LONDON, May 17 (Reuters) – Top baby formula makers Reckitt Benckiser (RKT.L) and Nestle have ramped up supplies to the United States to resolve a shortage that has emptied shelves and caused panic among parents.
Baby formula aisles at U.S. supermarkets have been decimated since top U.S. manufacturer Abbott Laboratories (ABT.N) in February recalled formulas after complaints of bacterial infections.
Abbott said on Monday it had reached an agreement with the U.S. health regulator to resume production of baby formula at its Michigan plant, marking a major step towards resolving the nationwide shortage. read more
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In the meantime, other baby formula makers have stepped up production and shipped extra supplies to the United States.
Reckitt Benckiser is boosting baby formula production by about 30% and making more frequent deliveries to U.S. stores, an executive told Reuters on Tuesday. read more
The company, which makes its U.S. formula in three facilities in Michigan, Indiana and Minnesota, has granted plants “unlimited overtime” to put in extra shifts, Robert Cleveland, senior vice president, North America and Europe Nutrition at Reckitt, told Reuters in an interview.
Empty shelves show a shortage of baby formula at a CVS store in San Antonio, Texas, U.S. May 10, 2022. REUTERS/Kaylee Greenlee Beal/Files
Prior to the Abbott recall, Reckitt supplied just over a third of the U.S. infant formula market compared with Abbott’s roughly 44%. Britain-based Reckitt told Reuters it now accounts for more than 50% of total baby formula supply in the country.
“We normally might pack an entire truck before we ship it. For timeliness, we’re not doing that. We’re packing it with as much product as we have and then we’re just getting it out the door,” Cleveland said.
The United States will allow baby formula imports from foreign makers that do not usually sell their products there, the Food and Drug Administration said on Monday. read more
Nestle is flying baby formula supplies to the United States from the Netherlands and Switzerland, the company said in an emailed statement to Reuters on Tuesday. L2N2X90E1
The world’s largest packaged food group is moving Gerber baby food formula to the United States from the Netherlands and Alfamino baby formula there from Switzerland, it said.
“We prioritized these products because they serve a critical medical purpose as they are for babies with cow’s milk protein allergies,” the company said. “Both products were already being imported but we moved shipments up and rushed via air to help fill immediate needs.”
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Editing by Matt Scuffham and Mark Potter
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May 17 (Reuters) – Abbott Laboratories (ABT.N), the biggest U.S. supplier of powder infant formula including Similac, has agreed with regulators on steps needed to resume production at its Sturgis, Michigan, manufacturing plant.
Abbott initiated a recall of its infant formula products and closed its Michigan plant in February after reports of serious bacterial infections in four infants, worsening a shortage among multiple manufacturers that began with pandemic supply chain issues. Here are some details about what has happened:
WHY DID ABBOTT INITIATE A RECALL AND PLANT SHUTDOWN?
Consumers reported four infants who were sick, including three with Cronobacter sakazakii infections and one with Salmonella newport, who had been fed formula products made at the Sturgis plant. A fourth infant with cronobacter sakazakii was later added to the investigation by the U.S. Centers for Disease and Control Prevention (CDC).
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Cronobacter sakazakii can cause life threatening sepsis infections or meningitis and may have contributed to the death of two of the infants, the U.S. Food and Drug Administration has said.
WHAT WAS RECALLED?
The recall began in mid-February with dozens of types of Similac, Alimentum and EleCare powdered formulas. A specialty liquid formula called Similac PM 60/40 was added to the recall at the end of February.
DID THE FDA OR CDC FIND A LINK?
Abbott says there is no evidence to link its formulas to these illnesses. The FDA and the CDC have not disclosed any information that connects the illnesses and the plant. FDA officials said that the investigation was impeded by having only two of the four sickened babies’ clinical samples.
The CDC analyzed clinical samples from two of the infants and did not find a genetic match to the environmental strains found at the plant. It also said the bacteria from the patient samples were not closely related to one another.
The FDA and Abbott tested environmental and product samples at the plant. They found five environmental samples containing Cronobacter sakazakii. The product samples tested negative.
WHEN WILL THE ABBOTT PLANT RESUME PRODUCTION?
Abbott, as part of a pre-negotiated injunction filed by the FDA, has agreed to take corrective actions to address issues raised by federal inspectors in order to restart the plant. It will retain an independent expert to ensure the facility is in compliance with the law.
Once the FDA confirms that the initial requirements have been met, Abbott said the site could be restarted within two weeks.
Peter Pitts, president of the Center for Medicine in the Public Interest and former FDA associate commissioner, said Abbott should be able to meet its two weeks target for re-opening the facility, and expects it to be fully operational in another four-to-six weeks.
Abbott has imported millions of cans of infant formulas from its Ireland facility to help with the U.S. shortage. The recall affected formula shipped to other countries, including Israel.
HOW LONG WILL IT TAKE FOR THE SHORTAGE TO SUBSIDE?
The shortages may last another two to four months even as lawmakers and the White House try to increase supplies. Abbott has said it will take six to eight weeks to get formula on shelves after the facility restarts.
WHAT CAUSED THE SHORTAGE?
The shortage began in 2020 as consumers stockpiled due to COVID-19 lockdowns. Formula makers ramped up production but then cut back in 2021 as demand slowed. Global shipping logjams have also prevented retailers from promptly restocking shelves.
(This story corrects to drop “Dr” title before Peter Pitts’ name in paragraph 11)
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Reporting by Manas Mishra, Leroy Leo and Deborah Sophia in Bengaluru and Richa Naidu in London; Editing by Caroline Humer, Sandra Maler and Bill Berkrot
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On Dec. 29, The Gateway Pundit, a far-right website that often spreads conspiracy theories, published an article falsely implying that the Centers for Disease Control and Prevention had withdrawn authorization of all P.C.R. tests for detecting Covid-19. The article collected 22,000 likes, comments and shares on Facebook and Twitter.
On TikTok and Instagram, videos of at-home Covid-19 tests displaying positive results after being soaked in drinking water and juice have gone viral in recent weeks, and were used to push the false narrative that coronavirus rapid tests don’t work. Some household liquids can make a test show a positive result, health experts say, but the tests remain accurate when used as directed. One TikTok video showing a home test that came out positive after being placed under running water was shared at least 140,000 times.
And on YouTube, a video titled “Rapid antigen tests debunked” was posted on Jan. 1 by the Canadian far-right website Rebel News. It generated over 40,000 views, and its comments section was a hotbed of misinformation. “The straight up purpose of this test is to keep the case #’s as high as possible to maintain fear & incentive for more restrictions,” said one comment with more than 200 likes. “And of course Profit.”
Previous spikes in pandemic-related falsehoods focused on the vaccines, masks and the severity of the virus. The falsehoods help undermine best practices for controlling the spread of the coronavirus, health experts say, noting that misinformation remains a key factor in vaccine hesitancy.
The categories include falsehoods that P.C.R. tests don’t work; that the counts for flu and Covid-19 cases have been combined; that P.C.R. tests are vaccines in disguise; and that at-home rapid tests have a predetermined result or are unreliable because different liquids can turn them positive.
These themes jumped into the thousands of mentions in the last three months of 2021, compared with just a few dozen in the same time period in 2020, according to Zignal Labs, which tracks mentions on social media, on cable television and in print and online outlets.
The added demand for testing due to Omicron and the higher prevalence of breakthrough cases has given purveyors of misinformation an “opportune moment” to exploit, said Kolina Koltai, a researcher at the University of Washington who studies online conspiracy theories. The false narratives “support the whole idea of not trusting the infection numbers or trusting the death count,” she said.
policies that prohibit misinformation that could cause harm to people’s physical health. YouTube said it was reviewing the videos shared by The New York Times in line with its Covid-19 misinformation policies on testing and diagnostics. Twitter said that it had applied a warning to The Gateway Pundit’s article in December for violating its coronavirus misinformation policy and that tweets containing false information about widely accepted testing methods would also violate its policy. But the company said it does not take action on personal anecdotes.
Facebook said it had worked with its fact-checking partners to label many of the posts with warnings that directed people toward fact checks of the false claims, and reduced their prominence on its users’ feeds.
“The challenges of the pandemic are constantly changing, and we’re consistently monitoring for emerging false claims on our platforms,” Aaron Simpson, a Facebook spokesman, said in an email.
No medical test is perfect, and legitimate questions about the accuracy of Covid-19 tests have abounded throughout the pandemic. There has always been a risk of a false positive or a false negative result. The Food and Drug Administration says there is a potential for antigen tests to return false positive results when users do not follow the instructions. Those tests are generally accurate when used correctly but in some cases can appear to show a positive result when exposed to other liquids, said Dr. Glenn Patriquin, who published a study about false positives in antigen tests using various liquids in a publication of the American Society for Microbiology.
“Using a fluid with a different chemical makeup than what was designed means that result lines might appear unpredictably,” said Dr. Patriquin, an assistant professor of pathology at Dalhousie University in Nova Scotia.
Complicating matters, there have been some defective products. Last year, the Australian company Ellume recalled about two million of the at-home testing products that it had shipped to the United States.
But when used correctly, coronavirus tests are considered reliable at detecting people carrying high levels of the virus. Experts say our evolving knowledge of tests should be a distinct issue from lies about testing that have spread widely on social media — though it does make debunking those lies more challenging.
said in July that it would withdraw its request to the Food and Drug Administration for emergency-use authorization of one specific test at the end of the year. Hundreds of other Covid-19 tests are still available from other manufacturers, the C.D.C. later clarified.
Still, posts claiming that the agency had withdrawn support of P.C.R. tests went viral on Facebook. The most widely shared post pushing the falsehood in July collected 11,500 likes, shares and comments, according to data from CrowdTangle, a Facebook-owned social media analytics tool. The post added the falsehood that the C.D.C.’s advisory meant that P.C.R. tests could not distinguish between the coronavirus and the flu, when in fact the agency had simply recommended the use of tests that could simultaneously detect and distinguish between the flu and Covid-19.
Despite being fact-checked within days, the claim never fully went away. The Gateway Pundit article revived the claim at the end of the year, collecting nearly double the earlier post’s likes, shares and comments on Facebook. On Instagram, screenshots of the article also went viral, collecting hundreds of likes.
Mr. Gregory said a similar phenomenon had occurred with social media posts claiming various liquids turned at-home coronavirus tests positive.
On Dec. 23, 2020, a video on YouTube showed coronavirus tests turning positive after being tested on kiwi, orange and berry fruit juice. It collected over 102,000 views. In the same month, a video producing the same results with Coca-Cola was posted on YouTube, collecting 16,800 views.
One year later, a spate of similar videos with the same theme appeared on TikTok and Instagram.
For Ms. Koltai, the re-emergence of false narratives even after social media companies labeled them a year earlier shows the power of misinformation to “thrive when it can latch on to a current event.”
“That is how narratives can peak at different times,” she said.
A box of material for rapid COVID-19 antigenic tests made by Swiss drugmaker Roche is pictured at the University Hospital (CHUV) during the coronavirus disease (COVID-19) outbreak in Lausanne, Switzerland, November 13, 2020. REUTERS/Denis Balibouse
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Dec 24 (Reuters) – Roche said on Friday that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to its COVID-19 at-home rapid test that can be used by people as young as 14.
The test, which uses a anterior nasal swab sample, is “able to produce accurate, reliable and quick results in as few as 20 minutes” for SARS-CoV-2 and all variants of concern, including Omicron, the drugmaker said in a statement.
The variant has become dominant in the United States with lightning speed, dashing hopes for a more normal holiday season, resurrecting restrictions and stretching the country’s testing infrastructure ahead of holiday travel and gatherings. read more
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“Roche has the capacity to produce tens of millions of tests per month to help support the pandemic response,” the Swiss firm said, adding that the test will be available across the U.S. from January.
The test’s approval comes at a time when companies such as Walmart Inc (WMT.N), Walgreens Boots Alliance (WBA.O) and CVS Health Corp (CVS.N) have limited sales of at-home COVID-19 testing kits as demand surged owing to the swift spread of the variant of the coronavirus.
U.S. President Joe Biden recently unveiled plans to buy 500 million rapid COVID-19 tests to be distributed for free to Americans who request them starting in January. read more
The test can also be used by for children aged 2-13 years under adult supervision, according to the company. “The launch will be in partnership with SD Biosensor Inc (137310.KS), with whom Roche has a global distribution agreement.”
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Reporting by Vishal Vivek in Bengaluru; Editing by Sandra Maler
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Barbara Sibley’s four New York restaurants had already weathered the city’s initial Covid-19 wave, the prevaccine surge last winter and this summer’s Delta spike when last weekend it finally happened: Fearing an outbreak and struggling with staffing after one of her workers got sick with Covid, she temporarily shut down one of her locations.
That was only the start of Ms. Sibley’s worries. She also had to weigh how long the employee, who was fully vaccinated, should isolate before returning to the job. And the messaging from public health experts was not clear-cut.
In the early days of the pandemic the Centers for Disease Control and Prevention recommended that most people who tested positive for the coronavirus isolate for 14 days. It later reduced its recommended isolation period to 10 days. But these policies were based on data from unvaccinated individuals and were implemented before the widespread availability of rapid tests. An increasing number of health and policy professionals now suggest that vaccinated people can end their isolation after five to seven days, so long as they are not symptomatic and they test negative.
On Thursday, the C.D.C. reduced, in some circumstances, the number of days it recommends that health care workers who test positive for the coronavirus isolate themselves, but it did not address other businesses.
said on Friday that fully vaccinated critical workers could return to work five days after testing positive, so long as they have no symptoms or their symptoms are resolving and they have had no fever for 72 hours. Those workers will also have to wear a mask, she said.
Omicron has intensified staffing shortages across industries, and the spike in cases has disrupted travel during the holidays, stranding thousands of customers and underscoring the economic toll of employees needing to isolate. Already, some economists are warning about the potential impact that shutdowns can have on consumer spending.
Delta Air Lines asked the C.D.C. on Tuesday to cut isolation time to five days for fully vaccinated people, warning that the current 10-day period may “significantly impact” operations. It was followed by JetBlue and Airlines for America, a trade group that represents eight airlines.
eliminated weekly testing for vaccinated players who are asymptomatic, with its chief medical officer saying the pandemic had reached a stage in which it’s unnecessary for vaccinated players to sit out if they feel healthy.
canceled performances through Christmas. CityMD, the privately owned urgent care clinic, temporarily shut 19 sites in New York and New Jersey because of staffing shortages. At least a dozen New York restaurants have temporarily closed in response to positive tests.
“I think lots of companies are looking at a lot of disruption in the next month and trying to put in policies right now, because they know their employees are going to get infected in very high numbers,” said Dr. Jha.
The United States might take direction from policy shifts abroad. Britain said on Wednesday that it was reducing to seven from 10 the days that people must isolate after showing Covid-19 symptoms.
After the British government lifted nearly all its pandemic restrictions in July, hundreds of thousands of workers were pinged by the National Health Service’s track-and-trace app and told to isolate because they had been exposed to the coronavirus. Businesses complained of being short-staffed, and economists said the “pingdemic” may have slowed economic growth in July.
In the United States, new tools to help manage through the pandemic are on the way.
The Food and Drug Administration this week authorized two pills to treat Covid, from Pfizer and Merck. Those treatments have been shown to stave off severe disease and have potential to reduce transmission of the virus, though supply of both pills, especially Pfizer’s, will be limited in the next few months.
President Biden said on Tuesday that he planned to invoke the Defense Production Act to buy and give away 500 million rapid antigen tests, a crucial tool in detecting transmissibility, though those tests will not be available for weeks or longer.
If a combination of the antiviral pills and rapid tests is able to get individuals back to work faster, “that’s a big economic point,” said Dr. Eric Topol, a professor of molecular medicine at Scripps Research.
Molly Moon Neitzel, who owns an ice cream business in Seattle with just over 100 employees, said she had kept guidelines for isolation conservative.
“I’m on the side of protecting people over getting them back to work right now,” she said, adding that if it were summer and her business were busier, she might consider a shorter isolation period. “It’s the slowest time of the year for an ice cream company, so that is in my favor.”
Some public health experts worry that if the C.D.C. shortens its guidelines on isolating, employers could pressure workers to get back before they’re fully recovered.
“What I don’t want to see happen is for this to be used as an excuse to force people to come back while they are unwell,” Dr. Ranney of Brown said.
And even with clearer guidelines, putting policies in place can be tricky. While some experts suggest different isolation rules for vaccinated and unvaccinated employees, some companies do not yet have a system for tracking which of their workers have gotten a vaccine. The question of whether the C.D.C. will change its definition of fully vaccinated to include booster shots adds another layer of complexity.
It’s not just sick employees who may have to stay home: Companies are also grappling with whether vaccinated workers should quarantine after exposure to someone with Covid-19, which C.D.C. guidelines do not require.
“It becomes a challenge for employers to choose between providing a safer environment and keeping staff intact, or going with the C.D.C. guidance,” said Karen Burke, an adviser at the Society for Human Resource Management.
But almost two years into the pandemic, that’s the position that employers continue to find themselves in, amid an ever-flowing cascade of new data, guidelines and considerations.
“Every moment, you’re making life or death decisions,” Ms. Sibley said. “That’s not what we signed up for.”
MADRID — Covid-19 infections were rising all across Spain, but the message from the country’s leader was clear: The government was not entering 2022 with the restrictions of 2020.
“The situation is different this time, and because of that, we’re taking different measures,” Pedro Sánchez, the prime minister, said this week, adding that he understood his people had grown impatient with the pandemic and that he was “fully aware of the fatigue.”
Across Europe, that fatigue is as palpable as the dampened Christmas spirit. The fatigue of another named variant of the coronavirus and another wave of infections. The fatigue of another grim year watching New Year’s Eve gatherings get canceled or curtailed, one by one.
But along with the exhaustion, another feeling is taking root: that the coronavirus will not be eradicated with vaccines or lockdowns, but has become something endemic that people must learn to live with, maybe for years to come.
reducing the risk of severe disease and hospitalization, according to recent studies.
Pfizer and Merck. The new drugs, which can be taken at home with a doctor’s prescription, will be available to some Covid patients who are at higher risk of becoming severely ill.
“I worry a bit because we don’t know much about Omicron,” Susanne Sesterer, 63, a retiree in Hanover, Germany, said on Thursday as she was doing her last shopping before Christmas. “But how much worse can it get?”
Others were giving up.
Dorotea Belli, a 42-year-old Italian who has had two vaccine doses, said she would not go to a family gathering for Christmas and instead stay home in Rome. Many of her colleagues had tested positive for the virus, she said, and her children, 4 and 1, are not eligible for vaccination.
“They and I will miss my parents very much,” she said. “But I don’t want to bring Covid around, and even if my husband and I are vaccinated, who knows?”
Spain’s calculus on new restrictions is not only factoring in the all-important holidays, but also legal barriers that emerged after measures taken by the government in 2020.
In July, Spain’s Constitutional Court ruled that the government did not have the authority to impose the lockdown measures that began in March 2020, which restricted Spaniards from leaving their homes except for essential trips like food shopping. Instead, the judges said, the measures required a full parliamentary vote, which few see passing with a majority in the future given how controversial the previous restrictions were.
“The government has its hands tied now,” said Luis Galán Soldevilla, a law professor at the University of Córdoba.
Spain’s lighter measures announced on Thursday received criticism from some sectors, like the Spanish Society of Public Health and Health Administration, a group that includes many health professionals.
“These measures don’t help much,” said Ildefonso Hernández, the group’s spokesman, saying limiting capacity indoors would be more effective. “It makes no sense that people walk the street with a mask and then take it off when they enter a bar.”
In Madrid, residents were charging ahead with their Christmas plans, despite the rising caseload and risks.
Fernando Sánchez, 55, a taxi driver, lost his mother and brother to Covid-19 six months ago. Nevertheless, he was unwilling to cancel his Christmas plans, which this year take place at the home of his in-laws, much as they had before the pandemic.
Antonio Jesús Navarro, 33, a software engineer, had been looking forward to spending Christmas with his girlfriend, who had traveled to Spain for the holidays from the United States. The two had not seen each other since before the pandemic began.
But then Mr. Navarro learned he had come into contact with someone who had tested positive for the coronavirus. The couple were isolating until he could get his own test results. He said he was frustrated with public messaging on how to stay safe from Omicron.
“Is an antigen test acceptable?” he said by telephone. “What happens if there are no symptoms?”
Hours later, Mr. Navarro called back to say he and his girlfriend had tested positive for Covid-19.
Nicholas Casey and José Bautista reported from Madrid, and Constant Méheut from Paris. Reporting was contributed by Raphael Minder from Geneva; Gaia Pianigiani from Rome; Christopher F. Schuetze from Hanover, Germany; and Léontine Gallois from Paris.
“You can’t really mandate booster shots yet,” he said. “It hasn’t been signed off on by any federal agency.”
JPMorgan Chase, whose decision to require vaccines is complicated by its sprawling retail operations across the United States, declined to comment on how the court’s most recent decision, along with the recent spike in cases, affects any plans to mandate vaccines. But the bank on Friday told its American employees who do not work in bank branches that “each group should assess who needs to come into the office, work priorities and who should revert to working from home on a more regular basis over the next few weeks.”
Walmart, which has mandated vaccines for mainly its corporate staff, also did not have any comment on broadening that requirement. Only 66 percent of its roughly 1.6 million U.S. employees are vaccinated, according to data compiled by the Shift Project at the Kennedy School of Government at Harvard.
Legal questions about the OSHA rule are far from resolved. Immediately after the U.S. District Court of Appeals for the Sixth Circuit ruled on Friday, several of the many plaintiffs who have challenged that rule asked the Supreme Court to intervene as part of its “emergency” docket. Appeals from the Sixth Circuit are assigned for review by Justice Brett Kavanaugh, who under Supreme Court rules could in theory make a decision on his own but is more likely to refer the matter to the full Supreme Court. With the Labor Department now delaying full enforcement of its rule until Feb. 9, the justices have several weeks to ask for abbreviated briefings if they want them.
“Things are going back and forth literally in a matter of hours,” said Sydney Heimbrock, an adviser on industry and government issues at Qualtrics, who works with hundreds of clients on using the company’s software to track employee vaccination status. “The confusion stems from the on-again-off-again, is it a rule or isn’t it a rule? The litigations, appeals, reversing decisions and making decisions.”
Even the spread of Omicron hasn’t changed the position of some of the vaccine rule’s most ardent opponents. The National Retail Federation, one of the trade groups challenging the administration’s vaccine rule, is among those that have filed a petition with the Supreme Court. The group is in favor of vaccinations but has pushed for companies to get more time to carry out mandates. Still, even as it fights the administration’s rule, the federation is also holding twice weekly calls with members to compare notes on how to carry it out.
“There’s no question that the increased number of variants like Omicron certainly don’t make it less dangerous,” said Stephanie Martz, the group’s chief administrative officer and general counsel. “The legitimate, remaining question is, is this inherent to the workplace?”
Scott Kirby, the chief executive of United Airlines, reached a breaking point while vacationing in Croatia this summer: After receiving word that a 57-year-old United pilot had died after contracting the coronavirus, he felt it was time to require all employees to get vaccinated.
He paced for about half an hour and then called two of his top executives. “We concluded enough is enough,” Mr. Kirby said in an interview on Thursday. “People are dying, and we can do something to stop that with United Airlines.”
The company announced its vaccine mandate days later, kicking off a two-month process that ended last Monday. Mr. Kirby’s team had guessed that no more than 70 percent of the airline’s workers were already vaccinated, and the requirement helped convince most of the rest: Nearly all of United’s 67,000 U.S. employees have been vaccinated, in one of the largest and most successful corporate efforts of the kind during the pandemic.
The key to United’s success, even in states where vaccination rates are at or below the national average, like Texas and Florida, was a gradual effort that started with providing incentives and getting buy-in from employee groups, especially unions, which represent a majority of its workers.
praise from President Biden, who weeks later announced that regulators would require all businesses with 100 or more workers to require vaccinations or conduct weekly virus testing. And the company drew scorn from conservatives.
Other mandates are producing results, too. Tyson Foods, which announced its vaccine requirement just days before United but has provided workers more time to comply, said on Thursday that 91 percent of its 120,000 U.S. employees had been vaccinated. Similar policies for health care workers by California and hospitals have also been effective.
charge its unvaccinated employees an additional $200 per month for health insurance.
A Year in the Making
United had been laying the groundwork for a vaccine mandate for at least a year. The airline already had experience requiring vaccines. It has mandated a yellow fever vaccination for flight crews based at Dulles International Airport, near Washington, because of a route to Ghana, whose government requires it.
In January, at a virtual meeting, Mr. Kirby told employees that he favored a coronavirus vaccine mandate.
Writing letters to families of the employees who had died from the virus was “the worst thing that I believe I will ever do in my career,” he said at the time, according to a transcript. But while requiring vaccination was “the right thing to do,” United would not be able to act alone, he said.
The union representing flight attendants pushed the company to focus first on access and incentives. It argued that many flight attendants couldn’t get vaccinated because they were not yet eligible in certain states.
Mr. Kirby acknowledged that widespread access would be a precondition. The airline and unions worked together to set up clinics for staff in cities where it has hubs like Houston, Chicago and Newark.
was calling on all employers to do so. A mandate would strike workers as unfair and create unnecessary conflict, the flight attendants’ union argued.
“The more people you get to take action on their own, the more you can focus on reaching the remaining people before any knock-down, drag-out scenario,” said Sara Nelson, the president of the Association of Flight Attendants, which represents more than 23,000 active workers at United.
In May, the pilots reached an agreement that would give them extra pay for getting vaccinated and the flight attendants worked toward an agreement that would give them extra vacation days. Both incentives declined in value over time and typically expired by early July.
vaccinated by Oct. 25 or within five weeks of a vaccine’s formal approval by the Food and Drug Administration, whichever came first. The timing was intended to ensure that the airline had adequate staffing for holiday travel, said Kate Gebo, who heads human resources.
This time, the unions were more resigned.
“For those 92 percent of pilots who wanted to be vaccinated, we captured $45 million in cash incentives,” said Captain Insler, whose union is challenging the decision to fire employees who don’t comply. “For those who did not want to be vaccinated, we were able to hold off a mandate for several months.”
Getting Over the Finish Line
The success of the incentives — about 80 percent of United’s flight attendants were also vaccinated by the time the airline announced its mandate in August — inspired the company to expand them to all employees, offering a full day’s pay to anyone who provided proof of vaccination by Sept. 20.
The company hadn’t surveyed its workers, but estimated that 60 to 70 percent were already vaccinated. Getting the rest there wouldn’t be easy.
The State of Vaccine Mandates in the U.S.
Vaccine rules.On Aug. 23, the F.D.A. granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and up, paving the way for mandates in both the public and private sectors. Such mandates are legally allowed and have been upheld in court challenges.
College and universities. More than 400 colleges and universities are requiring students to be vaccinated against Covid-19. Almost all are in states that voted for President Biden.
Schools. California became the first state to issue a vaccine mandate for all educators and has announced plans to add the Covid-19 vaccine as a requirement to attend school as early as next fall. Los Angeles already has a vaccine mandate for public school students 12 and older who are attending class in person starting Nov. 21. New York City has introduced a vaccine mandate for teachers and staff, but it has yet to take effect because of legal challenges. On Sept. 27, a federal appeals panel reversed a decision that temporarily paused that mandate.
Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get vaccinated. Mandates for health care workers in California and New York State appear to have compelled thousands of holdouts to receive shots.
New York City. Proof of vaccination is required of workers and customers for indoor dining, gyms, performances and other indoor situations. City education staff and hospital workers must also get a vaccine.
At the federal level. On Sept. 9,President Biden announced a vaccine mandate for the vast majority of federal workers. This mandate will apply to employees of the executive branch, including the White House and all federal agencies and members of the armed services.
In the private sector. Mr. Biden has mandated that all companies with more than 100 workers require vaccination or weekly testing, helping propel new corporate vaccination policies. Some companies, like United Airlines and Tyson Foods, had mandates in place before Mr. Biden’s announcement.
Margaret Applegate, 57, a 29-year United employee who works as a services representative in the United Club at San Francisco International Airport, helps illustrate why.
Ms. Applegate normally does not hesitate to get vaccines, noting that her late father was a doctor and that her daughter does research in nutritional science.
Her daughter urged her to get vaccinated, but she remained deeply ambivalent. Friends and co-workers “were feeding me stories about horrible things happening to people with the vaccine,” she said. She worried about the relatively new technology behind the Pfizer and Moderna vaccines, and whether her heart condition could pose complications, though her cardiologist assured her it wouldn’t.
six employees sued United, arguing that its plans to put exempt employees on temporary leave — unpaid in many circumstances — are discriminatory. United has delayed that plan for at least a few weeks as it fights the suit.
Still, United’s vaccination rate has continued to improve. There was another rush before the deadline to receive the pay incentive and one more before the final Sept. 27 deadline. Toward the end of September, the company said 593 people had failed to comply. By Friday, the number had dropped below 240.
“I did not appreciate the intensity of support for a vaccine mandate that existed, because you hear that loud anti-vax voice a lot more than you hear the people that want it,” Mr. Kirby said. “But there are more of them. And they’re just as intense.”
The handwritten doctor’s order was just eight words long, but it solved a problem for Dundee Manor, a nursing home in rural South Carolina struggling to handle a new resident with severe dementia.
David Blakeney, 63, was restless and agitated. The home’s doctor wanted him on an antipsychotic medication called Haldol, a powerful sedative.
“Add Dx of schizophrenia for use of Haldol,” read the doctor’s order, using the medical shorthand for “diagnosis.”
But there was no evidence that Mr. Blakeney actually had schizophrenia.
Antipsychotic drugs — which for decades have faced criticism as “chemical straitjackets” — are dangerous for older people with dementia, nearly doubling their chance of death from heart problems, infections, falls and other ailments. But understaffed nursing homes have often used the sedatives so they don’t have to hire more staff to handle residents.
one in 150 people.
Schizophrenia, which often causes delusions, hallucinations and dampened emotions, is almost always diagnosed before the age of 40.
“People don’t just wake up with schizophrenia when they are elderly,” said Dr. Michael Wasserman, a geriatrician and former nursing home executive who has become a critic of the industry. “It’s used to skirt the rules.”
refuge of last resort for people with the disorder, after large psychiatric hospitals closed decades ago.
But unfounded diagnoses are also driving the increase. In May, a report by a federal oversight agency said nearly one-third of long-term nursing home residents with schizophrenia diagnoses in 2018 had no Medicare record of being treated for the condition.
hide serious problems — like inadequate staffing and haphazard care — from government audits and inspectors.
One result of the inaccurate diagnoses is that the government is understating how many of the country’s 1.1 million nursing home residents are on antipsychotic medications.
According to Medicare’s web page that tracks the effort to reduce the use of antipsychotics, fewer than 15 percent of nursing home residents are on such medications. But that figure excludes patients with schizophrenia diagnoses.
To determine the full number of residents being drugged nationally and at specific homes, The Times obtained unfiltered data that was posted on another, little-known Medicare web page, as well as facility-by-facility data that a patient advocacy group got from Medicare via an open records request and shared with The Times.
The figures showed that at least 21 percent of nursing home residents — about 225,000 people — are on antipsychotics.
The Centers for Medicare and Medicaid Services, which oversees nursing homes, is “concerned about this practice as a way to circumvent the protections these regulations afford,” said Catherine Howden, a spokeswoman for the agency, which is known as C.M.S.
“It is unacceptable for a facility to inappropriately classify a resident’s diagnosis to improve their performance measures,” she said. “We will continue to identify facilities which do so and hold them accountable.”
significant drop since 2012 in the share of residents on the drugs.
But when residents with diagnoses like schizophrenia are included, the decline is less than half what the government and industry claim. And when the pandemic hit in 2020, the trend reversed and antipsychotic drug use increased.
A Doubled Risk of Death
For decades, nursing homes have been using drugs to control dementia patients. For nearly as long, there have been calls for reform.
In 1987, President Ronald Reagan signed a law banning the use of drugs that serve the interest of the nursing home or its staff, not the patient.
But the practice persisted. In the early 2000s, studies found that antipsychotic drugs like Seroquel, Zyprexa and Abilify made older people drowsy and more likely to fall. The drugs were also linked to heart problems in people with dementia. More than a dozen clinical trials concluded that the drugs nearly doubled the risk of death for older dementia patients.
11 percent from less than 7 percent, records show.
The diagnoses rose even as nursing homes reported a decline in behaviors associated with the disorder. The number of residents experiencing delusions, for example, fell to 4 percent from 6 percent.
A Substitute for Staff
Caring for dementia patients is time- and labor-intensive. Workers need to be trained to handle challenging behaviors like wandering and aggression. But many nursing homes are chronically understaffed and do not pay enough to retain employees, especially the nursing assistants who provide the bulk of residents’ daily care.
Studies have found that the worse a home’s staffing situation, the greater its use of antipsychotic drugs. That suggests that some homes are using the powerful drugs to subdue patients and avoid having to hire extra staff. (Homes with staffing shortages are also the most likely to understate the number of residents on antipsychotics, according to the Times’s analysis of Medicare data.)
more than 200,000 since early last year and is at its lowest level since 1994.
As staffing dropped, the use of antipsychotics rose.
Even some of the country’s leading experts on elder care have been taken aback by the frequency of false diagnoses and the overuse of antipsychotics.
Barbara Coulter Edwards, a senior Medicaid official in the Obama administration, said she had discovered that her father was given an incorrect diagnosis of psychosis in the nursing home where he lived even though he had dementia.
“I just was shocked,” Ms. Edwards said. “And the first thing that flashed through my head was this covers a lot of ills for this nursing home if they want to give him drugs.”
Homes that violate the rules face few consequences.
In 2019 and 2021, Medicare said it planned to conduct targeted inspections to examine the issue of false schizophrenia diagnoses, but those plans were repeatedly put on hold because of the pandemic.
In an analysis of government inspection reports, The Times found about 5,600 instances of inspectors citing nursing homes for misusing antipsychotic medications. Nursing home officials told inspectors that they were dispensing the powerful drugs to frail patients for reasons that ranged from “health maintenance” to efforts to deal with residents who were “whining” or “asking for help.”
a state inspector cited Hialeah Shores for giving a false schizophrenia diagnosis to a woman. She was so heavily dosed with antipsychotics that the inspector was unable to rouse her on three consecutive days.
There was no evidence that the woman had been experiencing the delusions common in people with schizophrenia, the inspector found. Instead, staff at the nursing home said she had been “resistive and noncooperative with care.”
Dr. Jonathan Evans, a medical director for nursing homes in Virginia who reviewed the inspector’s findings for The Times, described the woman’s fear and resistance as “classic dementia behavior.”
“This wasn’t five-star care,” said Dr. Evans, who previously was president of a group that represents medical staff in nursing homes. He said he was alarmed that the inspector had decided the violation caused only “minimal harm or potential for harm” to the patient, despite her heavy sedation. As a result, he said, “there’s nothing about this that would deter this facility from doing this again.”
Representatives of Hialeah Shores declined to comment.
Seven of the 52 homes on the inspector general’s list were owned by a large Texas company, Daybreak Venture. At four of those homes, the official rate of antipsychotic drug use for long-term residents was zero, while the actual rate was much higher, according to the Times analysis comparing official C.M.S. figures with unpublished data obtained by the California advocacy group.
make people drowsy and increases the risk of falls. Peer-reviewed studies have shown that it does not help with dementia, and the government has not approved it for that use.
But prescriptions of Depakote and similar anti-seizure drugs have accelerated since the government started publicly reporting nursing homes’ use of antipsychotics.
Between 2015 and 2018, the most recent data available, the use of anti-seizure drugs rose 15 percent in nursing home residents with dementia, according to an analysis of Medicare insurance claims that researchers at the University of Michigan prepared for The Times.
in a “sprinkle” form that makes it easy to slip into food undetected.
“It’s a drug that’s tailor-made to chemically restrain residents without anybody knowing,” he said.
In the early 2000s, Depakote’s manufacturer, Abbott Laboratories, began falsely pitching the drug to nursing homes as a way to sidestep the 1987 law prohibiting facilities from using drugs as “chemical restraints,” according to a federal whistle-blower lawsuit filed by a former Abbott saleswoman.
According to the lawsuit, Abbott’s representatives told pharmacists and nurses that Depakote would “fly under the radar screen” of federal regulations.
Abbott settled the lawsuit in 2012, agreeing to pay the government $1.5 billion to resolve allegations that it had improperly marketed the drugs, including to nursing homes.
Nursing homes are required to report to federal regulators how many of their patients take a wide variety of psychotropic drugs — not just antipsychotics but also anti-anxiety medications, antidepressants and sleeping pills. But homes do not have to report Depakote or similar drugs to the federal government.
“It is like an arrow pointing to that class of medications, like ‘Use us, use us!’” Dr. Maust said. “No one is keeping track of this.”
published a brochure titled “Nursing Homes: Times have changed.”
“Nursing homes have replaced restraints and antipsychotic medications with robust activity programs, religious services, social workers and resident councils so that residents can be mentally, physically and socially engaged,” the colorful two-page leaflet boasted.
Last year, though, the industry teamed up with drug companies and others to push Congress and federal regulators to broaden the list of conditions under which antipsychotics don’t need to be publicly disclosed.
“There is specific and compelling evidence that psychotropics are underutilized in treating dementia and it is time for C.M.S. to re-evaluate its regulations,” wrote Jim Scott, the chairman of the Alliance for Aging Research, which is coordinating the campaign.
The lobbying was financed by drug companies including Avanir Pharmaceuticals and Acadia Pharmaceuticals. Both have tried — and so far failed — to get their drugs approved for treating patients with dementia. (In 2019, Avanir agreed to pay $108 million to settle charges that it had inappropriately marketed its drug for use in dementia patients in nursing homes.)
‘Hold His Haldol’
Ms. Blakeney said that only after hiring a lawyer to sue Dundee Manor for her husband’s death did she learn he had been on Haldol and other powerful drugs. (Dundee Manor has denied Ms. Blakeney’s claims in court filings.)
During her visits, though, Ms. Blakeney noticed that many residents were sleeping most of the time. A pair of women, in particular, always caught her attention. “There were two of them, laying in the same room, like they were dead,” she said.
In his first few months at Dundee Manor, Mr. Blakeney was in and out of the hospital, for bedsores, pneumonia and dehydration. During one hospital visit in December, a doctor noted that Mr. Blakeney was unable to communicate and could no longer walk.
“Hold the patient’s Ambien, trazodone and Zyprexa because of his mental status changes,” the doctor wrote. “Hold his Haldol.”
Mr. Blakeney continued to be prescribed the drugs after he returned to Dundee Manor. By April 2017, the bedsore on his right heel — a result, in part, of his rarely getting out of bed or his wheelchair — required the foot to be amputated.
In June, after weeks of fruitless searching for another nursing home, Ms. Blakeney found one and transferred him there. Later that month, he died.
“I tried to get him out — I tried and tried and tried,” his wife said. “But when I did get him out, it was too late.”
Some of the nation’s largest employers, for months reluctant to wade into the fraught issue of whether Covid-19 vaccinations should be mandatory for workers, have in recent days been compelled to act as infections have surged again.
On Tuesday, Tyson Foods told its 120,000 workers in offices, slaughterhouses and poultry plants across the country that they would need to be vaccinated by Nov. 1 as a “condition of employment.” And Microsoft, which employs roughly 100,000 people in the United States, said it would require proof of vaccination for all employees, vendors and guests to gain access to its offices.
Last week, Google said it would require employees who returned to the company’s offices to be vaccinated, while Disney announced a mandate for all salaried and nonunion hourly workers who work on site.
Other companies, including Walmart, the largest private employer in the United States, and Lyft and Uber, have taken a less forceful approach, mandating vaccines for white-collar workers but not for millions of frontline workers. Those moves essentially set up a divide between the employees who work in offices and employees who deal directly with the public and, collectively, have been more reluctant to get the shots.
different set of reasons that are not primarily political. They say many of their members are worried about potential health side effects or bristle at the idea of an employer’s interfering in what they regard as a personal health decision.
Marc Perrone, the president of the United Food and Commercial Workers union, representing 1.3 million employees in grocery chains such as Kroger and at large meatpacking plants, said he would not support employer mandates until the Food and Drug Administration gave full approval to the vaccine, which is being administered on an emergency basis.
“You can’t just say, ‘Accept the mandate or hit the door,’” Mr. Perrone said in an interview on Monday.
After Tyson announced its vaccine mandate on Tuesday, Mr. Perrone issued a statement that the union “will be meeting with Tyson in the coming weeks to discuss this vaccine mandate and to ensure that the rights of these workers are protected and this policy is fairly implemented.”
several meat plants became virus hot spots. Now, it is requiring its leadership team to be vaccinated by Sept. 24 and the rest of its office workers by Oct. 1. Frontline employees have until Nov. 1 to be fully inoculated, extra time the company is providing because there are “significantly more frontline team members than office workers who still need to be vaccinated,” a Tyson spokesman said.
Throughout the pandemic, companies have treaded carefully in carrying out public health measures while trying to avoid harm to their businesses.
Last year, when major retailers began requiring customers to wear masks, they quietly told their employees not to enforce the rule if a customer was adamant about not wearing one.
Companies like Walmart have tried a similarly tentative approach with vaccine requirements.
Walmart announced last week that it was requiring the roughly 17,000 workers in its Arkansas headquarters to be vaccinated but not those in stores and distribution centers, who make up the bulk of its 1.6 million U.S. employees.
In a statement, the retailer said the limited mandate would send a message to all workers that they should get vaccinated.
“We’re asking our leaders, which already have a higher vaccination rate, to make their example clear,” the company said. “We’re hoping that will influence even more of our frontline associates to become vaccinated.”
Lyft told their corporate employees last week that they would need to show proof they had been inoculated before returning to company offices.
Requiring vaccinations “is the most effective way to create a safe environment and give our team members peace of mind as we return to the office,” said Ashley Adams, a spokeswoman for Lyft.
But those mandates did not extend to the workers the companies contract with to drive millions of customers to and from their destinations. The drivers are being encouraged to be vaccinated, but neither Lyft or Uber has plans to require them.
Public health experts warn that limited mandates may reinforce the gaping divide between the nation’s high- and low-wage workers without furthering the public health goal of substantially increasing vaccination rates.
They also say it’s naïve to think that workers who resisted vaccines for ideological reasons would suddenly change their mind after seeing a company’s higher-paid executives receive the shots.
“Ultimately we want to ensure that they really have the broadest reach,” Dr. Kirsten Bibbins-Domingo, the vice dean for population health and health equity at the University of California, San Francisco, said of company directives. “Failing to do that, I think, will only cause others to be more suspicious of these types of mandates.”
Legally, companies are likely to be on solid ground if they mandate vaccines. Last year, the Equal Employment Opportunity Commission said employers could require immunization, though companies that do could still face lawsuits.
George W. Ingham, a partner at the law firm Hogan Lovells, said companies with mandates would potentially have to make difficult decisions.
“They are going to have to fire high performers and low performers who refuse vaccines,” he said. “They have to be consistent.” Reasons an employee could be exempted include religious beliefs or a disability, though the process of sorting those out on an individual basis promises to be an arduous one.
Companies may also have to contend with pushback from state governments. Ten states have passed legislation limiting the ability to require vaccines for students, employees or the public, according to the National Conference of State Legislatures.
Disney is among the few big companies pursuing a broad vaccine mandate for their work forces, even in the face of pushback from some employees.
In addition to mandating vaccines for nonunion workers who are on-site, Disney said all new hires — union and nonunion — would be required to be fully vaccinated before starting their jobs. Nonunion hourly workers include theme park guest-relations staff, in-park photographers, executive assistants and some seasonal theme park employees.
It was the furthest that Disney could go without a sign-off from the dozen unions that represent the bulk of its employees. Walt Disney World in Florida, for instance, has more than 65,000 workers; roughly 38,000 are union members.
Disney is now seeking union approval for the mandate both in Florida and in California, where tens of thousands of workers at the Disneyland Resort in Anaheim are unionized. Most of the leaders of Disney’s unions appear to be in favor of a mandate — as long as accommodations can be worked out for those refusing the vaccine for medical, religious or other acceptable reasons.
“Vaccinations are safe and effective and the best line of defense to protect workers, frontline or otherwise,” Eric Clinton, the president of UNITE HERE Local 362, which represents roughly 8,000 attraction workers and custodians at Disney World, said in a phone interview.
Mr. Clinton declined to comment on any pushback from his membership, but another union leader at Disney World, speaking on the condition of anonymity so he could speak candidly, said “a fair number” of his members were up in arms over Disney-mandated vaccinations, citing personal choice and fear of the vaccine.
“The company has probably done a calculation and decided that some people will unfortunately quit rather than protect themselves, and so be it,” the person said.