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Officials Wrestle With Whether to Allow New Monkeypox Vaccination Strategy

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WASHINGTON — It sounded like a simple solution to the shortage of monkeypox vaccine: Merely by changing the way doses are injected, the federal government could vaccinate five times as many people with the supply it has in hand.

But the approach — injecting one-fifth of the current dose into the skin instead of a full dose into underlying fat — is not actually all that simple, experts say. And some federal officials are concerned about changing the method without more research, even though Dr. Robert M. Califf, the head of the Food and Drug Administration, described the proposal on Thursday as promising.

Some outside experts, too, are urging caution. “From a basic science perspective, this should work,” said Dr. Jay K. Varma, the director of the Cornell Center for Pandemic Prevention and Response. “But, of course, there are lots of things in life, in science, that we think should work, and then when we actually do them, they don’t.”

Stretching out doses of the vaccine, Jynneos, could help the federal government resolve a predicament partly of its own making. Even though it invested more than $1 billion developing the two-dose vaccine to use against both monkeypox and smallpox, the government only has 1.1 million shots on hand, partly because it was slow to order bulk vaccine stocks to be processed into vials.

That supply is enough to cover 550,000 people, but about three times as many doses are needed to cover the 1.6 million to 1.7 million Americans who, according to the Centers for Disease Control and Prevention, are at high risk of monkeypox. For now, the virus has been spreading primarily through skin-to-skin contact during sex among gay and bisexual men, the C.D.C. has said.

Some federal officials are hoping that by injecting a smaller dose of the vaccine between skin layers, called an intradermal shot, the Biden administration could tamp down the outbreak before it spreads more widely.

But some experts argue that this approach has not been sufficiently studied. They also warn that some vaccinators will need training to properly deliver the shots, which could slow vaccination efforts. Otherwise, the government could end up wasting doses, not saving them.

Intradermal injection involves carefully guiding a needle into skin layers, a thin space with immune cells. If a vaccinator goes too deep and inserts the dose into fat, the patient might not receive enough vaccine, experts say. But if the needle is not inserted far enough, some of the vaccine could leak back out.

“If you’re giving a lower dose and you don’t inject it properly into the skin — you might inject it into the wrong place — you may not be giving a protective vaccine,” said Dr. Phil Krause, who retired as a senior F.D.A. vaccine regulator last year and worked on the agency’s licensing of Jynneos. “If you ask this to be done nationwide in millions of doses, it’s a lot easier for there to be mistakes made in the administration of the vaccine.”

On the other hand, the method has a track record. It has been used in polio vaccination campaigns when doses have been limited, as well as for rabies and for tuberculosis skin tests.

“It’s not a brand-new concept,” said Dr. Anthony S. Fauci, President Biden’s chief medical adviser. “We were thinking about this as a strategy in the event of a paucity of vaccines years ago.”

Vaccinators have used special bifurcated needles in smallpox inoculation campaigns that have allowed them to perform intradermal injections more uniformly and cheaply.

Dr. John Beigel, an associate director of clinical research at the National Institutes of Health, said a government-sponsored study of Jynneos published in 2015 compared the intradermal approach with the standard injection method and found that it triggered a comparable level of neutralizing antibodies, a measure of the strength of the immune response. The intradermal method caused more redness, swelling and itching, but the standard injection was more painful.

Dr. Beigel said that switching to the intradermal method was a better option for preserving vaccine than administering just a single shot, as some jurisdictions are now doing, because research has shown that one shot does not prompt nearly as strong of an immune response.

“One dose is not likely to be effective,” he said, adding that the intradermal method “is an acceptable way to go.”

Although the 2015 trial involved hundreds of participants, some experts note that it was a single study that was limited in what it measured. Researchers at the N.I.H. had been planning to test the intradermal strategy for Jynneos in a trial that was set to begin in a few weeks. But results were not expected until the late fall or early winter, and that plan is up in the air for now.

Dr. H. Clifford Lane, the clinical director of Dr. Fauci’s National Institute of Allergy and Infectious Diseases at the N.I.H., said that while researchers could glean insight by following people who get vaccinated, a traditional clinical trial would provide a clearer picture.

“I can understand doing it as long as it’s very clear why it’s being done,” he said of the intradermal strategy. “The question is: How can we stretch the current supplies without significantly compromising efficacy?”

Another question is how well the vaccine will actually work. It was licensed in 2019 for use against both monkeypox and smallpox after studies showed it provoked a stronger immune response than an earlier vaccine. That drug itself was approved because it compared favorably to an even earlier vaccine, federal officials said.

Monkeypox is rarely fatal and no deaths have been reported in the United States. Symptoms typically resolve within two to four weeks. But with the outbreak spiraling from eight reported cases in late May to 7,510 now, the administration is scrambling to try to improve the vaccination rate and the availability of tests and treatments.

As of now, the outbreak is almost entirely limited to men who have sex with men, with those who have multiple partners considered at particular risk. But five cases involving children have been reported so far On Friday, the Illinois Department of Public Health announced that an adult working at a day care center had tested positive for monkeypox and that children and other staff members there were being screened.

Thursday’s declaration of a public health emergency allowed the federal government to speed up investigations of monkeypox and approve grants, but did not invoke the F.D.A.’s emergency powers. Changing the injection mode would require a second kind of emergency declaration, giving the Food and Drug Administration more leeway to issue emergency use authorizations.

Federal regulators can issue emergency authorizations of products when they believe the potential benefits outweigh potential risks. Early in the coronavirus pandemic, the Trump administration issued the same type of emergency declaration, allowing the F.D.A. to make Covid-19 vaccines available to Americans many months before regulators issued full approvals.

Dr. Califf, the F.D.A. commissioner, said on Thursday that regulators would continue to ensure the vaccine was delivered in a safe and effective manner. He said regulators would probably decide in the next few days whether to go with the intradermal strategy, but that it was “looking good right now” — a comment that some outside experts said seemed to get ahead of deliberations by career regulators.

Emily Cochrane and Tracey Tully contributed reporting.

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The Best Fashion Instagrams of the Week: Zendaya, the Biebers, Kendall Jenner, and More

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Among the many things we gave thanks for on Thursday are the best fashion instagrams of the week. We’re mostly kidding, but there were some stellar looks these past seven days. First up, was sun-drenched Zendaya, who posed in a sand-colored cropped cardi in front of, well, a dune. Perhaps, she is on the set of…Dune

Justin and Hailey Bieber headed to Japan to celebrate Mrs. Bieber’s birthday. The duo were dressed in their coziest clothes: Justin opted for a pale yellow sweatsuit with a beanie and hulking chain, while Hailey wore an oversized collar shirt with sweats. While it’s not a high fashion moment, we did learn that Justin has a cute nickname for his wife thanks to his love-packed caption: “bum bum”.

Kendall Jenner went the less clothed route in an outré way. Taking a mirror selfie, she wore a cozy black sweater, but in lieu of pants or a skirt, the model opted for a pair of black tights. An even bolder moment? Jenner stepped out in the look, which was captured by paparazzi. 

Finally, Devon Lee Carlson is putting her twist on the latest suiting craze. The phone case influencer wore a super polished ’90s-era suit with a cubicle-ready belt, but with a tiny playful colorful graphic T-shirt and red sneakers for a casual touch. Hire us, Carlson! 

Here, see the best fashion Instagrams of the week. 

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American Rituals

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Abiquiú, New Mexico

At the Monastery of Christ in the Desert, a remote abbey beside the Chama River in northern New Mexico, some two dozen Benedictine monks begin their days in darkness.

At 3:30 a.m. one Sunday this past winter, a bell summoned the monks to vigils, the night prayer. Under a clear sky full of stars, they made their way in silence from their cloister cells to an adobe chapel. Seated in wooden pews, the brothers, most in black habits, began chanting the first of 12 psalms. They used the ancient Gregorian melody, but with English words: “O Lord, open my lips, and my mouth shall proclaim your praise.”

The sky was still dark when a second bell rang, just before 6, calling the monks to the dawn prayer, lauds. Back in the chapel, now wearing white cowls over their habits, they chanted again. As they began Psalm 150 — “Praise God in his holy place” — the tall windows above the sanctuary turned from black to midnight blue, the first hint of daybreak.

The sun rose over the next hour, illuminating the chapel’s backdrop — the Mesa de las Viejas, whose 500-foot rock walls faded from red to shades of sand and cream in a glowing gradient. Save for the faint rush of the Chama River, a sage green tributary of the Rio Grande, the canyon was soundless.

The setting was carefully chosen. The Rev. Aelred Wall, who founded the monastery in 1964, had scoured the country for a spot where he and his brother monks could “return to the sources” — to the quiet and isolation necessary for their contemplative vocation. Passing through New Mexico, he heard about an old ranch house for sale 75 miles northwest of Santa Fe — 115 acres along the Chama, surrounded by national forest.




The adobe chapel of the Monastery of Christ in the Desert.

Father Wall found the property at the end of a 13-mile dirt road. He sent an ecstatic letter to his friends at the Mount Saviour Monastery in Elmira, N.Y., waxing poetic about the river valley and its “great sentinels” of colorful cliffs. “Then came the cathedrals in stone, some of them Romanesque, some of them Gothic,” he wrote.

Father Wall bought the ranch house. He asked his friend George Nakashima, the master woodworker and architect, to design a chapel.

The chapel was built of adobe in the shape of a Greek cross, with arms of equal length, using clay from the site. Hand-carved doors were brought from Mexico, the bell from an old church in the northern New Mexican village of Questa. The artist Ben Shahn, a friend of Mr. Nakashima’s, contributed two large stained-glass windows. Georgia O’Keeffe, who lived 25 miles away, in Abiquiu, served as an artistic consultant.

Set against the towering cliffs, the adobe chapel looks otherworldly. The Cistercian monk and writer Thomas Merton, who visited the monastery in 1968, once likened its bell tower to “a watchman looking for something or someone of whom it does not speak.”

Shortly after 9 a.m., the bell rang again, for Mass. About 20 visitors settled into chairs in the back of the chapel. Abbot Christian Leisy, in purple vestments, walked around the altar, swinging a thurible of smoldering incense. Smoke swirled and billowed in the light as it rose.




The Tabernacle in the Abbey Church.



Brother Bede in the Cloister.



Brother Chrysostom held a rosary.

A monk read from the Book of Baruch: “Take off your robe of mourning and misery; put on the splendor of glory from God forever.” The second reading was from Paul’s letter to the Philippians. The Gospel was from the third chapter of Luke, in which John calls on the people of Judea to repent and be baptized and “prepare the way of the Lord.”

Abbot Christian’s homily noted that the first lines of the Gospel situated us in history — “the 15th year of the reign of Tiberius Caesar, when Pontius Pilate was governor of Judea.” Luke, he said, wants us to understand that these events really happened. The passage is also a reminder that God often surprises. God intervenes on the margins, speaking not through Caesar or Pontius Pilate, but through John — “someone unknown, someone living in the desert, eating wild honey and insects.”

Abbot Christian closed by reading a Jewish folk tale from the philosopher Martin Buber. It told of a Rabbi Eisik, in Krakow, who dreams three times that someone suggests he look for treasure under a bridge in Prague. The rabbi travels to Prague, only to learn that the treasure was at home, buried under his stove.

After Mass, most of the monks retreated to private quarters. A boisterous group from the Washington National Cathedral migrated over to the gift shop and loaded up on wares made by the brothers: goat-milk soap; scented candles; their latest album of Gregorian chant, “Blessings, Peace, and Harmony.”

Shortly after 11 a.m. the bell rang again, calling the monks. As the visitors drove off in a caravan, sending dust clouds into the blue sky, the brothers filed back into the chapel. — Abby Aguirre




The Monastic Cemetery near the chapel.

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Sweating Through a Honeymoon in Paradise

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Listen. I can be laid back when I have to be. I have been known to wait five or six hours before answering the occasional email. I have at times neglected to shake a towel vigorously before using it, risking unknown vermin latching onto my vulnerable, naked body. So when my husband and I decide to honeymoon in Bali, I have faith I will be able to enjoy it. To appreciate the views of unadulterated nature as I drift up and down a luxurious hotel infinity pool. And not necessarily think about, say, what kind of exotic parasites might potentially be inserting themselves into my vagina within said infinity pool.

At some point, perhaps basking in the glow of our travel agent’s enthusiasm, I must have decided my rampant O.C.D. wouldn’t be able to follow me to Bali, through interminable customs lines and sprawling opulent resorts and into the river-facing hotel spa where the woman in charge of my three-and-a-half-hour massage is now telling me to relax.

A three-and-a-half-hour massage is long. Longer than James Cameron’s “Titanic.” As the masseuse cakes my back with mud, I wonder what would be happening right now in “Titanic” if I had started it at the same time as this massage. Would Jack be learning to use utensils yet? Or would the ship be filling up with water already and I can break free sooner than I thought because time stops still here and in fact all notion of time as I know it has changed, and I will now understand time as a circle like Amy Adams’s character in “Arrival”?

“Relax,” the masseuse whispers as she applies pressure to my very tense neck, and I try not to think about the mysterious animal feces I found on the floor of our bungalow last night which my husband, in a bout of self-preservation, attempted to convince me were just a bit of rubble.

After the massage, in an attempt to relax further, I scan our bedroom floor with the iPhone flashlight because the lighting in the room is elegantly dim and by elegantly I mean frustratingly for someone who is not planning to engage in seduction at any point during this trip. I look up different critter feces on Google. I conclude the ones dotting our bungalow floor are salamander feces.

“Salamanders are great!” my mom gushes over our WhatsApp call, which I have initiated in a whispered panic from the locked bathroom so my husband won’t accuse me of failing to enjoy our honeymoon.

The smart toilet keeps greeting me, its lid opening and closing with a little whir, confused as to why I’m not using it.

“Salamanders eat all the bugs! They’re there to help you!” my mom says with forceful enthusiasm.

I do not ask her what if a salamander’s feces drops from the ceiling into my mouth because I’ve noticed her patience run short with this type of question over the years.

In the morning I am awakened by what I assume are ambulances but which are allegedly cicadas. My left ankle is swollen with two mosquito bites. I suffer from “skeeter syndrome,” which means mosquito bites on my skin distend to tumoral degrees and erupt in tiny welts. So the salamanders are clearly not doing their job, or: there are so many mosquitoes in this room their predators are sated and unable to eat them all — a frightening prospect.

I casually let this information drop as our concierge drives us through the resort in a buggy, a frangipani flower tucked behind his ear. He promises to fix the bug problem and drops us off at the lobby. A car is taking us to a traditional Balinese dance at a nearby temple. It is on a cliff top with scenic views of the Indian Ocean and sheathed in what the internet calls a “peaceful ambience.”

According to my iPhone, there is 90 percent humidity during the outdoor dance. I presume 100 percent humidity involves drowning. Rivulets of sweat pour down my spine like caressing fingers. I spray DEET on myself so profusely I can taste the chemicals on my tongue through my nostrils. The sun sets and the temperature cools slightly. Then the dancers set the stone stage on fire.

Suddenly (to the tune of Wagner’s “Ride of the Valkyries,” in my head), swarms of moths the size of industrial pedestal fans descend from the heavens, slapping us in the face and alighting on our backs so that unacquainted audience members begin to pick them off one another in a display of solidarity. They’re just moths, relax, I repeat to myself, smiling emptily for my husband’s camera as the family seated behind me swat them off my shoulder blades.

Once the dance ends, our pores dilated from our impromptu steam bath, we make our way down the steep cliff to the parking lot, monkeys as big as dogs on either side of us, eyeing our purses and phones. One of them sits alarmingly close to our car. Our guide advises us to hide our jewelry and avoid eye contact.

When we return to the hotel, we find that a dramatic mosquito net has been swathed over the bed, and rubber has been stuffed into the window gaps. I DEET myself regardless. I trust no one.

On our last day in Bali my husband and I perform a Balinese wedding ceremony because it’s too late to cancel. The officiants warn us that they will sprinkle a little ceremonial water on us. We agree to this, and thus commences our soothing, spiritual journey. The priest proceeds to pour bowl after bowl of ceremonial water on our scalps. My makeup, hair and contact lenses stream down my cheeks. My eyes burn. I wonder if I could get a urinary tract infection this way. The priest sticks grains of rice to our dripping foreheads. They slide off and pellet our laps. The water never stops. It is more eternal than our love.

I count the hours until I return home. I berate myself for doing this, reminding myself this is the only trip of this scale I will ever take and as such it should be enjoyed.

On the two plane rides home I watch three “Bridget Jones” movies in a semi-catatonic state. I feel numb when we step into our apartment. I Google “Bali parasites you have to extract with tweezers from eyeballs weeks later.” The results are inconclusive. I start to relax. Then I notice them. Crawling up our kitchen walls. Pantry moth larvae. I cry a little bit. My husband cries a little bit. I miss Bali.

Episode is a column of first-person essays exploring a moment in a writer’s life. Virginia Feito is the author of the novel “Mrs. March” and a writer for Vanity Fair Spain. She lives in Madrid.

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