For nearly two years now, Americans have lived with SARS-CoV-2. We know it better than we once did. We know that it can set off both acute and chronic illness, that it spreads best indoors, that masks help block it, that our vaccines are powerful against it. We know that we can live with it--that we’re going to have to live with it—but that it can and will exact a heavy toll. Still, this virus has the capacity to surprise us, especially if we’re not paying attention. It is changing all the time, a tweak to the genetic code here and there; sometimes, those tweaks add up to new danger. In a matter of weeks, the Delta variant upended the relative peace of America’s early summer and ushered in a new set of calculations about risk, masking, and testing. The pandemic’s endgame shifted. Do vaccines work as well as they need to? Who is now most vulnerable? What new variants might emerge? Our lost summer has layered on new anxieties to pandemic life. But these questions do have some clear answers, which have come up time and again in our reporting and will continue to guide us through the coming months. Even after this latest surge crests and subsides, the new pandemic reality will linger, through fall and winter and into the spring, as vaccination rates rise and the virus continues to change. Here are six principles that are helping us make sense of the pandemic now: The role of vaccines has changed (again)The COVID-19 vaccines were originally meant to prevent severe infections. They do so very well. But for a few brief months, we thought they could do even better. Unexpectedly spectacular clinical-trial results from Pfizer and Moderna raised hopes that these vaccines could protect against almost all symptomatic infections and might even be as good as the vaccines against polio and measles, which eliminated transmission of those diseases in the United States. But, from the very beginning, vaccine experts warned that respiratory diseases are especially tricky to immunize against. The coronavirus first takes hold in the nose, and injections in the arm are just not very good at stimulating immunity in the nose. (They are still good, however, at raising immunity deep in the lungs to protect against severe disease.) Flu shots, for example, tend to be only 10 to 60 percent effective at keeping people out of the doctor’s office. If COVID-19 vaccines end up somewhere similar, they would prevent hospitalizations and death, but the coronavirus would still circulate. Given Delta’s ability to slightly evade vaccines, combined with its extreme transmissibility, this is again looking like the most likely scenario. So we need to adjust our expectations, again. Vaccines work more like dimmer switches than on/off buttons, and as their protection fades out, there are three thresholds that we care about: protection against infection, against symptoms, and against severe disease. Protection against infection is always the first to erode—either because of new variants or because of waning immune responses over time. Protection against symptoms goes next, but protection against severe disease is the most durable. (One unknown is how much vaccines prevent long COVID, although a recent study found that full vaccination can decrease the risk of long-lasting symptoms.) We’ve seen this pattern play out: Breakthrough infections are happening with Delta, but they tend to be mild or even asymptomatic. And especially when case numbers get very high—as they are in many parts of the U.S. now--additional layers of protection, including improved ventilation and masks, are necessary to protect people, such as young children, who are still unvaccinated. Vaccinating as many people as possible as quickly as possible is still the most powerful way to control the virus. We can already see how well the vaccines are working. The proportion of vaccinated people matters, but who they are and how they cluster also mattersDelta caused a new wave of cases in even the most vaccinated countries in the world, but the wave of hospitalizations that followed there have generally been much more modest. In the U.K., for example, where 66 percent of people are fully vaccinated, cases reached 80 percent of their winter peak this summer. But hospitalizations rose less than 25 percent. As U.K. health officials have declared, vaccines are “breaking the link” between infections and hospitalizations. Again, this means the vaccines are working. The United States seems to paint a different picture. Overwhelmed hospitals are turning patients away. They’re running out of oxygen. They’re once again cramming beds into conferences rooms and cafeterias. It feels like déjà vu—even though 54 percent of Americans are also fully vaccinated. The difference between the U.K. and the U.S. isn’t just that fewer Americans are vaccinated. It’s that fewer of the most vulnerable Americans are vaccinated, and they tend to cluster together. Risk of death and hospitalizations from COVID-19 rises sharply with age, and in the U.K. nearly everyone over 65 is vaccinated. A New York Times analysis found very few areas in the U.K. where more than 2 percent of residents are 65 and not fully vaccinated. In contrast, that number is above 10 percent in many counties in the American South and Mountain West. Even small differences in these rates can determine the level of crisis: A community where 10 percent of residents are unvaccinated seniors has essentially five times as many people who might need an ICU bed than a community where that number is only 2 percent. Vaccine coverage also varies dramatically from county to county in the U.S. The more unvaccinated people are concentrated, the more easily the virus can find its next victim. Imagine three out of four people in every household are vaccinated; the unvaccinated person is unlikely to spread the virus very much at home, says Graham Medley, an infectious-disease modeler at the London School of Hygiene & Tropical Medicine. Now imagine three out of every four households are completely vaccinated; the virus will spread through the unvaccinated households. The overall vaccination rate is the same, but the results are very different. This unevenness also means that … The people at greatest risk from the virus will keep changingSince the pandemic’s early days, vaccines have shifted the risk the virus poses to us, at a community level. Older people and health-care workers were among the first in line for the shots—a practical move to protect the people whose underlying conditions or jobs ranked them among the most vulnerable. But younger members of the community had to contend with a slower schedule, and vaccine makers are still figuring out the correct dosages for the youngest among us. That’s all shifted the virus’s burden down to uninoculated children. At the same time, the virus has been evolving into speedier and speedier forms; by the time Delta slammed the world this spring, many of its most viable hosts were at risk not because of their age or circumstances, but in spite of it. [Read: You might want to wait to get a booster shot] Kids still seem relatively resilient against SARS-CoV-2 compared with adults, as they always have been. But compared with the variants that came before it, Delta is a faster spreader, and therefore a larger threat to everyone who is unvaccinated—which means children are now at greater risk than they were before. Relative risk will keep shifting, even if the virus somehow stops mutating and becomes a static threat. (It won’t.) Our immune systems’ memories of the coronavirus, for instance, could wane—possibly over the course of years, if immunization against similar viruses is a guide. People who are currently fully vaccinated may eventually need boosters. Infants who have never encountered the coronavirus will be born into the population, while people with immunity die. Even the vaccinated won’t all look the same: Some, including people who are moderately or severely immunocompromised, might never respond to the shots as well as others. The assumptions we first had about whom the virus might hit hardest will keep changing, as will the population of people who fall ill at all. As vaccination increases, a higher proportion of cases will appear in vaccinated people—and that’s what should happenIn July, after a COVID-19 outbreak in Provincetown, Massachusetts, a Washington Post headline noted that three-quarters of the people infected were vaccinated. Throughout the summer, many stories have reported similar figures, always with the same alarming undercurrent: If vaccines are working, how could vaccinated people make up such a large proportion of an outbreak? The answer is simple: They can if they make up a large proportion of a population. Even though vaccinated people have much lower odds of getting sick than unvaccinated people, they’ll make up a sizable fraction of infections, hospitalizations, and deaths if there are more of them around. Let’s work through some numbers. Assume, first, that vaccines are 60 percent effective at preventing symptomatic infections. (There’s a lot of conflicting information about this, but the exact number doesn’t affect this exercise much.) Vaccinated people are still less likely to get infected, but as their proportion of the community rises, so does the percentage of infections occurring among them. If 20 percent of people are fully vaccinated, they’ll account for 9 percent of infections; meanwhile, the 80 percent of the population that’s unvaccinated will account for 91 percent. Now flip that. If only 20 percent of people are unvaccinated, there will be fewer infections overall. But vaccinated people, who are now in the majority, will account for most of those infections—62 percent. That is why this particular statistic—the proportion of vaccinated people in a given outbreak—is so deeply misleading. “The better the vaccine uptake, the scarier this number will seem,” wrote Lucy D’Agostino McGowan, a statistician at Wake Forest University. By extension, the safer communities become, the more it will seem like the sky is falling—if we continue focusing on the wrong statistics. “If you’re trying to decide on getting vaccinated, you don’t want to look at the percentage of sick people who were vaccinated,” McGowan wrote. “You want to look at the percentage of people who were vaccinated and got sick.” Note percentage. In July, an NBC News article stated that “At Least 125,000 Fully Vaccinated Americans Have Tested Positive” for the coronavirus. In isolation, that’s an alarming number. But it represented just 0.08 percent of the 165 million people who were fully vaccinated at the time. More recently, Duke University reported that 364 students had tested positive in a single week—a figure that represents just 1.6 percent of the more than 15,000 students who were tested. The denominator matters. The denominators in these calculations also change, dragging the numerators higher along with them. As surges grow, so too will the number of infected people, which means the number of breakthrough infections will also grow. Even if the percentage of breakthroughs stays steady, though, vaccines will feel less effective if the pandemic is allowed to rage out of control, because … Rare events are common at scaleThroughout the past year and a half, commentators have downplayed a variety of pandemic-related risks because they were “rare”—deaths, long COVID (which isn’t actually rare), infections and multisystem inflammatory syndrome in children, and more. But infectious diseases spread, and if they do so widely enough, events that are relatively rare can rack up large numbers: A one-in-a-thousand event will still occur 40,000 times when 40 million people are infected. Such events can’t be written off, especially when they involve decades of lost health or life. As outbreaks spread, more types of rare events become noticeable as well. A wider pandemic is also a weirder pandemic. Many aspects of COVID-19’s mystique—the range of symptoms and affected organs, the possibility of persistent illness, reinfections—are common to other viral illnesses, but go unnoticed because most illnesses don’t sweep the world in a short span of time. Similarly, as this current post-vaccine surge continues, breakthrough infections will feel more common, newspapers will have more stories to run about them, and more people will know someone who had one. Our reaction to such events must account for both the denominator and the numerator—both how relatively common they are and how much they cost each affected individual. And that assessment will change as the pandemic waxes and wanes, and as the virus itself continues to mutate. There is no single “worst” version of the coronavirusAs in every game, who the most formidable opponent is depends on who else is playing, and the nature of the field. Right now Delta, a super-transmissible variant that hops into human airways, copies itself, and blazes back out, is especially well poised to rip through the world’s mostly unvaccinated, mostly immune-naive population—which is exactly what it’s doing. Laxness around masking, distancing, and other infection-prevention measures, in the United States especially, has given Delta plenty of opportunities to hop from human to human, further fueling its rise. The variant, for now, has about as good a home-field advantage as it can get. But the ideal strategy, from the perspective of the virus, might look drastically different for a population with a lot more immunity. Strong, speedy immune responses will keep the virus from getting by on swiftness alone. In these environments, a stealthy version of the virus that can slip by antibodies unnoticed might be the one that wins out. The virus’s goal will still be to spread, just through different means: Mutations that make the virus less visible will help it stick around in airways longer, and potentially transmit to more people in the process. As the world gradually acquires immunity, variants like Delta might eventually be succeeded by these wilier morphs. But these transitions will likely happen at different rates in different countries, depending on who gets access to vaccines. The definition of most threatening will splinter along borders. (There is, by the way, little incentive for the virus to get deadlier along the way. Viruses want to spread, not kill. Still, some pathogens can get symptomatically nastier as a by-product of transmissibility, or if those symptoms facilitate their spread.) All variants, though, will have some common weakness: They can be stopped through the combined measures of vaccines, masks, distancing, and other measures that cut the conduits they need to travel. When viruses spread faster, they can be tougher to control. But they can’t persist without us, and our behavior matters too. from https://ift.tt/3lFTxKt Check out http://natthash.tumblr.com
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After a long and tense meeting today, an FDA committee unanimously recommended that the agency authorize third shots of the Pfizer COVID-19 vaccine for Americans who are over 65 or at high risk of severe COVID. The vote came after the panel voted overwhelmingly against the original question up for its consideration: authorizing boosters for everyone over 16. If the FDA follows the committee’s recommendation (as is expected), a CDC committee will help refine those guidelines next week, clarifying which groups qualify as “high risk.” Even as we await these final decisions, the nation’s summer wave of COVID infections seems like it’s beginning to pass. Cases and hospitalizations are trending slightly downward. Now that we have more clarity about whether (and which) Americans need booster shots—and given that so many people are already getting boosters, eligibility be damned—more questions loom: When, exactly, should those people get those shots? Is it better to load up on extra antibodies as soon as possible, or should people wait until COVID rates start to rise again? Here’s a simple starting point: If you’re already eligible for a third shot because you’re immunocompromised, get it on the sooner side. The CDC recommends at least a 28-day wait after your second mRNA dose or first Johnson & Johnson jab, while two experts told me that the best window is four to five months after. In many immunocompromised people, the first one or two shots might not have triggered a strong enough response in the body to provide lasting protection. For them, the booster shot isn’t meant to fill in the cracks of your shield against the virus; it’s meant to create that shield in the first place. Things get squishier for vaccinated people with relatively healthy immune systems. They’ll already be flush with newly minted B and T cells, which lie in wait to produce antibodies and attack the coronavirus. Ali Ellebedy, an immunologist at Washington University in St. Louis, told me that the longer those cells mature in the body, the more prepared they are to fight off the invader. Delivered too early, another dose of the vaccine could end up “restarting something that was already working,” he said. Ellebedy recommended delaying any booster shots by at least six months from your initial course of vaccination. Eight months is better; even a year would be fine. At the same time, booster shots do increase the measurable level of antibodies in the blood, pretty much whenever they’re received. The clinical benefits of this spike for fully vaccinated people remain unclear, though some preliminary evidence suggests that an antibody surge could reduce your chances of getting sick, or of transmitting the Delta variant to other people—at least until your antibody levels wane once more. Most people’s antibody levels peak a few weeks after their initial COVID-vaccine shots. If that holds true for boosters, too, then you might be tempted to time your next injection for three-ish weeks before you’d most want to be protected. Maybe the virus surged in your county last December, and you’re afraid it’ll do the same this year—so you decide to get your booster around Veterans Day. Maybe you want to make sure you don’t infect Uncle Dave at Thanksgiving—so you make an appointment for Halloween. The problem is, “a few weeks” is just an average. Müge Çevik, a virologist at the University of St. Andrews, told me that different people develop antibodies at wildly different rates. In general, young, healthy people’s immune systems work quickly and can start to approach their peak antibody levels in as little as seven days. Older people, or those with compromised immune systems, can take weeks longer. Given that we don’t know how long those spikes last, these differences could be crucial. Also, predicting when you’ll be in the most danger requires predicting when transmission in your community will be at its highest, which is nearly impossible to do with any precision. “It is very likely we will see another surge” this winter, Saskia Popescu, an infectious-disease epidemiologist at George Mason University, told me, but identifying the specific week or month when cases will peak in a given place just isn’t feasible. (Even a winter surge isn’t a sure bet: “At the moment, we don’t really have a consistent seasonal pattern,” because all of our surges have been shaped by behaviors like masking and distancing, Çevik said.) Popescu also pointed out that the rise of at-home testing and the decline of mass testing sites could make it harder to detect smaller upward ticks until a surge is fully upon us. Still, the mere likelihood of a winter surge does make it reasonable to wait, at least a bit. Çevik worries that if a large number of people rush out to get their extra shots, their antibodies will have faded by the time they’re needed most, and a winter surge could see even more breakthrough infections. Çevik advised her own parents, whom she described as being “in clinically vulnerable groups,” to get their boosters at the end of September or in October. Young people with healthy immune systems could stand to wait until November or early December. (This advice comes with exceptions: If you’re, say, a nurse on a COVID ward in a county where cases are spiking, getting a booster now might be prudent.) Ultimately, the dynamics of transmission in your area may be more important than the details of your personal vaccine schedule. David Dowdy, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, would rather see boosters distributed sparingly and strategically to communities that show signs of an impending surge. While everyone else waits, vaccine makers could update their formulas to better protect against Delta and set up randomized controlled trials to gather better data on how their original doses and boosters are performing. On an individual level, Dowdy told me, there’s probably minimal harm in eligible people getting third shots now. But vaccine makers might have a new shot in a few months, designed around circulating variants, or even an intranasal option that can stop infections sooner. Once the government announces that tens of millions of people should get a booster now, persuading them to do so again in a few months, when a better option is available, could be difficult. And those who decide to get a booster now might find they’re ineligible for a fourth shot when that better option comes. Case rates might seem scary now, but this pandemic has proved time and again that things can certainly get worse. “I think it’s important to not just say, Should I get a booster or not?” Dowdy said, “but rather, Would I prefer to have a booster now or save the opportunity for later?” from https://ift.tt/3tPdIcw Check out http://natthash.tumblr.com Immune cells can learn the vagaries of a particular infectious disease in two main ways. The first is bona fide infection, and it’s a lot like being schooled in a war zone, where any lesson in protection might come at a terrible cost. Vaccines, by contrast, safely introduce immune cells to only the harmless mimic of a microbe, the immunological equivalent of training guards to recognize invaders before they ever show their face. The first option might be more instructive and immersive—it is, after all, the real thing. But the second has a major advantage: It provides crucial intel in the absence of risk. Some pathogens aren’t memorable to the body, no matter the form in which they’re introduced. But with SARS-CoV-2, we’ve been lucky: Both inoculation and infection can marshal stellar protection. Past tussles with the virus, in fact, seem so immunologically instructive that in many places, including several nations in the European Union, Israel, and the United Kingdom, they can grant access to restaurants, bars, and travel hubs galore, just as full vaccination does. In the United States, conversely, only fully vaccinated Americans can wield the social currency that immunity affords. The policy has repeatedly come into heated contention, especially as the country barrels forward with plans for boosters and vaccination mandates. No one, it seems, can agree on the immunological exchange rate—whether a past infection can sub in for one inoculation or two inoculations, or more, or none at all—or just how much immunity counts as “enough.” Even among the nation’s top health officials, a potential shift in the social status of the once-infected remains “under active discussion,” Anthony Fauci, President Joe Biden’s chief medical adviser, told me. For now, though, he reiterated, “it still is the policy that if you’ve been infected and recovered, that you should get vaccinated.” And in the United States, which is awash in supplies of shots, some version of that policy is likely to stick. Infections and vaccinations, down to a molecular level, are “fundamentally different” experiences, Akiko Iwasaki, an immunologist at Yale, told me. Surviving a rendezvous with SARS-CoV-2 might mean gaining some protection, but it’s no guarantee. What the experts do converge on is this: Opting for an infection over vaccination is never the right move. An unprotected rendezvous with SARS-CoV-2 ultimately amounts to taking a double gamble—that the virus won’t ravage the body with debilitating disease or death, and that it will eventually be purged, leaving only immune protection behind. Questions linger, too, about how long such safeguards might last, and how they stack up against the carefully constructed armor of inoculation. Vaccines eliminate the guesswork—a fail-safe we’ll need to keep relying on as the coronavirus persists in the human population, threatening to invade our bodies again, and again, and again. There’s a reason many of our best vaccines—measles shots, smallpox shots—are near-perfect pantomimes of the pathogens they guard against. The whole point of immunization is to recapitulate infection in a safer, more palatable package, like a driver’s ed simulation, or a practice quiz handed out in advance of a final exam. That means there will usually be big overlaps in how infections and inoculations rouse the immune system into action. COVID-19 vaccines and SARS-CoV-2 infections each elicit gobs of virus-trouncing antibodies, along with a long-lasting supply of the plucky B cells that manufacture them; they each rouse lingering hordes of T cells, which blow up virus-infected cells and coordinate other immune responses. SARS-CoV-2 reinfections and breakthroughs do happen. But they’re uncommon and tend to be milder than the norm, even symptomless. Early evidence in several countries suggests that the two types of immunity are blocking illness at roughly similar rates. “The reality is, both are exceptionally good,” Rishi Goel, an immunologist at the University of Pennsylvania, told me. (One caveat: There’s a paucity of data on how the one-shot Johnson & Johnson vaccine stacks up, though it’s definitely very good at staving off severe disease.) Infection arguably delivers a more comprehensive lesson on the virus, introducing the body to the entirety of its anatomy. Most COVID-19 vaccines, meanwhile, focus exclusively on the spike protein, the molecular lock pick the coronavirus uses to break into cells. And while SARS-CoV-2 first infiltrates the moist mucosal linings of the nose, mouth, and throat, where it can tickle out airway-specific immune defenses, typical COVID-19 shots are blitzed into the arm, mostly marshaling all-purpose antibodies that bop through the blood. That makes it tough for vaccinated bodies to waylay viruses at their point of entry, giving the invaders more time to establish themselves. Some of these differences might help explain the results of a recent, buzzy study out of Israel, in which researchers reported that previously infected individuals were better protected than people who had been fully vaccinated with the Pfizer shots, including against severe cases of COVID-19. “As soon as that paper came out,” Fauci told me, “we obviously discussed the inevitable issue”—whether infection should be enough to exempt someone from a shot. But Fauci, as well as most of the other experts I talked with, cautioned against overinterpreting the results of a single study, especially one documenting only a snapshot in time. Even taken at face value, the “better” defenses offered by post-infection immunity come at a massive potential cost, said Goel, of the University of Pennsylvania. Cells and molecules are scrambling to learn the traits and weaknesses of a foreign invader while their home is being attacked; any infection bears some risk of hospitalization, long-term disability, or death. The virus can also interfere with the immune response, muffling antiviral defenses, severing the ties among disparate branches of immune cells, and, in some cases, even duping the body into attacking its own tissues. And unlike the vaccines, infections are, well, infectious, turning each afflicted person into “a public-health threat,” Nahid Bhadelia, the founding director of Boston University’s Center for Emerging Infectious Diseases Policy and Research, told me. Those who surface from these encounters seemingly unscathed might not have much immunity to show for it, either. Several studies have shown that a decent percentage of infected people might not produce detectable levels of antibodies, for the simple reason that “not all infections are the same,” Beatrice Hahn, a virologist at the University of Pennsylvania, told me. The immune system tends to use its own threat assessment to calibrate its memory, dismissing many brief or low-symptom encounters. That could be an especial concern for people with long COVID, many of whose initial infections were asymptomatic or mild. At the other end of the spectrum, very severe disease can so traumatize the immune system that it fails to recollect the threat it’s fighting. Researchers have watched immune-cell training centers “completely collapse” beneath the blaze of inflammation, Eun-Hyung Lee, an immunologist at Emory University, told me. In some cases, the virus might find its prior hosts nearly as unguarded as before. “It would be dangerous to assume good immunity across all individuals in this group,” says Kimia Sobhani, who’s studying antibody responses to the virus at Cedars-Sinai Medical Center, in Los Angeles. Vaccines strip away some of the ambiguity. For a given brand, every injection contains the same ingredients, doled out at the same dose, to generally healthy people. The shots still won’t work the same way in everyone, especially people with compromised immune systems, or certain older individuals whose defenses have started to wane. But nearly every healthy recipient of a COVID-19 shot temporarily transforms into a coronavirus-antibody factory—including many of the people for whom infection wasn’t triggering enough. “What we know is that you get a much, much better response following infection if you vaccinate somebody,” Fauci told me. “I tend to go with what’s much, much better.” Neither immunity nor pathogenicity is static. Immune cells can experience amnesia; viruses can change their appearance and sneak by the body’s defenders. Stacking vaccinations atop prior infections, then, is an insurance policy. Post-infection shots can buoy whatever defenses are already there, likely boosting not just the quantity of protective cells and molecules, but their quality and longevity as well, John Wherry, an immunologist at the University of Pennsylvania, told me. A similar rationale backs up the two-dose mRNA shots and other multi-dose vaccines, including the ones we use for HPV and hepatitis B. Growing evidence suggests that the combination of infection and inoculation might even be synergistically protective, outstripping the defenses offered by either alone—something the immunologist Shane Crotty calls hybrid immunity. Some reports have shown that “people who have previously been infected then get vaccinated have higher antibody levels” than people who have only one of those experiences, Jackson Turner, an immunologist at Washington University in St. Louis, told me. Antibody potency, too, seems to get souped up, potentially equipping the molecules to better grapple with a wide range of coronavirus variants, even ones they haven’t seen before. Accordingly, the hybrid-immune seem to be reinfected less often. “You basically supercharge your immune response,” Goel told me. This could all be good news for the durability of protection as well. Viruses and vaccines will inevitably prod different subsets of immune responses—a more comprehensive education than any single teacher can accomplish alone. The pairing is a good way, Wherry said, to goad immune cells into doubling down on their lessons, and acquiring more sophisticated attack plans over time. Where experts splinter in opinion is regarding the number of COVID-19 shots to give the once-infected, at least for multi-dose vaccines. In some countries, including France, healthy people who have had SARS-CoV-2 need to get only a single shot. The strategy can, potentially, free up doses for others who remain unimmunized, among whom first injections would save more lives. So far, not much evidence suggests that adding a second shot on schedule has “benefit, quantitatively or qualitatively,” for the recovered, Wherry said. But given the unpredictability of past infections, some experts think a two-dose vaccination course is still a safer policy to ensure that no one is left with suboptimal protection. “I tend to lean toward what is prescribed, and say people should get the full two doses,” Bhadelia told me. This more conservative tactic is also an easier logistical lift, because confirming a prior brush with the pathogen can be difficult. Some experts have suggested that potential vaccine recipients could be screened for antibodies as a rough proxy for a past protective infection, but even that’s a bit of a “nightmare,” Wherry told me, especially because researchers haven’t yet pinpointed a threshold that denotes even partial immunity. [Read: What we actually know about waning immunity.] If the perfect post-infection shot combo is elusive now, that equation becomes even more complicated as third shots go on offer to those who are currently fully vaccinated. Despite calls for additional injections from the White House, many researchers are skeptical that the young and healthy need these inoculations so soon, and some are wary of the potential for overboosting, which can exhaust immune cells or stir up side effects. Still, Fauci, who’s come out strongly in favor of delivering COVID-19 vaccines in three doses, thinks a duo of shots might be necessary to clinch the protective process for most previously infected people. “To me, if you have enough vaccine, it’s worth giving a second dose,” he said. That strategy could, in theory, work especially well if the doses are spaced several months apart, giving the immune system time to recuperate and mull over the intel it’s gathered. This grace period might even help explain the strong synergy with post-infection inoculation: Most recovered people are getting their shots well after the virus has vacated their body, which means the vaccine’s lessons are being imparted to refreshed and well-rested cells. Eventually, fewer and fewer of us will have the option of either vaccination or infection; soon, most of us will be dealing in scenarios of and. With the virus so thoroughly enmeshed in our population, the order of exposures is inevitably shifting: More and more vaccinated people are catching the coronavirus and sometimes falling ill. Arguably, all of these pathogen parleys are boosts—but whether they leave lasting impressions on our immune systems still isn’t clear. Immune responses have both ceilings and floors; it’s not always easy to know what we’re knocking up against. The long view, then, becomes about seeing infection and inoculation not as a dichotomy but as an inevitable interaction—which is actually the point of vaccines. We immunize as a hedge, one predicated on the assumption that we could all chance upon the pathogen in question. It’s a reality our bodies have spent an eternity preparing for: that certain threats take time to abate; that some battles have to be fought over and over; that, with the right defenses in place, some enemies become less dangerous over time. from https://ift.tt/3nG0EFi Check out http://natthash.tumblr.com Last week, prosecutors and defense attorneys made opening statements in the criminal trial of Elizabeth Holmes, the former CEO of Theranos, who is accused of defrauding investors and patients with false promises of cheap, rapid blood tests. The next day, the Biden administration announced a plan to purchase 280 million cheap, rapid COVID-19 tests—an action for which some lawmakers have been advocating for more than a year. The serendipity of these two events exposes an unresolved tension in health care: How do we balance the risks of disruptive innovation with the mortal costs of administrative inertia? Theranos and COVID-19 testing are both cautionary tales of failed medical oversight, but the morals flip from one case to the other. Each addresses, in its way, how much control the FDA should exert over laboratory tests before they come to market. COVID-19 testing epitomizes the agency’s risk-averse instincts. In the first months of the coronavirus pandemic, the FDA notoriously delayed private labs from developing their own COVID-19 tests. This allowed the coronavirus to spread mostly undetected, and demolished any early possibility of eradicating the virus in the United States. The agency has also been accused of stonewalling the approval of rapid tests for use at home. (The first over-the-counter device wasn’t authorized until December.) Now that home tests are available at drugstores, some deregulation advocates are still complaining. Germany has at least 60 such devices in circulation, for example, and some cost less than $1. The U.S. has just six, which sell for more than $10 each (when they’re in stock). The Theranos story unfolded a few years before the pandemic as the regulatory mirror image of these events—with Big Government cast as the hero. Theranos began collecting patient samples through its Walgreens wellness centers in 2013. At its peak, in 2014 and 2015, the company was generating 890,000 results a year—tens of thousands of which the company would later admit were erroneous. Yet Theranos only ever received FDA clearance for a single type of test out of the hundreds it performed. Ultimately, it was the FDA that took the first real action against the company. By declaring its “nanotainer” blood-collection tube an uncleared medical device, regulators were able to protect thousands of additional patients from receiving potentially inaccurate diagnostic results. At the center of both the Theranos and the COVID-testing controversies was a bureaucratic dead zone around what are called “laboratory-developed tests,” or LDTs. Because of legislative ambiguity, the makers of these tests, which are designed and used within a single location rather than sold to health-care providers around the country, can skirt careful evaluation by the FDA. Oversight comes instead from the Centers for Medicare and Medicaid Services, which carries out routine inspections of all labs every two years. This type of retrospective supervision mostly works fine; there are plenty of important LDTs in common use, including nearly all genetic tests. But in rare cases, such as Theranos’s, a lot of damage can take place between inspections, or if officials are intentionally misled. Former employees have accused Theranos of hiding its proprietary devices from inspectors, and the company eventually failed an inspection because of poor quality-control procedures. Officials from the Centers for Medicare and Medicaid Services concluded that these deficiencies put patients in immediate jeopardy, and revoked the company’s laboratory licenses in 2016 and 2017. With the onset of the pandemic, the FDA was able to utilize special powers to close the LDT loophole. After the secretary of health and human services declared a public-health emergency on February 4, 2020, any labs that wanted to evaluate patient samples for the coronavirus with their own, homemade procedures would first need a sign-off from the FDA. The FDA commissioner at the time, Stephen Hahn, said this tighter leash on LDTs “balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed.” But the process that his agency put in place proved slow and cumbersome: It required pathologists to spend hundreds of hours completing documentation before using their tests for clinical care. By March 2020, the policy was relaxed in the face of widespread criticism, then abolished that August. The FDA’s policy on COVID tests may have been a failure, but that doesn’t mean Hahn’s defense of it was empty rhetoric. The Holmes trial serves as an important counterfactual: The same emergency protections that slowed test availability in early 2020 had also blocked Theranos from deploying potentially inaccurate Ebola and Zika tests half a decade earlier. Fraud remains a real concern in any disaster. The ever-present tension between medical-testing speed and reliability even played out as an ironic side plot at the start of the Holmes trial. The proceedings were delayed on their second day after a juror was potentially exposed to the coronavirus. Although the juror reportedly received negative rapid-test results, the court decided to wait on the findings of a traditional laboratory analysis. Holmes, who once promised to upend the old-school laboratory industry with her magic device, was now at the industry’s mercy. It has ultimately been left up to Congress to strike the right balance for regulating diagnostics. Competing bills meant to promote safety and access to laboratory testing, called the VALID and VITAL Acts, are currently winding their way through the legislative process. The VALID Act would enable the FDA to regulate a greater number of lab-developed tests, and the VITAL Act would do the opposite, preventing the FDA from overseeing LDTs at all—even during public-health emergencies. As with many contentious political issues, however, chances are good that Congress will do nothing at all. Holmes herself was a master at exploiting political conflict. She publicly supported greater oversight by the FDA even as she flouted existing requirements. Increased scrutiny would have proved disastrous for her business; the real purpose of Holmes’s endorsement may have been to signal righteousness, engender public trust, and gobble up further investments. More recently, we’ve seen that in the midst of a deadly viral outbreak, all policy questions become imbued with moral significance. Botched testing, for example, can be seen as the “original sin” of America’s pandemic response. Any action that the FDA might take—whether it’s approving drugs for Alzheimer’s or slowing down COVID-19 vaccines for kids—gets absorbed into a grand battle between sinners and saints, disruption and stagnation. But the best public policy will have to accommodate the existence of both. from https://ift.tt/3tHIofP Check out http://natthash.tumblr.com The day I was diagnosed with cancer—serious cancer, out-of-the-blue cancer—I reeled out of the doctor’s office and onto the familiar street. My children’s dentist was on that block, and the Rite Aid where we got cheap toys after their checkups. Just an hour and a half earlier, I’d walked down that street and my world had been safe and whole—my two little boys, my good husband, my career as a writer just beginning to unfold. My life! I hadn’t even known to give it a backward glance. In the car, I was gripped by two thoughts, both about my children, Patrick and Conor, who were about to turn 5. The first was that there was only one bright spot in this terror, but it was a big one: The cancer had struck me instead of them. At least the boys were safe. But they were in a different kind of danger: that of losing their mother. I grew up in a household in which my mother’s grief over losing her own mother as a very young child was never expressed. She didn’t come from a generation that helped kids cope with trauma; she came from the generation that just carried on—and she had. But something in her never healed, and my sister and I felt it in a hundred ways. The page in Babar that described his mother’s death had been neatly torn out of the book; many fairy tales could not be read at all. Secrets were kept. The lesson I learned about talking with children about sad things was this: Wrap everything in a happy story, no matter how implausible; protect them at all costs; lie. Caitlin Flanagan: [I’ll Tell You the Secret of Cancer] Like many people, I thought that it was possible to control what children know by telling them only what you want them to understand. But children know everything. They may not accurately understand the facts, but they take in all the pieces of what is going on at home and make some meaning out of them. From the minute I got back that first day, and friends and relatives started bringing them presents and whispering behind closed doors, the boys knew that something was up. As the next terrible week unfolded, and the week after that, my husband became more and more insistent that we tell them what was happening. He’d had his own childhood trauma; his parents had kept bad secrets. All his life, he’s believed in telling the truth, no matter the cost. But I still felt that telling our children this truth would mark the end of their childhood. So I developed a language for it. When I went to the hospital for surgery, I told them that the doctor had found a “bump,” and that he was going to take it out. I told them that I was going to take a special medicine and that it was a silly kind of medicine because it would make my hair fall out. They didn’t think that was silly. Chemo began, and I made sure to always have a scarf or wig on when I was with them, but one morning I was lying in bed without one while my husband dressed for work. Patrick walked in wearing his pajamas, and he gave me a cool, appraising look, a look I’d never seen on him before. “Who’s that?” he asked my husband. Often, when I checked on the boys at night, they were sleeping together, for comfort. They started wetting the bed and coming into our room cold and crying. What could I do? I felt like all was lost, like this happy, regular family was crumbling in front of my eyes, and I couldn’t stop it. But then an ordinary thing happened: Someone helped me. I’d wandered into the UCLA oncology center looking for its director. She wasn’t there, and I turned to leave, but the social worker on duty stopped me. “Don’t go,” she said kindly. “Come in and sit down.” One of the main side effects of cancer treatment, which embarrasses me still, is that a lot of the time, I really want to sit down. But I wasn’t embarrassed in that office, so I sat, and she asked me what I was going through. I told her about the boys, and she asked what they understood about my cancer. I told her about the bump and the special medicine. Gently but firmly, she said that I couldn’t do that. She told me that the next time they fell down and got a bump, they would think they’d become seriously sick. And when they had to take medicine, they would be afraid their hair would fall out. I thought about the bottle of bright-red children’s Tylenol with its special measuring spoon, and about the pink antibiotics they got for ear infections, and I realized she was right. Instead, she said that I should tell them that I had a disease called cancer, that it was a very rare disease, and that they couldn’t catch it. And she said that I should tell them I was on chemotherapy. It seemed obscene. Tell two 5-year-olds about chemotherapy? She looked at a shelf filled with children’s books—the kind of children’s books you never, ever want to read to your children. She gave me one, and I drove home with it. I didn’t think this was the right thing to do, but what did I know? I got home and I sat down with that terrible book, and the boys scrambled up on either side of me, the way they always did at story time, and I started to read. From the very first page, I knew that the boys loved this book. They sat next to me, not moving, only breathing and looking. The mother in the book was already in treatment, and she was wearing a scarf like mine. The book explained cancer and chemotherapy and even radiation. When I finished, Patrick grabbed the book, opened the front door, and ran to the house next door to show it to the neighbors; then he ran back across the yard to the other side and showed it to those neighbors too. I followed along with Conor, laughing and sort of explaining that the boys had this new book about cancer. All the adults on the street knew what was going on, and they immediately took time to look at it. When we got back inside, the boys wanted to read it again, and again. I realized that they had desperately needed to know what was happening. They had been trying to understand and had picked up on the idea that they shouldn’t ask questions—or maybe they didn’t know what questions to ask. With that book, which we read night after night, they were no longer two children who had been shoved out of normal life. They weren’t experiencing something no other child ever had before. They were in the midst of something normal, something so unremarkable that a picture book had been written about it. The mom in the book loved her children, the way their mom loved them, and she wore a scarf because she didn’t have any hair, the same as their mom. I don’t think they ever wet the bed again. People often say that children are stronger than we assume. Sure, I believed that, but I never wanted my own children to have to prove it. I thought I had the power to protect them from hardship. No one has that. Children are no different from adults: Their lives are bound by events beyond their control, experiences that are contrary to the ones they want or the ones we wanted for them. But endurance is built into the human condition, and it’s as powerful in children as it is in adults. Small children don’t need much when there’s a crisis at home. They need simple, accurate information about what’s happening, and they need to know who is going to take care of them as long as the crisis lasts. Your heart is breaking, but theirs might not be. They don’t know the script. Many years ago, a little boy who lived on my street, an only child, lost his father. One October day, a couple of months after the death, I set out for a walk with my dog and saw some kind of cheerful production under way at the little boy’s house. His uncle—who lived a couple of hours away—had come over to create a giant Halloween display, with enormous spiders and webs, and the boy showed me everything. I could see how delighted he was. His home wasn’t just a place of mourning; it was a place where something fun and wonderful was happening. A few weeks later, the uncle came back with one of those little soccer nets, and I would see them kicking the ball around on Sunday mornings. They were healing each other on that tiny front lawn—the man grieving his brother, the little boy mourning his father. I always felt like I might cry when I saw them out there, a little bit because of the sorrow of the father’s death, a little bit because of the sweetness of the uncle’s visits, and a little bit because I knew I was watching a scene that was probably very like what would have happened at my house if I had died when my boys were young. It would have been very sad, but soon enough they would have been stumbling forward into a new life, a life without me, but a good life nonetheless, filled with plenty of people who loved them. My job as their mother would have been to prepare them for that, and to let them know that even without me, everything was going to be okay. I’m sure there’s a book for that, too, but I caught a lucky break, and we never had to read it. from https://ift.tt/3k9q8st Check out http://natthash.tumblr.com At least 12,000 Americans have already died from COVID-19 this month, as the country inches through its latest surge in cases. But another worrying statistic is often cited to depict the dangers of this moment: The number of patients hospitalized with COVID-19 in the United States right now is as high as it has been since the beginning of February. It’s even worse in certain places: Some states, including Arkansas and Oregon, recently saw their COVID hospitalizations rise to higher levels than at any prior stage of the pandemic. But how much do those latter figures really tell us? From the start, COVID hospitalizations have served as a vital metric for tracking the risks posed by the disease. Last winter, this magazine described it as “the most reliable pandemic number,” while Vox quoted the cardiologist Eric Topol as saying that it’s “the best indicator of where we are.” On the one hand, death counts offer finality, but they’re a lagging signal and don’t account for people who suffered from significant illness but survived. Case counts, on the other hand, depend on which and how many people happen to get tested. Presumably, hospitalization numbers provide a more stable and reliable gauge of the pandemic’s true toll, in terms of severe disease. But a new, nationwide study of hospitalization records, released as a preprint today (and not yet formally peer reviewed), suggests that the meaning of this gauge can easily be misinterpreted—and that it has been shifting over time. If you want to make sense of the number of COVID hospitalizations at any given time, you need to know how sick each patient actually is. Until now, that’s been almost impossible to suss out. The federal government requires hospitals to report every patient who tests positive for COVID, yet the overall tallies of COVID hospitalizations, made available on various state and federal dashboards and widely reported on by the media, do not differentiate based on severity of illness. Some patients need extensive medical intervention, such as getting intubated. Others require supplemental oxygen or administration of the steroid dexamethasone. But there are many COVID patients in the hospital with fairly mild symptoms, too, who have been admitted for further observation on account of their comorbidities, or because they reported feeling short of breath. Another portion of the patients in this tally are in the hospital for something unrelated to COVID, and discovered that they were infected only because they were tested upon admission. How many patients fall into each category has been a topic of much speculation. In August, researchers from Harvard Medical School, Tufts Medical Center, and the Veterans Affairs Healthcare System decided to find out. [Read: America’s entire understanding of the pandemic was shaped by messy data] Researchers have tried to get at similar questions before. For two separate studies published in May, doctors in California read through several hundred charts of pediatric patients, one by one, to figure out why, exactly, each COVID-positive child had been admitted to the hospital. Did they need treatment for COVID, or was there some other reason for admission, like cancer treatment or a psychiatric episode, and the COVID diagnosis was merely incidental? According to the researchers, 40 to 45 percent of the hospitalizations that they examined were for patients in the latter group. The authors of the paper out this week took a different tack to answer a similar question, this time for adults. Instead of meticulously looking at why a few hundred patients were admitted to a pair of hospitals, they analyzed the electronic records for nearly 50,000 COVID hospital admissions at the more than 100 VA hospitals across the country. Then they checked to see whether each patient required supplemental oxygen or had a blood oxygen level below 94 percent. (The latter criterion is based on the National Institutes of Health definition of “severe COVID.”) If either of these conditions was met, the authors classified that patient as having moderate to severe disease; otherwise, the case was considered mild or asymptomatic. The study found that from March 2020 through early January 2021—before vaccination was widespread, and before the Delta variant had arrived—the proportion of patients with mild or asymptomatic disease was 36 percent. From mid-January through the end of June 2021, however, that number rose to 48 percent. In other words, the study suggests that roughly half of all the hospitalized patients showing up on COVID-data dashboards in 2021 may have been admitted for another reason entirely, or had only a mild presentation of disease. This increase was even bigger for vaccinated hospital patients, of whom 57 percent had mild or asymptomatic disease. But unvaccinated patients have also been showing up with less severe symptoms, on average, than earlier in the pandemic: The study found that 45 percent of their cases were mild or asymptomatic since January 21. According to Shira Doron, an infectious-disease physician and hospital epidemiologist at Tufts Medical Center, in Boston, and one of the study’s co-authors, the latter finding may be explained by the fact that unvaccinated patients in the vaccine era tend to be a younger cohort who are less vulnerable to COVID and may be more likely to have been infected in the past. [Read: Why the pandemic experts failed] Among the limitations of the study is that patients in the VA system are not representative of the U.S. population as a whole, as they include few women and no children. (Still, the new findings echo those from the two pediatric-admissions studies.) Also, like many medical centers, the VA has a policy to test every inpatient for COVID, but this is not a universal practice. Lastly, most of the data—even from the patients admitted in 2021—derive from the phase of the pandemic before Delta became widespread, and it’s possible that the ratios have changed in recent months. The study did run through June 30, however, when the Delta wave was about to break, and it did not find that the proportion of patients with moderate to severe respiratory distress was trending upward at the end of the observation period. The idea behind the study and what it investigates is important, says Graham Snyder, the medical director of infection prevention and hospital epidemiology at the University of Pittsburgh Medical Center, though he told me that it would benefit from a little more detail and nuance beyond oxygenation status. But Daniel Griffin, an infectious-disease specialist at Columbia University, told me that using other metrics for severity of illness, such as intensive-care admissions, presents different limitations. For one thing, different hospitals use different criteria for admitting patients to the ICU. One of the important implications of the study, these experts say, is that the introduction of vaccines strongly correlates with a greater share of COVID hospital patients having mild or asymptomatic disease. “It’s underreported how well the vaccine makes your life better, how much less sick you are likely to be, and less sick even if hospitalized,” Snyder said. “That’s the gem in this study.” “People ask me, ‘Why am I getting vaccinated if I just end up in the hospital anyway?’” Griffin said. “But I say, ‘You’ll end up leaving the hospital.’” He explained that some COVID patients are in for “soft” hospitalizations, where they need only minimal treatment and leave relatively quickly; others may be on the antiviral drug remdesivir for five days, or with a tube down their throat. One of the values of this study, he said, is that it helps the public understand this distinction—and the fact that not all COVID hospitalizations are the same. But the study also demonstrates that hospitalization rates for COVID, as cited by journalists and policy makers, can be misleading, if not considered carefully. Clearly many patients right now are seriously ill. We also know that overcrowding of hospitals by COVID patients with even mild illness can have negative implications for patients in need of other care. At the same time, this study suggests that COVID hospitalization tallies can’t be taken as a simple measure of the prevalence of severe or even moderate disease, because they might inflate the true numbers by a factor of two. “As we look to shift from cases to hospitalizations as a metric to drive policy and assess level of risk to a community or state or country,” Doron told me, referring to decisions about school closures, business restrictions, mask requirements, and so on, “we should refine the definition of hospitalization. Those patients who are there with rather than from COVID don’t belong in the metric.” from https://ift.tt/2Xdss94 Check out http://natthash.tumblr.com Americans have been getting booster shots for months now. By the end of April, when less than one-third of the country was fully vaccinated, at least one person had already reportedly gamed the system. It was taboo and took some finagling to pull off—IDs shuffled, erroneous vaccine cards presented—but through the spring and summer, the most shot-happy Americans found a way. Now a third jab is downright mainstream, and not just for the immunocompromised people who have the CDC’s blessing. Some people, like the couple who wanted to be extra protected ahead of their wedding, are still lying to get their shots. But at least a few hospitals are allegedly handing third doses out to healthy employees, and doctors to healthy patients. And many of the people who have gotten their shots ahead of any official government guidance to do so are happily posting about it on the internet. Americans who have gotten a third (or, for people who got the one-dose Johnson & Johnson vaccine, second) shot before they’re eligible—let’s call them booster bandits—have considered the risks to their body and their conscience and concluded, Hey, it couldn’t hurt. Like the people who crossed state lines or lied about their job to get a first shot in the winter and early spring, they are blurring the truth and fudging the rules. The careful dance of morals and personal peril involved in booster banditry is far more complicated than the obvious ethical dumpster fire of taking a first dose from an essential worker or a cancer patient. But, even though the line-jumpers are loud and proud this time, the illegitimate third doses aren’t always quite as innocuous as they seem to think. No one knows exactly how many booster bandits are out there. The CDC estimated that more than 1 million Americans got an unauthorized third shot before the recommendations for immunocompromised people came out a month ago. Since then, the agency has counted nearly 1.8 million people who have gotten an “additional” shot, but it told me that there’s virtually no way to know how many of those actually went to folks with qualifying immune conditions, because patients only have to say they’re immunocompromised to get the jab. There’s also virtually no way to know how many reported first doses are actually illegitimate third shots. But unsanctioned booster shots do seem to have become more popular in recent months, with people reporting that they’ve gotten them everywhere from major pharmacy chains to local churches. I spoke with three people who posted online about doing so. Tiffany Doran, a 41-year-old who lives in Griffin, Georgia, told me she tried and failed to get a third Moderna shot at her local pharmacy when she gave her name. So instead, she found an at-home medical company and revealed “as little information as possible.” One middle-aged woman I spoke with, who works as a medical coder and biller at a Texas hospital, got her third Pfizer shot from her employer. (She requested anonymity for fear of professional repercussions.) Richard Signorelli, a lawyer and former assistant U.S. attorney for the Southern District of New York, told me he got his Pfizer booster from his primary-care provider, who recommended the shot during Signorelli’s annual physical even though Signorelli doesn’t think he has any qualifying immune conditions. [Read: When ‘talk to your doctor’ goes so, so wrong] When I asked Doran, the medical coder, and Signorelli about why they chose to defy CDC recommendations to get a booster—and why they felt comfortable enough in their choice to post about it—their answers largely revolved around trust, fear, and waste. Signorelli trusts his doctor. The medical coder trusts her colleagues, who have assured her that the vaccines, including the booster, are safe. And Doran trusts the small academic papers from which she has gleaned that boosters are effective. She follows those studies religiously because she has long COVID, and she says the researchers performing them are among the few people she sees taking her needs seriously. Their fear mostly centered on the Delta variant—the same thing that’s spurring the government to even consider third shots for everyone who’s gotten an mRNA vaccine. The National Guard has been deployed to hospitals where Doran lives, and her county is in the midst of its biggest pandemic surge yet. The ICU in the Texas hospital where the medical coder works has been nearly full since July. Although Signorelli said he mostly got the booster to avoid passing the virus on to immunocompromised family members who hadn’t yet gotten their third doses, he was eager to shield himself too. “Even in New York, there are so many unvaccinated, unmasked people that I felt it prudent to give myself additional protection,” he said. [Read: The only way we’ll know when we need COVID-19 boosters] All three of the booster bandits I spoke with told me that they weren’t worried about taking anything from others who need it by boosting “early,” because the country has so many vaccines that it’s regularly throwing doses out. They have a point: While other countries are still struggling to access and distribute vaccines, the U.S. reportedly wasted at least 12.9 million doses just in June, July, and August. Doran said that vaccine waste “makes me sick,” and that “whoever wants them should have them instead of putting them in the trash.” But the moral dilemma of booster banditry is more complicated than that. For Arthur Caplan, a bioethics professor at NYU Langone Health, the details of each case matter. “Jumping the line at age 88 is not the same as running in to get a booster at age 33,” he told me. Still, he thinks that in many cases, overabundance really is enough to justify sneaking a booster, and the practice is a personal gamble with your health more than anything else. Caplan’s right: As my colleague Katherine J. Wu has reported, very early data suggest that extra antibody production spurred by extra doses could cut down on infection and transmission, but by how much—and, more important, for how long—isn’t clear. And while there’s no reason to suspect that a third dose would be particularly unsafe in healthy people, the FDA hasn’t explicitly declared it safe. [Read: What we actually know about waning immunity] Even as some public-health experts swear they won’t get boosters at all, Caplan, who’s in his 70s, said he’s compelled by data that suggest a third shot could improve his own protection. If the CDC still hasn’t recommended third shots for people with healthy immune systems by the end of September, he would consider getting one anyway. By then, he’ll be eight months past his second dose, the point at which the White House has suggested the general public could be eligible for a third. How exactly you get your booster shot matters too. Say you don’t qualify for an extra shot and one falls into your lap anyway. Taking it isn’t necessarily a moral error as long as you’re truthful, Faith Fletcher, an assistant professor at Baylor College of Medicine’s Center for Medical Ethics and Health Policy, told me. But lying about your health or vaccine status is strictly out, she said, because it undermines the rules and guidelines that public-health officials design “to really maximize the greatest good among the greatest amount of people.” The real moral failure, Fletcher said, is a systemic one: the fact that shots are falling into the laps of the healthy and vaccinated, rather than programs that bring vaccines to essential workers at their jobs, or to Black Americans at barber shops and stylists, or to walk-up and mobile clinics that can reach people who don’t have internet access. [Read: America is getting unvaccinated people all wrong] Regardless of how much booster banditry compromises your morals, for now, not much is stopping anyone from doing it—or stopping vaccine providers from letting it happen. The CDC spokesperson told me that using the vaccines improperly can “raise issues” about vaccine providers’ commitment to their contract with the CDC, but did not elaborate on what exactly could happen to providers who are indeed found to not be compliant. When I reached out to Walgreens, CVS, and Rite Aid, representatives from all three pharmacy chains insisted that their stores are following the rules, but acknowledged that they’re relying on customers to tell the truth. Asking patients to do anything more in order to get the vaccine would be a mistake, Jason Schwartz, a vaccine-policy expert at the Yale School of Public Health, told me. “It’s far more important to get folks vaccinated and to take down barriers that could keep folks who want to get vaccinated from getting [their shots], even if it means that some folks may be playing fast and loose with their own eligibility,” he said. Perhaps the most troubling thing about booster banditry is not that it’s happening at all, but that it’s happening at an unknowable scale. Esther Choo, an emergency-medicine professor at Oregon Health and Science University, recently told me that lying (overtly or by omission) to get a third dose can mess up the data on how well third shots are performing among the immunocompromised and how well a two-dose regimen is protecting those with healthy immune systems. On an even more basic level, under-the-table boosting could skew data on national vaccination rates, making public-health authorities think more people have gotten their first or second shots than is actually the case. Essentially, getting a third shot before the CDC’s go-ahead can make it harder for health officials to determine when and if everyone else will really need them. [Read: Why wait eight months?] Unless and until the CDC gives the all-clear to universal third shots, booster banditry is probably only going to get more popular. Reports about waning immunity, overblown though they may be, are a terrifying prospect. Nearly half the country has yet to be fully vaccinated. And Delta has upended many Americans’ carefully cultivated approaches to pandemic safety. You can understand why the booster bandits have done what they’ve done: Getting another shot offers a sense of safety and control, however fleeting. After 18 months of pandemic life, it’s hard to begrudge anyone that. But the rule-breaking and the lying could help keep us all from really getting the virus under control for that much longer. from https://ift.tt/3C8kcq4 Check out http://natthash.tumblr.com When Kimberly Sheldon was 47, she says made the biggest mistake of her life. That was in 2018, when she says that a dentist explained to her that cutting the tissue under her tongue would help her jaw pain, gum recession, and occasional headaches. Her issues, he said, could be due to the fact that the back of her tongue couldn’t reach the roof of her mouth. With a quick laser slice, a $600 charge, and some instruction on tongue exercises, he seemed confident that she would feel better soon after. But, according to her account, the dentist didn’t explain the possible risks, which include nerve damage and scarring that can restrict the tongue. Sheldon only found out about the issues after she experienced them. Since then, she says, the effects have torn her life apart. The idea that tongue position can contribute to health problems is not well-supported by research, but it’s edging towards the mainstream. Millions of people are watching YouTube videos about how the tongue allegedly influences the face and jaw, and books, videos, websites, and social-media posts say that improper tongue position can contribute to a host of health issues—dental problems, sleep apnea, headaches, neck and back pain, and more. These ideas are especially becoming popular in dentistry—echoed by Colgate and a dental hygienists’ magazine. Some even claim that changing the tongue position can make people more attractive. Two proposed solutions to help with an allegedly poor tongue posture are becoming more popular, which may be done together or separately (in Sheldon’s case, her dentist recommended both). The first is myofunctional therapy, a series of exercises to strengthen the tongue so that it can rest on the roof of the mouth. Celebrities, including Kourtney Kardashian, are promoting this therapy. The second is surgery on what some practitioners call a “tongue-tie”—a condition in which the tissue under the tongue, called the frenulum, is supposedly restricted. Some tongue-ties are undisputed diagnoses—generally in very young children. In infancy, a type of tongue-tie where the frenulum attaches all the way to the front of the tongue and severely restricts its movement has been treated for hundreds of years. More controversial are hidden, or posterior, tongue-ties, which, as Undark previously reported, are increasingly diagnosed and cut in children. Adult tongue-tie diagnoses also lack rigorous evidence. Despite the limited evidence, myofunctional therapy and tongue-tie surgeries are often promoted as a treatment for the many ailments attributed to poor tongue posture in adults. Especially concerning, some experts say, is the claim that the therapy is an alternative treatment for sleep apnea, despite a lack of evidence and with possible risks to patients. Many doctors, however, caution against the idea that changing tongue posture is a panacea. “I think people want to believe that myofunctional therapy is helpful,” Eric Kezirian, a professor and physician of otolaryngology at the University of Southern California, wrote in an email. “The problem is that the history of health care is littered with thousands upon thousands of treatments that were not helpful, or were in many cases harmful, in spite of people’s best intentions.” (An otolaryngologist is also called an ear, nose, and throat doctor, or ENT.) To be sure, some patients say that tongue surgery and therapy has been life changing. In an invite-only Facebook group for tongue-tied adults, which has more than 15,000 members, some advocates report improvements in everything from facial composition to migraines, neck tension, anxiety, and even bowel movements. But not everyone has a positive experience. After the numbing wore off from Sheldon’s procedure, she says the pain was horrific; her tongue was pulled backwards and pinned down, gagging her. Her dentist recommended more tongue exercises, she says. It didn’t help. After months without improvement, Sheldon said a member of the Facebook group referred her to an oral surgeon four hours away, who also set her up with a myofunctional therapist. The new surgeon said her problems were obvious: The first dentist missed a bit of tissue or ligament, and he would fix it with a second procedure. But after that second laser cut, Sheldon had a persistent painful burning sensation at the base of her tongue, and the tip and the underside became permanently numb—some of the nerves were damaged, she recalls being told. She couldn’t swallow solid foods, she says, and her weight dropped from 140 pounds to 106. Eventually, she was hospitalized due to difficulty swallowing, and got occupational therapy to help. Now, she sees a doctor every three months for related chronic pain. Cutting the frenulum can damage nerves, salivary glands, and ducts that lead to salivary glands, says Soroush Zaghi, an otolaryngologist and sleep surgeon, as well as the medical director of The Breathe Institute in California, where Kardashian is a patient. There’s also a risk of scarring, which Zaghi says is the most common adverse outcome. Scar tissue can cause the tongue to contract and reduce tongue mobility. Nonetheless, Zaghi advocates for a surgery that cuts through the frenulum and sometimes into the muscle. He calls the procedure a frenuloplasty, during which he cuts until the patient is able to lift their tongue so the tip is just behind the front teeth when their mouth is fully open, and the back of their tongue can reach the roof of the mouth. (Sheldon’s laser surgery was a different approach, and there is no consensus or evidence to indicate if one technique is better.) A tongue-tie, Zaghi asserts, can contribute to improper facial development in children, plus mouth breathing, sleep apnea, and more. However, Cristina Baldassari, an otolaryngologist and sleep-medicine specialist at Children’s Hospital of The King’s Daughters in Norfolk, Virginia, wrote in an email that there are no high-quality research studies that demonstrate that tongue-tie causes any of these issues. The few studies that do exist have included small numbers of patients, or lack a control group. Zaghi and others also promote myofunctional therapy, sometimes in conjunction with frenuloplasty, as a treatment for obstructive sleep apnea. But Baldassari says there isn’t sufficient evidence to support myofunctional therapy as a sleep-apnea treatment, either. The few small studies that have been done did not show that the therapy alone could treat moderate to severe sleep apnea. Baldassari says she worries that real harm could come to sleep-apnea patients with a severe disorder if they eschew conventional medical treatment for tongue therapy, because there are risks for medical complications like stroke and heart attack if the disease goes untreated. Cutting the frenulum could even make sleep worse, Baldassari says. Slicing through the tether could cause the tongue to fall back into the throat, obstructing the airway during sleep. This concern was echoed by Karthik Balakrishnan, a professor and physician of otolaryngology at Stanford University, though he pointed out that there’s no research on the subject to know for sure. And even Zaghi says some people are better off with an intact frenulum, including those who don’t have enough space to accommodate their tongue high in their mouth, and those with low tongue muscle tone (though Zaghi cannot point to a method for providers to objectively assess these things, he says he’s working on it). Baldassari points out that researchers know the tongue is involved in sleep apnea—devices that send electrical signals to the tongue, which cause it to move outward during inhalation during sleep, are effective at enlarging the airway. But, she says, if this tongue stimulation is strengthening the tongue, like myofunctional therapy proposes to do, it doesn’t have a lasting effect; if doctors turn the device off after a year, patients still have sleep apnea. Yet Baldassari doesn’t mind if someone with mild sleep apnea or other conditions like neck tension, anxiety, bad posture, allergies, or teeth grinding, wants to try myofunctional therapy, despite the lack of research, because she says there’s little risk. Still, she added in an email, “it likely will be a waste of time and money.” In addition to the lack of strong evidence, both the tongue therapies and surgeries don’t have strong professional standards. Neither has a standardized protocol, so the process varies from one practitioner to another. And while tongue-tie surgeries are performed by licensed doctors or dentists, myofunctional therapists have no system of licensure. Sarah Hornsby, a myofunctional therapist with a sizable YouTube following and a therapy co-director at The Breathe Institute, where she offers a training program, acknowledges that this lack of standardization is one reason the medical community is skeptical of the therapy and says it is something therapists are working toward. Though Zaghi has published a method for assessing tongue-ties, he argues that at least some standards for myofunctional therapy are unnecessary. For instance, he says that myofunctional therapy shouldn’t all be based on one person’s protocols—he compared it to an exercise regimen, pointing out that there are benefits whether someone does yoga, pilates, weight lifting, or running. Other experts disagree. If an exercise is used as a medical treatment, it needs to be researched to show it’s effective, says Kezirian. “Myofunctional therapy has nothing like this,” he wrote in an email. (Kezirian holds a patent for a device to correct obstructive sleep apnea, as well as for head and neck exercises done with an apparatus to improve sleep-disordered breathing, though he is not currently selling either product.) Not only do variations in practices mean that researchers have difficulty evaluating whether it works, Baldassari wrote that “if there is a lack of standardization, there is no way to ensure that patients are getting adequate therapy.” Myofunctional therapy lacks standardized training programs, too. Many myofunctional therapists are dental hygienists, as Hornsby was; other times, the therapist may be a dentist or speech-language pathologist who has completed a short online training program. Most of these programs, which are not accredited by a professional organization, cost thousands of dollars. (Several organizations, including the International Association of Orofacial Myology, do offer certifications to those who complete their training.) Even tongue-tie-revision-surgery training for dentists can be done online, and Zaghi has been teaching his frenuloplasty method online since the pandemic began. Despite the lack of training and standards, myofunctional therapists stand to earn more than they did as dental hygienists, with fees ranging from $80 to $250 per session; those who are also dentists or speech therapists can charge more. And dentists who revise adult tongue-ties can charge up to about $1,500 for the procedure. “I do not want to suggest ulterior motives,” Kezirian wrote in an email, “but of course treatment is offered to patients that pay for services, often on their own because these treatments are not covered by medical insurance.” Sheldon has also noticed these financial incentives. She avoids the adult tongue-tie Facebook group these days because she says practitioners are also members, and stand to profit from the groups’ messages. And when someone has an issue after a tongue-tie surgery, members tend to doubt whether that person did enough myofunctional therapy or found the right provider, instead of questioning the procedure itself. Sheldon says she has struggled to forgive herself for agreeing to do something that brought her chronic pain and health problems. But one thing brings her peace: Because of her experience, she sought a second opinion when an orthodontist suggested that her son needed tongue-tie surgery in order for his teeth to be straightened. What happened to her, she says, saved her son from the possibility of a similar fate. Now, she adds, “I don’t believe that we’re supposed to be cutting people’s frenulums.” This post appears courtesy of Undark Magazine. from https://ift.tt/3k1mK2O Check out http://natthash.tumblr.com Jonathan Neman really seemed to think he was onto something. Last week, in a lengthy, now-deleted post on LinkedIn, the CEO and co-founder of the upscale salad chain Sweetgreen expounded on a topic that might seem a little far afield for a restaurant executive: how to end the pandemic. “No vaccine nor mask will save us,” he wrote. (The vaccines, it should be noted, have so far proved to be near-miraculously effective at saving those who get them.) Instead, he lamented that Americans are simply too fat to survive COVID-19, a reality that he says could be addressed with “health mandates.” Neman did not go into many specifics about how health should be mandated, or what such mandates would mean for disabled people, though efforts at national improvement that focus on those designated as physiologically undesirable have historically ended poorly for them. He did offer one proposal: The federal government could decide which types of food Americans are allowed to eat. More specifically, he argued, the government could ban or heavily tax some foods, including any kind of processed food, a category so meaninglessly broad it would wipe out virtually everything stocked on the inner aisles of the average grocery store—not to mention much of what is sold by Sweetgreen’s competitors. Neman faced backlash after Vice’s Edward Ongweso Jr. reported on the post. The CEO apologized to Sweetgreen’s staff in an email, and later, at a town-hall meeting with employees, acknowledged that indeed “Sweetgreen alone is not going to solve this. Salads alone are not going to solve this,” according to a recording obtained by Vice. Even so, Neman defended the intent of the proposal. And Ongweso Jr. has since found evidence that Neman previously advocated similar measures within the company. (Sweetgreen did not respond to multiple interview requests for this article.) It is, of course, almost hilariously convenient for a man who’s made millions slinging expensive lettuce to believe that the future of the republic might depend on the feds force-feeding people the food he already sells; that salad is the ideal medicine for an incredibly contagious respiratory virus might not be a trustworthy argument coming from a literal salad millionaire. More interesting, though, is how telling Neman’s salvational ramblings are of a harmful conviction about health that America’s wealthiest, most privileged class long ago laundered into common sense: that people who, unlike them, end up sick or poor have simply refused to make the right choices and help themselves. Speculating that America’s health-care crisis could be solved if everyone just had to eat some salad is not only lazy and wrong; it’s perpetuating an attitude that is making health—and the pandemic—worse for millions of people. As proof for his idea, Neman offered an argument that’s often cited by people looking to reframe America’s pandemic failures as those of individual responsibility instead of institutional rot: According to one CDC study, 79 percent of people hospitalized with severe COVID-19 in the United States in 2020 had a BMI categorized as overweight or obese. The percentage is alarming in a vacuum, and the CDC does assert that high body weight is a risk factor for severe COVID-19. But it’s far from clear that it’s a major risk factor—the CDC’s own numbers suggest that almost 74 percent of all Americans over the age of 20 fall into that same BMI range, which means that, even if weight had no correlation to or effect on outcomes, you’d still expect about three-quarters of those hospitalized with COVID-19 to have a high BMI. BMI’s uselessness as a proxy for health is a fight for another day, but even if you leave out confounding factors that might help explain the five-point difference—for example, that poor people are more likely to have a high BMI, to delay seeking costly medical treatment, and to work in-person jobs that expose them to the coronavirus—it hardly justifies making cookies illegal. If a bodily variation causes a difference in COVID-19 risk, that doesn’t mean it must be eliminated by force. If you disagree, I’d love to hear your plan for dealing with men, who are much more likely to be hospitalized or die after catching COVID-19 than women. Neman appended to his LinkedIn post a link to a CNN article that details a report on the global distribution of 2020’s COVID-19 deaths. The report, released in March by the World Obesity Federation, found that the overwhelming majority of deaths occurred in countries where more than half the population has an obese or overweight BMI. CNN used Vietnam’s impressive track record against the pandemic and the nation’s low obesity rates as a foil for Americans’ own failures, both in the pandemic and on the scale. But ample evidence exists that Vietnam didn’t contain the pandemic because its people are slender. The country relied on the kinds of interventions that aren’t very profitable to outside businesses: proactive governmental action, robust contact tracing, strategic testing, and free food and housing for those who need to quarantine. Vietnam also benefits from a populace whose median age is 6 years younger than that of the U.S.—a meaningful difference when the worst outcomes of a disease are more closely associated with advanced age than anything else. The CNN article omits any information about Vietnam’s COVID-19 response or other risk-mitigating population differences. It also doesn’t disclose that the World Obesity Federation is an advocacy group that receives funding from corporations who profit when people are pressured to get thin: a number of pharmaceutical companies that already sell weight-loss drugs or have new ones in much-hyped clinical trials, as well as WW, the diet company formerly known as Weight Watchers. Neman gets one basic thing right, though, which is what helps these kinds of ideas gain acceptance even among those they might harm, or among those notionally opposed to state punishment for poor health: Fresh, high-quality, nutritionally dense food plays a distressingly minor role in the diet of millions of Americans. Before the government starts slapping chicken nuggets out of your hand, though, it would be useful to consider why that is, beyond the apparent belief that most Americans are too stupid or gluttonous to be given a choice in what they eat. For many of them, the choices don’t exist. Research has shown that poor people know what they’re missing from their diets, and they want quite badly to have those things. Still, the gap between how well high-income people eat and how well low-income people eat has continued to widen. The problem isn’t them. High-quality ingredients are expensive and time-consuming to prepare when they’re available at all, and people with low wages and long hours—the people most likely to have suffered catastrophic effects of the pandemic, no matter their weight—do not have much time or money to spare. Sweetgreen and restaurants like it exist precisely because so many Americans are time-poor, but they address the problem of food prep only for those who can regularly purchase $15 greens-and-grains bowls. People who now must subsist on frozen dinners and the McDonald’s dollar menu wouldn’t start eating salads topped with salmon and roasted vegetables if their current food sources were taken away, even if they wanted to. Many of them would simply go hungry, which I suppose is one way to lose weight. Requiring people to prove they’ve made all the right choices before their lives are valued underpins virtually every cruelty in American health. Lots of people feel no apparent shame in asserting that those without full-time jobs don’t deserve the same access to medical care as those who are more economically productive, or that people with addictions deserve to die or rot in jail for their failures of discipline, or that hospitals should deny life-saving care for COVID-19 to people who are not yet vaccinated. The people who benefit most from this belief system tend to be those who have parlayed personal advantages into even more enormous personal wealth; they were born on third base and swear they hit a triple. One of Neman’s most prolific forebears in this regard is the Whole Foods co-founder John Mackey, who has been arguing publicly against affordable health care since at least 2009, and who said in January, during the pandemic’s deadly winter spike, that health care wouldn’t be necessary if people would just make the right lifestyle choices, and that medicine wouldn’t solve things; his father, who was an investor in Whole Foods, was also the CEO of a health-care company. Neman and his Sweetgreen business partners met while in school at Georgetown University, and their parents, who helped fund Sweetgreen’s founding, all own their own companies. This is Marie Antoinette telling starving French peasants to eat cake, except the cake story is apocryphal, and this one happened for everyone to see on LinkedIn. No room exists in this worldview for generosity toward others, or for a basic belief in the inherent value of human life. It’s a policy of coercion and deprivation. Absent from Neman’s call for mandates was any intimation that perhaps the government should use its power to ensure that no American has to choose between low-quality food and starvation; that everyone can find fresh, nutritionally dense, affordable foods in their neighborhood; that people have enough time away from work to prepare meals for themselves and their families if they so choose. Those solutions don’t do much to reinforce the superiority complex of the wealthy, and they probably wouldn’t be very profitable for companies that sell high-end groceries, premade salad, weight-loss pills, or diet plans. from https://ift.tt/2XaALT3 Check out http://natthash.tumblr.com In 1846, the Danish physician Peter Ludvig Panum traveled to the Faroe Islands in search of measles. The rocky archipelago, which sits some 200 miles north of Scotland, had been slammed with an outbreak, and Panum was dispatched by his government to investigate. The trip predated the formal discovery of viruses and antibodies by several decades, but Panum still stumbled upon a beguiling immunological trend: Dozens of the islands’ eldest residents, who had survived another measles epidemic in 1781—65 years earlier—weren’t getting sick this time around. “Not one, as far as I could find out by careful inquiry,” he wrote in a treatise, “was attacked the second time.” Panum probably didn’t realize it then, but his observations helped spark the inklings of a notion that would survive his century, into the next, and the next: the promise of perfect immunity, a protection so comprehensive and absolute that it might even stave off measles for a lifetime. After measles vaccines were licensed in the 1960s, that expectation ballooned even further. Experts eventually came to describe the shot’s defenses as so strong and swift that the virus could be immediately purged from the body in nearly everyone who received it—stomping out not only the symptoms of measles, but the very possibility of the pathogen’s proliferation at all. To modern immunologists, the phenomenon is known as sterilizing immunity, the ability to “totally prevent infection,” Taia Wang, an immunologist at Stanford University, told me. The measles vaccine is still often held up as its paragon. No infection means no disease, no death, and no transmission, the absolute immunological trifecta. It’s why sterilizing immunity has often been framed as a “holy grail,” what researchers aim for when they’re designing their shots, says David Martinez, a vaccinologist at the University of North Carolina at Chapel Hill. But sterilizing immunity also has been a source of trouble. Some people hoped the COVID-19 vaccines could achieve sterilizing immunity, especially after reports in the winter and spring trumpeted the jabs’ surprising power at preventing infections—enough that the CDC told vaccinated people they could shed their masks in May. Then sterilizing immunity came back to bite us, when breakthrough infections began to pop up among the immunized, prompting fear and confusion among those who’d been certain that the vaccines alone could quash the coronavirus’s spread. COVID-19 vaccines were never going to give us sterilizing immunity; it’s possible they never will. But the reason isn’t just their design, or the wily nature of the virus, or heavy and frequent exposures, though those factors all play a role. It’s that sterilizing immunity itself might be a biological myth. The classic tale of sterilizing immunity unfolds something like this: A pathogen attempts to infiltrate a body; antibodies, lurking in the vicinity thanks to vaccination or a previous infection, instantly zap it out of existence, so speedily that the microbe can’t even reproduce. No symptoms manifest, and most of the body’s immune cells never get involved, a bit like an intruder smacking up against an electric fence around a building, leaving the security guards inside none the wiser. This is a very neat story. And it is “almost impossible to prove,” Mark Slifka, an immunologist and vaccine expert at Oregon Health & Science University, told me. To show sterilizing immunity, researchers have to demonstrate that an infection never occurred—a big ask, considering that microbiologists can’t even agree on what an infection actually is. An onslaught of pathogens ravaging the airway or gut certainly counts. But according to some experts, so does a single viral particle commencing the process of copying itself inside a cell. This is further muddled by the fact that many pathogens, including SARS-CoV-2, can set up shop inside their hosts without causing a single symptom. There is, and always has been, a disconnect between infection and disease. One way to check for infection is to look for the pathogen itself, by, say, trying to extract it from a human or animal sample and getting it to grow in a lab, or scouring swabs for its genetic material. But not all bugs are amenable to replicating in a dish, and the genetic approach has sensitivity limits. Scientists also have the option of using bodily reactions to a microbe as a readout—if a person’s immune cells, for example, produce more antibodies, secrete alarm molecules, or rush to the site of infection. But many types of immune responses exist, and a lot of them are transient or extremely difficult to measure without invasive procedures. Even the most precise methods could miss the mark if deployed at the wrong time or in the wrong place. That technical coarseness might help explain why several historical vaccines have been assumed to be sterilizing. With measles, for instance, scientists initially lacked the tests needed to show them otherwise, Diane Griffin, an immunologist at Johns Hopkins University, told me. When virtually no one fell ill after an inoculation campaign, researchers figured that infections had evaporated as well. Now, however, techniques are far more powerful, giving researchers the ability to zero in on even tiny blips of infection. Post-vaccination measles infections, though still uncommon, are much more “regularly observed” than they were once believed to be, Griffin said. As detection tools improve, each data point further erodes the mythos of sterilization. With enough scrutiny, the experts I spoke with told me that similar illusions can probably be shattered against supposedly “sterilizing” shots that guard against other pathogens, including poxviruses such as smallpox, the bacteria that cause meningitis, and the parasites that cause malaria. “I think it’s literally chasing rainbows,” Slifka said. “The closer you get, the sooner you realize it’s not there.” To be clear, many pathogens do regularly get knocked out by the immune system. Some isolated incidents may even be “sterilizing”—for example, when just a couple viral particles bop into someone’s nose, and immediately get clobbered by a glut of antibodies, or even the fast-acting cells of the innate immune system, which are always on patrol. With the right ratio of pathogen to antibody, “it’s achievable,” Stephanie Langel, an immunologist at Duke University, told me. But that’s not the same thing as observing long-term immunity that consistently obliterates the same bug over and over, across populations of people—the way that the term sterilizing immunity is often leveraged. Perhaps it’s more useful, Yonatan Grad, an epidemiologist at Harvard, told me, to understand the ideal of sterilizing immunity as just that—an ideal, rather than a practical goal, like the unattainable end of an asymptote. Some vaccines certainly sit very far along this curve, including the HPV vaccine, which prevents infectious cervical cancer “essentially 100 percent” of the time, Bryce Chackerian, a vaccinologist at the University of New Mexico, told me. John Schiller, who helped invent the HPV vaccine, points out that even very low antibody levels are enough to obliterate the virus past detection, and vaccinated people seem to maintain these defenses for years. But he and Chackerian still admit that confirming the strictest case of sterilization may not be possible. “Have we absolutely shown sterilizing immunity?” Chackerian said. “We haven’t.” Eventually, all discussions about sterilizing immunity become nerdy quibbles over semantics. Clearly, not every infection is clinically meaningful, or even logistically detectable, given the limits of our technology—nor do they need to be, if there’s no sickness or transmission. (A koan for pandemic times: If a microbe silently and inconsequentially copies itself in a tissue, and the body doesn’t notice, did it actually infect?) There is, for every pathogen, a threshold at which an infection becomes problematic; all the immune system has to do is suppress its rise below this line to keep someone safe. But that might be exactly the point. Say that sterilizing immunity is impossible, that our immune systems cannot, in fact, be trained to achieve perfection. Then it’s neither a surprise nor a shortcoming that COVID-19 vaccines, or other vaccines, don’t manage it: An inoculation that guards marvelously well against disease—offering as much protection as it can—can still end an outbreak. Life would certainly be easier if vaccines offered invincible armor, with pathogens simply ricocheting off. But they don’t, and assuming or expecting them to manage that can be dangerous. The dubiousness of sterilizing immunity is a reminder that just about any immune response can be overwhelmed, if exposures are heavy and frequent enough, Grad told me. The best we can all hope for is functional immunity, more like a flame retardant than a firewall, that still keeps bad burns at bay. That’s the effect our COVID-19 vaccines are delivering in spades. Yes, immunized people can get sick; a few of them might even end up in the hospital, or die from their viral encounter. But vaccines substantially slash those chances by making hosts inhospitable. Breakthroughs of any severity remain uncommon, and when they do happen, they tend to be milder and shorter; people carry less of the virus, and seem less likely to pass it on to others. Even silent infections seem to be rarer among the inoculated—a sign that immunized bodies are meeting the virus in near-full force. (Langel points out that there’s even a potential silver lining to non-sterilizing immunity: Low-level infections, suppressed by vaccination, might occasionally remind the immune system of an ongoing threat, like a crude booster.) For most of vaccination history, humans have been guided by stopping sickness, and that’s been enough. The smallpox vaccine wasn’t sterilizing; it still helped us eradicate a pathogen. Even measles, a virus that’s much more contagious than SARS-CoV-2, can offer an optimistic example. Some people do end up getting infected after vaccination. But the vaccine has, in the decades since its premiere, largely driven measles into the ground in the United States, apart from recent outbreaks largely linked to low immunization rates. And the few immunized people who do fall ill tend to get what’s called “modified” measles, which isn’t “as bad as usual,” Griffin told me. “Measles vaccine is not perfect,” Elena Conis, a measles historian at UC Berkeley, told me. No vaccine is. But that doesn’t make a shot “useless,” Conis said. “The truth is somewhere in between.” Our future with SARS-CoV-2, then, will be more about domesticating the virus than eliminating it. With widespread vaccination, many of us will still be exposed, maybe even temporarily colonized, but it won’t often be a big deal. Most of the time, we might not even notice. Positive tests, too, may be less alarming: In the absence of symptoms, detecting hunks of virus might simply indicate that immune cells have squashed the pathogen, leaving only debris behind. The virus will become less of a pathogen, and more of a passenger—one that keeps the defensive wheels turning, for the short time that it’s there. from https://ift.tt/3ldky7I Check out http://natthash.tumblr.com |
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