths. Indeed, suicides did go up in 2020 compared with 2019, as The New York Times reported: The Clark County coroner’s office, according to the most recent tally, lists 16 youth suicides last year and 11 in 2019. (Those totals differ only slightly from the school district’s.) But that uptick tracks well within the county’s range in recent years. In 2017, the coroner’s office reported 12 suicides in this age group; in 2018, there were 20. The state numbers tell a similar story. Preliminary data from Nevada’s Department of Health and Human Services indicate that the rate of suicides per 100,000 youths last year was 2.3. The state’s average rate across the five years prior was 2.7. That doesn’t in any way diminish the tragedy of the suicides that did occur, or prove that the pandemic played no role in individual deaths. Still, when it comes to suicide rates for teens in Clark County, and in Nevada as a whole, 2020 was a sadly typical year. Accounts of other supposed suicide hot spots also tend to fall apart on closer inspection. In November, The Washington Post published a lengthy article that examined both teen and adult suicide during the pandemic. It quoted unnamed experts who feared that a “toxic mix of isolation and economic devastation could generate a wave of suicides,” and the piece described some “troubling signs” that the wave had already begun. The Post said that in DuPage County, Illinois, for example, deaths from suicide had increased by 23 percent: 54 occurred in the first six months of 2020, compared with 44 during the same period in 2019. That may be a 23 percent increase, but given that more than 900,000 people live in DuPage, it shouldn’t be overinterpreted. In fact, when you look at deaths from suicide in the county for all of 2020 (as opposed to just the first half), there’s hardly any change at all: There were 94 suicides in total last year, compared with 90 the year before. (There were 107 in 2018.) As for teenagers and adolescents, six died by suicide in DuPage in 2020, compared with eight in 2019. With more than 3,000 counties in the United States, it would be easy, in any year, to pick out some where the number of deaths from suicide went up. It would also almost certainly be meaningless. Inevitably, some counties will record an increase, while others will record a decline. And if you wanted to find some place where youth suicides had doubled, like they did in the Clark County school district, that’s easy too: When the number of incidents is relatively small, you’re likely to find places where the total goes from 10 to 20. Or vice versa. Whatever narrative you’re trying to support, a county or a school district will provide the numbers you need. At times, evidence for the broader mental-health troubles teens have faced during the pandemic has been overstated too. The most recent round of dramatic headlines was prompted by a study of insurance claims for mental-health services from a nonprofit called FAIR Health. The numbers for teenagers had “skyrocketed,” according to the coverage: In just the first two months after schools closed, teens’ insurance claims for mental-health treatment were “approximately double” what they’d been during the same period in 2019. In a similar vein, reports about a CDC study from November emphasized that youth mental-health emergencies had soared during the pandemic, and that related ER visits among teens had gone up by nearly one-third from the year before. All of these data were said to reveal that the pandemic’s effect on kids’ mental health was “in some ways worse than the experts feared.” But what many news outlets called a rise in claims or an increase in emergency-room visits was actually a rise in the percentage of claims or visits. So, for instance, the number of insurance claims related to intentional self-harm among those ages 13 to 18 did almost double as a percentage of overall medical claims in March 2020 compared with March 2019. But the total number of medical claims dropped by about half that month, likely because people were postponing their less urgent trips to the doctor. Similarly, the total number of ER visits among teens went down by roughly one-third. At the same time, the absolute number of insurance claims related to intentional self-harm among teens decreased by 2 percent compared with the previous year, and the absolute number of teens’ mental-health ER visits decreased by 15 percent. The FAIR Health study did show a modest year-over-year increase—of less than 10 percent—in overall mental-health insurance claims for teenagers from March to November 2020. That’s worth taking seriously, but the stats did not skyrocket. In a column earlier this month, the Washington Post’s Glenn Kessler, who writes the paper’s Fact Checker feature, dug into Biden’s claim that “suicides are up.” (He also referenced his own newspaper’s coverage of an apparent suicide crisis.) “Politicians should be wary about citing preliminary or partial data and declaring that it is a fact,” he concluded. It's possible that suicides were up last year, he wrote, in part because some deaths from drug overdoses may have been suicides in disguise, but we can’t know for sure, because some of the numbers are still being tabulated. It’s true that suicide tallies from around the country trickle in over months, and we don’t yet have a complete picture from last year. What we do know at this point, however, doesn’t suggest a new dimension of calamity. According to Tyler Black, a suicidologist and the medical director of emergency psychiatry at British Columbia Children’s Hospital, 2020 was, for all its many horrors, likely just an average year when it comes to suicide in both children and adults. “There was no wave from March to August—like, none—and we’re quite certain about that,” he told me. In fact, the preliminary data from the CDC show that deaths by suicide dropped by 5.6 percent in 2020 from the year before, reaching their lowest total since 2015. Other recent research seems to bear this out: A new paper in The Lancet Psychiatry found that in 21 countries, “suicide numbers ... remained largely unchanged or declined in the early months of the pandemic,” while an analysis of national mortality data for the U.S. concluded that suicide numbers went down during the first five months of the pandemic. Jeremy Faust, an author of both of those papers and a doctor in the emergency-medicine department at Brigham and Women’s Hospital, in Boston, says he’s noticed that any news of a drop in suicides, however welcome it might seem, leads to pushback. “There’s this knee-jerk reaction to say, ‘Ah, well, that doesn’t mean that everyone’s fine,’” Faust told me. Of course the pandemic has led to mental-health fallout, but it doesn’t necessarily follow that deaths by suicide went up. As for whether a spike in suicides might be hidden in other categories, such as drug overdoses, Faust calls that idea “extremely unlikely.” Deaths by suicide or overdose undergo medical investigation, and while some misclassification is inevitable, those determinations are considered largely reliable. Black noted, likewise, that the CDC’s final mortality numbers don’t usually differ by more than a percentage point or two from its preliminary numbers, so the suicide total from 2020 will “almost certainly be a decrease when all is said and done.” [Read: When will people get better at talking about suicide?] Surely the upheaval of the last year has exacted a psychological toll on young and old people alike, and we’re still in the midst of that trauma and disruption. Some have also clearly suffered more than others. But Jonathan Singer, the president of the American Association of Suicidology and an author of Suicide in Schools, cautions against drawing a straight line between pandemic shutdowns and suicide rates among teenagers. He believes there were indeed teens and adolescents at higher risk from suicide last year, or who died by suicide, because they felt cut off from their friends, or were in an abusive home, or found a parent’s firearm. But other kids might actually have been protected from harm by being out of school, because “their stressors were in-school bullying, or being misgendered, or maybe access to substances through peers,” Singer told me. He pointed out that school attendance is itself a known risk factor for suicide, as rates have dipped consistently during the summer months and over winter break. Meanwhile, on Twitter, Black has been skewering stories like the Times piece about Clark County, and likens the rhetoric regarding school closures and teen suicide to the moral panics linking video games and violence. And while he’s always annoyed when he sees suicide statistics either misunderstood or intentionally misconstrued, in this case he believes the stakes are much higher. “People are using that disinformation to advocate for, for example, ending lockdowns in schools where maybe the viral numbers support the school being locked down, or maybe it’s returning to work before we’re ready, or maybe ending a mask mandate,” Black said. “The part of it that bothers me the most is the fact that suicides were politicized as a tool to argue for particular outcomes.” The wrangling over school closures and other pandemic restrictions—whether they went on too long or not long enough, how much good they really did—will continue to play out for some time. And while it's reasonable to worry about the pandemic’s effect on teenagers, unfounded claims about a spike in suicides only muddle the important issues. The irony is that youth suicide is a vexing public-health situation that deserves our attention, says Julie Cerel, a social-work professor at the University of Kentucky and a past president of the American Association of Suicidology. Researchers like her will keep sifting through the data for explanations of the disturbing long-term trend, and they’ll keep searching for solutions, well after the threat of shutdowns to teenagers’ mental health has disappeared from the headlines. “It’s not a schools-are-closed, kids-are-killing-themselves problem,” Cerel told me. “That makes it look very simplistic, and like reopening schools is going to solve it. The problem is that there isn’t an easy fix.” from https://ift.tt/3tDzxej Check out http://natthash.tumblr.com The Johnson & Johnson shot is teetering on the precipice of becoming America’s “dudes only” vaccine. On Tuesday, the CDC and FDA advised halting the vaccine’s nationwide rollout to investigate six cases of a rare blood-clotting disorder that’s occurred in people within about two weeks of receiving the vaccine—all of them women under the age of 50. In an emergency meeting convened Wednesday by the CDC, experts raised the possibility of limiting its future use to males, reserving Johnson & Johnson’s vaccine, as some have unfortunately put it, for johnsons alone. That idea, crude though it may be, has something to it. The demographic pattern that’s emerged is striking, and many of the experts I talked with this week told me they suspect that, if the vaccine is ultimately linked to these clots, the relationship will come with a clear-cut sex or gender difference too. (These questions are also being debated with regard to the AstraZeneca vaccine, which contains comparable ingredients and might very rarely cause a similar or identical type of clotting disorder.) But health officials have strongly cautioned that it’s too early to tell for certain whether a specific subset of the population is at increased risk of this clotting disorder; scientists haven’t even definitively pinpointed the J&J shot as its cause. Prematurely masculinizing the J&J vaccine could not only reinforce biases that compromise health care, but also run counter to one of the most important goals of the ongoing pause: identifying what factors, if any, do contribute to these unusual clots, and protecting the people they affect. [Read: The blood-clot problem is multiplying] The post-vaccination clots under investigation belong to a class called cerebral venous sinus thrombosis (CVST), and they seem to manifest when antibodies, perhaps produced in response to the shots, inadvertently rile up platelets in the blood. Platelets exist to keep wounds from bleeding indefinitely: They clump blood cells and proteins together to plug up leaks. But in CVST, they seem to spark a clotting cascade that can clog veins in dangerous places, including the brain, and lead platelet levels to plunge. The disorder is a collision between a powerful immune response and a naturally clot-prone environment; a potentially simple explanation for why they might show up more in women is that the hormone estrogen can amp up both of these factors. Estrogen has many jobs in the body, and in a lot of contexts, it’s an instigator: It can boost a person’s propensity to clot, and it can goad immune cells into responding more vigorously to pathogens and vaccines. (There’s also some evidence that having two X chromosomes can make immune systems more reactive.) CVSTs are rare among the general population, but are more common in women. Menaka Pai, a hematologist who specializes in blood clots at McMaster University, in Ontario, likens clotting to falling off a cliff; estrogen, among other things, “pushes us closer to the edge.” Estrogen and chromosomes aren’t the only variables here, though. Physiology undoubtedly influences a person’s responses to diseases, treatments, and vaccines, but behavior and social factors can, too. In recent weeks, dozens of similar CVST cases have cropped up amid millions of doses of the AstraZeneca shot (which hasn’t yet been green-lit in the United States). As with the J&J effect, most of these cases involved younger women. But in certain countries, women also made up the majority of people who were inoculated early on, weakening the clots’ link with gender. Some experts I talked with also noted that women tend to stay in more frequent contact with their health-care providers than do men, and might feel less wary about reporting unusual side effects or symptoms after getting a vaccine. [Read: The rural pandemic isn’t ending] If researchers confirm that these two vaccines are operating in similar ways, “being older, being a man—that’s not going to protect you,” Pai told me. In addition to the six cases in women, researchers are now reevaluating a potentially similar CVST case that was identified in a young man who had received J&J’s vaccine during the company’s late-stage clinical trials. Still, the extreme gender trend in the early J&J reports has been hard to ignore. Prior to the pause, roughly equal numbers of men and women had received the company’s shot, according to the CDC. I asked Alfred Lee, a hematologist at Yale New Haven Hospital, how often his discussions with colleagues about the clotting disorder had turned to the topic of sex or gender since Tuesday’s news broke. “Literally almost every single one,” he told me. Lee and his team are now being particularly vigilant about monitoring their recently vaccinated female patients, especially those taking estrogen-containing oral contraceptive pills—the group of people they’ve deemed to be “high-risk right now,” he said. It’s heartening, several people told me, to see the possibility of sex and gender differences in vaccine side effects being openly acknowledged and addressed. For years, gender norms have influenced health-care providers in ways that haven’t served patients well—by dismissing women’s “hysterical” complaints of pain, for instance, or accusing them of falsifying their symptoms. But grabbing onto a still-tenuous link between sex and certain side effects could create problems, too. The seemingly obvious culprit of estrogen, for example, could end up obscuring some more obtuse cause. Sarah Richardson, the director of the Harvard GenderSci Lab, pointed me to the case of the sleep aid zolpidem, also known by its brand name Ambien. In 2013, the FDA recommended that women should receive a lower dose of the drug than men. The agency claimed that women’s bodies were more sluggish at clearing Ambien, leaving female users more cognitively impaired eight hours after ingesting it. That analysis later turned out to be flawed and incomplete, in part because the agency hadn’t properly accounted for differences in body weight; the drug wasn’t leaving all women worse off. “There isn’t any scientific evidence supporting sex-based dosage for zolpidem,” Richardson wrote in a 2019 op-ed for The Washington Post. Ambien, once hailed as a “flagship example of how sex differences can influence health,” she wrote, has morphed into a cautionary tale. To truly home in on what’s at play with the Johnson & Johnson vaccine, Richardson told me, researchers will need to consider factors such as age, sex, gender, race, ethnicity, medical history, even social norms around how unusual symptoms are reported to health-care providers, and figure out how these variables intersect. That work is extraordinarily hard to do with just a handful of people, a likely reason the vaccine’s pause has been prolonged—so more data could be collected and analyzed. “People are really interested in the gender thing,” Lee, of Yale, told me. “But we can’t prove it yet.” That’s in part why a universal halt—one that didn’t segregate by gender, age, or any other demographic—was probably “the right approach” for now, Janna Shapiro, who studies sex differences in immune responses at Johns Hopkins University, told me. Categorizing these clotting events incorrectly or too early also comes with dangers. The repetitive association of women and clots could stoke vaccine hesitancy in skewed ways. One recent poll showed that public confidence in the safety of the J&J vaccine plunged after the pause, and Elaine Hernandez, a medical sociologist at Indiana University, told me she’s concerned that reluctance about vaccines might concentrate among certain subgroups of women. She and her colleagues have found that young women who are Black and Latinx—groups that already have more limited access to vaccines—are more wary of getting immunized than their white peers. Pushing this association too hard and too quickly could also skew data collection. Health workers could narrow their clinical lens; women might scour themselves for symptoms, while men and other people who don’t identify as women “may not take the symptoms [of CVST] seriously,” Krutika Kuppalli, an infectious-disease physician and vaccine expert at the Medical University of South Carolina, told me. That bell could be especially tough to un-ring in a culture where masculinity is so often considered incompatible with sickness. “People want to appear strong and tough, men in particular,” Hernandez told me. “There are already social pressures to not complain.” Casting the clotting condition as a “female problem” too early means donning blinders. “That’s troubling for the objectivity of the investigation going forward,” Richardson, of Harvard, said. (There’s still a paucity of data on whether transgender, intersex, or nonbinary people, especially those who are on hormonal therapies, might be vulnerable to unique vaccine side effects.) [Read: The pandemic broke America’s health-care workers] If a clear sex or gender difference does emerge, nuanced messaging will be necessary. As coronavirus cases surge, the risk of taking the vaccine might still be relatively low, especially in parts of the country where the fragile Pfizer and Moderna vaccines are harder to store and administer. Restricting the vaccine to certain age or gender groups could seed equity issues, both in the U.S. and internationally, or trigger repeated rounds of sociopolitical fallout. Shapiro pointed to the HPV vaccine, which was initially targeted to adolescent girls. The shots are now recommended for children of all genders, but misperceptions of the early rollout stigmatized the mostly female preteens who signed up for the shots as promiscuous, and the sole bearers of disease. The goal in the coming days and weeks, Pai told me, is to appropriately titrate expectations of risk—to address concerns, but also avoid sensationalizing them. Our understanding of the clots’ danger could shift quickly as more data are collected. The dangers implied by six cases of a rare clotting disorder out of the roughly 7 million Americans who have received the J&J shot is much lower than the risk implied by six cases within the smaller population of the 1.4 million vaccinees who are women under 50. But now that physicians know what to look for, the numerator in that ratio will likely change as well. More cases will certainly appear, spanning a wider range of genders, ages, races, and ethnicities. These shifting odds will be easier to communicate if our lens isn’t unnecessarily narrowed: Expanding the definition of an at-risk population is harder than paring it down. The suspension might already seem frustratingly long to some; plenty of people have called it out as cowardly and unwise, and questioned why federal officials prolonged it. But nearly everyone I’ve spoken with this week has praised the move as prudent, during a time of great uncertainty about who’s most at risk. “Ideally, we find out over time which vaccines are best for which groups, and why,” Leana Wen, an emergency physician affiliated with George Washington University, told me. “That’s the positive way of seeing this—this is in part the kind of information we’re getting here.” from https://ift.tt/2Q2KQOK Check out http://natthash.tumblr.com If there’s a villain of the pandemic, other than COVID-19, it’s probably Zoom. The video-chatting platform is making people tired, it’s making people awkward, and it’s making people sick of their own faces. Zoom is such a shoddy substitute for real life that, according to one survey, nearly one in five workers has illicitly met up in person with colleagues to discuss work. And in another poll, a third of women said they were “talked over, interrupted or ignored more frequently” in virtual meetings than in person. Zoom haters: I hear you, and I validate your experiences. But Zoom is actually great! Don’t get me wrong. I love reporting in person—in fact, I’ve missed it dearly. But I find working in an office, public speaking, going to big parties, and attending important meetings in person enormously stressful. I prefer Zoom for all of these things, and I’m going to miss it when it’s gone. So will many other socially anxious people. Though I enjoy elements of in-person socializing, I don’t really miss some of its trappings, like doing my makeup, parking, or sitting in an overly air-conditioned Starbucks, buying coffee I don’t want, just to talk with someone for 45 minutes. My favorite quote that captures this sentiment is by a man named William, who told New York magazine, “I’m just dreading traffic, ‘meet me at the coffee shop at three,’ ‘I’m ten minutes late,’ baby showers, [gender] reveals. Like, I don’t want to do any of that fucking shit.” Some of us cannot wait for the bustling energy of normal society; others of us are standing athwart all the fucking shit yelling, “No thanks!” I have a type of social anxiety that most often surfaces when I’m interacting with authority figures, like bosses or police officers. It was exacerbated by a few managers I had early in my career, who would milk my nervousness for extra output. Now when I leave an in-person interaction with an authority figure, I tend to spend the rest of the day wondering whether I phrased something wrong and therefore my career is over. In big work meetings, I basically try to evaporate. And don’t even get me started on “networking receptions.” But with Zoom, I’ve found myself feeling more relaxed, more emotionally regulated, and better able to advocate for myself. I feel as though I can more easily speak up in big meetings, and I can express myself to my bosses without worrying about my self-presentation. To me, Zoom turns everyone else into fake people—not people with power over me, just little faces in boxes on my screen. If the trick to beating stage fright is to imagine the audience members in their underwear, it helps that on Zoom, even the most important people are athleisure-clad and holding babies. Social anxiety is driven by a fear of being perceived negatively by others because you’ve misunderstood the subtle norms of a situation. But on Zoom, the rules are simpler. There’s no handshake, no decision about where in the room to sit, no need to even pick out an outfit from the waist down. “Real social interaction is so much more terrifying for people because there’s uncertainty, so many unknowns. This is greatly reduced in the online format,” says Stefan G. Hofmann, a psychology professor at Boston University and an expert on social anxiety. “A lot of things that happen in real life can’t happen in an online format.” On Zoom, awkward moments can be attributed to technical issues. In a face-to-face meeting, telling your boss that you didn’t hear them or didn’t understand them might be uncomfortable. Over Zoom, it’s perfectly normal. [ Read: Work From Home Is Here to Stay ] Socially anxious people tend to play a little movie in our mind of what we assume we look like to others. But instead of the dashing protagonist, we picture ourselves as the bumbling stooge. The Zoom self-view helps correct that image. “It counteracts the view in our head of us looking like a babbling idiot,” says Ellen Hendriksen, a clinical psychologist and the author of How to Be Yourself. Zoom provides a mirror, and a reality check: Oh, I look and sound fine. Many people say the pandemic has damaged their mental health. But some have told Hofmann that they prefer interacting over Zoom. Some of the legions of office workers who began working from home last year found that they love it. A few of Hofmann’s psychologist colleagues gave up their expensive leases in New York City and have started offering therapy exclusively online. And some people, he says, “find it easier to maneuver the social world in a more simplistic way—an online way.” Unlike almost every other person on Earth, I also prefer Zoom parties to regular parties. At many in-person parties, I drink too much because I’m uncomfortable and then have to leave early because I’m too uncomfortable and too drunk. By contrast, I find that Zoom parties offer just the right amount of stimulation. I will often put on a big group Zoom and do other things, such as fold laundry or cook. I don’t feel the urge to drink, or even participate much, because it’s really just me and a computer. This blending of regular chores and socializing makes me think of what the pioneer days must have been like, with people catching up while quilting or whatever. Except Laura Ingalls Wilder didn’t have Zoom. Lucky us! Like Zoom work, Zoom socializing can be easier for socially anxious people, Hendriksen told me. Real parties are a labyrinth of confusing decisions and expectations. You have to navigate “Who am I going to go talk to now? Have I been talking to them for too long? Should I go to the bathroom now?” Hendriksen said. “Whereas with Zoom, there’s a lot more structure. Really only one person can talk at a time. Everybody’s laid out in this nice Brady Bunch grid. You can turn your camera off and just put ‘BRB’ in the chat. If we increase the structure, we can lower the uncertainty, and therefore lower our anxiety.” In addition to being a fine alternative to real life, Zoom has, for me, conferred benefits over and above in-person gatherings. My book came out last April, amid the throes of the initial pandemic freak-out. Although I was at first frustrated that I wouldn’t get the full “book-tour experience,” my virtual book tour was more fun and more accessible. More people were willing to sign in to Zoom on a pandemic Tuesday than were willing to trudge to a random D.C. bookstore in the April rain. And because the book talks were so easy, I was able to do more of them—on bookstore websites, on Instagram, on YouTube, and, yes, on Zoom. Book clubs and other get-togethers are also more geographically inclusive when they’re online. Through Zoom, I’ve caught up with friends who live in other cities, whom I have not been able to visit. The only awkward part of a Zoom chat is figuring out how to end it. But you have to do that when you’re talking on the phone, anyway. Some people have tried “I have to go make dinner/go for my little walk/finish up some work,” but I recommend the genteelly passive-aggressive “I should let you go.” I learned this while living in the South and have yet to find a better alternative. All the experts I spoke with said that Zoom will continue to play a role in our lives, but probably a smaller one than it has this past year. “Far from getting tired of [working from home], the average American actually seems to be getting used to it and increasing their desire to continue to work from home post-pandemic,” the Stanford University economist Nick Bloom told me via email. About 46 percent of workers would like to continue working from home forever, according to research from ZipRecruiter. But remote jobs aren’t available for all of those workers. The share of jobs explicitly offering remote work has gone up from about 3 percent before the pandemic to about 10 percent now, says Julia Pollak, a labor economist at ZipRecruiter, and that number is now coming down slightly. Bloom told me that although employers are planning to increase work-from-home days after the pandemic, they’re not as enthusiastic about the change as employees are—and they don’t envision workers spending quite as many days at home as workers might hope. Some percentage of Zoom lovers will likely be dragged back into the office, whether we like it or not. The pandemic probably hasn’t ended in-person conferences, either, though Pollak says more conferences will likely offer a cheaper, remote ticket option. Steve Moster, the president of GES, which helps companies put on live events, says many clients have told him that virtual events don’t yield the same sales leads or opportunities as in-person conventions do. “So there’s a lot of compelling reasons for in-person, live events,” he told me. He believes that by 2022, Americans will return to live events at their previous levels. [ Read: Only Your Boss Can Cure Your Burnout ] By using Zoom so much this past year, I’ve grown soft. My social anxiety, which is usually provoked in a million tiny ways each week, has been lulled into a peaceful slumber while I interact with people only virtually. It might be hard for people like me to jump back into meatspace. For future in-person interactions that can’t be conducted over Zoom, Hofmann recommended that I try to make the rules of the interaction as explicit as possible, at least in my mind. Having an agenda to discuss, a specific start and end time, and clear talking points can make daunting in-person meetings feel more Zoomlike. Hendriksen reminded me that there will be lots of reentry points. First, I’ll have an in-person meeting with my boss. Then I’ll go to a big, loud party. And finally, I’ll have to do an onstage presentation. I’m not going to have to do them all at once. My brain will be recalibrating all along, preparing me for the next stressful thing. “It doesn’t have to be a cannonball into the deep end,” she said. Our brains are flexible, and real life isn’t anything they haven’t seen before. from https://ift.tt/2Q0SV6A Check out http://natthash.tumblr.com People come to Shelly Hughes to get better. Most patients at the Washington State long-term-care facility she works at are there for the express purpose of getting well enough to go home. In a typical year, she would rarely see cases of “failure to thrive,” the technical term for a sharp and sudden decline in health. But last year, multiple people who were expected to make a full recovery went into rapid decline: They refused to eat, drink, or move, and then died. She blames isolation, in part. Her facility has dramatically limited inside visitors since the start of the coronavirus pandemic, and employees wear full personal protective equipment, which makes communication difficult, especially with patients who are hard of hearing or have dementia. “Everyone that you see is basically a spaceman with no face,” she told me. She used to be able to comfort scared and lonely patients not just with her words, but with body language and facial expressions. Now she’s resorted to exaggerated gestures and writing questions down on a pad of paper. Hughes and her co-workers are also trying to provide care while significantly understaffed, tending to far more patients than they should. Every shift has open slots, putting a greater burden on those who come in to work. “You physically do not have the caregivers and the nurses and social workers in the building to be able to sit and talk with people in a way that makes them feel like they’re not alone,” she said. “You feel really helpless.” It’s made Hughes consider whether she can stay in her job for only the second time in nearly a decade. The other time was eight years ago, right after she miscarried twins. The facility was severely short-staffed, and she had been picking up a lot of extra hours. “I really blamed the work for my miscarriage,” she said. She got through it and decided to stay. This time might be different. “I love my job, and I want to keep doing it for as long as I can,” she said. But, she added, “I know that there is an expiration date on this job or me.” No one has endured the past year unscathed, but America’s health-care workers have witnessed the worst of it while trying to keep the rest of us healthy and safe. They’ve fought for PPE, and with patients and visitors who refuse to wear masks. They’ve watched their patients give birth alone, suffer alone, die alone. Hundreds of thousands got sick themselves, and many more lived with the daily worry of bringing the virus home to their loved ones. Many began to wonder if it’s worth it. “People are definitely looking for greener pastures,” says Rob Baril, the president of SEIU 1199 New England, a union chapter that represents about 25,000 nursing-home employees, home health aides, and other health-care workers. Many of the facilities that employ these workers already struggled with retention given the low pay and high workload. “Pre-pandemic, this was a workforce that in many ways was very fragile and underappreciated and underpaid,” Rachel Werner, the executive director of the Leonard Davis Institute of Health Economics at the University of Pennsylvania, told me. Baril estimates that about 80 percent of his members are women, and that 80 percent are Black or Latino. And because their work is associated with the work that women are expected to do at home for free, it’s long been undervalued. “It’s a workforce that’s quite invisible, easy to dismiss,” Werner said. “It doesn’t have a lot of political capital or clout.” Now the stakes are even higher. “You can’t get people to go risk their lives for $15 an hour,” Baril told me. Chronic understaffing became an acute crisis last year, as people got sick or feared for their safety if they came to work; one in five nursing homes was short on staff last summer. But workers without paid sick leave faced financial ruin if they had to stay home to quarantine or recover from COVID-19. It was a vicious cycle. Take nursing homes: COVID-19 outbreaks were significantly more common in facilities that didn’t offer paid sick leave. Sky-high turnover rates helped spread the disease far and wide. So far, more than 1,800 nursing-home staff and 130,000 residents have died of COVID-19. At one facility in Connecticut, Kimberly Hall North, which has 150 beds, the state reported in May that 40 patients had died; Baril said that one employee had died and another had brought the disease home to her mother, who died. The long-term-care system “has historically been held together with duct tape and spit,” Werner said. “The pandemic revealed how fragile that system is.” Read: [‘No one is listening to us’] In a recent report published by the Department of Health and Human Services’ Office of Inspector General, hospital administrators said increased workloads and the trauma of caring for COVID-19 patients have left staff “exhausted, mentally fatigued, and sometimes experiencing possible PTSD.” That has led to even higher turnover than normal—38 of the 296 hospitals surveyed faced a critical staffing shortage. One Texas hospital saw its annual nurse turnover rate jump from 2 to 20 percent, according to the report. A hospital network reported an increase in life-threatening central-line blood infections—an increase it attributed to a lack of staff and the fatigue of those who were working. Hospitals don’t expect the crunch to ease after the pandemic fades, but instead to worsen, because so many people have been deterred from entering the industry. One hospital that usually recruits new nurses from its teaching hospital graduated only 100 in 2020, yet had 200 open positions. Several of Hughes’s co-workers have quit; many have left the medical field altogether. Hughes tries to persuade them to instead take a leave of absence so they could come back. “So far no takers,” she said. Melanie Arciaga worked her last shift as a registered nurse at Harborview Medical Center, in Seattle, on April 3, 2020. Back then, her hospital’s PPE was often locked up; nurses had to request it each time they needed it. New patients were tested for COVID-19 as they were admitted, but if they tested negative, no extra precautions were then taken. At the end of that last shift, Arciaga had to take the vital signs of a patient whose roommate had just developed respiratory symptoms. The only protection she had was a pair of gloves; she wasn’t wearing a mask or eye protection. The patient coughed, “and I felt it [go] straight into my face and my eyes,” she told me. She was too busy to give it much thought until she overheard another nurse say that the roommate had tested positive for COVID-19. There wasn’t much Arciaga could do, so she finished her charts, went home, and went to sleep. She woke up to a voicemail saying that the patient who’d coughed on her had tested positive. Less than 48 hours later, she was in pain “from head to toe,” she said. “It felt like nails driving through my fingers, my toes, my foot, my head.” One night, her husband later told her, she woke up and said to him, “Just kill me right now. I can’t have this pain anymore.” When her husband drove her to the emergency room, he refused to leave the parking lot—he thought she was going to die in the hospital. She had a fever for nine days and the pain lasted for two weeks. Nearly a year later, Arciaga still has an acute burning sensation in her nose. Her lungs didn’t heal until January; she had to pause every so often to cough while we spoke over the phone in early March, and she still gets short of breath. “I think this is going to be my new norm,” she said. She wants desperately to go back to working in the hospital, but can’t tolerate wearing a surgical mask for more than two hours without intense coughing spells. “I feel really, really bad because they’re really, really short-staffed,” she said. “I just feel so helpless.” She’s also furious. Before she was forced to stop working, she had been fighting for adequate PPE—and her colleagues are still fighting. Hospitals and nursing homes were notoriously flat-footed at the start of the pandemic, but even as recently as November, more than 80 percent of National Nurses United members reported reusing at least one type of single-use PPE such as masks. Arciaga likened herself and her co-workers to soldiers. “You’re throwing me into a war, fighting a battle without a gun, without shoes, without a helmet, no armor.” She’s become afraid to go outside and be around other people. The first time her husband made her leave the house, they drove to the ocean, with just a stop for gas, and she gripped his hand in fear the whole time. “I still have some sort of PTSD,” she said. Read: [The visible exhaustion of doctors and nurses fighting the coronavirus] When I asked Adarra Benjamin, a home health and personal-care aide in Chicago, to sum up the past year, all she could get out was, “Panic, panic, suspense.” Eventually she added, “Every day is like a waiting game to see if someone gets sick.” Because she works in people’s homes, she’s lost most of her clients and income this year. She wants to take on more clients as they become willing, but worries she’ll be exposed to COVID-19. After months of seeing co-workers, patients, and others engage in risky behavior, Bartie Scott, a nurse practitioner in Fayetteville, Tennessee, is similarly at the end of her rope. The week after Thanksgiving, one 70-year-old woman who came to her clinic to get a COVID-19 test after her co-workers had tested positive admitted that, despite feeling under the weather a few days before Thanksgiving, she had eaten her holiday meal at a restaurant with her daughter. Her test was positive. Scott has tried to ignore the people around her not wearing masks, but when she recently had to wait in a crowded room with two men who weren’t, she couldn’t stay silent anymore. She asked them to wait somewhere else, but instead of leaving, other people jumped in to defend them. “It’s like a slap in the face,” she told me. It feels like “a personal insult.” “On the surface, I tell myself I’m keeping it all together,” she said. But “underneath, I’ve been kind of angry.” In the fall, Shelley Hughes started adding an extra night to her weekly schedule to help ease the staffing shortage at her facility. But it took a toll. “I felt like I was dying,” she said. “It just felt like all of the life and energy was gone.” She went to work, came home, and was capable of doing nothing else—not playing the piano, cuddling with her puppy, or any of the other activities she had been using to distract herself. Her relationship with her husband suffered. She finally got blood work done and was diagnosed with hypothyroidism right before New Year’s. Her doctor suggested that stress from work was a trigger. In some places, the trauma of this year has resulted in large-scale political change. In February, the Virginia legislature passed a law mandating five days of guaranteed sick leave for home health-care workers. Adarra Benjamin’s union was able to secure paid sick leave—a benefit they’d never had before—for home health workers who contract COVID-19. She hopes the union can secure even more improvements, such as a higher minimum wage and sick-leave benefits that will remain after the pandemic subsides. Read: [‘The reality is, it’s incredibly hard’] All 25,000 of Rob Baril’s union members are currently negotiating new contracts. Long-term-care workers are fighting for a base wage of $20 an hour, good health insurance, and retirement benefits. “I’ve never seen our membership so angry. They just feel that they’ve been violated,” he said. Others have less fight in them. Hughes’s union contract is up this year, and normally she’d be trying to get her co-workers energized to fight for better pay. This year she’s preparing them to “beg,” she said—not with bosses, but with lawmakers. Workers are planning a rare team-up with management to plead with the Washington State legislature to devote more funding to long-term care. In past contracts, the union has won guaranteed raises and increased sick and vacation time from management. This year Hughes will be relieved if the company doesn’t try to claw any of that back. Only recently have health-care workers had a glimpse of a different future. When I spoke with Bartie Scott in March 2020, her greatest fear was bringing the virus home to her 75-year-old ex-smoker husband. But on Christmas Eve she got a call saying that if she could get to the health department within an hour, she could get her first vaccine dose. “Boom, I was out of there in my dirty clothes,” she said. When I spoke with her more recently, she had received both shots and her husband had gotten one. “We made it,” she said. They’re lucky. According to The Guardian and Kaiser Health News, at least 3,600 U.S. health-care workers have died of COVID-19. After Hughes got her first vaccine shot, in February, she sat in her car and cried. “It was relief,” she explained. But it was also “sadness for the people that are already gone and didn’t get a chance to get it.” from https://ift.tt/3spyXze Check out http://natthash.tumblr.com Despite weeks of growing vaccinations and good news, headlines about blood clots and a “pause” in deploying the much-anticipated Johnson & Johnson shots have people worried. Atlantic science writer Katherine J. Wu joins hosts James Hamblin and Maeve Higgins on the podcast Social Distance to explain the situation. Listen to their conversation here: What follows is a transcript of their conversation, edited for length and clarity: Maeve Higgins: You wrote about the Johnson & Johnson vaccine pause recently. Could you fill us in on what happened? Katherine J. Wu: First, to put it in perspective: This was identified very quickly and then addressed very quickly. And that is all a good thing. But basically the situation is: The CDC and FDA reported that they had picked up on six cases of a very specific kind of blood clot in six women under the age of 50. They detected the blood clot in these women within about two weeks of when they had gotten their Johnson & Johnson vaccine. And this is out of nearly 7 million people in the United States who have gotten these vaccines. So it is a very, very low number of cases so far. More certainly could emerge. But this was enough for federal health officials to say: Hey, this is concerning. We are seeing really the same problem arising in all six of these people. We should stop and take a look. And to be really clear here, what’s going on is a pause. They are literally hitting the pause button here and saying: Let’s get some time, evaluate the data, consult our experts, figure out what’s going on, and critically give doctors the information they need to detect these symptoms in patients and then treat them with the right therapies. This is not a revocation of the emergency authorization. This is not a withdrawal. This is not like a full recall. This is just: “Let’s wait and see what happens here. Hopefully we’ll have more information to you very soon.” James Hamblin: Do you have a sense of how confident regulators feel that these clots are indeed related to the vaccine? Wu: My pulse on the situation is that there’s a moderately confident link at this point. Part of the point of the meetings is to really see how strong that link is, so I can’t conclusively say it, but I think there’s kind of a bump in confidence right now because what they’re detecting with these specific clots looks a lot like what has been going on with the AstraZeneca vaccine, which in terms of vaccine recipe, looks pretty similar to the J&J vaccine. And it’s probably not a complete coincidence that we’re seeing the same side effect appear shortly after both of these very similar-looking vaccines. I think they probably acted more swiftly here with J&J because of what’s already been going on with AstraZeneca. Hamblin: Yeah, that makes sense. These are both adenoviral vector vaccines, so there are some similarities. AstraZeneca has been associated with clots in Europe, and so it seems like there is a low threshold here. And these specifically were clots in the cerebral veins. Wu: Yeah, what’s going on here is a very, very specific kind of blood clot. Blood clots happen all the time. These are especially concerning because it’s a super-specific kind of blood clot … appearing in combination with low platelet counts. That’s another linked phenomenon that’s led a lot of researchers to hypothesize something is going on. And that specific combination has raised some eyebrows. [It’s also] been seen also in response to, ironically, a blood-thinning drug called heparin. And that’s really important to know because heparin is one of the most common blood thinners that doctors use to treat clots. In this specific case, officials are recommending against using heparin because it could potentially make the situation worse. And I think that’s another plus of the pause. Doctors are getting the message loud and clear. Let’s not use it until we really know more and maybe never again for this specific condition. Hamblin: Right, part of the pause is to help doctors understand what to look for and how to deal with symptoms that might be related to a clot like this. And part of it seems to be messaging to patients who are within this window of having recently had a Johnson & Johnson vaccine. If people experience basically any neurologic symptoms—from dizziness and headaches to anything more significant than that—contact a physician, because it’s going to be especially important to keep a close eye on things like that. Higgins: [In your piece] you quoted Dr. Angie Rasmussen, an amazing virologist we’ve had on Social Distance before. She got the Johnson & Johnson vaccine nine days ago as we tape, and she’s in the age range of the six women who got the blood-clotting symptoms. So what was her take as a person who got the vaccine and also just as a virologist? Wu: She had been tweeting about this, and I knew she would provide some really balanced perspective here. First things first: She has gotten the vaccine. There is really no undoing that. But she’s not spending all of her time worrying about getting a clot—partly because that won’t affect whether or not she does—but also because these cases have so far been really, really rare. I don’t think we yet have enough information to say they’re going to appear in exactly X percentage of people, but it’s probably going to be an extraordinarily low number. Higgins: What are the symptoms to look for in that very rare case? Wu: There’s a list that the CDC and FDA put out. They said if you develop severe headaches, abdominal pain, leg pain, or shortness of breath within three weeks of your injection, reach out to your health-care provider. But that is going to be the next level up from the expected side effects that some people might get within the first couple of days after getting their injection, which might include a mild headache. So there’s a little bit of subjectivity there, but hopefully people are just keeping an eye out in those three weeks. That’s the critical window we’re looking at here. Hamblin: Do you think this has been handled correctly? Do you think pausing Johnson & Johnson for everyone was the right move? Wu: That’s a tricky question to answer, but I think I lean on the side of “yes.” Imagine if the CDC and FDA had waited until it was 20 cases, or 30 cases, or 100 cases … [they] would have gotten questions about why they didn’t pause it when it was just six and we could have prevented 94 more cases. I think they saw a signal and not just a random cluster of blood clots [that] all looked so similar in this demographic slice of the population. And so they acted quickly. This pause could just be a matter of days to get clarity and make sure that people are aware and looking out for it. I wouldn’t be surprised if more cases come up because we now know to look for it. [But] they are not hoping to permanently derail this vaccine. Hamblin: Do you think this pause—assuming it doesn’t pan out to be over a major risk factor and Johnson & Johnson gets back online—will, over time, lead to vaccine hesitancy of the sort that we’ve seen with AstraZeneca in Europe? How concerned are you about it exacerbating what we’ve already seen in the U.S.? Wu: I am concerned about this, but I don’t want to jump to conclusions about how hesitancy will be affected. It’s so tricky because exacerbating hesitancy can occur in a multitude of ways. One is: People hear something negative about the vaccine and they feel less good about taking it. Another is that experts conceal something about the vaccine and the public feels like they’re not being trusted with the relevant information. The CDC and FDA are in a bit of a “damned if you do, damned if you don’t” situation, but I’ve been really impressed with how a lot of experts have tried to communicate the situation as clearly as they can, and really stress the point that we can make better-informed decisions with this information being publicly out there. That said, I have spoken to a few people who have already said someone in their life was signed up to get this vaccine and now aren’t feeling as great about getting this one in particular, but they’re also not feeling very good about the other vaccines. Higgins: I also read your story about second-dose side effects. Our producer Kevin Townsend got his second shot last week, and he was really knocked out. Have you heard from a lot of people who’ve had this tough ride? Wu: What’s so interesting about this whole vaccine rollout is we’re really coming to grips with just the diversity of the human experience. I’ve talked to people who have had no side effects whatsoever—my mom was actually one of them—[to people like] my husband, who had really bad side effects to both injections. And they are both totally fine. I feel great about both of them being protected. That said, when there is a second dose, it does seem to, on average, pack a bigger punch. And I think that can be chalked up to the fact that that second dose is a reminder for the immune system about what it’s already seen. You’re just going to rile up the immune system a little more. The second time you annoy someone, they’re going to yell at you a little louder. And I think that’s roughly equivalent to what’s happening here. I do think it’s a comforting and visible sign that the process is working as expected, but I also don’t think people should worry if they don’t have side effects. Something else that’s comforting is that we did see a lot of side effects documented in the clinical trials. So this was not a surprise. We saw this coming. But the percentage of people who were protected from COVID-19 far exceeded the percentage of people who had tons of side effects. And so, you can have a ton of different experiences in those first few hours after the shot, but don’t read too much into it. Hamblin: I have a little soreness in my arm, and I take it as evidence that it’s working, that I’m gaining this protection. And the side effects you’re talking about after a second dose are mostly: low energy, fever, aches, chills, occasionally rashes … but they go away pretty quickly. This is nothing like getting COVID-19, nothing like even getting the flu. Wu: Exactly. It’s like the body reacting to the idea of a pathogen. People have said it’s like having 24 hours of flu-like symptoms, but you’re exactly right—it is not equivalent and certainly not worse than getting COVID-19. The risk calculation here is absolutely clear-cut. from https://ift.tt/3shcepa Check out http://natthash.tumblr.com On February 25, I got my first shot of the Pfizer vaccine bright and early, picked up a breakfast burrito on the walk home, and spent the rest of the day sitting in my desk chair, doing what can only be described as vibing. I felt a little bit stoned, like I had taken a low-grade edible instead of being shot up with cutting-edge technology that would help end a year-long global disaster. This acute, mildly high feeling—“brain fog,” a known side effect of the vaccines—lasted about two days. As potential side effects go, it was rad. More durable, though, was the strange feeling that began when I made my appointment. In the hours after scheduling my shot, I blew a deadline and was late to meet up with friends for a very cold outdoor hang. I was overcome with relief, everything felt slightly unreal, and the time-dependent obligations of my life faded to the periphery of my consciousness. In the two months since, the delirium has settled into something duller, less frantic—the keys are in the ignition, but my mind simply will not turn over. Unlike all the other distinct ways in which my brain has felt and functioned like canned tuna at various stages of the pandemic—the dread, the confusion, the period in which I was constantly dropping things—this one is unique in that it isn’t exactly bad. My mood has been mostly fine, at least relative to much of the previous year. But I am occupied by meandering thoughts of what the next few months might be like. Do I want to go on a vacation? Maybe I just want a dinner reservation—what’s available a couple of weeks from now? Do I want to move out of the apartment I’ve been sitting in for nearly every waking moment of the past 13 months? What’s everyone doing this weekend? In the meantime, I have done virtually nothing that I’m supposed to be doing in order to get myself through this pandemic, which is definitely not over yet. I have had an impossible time not just completing work tasks, but cooking for myself, working out, running errands, reading books, and even finishing shows I’ve started on Netflix. My executive function, feeble in the best of times, is apparently never coming back from war. I couldn’t even think of a name for this phenomenon until a co-worker invoked an old high-school trope to explain why she was feeling similarly. As soon as she did, it made perfect sense: We’ve got pandemic senioritis. For those who are unfamiliar with the concept—or who were simply more committed students than I ever was—senioritis is a psychological affliction both totally made up and very real. More a mood than a diagnosis, you can find many students afflicted by it in their last semester of high school or college. Senioritis comes from reaching the end stages of the lengthy work necessary to achieve a difficult—and often not altogether voluntary—goal. (Sound familiar?) It’s an abrupt bout of laziness, or flakiness, or riskiness. It is sudden-onset farting around, and maybe breaking a few rules in the process. This might be hitting a little close to home for you right now. Taking a nation’s behavioral temperature can be a bit tricky, but data are beginning to show that even people who have stuck to safety protocols for much of the pandemic are getting antsy and letting things slip. In a March poll, Gallup found that only 46 percent of unvaccinated Americans who intended to get a shot were still mostly or completely isolating. That was a 12-point drop from January—a much larger change in activity than even that of the newly vaccinated. This shift comes as COVID-19 cases have once again begun to rise in many places in the United States; even as the country vaccinates millions of people a day, the danger of the pandemic has not yet subsided for the majority of people. Nonetheless, more Americans are traveling, salons and spas have started to book up, and many restaurants are desperate to rehire workers to meet increased demand. I was among the very first of my friends to get a vaccine, and seeing it become a reality for a few of us seemed to poke the pandemic soft spots on the whole group’s skulls. Some of my friends became the people from the Gallup poll who were still anticipating their own jab but started to cut some corners anyway, after almost a year of toeing the line. Maybe we could sit in one of those weird, unventilated dining huts that have sprouted on city sidewalks. Maybe we could all pile into one of our apartments after an evening getting before-times drunk outdoors at a series of bars. My colleague Katherine J. Wu refers to this type of rule-bending as “vaccine cheat days,” and as she predicted recently, they are indeed adding up. That all these activities aren’t necessarily safe just yet appears not to matter to some of the same people who have held out for more than a year. Some of them are reaching the limits of their resiliency, which is not, as it turns out, an infinitely renewable resource. Part of this different behavior comes down to people’s need for “autonomy and freedom and independence—the ability to follow their impulses,” Darcia Narvaez, a psychology professor emerita at the University of Notre Dame, told me. “That’s been curtailed for so long that you just kind of run out of the capacity to hold back.” Especially for those who have returned to in-person work—which the Gallup poll indicates is now the majority of people, and more than at any previous point in the pandemic—forgoing other joyful in-person activities might not feel logical anymore, or like it’s worth the sacrifice. Even if you’re abstaining from new risks, you still might be having a hard time channeling your energy toward anything but fantasizing about the summer ahead. To explain that, Narvaez pointed to the concept of anticipatory euphoria. That’s what people are experiencing when they cover their house in Christmas decorations as soon as Thanksgiving is over, or why buying a wedding dress can be so emotionally affecting a year before the big day. These moments might not make the desired event come any faster, but they give people access to some of the joy they expect those occasions will bring. Whether you’re browsing future vacation destinations or plotting your post-pandemic wardrobe, Narvaez said, it’s easy to let an obsession with arriving at a particular goal distract you from the things that need to be done in order to get there. That’s true even if those things are the rote tasks of living your life, staying safe, and keeping your job until your brain returns to its regularly scheduled programming. For people who aren’t overjoyed about returning to pre-pandemic life, the darker side of senioritis might feel more applicable. Adolescence is, after all, a traumatic time for many, and the process of transitioning out of it can spur grief and a search for closure. With a return to some sort of normalcy in sight, the acutely painful parts of the past year might be catching up to some people, and their brain might be hitting the brakes as a result. “It could be that you have unresolved emotional things to deal with,” Narvaez said. “You need to stop and take time to feel your grief or sadness.” Many people who have lost loved ones in the past year still haven’t been able to hold a funeral, and few people have had the time to stand still and take in the enormity of the pandemic’s tragedy—not just the dead, but the loss of the year people had planned for themselves, and everything that meant. My own recent affliction seems like some combination of the two. I’m so excited for what’s to come—to see my parents for the first time since 2019, to go on vacation, to sit in a crowded bar in the middle of the night. But the horror of what we have been expected to live through, and what we are now expected to leave behind, seems too enormous to conceptualize. Between those two poles, my brain is stuck in neutral, unable to wait for the future or trudge through what’s left of the present. Senior skip day never sounded so good. from https://ift.tt/3dYHhRi Check out http://natthash.tumblr.com In early March 2020, Rick Phillips, 63, and his wife, Sheryl Phillips, quietly cloistered themselves in their Indianapolis home. They swore off markets, movie theaters, the gym, and, hardest of all, visits with their three young grandchildren. This April, three weeks after receiving her second shot of Pfizer’s vaccine, Sheryl broke her social fast and walked into a grocery store for the first time since last spring. Rick has yet to join her. He received his shots on the same days his wife received hers. By official standards, he, too, can count himself as fully vaccinated. But he feels that he cannot act as though he is. “I personally remain scared to death,” he told me. Rick has rheumatoid arthritis, which once rendered him “barely able to walk across the room,” he said. He now treats the condition with an intensely immunosuppressive drug that strips his body of the ability to churn out disease-fighting antibodies. Rick credits the treatment with changing his life. But it might also keep him from developing lasting defenses against COVID-19. Vaccines have promised, to the rest of the world, a return to a semblance of normal life; the ones currently cleared for use against the coronavirus are, by all accounts, extraordinary. But they were not designed for, or tested extensively on, immunocompromised or immunosuppressed individuals, whose immune systems have been subdued by underlying conditions, environmental exposures, drugs, or viruses such as HIV. With their defenses down, many of these people can’t yet count on what the rest of us can: that the new shots will protect them from the coronavirus. The benefits of vaccination still far outweigh the risks: Experts told me they had no safety concerns about vaccinating people with weakened immune systems, who are often at higher risk of getting severe COVID-19. And in signing up for their shots, Rick and others like him can also help fill the data void that the clinical trials left, and potentially advance our understanding of how vaccines guard against the virus. Certain immunosuppressive drugs will undermine the vaccines in different ways; by pinpointing where, how, and in whom the shots most often falter, scientists might be able to discover which parts of the immune system are most essential for immunity against the coronavirus. “We still don’t understand why only certain people get so sick and die [from COVID-19],” Meena Bewtra, a clinical epidemiologist at the University of Pennsylvania who treats patients with inflammatory bowel disease, told me. But inoculating the immunocompromised remains, in some ways, fraught. As the vaccine rollout continues, many people with weakened immune systems are unsure of how to navigate their post-vaccination existence. The milestone they must wait for isn’t their own vaccination, but everyone else’s—when society reaches an immunological tipping point that will shield the still-vulnerable from the disease. There is no single way to build a well-functioning immune system. But there are countless ways to derail one. A typical immune system, if such a thing exists, relies heavily on precision and coordination. The body must first accurately distinguish an assailant from its own healthy tissue, then launch a series of well-timed attacks without marshaling extraneous fighters to the fore. The what, when, and where of these immunological assaults are all crucial to the body’s ability to waylay disease; any perturbation threatens to set the whole system askew. [Read: The body is far from helpless against coronavirus variants] Some people are born with genetic mutations that hamstring immune cells’ abilities to recognize and thwart infections; others struggle to mount strong responses because of environmental causes, such as poor nutrition, cancers, or chemotherapies and pathogens that attack some of the body’s most potent defenders. Immunosuppression can also be an intentional, lifesaving tactic. Drugs that deliberately muzzle immune cells can help people with autoimmune conditions, such as rheumatoid arthritis, lupus, multiple sclerosis, and inflammatory bowel disease; organ-transplant recipients must take them, typically for the rest of their lives, to boost tolerance for unfamiliar tissue. Overlaying vaccines onto this inherent diversity becomes a complex tangle. Vaccines are intel-packed training regimens designed for well-functioning immune cells—rookie soldiers who can sponge up info, strategize with their peers, and prepare for an upcoming encounter with a dangerous microbe. But the protection calculus changes when the contents of the shots are met by fighters who have been restrained. Some medications are expected to present a slight setback, but aren’t necessarily disastrous for COVID-19 immunization, because they suppress just a sliver of the immune system’s typical operations. One example is ustekinumab (Stelara), a common treatment for Crohn’s disease, which zaps the signals that immune cells send one another—an intervention akin to temporarily putting a military’s radio system on the fritz. Many of these treatments can continue on schedule during vaccination, under the advisement of a physician. Other drugs, however, are far blunter tools, clobbering large swaths of the immune system. Among them is Rick Phillips’ drug, rituximab (Rituxin), which is used to treat rheumatoid arthritis, multiple sclerosis, lupus, and white-blood-cell cancers such as leukemia and lymphoma. It destroys entire populations of B cells—on par with blitzing a fleet of naval forces. B cells are antibody factories, and without them the immune system has more difficulty committing new viruses to memory. “We’ve pharmacologically made a hole in the immune system,” Erin Longbrake, a neurologist at Yale New Haven Hospital who is studying COVID-19 vaccine responses in multiple-sclerosis patients, told me. After a rituximab infusion, B cells can take six months or more to bounce back. The lasting impacts of B-cell-depleting therapies have prompted many physicians to recommend that such drugs be administered with careful timing around a COVID-19 shot. “It’s the medication I worry about the most,” Anna Helena Jonsson, a rheumatologist at Brigham and Women’s Hospital, in Boston, told me. Rick Phillips was three months out from his most recent infusion of rituximab when he received his first dose of Pfizer’s vaccine, in February. He pushed back his next infusion until mid-April—a month later than usual—in hopes of giving his COVID-19 shots’ protective powers time to take hold. [Read: Immunology is where intuition goes to die] People who have an autoimmune disease that’s poorly controlled, though, could risk a symptom flare by delaying their medications; others who have received organ transplants, or who are at the beginning or middle of a chemotherapy course, can’t simply flip their medications off. Some people will need to prioritize their existing treatment, “then just get the vaccine when you can,” Chaitra Ujjani, an oncologist at the Seattle Cancer Care Alliance who is studying COVID-19 vaccine responses in people with blood cancers, told me. People living with HIV are facing a different type of immune deficit. The virus annihilates immune cells called helper T cells, which coax young B cells into churning out antibodies and spur other T cells, called killers, to assassinate infected cells. Without helper T cells, the body’s coordinated defenses against disease very often crumble. “We know from other vaccines that people with very low [helper T-cell] counts do not mount a good response,” Boghuma Kabisen Titanji, an infectious-disease physician who works with HIV patients at Emory University, told me. Potent antiretroviral therapies can buoy helper T-cell counts, but they don’t work for everyone. Titanji’s strategy with her patients has been to manage expectations about vaccination: “You will get some protection, but I can’t tell you for certain you’ll have the same degree of protection as others.” “We’re still telling them to use full precautions and social distance” after vaccination, Ujjani told me of her own patients. Some people might benefit from the most conservative approach of all, she said: “It’s almost as if the vaccines didn’t exist.” Laboratory immunology is often a game of subtractions and additions. Scientists will snuff out certain genes, or monitor the health of animals with faulty immune cells, and see how they react to a bevy of infections. Translating those results to humans is inevitably messy; researchers can’t tinker with the health of people in the same invasive ways. But vaccinating real, diverse patient populations could offer a similar set of immunological hints. Multiple sclerosis and other autoimmune diseases, for example, can be treated with a multitude of drugs, each targeting a slightly different branch of the immune system. John Wherry, an immunologist at the University of Pennsylvania, told me that he and his colleagues hope to suss out which of these medications most often punches holes in vaccine-induced protection: If one group of patients is unusually vulnerable after vaccination, that distinction might then clue scientists into which cells and molecules are most crucial for protection. “The composite picture can really tell you a lot,” Wherry said. Data like these could help tailor future vaccines to immune systems that have been altered by drugs or disease, or that have simply aged out of maximal protection. In early results, researchers are already seeing how different groups of immunocompromised people are varying in their response to the shots. Ghady Haidar, a transplant infectious-disease physician at the University of Pittsburgh, told me that his team did not detect antibodies in about 46 percent of blood-cancer patients who had received both doses of the Pfizer or Moderna vaccine. Two studies out of Johns Hopkins University found no evidence of antibodies in 26 percent of people with rheumatic or musculoskeletal disease (a group that includes rheumatoid arthritis and lupus), and 83 percent of organ-transplant recipients, after their first dose of the Pfizer or Moderna vaccine. Dorry Segev, a transplant surgeon and an author of both studies, told me that his team will soon publish data that show those percentages do drop after the second vaccine dose, down to below 50 percent or so in the transplant group. Still, across studies, even patients who did produce antibodies seemed to mount a somewhat muted response. For many people in these studies, negative antibody results have been a source of anxiety, especially while vaccinated friends and family are presumably antibody-rich and beginning to venture back into public. Rick Phillips, who is participating in Johns Hopkins’s research, told me he was “very stressed” to discover that he had not produced detectable antibodies in response to his first vaccine dose; he’ll be taking another test tomorrow to see if the second shot made a difference. But these early antibody data have big caveats. Measuring antibody levels captures only a small subset of the immune system’s protective potential, which includes a dizzying array of other cells. In some cases, antibodies might be almost entirely dispensable, as long as there are other immune defenders to fill the void. “The immune system doesn’t put all its eggs in one basket,” Wherry said. [Read: Leave your antibodies alone] Researchers also don’t yet know the quantity or quality of antibodies necessary to guard against the coronavirus or the symptoms it can cause. The vaccines available in the United States all tickle typical immune systems into making gobs and gobs of antibodies—very possibly more than is absolutely necessary to guard against the coronavirus. People with ostensibly healthy immune systems exhibit an enormous range of antibody responses to vaccines. So for individuals, low antibody levels shouldn’t be cause for panic, Robin Avery, one of the authors on the Johns Hopkins transplant study, told me. Even if antibody levels fall below the as-yet-undefined threshold of complete protection, the molecules might still be abundant and potent enough to curb the severity of symptoms, as they often do when the flu vaccine is given to people who are immunocompromised. (For these reasons and more, nearly every expert I spoke with advised extreme caution against, or actively discouraged, seeking out commercial antibody tests—many of which don’t even look for the antibodies that will be produced after a vaccine—as a way to test whether a shot was “successful.”) If certain people are confirmed to be less protected by current vaccine regimens, they’ll likely have other options for protection. Haidar, of the University of Pittsburgh, noted that people who don’t produce antibodies in response to the hepatitis B vaccine, for example, will sometimes be administered a second three-dose series of the vaccine. Avery, of Johns Hopkins, also noted that older people, whose immune systems tend to be a little sluggish, are given higher doses of flu vaccines, which might have a better shot at jump-starting their cells. And early trials in nursing homes have hinted that monoclonal-antibody treatments can be administered as a preventative to keep coronavirus infections at bay—a sort of temporary pseudo-vaccine. None of these options has yet been rigorously tested, though. For now, there’s a clear approach for immunocompromised people, Dorlan Kimbrough, a neurologist who treats people with multiple sclerosis at Duke University, told me. As one of his colleagues put it: “Get vaccinated, but behave as though you’re not." In some ways, the habits many people adopted during the pandemic are familiar for immunocompromised people. “We don’t spend a lot of time out and about in crowds,” Toni Grimes, a 48-year-old retired Army major in Phoenix, Arizona, who takes rituximab for lupus, told me. “The way everything felt with the pandemic—masks, hand sanitizing, staying away from people who are sick—we already do that every day.” But as vaccinated friends and family loosen up on masking and distancing, some people, like Patty Adair, 74, of Newton, Massachusetts, have felt left behind. Adair takes a heavily immunosuppressive drug called mycophenolate, which subdues both B cells and T cells, to treat her autoimmune hepatitis, and worries that the treatment hampered her ability to respond to the Moderna vaccine, which she completed in early March. “I feel almost as vulnerable as before I had the vaccine,” she told me. “I have done so much to keep safe over this past year. I would not change any of it. But I’d just like to feel a little safer.” [Read: Pregnant? The vaccine may protect you and your baby] For now, immunocompromised people will have to rely on those who can confidently derive protection from vaccines, such as household members, health-care providers, and other close contacts. That puts some of the impetus on the rest of the world: “Every vaccine that goes into an arm is protection for these people,” Longbrake, of Yale, said. The cost of neglecting the health of immunocompromised people can be staggeringly high. It will be far harder to stop the coronavirus from spreading if entire swaths of people remain unprotected. Those who struggle to clear the virus may also end up harboring it for months at a time, allowing it to mutate before it hops to another host. “This is how some variants emerged,” Ali Ellebedy, an immunologist at Washington University in St. Louis, who is studying vaccine responses in immunocompromised patients, told me. It’s a clear reason, he and many others noted, to ensure the needs of these individuals are understood and met, for their sake and everyone else’s.At home in Indianapolis, Rick Phillips remains hunkered down. Sheryl, his wife, is becoming “more adventurous” by the day, Rick told me. It’s painful, he said, to have to keep turning down lunch invitations from old work colleagues and friends, and to still not know when he’ll next see his grandchildren. He is already seeing the world inch forward without him. But Rick plans to stay the course; he can’t risk making any other choice. “We’re too close to the end,” he said. Slip up now, “and you don’t get a second chance.” The Atlantic’s COVID-19 coverage is supported by a grant from the Chan Zuckerberg Initiative. from https://ift.tt/2Q3rg4E Check out http://natthash.tumblr.com A year ago, when the United States decided to go big on vaccines, it bet on nearly every horse, investing in a spectrum of technologies. The safest bets, in a way, repurposed the technology behind existing vaccines, such as protein-based ones for tetanus or hepatitis B. The medium bets were on vaccines made by Johnson & Johnson and AstraZeneca, which use adenovirus vectors, a technology that had been tested before but not deployed on a large scale. The long shots were based on the use of mRNA, the newest and most unproven technology. The protein-based vaccines have moved too slowly to matter so far. J&J’s and AstraZeneca’s vaccines are effective at preventing COVID-19—but a small number of recipients have developed a rare type of blood clot that appears to be linked to the adenovirus technology and may ultimately limit those shots’ use. Meanwhile, with more than 180 million doses administered in the U.S, the mRNA vaccines have proved astonishingly effective and extremely safe. The unusual blood clots have not appeared with Pfizer’s or Moderna’s mRNA technology. A year later, the risky bet definitely looks like a good one. The U.S. has ordered enough mRNA vaccines to inoculate its entire population. In that context, the CDC and FDA’s call to pause the J&J rollout this week is a blow to the American inoculation campaign, but hardly a devastating one. (J&J’s vaccine accounts for less than 5 percent of doses administered so far, and AstraZeneca’s has not yet been authorized in the U.S.) But the rest of the world has been banking on the J&J and AstraZeneca vaccines, which are both cheaper and easier to distribute because they don’t require the same cold storage as mRNA vaccines. If the blood-clot risk is real, the divide between the mRNA-vaccine haves and have-nots will only grow. The U.S. will be fine; the rest of the world will face difficult questions about balancing the risks and benefits of an affordable, good-but-not-best vaccine against a disease that has killed nearly 3 million people. [Read: What’s the use of a pretty good vaccine?] The blood-clot events with the AstraZeneca and J&J vaccines are so rare—appearing in one in 100,000 to one in 1 million vaccine recipients—that they would not have shown up in clinical trials, even ones conducted within more leisurely, non-pandemic timelines. (The COVID-19 vaccine trials, which generally included tens of thousands of participants each, were actually unusually large because researchers wanted data as quickly as possible.) “It’s true with all new medications of any sort. You only find rare events when things are rolled out to very vast numbers of people,” says John Grabenstein, the associate director of scientific communication for the Immunization Action Coalition, who used to work on vaccines for the pharmaceutical giant Merck. “One-in-a-million events are just barely measurable.” That faint signal is especially difficult to see against a noisy background: Some people get blood clots for reasons unrelated to the vaccine, too. In Europe, the strange nature of these blood clots tipped doctors off to a possible link to AstraZeneca’s vaccine. The patients with clots also had low numbers of platelets, which are tiny blood cells that help with clotting. Normally, someone with a low platelet count cannot form clots and bleeds as a result. But in these people, who had all recently gotten an AstraZeneca shot, an immune reaction may have set off uncontrolled clotting that bound up all their platelets. Some scientists now hypothesize that the immune reaction is triggered by some part of the adenovirus-vector technology. If that’s true, these blood clots might show up as a rare side effect with other adenovirus-vector vaccines, such as Russia’s Sputnik V and China’s CanSino, as well as J&J’s Ebola vaccine. But they clearly are very infrequent. The AstraZeneca and J&J coronavirus vaccines are the first adenovirus-vector vaccines to even be deployed widely enough in the U.S. and Europe for a pattern to emerge. [Read: 3 different futures for the Johnson & Johnson vaccine] mRNA vaccines are similarly new, but they have so far racked up a good safety record. So many doses have been administered that these unusual blood clots—or any serious one-in-a-million event—would very likely have shown up by now. Back in December, experts quickly noticed and warned the public about a handful of severe allergic reactions to the Pfizer and Moderna vaccines, which is why vaccination sites now monitor recipients for 15 to 30 minutes after the jab. In addition, doctors have picked up on a possible one-in-a-million risk of a bleeding disorder called immune thrombocytopenia, which happens when the immune system attacks platelets after vaccination. (It’s a rare but documented side effect of some other vaccines, such as the one against measles.) These patients do have low platelet counts, but they do not have the accompanying blood clots that seem unique to adenovirus-vector vaccines. Immune thrombocytopenia is easily diagnosed and treated, James Bussel, a pediatrics professor at Weill Cornell Medicine who studies the condition, told me in an email. But the unusual combination of blood clots and low platelets is trickier. For example, one standard treatment for clots is a blood thinner called heparin, but the drug can, in very rare cases, cause the exact combination of low platelets and blood clots that doctors are concerned about. Experts now fear that heparin might make the potential vaccine reaction even worse. This combined condition also seems to be more dangerous than immune thrombocytopenia, but the prognosis may improve as more doctors learn how to treat it. U.S. officials expect the J&J pause to last no more than a few days, as experts review the safety data and potentially revise recommendations. After a similar pause and review of the AstraZeneca data in Europe, several countries restricted that vaccine to older residents. (Most of the 86 blood-clot cases observed with the AstraZeneca vaccine in Europe were in women under 60, as were all six cases observed with the J&J vaccine in the U.S.) The U.K. now recommends that people younger than 30 be offered a different vaccine if possible. [Read: The differences between the vaccines matter] The recommendations take into account individual risk: For older people at high risk of severe COVID-19 complications, the benefits of the vaccine clearly outweigh the risks of a blood clot. But for young people at lower risk from the coronavirus, the benefits are not so clear. For regulators, that balance also depends on whether a country has any other vaccines available and the severity of its local COVID-19 outbreak. The European Union and the U.K. do not have as many mRNA vaccines as the U.S., and less wealthy nations have even less supply. Ultimately, every country will have to do its own benefit-risk calculation. The U.S.’s recommendations may end up diverging from other countries’, but they may also influence them. Sean O’Leary, a pediatrician at the University of Colorado and a liaison to the CDC’s Advisory Committee on Immunization Practices, notes two historical examples. Although the United States has discontinued use of the oral polio vaccine—which is more effective and easier to administer than the shot, but also carries a one in 2.5 million risk of paralysis after infection with the live virus in the oral vaccine—the WHO continues to recommend it in countries where polio is endemic. But when the U.S. in 1999 stopped using a vaccine against rotavirus because of rare reports of intestinal blockage, the rest of the world fell in line, despite the fact that the virus was killing about half a million kids worldwide each year. “The decision was made, essentially, if it’s not good enough for you, it’s not good enough for us,” O’Leary says. Eventually, two newer rotavirus vaccines with a lower risk of complications were developed. They are now used in the U.S. and around the world. With rotavirus, the vaccine conundrum became moot as new alternatives became available. With COVID-19, those alternatives already exist in the form of mRNA vaccines. There was no guarantee that the mRNA shots would be ready so quickly, or turn out to be so good and so safe. That they did is a great stroke of luck. But in the near future, the Pfizer and Moderna vaccines’ limited supply, high price, and distribution challenges will make them functionally unavailable to much of the world. The U.S. can afford, literally, to vaccinate most of its population with Pfizer’s and Moderna’s vaccines. Most other countries cannot. The Atlantic’s COVID-19 coverage is supported by a grant from the Chan Zuckerberg Initiative. from https://ift.tt/2ORPsXk Check out http://natthash.tumblr.com The Johnson & Johnson vaccine has entered regulatory purgatory. This morning, the CDC and FDA jointly recommended, “out of an abundance of caution,” a nationwide halt to the single shot’s rollout. The two agencies are investigating a rare blood-clotting disorder: In the six cases reported so far, all in the United States, women ages 18 to 48 developed an unusual type of blood clot within about two weeks of receiving the company’s inoculation. Experts haven’t yet conclusively determined whether J&J’s vaccine is directly causing these strange clots, or how frequently the condition might be occurring, because they’re relying largely on people reporting their health conditions to federal agencies. Roughly 7 million doses of the vaccine have been administered so far in the United States; among them were about 1 million women under the age of 50. “I think it’s reasonable to say it is a rare event, but I don’t think we should go into false precision in this kind of situation,” Saad Omer, a vaccine expert at Yale, told me. “Our numerators and denominators are still emerging.” Though the pause isn’t mandatory, most states have decided to temporarily pull the J&J vaccine and replace it with shots made by Moderna and Pfizer-BioNTech—neither of which has been associated with clots—when possible. The announcement has, within a matter of hours, trapped past and future recipients of J&J’s jabs in an uneasy limbo. Still, this particular in-between place has an exit, and the situation is in many respects more reassuring than not. I talked with 12 people today, including one who had recently received the J&J shot and several others who had originally intended to. They all struck a similar note: The pause is a reflection, they told me, of federal regulation in action—responding to even the tiniest hint of a safety issue, in case it blossoms into something serious. In similar situations, other vaccines have been subject to the same scrutiny; it’s not that uncommon for products to hit roadblocks after initial clearance. “I’m somewhat concerned, but I’m not freaking out,” Omer said. With the right monitoring systems in place, investigations like this can and should happen, with transparency. “This is the system working as intended,” Natalie Dean, a biostatistician at the University of Florida who studies vaccine trials, told me. “We’re paying close attention to even these exceedingly rare outcomes.” People who have already gotten the J&J vaccine absolutely shouldn’t panic, especially if more than a month has passed since they received their dose. So far, the incidents documented seem to be occurring with the first couple of weeks post-vaccination. The CDC and FDA recommend that more recent recipients should contact their health-care provider if they develop severe headaches, abdominal pain, leg pain, or shortness of breath within three weeks of their injection. (Those worrisome symptoms shouldn’t be confused with the mild headaches, aches, and other flu-like symptoms that commonly arise as side effects within the first couple of days of any COVID-19 vaccine.) Adverse effects also don’t detract from a vaccine’s effectiveness at preventing COVID-19, so there’s no need to seek out another vaccine to supplant J&J’s. Angela Rasmussen, a virologist affiliated with Georgetown University, told me she received J&J’s vaccine eight days ago, which puts her squarely in this sensitive window. She also falls within the age range of the women who reported post-vaccination clotting. She’ll be on the lookout for any unusual symptoms, but is “keeping it all in perspective,” she said. Even if experts do determine that the vaccines are at the root of these clots, they are probably very, very rare. “If I thought I was going to get a blood clot, I would also buy a lottery ticket,” Rasmussen told me. Blood clotting disorders, should they ultimately be tied to this vaccine, won’t necessarily end Johnson & Johnson’s current bid for COVID-19 immunization. Certain types of estrogen-containing oral contraceptives and hormone therapies carry similar concerns, but have yet to be pulled from the market. (Rasmussen told me that those potential side effects didn’t stop her from using oral birth control for the better part of 20 years.) The clots reported after J&J immunization—called cerebral venous sinus thromboses--are in an unusual class. A very similar clotting problem has been reported after injections of AstraZeneca’s COVID-19 vaccine, which strongly resembles the J&J shot in formulation; several European countries have restricted the Astrazeneca shot for use in older adults only. One benefit of publicizing the potential problem with J&J right now is that federal health officials can alert doctors to the right treatments. They have advised against deploying heparin, one of the most common blood thinners prescribed for clots, in these patients, because it has the potential to exacerbate this specific condition. Luckily, an entire arsenal of alternative treatments exists. “It’s really important to know what to be looking for right now,” Céline Gounder, an infectious-disease physician at Bellevue Hospital in New York, where some patients have been receiving the J&J vaccine upon discharge, told me. For people still waiting to get vaccinated, the pause could introduce some temporary, regional speedbumps into the rollout. But Johnson & Johnson shots already made up a minority of the injections being doled out to Americans, and supply has sputtered because of a recent factory snafu that compromised up to 15 million doses. Many people who were signed up for these shots in the near future should be able to switch to an mRNA-based alternative. (I was signed up to get a J&J shot this week; I’ll be getting Pfizer instead.) The CDC and FDA are also expected to issue updates within the next few days, leaving open the possibility that vaccines will continue largely on schedule thereafter. The forecast further out is murky. A panel of experts must now determine if the vaccine and these clots are conclusively linked. This will involve comparing the rate at which blood clots occur shortly after a J&J vaccination to their incidence in the general, uninoculated population. These cases could still be chalked up to coincidence, or possibly to an unidentified underlying condition that afflicted all six women. Clinical trials found the J&J vaccine to be safe as well as effective; that verdict could certainly hold after this new round of federal vetting. Pauses, Omer told me, aren’t revocations or excoriations of a product. Instead, they make space for experts to suss out a situation and revise the playbook as needed. “Hopefully one outcome would be that we develop a better understanding of this issue, and who’s specifically at risk,” Dean told me. If researchers establish that there is a risk relationship, they’ll next need to determine its extent, and weigh it against the relative risk of remaining unvaccinated. Since the start of the pandemic, the coronavirus has killed nearly 3 million people around the globe, and saddled many thousands of others with lasting, debilitating symptoms. Contracting the coronavirus, too, has been linked to blood clots, which appear, by some estimates, in about 20 percent of COVID-19 patients, and 31 percent of patients who end up in intensive care. Several experts told me that they’d need to see many, many more clotting events to even consider pulling an otherwise highly successful and effective vaccine from the global market, especially while many countries struggle to acquire, store, and administer vaccines. A Johnson & Johnson recall would be “a disaster,” Rasmussen told me. “We need all the doses we can get.” Strictly by the numbers, the United States could get by without Johnson & Johnson. Hopefully, it won’t have to. Federal regulators could follow the lead of their counterparts in Europe, who have recommended alternatives to the AstraZeneca vaccine for younger people; they could also add a cautionary clause specifically for cisgender women and certain transgender or intersex people who might be at higher risk. Johnson & Johnson’s vaccine still has immense appeal. Unlike its two-dose Moderna and Pfizer counterparts, it’s a one-and-done shot—a potentially big boon for people who can’t easily travel to and from inoculation sites, or otherwise access the injections. Vials can also be stored at refrigerator temperatures for months, making the shots easier to ship to parts of the world with few resources. “We were really counting on these to help vaccinate the world,” Gounder told me, referring to J&J, AstraZeneca, and other shots with similar recipes. Based on what we know so far, the future of the J&J vaccine can fork in at least three different directions. In one, the vaccine flames out; unless many, many more cases come to light soon, this seems unlikely. There’s a higher chance that officials will end the pause and return the nation to its regularly scheduled vaccine programming, with or without restrictions on who gets J&J next. Either way, though, today’s announcement won’t quickly be forgotten. Pauses in clinical trials, sprinkled through the past year, have already stoked vaccine hesitancy, skepticism, and outright denialism in many circles. The Johnson & Johnson vaccine, previously stigmatized for being “less effective,” now risks a second label—“less safe.” It’s on the precipice of becoming our country’s grody vaccine; maybe it’s already toppled over the edge. An altered reputation in the U.S. will reverberate throughout the world, and set back the global struggle to contain the coronavirus. If the J&J vaccine does return with the FDA’s blessing, we’ll need to rehabilitate it with clear and nuanced messaging, Gounder and many others told me. A vaccine can be excellent. A vaccine can also carry risks. Both can be true; both have been true, for other shots we’ve used. In this case, the gamble could be very small—and still be well worth it. The Atlantic’s COVID-19 coverage is supported by a grant from the Chan Zuckerberg Initiative. from https://ift.tt/3uN3gBB Check out http://natthash.tumblr.com |
Authorhttp://natthash.tumblr.com Archives
April 2023
Categories |