U.S. Could Have Had Many More Doses of Monkeypox Vaccine This Year | Big Indy News
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U.S. Could Have Had Many More Doses of Monkeypox Vaccine This Year



WASHINGTON — The shortage of vaccines to combat a fast-growing monkeypox outbreak was caused in part because the Department of Health and Human Services failed early on to ask that bulk stocks of the vaccine it already owned be bottled for distribution, according to multiple administration officials familiar with the matter.

By the time the federal government placed its orders, the vaccine’s Denmark-based manufacturer, Bavarian Nordic, had booked other clients and was unable to do the work for months, officials said — even though the federal government had invested well over $1 billion in the vaccine’s development.

The government is now distributing about 1.1 million doses, less than a third of the 3.5 million that health officials now estimate are needed to fight the outbreak. It does not expect the next delivery, of half a million doses, until October. Most of the other 5.5 million doses the United States has ordered are not scheduled to be delivered until next year, according to the federal health agency.

To speed up deliveries, the government is scrambling to find another firm to take over some of the bottling, capping and labeling of frozen bulk vaccine that is being stored in large plastic bags at Bavarian Nordic’s headquarters outside Copenhagen. Because that final manufacturing phase, known as fill and finish, is highly specialized, experts estimate it will take another company at least three months to gear up. Negotiations are ongoing with Grand River Aseptic Manufacturing, a Michigan factory that has helped produce Covid-19 vaccines, to bottle 2.5 million of the doses now on order, hopefully shaving months off the timetable, according to people familiar with the situation.

Health and Human Services officials so miscalculated the need that on May 23, they allowed Bavarian Nordic to deliver about 215,000 fully finished doses that the federal government had already bought to European countries instead of holding them for the United States.

At the time, the nation had only eight confirmed monkeypox cases, agency officials said. And it could not have used those doses immediately because the Food and Drug Administration had not yet certified the plant where the vaccine, Jynneos, was poured into vials.

But it could now. Some states are trying to stretch out doses by giving recipients only one shot of the two-dose vaccine. California, Illinois and New York have declared public health emergencies. In New York City, every available slot for a monkeypox shot is taken.

Lawrence O. Gostin, a former adviser to the Centers for Disease Control and Prevention who has consulted with the White House about monkeypox, said the government’s response has been hobbled by “the same kinds of bureaucratic delays and forgetfulness and dropping the ball that we did during the Covid pandemic.”

The obstacles to filling and finishing vials follow other missteps that have limited vaccine supply. The United States once had some 20 million doses in a national stockpile but failed to replenish them as they expired, letting the supply dwindle to almost nothing. It had 372,000 doses ready to go in Denmark but waited weeks after the first case was identified in mid-May before requesting the delivery of most of those doses. Another roughly 786,000 doses were held up by an F.D.A. inspection of the manufacturer’s new fill-and-finish plant but have now been shipped.

The government also owns the equivalent of about 16.5 million doses of bulk vaccine produced and stored by Bavarian Nordic. But by the time the health agency ordered 500,000 doses worth to be vialed on June 10, other countries with outbreaks had submitted their own orders and the earliest delivery date was October.

Another order for 110,000 doses for European nations soon followed. When the United States came back with two more orders of 2.5 million doses each on July 1 and July 15, the bulk could only be delivered next year.

Mr. Gostin, who now directs the O’Neill Institute for National and Global Health Law at Georgetown University, predicted that President Biden’s decision to appoint two new monkeypox response coordinators would help “light a fire” under federal health agencies. The White House announced Tuesday that Robert Fenton, an administrator at the Federal Emergency Management Agency, and Dr. Demetre Daskalakis, a C.D.C. official, will lead the response.

Mr. Gostin said the nation’s public health agencies have been “kind of asleep at the wheel on this,” and the new coordinators should help with “unblocking all of the obstacles to procuring and delivering vaccines and drugs, which has been deeply frustrating.”

Two senior federal officials, who requested anonymity in order to speak frankly, said Mr. Biden is upset by the vaccine shortage. His administration has often touted its success delivering hundreds of millions of coronavirus shots to Americans, and is stung by criticism that a lack of foresight and management has left gay men — the prime risk group for monkeypox — unprotected.

Some critics blame a failure of leadership at the Health and Human Services Department, saying the department’s secretary, Xavier Becerra, has taken a hands-off approach to an increasingly serious situation. His department not only oversees both the C.D.C. and the Food and Drug Administration, but also runs the Biomedical Advanced Research and Development Authority, or BARDA, which helps develop and buys vaccines, tests and treatments to protect against highly contagious viruses, bioterrorism and other hazards.

During a press call on monkeypox last week, Mr. Becerra said his department is doing all it can to ensure that “we not only stay ahead of this virus but that we end this outbreak.” He noted that he had recently elevated the agency’s Office of Strategic Preparedness and Response so it can respond more quickly to public health emergencies.

Sarah Lovenheim, the department’s chief spokeswoman, said in a statement: “Our response has accelerated to meet evolving needs on the ground, and it will keep accelerating. We will use every lever possible to continue allocating doses ahead of timelines, as possible.”

So far, according to the C.D.C., 6,326 cases of monkeypox have been reported. For now, the virus is spreading almost entirely among gay and bisexual men, and those with multiple or anonymous partners are considered especially at risk. Mr. Becerra noted that while more than a million Americans have died of Covid-19, no one in the United States has died of monkeypox.

The official case count is widely considered an underestimate. Not only is testing limited, but public health officials like Dr. Joseph Kanter, the top medical official in Louisiana, said that monkeypox can be hard to diagnose. “It can be one or two solitary lesions, so if it’s not on a clinician’s radar,” he said, it can be missed.

With too few doses, health officials apparently plan to rely heavily on the “test and trace” strategy that figured heavily in the early stages of the Covid pandemic. As the pandemic escalated, the sheer torrent of cases overwhelmed the ability of health officials to contact people who might have been infected by someone who had tested positive for the coronavirus. Once Covid vaccines became available, they became the cornerstone of the administration’s pandemic response.

Through early June, Health and Human Services officials appeared firmly convinced that the United States had more than enough supply of the monkeypox vaccine, called Jynneos, to handle what appeared to be a handful of cases.

Bavarian Nordic was able to develop the vaccine, which also works against smallpox, largely thanks to the federal government’s backing, which surpassed $1 billion in 2014 and is now edging toward $2 billion. Dawn O’Connell, the federal health agency’s assistant secretary for preparedness and response, told reporters in early June: “The world has Jynneos because we invested in it.”

The company opened a new $75 million fill-and-finish plant in 2021 that is now bottling as many as 200,000 to 300,000 doses a week. At the time, the United States was counting on Jynneos to protect against smallpox, not monkeypox, and the government had a large stockpile of another effective smallpox vaccine. No F.D.A. inspection was scheduled until after the monkeypox outbreak, and it did not conclude until July 27.

In early June, Health and Human Services officials agreed to essentially loan back about 215,000 finished doses of vaccine to Bavarian Nordic so the firm could supply them to European countries that were suffering outbreaks.

“It didn’t make sense while we were waiting for F.D.A. to get the inspection done — which is coming — that we sit on doses that our international colleagues in Europe could actually use,” Ms. O’Connell said on June 10. Now the government is trying to reschedule delivery of those doses for later this year, a company spokesman said.

The final stage of putting the liquid vaccine into vials accounts for a substantial share of the cost of vaccine production. Some federal officials say the health department was slow to submit its orders for that work because officials at BARDA argued they were short on funds.

When the demand for vaccines became an outcry, though, the agency found the money to pay for five million more doses to be vialed. Officials are now contemplating shifting half the work to another firm that may be able to finish and fill doses more than twice as fast.

Some experts say it can take as long as six to nine months for a plant to gear up to handle a vaccine like Jynneos, which contains a live virus in a weakened state. Carlo de Notaristefani, who oversaw coronavirus vaccine manufacturing for the federal government until last year, said that such factories must operate at a high “biological safety level,” including a fully enclosed, segregated manufacturing line.

But he and other experts said it should be possible to streamline the transfer of Bavarian Nordic’s process so another plant could be ready in about three months. A company spokesperson said Bavarian Nordic agreed to pay $10 million of the cost of such a transfer after federal officials said they did not have the budget for it.

Kitty Bennett contributed research.

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Love Letter: A Mysterious Delivery



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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How One Japanese-American Designer Is Revitalizing Vintage Kimonos



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 

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



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. 

Olivia Von Halle Coco silk-satin pajama set

Ugg Scuffette II slippers

Brooklinen Mulberry silk eyemask

Augustinus Bader The Rich Cream with TFC8® face moisturizer

Maude Soak No. 2 nourishing mineral bath salts

Shop More: 

Leset Lauren cropped stretch-knit cardigan

Leset Lauren stretch-knit wide-leg pants

Éterne oversized crewneck sweatshirt

Éterne classic sweatpants

Lisa Yang Jonny cap-sleeved cashmere sweater

Lisa Yang Sierra wide-leg cashmere trousers

Zara basic hoodie sweatshirt

Girlfriend Collective ReSet cropped stretch recycled top

Girlfriend Collective compressive stretch recycled flared leggings

Le Kasha Etretat organic cashmere sweater

Le Kasha Sumbal cashmere wide-leg pants

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