Lifestyle

Officials Wrestle With Whether to Allow New Monkeypox Vaccination Strategy

Published

8 months ago

August 7, 2022

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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Lifestyle

Love Letter: A Mysterious Delivery

Published

3 months ago

December 23, 2022

Press Room

After Charlotte Maya lost her husband to suicide, she and her young sons were used to unexpected visitors. But when her doorbell rang one mid-December evening, nobody was there.

Instead, on her doormat was a kit to make a gingerbread house with a note that only said, “On the First Day of Christmas. … ”

In this week’s Modern Love essay, “When a Doorbell’s Ring Means Hope,” Ms. Maya describes how a series of mysterious deliveries buoyed her family during their darkest days.

Join the 7-Day Happiness Challenge.

Research shows that the single most important driver of happiness is the strength of our relationships. Sign up for a week of exercises from the New York Times Well desk that will help set you up for a happier, more connected year.

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Lifestyle

How One Japanese-American Designer Is Revitalizing Vintage Kimonos

Published

3 months ago

December 23, 2022

Press Room

In her Brooklyn studio, designer Sara Sakanaka keeps a small drawstring bag that her grandmother made for her decades ago. Sewn from textile scraps, the striped pouch is one of Sakanaka’s oldest keepsakes, an heirloom representing a generations-old philosophy. “My mom used to tell me this story. It was about how if we treat objects with love and care for one hundred years, they can obtain a soul,” she shares as pours each of us a cup of Mugicha, a Japanese Barley tea that she grew up drinking. We met at her studio on a gray Tuesday morning, where a collection of silk separates, each made from reclaimed Japanese kimonos, hangs neatly. On a shelf, folded piles of salvaged textiles wait for her to sew them into something new, just like her grandmother once did as a hobby. “There’s this whole idea that objects have lives,” she says. “I like to see every piece as a true considered object in that way.”

Nick Krasznai / courtesy of Considered Objects

It makes sense then that Sakanaka would name her own label Considered Objects. The 39-year-old launched her line—a collection of hand-sewn jackets, dresses, and shirtings that are made entirely from reclaimed Japanese kimonos and textiles—just two years ago. “I never had the dream of starting a business,” she shares. “I was happy working toward someone else’s vision. But at some point, there’s this part of you that wants to explore what you want to say. It took time for me to be able to discover that.”

Sakanaka has a lot to say. With 20 years of experience under her belt, she has developed a design philosophy of her own. “I have no interest in buying new materials or producing with mills,” she says while showing me the intricate, hand-stitched panels of a vintage summer kimono. As she points out its cotton lining and hand-painted family crests (her own paternal and maternal family crests are tattooed on each of her arms), it becomes clear that she is not just making clothing; she’s stitching age-old stories into contemporary garments. “After years of working at different fashion brands, I found that you can get stuck on this hamster wheel. What has always grounded me was the question, ‘how can I not only find true meaning in these things, but how can I offer connection through these pieces?’”

Nick Krasznai / courtesy of Considered Objects

An FIT graduate, the apparel designer previously worked for fashion label Imitation of Christ, luxury line Ports 1961, bespoke womenswear collection Honor, and the Japanese fashion house Foxey. In 2020, after spending nearly four years traveling back and forth between New York and Japan for work, she felt she was ready for something new. “I started to wonder how I would mentally, physically, and creatively sustain. I was burnt out.” she tells me. Around that time, her grandmother, the one who gave her the collaged drawstring bag and taught her how to sew, passed away. “This was during the pandemic, so I wasn’t able to attend her funeral in Japan. I had previously inherited her collection of kimonos and rediscovered them during that time. I had completely forgotten about them, but learning about them became part of my grieving process. Having those made me feel close to her,” Sakanaka reflects.

It was then that she took a page from her grandmother’s book. “Studying these shambled garments and giving them new life through reconstruction was a way for me to heal while reconnecting with myself and my culture,” she says. Preserving the original rectangular panels and stitching style from each kimono, the designer began dismantling and reassembling each one. Her first design? A classic, collared, button-down shirt. Inside each shirt she constructed, Sakanaka sewed a layered patchwork flower made from leftover silk scraps. “That flower, that mark, it was sort of my way of memorializing the whole experience of my creation and of finding closure. It was a way of bestowing my honor upon each piece.”

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Lifestyle

Here’s How to Style 5 Luxurious Loungewear Sets This Winter

Published

3 months ago

December 23, 2022

Press Room

_{All products featured on Vogue are independently selected by our editors. However, we may earn affiliate revenue on this article and commission when you buy something.}

Cozying up for the winter has never looked chicer courtesy of luxurious loungewear sets from The Row, Wardrobe.NYC, Éterne, and more. Crafted from ultra-soft cashmeres and sultry silks, these matching sets are as indulgent as it gets and can be worn in the comfort of your own home or out and about for casual coolness. As the newly appointed foundation of your winter wardrobe, styling a luxe loungewear set properly can offer both ease and elegance at the same time.

For an elevated errand ensemble, The Row’s ‘Jaspar’ hoodie and matching ‘Anton’ wide-leg pants are knitted from the softest of cashmere. The chic combination is so comfortable that you won’t want to change once you get home. Enhance the look with stylish sneakers from Nike, plush cable-knit socks from Johnstons of Elgin, and Nothing Written’s minimalist bag. Loungewear sets, like this cashmere turtleneck and midi skirt pairing from Altuzarra, also have the power to be dressed up for festive evenings out, especially when adorned in jewels from Missoma and Laura Lombardi. A matching activewear set from Sporty & Rich ensures that you arrive at any workout in style. Sofa-ready outfits from Wardrobe.NYC and Olivia Von Halle help curate the perfect night in this holiday season and beyond.

This winter, investing in a loungewear set has never looked better. Below, here are five ways to style luxe loungewear sets that are as comfortable as they are chic. (Plus, also find a few more statement sets to add to your winter wardrobe.)

The Elegant Errand Runner

Nothing says chic errand runner like this matching cashmere hoodie and pant set from The Row. Knitted from the softest of cashmere, it’s a chic combination so comfortable that you won’t want to change once you get home. Enhance the look with stylish sneakers from Nike, plush cable-knit socks from Johnstons of Elgin, and Nothing Written’s minimalist bag. Jewels from Mejuri are welcome embellishments.

The Row Jaspar cashmere hoodie

The Row Anton cashmere high-rise pants

Johnstons of Elgin cable-knit cashmere socks

Nothing Written Ferry bag

Mejuri bold Croissant dôme huggies

The Cozy, Yet Chic Evening Look

A loungewear set doesn’t have to be confined to the comforts of your own home or even resemble a traditional sweatsuit, for that matter. Case in point: find this dazzling skirt set from Altuzarra that is crafted from pure cashmere. Complete the elegant evening ensemble with Saint Laurent’s croc-effect pumps and Anine Bing’s minimalist handbag. Drip in gold thanks to Missoma hoop earrings and Laura Lombardi’s cult-classic necklace.

Saint Laurent Blade chain croc-effect leather slingback pumps

Anine Bing Colette shoulder bag

Missoma x Lucy Williams chunky entwine hoop earrings

Laura Lombardi Calle gold-plated necklace

The Statement Sporty Attire

When it comes to activewear, a matching set, like this one from Sporty & Rich, will ensure that you arrive at any workout in style. Go one step further and tie the brand’s ‘Wellness’ sweatshirt around your waist for extra comfort. New Balance ‘Core’ sneakers are a staple in any workout wardrobe, as are these Bala Bangles and Stanley’s tumbler to keep you nice and hydrated.

Sporty & Rich appliquéd cotton-jersey sweatshirt

Sporty & Rich cropped printed stretch-jersey tank

Sporty & Rich printed stretch-jersey leggings

New Balance 574 Core sneakers

Stanley Quencher H2.O travel tumbler, 40oz

The Luxurious Loungewear Set

Wardrobe.NYC x Hailey Bieber’s simple grey sweatshirt and sweatpants are prime examples of luxurious loungewear. Wear with a coveted pair of Birkenstocks—or even heels for an elevated athleisure look. But because we’re sticking with loungewear, cozy up even more courtesy of cashmere socks from Raey and Brunello Cucinelli’s alpaca-blend blanket. Loewe’s scented candle is an immediate ambiance enhancer.

Wardrobe.NYC x Hailey Bieber cotton sweatshirt

Wardrobe.NYC x Hailey Bieber wide-leg cotton sweatpants

Birkenstock Boston shearling clogs

Raey ribbed cashmere-blend socks

Brunello Cucinelli speckled-jacquard fringed alpaca-blend blanket

Loewe Home Scents Honeysuckle medium scented candle, 610g

The Perfect Pair of Pajamas

Olivia Von Halle’s ‘Coco’ pajama set is crafted from the finest of satins to create a soft-to-the-touch feel you’ll never want to take off. Meanwhile, Ugg slippers are the perfect accoutrement. Continue to wind down with the help of scented bath salts from Maude and Augustinus Bader’s luxurious face cream. Reflect on your day with The Five Minute Journal and finally get some shut-eye thanks to Brooklinen’s silk eye mask.