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

Lifestyle

U.S. Could Have Had Many More Doses of Monkeypox Vaccine This Year

Published

on

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.

Read the full article here

Lifestyle

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

Published

on

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. 

Instagram content

This content can also be viewed on the site it originates from.



Read the full article here

Continue Reading

Lifestyle

American Rituals

Published

on

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.

Read the full article here

Continue Reading

Lifestyle

Sweating Through a Honeymoon in Paradise

Published

on

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.

Read the full article here

Continue Reading

Trending