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Illumina Wins Case Against FTC on Grail Acquisition

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Illumina said the judge rejected the FTC’s position that the deal would hurt competition in the market for multicancer early-detection tests.

“As we’ve stated from the outset, this transaction is procompetitive, will advance innovation, lower healthcare costs and save lives,” said Charles Dadswell, general counsel of Illumina.

The decision, which the FTC staff can appeal, suggests the agency could face hurdles as it tries to push into newer theories of harm that can result from unchecked merger activity. The FTC alleged Illumina’s purchase of Grail could diminish innovation—a concern that goes beyond antitrust’s traditional focus on price levels and output.

In a statement, FTC Bureau of Competition Director Holly Vedova said the agency’s staff is disappointed with the decision and believes it mounted a strong case. “We are reviewing the opinion and evaluating our options,” Ms. Vedova said.

San Diego-based Illumina, which makes genetic-sequencing products, agreed in 2020 to acquire Grail, which is developing blood tests for early cancer detection. Illumina founded Grail and had spun it off in 2017, retaining a minority ownership stake. The 2020 deal was to acquire the part of Grail that it didn’t already own.

But in 2021, the FTC moved to block the deal, claiming that it would harm competition in an emerging field of tests for early-stage detection of multiple types of cancers.

The FTC said Grail and other developers of early-stage cancer tests all rely on Illumina’s DNA-sequencing platform. “If the acquisition is consummated, Illumina will gain the incentive to foreclose or disadvantage firms that pose a significant competitive threat to Grail,” the FTC wrote in its complaint last year. Illumina countered that it has made an open offer to provide continued access to its DNA sequencing to any Grail competitors.

Illumina closed its acquisition of Grail in 2021, despite the pending legal challenges.

The case isn’t the first time that Chief Administrative Law Judge D.

Michael Chappell

has ruled against the FTC on one of its lawsuits. Earlier this year, he rejected the FTC’s challenge of

Altria Group Inc.’s

purchase of a large stake in e-cigarette maker Juul Labs Inc. The FTC’s staff appealed that decision. The case is now pending before the commissioners.

Judge Chappell also ruled against the FTC in a data-security case in 2015.

The FTC under Chair Lina Khan has investigated more proposed mergers and vowed to take a stronger position against deals that could threaten competition. Ms. Khan has said antitrust enforcers need to be more forward-looking, prioritizing concerns such as preserving incentives for innovation, protecting workers and buttressing small businesses.

Illumina’s deal was an example of vertical merger, a type of transaction that integrates complementary instead of competing companies, allowing the combined firm to expand into new or related businesses or lower its input costs. Vertical deals have often been viewed with far less skepticism, but the FTC last year withdrew guidelines for reviewing them, indicating enforcers planned to apply tougher scrutiny to them.

“This case was always something of a stretch,” said

Stephen Calkins,

a law professor at Wayne State University. “It was a vertical case, which is a challenging area of law, and the law judge conspicuously noted during the oral arguments that there were very high stakes in terms of healthcare innovation.”

Illumina’s legal challenges aren’t over, as the FTC’s staff could appeal Judge Chappell’s decision to the agency’s commission. The commission authorized the legal challenge to the deal in March 2021 on a bipartisan vote. If the commission overruled Judge Chappell, the companies could take their case to a federal appeals court.

The FTC had initially sought a federal court injunction that would have blocked the closing of the acquisition, but it backed off because Illumina and Grail were facing antitrust scrutiny in Europe.

Instead, the FTC proceeded with an administrative complaint over the deal, resulting in a trial before an administrative law judge in August and September of 2021. The new ruling arises from that trial and post-trial briefs filed by Illumina and the FTC.

In July, a European Union court ruled that the EU’s competition regulator has jurisdiction to review the Illumina-Grail deal under European merger regulations. Illumina said it intends to appeal that decision. The European Commission said in July that Illumina’s decision to complete the Grail deal breached European regulations.

Illumina is keeping the Grail business separate from the rest of its business while these legal challenges play out.

For Illumina, full control of Grail would give it a solid position in what analysts estimate could be a $50 billion market for tests that can detect multiple cancers early.

Last year, Grail introduced Galleri, a test designed to detect more than 50 types of cancer. The test is intended for people with elevated risk of cancer, such as adults 50 and older, and as a complement to standard single-cancer screening tests. Galleri costs about $950 per test and generally isn’t covered by insurers.

But Galleri sales to date have been lower than expected, as some health systems have taken a measured approach toward using the test.

“We believe it’s a fantastic test,” Illumina Chief Executive Francis deSouza said in an interview. “We believe that in Illumina’s hands, we can make this test available to more people, more affordably and more quickly than in Grail’s hands.” He added that it could save many lives and healthcare costs.

Illumina shares declined 0.5% to $200.62 Thursday. SVB Securities analysts said in a research note that despite the win, there continues to be regulatory uncertainty around the deal, delaying Illumina’s full integration of Grail and its benefits.

Write to Peter Loftus at peter.loftus@wsj.com and Dave Michaels at dave.michaels@wsj.com

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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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Health

Monkeypox Likely Circulated for Years Before Outbreak, Scientists Say

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For more than half a century, monkeypox was a rare infectious disease confined to one region of the world. A few months ago, that suddenly changed. Scientists are building a picture of what happened.

The explosion of monkeypox around the world is a case study in how infectious diseases can leap from limited circulation to wide geographic spread with just a few chance events. Infectious-disease experts knew that the virus was on the rise in parts of West and Central Africa. All it took for monkeypox to take off around the world was for the virus to get into a group that would give it more opportunities for transmission.

“You have a virus that was able to establish itself in a dense social and sexual network and transmit efficiently because there’s no immunity,” said Anne Rimoin, professor of epidemiology at the University of California, Los Angeles.

A gradual decline of herd immunity against the closely related smallpox virus gave monkeypox more possibilities to jump from its natural animal hosts, infection-disease experts say. And one day, years ago, it infected someone who was part of a network with close physical contact between members—maybe a gay man with multiple sexual partners, or a sex worker—allowing it to spread sustainably among humans for the first time, these experts theorize.

In 2017, researchers in Central Africa were examining animals who may have carried the monkeypox virus.



Photo:

The Washington Post via Getty Images

That spread likely continued for years, undetected, until someone—or some people—with the virus traveled to large international events in Europe in May. Some attendees caught the virus and brought it back to their home countries, setting in motion the global outbreak that has now infected more than 29,000 people.

In the 1970s, many countries stopped routine vaccination against smallpox. A long-running campaign to eradicate one of the world’s deadliest diseases had the added benefit of preventing human infections of monkeypox, a closely related, though less severe, virus.

Starting in 1970, sporadic cases of monkeypox sprang up, mainly in people who lived in small villages in the rainforests of Central and West Africa, in close proximity to some animal populations—such as tree squirrels and other rodents—known to harbor monkeypox. Between 1970 and 1979, the World Health Organization recorded 45 cases. The majority were young children who had been infected by an animal. The virus spread to a close family member on four occasions, but went no further.

As the proportion of unvaccinated people increased, so too did the frequency of monkeypox. A 2010 study, published in the Proceedings of the National Academy of Sciences, found that in one of the most affected regions in Congo, the rate of monkeypox was 20 times higher between 2005 and 2007 than during the 1980s, a period when the WHO conducted widespread testing for the virus.

Before this year, the longest known chain of person-to-person infections for monkeypox was just nine people, according to the World Health Organization.



Photo:

NurPhoto via Getty Images

Almost all cases were in younger people who had been born after mass vaccination ended in 1980. UCLA’s Dr. Rimoin, who led the study, at the time urged governments to tackle the rise of monkeypox in central Africa, while the disease’s geographic range was still limited.

As population immunity declined, the virus was still held back by its limited ability to spread between people. Monkeypox requires close contact to spread. Typically, that means direct contact with the skin lesions caused by the virus, although it can also spread through shared personal items like bed linens or respiratory droplets from prolonged face-to-face contact. African researchers believe that, for most of the last five decades, monkeypox outbreaks quickly fizzled out, with a person catching the virus from an animal and then maybe spreading it to a few people they lived with. Before this year, the longest known chain of transmission—meaning the number of successive person-to-person infections—for monkeypox was just nine people, according to the WHO.

Now, though, virologists and infectious-disease experts say that at some point in the past few years, the virus jumped from an animal to a person and then kept spreading.

Genomic analysis of samples from the current outbreak suggests that the virus has been spreading among people for years, according to Geoffrey Smith, professor of pathology at the University of Cambridge and an expert in poxviruses. The pattern of mutations, he says, is consistent with genetic blips that would have been introduced by a human protein that interferes with viral replication.

So far, there is no evidence that those mutations have led to the virus becoming more transmissible, or brought about any other new properties such as drug resistance or increased severity, said Prof. Smith.

U.S. health officials have declared monkeypox a public-health emergency, after the World Health Organization declared it a global health emergency in late July. WSJ explains what you should look out for and what scientists know about how the virus is spreading. Illustration: Adele Morgan

It isn’t known precisely when that sustained human-to-human transmission began. The number of genetic mutations linked to the human protein suggests that the current outbreak can be traced to an animal-to-human infection that took place around April 2016, according to researchers at the University of Edinburgh.

Dimie Ogoina, an infectious-disease doctor in Nigeria, said he suspected that sexual contact had become an important route of transmission for monkeypox when the virus suddenly resurfaced in that country in 2017, after nearly four decades without a case.

An early clue, he said, came from a husband and wife. The husband had a rash that was most prominent in his genitals. The wife later developed a single lesion in her genital area, but had no other symptoms. The couple had two children at home under the age of 10, neither of whom caught the virus.

Dr. Ogoina, who has treated a few dozen cases since 2017, said he could link the virus with sexual contact in the majority of patients that he has seen. However, when he shared this observation with colleagues at a conference in 2019, some were skeptical, as it didn’t fit with how monkeypox had spread in the past.

“It’s a roll of the dice as to whether or not it’s going to end up in a dense network,” said Dr. Rimoin. She said it is likely that the virus was already circulating among men who have sex of men and that some of them traveled to large gatherings in the Canary Islands and Belgium that took place in May. Those events were linked to multiple cases that were later identified in various European countries including the U.K., Spain and Portugal.

Although the virus is circulating predominantly through sexual networks of gay and bisexual men, that isn’t its only mode of spread. A small number of women and children have also caught the virus by, for example, catching it from someone they live with.

“This is something that was wholly predictable if monkeypox got itself into the right population for spread,” said Dr. Rimoin. “Now we have to wake up and get to work.”

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

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Health

Health Authorities Issue New Advice for Avoiding Monkeypox

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The Centers for Disease Control and Prevention released data finding the monkeypox outbreak is concentrated among men who have had sex with several men, and issued more detailed recommendations on how to avoid exposure to the disease.

Among 291 men surveyed, 40% reported that they had two to four partners and 14% reported five to nine partners in the three weeks before developing monkeypox, according to the report. About 19% reported 10 or more partners during that period, the CDC said Friday.

And among 86 men who reported information, 28% said they had had group sex, which is defined as sex with more than two people, at a festival, group sex event or sex party, based on the report. The research was conducted from May 17 through July 22.

After releasing the data, the CDC also issued more specific warnings and recommendations for reducing the risk of monkeypox than its earlier guidelines. The CDC also extended its recommendations to anyone sexually active, not just those who suspect they are infected.

In addition to advising people to limit their number of sex partners, the CDC recommended wearing latex, polyurethane or nitrile gloves, and changing or cleaning clothes, bedding, towels and sex toys after sex.

The new developments come after cases increased to more than known 7,000 in the U.S., prompting the federal government to declare a public-health emergency.

Monkeypox is a viral disease that can spread to anyone through close, personal contact that is often skin-to-skin as well as contact with respiratory secretions, direct contact with rash or scabs, and touching objects used by someone with the virus, the CDC said.

U.S. health officials have declared monkeypox a public-health emergency, after the World Health Organization declared it a global health emergency in late July. WSJ explains what you should look out for and what scientists know about how the virus is spreading. Illustration: Adele Morgan

Direct contact can happen during sex or touching of genitals, as well as kissing, hugging, massage, and touching fabrics and objects used during sex such as fetish gear, according to the agency.

Scientists are still researching if monkeypox can be spread through semen or vaginal fluids. Monkeypox DNA was present in semen in one study of Italian men conducted in May, but health experts have said they don’t know for sure if that means the virus can transmit sexually.

While anyone can get monkeypox, the CDC said in June that the outbreak may be concentrated among gay and bisexual men because the virus is taking advantage of social and sexual networks in that group.

Yet health authorities had held off on some direct warnings out of fear of stigmatizing the population, according to people familiar with the discussions.

The release of the data and guidelines suggests a new phase in the response, however, with the Biden administration speaking more directly about who is at risk and how they can reduce it.

Government officials expressed hope that the new recommendations could help slow the spread of the virus by getting through to people most at risk. Shortages of tests, vaccines and drugs have hurt the effort and drawn criticism from some doctors and health experts.

“Given the current limited supply of vaccine, CDC recommends temporarily changing some behaviors that may increase a person’s risk of being exposed,” an agency spokeswoman said. “These temporary changes will help slow the spread of monkeypox until vaccine supply is adequate.”

Even people who feel well, the CDC said, should consider such steps as limiting the number sex partners, having sex with clothes on and covering areas where a rash is present. Aside from recommending gloves to reduce exposure, the CDC also described the benefits of wearing leather or latex gear.

U.S. health authorities have struggled with how to communicate about the virus that is hitting communities already subject to historical discrimination.

Federal officials had been careful to avoid warnings that they think would lead to stigma of certain sexual activities, but such caution has led to criticism that government leaders are being unclear and that messages aren’t getting through to people most at risk for the virus.

“They are harming the very group they’re trying so hard not to stigmatize,” said Dr. Greg Poland, head of the Mayo Clinic’s Vaccine Research Group.

Absent detailed recommendations from the federal government, LGBT activists had written their own guidelines for safe sex. One guide advised against group sex in public places and recommended creating pods of small groups men who would only have sex with each other.

“I think the CDC should be saying the truth,” said David Kilmnick, president and founder of the New York LGBT Network, who praised the new recommendations. “We have to be direct and real and not sugarcoat anything.”

The head of the World Health Organization warned in late July that men who have sex with men should limit their number of sexual partners, think twice about sex with new people and exchange contact information when they do have sex.

The Biden administration had initially adopted a strategy known as ring vaccination that has often worked in instances of household transmission. The approach focuses on vaccinating contacts of confirmed patients and people who had close contacts with those people.

This monkeypox outbreak has instead been centered in sexual networks, according to one federal official. An effort was made to do contact tracing, the person said, but the number of contacts was “significantly greater and often anonymous.”

Because of the challenge, the official said, the administration abandoned the initial ring vaccination strategy and moved instead to encouraging people who may have been exposed or had multiple partners in areas of high monkeypox transmission to get vaccinated.

The administration sought to conduct outreach during the recent Pride month. The CDC on June 2 began conversations with Interpride, a group that organizes Pride events throughout the country, to share information about monkeypox with event organizers and attendees. It also joined with sites such as Grindr to spread warnings about monkeypox.

The CDC in June also worked with social-media influencers such as

Shea Coulee,

a drag queen, musician and podcaster and social-media platforms to get messages on monkeypox out to followers and users.

Monkeypox can cause symptoms such as fever, chills, exhaustion, headache, sore throat and a rash. Some cases of monkeypox are mild, but others come with excruciating rectal pain or swelling. The symptoms usually appear within three weeks of exposure. The illness typically lasts two to four weeks. CDC recommends the infected isolate for the duration of their illness.

Write to Liz Essley Whyte at liz.whyte@wsj.com and Stephanie Armour at stephanie.armour@wsj.com

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Health

Monkeypox Patients Report Excruciating Pain and Lack of Guidance as U.S. Cases Mount

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Taber Feltner, a research associate in Iowa City, Iowa, said he noticed some worrying symptoms in mid-July, a few days after returning home from a trip to Chicago.

A rash developed in his groin, which he initially brushed off as ingrown hairs. But within a few days, he developed a fever of over 103 degrees Fahrenheit and the rash transformed into painful, pus-filled lesions.

“I’ve never been that sick in my life,“ said Mr. Feltner.

More than two months after monkeypox was detected in the U.S. as part of a global outbreak mostly among men who have sex with men, transmission shows no sign of slowing. The U.S. has surpassed Spain as the country with the most known cases. Federal officials are considering whether to declare monkeypox a public-health emergency.

The continuing spread of monkeypox has prompted the World Health Organization to declare a global health emergency. WSJ’s Denise Roland explains what you need to know about the outbreak. Photo: Kena Betancur/AFP/Getty Images

Patients said they are navigating the outbreak without sufficient guidance from physicians and public-health officials on how to treat the disease and prevent its spread. Mr. Feltner said he wasn’t able to get vaccinated before travel because Iowa gave priority to people who had been exposed to monkeypox. He said he was mocked by healthcare providers when he attempted to seek care and struggled to find adequate expert information about the disease. He said he has relied on social media and the anecdotal accounts of other patients to fill the gaps.

“Trying to get questions answered was impossible,” said Mr. Feltner.

Public-health experts and community advocates said the Biden administration and the Centers for Disease Control and Prevention were too slow at responding to the outbreak when it first emerged and continue to take insufficient action to stem the spread of the virus.

“We’re not getting streamlined communication to communities. People are making things up as they go. That’s not the best public-health strategy,” said Jason Rosenberg, a member of ACT UP NY, an HIV/AIDS advocacy organization.

Taber Feltner, a research associate in Iowa City, Iowa, said it took several days to get access to testing and treatment for monkeypox.



Photo:

Taber Feltner

The CDC said it was wrong to suggest that it hadn’t taken early and adequate action to mitigate the outbreak and to educate communities about monkeypox.

“All summer, [the] CDC has been working with partners to help put information in the hands of people who may be at highest risk for contracting monkeypox,” an agency spokesperson said, adding that the CDC continues to work with community health organizations to raise awareness about the virus.

The Department of Health and Human Services didn’t immediately respond to requests for comment.

To date, there have been more than 5,800 confirmed or suspected cases in the U.S., mostly among men who have sex with men, federal health officials said. Epidemiologists said the virus is exploiting close-knit social and sexual networks, but knowledge of how the virus is spreading in this current outbreak remains incomplete.

“We have to be very humble about what we know and what we don’t,” said Anne Rimoin, an epidemiologist at the University of California, Los Angeles, who spent two decades studying monkeypox in Africa, where the disease has long been endemic. “What we know is based on studies done in very different epidemiological and ecological contexts. We need to know much more about transmissibility.”

The World Health Organization, which declared monkeypox a global health emergency, says monkeypox is most commonly spread through close contact with an infected person’s rash, lesions and bodily fluids. The virus can also spread via fabrics and other materials, and through prolonged exposure to an infected person’s saliva or mucus.

Aerosol, also known as airborne, transmission of the virus hasn’t been considered to be of significant concern by public-health experts, but some early research suggests it could be possible in certain conditions. Airborne transmission is defined as the dissemination of a virus through very small droplets that remain suspended in the air over long distances and time.

Public-health experts recommended that people at risk for infection get vaccinated when possible, not share bedding or towels, wash hands often, and avoid intimate physical contact with someone with rashes or sores, or limit sexual partners altogether.

People waiting in line for the monkeypox vaccine in Los Angeles last week.



Photo:

robyn beck/Agence France-Presse/Getty Images

A person can spread monkeypox until all their lesions have scabbed and the scabs have fallen off, infectious-disease experts said. Public-health officials have advised potentially infectious people to remain quarantined for the duration of their illness. Monkeypox symptoms typically last two to four weeks, the CDC said.

Most monkeypox cases in the U.S. have been mild, though moderate and severe cases have been reported. A recent study in the New England Journal of Medicine of more than 500 monkeypox patients in 16 countries found that 13% were hospitalized, mostly for pain.

It is hard to predict who will experience a severe case, said Peter Chin-Hong, a professor of medicine at the University of California, San Francisco, noting that patients in his care haven’t been immunocompromised or very old. “The people who are hospitalized are very, very sick,” he said.

Josh Watson of Chicago said he developed lesions on different parts of his body, including some in his throat that made it difficult to eat and drink. He was hospitalized and treated with the antiviral drug tecovirimat in mid-July. The drug, sold by New York-based

Siga Technologies Inc.

under the brand name TPOXX, has been approved by the Food and Drug Administration for the treatment of smallpox, a disease closely related to monkeypox.

Amid the outbreak, the FDA and CDC have approved expanded access of TPOXX to monkeypox patients, but healthcare providers said obtaining the drug has been burdensome. Until recently, it took providers several hours to complete extensive FDA and CDC paperwork and other requirements to get the drug to patients, said Cathy Creticos, medical director of infectious disease at Howard Brown Health, a nonprofit LGBTQ healthcare and social services provider in Chicago. The CDC simplified the protocol to obtain TPOXX late last month.

Twenty days after his first monkeypox symptoms appeared, Mr. Watson said he remained quarantined with a lesion on his foot and lingering fatigue.

“The risks of monkeypox have been severely downplayed,” Mr. Watson said. “People need to know that the risk is greater, the symptoms are greater. What I’d heard is that you get a rash for a couple of weeks and then it’ll go away, you won’t die. But no one was talking about the pain, the difficulty urinating or having bowel movements.”

Tecovirimat, also known as TPOXX, a treatment for smallpox, has been prescribed for monkeypox patients amid the outbreak.



Photo:

yuki iwamura/Agence France-Presse/Getty Images

Some patients with moderate to severe symptoms said their symptoms improved significantly after taking TPOXX. Healthcare providers said most monkeypox cases in the U.S. have resolved without medical intervention.

Mr. Feltner said it took many days before he was able to get access to testing and treatment for monkeypox.

He said a nursing assistant at an urgent-care clinic in Iowa City laughed at him when he suggested he had monkeypox. A doctor at the clinic diagnosed him with herpes and refused to test him for monkeypox, Mr. Feltner said. The doctor sent him home with Valtrex, an antiviral drug used to treat herpes.

The medication didn’t work. “Things just got worse,” said Mr. Feltner, who was eventually hospitalized and given TPOXX.

“Our healthcare system here is definitely not ready for this disease,” Mr. Feltner said.

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Health

Two HIV Patients Appear to Have Beaten Virus, Offering Hope for Cure

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A 66-year-old man in Southern California and a woman in her 70s in Spain are the latest in a small group of people who appear to have beaten their HIV infections, providing researchers new clues to a possible cure at a time when Covid-19 and other crises are slowing progress against the spreading virus.

Doctors caring for the man said they have not found any human immunodeficiency virus that can replicate in his body since he stopped antiretroviral drug therapy in March 2021 after a transplant of stem cells containing a rare genetic mutation that blocks HIV infection. He was given the transplant for leukemia, for which people with HIV are at increased risk. Details of his case were made public Wednesday and will be presented at a large international AIDS conference in Montreal, which opens Friday.

He is the oldest of five patients thus far who appear to have rid their bodies of HIV after the risky procedure and had been infected the longest, since 1988, offering hope for a growing cohort of aging HIV patients, said Jana Dickter, an infectious disease doctor who cares for the man at City of Hope, a cancer research and treatment center in Duarte, Calif., in the Los Angeles area.

“He saw many of his friends and loved ones become ill and ultimately succumb to the disease and had experienced some stigma associated with having HIV,” she said. His success “opens up the opportunity potentially for older patients to undergo this procedure and go into remission from both their blood cancer and HIV.”

The woman in Spain still has HIV lying dormant in some cells in her body. But the amount is declining, and the virus isn’t replicating even though she stopped antiretroviral therapy more than 15 years ago, said Juan Ambrosioni, one of the doctors caring for her at the Hospital Clinic of the August Pi i Sunyer Biomedical Research Institute in Barcelona.

She was diagnosed with HIV at age 59 shortly after becoming infected, and entered a clinical trial in which she received antiretroviral drugs as well as therapies to boost her immune system. After nine months, the antiretrovirals were stopped, Dr. Ambrosioni said.

Researchers and doctors at the Hospital Clinic of the August Pi i Sunyer Biomedical Research Institute in Barcelona who have cared for a woman in her 70s who appears to have beaten her HIV infection.



Photo:

Daniel Arbos

Years of research finally revealed how she keeps her HIV naturally under control, he said: she has high levels of two types of immune cells that the virus normally suppresses and that probably help control viral replication, he said. Details of her case will be presented at the same conference. Both patients declined to be identified publicly.

The two cases “provide continued hope for people living with HIV and inspiration for the scientific community,” said Sharon Lewin, director of the Peter Doherty Institute for Infection and Immunity and a leader in HIV cure research who wasn’t involved in the studies.

Finding a cure for HIV is a major scientific challenge because even when reduced to low levels with medication, the virus can hide from the body’s immune system, going latent in certain cells. It can then roar back to life and start replicating.

So difficult is HIV to get rid of that researchers are often reluctant to declare patients cured even when they can’t find any sign of the virus. Some patients have relapsed. “We don’t use the term ‘cure’ lightly in the world of HIV,” said Dr. Dickter, who says her patient is in remission but that to call him “cured” will take “more time and data.”

Doctors caring for the woman in Spain consider her to have achieved a “functional cure,” meaning that the virus hasn’t been completely eliminated but is under control without medication.

Other research released Wednesday identified a series of steps by which HIV becomes latent in a rare type of immune cell, an important finding that could help guide scientists searching for ways to flush those viruses out of the body, HIV researchers said. It shows that drugs tried so far attack only part of that latency process, said Eli Boritz, an HIV cure research scientist who led the work at the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

Jana Dickter is an infectious disease doctor at City of Hope in Duarte, Calif.



Photo:

City of Hope

Transplants such as the one the Los Angeles area patient received cannot be a cure for the 37.7 million people living with HIV globally, Dr. Lewin said. They are risky, expensive, and only for people who need them for a life-threatening disease such as cancer, she and other researchers say. But they say scientists who are searching for a cure are learning from them.

“There are fancy new gene editing methods emerging that might one day be able to achieve a similar outcome with a shot in the arm,” said Steven Deeks, a professor at the University of California, San Francisco who leads research for an HIV cure and wasn’t involved in the studies of the two patients.

Dr. Ambrosioni said findings from the woman in Barcelona could be used to develop a treatment that could be given more widely than transplants.

He said he and his colleagues hope to determine whether her control of her HIV is the result of genetic factors, the immune-boosting treatment she received in the trial, or both. If a treatment for others results from the findings, “that could be something you could scale up for many, many people,” he said.

Write to Betsy McKay at betsy.mckay@wsj.com

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U.S. Leads Globally in Known Monkeypox Cases, CDC Says

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The U.S. has reported more than 3,400 confirmed or suspected monkeypox cases, federal data showed, becoming the country with the most known infections since the onset of the global health emergency.

The rise in cases comes as the U.S. expands testing capacity, broadening the ability to spot new infections, but also as the global outbreak continues to grow. Some public-health experts said rising transmission heightens the chances a broader population will face the risk of infections as the opportunity to slow and potentially stop the outbreak is fading.

The outbreak has largely been recorded among men who have sex with men, as the virus exploits social networks among people in close contact. This is already a concern, but spreading more broadly means the potential added challenge of trying to educate and protect a broader population, health experts said.

“We are at a very critical juncture in the outbreak,” said Jay Varma, a physician and epidemiologist who directs Weill Cornell Medicine’s Center for Pandemic Prevention and Response in New York City.

The continuing spread of monkeypox has prompted the World Health Organization to declare a global health emergency. WSJ’s Denise Roland explains what you need to know about the outbreak. Photo: Kena Betancur/AFP/Getty Images

The U.S. surpassed the reported case count in Spain after recently surpassing other European countries, including Germany and the U.K. There are now at least 17,852 cases in nearly 70 countries where the viral disease doesn’t typically occur, including at least 3,487 in the U.S., which has a significantly larger population than European countries that also have outbreaks, according to the Centers for Disease Control and Prevention.

The true case count is likely significantly higher than the known count, in part due to more limited testing early on in the outbreak, and completely beating back the virus is already unlikely, Dr. Varma said. But there is still a chance through vaccinations, education and treatment to hem the virus in, slowing transmission enough to make it a very rare disease, he said.

The World Health Organization on Saturday said monkeypox is a public-health emergency of international concern, marking the first such declaration since the start of the Covid-19 pandemic in January 2020.

Another risk from a growing outbreak is that the virus will reach a U.S. animal population, creating a reservoir where it could be passed back to people, said Aileen Marty, a distinguished professor of infectious disease and outbreak response at Florida International University.

“The last thing we need is for our animals to get infected,” Dr. Marty said.

Classic monkeypox starts with flulike symptoms including fever and aches, with the later appearance of a rash usually starting on the face. In the current outbreak, doctors have described some cases in which the rash appears before a fever and other cases in which the rash remains concentrated in the genital area, for example.

Health authorities have been focusing vaccination and outreach efforts among gay and bisexual men, since the outbreak thus far has been heavily concentrated in that population. But there are also two known pediatric infections in the U.S., one in a California toddler and the other in an infant in Washington, D.C., according to the CDC.

The two cases are likely the result of household transmission and aren’t related, a CDC spokeswoman said Monday. The cases are under investigation, and both children, though symptomatic, were in good health and receiving treatment medication, she said. In the case of children, monkeypox could spread through activities like holding, cuddling, feeding and shared items like towels and bedding, the CDC said.

The virus requires close contact to spread. Health authorities haven’t reported deaths beyond Africa in the current outbreak, but there have been several deaths in two African countries since the start of the year, WHO data show.

Although there are available vaccines to combat the monkeypox outbreak they have been in short supply.



Photo:

EDUARDO MUNOZ/REUTERS

Because some countries such as the U.S. have invested in adding defenses against smallpox, which is related to monkeypox, there are already available vaccines to combat the current outbreak. Still, the vaccines have been in short supply as gay and bisexual men clamor for shots.

U.S. health authorities, criticized by some activists for not moving faster to bolster the vaccine stockpile, have said the numbers are growing. The Department of Health and Human Services says it has shipped more than 300,000 doses of the two-dose Jynneos vaccine, made by

Bavarian Nordic

A/S, to jurisdictions around the U.S. The government said it accelerated inspection for another 800,000 doses coming this summer and that there are millions of shots that are set for delivery by mid-2023, HHS said.

Supply constraints have improved, but demand still seems to be outpacing available shots, said Amanda Babine, executive director with the advocacy group Equality New York.

New York City, which recently counted more than 1,000 confirmed and presumed cases, said there are likely many more cases that haven’t been diagnosed.

Meanwhile, testing capacity, another bottleneck, has improved. With private laboratories now online, U.S. capacity recently reached 80,000 tests a week, up from 6,000 a week at the start of the outbreak, HHS said.

Write to Jon Kamp at jon.kamp@wsj.com

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Hopes of Covid-19 Reprieve Fade as BA.5 Subvariant Takes Over

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Covid-19 is circulating widely as the BA.5 Omicron subvariant elevates the risk of reinfections and rising case counts, spoiling chances for a summer reprieve from the pandemic across much of the U.S.

Covid-19 levels are high in a fifth of U.S. counties, according to the Centers for Disease Control and Prevention’s metric based on case and hospital data, a share that has been mostly rising since mid-April. BA.5 is estimated to represent nearly two in three recent U.S. cases that are averaging just more than 100,000 a day, CDC data show. The true number of infections may be roughly six times as high, some virus experts said, in part because so many people are using at-home tests that state health departments largely don’t track.

“We think we’re in a very high level of community transmission, second only to the Omicron peak from the wintertime,” said

Jeffrey Duchin,

health officer for the public-health agency covering Seattle and King County, Wash.

Biden Administration health officials said Tuesday that BA.5 has the potential to push the number of infections higher in the coming weeks. They urged eligible people to get vaccine booster shots to lower the risk of hospitalization and death, and not to wait for potential updated boosters targeting Omicron subvariants.

Getting a booster now “does not preclude your also doing it in the fall,” said

Anthony Fauci,

director of the National Institute of Allergy and Infectious Diseases, during a White House briefing. “If the risk is now, address the current risk.”

Nationally, wastewater data tracking the prevalence of the Covid-19 virus through July 6 has recently trended up, according to Biobot Analytics. Such data can provide clues about the pandemic’s trajectory.

Covid-19 hospital admissions are going up in Los Angeles County, and local authorities have said they might impose a mask mandate.



Photo:

caroline brehman/Shutterstock

New York City last week urged people to resume masking in public, indoor settings and around crowds outside. Los Angeles County’s public health department said rising Covid-19 hospital admissions mean that the county also could soon reach high community prevalence and that officials would reinstate a mask mandate if the county stayed at that level for two weeks.

Signs of acute illness remain muted, continuing a hallmark of the spring surge, as treatments plus immunity from vaccines and previous infections reduce risks for many people. But the high prevalence of infection in many areas continues to cause disruptions, including canceled flights and spoiled travel plans, sick children sidelined from camp and child care and hospital employees who can’t report to work.

BA.5’s mutations make it particularly adept at causing repeat infections, even in people who had the version of Omicron that caused the largest recorded spike in cases last winter. There is no evidence to suggest BA.5 causes more severe disease, CDC Director

Rochelle Walensky

said.

Ashish Jha,

the White House’s Covid-19 response coordinator, noted some mixed signals from overseas. Portugal, where vaccine and booster coverage is robust, experienced a sizable wave of serious illness and death after BA.5 hit there recently, Dr. Jha said over the weekend. South Africa, on the other hand, recorded a low rate of deaths after BA.5 surged there this spring, he said.

The BA.5 Omicron subvariant surged in South Africa in the spring, and the death rate was low.



Photo:

Denis Farrell/Associated Press

In addition to vaccines, health officials urged people to use treatment medications such as

Pfizer Inc.’s

Paxlovid. They encouraged people to test before gatherings and use high-quality masks in crowded, indoor spaces.

The pace of hospital admissions for Covid-19-positive patients has recently sped up, federal data indicate. The seven-day moving average for confirmed Covid-19 patients in hospitals has topped 33,000, federal data show, up from a low near 10,000 in April but far below January’s record peak topping 150,000.

Many of the hospitalizations are cases where patients test positive after being admitted for other reasons. Data indicate the portion of Covid-19 patients who need intensive care remains low. Deaths are hovering around 300 to 350 a day, Dr. Jha said Tuesday. This is much closer to historic lows than highs, though he called the current level unacceptable.

Couples whose weddings were cancelled or diminished because of Covid-19 participated in a symbolic ceremony Sunday in New York City, one sign that many people are less shy about crowds at this point in the pandemic.



Photo:

Julia Nikhinson/Associated Press

The reduced threat is one reason a pandemic-fatigued populace is less likely to change behavior when cases are high, said

Robert Wachter,

chairman of the department of medicine at the University of California, San Francisco. Crowds are once again common, from concerts to restaurants to airport terminals. Mask use is scattered, while mandates remain rare.

“Part of what motivated people to be super careful for a long time was the fear that I’m going to die of this thing,” Dr. Wachter said. “I think people have less fear of that, and that’s not inappropriate.”

He and other health experts said they continue to take precautions in their own lives because of the risk of developing long Covid symptoms after an infection. Persistently high levels of infections in communities can also leave elderly people and those with compromised immune systems more exposed, according to epidemiologists. Tamping down on the spread of the virus also gives it less chance to mutate, Dr. Fauci said.

As a surge that started in early spring grinds along through the summer, some health officials are thinking about the fall. U.S. health authorities are planning a fall booster campaign to protect against a potential winter surge, and vaccine makers are racing to update their vaccines to target Omicron subvariants, including BA.5.

Public-health officials and experts hope modified shots will help get some booster-hesitant people off the fence. “With a good public-health campaign behind the rollout of the vaccine, we can shift the scales of that trajectory of people getting both their boosters and vaccinated,” said

Debra Furr-Holden,

dean of New York University School of Global Public Health.

Dr. Duchin, in Seattle, said he hoped communities would head toward the fall at a low level of Covid-19 transmission to ease pressure on health systems. He said he was worried about the consequences if instead Covid-19 is circulating widely at what is traditionally a more intense time for respiratory illnesses generally.

“This virus is relentless in the way it’s challenging us in unexpected ways,” he said.

Write to Jon Kamp at jon.kamp@wsj.com and Jared S. Hopkins at jared.hopkins@wsj.com

Corrections & Amplifications
The BA.5 subvariant is estimated to represent nearly two in three recent U.S. Covid-19 cases. An earlier version of this article misstated the portion as more than one in three cases. (Corrected on July 12)

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Omicron’s Trajectory Shows Challenge of Maintaining Immune Defenses

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New Omicron subvariants are proliferating even in the face of significant protection from vaccinations and prior infection, as policy makers consider measures including open-ended vaccination drives to keep the evolving virus at bay.

Much of the U.S. population already had some level of antibodies to the virus when Omicron hit late last year, the Centers for Disease Control and Prevention estimates. That likely shielded many from more-severe disease, but the variant still fueled a record case surge and the second-highest peak in Covid-19 deaths. Immune defenses bolstered by the massive wave appear to be muting the impact of the yet-more-infectious Omicron variants even as cases and hospitalizations increase once again.

These recurring run-ins with a changing virus demonstrate the challenge of maintaining long-lasting defenses, even as Covid-19 vaccines and exposures build up protection against the virus’s worst outcomes.

As fourth doses of Covid vaccines roll out, some are questioning whether the general population needs them. At the center of this debate are mysterious T-cells. WSJ’s Daniela Hernandez explains T-cells’ role in Covid immunity and how they relate to antibodies. Illustration: Laura Kammermann

“This is not a virus that a one-shot or a one-time infection gives you lifelong immunity,” said Jodie Guest, vice chair of the epidemiology department at Emory University’s Rollins School of Public Health. “And we’re now super-aware of that.”

A nationwide survey of blood donors published by the CDC estimated that about 94% of people ages 16 and up had some antibodies to the SARS-CoV-2 virus by November 2021, either through vaccination or prior infection. The U.S. had just come off a wave sparked by the Delta variant, and some hoped the country might have reached a turning point.

Then Omicron hit. A significant number of mutations helped it dodge our built-up immune responses, immunologists and epidemiologists said. Protection from prior infection and vaccination declined, studies found, and booster doses to guard against the virus became more imperative.

Data indicate Omicron triggered big surges in reinfections while it also pushed tallies of known cases to record highs.

“We knew before Omicron that SARS-CoV-2 was capable of some immune escape,” said Sarah Cobey, an associate professor of ecology and evolution at the University of Chicago. “Omicron made it clear that these adaptations could sometimes be leaps.”

Rhode Island’s health department estimates 3.2% of reported cases during the state’s Delta-variant surge last year were reinfections. The known reinfection rate there jumped to 13.3% from late December to mid-January. Data from Minnesota show the percentage of reinfections reaching similar highs early this year, during the Omicron surge.

States including New York, Louisiana and Washington are also collecting data on reinfections, which are generally considered to be new after 90 days. Health departments broadly acknowledge their counts are low because so many people go untested or use at-home tests, making reinfections particularly hard to track.

Omicron caught many people with diminished protection long after their first exposure or latest vaccination.



Photo:

David Goldman/Associated Press

Vaccinated people had lower rates of infection and severe outcomes during the surge than the unvaccinated, despite an increase in breakthrough cases, CDC data show. Colorado, a state that breaks out reinfection data by vaccination status, counted the highest number during Omicron among unvaccinated people and the lowest number among boosted people.

Arriving nearly two years into the pandemic, Omicron also caught many people with diminished protection long after their first exposure or latest vaccination. Protection against Covid-19 infection wanes in the months after vaccination or exposure, evidence suggests.

The jump in reinfections is “correlating with Omicron, and it is also correlating with waning immunity,” said Umair Shah, secretary of health in Washington state.

Weekly Covid-19 reinfections

200 per 100,000 population

Weekly Covid-19 reinfections

200 per 100,000 population

Weekly Covid-19 reinfections

Protection against severe disease can also diminish but appears to be more stable. The Omicron wave didn’t hospitalize or kill people at the same rate as earlier variants, likely because of built-up immune protection in the population, immunologists said.

“What we’ve seen with Omicron is a tremendous amount of infections. Not as many have translated to severe disease,” said Alessandro Sette, a professor at the La Jolla Institute for Immunology in California. “Vaccine efficacy against severe disease holds much better.”

Still, the explosion in cases still triggered the second-highest peak in reported deaths, and the sheer number of sick people strained hospitals. CDC data suggests that more than half of people in the U.S. have infection-induced antibodies, up from 34% in December.

Now, those infections from the Omicron surge are likely helping to blunt the effect of an Omicron subvariant, BA.2, that is currently dominant in the U.S. Some health officials and experts hope that built-up protection from Covid-19 vaccination and exposures is reaching a point where the virus is less dangerous for most people and its spread less disruptive.

But even mild Covid-19 cases can lead to lasting complications, public-health experts said, and the full health risks associated with repeated exposures aren’t clear. New variants could also spoil hard-won progress, they said, particularly if the virus spreads unimpeded. 

Only about half of eligible people in the U.S. have gotten a booster shot.



Photo:

Amir Hamja for The Wall Street Journal

“To decrease the changes, it’s about decreasing the space the virus can actually play in and limiting that space to evolve,” said Ali Ellebedy, an immunologist at Washington University School of Medicine in St. Louis.

Research that hasn’t been peer-reviewed suggests that other Omicron subvariants, such as BA.2.12.1, may better escape the immune responses from the Omicron variant that surged this winter. The CDC estimates BA.2.12.1 recently represented 36% of U.S. cases.

This fall will likely present another test. Respiratory viruses tend to flare as people congregate indoors, and people hit during the Omicron wave will be many months past their infections. Meantime, only about half of eligible people in the U.S. have gotten a booster shot, underscoring the challenge of asking people to repeatedly roll up their sleeves to bolster their protection.

“We will get exposures,” said Adolfo García-Sastre, director of the Global Health and Emerging Pathogens Institute of the Icahn School of Medicine at Mount Sinai in New York. “The question is how often, and what is the percentage of severe disease?”

The Omicron and BA.2 Variants

Write to Brianna Abbott at brianna.abbott@wsj.com and Jon Kamp at jon.kamp@wsj.com

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