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  • COVID Vaccines Are Turning Into Flu Shots

    COVID Vaccines Are Turning Into Flu Shots

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    For all the legwork that public-health experts have done over the past few years to quash comparisons between COVID-19 and the flu, there sure seems to be a lot of effort nowadays to equate the two. In an advisory meeting convened earlier today, the FDA signaled its intention to start doling out COVID vaccines just like flu shots: once a year in autumn, for just about everyone, ad infinitum. Whatever the brand, primary-series shots and boosters (which might no longer be called “boosters”) will guard against the same variants, making them interchangeable. Doses will no longer be counted numerically. “This will be a fundamental transition,” says Jason Schwartz, a vaccine policy expert at Yale—the biggest change to the COVID-vaccination regimen since it debuted.

    Hints of the annual approach have been dropping, not so subtly, for years. Even in the spring of 2021, Pfizer’s CEO was floating the idea of yearly shots; Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, teased it throughout 2022. This past September, Joe Biden officially endorsed it as “a new phase in our COVID-19 response,” and Ashish Jha, the White House’s COVID czar, memorably highlighted the convenience of combining a flu shot and a COVID shot into a single appointment: “I really believe this is why God gave us two arms.”

    Still, in today’s meeting, FDA officials were pushier than ever in their advocacy for the flu-ification of COVID vaccines. “We think that simplification of the vaccination regimen would contribute to easier vaccine deployment, better communication, and improved vaccine coverage,” Jerry Weir, the FDA’s director of the division of viral products, said at the meeting. The timing is important: After renewing the U.S.’s pandemic-emergency declaration earlier this month, the Biden administration seems set to allow its expiration this coming April. That makes the present moment awfully convenient for repackaging a chaotic, crisis-caliber vaccination paradigm as a scheduled, seasonal, normal-seeming one. A once-a-year strategy, modeled on a routine recommendation, suggests that “we’re no longer in emergency mode,” says Maria Sundaram, a vaccine researcher at the Marshfield Clinic Research Institute. Or at least, that’s the message that the public is likely to hear.

    But federal regulators may be trying to fit a COVID-shaped peg into a flu-shaped hole. The experts I spoke with largely agreed: Eventually, someday, annual autumn shots for COVID “will probably be sufficient,” says Gregory Poland, a vaccinologist at Mayo Clinic. “Are we ready for that yet? I’m not sure that’s the case at all.”

    Even in the short term, COVID-vaccination tactics need a revamp. “It’s clear above all that the current approach isn’t working,” Schwartz told me. Despite abundant supply, demand for COVID boosters in the U.S. has been abysmal—and interest seems to be declining with each additional dose. Last fall’s bivalent shot has reached the arms of only 15 percent of Americans; even among adults over 65—a majority of whom sign up for flu shots each fall—the vaccination rate hasn’t yet reached 40 percent.

    For most of the time that COVID shots have been around, figuring out when to get them has been a hassle, with different guidelines and requirements that depend on age, sex, risk factors, vaccination history, and more. Pharmacies have had to stock an absurd number of vials and syringes to accommodate the various combinations of brands and dose sizes; record-keeping on flimsy paper cards has been a total joke. “I do this for a living, and I can barely keep track,” Schwartz said. Recommendations on the proper timing and number of doses have also changed so many times that many Americans have simply checked out. After the bivalent recipe debuted, polls found that an alarming proportion of people didn’t even know the shot was available to them.

    Streamlining COVID-vaccine recommendations will remove a lot of that headache, Sundaram told me. Most people would need to keep only one mantra in mind—one dose, each fall—and could top off their flu and COVID immunity at the same time. Burdens on pharmacies and clinics would be lower, and communication would be far easier—a change that could make an especially big difference for those with children, among whom COVID-vaccine uptake has been the lowest. “It’ll be more scheduled, more systematic,” says Charlotte Hobbs, a pediatric infectious-disease specialist at the University of Mississippi Medical Center. COVID shots could simply be offered at annual well-child visits, she told me. “It’s something we already know works well.”

    The advantages of a flu-ified COVID shot aren’t just about convenience. If we have to shoehorn COVID vaccines into an existing paradigm, Sundaram told me, influenza’s is the best candidate. SARS-CoV-2, like the flu, is excellent at altering itself to dodge our defenses; it spreads readily in winter; and our immunity to infection tends to fade rather quickly. All of that adds up to a need for regularly updated shots. Such a system has been in place for decades for the flu: At the end of each winter, a panel of experts convenes to select the strains that should be targeted by the next formulation; manufacturers spend the next several months whipping up big batches in time for an autumn-ish rollout. The pipeline depends on a global surveillance system for flu viruses, as well as regular surveys of antibody levels in the community to suss out which strains people are still protected against. The premise has been so well vetted by now that researchers can skip the chore of running large-scale clinical trials to determine the efficacy and safety of each new, updated recipe.

    But a seasonal strategy works best for a seasonal virus—and SARS-CoV-2 just isn’t there yet, says Hana El Sahly, an infectious-disease physician at Baylor College of Medicine. Though flu viruses tend to hop between the globe’s hemispheres, alternately troubling the north and the south during their respective cold months, this new coronavirus has yet to confine its spread to one part of the calendar. (Marks, of the FDA, tried to address this concern at today’s meeting, asserting that “we’re starting to see some seasonality” and that fall was indeed the very sensible for an annual rollout.) SARS-CoV-2 has also been spitting out concerning variants and subvariants at a faster rate than the flu (and flu shots already have a hard time keeping up with evolution). The FDA’s new proposal suggests picking SARS-CoV-2 variants in June to have a vaccine ready by September, a shorter timeline than is used for flu. That still might not be fast enough: “By the time we detect a variant, it will have ripped through the global population and, in a few more weeks, died down,” El Sahly told me. The world got a preview of this problem with last year’s bivalent shot, which overlapped with the dominance of its target subvariants for only a couple of months. A flu model for COVID would make more sense “if we had stable, predictable dynamics,” says Avnika Amin, a vaccine epidemiologist at Emory University. “I don’t think we’re at that point.”

    Murkiness around vaccine effectiveness makes this transition complicated too. Experts told me that it’s gotten much more difficult to tell how well our COVID vaccines are working, and for how long, fueling debates over how often they should be given and how often their composition should change. Many people have now been infected by the virus multiple times, which can muddy calculations of vaccine effectiveness; better treatments also alter risk profiles. And many researchers told me they’re concerned that the data shortcuts we use for flu—measures of antibodies as a proxy for immune protection—just won’t fly for COVID shots. “We need better clinical data,” El Sahly told me. In their absence, the hasty adoption of a flu framework could lead to our updating and distributing COVID shots too often, or not often enough.

    A flu-ish approach also wouldn’t fix all of the COVID vaccines’ problems. Today’s discussion suggested that, even if a new COVID-shot strategy change goes through, officials will still need to recommend several different dose sizes for several different age groups—a more complex regimen than flu’s—and may advise additional injections for those at highest risk. At the same time, COVID shots would continue to be more of a target for misinformation campaigns than many other vaccines and, at least in the case of mRNA-based injections, more likely to cause annoying side effects. These issues and others have driven down interest—and simply pivoting to the flu paradigm “is not going to solve the uptake problem,” says Angela Shen, a vaccine-policy expert at Children’s Hospital of Philadelphia.

    Perhaps the greatest risk of making COVID vaccines more like flu shots is that it could lead to more complacency. In making the influenza paradigm a model, we also threaten to make it a ceiling. Although flu shots are an essential, lifesaving public-health tool, they are by no means the best-performing vaccines in our roster. Their timeline is slow and inefficient; as a result, the formulations don’t always match circulating strains. Already, with COVID, the world has struggled to chase variants with vaccines that simply cannot keep up. If we move too quickly to the fine-but-flawed framework for flu, experts told me, it could disincentivize research into more durable, more variant-proof, less side-effect-causing COVID shots. Uptake of flu vaccines has never been stellar, either: Just half of Americans sign up for the shots each year—and despite years of valiant efforts, “we still haven’t figured out how to consistently improve that,” Amin told me.

    Whenever the COVID-emergency declaration expires, vaccination will almost certainly have to change. Access to shots may be imperiled for tens of millions of uninsured Americans; local public-health departments may end up with even fewer resources for vaccine outreach. A flu model might offer some improvements over the status quo. But if the downsides outweigh the pluses, Poland told me, that could add to the erosion of public trust. Either way, it might warp attitudes toward this coronavirus in ways that can’t be reversed. At multiple points during today’s meeting, FDA officials emphasized that COVID is not the flu. They’re right: COVID is not the flu and never will be. But vaccines can sometimes become a lens through which we view the dangers they fight. By equating our frontline responses to these viruses, the U.S. risks sending the wrong message—that they carry equal threat.

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    Katherine J. Wu

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  • It’s Gotten Awkward to Wear a Mask

    It’s Gotten Awkward to Wear a Mask

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    Last week, just a couple of hours into a house-sitting stint in Massachusetts for my cousin and his wife, I received from them a flummoxed text: “Dude,” it read. “We are the only people in masks.” Upon arriving at the airport, and then boarding their flight, they’d been shocked to find themselves virtually alone in wearing masks of any kind. On another trip they’d taken to Hawaii in July, they told me, long after coverings became optional on planes, some 80 percent of people on their flight had been masking up. This time, though? “We are like the odd man out.”

    Being outside of the current norm “does not bother us,” my cousin’s wife said in another text, despite stares from some of the other passengers. But the about-face my cousin and his wife identified does mark a new phase of the pandemic, even if it’s one that has long been playing out in fits and starts. Months after the vanishing of most masking mandates, mask wearing has been relegated to a sharply shrinking sector of society. It has become, once again, a peculiar thing to do.

    “If you notice, no one’s wearing masks,” President Joe Biden declared last month on 60 Minutes. That’s an overstatement, but not by much: According to the COVID States Project, a large-scale national survey on pandemic-mitigation behaviors, the masking rate among Americans bounced between around 50 and 80 percent over the first two years of the pandemic. But since this past winter, it’s been in a slide; the project’s most recent data, collected in September, found that just 29 percent have been wearing masks outside the home. This trend may be long-standing on the population level, but for individuals—and particularly for those who still wear masks, such as my cousin and his wife—it can lead to moments of abrupt self-consciousness. “It feels like it’s something that now needs an explanation,” Fiona Lowenstein, a journalist and COVID long-hauler based in Los Angeles, told me. “It’s like showing up in a weird hat, and you have to explain why you’re wearing it.”

    Now that most Americans can access COVID vaccines and treatments that slash the risk of severe disease and death, plenty of people have made informed decisions to relax on masking—and feel totally at ease with their behavior while paying others’ little mind. Some are no longer masking all the time but will do so if it makes others feel more comfortable; others are still navigating new patterns, trying to stay flexible amid fluctuating risk. Saskia Popescu, an infectious-disease epidemiologist at George Mason University, told me that she’s now more likely to doff her mask while dining or working out indoors, but that she leaves it on when she travels. And when she does decide to cover up, she said, she’s “definitely felt like more of an outlier.”

    For some, like my cousin and his wife, that shift feels slightly jarring. For others, though, it feels more momentous. High-filtration masks are one of the few measures that can reliably tamp down on infection and transmission across populations, and they’re still embraced by many parents of newborns too young for vaccines, by people who are immunocompromised and those who care for them, and by those who want to minimize their risk of developing long COVID, which can’t be staved off by vaccines and treatments alone. Theresa Chapple-McGruder, the public-health director for Oak Park, Illinois, plans to keep her family masking at least until her baby son is old enough to receive his first COVID shots. In the meantime, though, they’ve certainly been feeling the pressure to conform. “People often tell me, ‘It’s okay, you can take your mask off here,’” Chapple-McGruder told me; teachers at the local elementary school have said similar things to her young daughters. Meghan McCoy, a former doctor in New Hampshire who takes immunosuppressive medications for psoriatic arthritis and has ME/CFS, has also been feeling “the pressure to take the mask off,” she told me—at her kid’s Girl Scout troop meetings, during trips to the eye doctor. “You can feel when you’re the only one doing something,” McCoy said. “It’s noticeable.”

    Read: Mask mandates are illogical. So what?

    For Chapple-McGruder, McCoy, and plenty of others, the gradual decline in masking creates new challenges. For one thing, the rarer the practice, the tougher it is for still-masking individuals to minimize their exposures. “One-way masking is a lot less effective,” says Gabriel San Emeterio, a social worker at Hunter College who is living with HIV and ME/CFS. And the less common masking gets, the more conspicuous it becomes. “If most people met me, they wouldn’t know I was immunocompromised,” McCoy told me. “There’s no big sign on our foreheads that says ‘this person doesn’t have a functioning immune system.’” But now, she said, “masks have kind of become that sign.”

    Aparna Nair, a historian and disability scholar at the University of Oklahoma who has epilepsy, told me that she thinks masks are becoming somewhat analogous to wheelchairs, prosthetics, hearing aids, and her own seizure-alert dog, Charlie: visible tools and technologies that invite compassion, but also skepticism, condescension, and invasive questions. During a recent rideshare, she told me, her driver started ranting that her mask was unnecessary and ineffective—just part of a “conspiracy.” His tone was so angry, Nair said, that she began to be afraid. She tried to make him understand her situation: I’ve been chronically ill for three decades; I’d rather not fall sick; better to be safe than sorry. But she said that her driver seemed unswayed and continued to mutter furiously under his breath for the duration of the ride. Situations of that kind—where she has to litigate her right to wear a mask—have been getting more common, Nair told me.

    Masking has been weighed down with symbolic meaning since the start of the pandemic, with some calling it a sign of weakness and others a vehicle for state control. Americans have been violently attacked for wearing masks and also for not wearing them. But for a long time, these tensions were set against the backdrop of majority masking nationwide. Local mask mandates were in place, and most scientific experts wore and championed them in public. With many of those infrastructural supports and signals now gone, masking has rapidly become a minority behavior—and people who are still masking told me that that inversion only makes the tension worse.

    San Emeterio, who wears a vented respirator when they travel, recently experienced a round of heckling from a group of men at an airport, who started to stare, laugh, and point. Oh my god, look at what he’s wearing, San Emeterio recalls the strangers saying. “They clearly meant for me to hear it,” San Emeterio told me. “It didn’t make me feel great.” Alex Mawdsley, the 14-year-old son of an immunocompromised physician in Chicago, is one of just a handful of kids at his middle school who are still masking up. Since the start of the academic year, he’s been getting flak from several of his classmates “at least once a week,” he told me: “They’re like ‘You’re not gonna get COVID from me’ and ‘Why are you still wearing that? You don’t need it anymore.’”

    Alex’s mother, Emily Landon, told me she’s been shaken by the gawks and leers she now receives for masking. Even prior to the pandemic, and before she was diagnosed with rheumatoid arthritis and began taking immunosuppressive drugs, she considered herself something of a hygiene stan; she always took care to step back from the sneezy and sniffy, and to wipe down tray tables on planes. “And it was never a big deal,” she said.

    Read: Put your face in airplane mode

    It hasn’t helped that the donning of masks has been repeatedly linked to chaos and crisis—and their removal, to triumph. Early messaging about vaccines strongly implied that the casting away of masks could be a kind of post-immunization reward. In February, CDC Director Rochelle Walensky described masks as “the scarlet letter of this pandemic.” Two months later, when the administration lifted its requirements for masking on public transportation, passengers on planes ripped off their coverings mid-flight and cheered.

    To reclaim a mask-free version of “normalcy,” then, may seem like reverting to a past that was safer, more peaceful. The past few years “have been mentally and emotionally exhausting,” Linda Tropp, a social psychologist at the University of Massachusetts at Amherst, told me. Discarding masks may feel like jettisoning a bad memory, whereas clinging to them reminds people of an experience they desperately want to leave behind. For some members of the maskless majority, feeling like “the normal ones” again could even serve to legitimize insulting, dismissive, or aggressive behavior toward others, says Markus Kemmelmeier, a social psychologist at the University of Nevada at Reno.

    It’s unclear how the masking discourse might evolve from here. Kemmelmeier told me he’s optimistic that the vitriol will fade as people settle into a new chapter of their coexistence with COVID. Many others, though, aren’t so hopeful, given the way the situation has unfolded thus far. “There’s this feeling of being left behind while everyone else moves on,” Lowenstein, the Los Angeles journalist and long-hauler, told me. Lowenstein and others are now missing out on opportunities, they told me, that others are easily reintegrating back into their lives: social gatherings, doctor’s appointments, trips to visit family they haven’t seen in months or more than a year. “I’d feel like I could go on longer this way,” Lowenstein said, if more of society were in it together.

    Americans’ fraught relationship with masks “didn’t have to be like this,” Tropp told me—perhaps if the country had avoided politicizing the practice early on, perhaps if there had been more emphasis on collective acts of good. Other parts of the world, certainly, have weathered shifting masking norms with less strife. A couple of weeks ago, my mother got in touch with me from one such place: Taiwan, where she grew up. Masking was still quite common in public spaces, she told me in a text message, even where it wasn’t mandated. When I asked her why, she seemed almost surprised: Why not?

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    Katherine J. Wu

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  • Are We Really Getting COVID Boosters Every Year Forever?

    Are We Really Getting COVID Boosters Every Year Forever?

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    School is in session, pumpkin spice is in season, and Americans are heading to pharmacies for what may soon become another autumn standby: your annual COVID shot. On Tuesday, the White House announced the start of a “new phase” of the pandemic response, one in which “most Americans” will receive a COVID-19 vaccine just “once a year, each fall.” In other words, your pandemic booster is about to become as routine as your physical exam or—more to the point—your flu shot. One more health-related task has been added to your calendar, and it’s likely to remain there for the rest of your life.

    From a certain standpoint, this regimen makes a lot of sense. The pandemic’s biggest surges so far have come in the winter, and a fall booster could go a long way toward mitigating the next of those surges. What’s more, the new plan greatly simplifies COVID-vaccination regimens, both for the public and for providers. “It has been bewildering in many cases to understand who is eligible for a booster, how many boosters, when, which boosters, how far apart,” Jason Schwartz, a vaccine-policy expert at Yale, told me. “I think that has held down booster uptake in some really discouraging ways.” In a sense, White House COVID-19 Response Coordinator Ashish Jha told me, the new plan just codifies the way things already worked: The last time low-risk Americans became eligible for another shot was last fall. (The elderly and immunocompromised have operated on a different schedule and will likely continue to do so, Jha said.)

    Still, some public-health experts worry that the White House is jumping the gun. Back in April, a number of them told Stat News’s Helen Branswell they were concerned that the U.S. would adopt such a policy without the data needed to support it. When the White House made its announcement on Tuesday, many felt their concerns had been vindicated. “We’ve had twists and turns and surprises every single step of the way with COVID, and the idea that we’re going to have one shot and then we’re done is not really consistent with how things have worked in the past,” Walid Gellad, a professor at the University of Pittsburgh School of Medicine, told me. The plan, in his view, glosses over considerable uncertainties.

    Read: America’s fall booster plan has a fatal paradox

    For one thing, it assumes that the virus will follow an annual schedule with peaks in the fall and winter—not unlikely, but also not a given. For another, we still don’t have a firm grasp on the magnitude or duration of the benefits offered by the new Omicron-specific vaccine. For all we know, Gellad told me, the added protection afforded to someone who gets the shot tomorrow may have largely dissipated by New Year’s Eve.

    And that’s not to mention the massive uncertainty presented by the specter of future variants. In a briefing Tuesday, Jha acknowledged that “new variant curveballs” could change the government’s plans. But the announcement itself includes no such caveats, which some public-health experts worry could cause problems if course corrections are needed down the line. For all we know, new variants could necessitate more frequent updates, or, if viral mutation slows, we might not even need annual shots, Paul Thomas, an immunologist at St. Jude Children’s Research Hospital, in Tennessee, told me.

    If the routine the White House describes sounds a lot like flu shots, that’s no accident. The announcement explicitly recommends that COVID vaccines be taken between Labor Day and Halloween—“just like your annual flu shot.” That comparison, though, is part of what concerns critics, who worry that the shift into a more flu-like framework will entail the adoption of a vaccines-only approach to COVID prevention. Many of the interventions that have proved so effective over the past two and a half years—masking, distancing, widespread testing—have not traditionally been a major part of our flu-season protocols. If we treat COVID like flu, the thinking goes, such interventions risk falling even further by the wayside. The announcement, which makes no mention of any other prevention tactics, doesn’t offer much reassurance to the contrary.

    Read: A simple rule for planning your fall booster shot

    But that reading, Jha told me, is “just clearly wrong.” Although vaccines are “the central pillar of our strategy,” he said, testing, masking, and improving indoor air quality are all important as well. But as my colleague Katherine Wu has written, the country has been relying more and more on vaccines—and less and less on the other interventions at our disposal—for some time. Even if you do read the new policy as an abnegation of masking, ventilation, and the like, it may not functionally be much of a departure from the status quo.

    For now, Thomas said, the White House’s plan makes sense—as long as it stays sensitive to changing circumstances. “We keep learning new things about this virus,” he told me. “The rate of mutation is changing. The spread through the population is changing.” And as such, he said, our response must be flexible.

    The White House announcement seems like a good-faith attempt to balance competing priorities: on the one hand, the need to communicate uncertainty and acknowledge complexity; on the other, the need to keep the message from getting so complex that it confuses people to the point that they tune it out entirely. In this case, the administration seems to have come down on the side of simplicity. That could be a mistake, Gellad says—one that public-health authorities have made over and over throughout the pandemic. “When you try and make things simple and understandable and present them without sufficient uncertainty,” he told me, “you get into trouble when things change.”

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    Jacob Stern

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