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Health

Why You Can’t Find Wegovy, the Weight-Loss Drug

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Novo Nordisk

NVO 0.61%

A/S flubbed the launch of its buzzy new weight-loss drug Wegovy, missing out on hundreds of millions of dollars in sales and squandering a head start before a rival could begin selling a competing product.

Wegovy is among a new class of drugs that health regulators have approved to cut the weight of people who are obese, a goal long sought by doctors and patients. Their weight-dropping potential became a viral sensation on social media. Elon Musk tweeted about Wegovy in October. And a related drug for diabetes, Ozempic, is a hot topic in Hollywood among celebrities seeking to stay thin, according to doctors.

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Yet Denmark-based Novo underestimated how big demand for the drug would be, and wasn’t ready to make enough to fill the prescriptions that flooded in after U.S. approval last year. Then a contract manufacturer halted production to address inspection issues.

“We should have forecasted better, which we did not,” Novo Chief Executive

Lars Fruergaard Jørgensen

said. “Had we forecasted that, we would have built a different supply chain.”

The missteps have proven costly for Novo, which was forced to ration Wegovy to patients who already had started taking it. The company has recorded around $700 million in sales to date, well short of the $2 billion in 2021 and 2022 sales that some analysts had projected before supply issues hit.

Novo Nordisk Chief Executive Lars Fruergaard Jørgensen admits the drug company misjudged how popular Wegovy would be.



Photo:

Carsten Snejbjerg/Bloomberg News

Amber Blaylock, a music teacher from Springfield, Mo., said she has been trying to get Wegovy to help her reduce weight since hearing about the drug on TikTok and YouTube. She asked her doctor in September to prescribe it, but hasn’t been able to find it. 

“Frustrated and impatient for sure,” said Ms. Blaylock, 29 years old.

To turn things around, Mr. Jørgensen said Novo has increased its capacity to make Wegovy and plans a “relaunch” early next year, which should fulfill all orders.

Novo, however, lost valuable time establishing a beachhead in the lucrative obesity-drug market before rival

Eli Lilly

LLY 1.20%

& Co. can enter. Lilly is expected to launch a similar, competing drug named Mounjaro late next year or in early 2024.

The market for anti-obesity drugs, now worth $2.4 billion worldwide, could reach $50 billion in 2030, Morgan Stanley estimates.

“Novo has left the door open for Lilly,” said BMO Capital Markets analyst Evan David Seigerman. 

Mr. Jørgensen said the company can regain lost ground because of high demand for Wegovy and the large potential for what is still a mostly untapped market. He said he was unconcerned with the looming competition with Lilly’s drug, because there is room for both products.

“We disappointed physicians and patients in the first round,” he said. “The company wants to be better prepared for the second round.” Novo lists Wegovy at $1,349 a month. Some commercial insurers cover the drug.  

Wegovy works by imitating a hormone called GLP-1, which occurs naturally in the body and suppresses appetite, among other effects. 

Novo developed GLP-1 drugs to treat diabetes. In 2017, the company began selling semaglutide, the active ingredient in Wegovy, under the brand name Ozempic to treat diabetes. 

During the drug’s development, Novo found that weight loss was a side effect, prompting the company to probe using semaglutide to treat obesity. A key trial found that Wegovy helped people with a high body-mass index shed up to 15% of their weight, surpassing the results for older obesity drugs like Novo’s Saxenda. 

Saxenda and other older weight-loss drugs had sold modestly, partly due to their limited weight loss, as well as some unpleasant side effects and the refusal of many health insurers to pay up. 

Novo worked with Catalent to fill its Wegovy weight-loss drug into syringes.



Photo:

yara nardi/Reuters

Given the experience, Novo figured Wegovy sales would increase gradually. To augment its own production, Novo contracted with a single manufacturer,

Catalent Inc.,

to fill the drug into syringes. Novo said it thought it would have time to add manufacturing capacity to meet a gradual increase in demand.

Wegovy may be superior to older drugs, but “we thought it would still be a journey to open up the market,” Mr. Jørgensen said. 

When Novo started selling Wegovy in the U.S. in June last year, however, demand took off. Doctors with large followings on social media touted Wegovy as groundbreaking, while users posted photos holding injection pens and shared their progress losing weight. 

“Demand for these new agents has been unlike anything I’ve ever seen in my time in medicine,” said Dr. Michael Albert, a physician specializing in weight-loss treatment at telehealth provider Accomplish Health who has consulted for Novo. Many of his patients began asking about Wegovy, he said, after they heard about it in Facebook groups or on TikTok.

It took only five weeks for doctors to write new prescriptions for Wegovy at the same weekly volume that Saxenda took four years to reach, according to Mr. Jørgensen. “It’s a completely different ballgame that we’re in,” said Ambre Brown Morley, the company’s vice president of media and digital global communication. 

Within weeks, supplies were strained. Novo warned that patients might experience delays in receiving their prescriptions. Then in December 2021, Catalent temporarily stopped deliveries and manufacturing at its plant after Food and Drug Administration inspections found faulty air filters and damaged equipment.

To date, Novo has recorded around $700 million in Wegovy sales compared with the $2 billion in 2021 and 2022 sales that some analysts had projected before supply issues emerged.



Photo:

JACOB GRONHOLT-PEDERSEN/REUTERS

Many people who couldn’t get Wegovy for weight loss have sought prescriptions for Novo’s Ozempic and Lilly’s Mounjaro, according to analysts, even though the FDA hasn’t approved the latter two drugs for such use. Ozempic sales increased so much that certain doses are in short supply through at least January, the FDA said.

Lilly is studying Mounjaro, its GLP-1-containing drug for diabetes, for weight loss. 

Novo and Lilly said they don’t promote their diabetes drugs for the “off-label” use treating obesity.

A Catalent spokesman said the company is still making improvements to the plant and working with customers to limit the impact of supply constraints on patients. The company restarted filling Wegovy syringes at the facility in the spring. 

Novo has been amassing a sufficient inventory before the Wegovy relaunch, Mr. Jørgensen said. When Wegovy relaunches, he said, insurance coverage will be broader than when the drug first went on sale. 

Write to Peter Loftus at Peter.Loftus@wsj.com and Denise Roland at denise.roland@wsj.com

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World

Biden Administration Pares Back Covid Fight as Funding Push Falls Short

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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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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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Health

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

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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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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.”

—Jared S. Hopkins contributed to this article.

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

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Business

Pfizer says updated booster can provide more protection against omicron

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Pfizer says changing its COVID-19 vaccine to better target the omicron variant is safe and effective.

The update, in a statement issued Saturday, comes just days before regulators determine if Americans should receive another round of booster shots beginning this fall.

The most widely used vaccines currently in circulation mostly target the original, more dangerous but less viral, coronavirus strain. Their effectiveness against any infection dropped significantly, however, when the super-contagious omicron mutant emerged.

The Food and Drug Administration will consider this week if it should order a formula change for the vaccines made by both Pfizer
PFE,
+2.99%,
and its partner BioNTech
BNTX,
+1.32%,
as well as their rival Moderna
MRNA,
+0.71%,
in hopes that modified boosters could better protect against another COVID-19 surge expected this fall and winter. Other major countries are mulling the same shift.

Read: Sanofi, GSK say next-generation COVID-19 booster has 72% efficacy against omicron

“Based on these data, we believe we have two very strong omicron-adapted candidates that elicit a substantially higher immune response against omicron than we’ve seen to date,” said Pfizer CEO Albert Bourla.

The statement said the companies are ready to “rapidly adapt” the updated vaccines to target newer versions of the virus if needed.

Pfizer says it studied two different ways of updating their shots — targeting just omicron, or a combination booster that adds omicron protection to the original vaccine. The company and its partner also tested whether to keep the current recommended dosage of 30 micrograms or double its strength.

In a study of more than 1,200 middle-aged and older adults who’d already had three vaccine doses, Pfizer said both booster approaches showed a significant increase in omicron-fighting antibodies.

Several experts have said combination shots may be the best approach because they would retain the proven benefits of the original COVID-19 vaccine while adding new protection against omicron.

Pfizer said a month after people received its combo shot, they had a 9- to 11-fold increase in omicron-fighting antibodies. That’s more than 1.5 times better than another dose of the original vaccine, the Associated Press reported.

Moderna recently announced similar results from tests of its combination shot, or what scientists call a “bivalent” vaccine.

The Associated Press contributed.

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Health

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Other COVID-19 news you should know about:

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

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

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

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

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

Here’s what the numbers say

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

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

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

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Entertainment

Neil Young Demands Spotify Remove His Music Over Joe Rogan’s Vaccine Comments

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Neil Young

has demanded that

Spotify Technology SA

SPOT -4.92%

remove his music due to what he says is vaccine misinformation spread by podcaster

Joe Rogan

on the streaming service. The folk-rock star and his record label were in discussions over the matter Tuesday, according to people familiar with the matter.

Mr. Young, whose hits including “Heart of Gold” and “Harvest Moon” have gained hundreds of millions of plays on Spotify, wrote an open letter to his manager and record label criticizing Mr. Rogan and Spotify. “I am doing this because Spotify is spreading fake information about vaccines—potentially causing death to those who believe the disinformation being spread by them,” he wrote. The letter has since been removed from his website.

Mr. Young didn’t respond to requests for comment.

The letter came in response to “The Joe Rogan Experience” podcast, which is currently Spotify’s most popular podcast and also tops

Apple’s

podcasting charts. In 2020, Mr. Rogan signed an exclusive podcasting deal with Spotify, worth more than $100 million, according to people familiar with the matter.

Joe Rogan has used his podcast to discuss Covid-19 vaccines and restrictions.



Photo:

Carmen Mandato/Getty Images

“With an estimated 11 million listeners per episode, JRE, which is hosted exclusively on Spotify, is the world’s largest podcast and has tremendous influence. Spotify has a responsibility to mitigate the spread of misinformation on its platform,” Mr. Young wrote in the letter. “I want you to let Spotify know immediately TODAY that I want all my music off their platform…They can have Rogan or Young. Not both.”

While Mr. Young’s label,

Warner Music Group Corp.

’s Warner Records, is the licensor to Spotify and may legally have control over how and where his music is distributed, it is typical for a record company to take an artist’s wishes into account. An act of Mr. Young’s cachet in particular tends to have more control over their career and creative output. If a decision is reached to remove the music, Spotify could take it down in a matter of hours, according to people familiar with the matter.

Streaming accounts for 84% of recorded music revenue in the U.S., according to the Recording Industry Association of America. Spotify is by far the largest music-streaming service by paid subscriptions.

Mr. Young’s letter cited an episode of the podcast in which Mr. Rogan spoke with

Dr. Robert Malone,

a virologist who worked on research into several mRNA Covid-19 vaccines but who is now critical of the treatments. Among the claims made was the suggestion that hospitals have been financially motivated to falsely diagnose deaths as having been caused by Covid-19.

Mr. Rogan has regularly used his podcast to discuss Covid-19 vaccines and restrictions, railing against vaccine mandates for indoor events and suggesting that young, healthy people shouldn’t be vaccinated.

Spotify’s bet on Mr. Rogan’s show has caused trouble in the past for the audiostreaming company. Some employees expressed concern over the podcast’s content during a town-hall meeting in September 2020, relating to material they felt was anti-transgender, according to people familiar with the matter.

The company stood by its star podcaster, with Chief Executive

Daniel Ek

saying that the ambition to make Spotify the “largest audio platform in the world” involves embracing diverse voices and differing opinions as the company chases scale in podcasting.

“The most important thing for us is to have very clear policies in place,” he said in an interview a month after the town hall. “It doesn’t matter if you’re Joe Rogan or anyone else, we do apply those policies and they need to be evenly applied.”

Amid a surge in cases, some countries are handing out second booster shots. In Israel, early data suggest a fourth vaccine dose can increase antibodies against Covid-19, but not enough to prevent infections from Omicron. WSJ explains. Photo composite: Eve Hartley/WSJ

Earlier this month, a group of 270 scientists and healthcare professionals signed an open letter to Spotify accusing the podcast of “promoting baseless conspiracy theories” and asking the service to take action against mass-misinformation events on its platform.

“Throughout the COVID-19 pandemic, Joe Rogan has repeatedly spread misleading and false claims on his podcast, provoking distrust in science and medicine,” it said.

Since the start of the pandemic, Spotify has removed over 20,000 Covid-related podcast episodes as a result of creators violating its policies, according to a person familiar with the matter. While more than 40 of Mr. Rogan’s episodes have been removed, none of them have been related to the pandemic, this person said.

Mr. Young also launched his own streaming service in 2018 called the “

Neil Young

Archives,” which offers different yearly subscriptions ranging from $19.99 to $99.99 to access the artist’s albums.

Mr. Young has previously had issues with streaming platforms. In 2015, he said he didn’t need his content “to be devalued by the worst quality in the history of broadcasting or any other form of distribution” and that he was pulling his music from streaming services. The artist’s music returned to Spotify in 2016. “That’s where people get music,” he later told Rolling Stone.

Monday’s letter wasn’t the first time the outspoken 76-year-old has used his website to take on big companies in the music business. Last summer, Mr. Young criticized concert promoters in a post, calling live shows super-spreader events and wondering why more artists weren’t canceling shows.

—Allison Prang contributed to this article.

Write to Anne Steele at anne.steele@wsj.com and Gareth Vipers at gareth.vipers@wsj.com

Corrections & Amplifications
Some Spotify employees expressed concern over the content of Joe Rogan’s podcast during a town-hall meeting in September 2020. An earlier version of this article suggested that the town-hall meeting took place last September. (Corrected on Jan. 25)

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Health

South Africa study shows boosters failed to block omicron, bolstering case for face masks, distancing and hand washing

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A study of some of the first breakthrough cases of COVID-19 caused by the highly infectious omicron variant found that booster shots of the mRNA vaccines failed to block that strain, although the infections involved only mild or moderate symptoms, confirming they are effective in preventing serious illness and death.

The study involved a group of seven Germans visiting Cape Town in South Africa who had the first documented breakthrough cases of COVID between late November and early December after receiving three vaccine doses, including at least two of the mRNA shots developed by Pfizer
PFE,
+0.95%
with German partner BioNTech SE
BNTX,
-3.17%

22UA,
-5.22%
or Moderna
MRNA,
-3.76%.
Findings were published in the medical journal the Lancet.

The group comprised five white women and two white men between 25 and 39 years of age, four of whom were participating in clinical training at hospitals, while the others were on vacation. All seven developed respiratory symptoms between Nov. 30 and Dec. 2 and tested positive for the omicron variant of the SARS-CoV-2 coronavirus. The study was approved by Stellenbosh University and the University of Cape Town.

“These findings support the need for updated vaccines to provide better protection against symptomatic infection with omicron and emphasize that non-pharmaceutical measures should be maintained,” the authors wrote.

Earlier this week, a preliminary study by a hospital in Israel found that a second booster dose failed to block omicron, even though it lifted antibodies to a higher level than they had been after a first booster shot.

See also: Omicron cases seem to have peaked in northeastern states, but national case tally remains at record levels and hospitals are slammed

In the U.S., omicron has pushed new cases and hospitalizations to record levels, according to a New York Times tracker. Cases are averaging close to 800,000 a day, while hospitalizations are above 158,000. That number includes patients in the hospital with other symptoms who have tested positive for the virus.

See: A record 8.75 million people missed work because COVID is in their house

And while case levels seem to have peaked in some of the states that were first hit hard by omicron — New York among them — the national rate remains at a record level and deaths, which lag cases and hospitalizations, are above 1,900. That’s an increase of 50% over the last two weeks and means the U.S. is suffering 9/11-scale casualties every two days.

Amid a surge in cases, some countries are handing out second booster shots. In Israel, early data suggest a fourth vaccine dose can increase antibodies against Covid-19, but not enough to prevent infections from Omicron. WSJ explains. Photo composite: Eve Hartley/WSJ

See: Opinion: We need a decisive pivot on COVID-19: Double down on treatments for those at high risk instead of boosters and tests for everyone

Other COVID-19 news you should know:

• The National Institutes of Health on Wednesday updated its COVID-19 treatment guidelines for patients with mild to moderate forms of COVID-19 who are at high risk for disease progression. The new guidelines now include the recently authorized antivirals developed by Pfizer and Merck
MRK,
-0.66%
with Ridgeback Biotherapeutics and not that GlaxoSmithKline
GSK,
-1.77%

GSK,
-0.09%
and Vir Biotechnology’s
VIR,
-2.53%
sotrovimab is the only monoclonal antibody that is thought to be effective against omicron, and have added a three-day course of Gilead Sciences Inc.’s
GILD,
-1.82%
 Veklury as a treatment option. The panel suggests that clinicians first use Pfizer’s Paxlovid, then sotrovimab, then Veklury, and the final option should be molnupiravir, which is the Merck/Ridgeback drug.

• The French government will unveil a timetable for easing COVID restrictions later Thursday, Reuters reported, citing spokesman Gabriel Attal, who cautioned that the omicron wave has not yet passed. Attal said France’s new vaccine-pass rules would help allow a softening of rules even as the incidence of infections continues to increase. France reported nearly half a million coronavirus infections on Wednesday to leave the seven-day average at 320,000 cases.

• Austria’s conservative-led government is introducing a national lottery to encourage holdouts to get vaccinated, Reuters reported separately. The news came hours before parliament passed a bill introducing a national vaccine mandate applicable to everyone 18 and older with exemptions for pregnant women, people who for medical reasons can’t be vaccinated and those who have recovered from infection by the coronavirus within a six-month span. Roughly 72% of Austria’s population is fully vaccinated against COVID-19, one of the lowest rates in Western Europe. Every 10th lottery ticket will offer a gift voucher valued at 500 euros ($568).

• Texas Attorney General Ken Paxton, an opponent of vaccine mandates, has tested positive for COVID, the Washington Post reported. It’s unclear whether Paxton was vaccinated or when he was infected, and his office reportedly did not reply to a request for comment. Paxton has opposed making vaccines compulsory for healthcare workers in facilities that receive Medicare and Medicaid funds, troops in the Texas National Guard and staff at Head Start programs.

Scientists are using automation, real-time analysis and pooling data from around the world to rapidly identify and understand new coronavirus variants before the next one spreads widely. Photo Illustration: Sharon Shi

Here’s what the numbers say

The global tally of confirmed cases of COVID-19 rose above 338.9 million, and the death toll is now more than 5.56 million, according to data aggregated by Johns Hopkins University.

The U.S. leads the world with 68.7 million cases and 858,481 fatalities.

The world set a record of more than 3 million COVID cases a day between Jan. 13 and Jan. 19, AFP reported, in the latest sign of how fast omicron has spread.

The Centers for Disease Control and Prevention’s vaccine tracker is showing that some 209.5 million people living in the U.S. are fully vaccinated, equal to 63.1% of the total population.

Some 81.7 million have received a booster, equal to 39% of the fully vaccinated.

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Health

Prior Covid-19 Infection Offered Better Protection Than Vaccination During Delta Wave

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Surviving a previous infection provided better protection than vaccination against Covid-19 during the Delta wave, federal health authorities said, citing research showing that both the shots and recovery from the virus provided significant defense.

The Centers for Disease Control and Prevention said Wednesday that data from 1.1 million Covid-19 cases in California and New York last year showed people who were unvaccinated and hadn’t previously contracted Covid-19 faced a far greater risk than both people who had gotten the shots and people who had been infected.

The data on testing, cases and immunization was collected between May and November, as the Delta variant emerged and became dominant in the U.S., before the more-infectious Omicron variant began to spread widely. The hospitalization data came from more than 50,000 people in just California.

“Before the Delta variant, Covid-19 vaccination resulted in better protection against a subsequent infection than surviving a previous infection,” CDC epidemiologist Benjamin Silk said. “When looking at the summer and fall of 2021, when Delta became predominant in this country, however, surviving a previous infection now provided greater protection.”

A Covid-19 vaccination site in New York last month.



Photo:

Brittainy Newman/Associated Press

The CDC also said the timing of the research coincided with many people likely experiencing waning vaccine-induced immunity and occurred before the wider rollout of Covid-19 booster shots. Dr. Silk said the research also didn’t apply to the current Omicron wave. “It would be like comparing apples and oranges,” he said.

Omicron is milder but more transmissible than earlier variants including Delta, research suggests, though the sheer number of cases caused by the variant has put further strain on hospitals in many parts of the country. It isn’t yet clear how the course of symptomatic Omicron infections differs in unvaccinated people and those who have some immunity from vaccination or prior infection, though reports suggest that the infections are milder in people with prior immunity.

Some people have said recovery from infection should count alongside vaccination as enough protection against the virus to be at work or enter restaurants in areas with vaccination requirements. Vaccines are a better tool in part because of the relatively consistent immune response they produce, public-health experts say, compared to infection with a virus that can cause long-term health problems and severe or fatal illness.

Amid a surge in cases, some countries are handing out second booster shots. In Israel, early data suggest a fourth vaccine dose can increase antibodies against Covid-19, but not enough to prevent infections from Omicron. WSJ explains. Photo composite: Eve Hartley/WSJ

“Although the epidemiology of this virus may continue to change as new variants emerge, vaccination remains the safest way to prevent infection, hospitalization and death,” Mary T. Bassett, study co-author and Acting State Health Commissioner in New York, said. The New York State Department of Health said it would publish a new dashboard on Covid-19 reinfection data, to be updated weekly.

Dr. Silk said the CDC still recommends that everyone who is eligible, including those previously infected, get vaccinated against Covid-19 and that it is the safest way to mount an immune response. The agency pointed to another recent study that found that several months after a Covid-19 infection, vaccinating previously infected people led to more protection against symptomatic disease than a prior infection alone.

The CDC said that later this week it would publish additional data on Covid-19 vaccines and boosters during the time that Omicron has been circulating.

Write to Brianna Abbott at brianna.abbott@wsj.com

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Business

Citigroup Sticks With Its Covid-19 Vaccine Mandate, While GE Drops Its Rules

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Citigroup Inc.

C -1.25%

is sticking with its Covid-19 vaccine mandate for its U.S. workers.

General Electric Co.

GE 0.68%

is not.

The two American companies are going in opposite directions after the Supreme Court blocked Thursday the Biden administration’s rule that big employers require their employees to get vaccines or submit to testing.

Citigroup, which has about 65,000 employees in the U.S., said it had reached 99% compliance one day before a Jan. 14 deadline the bank had set for U.S. workers to get vaccinated or request an accommodation for medical or religious reasons.

“Our goal has always been to keep everyone at Citi, and we sincerely hope all of our colleagues take action to comply,” the company’s human-resources chief Sara Wechter said in a LinkedIn post on Thursday after the high court’s decision.

The bank previously told employees anyone who was still unvaccinated would be placed on unpaid leave, according to people familiar with the matter. Their employment would terminate on Jan. 31, the people said. Saturday, after a wave of last minute vaccinations, around 150 employees were being placed on leave, one of the people said. They could keep their jobs if they comply by the end of the month.

General Electric suspended its remaining Covid-19 vaccine requirements.



Photo:

alwyn scott/Reuters

Citigroup and GE announced vaccine requirements for U.S. staff in October, after the Biden administration said large employers and government contractors would be required to enforce vaccination mandates. Both companies count the U.S. government as an important client.

At the start of 2021, GE had about 56,000 employees in the U.S. It originally told them they were required to get vaccinated or seek a religious or medical accommodation by early December. It suspended that policy in December after a court challenge temporarily blocked the rule for federal contractors.

The manufacturer still required U.S. employees to show proof of vaccination or submit to testing under the White House’s mandate for companies with more than 100 workers, until the Supreme Court blocked that policy on Thursday.

GE on Friday suspended its remaining Covid-19 vaccine requirements, a spokeswoman said. The company said most of U.S. employees are vaccinated and it was on track to comply with the federal contractor executive order before the court injunction.

Write to Thomas Gryta at thomas.gryta@wsj.com and David Benoit at david.benoit@wsj.com

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US

Appeals Court Reinstates Biden Covid-19 Vaccine Rules for Large Employers

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A federal appeals court Friday reinstated Biden administration rules that require many employers to ensure that their workers are vaccinated or tested weekly for Covid-19.

A divided panel of the Sixth U.S. Circuit Court of Appeals dissolved a stay issued by another court that had blocked the rules. The majority, in a 2-to-1 ruling, said legal challenges to the administration’s vaccination-and-testing requirements were likely to fail.

The ruling is a near-term boost to the White House but was immediately appealed on an emergency basis to the Supreme Court by some employers who oppose the mandate.

The requirements, issued by the Occupational Safety and Health Administration and scheduled to take effect in January, apply to businesses with 100 or more employees and cover roughly 84 million workers.

Employers who don’t comply with the requirements could face penalties of up to around $13,600 a violation. The requirements don’t apply to employees who don’t report to a workplace where other individuals are present, employees who only work from home or employees who work exclusively outdoors.

Three Biden administration vaccination requirements have been challenged in courts around the country. One set of rules, applying to many healthcare workers, is already pending at the high court after the Biden administration on Thursday asked the justices to reinstate the requirements as lower courts put them on hold in parts of the country.

The federal appeals court ruling was immediately appealed on an emergency basis to the Supreme Court by employers who oppose the mandate.



Photo:

Bill Clark/Zuma Press

Other vaccine rules that apply to federal-government contractors could land at the Supreme Court soon after lower courts have put them on hold.

The Biden administration has argued its rules are legally sound and urgently needed in light of the continuing health threats posed by the pandemic, including the new Omicron variant of Covid-19 that has led to a spike in infections.

“It’s critical we move forward with vaccination requirements and protections for workers with the urgency needed in this moment,” a White House spokesman said after the ruling.

Republican officials and business owners are among the litigants who have sued the administration, arguing the rules are heavy-handed regulations that exceed the powers of the executive branch.

The requirements “will cause irreparable harm to businesses and employees across the country, and will wreak havoc on supply chains that are already stretched to their limits,” said Robert Alt of the Buckeye Institute, an organization representing one group of employers challenging the rules.

Republican officials and business owners opposed to Covid-19 vaccine mandates are among the litigants who have sued the administration.



Photo:

Anna Moneymaker/Getty Images

In Friday’s decision reinstating the OSHA rules for private employers, the Sixth Circuit majority cited the continued Covid-19 public-health crisis and said the federal government had broad authority to ensure workplace safety.

“OSHA has wide discretion to form and implement the best possible solution to ensure the health and safety of all workers, and has historically exercised that discretion,” Judge Jane Stranch wrote for the court.

“It makes sense that OSHA’s authority contemplates the use of medical exams and vaccinations as tools in its arsenal,” wrote Judge Stranch, an Obama appointee. She was joined by Judge Julia Smith Gibbons, an appointee of

George W. Bush,

who said judges should not substitute their judgment for OSHA’s on a matter in which reasonable minds may disagree.

The ruling by the Cincinnati-based court negated a decision by a sister court, the Fifth Circuit in New Orleans, which put the vaccine-and-testing requirements on hold last month. That court said the Biden administration approach raised “grave statutory and constitutional issues.”

The Fifth Circuit lost jurisdiction over its case after legal challenges filed around the country were all consolidated and transferred to the Sixth Circuit by a judicial panel that manages multidistrict litigation.

In dissent Friday, Judge Joan Larsen, a Trump appointee, said OSHA had not offered sufficient justification for adopting a broad vaccine-or-testing mandate, and she questioned whether Congress had given the agency the power to do so.

“OSHA has alerted us to no prior attempt on its part to mandate a solution that extends beyond the workplace walls—much less a permanent and physically intrusive one, promulgated on an emergency basis, without any chance for public participation. But that … is what OSHA has done here,” Judge Larsen wrote. “A vaccine may not be taken off when the workday ends; and its effects, unlike this rule, will not expire in six months.”

Other conservative judges on the court registered displeasure with the Biden administration rules in dissent Wednesday, when the court declined to hear the case with all active Sixth Circuit judges participating, rather than just a three-judge panel. Almost all cases are heard initially by three judges.

Write to Brent Kendall at brent.kendall@wsj.com

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