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Americans Take Ketamine at Home for Depression With Little Oversight

Startups are prescribing ketamine online to treat serious mental-health conditions, raising concern among psychiatrists about the safety of taking the mind-altering anesthetic without medical supervision, sometimes at high doses that raise risks of side effects.

Ketamine is approved by the Food and Drug Administration to anesthetize people and animals and has been used safely in hospitals for decades. The out-of-body, hallucinogenic sensations it produces made it popular as a party drug known as Special K. Some doctors prescribe ketamine off-label to treat patients with conditions including severe depression, suicidal thoughts and post-traumatic stress disorder.

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Generic ketamine isn’t approved for those conditions. Studies have shown it can rapidly alleviate symptoms of severe depression when other treatments have failed.

There is less data on ketamine’s effectiveness for other conditions including anxiety and PTSD, and little data on its long-term use.

The FDA has approved a chemically related version of the drug, called esketamine, from

Johnson & Johnson

for treatment-resistant depression with suicidal thoughts.

Clinics that are certified to administer J&J’s nasal spray must monitor patients for two hours afterward.

People taking generic ketamine at home aren’t subject to the same oversight.

Clinics specializing in ketamine treatment for depression and other mood disorders have popped up across the U.S. in recent years. WSJ visits a clinic to learn why some entrepreneurs are betting that demand for ketamine will continue to rise. Photo illustration: Laura Kammermann

Mindbloom Inc., Nue Life Health PBC and Wondermed LLC are among around a dozen companies now selling ketamine tablets or lozenges online, making use of relaxed restrictions on the prescription of controlled substances during the pandemic.

The companies work with clinicians who prescribe ketamine to patients based on a questionnaire and virtual evaluation. The generic ketamine pills or lozenges are mailed to patients’ homes. The companies say they instruct people to take the medication with someone nearby, among other safety measures.

Taking ketamine at home without medical supervision increases risks of patients falling and hurting themselves or taking more of the drug than prescribed, doctors said. Ketamine can be addictive, and patients might not get the help they need if they have a distressing experience while taking the drug, psychiatrists said.

“Places that are doing virtual ketamine are negotiating a compromise between accessibility and safety,” said Dr.

Benjamin Yudkoff,

medical director of the ketamine and esketamine program at Brigham and Women’s Faulkner Hospital in Boston.

Ketamine increases heart rate and blood pressure, raising the risk of rare complications including stroke or heart attack at the higher doses that some telehealth patients have been prescribed, medical experts said.

“Giving any drug like that has the potential to cause general anesthesia at home in a completely unmonitored environment,” said Dr.

Michael Champeau,

president of the American Society of Anesthesiologists.

The companies said prescribing ketamine-assisted therapy at home can help fill a need for people who don’t respond to existing medications or can’t reach or afford treatment in person. Ketamine blocks a receptor in brain cells important for brain adaptability, which researchers say might help facilitate changes in mood and mind-set.

Ketamine was prescribed for Leon New Valentine, who said it alleviated symptoms of treatment-resistant depression and PTSD.



Photo:

Tara Pixley for The Wall Street Journal

Mindbloom and Nue Life cited peer-reviewed research they published suggesting that many patients reported feeling better after taking ketamine and that few reported problems related to taking the drug.

Mindbloom, Nue Life and Wondermed said they decline to treat people who have symptoms that are too severe or histories of conditions such as substance-use disorder, psychosis or uncontrolled hypertension. Nue Life said it sometimes consults with a patient’s doctor before prescribing ketamine, and Mindbloom said it often asks for medical records. Wondermed said patients can choose to have their doctors work with the company during treatment.

‘Places that are doing virtual ketamine are negotiating a compromise between accessibility and safety.’


— Dr. Benjamin Yudkoff, Brigham and Women’s Faulkner Hospital

Nue Life said it starts patients at around 125 milligrams and prescribes at most 750 milligrams for a dose. Wondermed said it prescribes patients between 100 milligrams and 400 milligrams for a dose. Mindbloom said that it starts patients at around 400 milligrams and that some patients graduate to doses of around 1,000 milligrams.

Doses of around 1,000 milligrams heighten risks for severe side effects including rare seizures, hemorrhages or strokes, said

Ari Aal,

a psychiatrist in Boulder, Colo., who prescribes ketamine at lower doses to patients who take it under supervision at his clinic.

“That’s way too much of a dose to be doing at home and probably at all, and way too much without a practitioner watching you,” Dr. Aal said.

Mindbloom and Wondermed said they provide blood-pressure monitors for patients to use before and during treatment. Nue Life said it instructs patients with controlled hypertension to monitor their blood pressure.

A ketamine kit provided by Mindbloom for Courtney Gable.



Photo:

Courtney Gable

Timothy Mitchell,

a 40-year-old patient advocate from Ballston Lake, N.Y., said Mindbloom started him on an 800-milligram dose last year. He said he is undergoing his third course of a six-dose regimen with Mindbloom at 1,200 milligrams a dose. The treatment helped quiet suicidal thoughts, he said.

Wondermed said it charges $399 for a month of ketamine tablets or lozenges and telemedicine treatment. Mindbloom said it charges around $1,000 for around three months of ketamine and telemedicine care. Nue Life said it charges as much as $2,999 for ketamine tablets and telemedicine treatment over four months. Health insurers usually don’t reimburse people for the off-label treatments.

Amanda Itzkoff,

a psychiatrist and chief executive of Curated Mental Health, which administers ketamine in clinics, said she declined to be on Mindbloom’s advisory board in part because she was concerned that at-home use might not include enough patient supervision.

Making a comparison with a crackdown on psychedelic-drug research decades ago, she said that if companies recklessly prescribe ketamine for home use, they could set back adoption of a valuable treatment. “We could blow it again,” Dr. Itzkoff said.

A spokesman said that Mindbloom ended its relationship with Dr. Itzkoff and that she didn’t raise safety concerns. Mindbloom’s medical director, Dr.

Leonardo Vando,

said striking the right balance between expanding access to ketamine and safe prescribing practices is critical to Mindbloom.

Courtney Gable,

47, said her husband checked on her when she took ketamine that Mindbloom prescribed for her this year to treat chronic pain and depression. The 400-milligram dose was higher than initial doses prescribed at a clinic where she works in Philadelphia, she said.

“There’s a safety net, but the spaces between the net are a little wider,” Ms. Gable said.

Leon New Valentine,

a 32-year-old actor and videogame model in Los Angeles, was prescribed 100 milligrams of ketamine online last year by Peak Health Global Inc., and took the medication with someone nearby. Mx. Valentine, who uses they as a pronoun, said they graduated to 150-milligram doses and took that alone. Ketamine alleviated symptoms of treatment-resistant depression and PTSD, Mx. Valentine said.

“Things are joyful again even though I’m in pain,” Mx. Valentine said. Peak said it would close in November because it expects rules allowing controlled substances to be prescribed remotely to be tightened soon.

Write to Brianna Abbott at brianna.abbott@wsj.com and Daniela Hernandez at daniela.hernandez@wsj.com

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Stocks Open Higher as Banks Give Updates

U.S. stocks rose in early Monday trading as investors considered another set of earnings reports from major companies and looked ahead to a week of key central-bank meetings.

The S&P 500 advanced 0.9% after the broad index on Friday ended higher, snapping a five-day losing streak. The blue-chip Dow Jones Industrial Average added 0.7% while the technology-heavy Nasdaq Composite Index gained 1.4%.

Big financial firms kicked off a bumper week of earnings reports Monday.

Bank of America

rose 2.4% after it said second-quarter profits declined 32%.

Goldman Sachs

advanced 5.3% after reporting better-than-expected earnings.

Synchrony Financial

rose 3.9% after reporting earnings per share that fell year-over-year but were better than analysts had expected.

Charles Schwab

gained less than 1% after reporting second-quarter profits rose by 42%, also beating Wall Street expectations.

IBM

will report later in the day. Companies due to provide updates later this week include

Johnson & Johnson

on Tuesday,

Tesla

on Wednesday and

Twitter

on Friday.

Investors are trying to reconcile a dire economic outlook with earnings forecasts that remain relatively positive. Economic growth is showing signs of slowing while inflation is soaring, last week reaching a fresh four-decade high. Meanwhile, central banks are raising interest rates rapidly, adding another cloud on the economy’s horizon. So far, corporate reports have been lackluster.

“It feels like something is wrong: Either the economic story is wrong or analysts are being too optimistic on earnings, and it feels like the latter,” said Altaf Kassam, head of investment strategy for Europe, the Middle East and Africa at State Street Global Advisors. “If you scrape the text of company earnings announcements, many are complaining.”

WSJ’s Dion Rabouin breaks down how inflation rises and why the Federal Reserve, Congress, the president and large corporations can all be held accountable. Illustration: Ryan Trefes

Data due Monday were expected to show declining confidence among U.S. home builders as mortgage rates are rising. Economists surveyed by The Wall Street Journal expect the National Association of Home Builders to report a seventh consecutive month of declining confidence in July. 

The European Central Bank is expected to raise interest rates for the first time in 11 years at a meeting Thursday. The region’s economy is feeling the effects of the war in Ukraine and an energy crisis more acutely than other economies. The Bank of Japan is expected to buck the trend among global central banks and keep rates unchanged on Thursday. 

The Federal Reserve has signaled it will raise interest rates by 0.75 percentage point for the second time in a row later this month.

Commodity prices rebounded following a stretch of weakness. Brent crude, the international oil benchmark, rose 3.8% to $105.03 a barrel. Copper prices in London rose 2.6% to $7,362 a metric ton. Gold prices rose 0.6%.

In bond markets, the yield on the benchmark 10-year U.S. Treasury note rose to 2.978% from 2.929% on Friday. Bond yields and prices move in opposite directions.

Traders worked on the floor of the New York Stock Exchange last week.



Photo:

Michael M. Santiago/Getty Images

Overseas, global markets were higher across the board. In Europe, the pan-continental Stoxx Europe 600 rose 1.1%. Oil-and-gas and mining stocks led the gains as commodity prices rose, while banks also rose. Commodity trader and miner

Glencore

rose 2.5% while oil major

Shell

gained 2.6%. Germany’s

Commerzbank

and

Deutsche Bank

each rose around 4%.

In Hong Kong, the Hang Seng Index jumped 2.7% while in mainland China, the Shanghai Composite Index rose 1.6%. Markets in Japan were closed for a holiday.

—Pia Singh contributed to this article.

Write to Will Horner at william.horner@wsj.com

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Kellogg Splitting Into Three Companies as It Shifts Focus to Global Snacks

Kellogg Co.

K 1.95%

said it plans to break up its business into three companies, seeking to jump-start its larger, faster-growing snacks business while helping its namesake cereal brands regain their footing on supermarket shelves.

The move, which Kellogg said would separate snacks such as Pringles, Cheez-Its and Pop-Tarts from cereal-aisle staples including Frosted Flakes and Froot Loops, aims to create more agile, focused companies and marks a shift from the food industry’s decadeslong strategy of pursuing acquisitions and building scale.

“Bigness for bigness sake doesn’t make a lot of strategic sense,” said Kellogg’s Chief Executive Steve Cahillane, who will head the $11.4 billion snacking business, which accounted for 80% of Kellogg’s net sales last year.

The Covid-19 pandemic delivered a boost in sales for Kellogg and other food makers, as families prepared more meals in their kitchens as they stayed home from work and school. The grocery industry now is working to retain that momentum, but food makers over the past year have been battered by rising costs for fuel, labor, ingredients and packaging, creating what Mr. Cahillane called an unprecedented stretch of inflation.

Kellogg said it expects to complete the split by the end of 2023, with the North America cereal business potentially separating first, followed by its plant-based foods business as the third company. Kellogg said it also is considering selling the plant-based foods unit, which is predominantly composed of the

MorningStar

Farms brand. It has yet to name the individual companies.

Kellogg’s stock price rose about 3% on Tuesday. Shares were already up 4.8% this year as of Friday, bucking the broader market slump. The S&P 500 packaged foods and meat index on Tuesday was down about 3% so far in 2022.

Kellogg’s breakup plan follows splits announced last year by General Electric Co. and Johnson & Johnson. In the food sector, Kraft Foods orchestrated a similar split about 10 years ago, spinning off its North American grocery business to focus on its faster-growing snack brands including Oreos and Triscuits, a business it named Mondelez International Inc.

Sara Lee Corp. in 2012 split its business into two companies, one a meat-focused operation renamed Hillshire Brands Co., and an international coffee and tea business called D.E. Master Blenders NV.

Hillshire, D.E. Master Blenders and Kraft all later merged with other big food companies.

The largest of Kellogg’s three planned companies would be the global snacks business, which would include brands such as Pringles and Cheez-Its, and breakfast items including Eggo waffles and Pop-Tarts. It also would include Kellogg’s international operations—fast-growing noodle business in Africa and cereal sales overseas.

“The snacking business will have all household names with just the right level of scale,” Mr. Cahillane said. “And when you don’t have the ‘conglomerate effect,’ you can get a lot more done.”

Kellogg said it would use its international cereal supply chain and retailer connections to expand Cheez-Its and other snacks globally. In recent years, Kellogg’s Pringles brand has gained momentum in Europe and Latin America, which executives said paves the way for others in its portfolio.

Snacks have been a driver of Kellogg’s growth and an area of particular interest to Mr. Cahillane since he joined the company almost five years ago. In 2019, he sold off Kellogg’s nearly $1 billion Keebler cookies and fruit snacks business to better focus on Kellogg’s other snack brands, which were already getting more of the company’s marketing and innovation resources. Since then, Mr. Cahillane said, he has been calculating a bigger corporate split.

“The pandemic pressed pause on a lot of things,” Mr. Cahillane said. “The time is right, now.”

Mondelez, the biggest global snack company, for years has added brands through small acquisitions, and on Monday it said it would acquire Clif Bar & Co. for $2.9 billion plus the potential for more tied to earnings targets. That deal could increase competition against Mars Inc.’s KIND bar brand, which Mars bought in 2020, and Kellogg’s smaller RX Bar business, which it acquired in 2017.

Mr. Cahillane said Kellogg would continue to pursue snacking acquisitions following the split.

Other food companies have reshaped their own operations.

General Mills Inc.

took on a substantial pet-food business via acquisitions, and divested less-profitable brands such as Green Giant vegetables and Hamburger Helper.

Campbell Soup Co.

has faced investor questions about whether it would be better off splitting its snack business and soup operation in two, though executives have maintained that they are better off together.

Kellogg’s decision to spin off its North America cereal business, with about $2.4 billion in sales last year, comes as it seeks to reverse sales declines and boost profit margins.

Consumers for years have been moving away from breakfast cereals, and Kellogg’s operations more recently were disrupted by a strike among factory workers and a fire at one plant that knocked out production and cost the company market share.

Corporate titans General Electric and Johnson & Johnson both announced in late 2021 that they were splitting, two of the latest in a long string of conglomerate break ups. Here’s why big businesses divide and what it could mean for investors. Photo illustration: Tammy Lian/WSJ

Kellogg, the second biggest U.S. cereal supplier after General Mills, has regained 4 percentage points of market share this year, Mr. Cahillane said. Still, Kellogg’s North America cereal sales fell 10% in the three months ended April 2 from the prior year, largely because of to supply-chain problems, the company said.

“Frosted Flakes doesn’t have to compete with Pringles for resources,” Mr. Cahillane said. “Economists might say we can do that without splitting. But we don’t live in a textbook, we live in the real world.”

Kellogg’s plant-based foods business, with estimated 2021 net sales of $340 million, as a stand-alone company will first aim to expand in North America and eventually globally, Kellogg said.

Meat alternatives have found traction in grocery stores’ freezer aisles and meat cases, though competition has grown. Kellogg in early 2020 brought out a line of plant-based burgers and tenders called Incogmeato, part of an effort to compete against

Beyond Meat Inc.

and Impossible Foods Inc.

Mr. Cahillane said MorningStar’s Incogmeato can be more aggressive with investments in technology and its supply chain once it no longer is contributing to Kellogg’s bottom line.

Some Wall Street analysts said divvying up Kellogg could hurt each business’s ability to secure competitive prices using the larger conglomerate’s purchasing power.

Piper Sandler’s

Michael Lavery

said that it could cost some 2% of Kellogg’s current total sales for each business to take on their own sales force, distribution system and other previously-shared expenses. Analysts with investment research firm Morningstar Inc. said that Kellogg’s snacks business could thrive on its own, though the benefits for the cereal and plant-based operations were less clear.

Kellogg said the North American cereal and plant-based foods businesses would both remain based in Battle Creek, Mich. The global snacking business would be based in Chicago, Ill., with dual corporate campuses in Battle Creek and Chicago.

Moving the snack company’s headquarters to Chicago will locate it in a city that is home to other food companies as Kellogg looks to hire and expand the business.

Boeing Co.

and

Caterpillar Inc.

said in recent weeks they planned to relocate their Chicago-area headquarters to Arlington, Virginia and Irving, Texas, respectively.

Write to Annie Gasparro at annie.gasparro@wsj.com

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New study finds omicron no less severe than earlier variants, and not just more transmissible

A new study conducted by researchers at Harvard Medical School among others has found that the omicron variant of the coronavirus that causes COVID-19 is just as severe as earlier variants, and not more transmissible but no less severe, as previously thought.

The study was based on the records of 130,000 COVID patients in Massachusetts and carried out by researchers at Massachusetts General Hospital and Minerva University along with Harvard and is currently being peer-reviewed by Nature Portfolio, according to a Reuters report.

But its findings, which evaluated the severity of omicron after accounting for the effect of vaccines, underscores how important vaccines and boosters are, and shows they helped rein in hospitalizations and deaths during the omicron surge.

“Although the unadjusted rates of hospital admission and mortality appeared to be higher in previous waves compared to the Omicron period, after adjusting for confounders including various demographics, Charlson comorbidity index scores, and vaccination status (and holding the healthcare utilization constant), we found that the risks of hospitalization and mortality were nearly identical between periods,” the authors wrote.

“Our analysis suggests that the intrinsic severity of the Omicron variant may be as severe as previous variants.”

The study comes after a Washington Post analysis of Centers for Disease Control and Prevention data earlier this week found that omicron caused a spike in deaths in January and February among people who were vaccinated. Those deaths were mostly among elderly people and those with compromised immune systems and are thought to have had waning protection from vaccination.

See now: Omicron caused spike in deaths in vaccinated people, analysis finds, though unvaccinated remain most at risk

Experts agree that vaccination and boosters remain the best protection against severe disease and death and continue to urge unvaccinated people to get their shots. And there are concerns that the initial view that omicron caused only mild symptoms may have actually persuaded the vaccine hesitant that they didn’t need to be inoculated.

The study comes as cases continue to rise across the U.S. after their steep decline early in the year, driven by the BA.2 variant of omicron, and two subvariants that appear to be even more infectious. The two, named BA.2.12 and BA.2.12.1, were highlighted by health officials in New York state recently.

The U.S. is averaging 67,953 cases a day, up 59% from two weeks ago, according to a New York Times tracker. Cases are climbing in all but four states and territories and have more than doubled from two weeks ago in more than a dozen, the tracker shows.

The country is averaging 18,181 hospitalizations a day, up 20% from two weeks ago, but still relatively low. The daily death toll has fallen below 400 to 366 on average.

The World Health Organization said Thursday that new estimates show that the full death toll associated either directly or indirectly with the COVID-19 pandemic between Jan. 1, 2020, and Dec. 31, 2021, is about 15 million.

That number compares with the tally provided by Johns Hopkins University of 6.24 million.

Coronavirus Update: MarketWatch’s daily roundup has been curating and reporting all the latest developments every weekday since the coronavirus pandemic began

Other COVID-19 news you should know about:

• U.S. regulators on Thursday strictly limited who can receive Johnson & Johnson’s COVID-19 vaccine due to a rare but serious risk of blood clots, the Associated Press reported. The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request the Janssen vaccine from J&J
JNJ,
-0.83%.
U.S. authorities for months have recommended that Americans starting their COVID-19 vaccinations use the Pfizer
PFE,
+0.98%
 or Moderna
MRNA,
-5.89%
 shots instead. FDA’s vaccine chief, Dr. Peter Marks, said the agency decided to restrict the vaccine after taking another look at the data on the risks of life-threatening blood clots and concluding that they are limited to J&J’s vaccine.

• North Carolina state employees will get an extra day of vacation for receiving a COVID-19 booster, Gov. Roy Cooper announced as the state government there uses a new incentive to increase vaccination rates, the AP reported separately. Cooper signed an executive order that provides the leave to permanent, probationary or time-limited workers whose cabinet-level agencies report to him. The extra time off will be given to those who have already received the first COVID-19 booster or those who show documentation by Aug. 31 of receiving one.

Beijing is racing to test more than 20 million people as residents scramble to stock up on food. WSJ’s Jonathan Cheng shows what life is like in the capital and unpacks the likely ripple effects if officials can’t control the fast-spreading virus. Photo: Kevin Frayer/Getty Images

• The number of unruly air-passenger incidents in the U.S. has fallen since a federal judge in Florida overturned the federal mandate, the New York Times reported, citing data from the Federal Aviation Administration. The agency reported 1.9 incidents per 10,000 flights during the week ending April 24, down from 4.4 incidents per 10,000 flights a week earlier. It declined to cite a reason for the drop. The CDC continues to recommend that people wear face masks on public transport and in public-transport hubs, especially as subvariants of omicron continue to circulate.

• China’s elderly population’s reluctance to get vaccinated is challenging the country’s zero-COVID strategy, the Washington Post reported. Unlike most of China’s coronavirus prevention measures, vaccination is not mandatory, and low uptake among the country’s most vulnerable groups is a major reason Communist Party leaders feel compelled to persist with a grueling “zero-COVID” approach. That has led to a strict lockdown in Shanghai that is now being eased. Chinese President Xi Jinping said relaxation of the strategy now would lead to “massive numbers of infections” and deaths.

Here’s what the numbers say

The global tally of confirmed cases of COVID-19 topped 516.2 million on Wednesday, while the death toll rose above 6.24 million, according to data aggregated by Johns Hopkins University.

The U.S. leads the world with 81.7 million cases and 996,996 fatalities.

The Centers for Disease Control and Prevention’s tracker shows that 219.9 million people living in the U.S. are fully vaccinated, equal to 66.3% of the total population. But just 101 million are boosted, equal to 45.9% of the vaccinated population.

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The Big Pivot: Merck Falters on Covid-19 Vaccine, Then Makes One for Rival J&J

Weeks after

Merck

MRK -0.33%

& Co. scrapped development of its Covid-19 vaccines in January, one of its senior manufacturing officials began phoning his deputies, telling them their work on a pandemic shot wasn’t actually over.

“We’re doing it,” John McGrath told his workers at Merck. “And we’re doing it with J&J.”

The

Johnson & Johnson

-Merck partnership, which the companies announced in March, is now bearing fruit to expand the world’s vaccine supply. After a frantic ramp-up that involved scouting for raw materials, buying equipment and upgrading plants all at the same time, the first Merck-made shots shipped Friday.

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How will cooperation in the Covid-19-vaccine race change the future for Merck and J&J? Join the conversation below.

Merck is churning out more than 500,000 doses daily for use outside the U.S., including countries desperate for shots.

J&J’s unusual collaboration with a rival, and Merck’s speedy manufacturing run-up, reflect one of the biggest challenges of the pandemic: making enough Covid-19 vaccines to meet the high demand.

Even in the U.S., early supplies were limited as drugmakers ramped up production lines. To this day, many countries are struggling with short supply.

J&J vials at the Merck plant in West Point, Pa; the first Merck-made shots shipped Friday.

At a sprawling plant in West Point, Pa., Merck is helping J&J with the final stages of its vaccine production, known as fill-finish, which involves thawing frozen doses made by J&J, adding a stabilizer to maintain their potency during storage, then putting them into vials for shipment.

Merck, one of the world’s biggest drugmakers by sales, said it retrofitted its manufacturing facilities in about three months, shaving almost a year off the time it normally takes to ready a plant.

“We broke all sorts of records on construction, on tech transfers, on just getting product ready,” Mr. McGrath said. The federal government, which gave at least $105 million to Merck to retrofit plants, also contributed by moving needed supplies quickly through customs.

Johnson & Johnson’s Covid-19 vaccine hasn’t been embraced by people and health authorities as much as initially expected, partly because of concerns about a rare blood-clotting condition. Manufacturing issues have also played a role in limiting its use.

Yet if enough doses are made, the vaccine still can play an important role in the pandemic because many poor countries lack access to other shots and J&J’s vaccine is easier to handle and store, public-health advocates and Wall Street analysts say.

Workers checking vaccines at the Merck plant in West Point, Pa., which scrambled to get special equipment to manufacture the J&J Covid-19 vaccine.

The J&J vaccine doesn’t require a special freezer to keep it cold, unlike messenger-RNA vaccines, and the primary series is one dose, not two.

“Our vaccine is uniquely positioned to be used in the world,” said Remo Colarusso, J&J’s global pharmaceuticals manufacturing chief. “The world is not completely vaccinated by a long shot.”

J&J and Merck, their headquarters separated by about 18 miles in New Jersey, are normally competitors in areas such as cancer and cardiovascular disease. Last December, at the urging of the federal government, the rivals began discussing whether Merck could help make J&J’s Covid-19 vaccine.

J&J Chief Scientific Officer

Paul Stoffels

was initially reluctant to work with another company, people familiar with the matter said. He was concerned it would stretch his staff too thin because of existing manufacturing partnerships, but agreed after an appeal by National Institutes of Health Director Francis Collins, the people said.

During a Jan. 4 call between U.S. officials, Dr. Stoffels and then-Merck Chief Executive

Ken Frazier,

the companies agreed to assess whether Merck’s plants could adapt to make J&J’s shot, the people said.

At the time, Merck was searching for a role in the pandemic response. It had begun clinical trials of two Covid-19 vaccines, but they ultimately failed, with Merck halting the programs in late January. Its Covid-19 antiviral, molnupiravir, was still being tested.

Merck fit as a partner because of its decades of manufacturing vaccines, Mr. Colarusso said.

Another key: Merck’s production line in West Point was sitting idle after the Covid-19 vaccines flopped. Merck also wasn’t using a freshly built 4,000-square-foot cold-storage room with 18 specialized freezers that the company had built for its Covid-19 shots. Each freezer could hold 5.5 million J&J doses.

The freezer room at the Merck plant in West Point, Pa.

The West Point plants sit on a leafy campus 30 miles outside Philadelphia. It is Merck’s largest workplace—in terms of space and number of workers—and has its own ZIP Code. Despite the available rooms and equipment, Merck needed to upgrade its facilities, because J&J’s vaccine uses vials smaller than Merck’s failed Covid-19 shots, as well as a newer vaccine technology.

“Our issue then became what equipment do we need, where can we get it, how quickly can we get it, is it available, and if not, then what’s our alternatives?” said Mr. McGrath, an industry veteran who joined Merck in 2019.

Merck found that it needed to quickly secure equipment and raw materials even as other drugmakers required them for their own products. Merck needed about 200 chemicals and devices such as filters. Such items typically take between two and three months to get, but Merck needed them in weeks.

Merck leaned on its relationships with suppliers, such as

Thermo Fisher Scientific Inc.,

which provided specialized plastic bags used to purify and filter the vaccine. Merck also paused production of some non-Covid-19 products, which might have yielded sales to competitors but freed up equipment and materials, Mr. McGrath said.

In April, workers discovered that a screw used to keep vials steady as they moved down the production line wasn’t working. The vials wobbled, and some fell down, jamming the production line. Merck worked with a vendor in Japan to redesign the screws.

In May, Merck workers discovered another issue with the vials while doing test-runs of the production line using water. They became top-heavy with water when filled. To resolve the issue, a Merck machinist designed a plate that held the containers securely, said Kim Dezura, the West Point plant manager.

“Those are the types of little things that you encounter,” she said. “We want to solve those early so that they don’t create bigger issues later.”

Once filled, vials must be transferred from trays to cardboard boxes for shipment without sustaining damage and before they get too warm. J&J didn’t specify how to do this, so its rival honed its own system.

Initially, Merck tried moving vials one by one, but that took too long and was too physically hard for workers. Using 3-D printers, Merck built workstations for workers to release vials from a tray, sort them into rows, scoop out the containers and transfer them 39 at a time.

In August, Merck began manufacturing commercial doses, Ms. Dezura said. It took the companies until recently to receive regulatory approvals clearing shipments. J&J then got the doses at its distribution center in the Netherlands, and released the doses Friday for global distribution.

Merck plans to make doses with J&J at its plant in North Carolina, a more difficult process that is taking longer to finish.

The Merck site in West Point, Pa., is the company’s largest facility.

Write to Jared S. Hopkins at jared.hopkins@wsj.com

Corrections & Amplifications
Remo Colarusso is Johnson & Johnson’s global pharmaceuticals manufacturing chief. An earlier version of this article misspelled his surname as Remo Colaruso. (Corrected on Dec. 11)

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Biden Administration Plans Covid-19 Vaccine Boosters Starting at Six Months Instead of Eight

Federal regulators are likely to approve a third Covid-19 shot for vaccinated adults starting at least six months after the second dose rather than the eight-month gap they previously announced, a person familiar with the plans said, as the Biden administration steps up preparations for delivering boosters to the public.

Data from vaccine manufacturers and other countries under review by the Food and Drug Administration is based on boosters being given at six months, the person said. The person said approval for boosters for all three Covid-19 shots being administered in the U.S.—those manufactured by Pfizer Inc. and partner BioNTech SE, Moderna Inc. and Johnson & Johnson —is expected in mid-September.

The Biden administration and companies have said that there should be enough supply for boosters. The U.S. has purchased a combined 1 billion doses from Pfizer and Moderna.

A White House spokesman declined to comment. An FDA spokeswoman declined to comment on interactions with vaccine manufacturers.

Pfizer and BioNTech said Wednesday that they had asked U.S. health regulators to authorize boosters of their Covid-19 vaccine and submitted additional data showing a third dose improves protection against the virus. The FDA granted full approval to the vaccine on Monday. Biden administration officials have said they hope full approval will encourage more people to get vaccinated, pushing up inoculation rates that recently climbed past 60% of the eligible U.S. population.

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Covid-19 Booster Shot to Be Offered to People Fully Vaccinated With Pfizer, Moderna

The Biden administration is expected to call for a third Covid-19 shot for Americans who were fully vaccinated with the two-shot regimen, citing the threat from the highly contagious Delta variant and heightened concerns over data showing initial immunity wanes over time.

The announcement on Wednesday is likely to cover the more than 155 million people in the U.S. who have been fully vaccinated with messenger RNA vaccines from Pfizer Inc. and partner BioNTech SE or from Moderna Inc., according to people familiar with the planning. The booster shot would be administered about eight months after the second dose of the vaccine.

Regulators already cleared booster shots for people with compromised immune systems. Under the expanded plan, people 65 and older and individuals in chronic-care facilities are expected to get boosters first, followed by health workers and others in the population, the people said. The third dose will be of the same vaccine from the two-dose regimen.

The Food and Drug Administration has been weighing whether adults who received Johnson & Johnson ’s single-dose shot will also need another Covid-19 vaccine shot, another person familiar with the situation said. Data about J&J’s shot isn’t complete but it is likely this population will also need booster shots, one of the people said.

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FDA Moving Towards Decision Authorizing Booster Shot for Immunocompromised

The U.S. Food and Drug Administration is nearing a decision to authorize Covid-19 booster shots for certain people with weak immune systems, people familiar with the matter said, a shift in the American vaccination strategy as the Delta variant drives up cases of infection.

The agency could make a decision as early as Thursday and probably by Friday, one of the people said.

The agency is closing in on the booster-shot authorization amid evidence that vaccines are less effective protecting immunocompromised people from Covid-19 than they are in protecting the general population.

Some public health experts and vaccine makers have also recommended boosters as necessary for broader swaths of the population to keep strong protection against newer variants of the coronavirus, and because some preliminary research indicates vaccines may lose effectiveness over time.

The Biden administration is expected to lay out a plan for boosters by early September.

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FDA Plans to Warn J&J Covid-19 Vaccine Raises Risk of Rare Neurological Condition

U.S. health regulators are expected to warn that the

Johnson & Johnson

JNJ -0.16%

Covid-19 vaccine is linked to a very small incidence of cases of a rare neurological disorder associated with other shots.

The U.S. Food and Drug Administration plans to add the warning language to the J&J shot’s label, after finding a handful of cases of Guillain-Barré syndrome among the millions of people who have gotten the vaccine, according to a person familiar with the matter.

Guillain-Barré syndrome is a rare neurological disorder in which the immune system attacks nerves, causing temporary but potentially severe paralysis. The risk is a known one with vaccines, including some influenza vaccines and a leading shot to prevent shingles.

J&J didn’t immediately provide a comment.

The warning would be the latest for a vaccine that federal health officials had cautioned raises the risk of a rare blood-clotting condition.

The risk of Guillain-Barré, however, is very low, the person said, with a rate of about three to five cases per million recipients. The risk in the general population is about 1 in one million.

Some 12.7 million people in the U.S. have gotten the one-dose J&J vaccine, according to the Centers for Disease Control and Prevention.

As more U.S. adults get their Covid-19 vaccines, a variety of side effects are emerging. WSJ’s Daniela Hernandez speaks with an infectious disease specialist on what is common, what isn’t and when to seek medical attention. Photo: Associated Press

The Johnson & Johnson vaccine uses a harmless type of common-cold virus called an adenovirus. It is engineered to carry a piece of genetic code instructing the body’s cells to make something resembling the spike protein that juts from the surface of the coronavirus.

Production of the spikelike protein, in turn, triggers an immune response that can protect a vaccinated person from Covid-19.

Another Covid-19 vaccine, from

AstraZeneca

PLC, which isn’t authorized in the U.S. but used in the U.K. and other countries, uses a technology similar to J&J’s. AstraZeneca’s shot also is linked to an increased risk of Guillain-Barré, federal health officials said.

AstraZeneca didn’t immediately respond to a request for comment.

The U.S. authorized the Johnson & Johnson vaccine in late February. Its rollout has struggled after regulators ordered a temporary pause in its administration as investigators studied the rate of the rare clotting disorder among vaccinated people.

The FDA recommends use of the vaccine, saying the benefits outweigh the risks. The agency, however, attached a warning to the vaccine’s label about the risk of the disorder and made recommendations for treatment.

The vaccine requires only one dose and doesn’t need to be stored at ultralow temperatures like messenger RNA vaccines do, which makes it a more straightforward and easier shot for vaccinating people, especially in places for which the freezer conditions and patient follow-up for a second shot would be more difficult to achieve.

Write to Thomas M. Burton at tom.burton@wsj.com and Felicia Schwartz at felicia.schwartz@wsj.com

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U.S. Government Scientists Skeptical of One-Shot Regimen for Pfizer, Moderna Covid Vaccines

WASHINGTON—U.S. government scientists are pushing back against calls for one-dose regimens for two Covid-19 vaccines designed to be administered with two shots, saying there isn’t enough evidence that a single dose provides long-term protection.

“It is essential that these vaccines be used as authorized by FDA in order to prevent Covid-19 and related hospitalizations and death,” Peter Marks, director of the Food and Drug Administration’s center that oversees vaccines, told The Wall Street Journal.

The FDA late last year approved a two-dose regimen for vaccines from

Moderna Inc.

and from a partnership of

Pfizer Inc.

and

BioNTech

SE. More recently it approved use of a one-dose regimen for a vaccine from

Johnson & Johnson.

Some scientists and lawmakers have called for shifting to a one-dose regimen for all the vaccines, citing preliminary studies showing one shot can be effective. They contend shifting to one shot will allow the U.S. to accelerate the pace of vaccinations.

In a March 2 letter to acting Health and Human Services Secretary

Norris Cochran,

seven physician members of Congress urged the department “to consider issuing a revised emergency use authorization as soon as possible” that might lead to single-dose use of the

Pfizer

and Moderna vaccines.

“Last week, the U.S. passed a sobering milestone of over 500,000 deaths related to COVID-19,” said the letter, signed by lawmakers including

Rep. Andy Harris

(R, Md.) and

Rep. Gregory F. Murphy,

(R., N.C.). “These are staggering statistics, and anything we can do to help prevent further tragedy—to further protect the public health and safety of the American people—should be fully employed.”

In interviews, senior government scientists at the FDA and the National Institutes of Health said such a shift isn’t warranted, saying the evidence used to approve the Pfizer and Moderna vaccines was based on two doses.

These scientists said one dose may offer short-term protection, but the longer-term protection is a question mark.

“You would be flying blind to just use one dose,” said one senior scientist and adviser to President

Biden.

“If you’re going to do something else other than follow the studies shown to the FDA, show me that this one-shot effect is durable.”

Another senior U.S. government doctor said the durability of the vaccination is especially important when more-resistant strains of Covid-19, including those from the U.K. and South Africa, are appearing in the U.S.

“We think it’s best to get people to as high a level of immunity as possible,” the doctor said.

The doctor added that the pace of vaccinations is accelerating with the recent decision by

Merck

& Co. to help produce the J&J vaccine.

“We’re going to have a good supply of vaccines very soon,” the doctor said.

Representatives of Pfizer and Moderna didn’t immediately respond to requests for comment Saturday. Pfizer has previously said it doesn’t have data regarding the single-dose approach, and Moderna has previously said it isn’t studying the issue.

Paul A. Offit

of the Children’s Hospital of Philadelphia, who served on the FDA advisory panel that recommended the use of the Pfizer and Moderna vaccines, said those clinical trials “found a level of neutralizing antibodies [with one dose] that was significantly less than what they got with two doses.”

The FDA advisory panel’s chairman,

Arnold Monto,

also said the two-shot regimen is best for the Pfizer and Moderna vaccines. Dr. Monto, a public-health doctor at the University of Michigan, stressed the need for two doses to counter the Covid-19 variants.

“We’ve got information on a two-dose strategy,” said Dr. Monto. “We need high antibody levels from those doses to deal with the variants.”

Others holding fast with similar views in the U.S. government are prominent infectious-disease doctor

Anthony Fauci

and

Andy Slavitt,

a senior White House adviser for Covid-19 response. Mr. Slavitt said it would be a mistake for the U.S. government to be persuaded by just one study.

University of Minnesota epidemiologist

Michael Osterholm

said in testimony Thursday before the Minnesota legislature that the U.S. should consider delaying second doses so more people can get first shots.

“We could get more of our over-65 group vaccinated,” he said. “I think the data will support that actually is a very effective way to go.”

Two weeks ago, researchers in Israel reported that one dose of the Pfizer vaccine was 85% effective in preventing symptomatic disease 15 to 28 days after inoculation.

In the U.K, the government has opted to stretch vaccine supplies by delaying a second dose by up to 12 weeks in a bid to reach more people.

British researchers released preliminary data in recent days saying that either of two vaccines—from Pfizer and from

AstraZeneca

PLC—reduced the risk of hospitalization among people older than 70 years old by 80%, compared with people of similar ages without vaccination.

AstraZeneca is still conducting a U.S. study of its vaccine, which hasn’t yet gained authorization from the FDA.

Write to Thomas M. Burton at tom.burton@wsj.com

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