Tag Archives: Outbreaks/Epidemics

Inside a Chinese iPhone Plant, Foxconn Grapples With Covid Chaos

HONG KONG—

Foxconn Technology

2354 -0.76%

Group is scrambling to contain a weekslong Covid-19 outbreak at an iPhone factory in central China, trying to appease frightened and frustrated workers during a crucial period for smartphone orders.

In Foxconn’s main Zhengzhou facility, the world’s biggest assembly site for

Apple Inc.’s

AAPL 7.56%

iPhones, hundreds of thousands of workers have been placed under a closed-loop system for almost two weeks. They are largely shut off from the outside world, allowed only to move between their dorms or homes and the production lines.

Many said they have been confined to their quarters for days and that distribution of food and other essentials has been chaotic. Many others say they are too scared to carry on working because of the risk of getting infected.

Foxconn on Wednesday denied what it said were online rumors that 20,000 cases had been detected at the site and said that for “the small number of employees affected by the pandemic,” it is providing necessary supplies.

“A sudden outbreak disrupted our normal life,” Foxconn said Friday in a post to its workers on

WeChat,

a social-media platform. “An orderly progress in both pandemic prevention and output depends on the efforts of all staff,” it said. It outlined plans to ensure proper food supplies and mental well-being support and pledged to respond to workers’ concerns.

Asked about the workers’ details of the situation at the site, Foxconn didn’t respond. Earlier when asked about the situation, the company referred to its Wednesday statement as well as to its Friday post on WeChat.

Covid-19 lockdowns, corruption crackdowns and more have put China’s economy on a potential crash course. WSJ’s Dion Rabouin explains how China’s economic downturn could harm the U.S. and the rest of the world. Illustration: David Fang

“It’s too dangerous to go to work,” a 21-year-old worker who has been confined to his dorm told The Wall Street Journal, saying that he was skeptical about the company’s claim that there was a low level of infections at the plant.

The disruption at Foxconn is the latest example of the economic and societal toll from China’s rigid pandemic control policies—which include swift and sweeping lockdowns, mass testing and compulsory quarantines to crush the virus whenever it appears. While Beijing says the virus is too potent to allow any easing of its zero-Covid policy, businesses must convince their employees that there is little risk coming to work when there are signs of an outbreak.

Zhengzhou’s flare-up—95 cases recorded in the city the past four days—began in early October, after people returned from other parts of the country from a one-week national holiday. At the first signs of Covid in the city, officials locked down some districts and began rounds of mass testing to stamp out the virus before it gained a foothold among Zhengzhou’s 12.7 million residents. As a major employer, Foxconn joined the campaign.

When more infections emerged at Foxconn midmonth, the company sought to maintain output by creating a “bubble” around its operations to lower the risk of exposure, a practice now common among major manufacturers in China to continue their business during a local outbreak.

Foxconn says it employs as many as 300,000 workers in Zhengzhou. Analysts estimate that the company produces half or more of Apple’s smartphones in the city, making it vital for delivering iPhones to consumers, including for the coming winter holiday season when demand for the handsets typically spikes.

Foxconn, in its statement on Wednesday, said that production at the site is “relatively stable” and that it is sticking to its operating outlook for the current quarter as the impact from the outbreak is controllable. It is set to report quarterly results Nov. 10.

Apple, in its quarterly earnings release Thursday, didn’t mention Foxconn’s Zhengzhou plant. Its chief financial officer said that supply is constrained for the new iPhone 14 Pro models due to strong demand.

Apple didn’t respond to requests for comment about conditions at the Foxconn plant.

Some workers interviewed by the Journal said many colleagues had refused to go back to the production lines. Others had simply left, they said, sometimes abandoning their belongings.

On Sunday, a state-run newspaper in Henan published official notices from various parts of the province welcoming their people to return, with quarantine protocols laid out.

Over the weekend, videos geotagged near the Foxconn site went viral on China’s social-media platforms, recording groups of people walking on highways or through farm fields carrying suitcases and backpacks. Other footage showed makeshift stations set up by local residents offering bottles of water in front of handwritten signs to support migrant Foxconn workers leaving for home.

Foxconn said in a statement Sunday that the situation is coming under control with help from authorities. The company said it is organizing transportation for workers who wish to return home and is coordinating production capacity with its plants elsewhere to minimize disruption. There is no shortage of medical supplies or daily necessities at the facility, it said.

Earlier on Friday, the company had posted a video on WeChat urging people to return to work. “The company needs people,” said a woman’s voice over footage of workers stepping off a bus. “If nobody comes to work, how can the company run?”

Another Foxconn employee said most of his dozen-strong team of night-shift workers had either been taken to a quarantine facility or had refused to return to work. Every night, he said, he saw workers covered in protective gear waiting to be taken away by bus.

“I don’t know who around me is a positive case,” said the worker, who has been confined to his dorm for a few days. “I’d be better off staying in the dorm.”

With so many stuck inside their quarters, sent to quarantine centers or simply absent from work, the pace of production at some assembly lines has slowed, two of the workers said.

Foxconn has created incentives to maintain production, according to Friday’s company notice.

Anyone turning up for work will get free meals and a daily bonus, it said. Those turning up every working day from Oct. 26 to Nov. 11 will get an award of 1,500 yuan, or about $200.

The 21-year-old employee who spoke to the Journal and who worked on an assembly line making an older iPhone version, said he had been confined to his quarters since Oct. 17, along with thousands of others.

Over the following days, meal deliveries were delayed and garbage was left unattended in the hallways, piling up on the ground floor as more dorms were locked down, he said.

A daughter of one worker said her mother was placed in the same dorm as some who tested positive. Some other workers made similar complaints.

Around 10 days ago, almost 300 employees from Foxconn suppliers were asked to move out of their dormitories and sleep in the factory, one of them said.

In photos he shared with the Journal, people slept on bedding and pillows placed on metal bed frames, under white fluorescent lights suspended from the hangar-like roof. Hygiene has become a problem, he said. Still, he said he isn’t supposed to leave the plant—and has nowhere to go if he did.

“Where can I go? Barriers are everywhere,” he said. “There are people manning every checkpoint.”

Business and the Pandemic

Write to Wenxin Fan at Wenxin.Fan@wsj.com and Selina Cheng at selina.cheng@wsj.com

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A Possible Covid, Flu and RSV ‘Tripledemic’ Has Doctors Worried. What to Know

A possible convergence of flu, RSV and Covid-19 has doctors worried.

Flu cases are rising earlier than usual, and pediatric hospitals are seeing surges of respiratory syncytial virus, commonly known as RSV. There are also signs that Covid-19 cases are increasing in parts of the country as Americans head into the cooler months.

Covid-19 precautions earlier in the pandemic—and their near-disappearance lately—are a big part of the reason flu and RSV are staging a comeback, doctors say. Measures such as masking and social distancing suppressed rates of other viruses, too, leaving those of us who haven’t had a recent infection with lower levels of protection now.

“It’s very clear that because people are relaxing Covid precautions that it’s very likely we will also see an increase in influenza at the same time,” says

Jay Varma,

director of the Cornell Center for Pandemic Prevention and Response in New York City and a physician and epidemiologist at Weill Cornell Medicine. 

All three viruses share similar symptoms, such as cough, sore throat, runny nose and fever, making it hard to tell what you have without a test. You can test for Covid-19 at home, and most health professionals can test for flu and RSV.

Worries Ahead for Covid-19

Protection from vaccines and prior infection have dramatically reduced the severity of Covid-19 infections since earlier in the pandemic. Yet the virus remains dangerous, especially for people who are older or have certain health conditions. Less-severe cases can still make you feel ill for a week or more, and ripple through your household, disrupting work and school. And even mild infections can cause longer-term symptoms associated with long Covid-19, such as brain fog, extreme fatigue and racing heartbeat.

“Particularly for people who are over the age of 50 and who are immunocompromised, Covid remains a very real threat,” says

Celine Gounder,

a senior fellow at the Kaiser Family Foundation and an infectious-disease specialist and epidemiologist.

The most recent Centers for Disease Control and Prevention data show decreases in nationwide numbers of Covid-19 cases, hospitalizations and death. The 21-day average of new weekly cases decreased about 31% as of Oct. 19 compared with the previous 21-day moving average. The seven-day average for hospitalizations fell 4% to 3,156, and the 21-day moving average of new deaths declined 13% to 388.

However, it is difficult to accurately monitor Covid-19 cases as most people use at-home rapid tests, which are typically not reported. The CDC is also reporting Covid-19 cases less frequently, issuing weekly rather than daily updates as of October. The most reliable indicator of Covid-19 cases is hospitalization data, says Dr. Varma, but hospitalizations tend to lag behind cases by about two to three weeks.

“We think this is the calm before the storm,” says

Katelyn Jetelina,

an epidemiologist who writes the popular “Your Local Epidemiologist” newsletter. “We think in November it will really start taking off on a national level.” 

Newer Omicron subvariants are staking a claim around the world, with some driving surges in other countries. Weekly data from the U.S. CDC indicates that the BQ.1.1 and BQ.1 subvariants—descended from BA.5, the dominant Omicron subvariant in the U.S.—make up more than 16% of cases as of Oct. 21, up from 11% the week before. Another subvariant, XBB, is driving a surge of cases in Singapore. 

Case numbers and hospitalizations in some Western European countries are starting to rise, which often is a harbinger of what is to come in the U.S. Wastewater monitoring in the Northeast also indicates that cases are starting to climb. Doctors worry that few people so far have gotten the updated version of the booster shot.

The new bivalent vaccine might be the first step in developing annual Covid shots, which could follow a similar process to the one used to update flu vaccines every year. Here’s what that process looks like, and why applying it to Covid could be challenging. Illustration: Ryan Trefes
Flu Season Starts Early

At the same time, flu is rearing its head sooner than usual with the CDC citing increased activity in most of the country, particularly the Southeast and south-central states. 

Rick Zimmerman,

a professor of family medicine at the University of Pittsburgh, has been doing flu surveillance for more than a decade and says he hasn’t seen activity this early since the 2009 influenza pandemic. 

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Public-health officials recommend that everyone 6 months and older get a flu vaccine ideally by the end of this month, and say that it is safe to get a flu shot and Covid-19 booster at the same time. The dominant influenza strain is a H3N2 and appears to be well-matched to this year’s vaccine, says Dr. Zimmerman.

“It takes about two weeks for really good immunity postvaccination, so get your flu vaccine now because we’re seeing the start,” he says.

Last flu season, approximately half of people ages 6 months and older in the U.S. received the flu vaccine, the CDC estimates. Projections are similar for this year, according to a National Foundation for Infectious Diseases survey.

It remains unclear if the U.S. influenza season, while starting earlier, will be more severe in hospitalizations and deaths. The season was bad in some parts of the Southern Hemisphere such as Australia, which already had its winter, but not so bad in other parts such as South Africa.

RSV Rebounds

Rates of another common virus—respiratory syncytial virus—are also surging earlier than usual, filling beds in pediatric hospitals.

RSV is a virus that infects the respiratory tract. Typically a mild cold in healthy people, RSV can be dangerous and even deadly in the very old and young, particularly babies under the age of 1. 

The only way to get immunity to RSV is exposure because there is no vaccine, notes Dr. Gounder. RSV cases dropped during the first year of the Covid-19 pandemic. The respiratory virus that typically circulates in the fall and winter then resurged in the summer of 2021. Young children who haven’t been exposed to the virus over the past few years are getting hit now. 

Public-health experts say the same precautionary measures that protect against other respiratory viruses help prevent transmission of RSV: washing your hands thoroughly often, covering coughs and sneezes or wearing a mask, staying home if you’re symptomatic, and improving ventilation in indoor spaces.

Parents should seek medical attention if a child is having trouble breathing, gasping and wheezing or coughing so hard they can’t breathe, says Dr. Gounder. Difficulty feeding and sinking in of the soft tissues around the clavicles and between the ribs are also concerning signs.

Write to Sumathi Reddy at Sumathi.Reddy@wsj.com

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Monkeypox Outbreak Leaves Risks, Questions in Its Wake

As a global outbreak of monkeypox loses steam, disease researchers said they need a better understanding of how the virus spreads, and how well vaccination protects against it to predict whether it could come roaring back.

A global outbreak that gained momentum in May spread the virus much farther than it had been found previously. The virus might have reached new animal hosts, increasing the risk of future outbreaks, said epidemiologists and infectious-disease specialists. The extent to which vaccination has protected the most at-risk people from catching monkeypox is unknown.

“We can’t get lulled into this sense that monkeypox has disappeared,” said Jason Kindrachuk, an assistant professor at the University of Manitoba with a focus on emerging viruses.

Case numbers have been steadily declining since early August. Daily reported cases in the U.S. have fallen to around 40, from a peak of around 440. In Ontario, once a hot spot, health officials in the Canadian province said they are considering whether to declare the outbreak over.

The slowdown is attributed to a combination of a buildup of immunity and behavioral change, disease researchers said. The exact role each played hasn’t been determined. “They are working together in many cases,” said

David Heymann,

professor of infectious-disease epidemiology at the London School of Hygiene and Tropical Medicine.

Dozens of countries bet that Jynneos, a vaccine made by Denmark’s

Bavarian Nordic

A/S that had sat in stockpiles as a biodefense against a possible reintroduction of smallpox, could curb the spread of monkeypox, which is part of the same virus family. Studies on smallpox vaccines in Africa had found that they were around 85% effective at preventing monkeypox, but no such studies had been undertaken with Jynneos.

Early evidence from Jynneos’s use during the outbreak suggests the bet paid off. A recent study from the Centers for Disease Control and Prevention found that among men ages 18 to 49 in the U.S. who were eligible for Jynneos, case rates among the unvaccinated were 14 times higher than for those who had received at least one dose at least two weeks earlier. As of Oct. 18, around 647,400 people in the U.S. had received at least one dose of Jynneos, according to the CDC.

Immunity doesn’t fully explain the drop in cases, disease experts said. In the U.K., new cases started to fall before a vaccination campaign gained momentum, said Jake Dunning, senior researcher at the University of Oxford’s Pandemic Sciences Institute.

Early evidence indicates that use of the Jynneos vaccine has helped contain monkeypox.



Photo:

patrick t. fallon/Agence France-Presse/Getty Images

“Vaccine probably helped to bring things down and keep it as one curve, rather than more of a roller coaster,” he said.

Also driving down cases, disease experts said, was a reduction in sexual contact by men at the highest risk of catching monkeypox. In an August survey of around 800 men who have sex with men in the U.S., around half reported taking at least one measure in response to the monkeypox outbreak to limit their number of sexual contacts. Those measures included reducing one-time sexual encounters and cutting down the number of sex partners. A U.K. report published in September found that rates of two sexually transmitted diseases that also disproportionately affect men who have sex with men fell in August, suggesting that behavior change contributed to the decline in monkeypox.

Uncertainty regarding the precise roles played by immunity and behavior change mean that it is impossible to predict the trajectory of the virus, disease experts said. “If there’s a significant proportion that is attributed to behavior change, if that behavior change is not sustainable, will we see increases again?” said Anne Rimoin, professor of epidemiology at the University of California, Los Angeles, who has been researching monkeypox in the Democratic Republic of Congo for many years.

Even if the virus fades in some places, it is likely to be reintroduced through international travel because it is present in so many countries, said Emma Thomson, a professor of infectious disease at the University of Glasgow.

Testing sewage to track viruses has drawn renewed interest after recent outbreaks of monkeypox and polio. WSJ visited a wastewater facility to find out how the testing works. Photo illustration: Ryan Trefes

It hasn’t been determined whether the virus made its way into any new animal populations during the global outbreak. While monkeypox is mainly associated with forest-dwelling rodents in western and central Africa, it has been detected in other animals. An Italian greyhound in Paris caught monkeypox in June, likely from one of its owners, according to a case report in the Lancet.

“More human infections may arise because of that,” Geoffrey Smith, an expert on poxviruses at the University of Cambridge, said of potential animal reservoirs.

In 2003, around 50 people in the U.S. caught monkeypox from pet prairie dogs that had contracted the virus after sharing caging and bedding with small animals imported from western Africa. None of those cases went on to infect other people.

The global outbreak has prompted fresh calls for more research. A U.K. government-backed science funding group this week provided 2 million pounds, the equivalent of $2.2 million, for monkeypox research to 25 scientists spanning 12 universities. The researchers said their work would include detailed genomic sequencing, studies into the immune response to vaccination, developing new therapies and investigating the potential for animals to spread monkeypox.

Scientists said they want more research into monkeypox in central Africa, where a more-severe strain of the virus known as clade I circulates, to reduce transmission in countries there and to lower the risk of its sparking a more widespread outbreak. Dr. Dunning said that a global outbreak arising from the milder clade II virus raised the possibility that it could happen with clade I.

“That would be even more concerning,” he said.

Write to Denise Roland at denise.roland@wsj.com

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Biden Administration Pares Back Covid Fight as Funding Push Falls Short

The Biden administration has stopped paying to mail out free Covid-19 tests and expects to end free vaccines for Americans after Congress dropped billions of dollars for such efforts from a government funding bill last month.

People familiar with the matter said the administration’s Covid-19 task force will remain in place ahead of an expected uptick in cases in the coming winter months. But the team will shift focus from emergency response to longer-term issues, such as boosting domestic manufacturing of personal protective equipment, researching long Covid and supporting genomic sequencing to identify variants, the people said.

The shift means that health insurers and employers will likely pay for Covid-19 vaccines, drugs and tests, as they do for most medical products and services.

The administration on Tuesday released updates to the national biodefense strategy that it said would strengthen surveillance for risky pathogens and preparedness for future outbreaks or biowarfare attacks. Some of the planning is under way, officials said, and other aspects are dependent on $88 billion in funding for pandemic preparedness and biodefense the administration has requested from Congress.

Changes in the administration’s pandemic strategy come as Covid-19 cases are climbing in Europe, which is often a precursor to rising case numbers in the U.S. And the arsenal of available treatments for people infected with Covid-19 has dipped as mutations allow variants to evade them.

The White House had sought $22.4 billion from Congress for more Covid tests, vaccines and treatments.



Photo:

Kyle Mazza/Zuma Press

“Just because we’ve ended the emergency phase of the pandemic doesn’t mean Covid is over,” said

Eric Topol,

executive vice president of Scripps Research, a medical-research facility.

After the coronavirus hit, the federal government funded development of some Covid-19 vaccines and took control of the purchase and distribution of the shots, tests and other products to guarantee sufficient supplies and make sure they went where needed.

Federal officials planned to relinquish their control to the private sector after the emergency subsided.

Eli Lilly

& Co. said in August it planned to start selling its Covid-19 antibody drug after federal supplies ran out and without new appropriations from Congress.

The federal government has also wound down its program of providing free Covid-19 tests to people who ordered them online, though it is still distributing free tests in other locations, such as long-term-care facilities and rural health clinics.

The issue is tricky for the Biden administration. President Biden had campaigned on a promise to get the pandemic under control, and the White House has sought to show progress in combating the virus. Yet many Americans have stopped masking and taking other precautions, which administration officials worry will put them at risk if a new wave emerges during the winter.

The administration had sought $22.4 billion for the Covid-19 response from Congress, and it recently extended the pandemic’s status as a public-health emergency. The White House said the money was needed to pay for more tests, vaccines—including development of new, next-generation vaccines—and treatments.

The money wasn’t included in a must-pass government-funding bill last month.

To build support for new funding, Biden administration officials have been warning about the risks to people if cases surge in the cold-weather months and there aren’t sufficient supplies of Covid-19 products because the federal government lacks the money to buy them.

“We are going into this fall and winter without adequate tests because of congressional inaction,”

Ashish Jha,

the White House Covid-19 coordinator, said recently. “You can’t fight a deadly virus without resources.”

The new bivalent vaccine might be the first step in developing annual Covid shots, which could follow a similar process to the one used to update flu vaccines every year. Here’s what that process looks like, and why applying it to Covid could be challenging. Illustration: Ryan Trefes

Republicans, who opposed including the Covid funds in the spending bill, said there had not been a thorough accounting of how pandemic-relief funds had been spent. Congress had allocated about $4.6 trillion as of August, according to USASpending.gov, which tracks federal-spending information.

“You have been given astonishing amounts of money,” Sen.

Richard Burr

(R., N.C.) said at a recent congressional hearing.

Without a new appropriation, funds for the federal government to buy and supply Covid-19 vaccines are expected to run out by early next year. The administration now is looking into ways to guarantee that about 30 million uninsured people can access future boosters, treatments and vaccines. Foundations, companies and other groups have paid for non-pandemic medicines for some people who don’t have insurance.

The administration is also in talks with various stakeholders such as vaccine makers about how to transition from the government procuring vaccines to more traditional models, such as insurance coverage of shots or treatments.

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Is Congress allocating enough money to fight Covid-19? Why or why not? Join the conversation below.

The administration is also figuring out how to move forward with efforts to develop a more durable, next-generation Covid-19 vaccine without the boost in funds. Without a vaccine that blocks both infection and transmission, the virus has been able to continue mutating to evade immunity. Members of the White House Covid-19 task force have said a nasal vaccine could be more effective because it targets immune responses where the virus first enters the body, though developing such a shot poses scientific challenges.

Anthony Fauci,

the president’s chief medical adviser, said the National Institutes of Health is giving grants totaling more than $60 million over three years to academic institutions for development of a broad coronavirus vaccine. But more funding will be necessary to finish that work, said Dr. Fauci, who leads the NIH’s National Institute of Allergy and Infectious Diseases.

Some public-health leaders and federal officials say the U.S. is falling behind countries such as China, which has introduced a vaccine that is inhaled through the nose and mouth.

“It’s a national-security risk,” said

Jennifer Nuzzo,

a professor of epidemiology and director of the pandemic center at the Brown University School of Public Health in Rhode Island. “Other countries have looked at how the U.S. is struggling.”

—Michael R. Gordon contributed to this article.

Write to Stephanie Armour at Stephanie.Armour@wsj.com

Corrections & Amplifications
The White House wants to show progress in combating the coronavirus. An earlier version of this article incorrectly said the White House wants to show progress in combating the vaccine. (Corrected on Oct. 18)

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China’s Xi Jinping Stakes Out Ambitions, With Himself at the Center

HONG KONG—Chinese leader

Xi Jinping

cast himself as the decisive helmsman his country needs in surmounting great adversity, pledging to build a more secure, powerful and egalitarian nation as he signaled plans to extend his decadelong rule.

In a Sunday speech, opening a Communist Party congress where he is set to defy recent norms and claim a third term as party chief, Mr. Xi issued a robust defense of his record, shaking off concerns over Covid-19, a sluggish economy and troubled ties with the U.S. He recalled his efforts to curb corruption, rally public support for the party and champion China’s political system as a counterweight to Western liberal democracy.

A campaign of “self-revolution,” marked by forceful crackdowns on corruption and political dissent, Mr. Xi said, has “ensured that the party will never change in quality, change its color, or change its flavor”—party parlance for threats to Communist rule in China.

In televised remarks delivered from Beijing’s Great Hall of the People, Mr. Xi also claimed significant successes in fighting Covid-19, enforcing order in Hong Kong and curtailing what he called separatist activism in the island democracy of Taiwan, which Beijing claims as its territory.

He reiterated that Beijing won’t renounce the use of force in unifying Taiwan, so as to deter outside interference and splittist elements. “The complete unification of the motherland must be realized, and it will be realized,“ he said, drawing loud applause.

Mr. Xi directed parts of his speech to addressing concerns about China’s ties to the rest of the world, amid rising geopolitical tensions and Beijing’s own Covid-imposed isolation, reaffirming his support for globalization and adherence to a decades-old national policy of “reform and opening up.”

While Mr. Xi warned of risks, challenges and “even dangerous storms” ahead, his report to the congress largely promised a continuation of his firm-handed rule at home and a more assertive exercise of power abroad, including by making the military combat-ready.

“The work report was unambiguously about continuity,” Joseph Torigian, a professor in Chinese politics and foreign policy at American University, said on Twitter. “Although historic, this Congress will almost certainly not signify fundamental new policy directions.”

In laying out his economic goals, Mr. Xi renewed his promise of a new era of “common prosperity,” in which the party exercises greater control over private capital and distributes China’s wealth more evenly. Such efforts have unnerved entrepreneurs at home and investors from abroad after sweeping regulatory crackdowns on Chinese tech giants and private businesses in recent years.

President Xi addressed several topics including Taiwan, Hong Kong and the fight against Covid-19 in his speech at the party gathering in Beijing.



Photo:

Mark Schiefelbein/Associated Press

Mr. Xi also trumpeted what he called “Chinese-style modernization,” doubling down on his program of party-led economic planning and development. He reiterated calls for ensuring China’s economic self-reliance, urging more indigenous efforts to develop high-end technologies that can serve the nation’s strategic needs—a demand that comes as the U.S. ramps up efforts to deny China access to critical components such as advanced semiconductors.

Since taking power in late 2012, Mr. Xi has assumed a degree of autocratic authority unseen since the Mao Zedong era and upended recent retirement practices to allow himself to stay in office indefinitely.

By taking a third term as party chief, the 69-year-old Mr. Xi would depart from the decadelong leadership cycle that his predecessor set and dismantle succession norms designed to prevent a return to a Mao-style dictatorship. Political analysts expect Mr. Xi to promote protégés and allies into senior party roles and thereby cement his political supremacy.

Mr. Xi devoted much of his speech to emphasizing how his party aligns itself with the Chinese people. “The country is the people, and the people are the country,” he said. The entire party must always “share its destiny and connect heart-to-heart with the people.”

The party has in recent years increasingly described Mr. Xi as renmin lingxiu, or “people’s leader,” a designation that echoes Mao’s title of weida lingxiu, or “great leader.” Party insiders say the congress could confer more tokens of power on Mr. Xi, such as by formally designating him renmin lingxiu and cementing his claim to being on par with Mao as China’s greatest statesmen.

Another possibility would involve shortening the label of Mr. Xi’s political philosophy, “Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era,” to simply “Xi Jinping Thought.” This would directly mirror “Mao Zedong Thought,” which the party exalts as a guiding ideology second only to Marxism-Leninism.

Chinese President Xi Jinping has used propaganda to extend his rule and set the stage for a third term. WSJ looks at three moments over his 10 years in power that trace his rise to become the country’s most powerful leader since Mao Zedong. Photo illustration: Adam Adada

Mr. Xi’s speech, lasting about 104 minutes, was roughly half the length of his remarks at the 2017 congress, where he spoke for more than 200 minutes. State broadcaster China Central Television said Mr. Xi’s address on Sunday comprised highlights from a full report that congress delegates will review over the coming week.

In the Sunday speech, Mr. Xi declared that the party had scored “historic victories” under his watch, citing the party’s centennial last year, its stewardship over a “new era” in Chinese socialism, and his campaign to eradicate rural poverty. He also reiterated long-term goals that he first laid out five years ago: ensuring that China achieves a degree of “socialist modernization” by 2035 and becomes a “modern socialist power” by the middle of the 21st century.

Some analysts have cited the 2035 target—when Mr. Xi believes China should have become a more equal and prosperous society with an innovative economy and a modernized military—as a possible timeline for his stint as paramount leader.

The party has pitched its twice-a-decade congress as a triumphant moment for China, even as it confronts wide-ranging challenges. Mr. Xi’s zero-tolerance approach to Covid-19 has throttled the domestic economy with repeated lockdowns and disruptions, exacerbated by a property-market slump.

Tensions with the U.S. and other Western powers have intensified as they challenge Beijing’s push for technological supremacy, territorial claims over Taiwan and continued support for Moscow following Russia’s invasion of Ukraine. Mr. Xi didn’t mention the war in Ukraine during his speech, which wasn’t expected to go into detail on foreign affairs.

Despite tightened security and censorship, frustrations with Mr. Xi’s policies boiled over into overt dissent on Thursday, when a protest took place on a highway bridge in Beijing. Dark smoke swirled over protest banners condemning Mr. Xi as a “traitorous dictator”—a rare display of defiance that was quickly snuffed out by local authorities.

More than 2,300 delegates were present at the Great Hall of the People, including retired party elders. Mr. Xi’s immediate predecessor,

Hu Jintao,

occupied a seat on the dais next to the incumbent’s. Notable absentees included

Jiang Zemin,

the 96-year-old former leader who served as general secretary for 13 years until 2002, as well as former Premier

Zhu Rongji,

who turns 94 this month.

Beijing’s Great Hall of the People, where the Chinese Communist Party’s twice-a-decade congress opened on Sunday.



Photo:

Mark Schiefelbein/Associated Press

The congress, which ends Saturday, will vote on the proposed changes to the party charter and elect a new Central Committee, which since 2007 has comprised more than 370 full and nonvoting alternate members, drawn from senior ranks of the party, government, military and state industry.

The new Central Committee will convene the day after to choose the next Politburo and its elite Standing Committee, the party’s top decision-making body. The Politburo has comprised 25 full members since 2007, while the Politburo Standing Committee has featured seven members since 2012, when it was reduced from nine.

The share of seats that Xi allies occupy in the next leadership would offer clues on how much clout the Chinese leader can exert in pursuing his priorities. Analysts say Mr. Xi isn’t likely to designate any potential successors, as doing so would undermine his own authority.

Top state positions, including the next premier and other ministerial roles, won’t be finalized until China’s annual legislative session next spring.

In his Sunday remarks, Mr. Xi didn’t say whether he plans to stay in power to fulfill the vision he outlined. Mr. Xi would turn 74 years old by the end of his third term, two years younger than Mr. Jiang was when he stepped down as party chief in 2002.

Write to Chun Han Wong at chunhan.wong@wsj.com

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Study finds Paxlovid can interact badly with some heart medications, and White House renews COVID emergency through Jan. 11

A new study has found that the COVID antiviral Paxlovid can interact badly with certain heart medications, raising concerns for patients with cardiovascular risk who test positive.

The study was published in the Journal of the American College of Cardiology and found the reaction involved such medications as blood thinners and statins. As patients who are hospitalized with COVID are at elevated risk of heart problems, they are likely to be described Paxlovid, which was developed by Pfizer
PFE,
-0.28%.

 “Co-administration of NMVr (Paxlovid) with medications commonly used to manage cardiovascular conditions can potentially cause significant drug-drug interactions and may lead to severe adverse effects,” the authors wrote. “It is crucial to be aware of such interactions and take appropriate measures to avoid them.”

The news comes just days after the White House made a renewed push to encourage Americans above the age of 50 to take Paxlovid or use monoclonal antibodies if they test positive and are at risk of developing severe disease.

White House coordinator Dr. Ashish Jha told the New York Times that greater use of the medicine could reduce the average daily death count to about 50 a day from close to 400 currently.

“I think almost everybody benefits from Paxlovid,” Jha said. “For some people, the benefit is tiny. For others, the benefit is massive.” 

Yet a smaller share of 80-year-olds with COVID in the U.S. is taking it than 45-year-olds, Jha said, citing data said he has seen.

On Thursday, the White House extended its COVID pubic health emergency through Jan. 11 as it prepares for an expected rise in cases in the colder months, the Associated Press reported.

The public health emergency, first declared in January 2020 and renewed every 90 days since, has dramatically changed how health services are delivered.

The declaration enabled the emergency authorization of COVID vaccines, as well as free testing and treatments. It expanded Medicaid coverage to millions of people, many of whom will risk losing that coverage once the emergency ends. It temporarily opened up telehealth access for Medicare recipients, enabling doctors to collect the same rates for those visits and encouraging health networks to adopt telehealth technology.

Since the beginning of this year, Republicans have pressed the administration to end the public health emergency.

President Joe Biden, meanwhile, has urged Congress to provide billions more in aid to pay for vaccines and testing. Amid Republican opposition to that request, the federal government ceased sending free COVID tests in the mail last month, saying it had run out of funds for that effort.

Separately, the head of the World Health Organization urged countries to continue to surveil, monitor and track COVID and to ensure poorer countries get access to vaccines, diagnostics and treatments, reiterating that the pandemic is not yet over.

Tedros Adhanom Ghebreyesus said most countries no longer have measures in place to limit the spread of the virus, even though cases are rising again in places including Europe.

“Most countries have reduced surveillance drastically, while testing and sequencing rates are also much lower,” Tedros said in opening remarks at the IHR Emergency Committee on COVID-19 Pandemic on Thursday.

“This,” said the WHO leader, “is blinding us to the evolution of the virus and the impact of current and future variants.”

U.S. known cases of COVID are continuing to ease and now stand at their lowest level since late April, although the true tally is likely higher given how many people overall are testing at home, where the data are not being collected.

The daily average for new cases stood at 38,530 on Thursday, according to a New York Times tracker, down 19% from two weeks ago. Cases are rising in six states, namely Nevada, New Mexico, Kansas, Maine, Wisconsin and Vermont, and are flat in Wyoming. They are falling everywhere else.

The daily average for hospitalizations was down 7% at 26,665, while the daily average for deaths is down 7% to 377. 

The new bivalent vaccine might be the first step in developing annual Covid shots, which could follow a similar process to the one used to update flu vaccines every year. Here’s what that process looks like, and why applying it to Covid could be challenging. Illustration: Ryan Trefes

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:

• Federal Health Minister Karl Lauterbach has urged German states to reintroduce face-mask requirements for indoor spaces due to high COVID cases numbers, the Local.de reported. Lauterbach was launching his ministry’s new COVID campaign on Friday. “The direction we are heading in is not a good one,” he said at a press conference in Berlin, adding it’s better to take smaller measures now than be forced into drastic ones later.

• Health officials in Washington and Oregon said Thursday that a fall and winter COVID surge is likely headed to the Pacific Northwest after months of relatively low case levels, the AP reported. King County (Wash.) Health Officer Dr. Jeff Duchin said during a news briefing that virus trends in Europe show a concerning picture of what the U.S. could soon see, the Seattle Times reported.

Two banners unfurled from a highway overpass in Beijing condemned Chinese President Xi Jinping and his strict Covid policies, in a rare display of defiance. The protest took place days before the expected extension of the leader’s tenure.

• Kevin Spacey’s trial on sexual-misconduct allegations will continue without a lawyer who tested positive for COVID on Thursday, Yahoo News reported. The “American Beauty” and “House of Cards” star is on trial in Manhattan federal court facing allegations in a $40 million civil lawsuit that he preyed upon actor Anthony Rapp in 1986 when Rapp was 14 and Spacey was 26. Jennifer Keller’s diagnosis comes after she spent about five hours cross-examining Rapp on the witness stand over two days — a few feet away from the jury box without wearing a mask.

• A man who presents himself as an Orthodox Christian monk and an attorney with whom he lived fraudulently obtained $3.5 million in federal pandemic relief funds for nonprofit religious organizations and related businesses they controlled, and spent some of it to fund a “lavish lifestyle,” federal prosecutors said Thursday. Brian Andrew Bushell, 47, and Tracey M.A. Stockton, 64, are charged with conspiracy to commit wire fraud and unlawful monetary transactions, the U.S. attorney’s office in Boston said in a statement, as reported by the AP.

Here’s what the numbers say:

The global tally of confirmed cases of COVID-19 topped 623.9 million on Monday, while the death toll rose above 6.56 million, according to data aggregated by Johns Hopkins University.

The U.S. leads the world with 96.9 million cases and 1,064,821 fatalities.

The Centers for Disease Control and Prevention’s tracker shows that 226.2 million people living in the U.S., equal to 68.1% of the total population, are fully vaccinated, meaning they have had their primary shots. Just 110.8 million have had a booster, equal to 49% of the vaccinated population, and 25.6 million of those who are eligible for a second booster have had one, equal to 39% of those who received a first booster.

Some 14.8 million people have had a shot of the new bivalent booster that targets the new omicron subvariants.

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Tesla, BYD Break China Delivery Records as EV Rivalry Goes Global

HONG KONG—

Tesla Inc.

TSLA 0.17%

and its Chinese rival BYD Co. have each broken their monthly records for deliveries of electric vehicles in China as the global competition between the world’s biggest makers of new-energy autos intensifies.

Tesla, the world’s biggest EV maker, delivered more than 83,000 Model 3s and Model Ys from its recently upgraded Shanghai plant in September, data released Sunday by the China Passenger Car Association show. The American EV maker controlled by

Elon Musk

had been ahead of BYD in China before production was disrupted by Covid-19 outbreaks in the country.

BYD made almost 95,000 EV deliveries in September—a record high for the Shenzhen-based company. BYD’s sales, including hybrids, totaled 201,000 units in September, also a record.

The rivalry between the world’s leading EV companies intensified this year after BYD—which counts Mr. Musk’s fellow billionaire

Warren Buffett

among its key investors—abandoned the production of traditional gasoline-powered vehicles to fully focus on new-energy cars.

Production capacity at Tesla’s Shanghai plant was recently increased.



Photo:

Qilai Shen/Bloomberg News

BYD has dominated the Chinese domestic market this year, defying supply-chain disruptions and shortages of chips and raw materials for batteries that have plagued other manufacturers, including Tesla. The company’s monthly year-over-year sales of electric and plug-in hybrid vehicles have risen more than threefold on average this year.

Behind the growth is the company’s ability to produce its own batteries as well as many of the parts its vehicles use, ensuring stability along its supply chain.

Tesla, meanwhile, lost ground after suffering production hiccups from Covid-19 lockdowns in Shanghai earlier this year.

In July, Tesla suspended operations for several days to upgrade its assembly lines for increased production capacity. Its Shanghai plant can now crank out more than 750,000 units a year, the company said at the time.

Tesla said last week it delivered 343,830 EVs globally during the quarter ended Sept. 30. Vehicles from Shanghai made up about 54% of its global deliveries during this period, up from 44% in the second quarter, according to calculations based on the association’s data.

The climate bill recently passed by the Senate could knock thousands of dollars off the sticker price of electric vehicles, but it’s also redefining which cars are eligible. WSJ’s George Downs breaks down the new rules and what it means for the EV industry. Illustration: George Downs

While Tesla tussles with BYD in its home market, the Shenzhen-based auto maker is also expanding abroad. Last week, German rental-car company

Sixt SE

said BYD will supply its fleet with several thousand EVs by the end of this year. The initial commitment will pave the way for the German company to purchase a total of 100,000 EVs from BYD by the end of 2028, Sixt said.

BYD’s foray into Europe began with supplying electric buses for public transport in countries including the U.K., Sweden and Spain. Last year, it exported 100 Tang sports-utility EVs to Norway.

This past summer BYD announced partnerships with dealers in several European countries to distribute its vehicles. By September this year, BYD began selling its EVs to customers in Australia. It exported some 7,000 EVs or plug-in hybrids from China that month, according to company data.

The company announced European presale prices for three of its popular passenger EV models two weeks ago. They will be made available to customers in Scandinavian countries but also in Luxembourg and Germany, the home turf for legacy car brands such as Volkswagen AG. Sales will roll out to France and the U.K. by the end of this year, the company said.

And as it seeks to capture the global market for EVs, BYD is moving to produce more passenger cars overseas. Last month it secured a deal with Thai industrial-estate developer WHA Group to set up an overseas passenger EV factory on the east coast of Thailand. The plant is expected to deliver 150,000 passenger EVs in 2024, WHA said at the time.

Meanwhile, Mr. Musk weighed in on China’s thorny territorial issues during an interview with the Financial Times. Mr. Musk suggested that a special administrative zone should be set up for the self-governed island of Taiwan, similar to Hong Kong’s relationship with the Chinese mainland. His comments were welcomed by Chinese Ambassador to Washington Qin Gang, who on Sunday tweeted his thanks to Mr. Musk for the suggestion.

China regards Taiwan as an integral part of its territory, to be reunited with the motherland by force, if necessary.

Write to Selina Cheng at selina.cheng@wsj.com

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Why ‘quantitative tightening’ is the wild card that could sink the stock market

Quantitative monetary easing is credited for juicing stock market returns and boosting other speculative asset values by flooding markets with liquidity as the Federal Reserve snapped up trillions of dollars in bonds during both the 2008 financial crisis and the 2020 coronavirus pandemic in particular. Investors and policy makers may be underestimating what happens as the tide goes out.

“I don’t know if the Fed or anybody else truly understands the impact of QT just yet,” said Aidan Garrib, head of global macro strategy and research at Montreal-based PGM Global, in a phone interview.

The Fed, in fact, began slowly shrinking its balance sheet — a process known as quantitative tightening, or QT — earlier this year. Now it’s accelerating the process, as planned, and it’s making some market watchers nervous.

A lack of historical experience around the process is raising the uncertainty level. Meanwhile, research that increasingly credits quantitative easing, or QE, with giving asset prices a lift logically points to the potential for QT to do the opposite.

Since 2010, QE has explained about 50% of the movement in market price-to-earnings multiples, said Savita Subramanian, equity and quant strategist at Bank of America, in an Aug. 15 research note (see chart below).


BofA U.S. Equity & Quant Strategy

“Based on the strong linear relationship between QE and S&P 500 returns from 2010 to 2019, QT through 2023 would translate into a 7 percentage-point drop in the S&P 500 from here,” she wrote.

Archive: How much of the stock market’s rise is due to QE? Here’s an estimate

In quantitative easing, a central bank creates credit that’s used to buy securities on the open market. Purchases of long-dated bonds are intended to drive down yields, which is seen enhancing appetite for risky assets as investors look elsewhere for higher returns. QE creates new reserves on bank balance sheets. The added cushion gives banks, which must hold reserves in line with regulations, more room to lend or to finance trading activity by hedge funds and other financial market participants, further enhancing market liquidity.

The way to think about the relationship between QE and equities is to note that as central banks undertake QE, it raises forward earnings expectations. That, in turn, lowers the equity risk premium, which is the extra return investors demand to hold risky equities over safe Treasurys, noted PGM Global’s Garrib. Investors are willing to venture further out on the risk curve, he said, which explains the surge in earnings-free “dream stocks” and other highly speculative assets amid the QE flood as the economy and stock market recovered from the pandemic in 2021.

However, with the economy recovering and inflation rising the Fed began shrinking its balance sheet in June, and is doubling the pace in September to its maximum rate of $95 billion per month. This will be accomplished by letting $60 billion of Treasurys and $35 billion of mortgage backed securities roll off the balance sheet without reinvestment. At that pace, the balance sheet could shrink by $1 trillion in a year.

The unwinding of the Fed’s balance sheet that began in 2017 after the economy had long recovered from the 2008-2009 crisis was supposed to be as exciting as “watching paint dry,” then-Federal Reserve Chairwoman Janet Yellen said at the time. It was a ho-hum affair until the fall of 2019, when the Fed had to inject cash into malfunctioning money markets. QE then resumed in 2020 in response to the COVID-19 pandemic.

More economists and analysts have been ringing alarm bells over the possibility of a repeat of the 2019 liquidity crunch.

“If the past repeats, the shrinking of the central bank’s balance sheet is not likely to be an entirely benign process and will require careful monitoring of the banking sector’s on-and off-balance sheet demandable liabilities,” warned Raghuram Rajan, former governor of the Reserve Bank of India and former chief economist at the International Monetary Fund, and other researchers in a paper presented at the Kansas City Fed’s annual symposium in Jackson Hole, Wyoming, last month.

Hedge-fund giant Bridgewater Associates in June warned that QT was contributing to a “liquidity hole” in the bond market.

The slow pace of the wind-down so far and the composition of the balance-sheet reduction have muted the effect of QT so far, but that’s set to change, Garrib said.

He noted that QT is usually described in the context of the asset side of the Fed’s balance sheet, but it’s the liability side that matters to financial markets. And so far, reductions in Fed liabilities have been concentrated in the Treasury General Account, or TGA, which effectively serves as the government’s checking account.

That’s actually served to improve market liquidity he explained, as it means the government has been spending money to pay for goods and services. It won’t last.

The Treasury plans to increase debt issuance in coming months, which will boost the size of the TGA. The Fed will actively redeem T-bills when coupon maturities aren’t sufficient to meet their monthly balance sheet reductions as part of QT, Garrib said.

The Treasury will be effectively taking money out of economy and putting it into the government’s checking account — a net drag — as it issues more debt. That will put more pressure on the private sector to absorb those Treasurys, which means less money to put into other assets, he said.

The worry for stock-market investors is that high inflation means the Fed won’t have the ability to pivot on a dime as it did during past periods of market stress, said Garrib, who argued that the tightening by the Fed and other major central banks could set up the stock market for a test of the June lows in a drop that could go “significantly below” those levels.

The main takeaway, he said, is “don’t fight the Fed on the way up and don’t fight the Fed on the way down.”

Stocks ended higher on Friday, with the Dow Jones Industrial Average
DJIA,
+1.19%,
S&P 500
SPX,
+1.53%
and Nasdaq Composite
COMP,
+2.11%
snapping a three-week run of weekly losses.

The highlight of the week ahead will likely come on Tuesday, with the release of the August consumer-price index, which will be parsed for signs inflation is heading back down.

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A Key to Long Covid Is Virus Lingering in the Body, Scientists Say

The virus that causes Covid-19 can remain in some people’s bodies for a long time.  A growing number of scientists think that lingering virus is a root cause of long Covid.

New research has found the spike protein of the SARS-CoV-2 virus in the blood of long Covid patients up to a year after infection but not in people who have fully recovered from Covid. Virus has also been found in tissues including the brain, lungs, and lining of the gut, according to scientists and studies 

The findings suggest that leftover reservoirs of virus could be provoking the immune system in some people, causing complications such as blood clots and inflammation, which may fuel certain long Covid symptoms, scientists say. 

A group of scientists and doctors are joining forces to focus research on viral persistence and aim to raise $100 million to further the search for treatments. Called the Long Covid Research Initiative, the group is run by the PolyBio Research Foundation, a Mercer Island, Wash., based nonprofit focused on complex chronic inflammatory diseases. 

Amy Proal, a microbiologist at PolyBio and chief scientific officer of the Long Covid Research Initiative



Photo:

Amy Proal

“We really want to understand what’s at the root of [long Covid] and we want to focus on that,” says Amy Proal, a microbiologist at PolyBio and the initiative’s chief scientific officer. Dr. Proal has devoted her career to researching chronic infections after developing myalgic encephalomyelitis/chronic fatigue syndrome, an illness that shares similar symptoms with long Covid, in her 20s. 

Three long Covid patients, frustrated at the lack of answers and treatments, have helped connect researchers. 

“Long Covid is this really incredible emergency,” says Henry Scott-Green, one of the patients, a 28-year-old in London who says brain fog, extreme fatigue and other debilitating long Covid symptoms prevented him from resuming full-time work as a product manager, though he plans to return soon. “We’re really trying to run really efficiently and cut out as many layers of bureaucracy as possible.”

So far, the group says it has received a pledge of $15 million from Balvi, an investment and direct giving fund established by Vitalik Buterin, the co-creator of the cryptocurrency platform Ethereum. 

Henry Scott-Green says debilitating long Covid symptoms have prevented him from resuming full-time work.



Photo:

Long Covid Research Initiative

Among the strongest evidence of viral persistence in long Covid patients is a new study by Harvard researchers published Friday in the journal of Clinical Infectious Diseases. Researchers detected the spike protein of the SARS-CoV-2 virus in a large majority of 37 long Covid patients in the study and found it in none of 26 patients in a control group.

Patients’ blood was analyzed up to a year after initial infection, says

David R. Walt,

a professor of pathology at Brigham and Women’s Hospital in Boston and Harvard Medical School and lead researcher of the study. Dr. Walt isn’t currently involved with the long Covid initiative. 

A year after infection, some patients had levels of viral spike protein that were as high as they did earlier in their illness, Dr. Walt says. Such levels long after initial infection suggest that a reservoir of active virus is continuing to produce the spike protein because the spike protein typically doesn’t have a long lifetime, he adds.

Dr. Walt plans to test antivirals such as Paxlovid or remdesivir to see if the drugs help clear the virus and eliminate spike protein from the blood.  He says it’s possible that for some people, the normal course of medication isn’t enough to clear the virus. Such cases may require “a much longer exposure to these antivirals to fully clear,” says Dr. Walt.

One of the research group’s goals is to find a way for people to identify whether they continue to have the virus in their bodies. There is no easy way to determine this now. 

New studies offer clues about who may be more susceptible to long Covid, a term for lingering Covid-19 symptoms. WSJ breaks down the science of long Covid and the state of treatment. Illustration: Jacob Reynolds for The Wall Street Journal

Long Covid patients experience such a wide range of long-term symptoms that scientists think there is likely more than one cause, however. Some cases may be fueled by organ damage, for instance. 

Yet consensus is growing around the idea that lingering virus plays a significant role in long Covid. Preliminary research from immunologist Akiko Iwasaki’s laboratory at Yale University documented T or B cell activity in long Covid patients’ blood, suggesting that patients’ immune systems are continuing to react to virus in their bodies. Dr. Iwasaki is a member of the new initiative. 

In a 58-person study published in the Annals of Neurology in March, University of California, San Francisco researchers also found SARS-CoV-2 proteins circulating in particles in long Covid patients’ blood, especially in those with symptoms such as fatigue and trouble concentrating.

Now, the group is completing a study using imaging techniques and tissue biopsies to detect persistent virus or reactivation of other viruses in tissue. It also is looking at T-cell immune responses in tissues and whether they correlate with symptoms. 

Some people may harbor the virus and don’t have long-term symptoms, says Timothy Henrich, an associate professor of medicine at UCSF involved with the study and a member of the long Covid initiative. For others, lingering virus may produce problems.

“I think there’s a real amount of mounting evidence that really suggests that there is persistent virus in some people,” says Dr. Henrich.  

Write to Sumathi Reddy at Sumathi.Reddy@wsj.com

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Latest Covid Boosters Are Set to Roll Out Before Human Testing Is Completed

The Food and Drug Administration is expected to authorize new Covid-19 booster shots this week without a staple of its normal decision-making process: data from a study showing whether the shots were safe and worked in humans.

Instead, the agency plans to assess the shots using data from other sources such as research in mice, the profiles of the original vaccines and the performance of earlier iterations of boosters targeting older forms of Omicron.

“Real world evidence from the current mRNA Covid-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe,” FDA Commissioner

Robert Califf

said in a recent tweet. The FDA pointed to Dr. Califf’s tweets when asked for comment.

Clearance of the doses, without data from human testing known as clinical trials, is similar to the approach the FDA takes with flu shots, which are updated annually to keep up with mutating flu viruses.

Some vaccine experts have urged the agency to wait before clearing the new Covid-19 booster doses.



Photo:

EMILY ELCONIN/REUTERS

The approach has raised concerns, however, among some vaccine experts who have urged the agency to wait.

“I’m uncomfortable that we would move forward—that we would give millions or tens of millions of doses to people—based on mouse data,” said

Paul Offit,

an FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

The comparison with flu vaccines isn’t sound, Dr. Offit said, because flu viruses mutate so rapidly that shots from one year don’t offer protection for the next, while currently available Covid-19 shots continue to keep people out of the hospital.

In addition to evaluating the boosters without clinical-trial data, the FDA won’t convene another element from its earlier Covid-19 vaccine reviews: a meeting of advisers who make recommendations whether the agency should authorize a shot.

Retooled Covid-19 boosters are similar to the original shots, including Moderna’s Covid-19 vaccines, seen last year, but have been customized to fight the latest variants.



Photo:

andrew caballero-reynolds/Agence France-Presse/Getty Images

The FDA scrapped the meeting, Dr. Califf said in his tweets on the subject, because the committee discussed the matter in June, and the agency doesn’t have new questions warranting its input.

The Covid-19 vaccines available in the U.S., which were first authorized for use in December 2020, haven’t been modified until now, though the virus they were designed to target has evolved.

The shots held up well against earlier strains, researchers found, but weren’t as effective against the newest Omicron subvariants like BA.5.

In planning for a fall booster campaign, federal health authorities in late June directed

Pfizer Inc.

and its partner

BioNTech SE,

and

Moderna Inc.

to update their shots to target BA.5, an Omicron subvariant called BA.4 and the original strain of the virus.

“We’ve validated the process several times over and continue to produce safe and effective vaccines against Covid-19,” a Pfizer spokeswoman said. Moderna said all current data indicates its shots are safe and effective.

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What decisions are you making around boosters for Covid-19? Join the conversation below.

Human trials for Moderna’s vaccine targeting the subvariants have started, and for the Pfizer-BioNTech vaccine are expected to start this month, the companies have said. Results won’t be available, however, before the U.S. government’s planned fall booster campaign.

“If we waited for clinical-trial results, thank you very much, we’d get them in the spring. It takes time to do clinical trials,” said

William Schaffner,

professor of medicine at Vanderbilt University Medical Center and a nonvoting liaison to the Centers for Disease Control and Prevention committee that will decide whether to recommend the shots, should the FDA sign off. “This is just an updating of the previous vaccine that we used.”

The retooled shots are similar to the original shots, but customized to fight the latest variants, much like keys that are nearly identical but have slightly different ridges and valleys, said

John Grabenstein,

director of scientific communications for Immunize.org, a nonprofit that seeks to boost immunization rates.

With each mutation, the Covid-19 virus is becoming more transmissible. WSJ’s Daniela Hernandez breaks down the science of how Covid variants are getting better at infecting and spreading. Illustration: Rami Abukalam

The similarities make it very reasonable for regulators to weigh the overwhelmingly safe track record of the original series when considering the new shots, he said.

The FDA has reviewed test results from a shot that Moderna modified to target an early version of Omicron as well as the ancestral strain of the coronavirus. The study found the shot generated a significant amount of antibodies in humans compared with the company’s currently available booster shot. That shot is now approved in the U.K.

The agency also looked at human data from Pfizer and BioNTech finding that their experimental shots, updated to target an earlier form of Omicron, also boosted antibody levels significantly. The companies have submitted one of those shots to the U.K., EU and Canada for authorization, Pfizer has said.

Such findings give the FDA confidence that the newest modified shots will also work well, said a person familiar with the agency’s deliberations.

“As we know from prior experience, strain changes can be made without affecting safety,” Dr. Califf said in a tweet.

Dr. Offit, however, said he would like to wait for clinical-trial data showing the shots are effective before asking people to take them.

“If you have some evidence that this is likely to be of value, sure,” he said. “But if you don’t have evidence, and you know that the current vaccine does offer protection against severe disease, I don’t think it’s fair to ask people to take risks.”

Write to Liz Essley Whyte at liz.whyte@wsj.com

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