Are You Sure You’re Not Guilty of the ‘Millennial Pause’?

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It took me two years to post my first TikTok. I’d press “Record,” mumble into the camera, and hastily hit delete before anyone could see just how awkward I was on video. I took the plunge only after practicing enough to eliminate any telltale signs that I was a near-30-year-old trying to be cool. Or so I thought.

Apparently, I’m still guilty of the “Millennial pause.” After hitting “Record,” I wait a split second before I start speaking, just to make sure that TikTok is actually recording. Last year, @nisipisa, a 28-year-old YouTuber and TikToker who lives in Boston, coined the term in a TikTok about how even Taylor Swift can’t avoid the cringey pause in her videos. “God! Will she ever stop being relatable,” @nisipisa, herself a Millennial, says. Gen Zers make up a larger portion of TikTok’s base, and have grown up filming themselves enough to trust that they’re recording correctly. Which is why, as short-form video comes to Instagram (Reels), YouTube (Shorts), and Snapchat (Spotlight), the Millennial pause is becoming easier to spot.

Unfortunately for me, today’s most culturally influential social platforms are not geared around Millennials anymore, and the pause is far from the only giveaway. Millennials—and their mannerisms—defined the online ecosystem that has ruled for a decade plus, treating sites such as MySpace, Tumblr, Facebook, and Twitter as the jungle gyms in their internet playground. But now that we’re well into the TikTok era, the cracks are starting to show. Instagram and Facebook, while still popular, are attempting to capture the magic of TikTok by pivoting to videos and other ultra-sharable content that doesn’t come quite as naturally to Millennials (even ones born in the early 1990s, like me). Now that Gen Z has all the attention, the internet quirks that Millennials have called their own for years can feel a bit stale, if not downright cringey. The first generation to grow up with social media in the mobile web era, Millennials are now becoming the first generation to subsequently age out of it, stuck parroting the hallmarks of a bygone digital age.

Once my eyes were opened to the Millennial pause, I started noticing my age in every part of my internet experience. I get confused whenever Instagram changes its layout. I use GIFs to make jokes in Slack. I have posted song lyrics on my Instagram Story. The range of mannerisms is so broad, the signs such a staple of my online behavior for the past 15 years, that it’s not even worth trying to fight them.

Naturally, Gen Z has picked up on them too, and the mockery that was once reserved for Boomers is now coming for me. “The way the quintessential Millennial behaves online is basically a bunch of silly little nuances strung together to create a personality that is very giddy and excitable about the normal or mundane,” Michael Stevens, a 24-year-old TikTok creator based in New England, told me over email. His impressions of Millennials have received millions of views on TikTok. Those “silly little nuances” include starting videos with a sigh, doing dramatic zooms into their own faces for emphasis, and using phrases popularized on Twitter and Tumblr—like “doggo” and “I can’t even”—in real life. “My husband just went to the new Trader Joe’s next to our house and I think it wins the internet for the day,” Stevens says in a Millennial parody from July. “If this is adulting, sign me up.”

Millennial internetisms exist because they were, at one time, the mainstream way of talking online. In 2014, someone tweeting that Parks and Recreation’s Leslie Knope and Ben Wyatt gave them “all the feels” would have been acceptable, but now Gen Z just uses it as fodder for some secondhand embarrassment, the same way that Millennials groan when their Boomer parents try to navigate an Apple TV. Millennial-isms have made for a whole genre of parody. On TikTok, the creator Bianca Scaglione makes Millennial parodies for her 910,000 followers, specifically skewering their awkwardness on a livestream. (“And then they accidentally end the live by trying to do a filter,” she captioned one impression.) Other creators have mocked Millennials for how they pose in photos (taking selfies from above is so over), for using Gen Z phrases (“slay, bestie”) on TikTok, for adopting something called a “BuzzFeed accent” when they talk to the camera. The list goes on: Millennials take Instagram way too seriously, using portrait mode and filling their captions with forced puns. They love to turn their social-media bios into lists—for instance, mine would read: “Kate. Ravenclaw. Cat mom. Knitting enthusiast. PA > OH > NYC.”

And, given their need to insert themselves into every new internet trend, Millennials are also sometimes active participants in their own critique. Since they can’t beat the Gen Z creators parodying them, some Millennials have joined them, re-creating the fashion, hair, and makeup of their youth in similarly popular videos.

Millennials aren’t the only generation that has been boiled down to broad and often unflattering stereotypes online: the notions that Boomers hate change, for example, or that Gen Xers are slackers. In 2019, the phrase OK Boomer took off online across both Gen Z and Millennial users as a symbol of collective exhaustion with battling the stereotypes handed down to them from above. That same year, a Facebook group titled “A group where we all pretend to be boomers” launched; 285,000 members still role-play daily, posting pixelated memes about cars and asking things like “DID anyone ELSE LOSE POWER??”

But that kind of mockery is different. Although Boomers fell out of the internet zeitgeist, they never had as far to fall as Millennials—the first cohort to watch their youth fade in real time, with evidence of their growing irrelevance meticulously documented in memes, trends, and headlines published on the very internet they once reigned over. They’re no longer the hot new item brands are scrambling to attract, nor the ones the world is turning to for the next fashion trend. The internet has moved on, and Millennials can either adapt or, like a Gen Xer still listening to Pearl Jam, not care if their choices make them seem old.

None of this is necessarily a bad thing, even if it bruises my ego. A 35-year-old desperately adopting the mannerisms of a 20-year-old is a different kind of cringe. Instead, in spite of the occasional embarrassment, the Millennial tics that remain have gone from trend to nostalgia. And besides, when Gen Alpha comes for Gen Z’s internet, you better believe I’ll have been taking notes.

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12 Books to Help You Love Reading Again

Reading is hard right now. The pandemic has pushed our already scattered attention spans to a crisis point. But even before 2020, stressors such as political chaos and the allure of our phones made it harder and harder to find the time and focus to get lost in a book. Even when we’re not living through a distracting moment, we will inevitably have personal fallow periods when reading as a habit and a respite just doesn’t happen.

Certain writing is able to grab us and shake us out of these ruts—by presenting a breakneck adventure we feel compelled to see through; by gently opening us back up to the thrill of a good story; by allowing us to spend time in the mind of a fictional character. When they appear to us at the right moment and in the right way, these books can act as a bridge that leads us back to the rewards of literature. Below, our staff members have compiled 12 books that rekindled our love for reading after a dry spell.

The cover of Heartburn

Heartburn, by Nora Ephron

After I had my twins in the summer of 2020, when my brain was as sludgy as risotto and I couldn’t imagine finishing a CNN chyron, let alone a novel, my very brilliant friend Annalisa recommended Heartburn as a “gateway” back into reading. I finished it in a few days, sucking up the chapters like air or a cocktail. The book is a lightly (very lightly) fictionalized version of Ephron’s own devastating marital crisis, when she discovered that her husband, the former Washington Post reporter Carl Bernstein, was having an affair with a mutual friend while Ephron was pregnant with their second child. Somehow, it’s hysterical. Ephron’s tone throughout is part stand-up comic, part beloved friend sending a bitchy, meandering email. In one paragraph, her thoughts turn from despair to suicidal ideation to the habits of “neurasthenic,” poetic sad girls to this take on that famous genre: “Show me a woman who cries when the trees lose their leaves in autumn and I’ll show you a real asshole.” Did I mention that recipes are folded into the text? An actually perfect novel. — Sophie Gilbert

The cover of The Plot

The Plot, by Jean Hanff Korelitz

Recently, during a particularly grim stretch of months, I was desperate to get lost in a book. I kept searching for something that would echo what I was feeling: serious reflections on sickness, grief and loss, the world ending. But I couldn’t finish anything. Getting to the last page always seemed like hiking up a mountain; it would be worthwhile, even beautiful, but also exhausting. When I read The Plot, I realized I’d been picking the wrong material. The title of Korelitz’s twisty thriller feels like a wink to the reader. It is, in fact, a plot-driven book about the power of a good plot. (Things kick off when a writer steals a dynamite story line from a dead person.) That’s not to say the book is only action; it plays with meaty questions about artistic ownership, gender, and creative identity. But Korelitz leans into the drama and the fun. Sometimes, when you want a book to take you away, you have to choose one that doesn’t hit home. — Faith Hill

The cover of Intimations

Intimations, by Zadie Smith

Reading about the pandemic may sound like a terrible idea for someone trying to move past the misery of the pandemic. But Smith’s Intimations, a collection of essays written during and about the isolation and anxiety of 2020, serves less as a bleak reminder of our social-distancing era and more as comforting evidence that even one of the most clear-eyed authors struggled to shape her thoughts. Some passages come off like first drafts, but that moved me: Smith seemed as reluctant as I was to contend directly with the virus’s toll, as torn as I felt about attempting to turn my dread into sourdough. Absorbing her musings, especially about writing, reassured me; her prose was as beautifully structured as ever, but she wasn’t forcing herself to find answers. At barely more than 100 pages long, Intimations is a literary compass, compact and unassuming, but essential to finding a way forward. — Shirley Li

[Read: The literature of the pandemic is already here]

The cover of Turtle Diary
New York Review Books

Turtle Diary, by Russell Hoban

Turtle Diary doesn’t move very fast. It doesn’t have any real dramatic tension, either: The book’s two melancholy and otherwise unconnected narrators, William and Neaera, encounter no obstacles in their shared quest to release three sea turtles living at the London Zoo back into the ocean. The zookeeper is an eager accomplice. Their journey across England, their charges tucked in the back of a rented van, is eventless. The turtles slip easily into the water and swim away. This is not a book that screams Don’t put me down! And yet, after I had spent more than a year with my attention frayed by the dual demands of editing stories about the pandemic and caring for my baby—after I had spent many months too distracted to think about books—I kept reading because of Turtle Diary’s calm, its quiet interiority. However undramatic, the turtles’ release is a transformative moment for both William and Neaera, and afterward, they feel more at ease in the world and with themselves. Only a book could capture the intimacy of a shift like that, and offer the pleasure of sharing in it. — Sarah Laskow

The cover of In the Dream House
Graywolf Press

In the Dream House, by Carmen Maria Machado

To borrow the architectural metaphor that animates In the Dream House, this isn’t a memoir you read so much as one that you wander through, room by room. I toured it, so to speak, in less than a day, trying to wean my brain off social media and reacquaint it with the slow, analog pleasures of following a single narrative for an extended period. To tell a difficult story about domestic abuse within a lesbian relationship, Machado resorts to an unconventional, fragmented structure. A mesmerizing narrator, she weaves personal narrative with intelligent and often darkly funny interrogations of literary and pop-cultural tropes. Chapters are short and given intriguing titles such as “Dream House as Schrödinger’s Cat” and “Dream House as Noir.” (The chapter “Dream House as Famous Last Words” is simply the sentence “‘We can fuck,’ she says, ‘but we can’t fall in love.’”) The effect is accumulative and devastating, and the memoir’s many pieces add up to an inventive reckoning with cultural silence. — Lenika Cruz

[Read: The shadow pandemic]

The cover of Goodbye, Vitamin
Henry Holt and Co.

Goodbye, Vitamin, by Rachel Khong

After Ruth’s fiancé breaks up with her, she quits her job, returns home, and helps care for her father, who is in the early stages of Alzheimer’s. It sounds like a bummer of a premise, but Goodbye, Vitamin is actually one of the most life-affirming books I’ve ever read. When I’m in a reading rut, it’s usually because of stress, which leaves me unable to focus on a dense narrative. This novel is the perfect antidote: It’s a short read, and most scenes are less than a page long; many are just a couple of lines. It’s a story told in small everyday moments, and the knowledge that Ruth has limited time left with her father imbues each with meaning. Its comforts are deeper than escapism; by showing, never telling, it demonstrates that all the moments of our stupid little lives, even the hard and mundane ones, add up to something profound. But it’s really funny too! Khong expertly balances the silly and the sublime until the last page—even now, years after I first read it, thinking of the book’s final lines can make me cry. — Julie Beck

The cover of All About Love
William Morrow

All About Love: New Visions, by bell hooks

In the blustering December days following the death of the Black feminist titan bell hooks, the first wave of the Omicron variant rapidly overtook New York City. Under such foreboding conditions, I rarely seek out nonfiction that isn’t explicitly work-related. But in reading so many moving tributes to hooks, I was compelled to revisit All About Love: New Visions, a brisk, personal read. Interspersing cultural analysis with anecdotes from her own life, hooks ponders what love could look like in action. “When we choose to love we choose to move against fear—against alienation and separation,” she writes. It’s at once an incisive critique of elevating romantic connections above all other kinds and a guide to employing what hooks calls a “love ethic” as a communal balm. This is the kind of nonfiction that feels like an invitation. All About Love holds the same enthralling power over me now as it did when I first encountered it as a college freshman. When I arrived at its final pages again, I was comforted by the thought that more awaited me—in the rest of hooks’s Love Song to the Nation trilogy, in her broader oeuvre, and in the other nonfiction it guided me back to. — Hannah Giorgis

The cover of Trio

Trio, by William Boyd

During the Trump era, I stopped reading books. Maybe this is understandable. The human brain is no more designed for a sustained assault on its attention than the human body is designed for metabolizing Froot Loops, and that’s essentially what Donald Trump’s presidency required: the unremitting ingestion of Twitter’s neon birdseed. Yet still I was alarmed. For two-plus years, I’d been a daily book critic at The New York Times. How on earth did I lose the skill to stay with a novel? Two things got me reading again: the election of a dull, steady, Twitter-indifferent president, which gave me the permission I needed to lose myself in fiction, and the arrival of a galley of Trio. It takes place in Brighton during the swinging ’60s, and though its scope is less ambitious than some of Boyd’s cradle-to-grave pseudo-biographies, it’s great fun nonetheless, focusing on a trio of characters (an actor, a writer, and a film producer) involved in the desperate and occasionally redeeming project of making art. I was instantly transported by their excesses, frailties, and deceptions. Boyd, an expert conjurer of worlds, writes with his customary energy and wit. Plus, one of his minor devils has the unimprovable name of Janet Headstone. Who could resist? — Jennifer Senior

[Read: The exquisite pain of reading in quarantine]

The cover of Piranesi

Piranesi, by Susanna Clarke

I read Clarke’s jewel of a novel during our first pandemic winter. At a time when creative virtuosity was the last thing on most of our minds, Piranesi floored me with its imaginative heft. A man called Piranesi lives in a house with many rooms that is sometimes flooded by the sea. He can’t remember how he got there, but he occupies his time by mapping its cavernous, statuary-filled halls. He fishes for food and makes coverings for his feet. (He wonders, at one point, whether he can knit socks from seaweed. He decides he cannot.) He also catalogs and gives names to the few people he knows or eventually discovers exist: the Other, the Prophet, 16. The reveal—why Piranesi is in the house, who his compatriots are, why his memory is so hazy—is wildly inventive. Clarke explores grand themes (consciousness, hubris) with tenderness and contrasts brilliantly austere environs with her protagonist’s warm curiosity, which registers like a beating heart. Reading along, I felt the pleasure of trusting a master storyteller; gently, slowly, she illuminated the dark until I was, like Piranesi himself, standing in the bright light of the world outside the house. — Jane Yong Kim

The cover of The Three-Body Problem

The Three-Body Problem, by Liu Cixin

After numbing my early-pandemic terror by getting lost in video games, I became immersed in a story that was, in part, about gaming through the apocalypse. Liu’s sci-fi landmark, The Three-Body Problem, opens with scenes from China’s Cultural Revolution in the ’60s and then traverses decades in which aliens seem to be messing with Earthly affairs, leading humankind’s brightest minds to treat their everyday reality as a puzzle to be solved. One character becomes mesmerized by a multiplayer virtual world that seems to hold clues about the mounting glitchiness of meatspace. Other characters devote themselves to quests—for hidden knowledge, for interstellar connection, for the reform of our species—with the kind of fervency that blots out all other pursuits. Devouring the book felt like completing a series of mind-bending challenges on the way to some unimaginable final level. But Liu’s exact prose and restless, point-of-view-switching narrative style paid off the obsession in a way that no game could. — Spencer Kornhaber

[Read: What happens if China makes first contact?]

The cover of The Thief
Greenwillow Books

The Thief, by Megan Whalen Turner

I felt like a ragged cuticle in 2020—exposed, inflamed, sensitive. Everything was overstimulating, even books. As the year dragged on, I decided that if reading was impossible, I’d try rereading. I began with Turner’s 1996 novel, which I’d loved in middle school but mostly forgotten. Set in a preindustrial Hellenistic world with a vividly imagined history and mythology, the book’s titular pickpocket, Gen, is a charming scoundrel who’s sprung from jail and drafted for a mysterious mission. The reasons why he travels across the country, and what his companions need a thief for, trickle out slowly alongside intrigue and banter. Turner’s story is heavy on politics and reality, which makes its mysterious supernatural implications irresistible. And when I reached the crucial, climactic twist that gives the entire journey a new meaning, the revelation of a character’s true identity and my giddy original discovery of it more than a decade ago rushed back. I immediately picked up its sequel, just as I had the first time around, and read all the way through the five other books in the series—ending with the serendipitously released 2020 conclusion, Return of the Thief. — Emma Sarappo

The cover of The Diary of a Young Girl

The Diary of a Young Girl, by Anne Frank

Early in the pandemic, I noticed that my daughters, who were 10 and 7 then, had stopped reading. Once the snow-day giddiness of those early weeks faded and some semblance of routine returned, they seemed incapable of losing themselves in books. I couldn’t blame them; my reading time was mostly spent refreshing websites that gave the numbers of the infected and dead. And then, one evening, I picked up Anne Frank’s diary. The choice was maybe morbid (and it’s possible they weren’t quite ready for it), but I sat on the floor in their room and began reading a few entries to them before bed. I’d forgotten how the diary starts with Anne in freedom, all earnestness and schoolgirl obsession. The girls loved it. And then Anne’s life begins to contract. What menaced her was so much more dangerous and deadly than COVID; they understood that. But they also couldn’t help relating: Anne peeks out the window of her attic to catch a glimpse of sky and rooftop. At one point, she wonders, “When will we be allowed to breathe fresh air again?” They kept asking for one more entry, and I kept wanting to slow down. Reading was giving them pleasure again, but I knew, as they didn’t yet, how her story ended. — Gal Beckerman

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Hotel Earth

Cornices overgrown with moss, the stoop
With nettles, flower beds
Hardly discernible beneath brambles and weeds—

Next door was a place where drinks
Were sold, so I ordered
A glass of red wine. The Earth?

For years it never changed, said the bartender.
Now kids won’t come around at night.
Doors close by themselves

As if clouds were gathering—bang!
Footsteps climb the staircase, one, two—

I paid the tab. Does anything stay

There—hatred, the capacity for love?
There’s the baby in the red striped sweater
Against blue sky, my left hand

Holding her, my right the camera.
She’s smiling at you.
We’re invisible, like the sea.

This poem appears in the September 2022 print edition.

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You Don’t Want a World Without Manual Transmission

I drive a stick shift. It’s a pain, sometimes. Clutching and shifting in bumper-to-bumper traffic wears you out. My wife can’t drive my car, which limits our transit options. And when I’m at the wheel, I can’t hold a cold, delicious slushie in one hand, at least not safely. But despite the inconvenience, I love a manual transmission. I love the feeling that I am operating my car, not just driving it. That’s why I’ve driven stick shifts for the past 20 years.

That streak may soon be over. When it comes time to replace my current car, I probably won’t be able to get another like it. In 2000, more than 15 percent of new and used cars sold by the auto retailer CarMax came with stick shifts; by 2020, that figure had dropped to 2.4 percent. Among the hundreds of new car models for sale in the United States this year, only about 30 can be purchased with a manual transmission. Electric cars, which now account for more than 5 percent of car sales, don’t even have gearboxes. There are rumors that Mercedes-Benz plans to retire manuals entirely by the end of next year, all around the world, in a decision driven partly by electrification; Volkswagen is said to be dropping its own by 2030, and other brands are sure to follow. Stick shifts have long been a niche market in the U.S. Soon they’ll be extinct.

We can’t say we weren’t warned. For years, the stick’s decline has been publicly lamented. Car and Driver ran a “Save the Manuals” campaign in 2010, insisting that drivers who “learned to operate the entire car” would enjoy driving more and do it better. A #SaveTheManual hashtag followed. Shifting gears yourself isn’t just a source of pleasure, its advocates have said, or a way to hone your driving. A manual car is also less likely to be stolen if fewer people know how to drive it. It’s cheaper to buy (or at least it used to be), and it once had lower operation and maintenance costs. You can push-start a manual if the battery dies, so you’re less likely to get stuck somewhere; and you can use the stick more easily for engine braking, which can reduce wear and make descending hills easier and safer.

But the manual transmission’s chief appeal derives from the feeling it imparts to the driver: a sense, whether real or imagined, that he or she is in control. According to the business consultant turned motorcycle repairman turned best-selling author Matthew Crawford, attending to that sense is not just an affectation. Humans develop tools that assist in locomotion, such as domesticated horses and carriages and bicycles and cars—and then extend their awareness to those tools. The driver “becomes one” with the machine, as we say. In his 2020 book, Why We Drive, Crawford argues that a device becomes a prosthetic. The rider fuses with the horse. To move the tool is to move the self.

Crawford argues that this cognitive enhancement is possible only when you can interpret the components of the tool you’re operating. As a rider must sense the horse’s gait, so must a driver grok the engine’s torque. But modern automotive technology tends to inhibit that sensation. Power steering, electronic fuel injection, anti-lock braking systems, and, yes, automatic transmissions obstruct the “natural bonds between action and perception,” Crawford writes. They inhibit the operator’s ability to interpret the car’s state and capacities through a healthy feedback loop of action and information. To illustrate the point, he tells a story about test-driving a 400-horsepower Audi RS3 with all the options, including a paddle-shifting automatic transmission. It was powerful and capable, he says, but “I could not connect with the car.” That description is a common one among gearheads, a way of expressing that the human operator and the machine are out of sync.

The stick shift has become a proxy object for that loss. When manual transmissions were the norm, drivers had to touch and manipulate the shifter, in tandem with the clutch, constantly while operating a vehicle. Passengers saw this action taking place, and shifting gears became imbued with meaning. It represented the allure of the road, for all its good and ill, and stood in for the human control of a big, hot, dangerous machine screaming down the pavement. The manual transmission’s impending disappearance feels foreboding not (just) because shifting a car is fun and sensual, but also because the gearshift is—or was—a powerful cultural symbol of the human body working in unison with the engineered world.

Crawford admits that he might connect with the Audi if he put in enough hours at the wheel. But even knowing this, “the car left me cold,” he writes. In part, that’s because the coarse feedback that one gets while driving an all-electronic vehicle might be—or feel—too subtle for a brute human mind. Cars have, in a way, become too good. Human understanding slips off their surface, like ice off a hot hood.

The decoupling of humans from their driving machines will accelerate in years to come. If the automatic transmission made the stick shift a monument to lost control, the autonomous (self-driving) vehicle aims to do the same for steering wheels. At that point, the loss will be so complete that it may not feel so alienating. Any pretense that the automobile is a prosthetic will be eliminated, so car passengers can move on to other things. Like people on a train, they might settle into a book or take a nap or open up an Excel spreadsheet.

But fully autonomous cars might never be in widespread use, and even mostly autonomous cars could be a long way off. In the meantime, the automotive industry will take away drivers’ control in slow, lumbering steps, just as other industries have for other appliances, apparatuses, and services. You can now flush a toilet or operate a sink not with the force of your hands, but by means of sensors. Web and product searches yield the results some third party wants you to see, rather than the best matches to your requests. Maps, now digital, show points of interest in place of raw information; travelers let the apps that host those maps tell them where to go and how to get there. Customer-service agents follow scripts to solve your problems, your doctors follow automatic diagnostic templates, and the streaming platforms on your television calculate which shows you should watch next.

People rued the decline of the stick shift for years before the “Save the Manuals” campaign (and hashtag, and merch) spun up. But it may be no accident that the formal crusade arose just as computation overtook culture, steering human lives in the direction of technology companies’ and data aggregators’ needs. Around that time, all the apps and services just mentioned (and many more) became widespread.

[Read: I’ll shift for myself]

The manual transmission, however marginal it has become during the smartphone age, remains a vestige of direct, mechanical control. When a driver changes speeds, their intention can be fruitfully realized in gratifying action, meshing literal gears. Even when your hand slips and the gears grind, the device still speaks in a way you can understand.

To lament the end of the manual transmission is to eulogize much more than shifting gears. When the manual dies, little about driving will fall away that hasn’t already been lost. But we’ll lose something bigger and more important: the comfort of knowing that there is one essential, everyday device still out there that you can actually feel operating. Even if you don’t own a stick, or if you don’t know how to drive one, its mere existence signals that a more embodied technology is possible—that it once was common, even—and that humans and machines really can commune. The stick shift is a form of hope, but it’s one we’ll soon have left behind.

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The Problem With Being Too Cautious in Vaccine Trials

Late last month, the CDC confirmed that two young children had been diagnosed with monkeypox. Although almost all infections in the United States are associated with men who have sex with men, the virus is spreading rapidly and, through household exposure or other transmission routes, could soon turn up in other populations, such as infants, adolescents, and pregnant people (including their fetuses).

Public-health officials recommend the Jynneos vaccine for household contacts of, and others recently in close contact with, people who have monkeypox. But this shot suffers from the same problem as many vaccines developed against emerging infectious diseases: It has never been rigorously tested in people who are pregnant or under 18 years old.

In vaccine research, the usual presumption has been that people who are pregnant or under 18 are uniquely vulnerable to being harmed by medical research. But in many cases, that means that they end up being studied last—and are systematically excluded from the benefits of innovation during epidemics.

Pregnant and lactating women were excluded from early COVID-19 vaccine trials. Although they were still allowed to get shots, only about a third of them were fully vaccinated against COVID-19 by the end of 2021. Many women who were pregnant or planning to become pregnant mistakenly believed, according to one poll, that pregnant women should not get vaccinated. Meanwhile, children under 16 were left out of initial COVID-vaccine trials, and some age groups waited more than a year longer than adults for vaccine approval.

[Read: Monkeypox vaccines are too gnarly for the masses]

This routine exclusion of vulnerable populations, such as children and pregnant people, in research trials is largely due to paternalistic ethical norms among scientists, who set the standard for the lawyers and ethicists who oversee research regulations. We, however, believe that some important factors—including the harms and inequity of not having proven vaccines during pandemics—are given too little weight. Vulnerable populations are least protected at a time when they are most in need of protection.

This outdated approach means that governments and foundations invest too little in preclinical research, novel clinical-trial designs, and vaccine-development policy and advocacy for pregnant patients and children. As a result, during epidemics of emerging diseases, pregnant patients and children suffer disproportionately, and future generations have a higher burden of disease because of the consequences of infections occurring in utero: birth defects, neurodevelopmental disorders, cardiovascular diseases.

Studies conducted after COVID-19 vaccines became broadly available showed that pregnant women infected with SARS-CoV-2 had a higher risk of serious illness and of losing their baby if they were unvaccinated. Meanwhile, according to the CDC, 1,180 children have died of COVID-19 in the U.S. since March 2020, the overwhelming majority of whom have been unvaccinated.

The harms continue to unfold: Many parents report that they are reluctant to vaccinate their children against COVID-19 because there have been too few studies on children conducted to date. Sadly, a similar pattern played out during Ebola epidemics in West and Central Africa in the 2010s.

Novel and reemerging infections are disrupting the world more severely and frequently than ever before. In the past two decades, three new coronaviruses have profoundly disrupted societies and economies in multiple regions of the world; existing diseases, such as Ebola and Zika, spread from remote, sparsely populated locations to major urban centers around the globe. Although governments, industry, and foundations have invested heavily in the development and deployment of vaccines for Ebola, Zika, SARS-CoV-2, and other pathogens, these research initiatives have generally left out children and pregnant people.

[Read: What should worry most Americans about our monkeypox response]

In 2019, the FDA approved the Jynneos vaccine, which is designed to protect humans against two related poxviruses (smallpox and monkeypox) and to have fewer side effects than the original smallpox vaccine. At the time of the decision, studies in animals had shown that Jynneos protected against infection; studies in nonpregnant adults showed that it caused an increase in antibodies that was believed to be sufficient to protect against infection. The primary target for the vaccine at the time was people working in laboratories on viruses related to smallpox, but the U.S. government still placed an order for millions of doses of the vaccine in case of a wider smallpox outbreak. In such an event, children would be among the most vulnerable to disease, and fetal complications would be expected in a smallpox or monkeypox outbreak. Nevertheless, the government did not require the manufacturer to formally study the vaccine in these populations.

We believe that the government and the biomedical industry need to work together to shift the paradigm for vaccine development to one in which children and pregnant and lactating patients are prioritized throughout the process—from early-stage research to delivery—rather than being left to the very end.

First, Congress, the FDA, and leading vaccine manufacturers must work together to encourage vaccine studies in children and pregnant people. Second, the FDA can revise its guidance to vaccine researchers to streamline development and approval for patients of all ages. Finally, the National Institutes of Health can also work to develop vaccine-research centers and fund scientists dedicated exclusively to children and pregnant people. Trials in these populations require special expertise to recruit volunteers effectively, communicate and manage concerns about potential harms, and collaborate with regulators, given the distinct immune-response profile and stricter safety requirements for studies in these populations.

The larger issue is that lawmakers, regulators, and other public officials frequently have difficulty recognizing when they are causing harm by being overly cautious—and even more difficulty changing policy after they have been made aware of that harm. This problem became apparent in the contentious debates around COVID-19 protections in schools and has resurfaced again as monkeypox patients struggle to gain access to an FDA-approved drug. When public health is at stake, policy makers need to recognize that equitable access to innovation is as important as protection from harm.

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