Baxter warns of possible oxygen level drops linked to Hillrom lung-expansion therapy

 A device that’s meant to clear out and expand the lungs may actually go too far, resulting in a potentially dangerous decrease in overall oxygen levels, Baxter said this week.

In light of that discovery, the devicemaker has put out an urgent medical device correction for its Volara system for oscillation and lung expansion therapy, focusing specifically on those devices used in a home care environment.

The Volara system provides a trio of respiration treatments. It simultaneously helps expand the lungs and move mucus out of them and into the large airways, all while delivering aerosol medication to the lungs to smooth out both processes.

The system arrived under Baxter’s purview late last year when the Illinois-based medtech completed its outsized acquisition of Hillrom, the original maker of the device.

The recently discovered safety issue can occur when the Volara system is connected to a ventilator—one of a handful of accessories that can be used to deliver its treatments. In some cases, according to Baxter, performing the therapy with an inline ventilator can lead to an overexpansion of the lungs, which could, in turn, cause a decrease in oxygen levels—known as oxygen desaturation—or possible damage to the lung tissue.

So far, Baxter said it has received one report of a patient experiencing oxygen desaturation while they were using the device in tandem with a ventilator in their home care environment.

Despite the identified risks, the company said patients at home can continue to use the devices as prescribed, though users and caregivers should keep an eye out for signs of respiratory distress, which include rapid breaths, wheezing, bluish coloring around the mouth or fingernails or a change in alertness.

If any of those symptoms arise, patients should stop using the Volara system immediately and seek medical attention if they don’t improve.

Baxter said it’s also currently working on updating the system’s instructions for use to make its correct usage more clear. As it rolls out that update, the company will also send out customer service agents to train users and their caregivers in the proper use of the device in the home.

Baxter initiated the safety event at the end of April. The FDA has already handed down its most serious classification to the event, naming it a Class I recall—the second for Baxter this year.

According to the agency’s database, the recall spans just 268 units currently in use across the U.S.: 259 circuit kits manufactured since the end of February 2020 and nine handsets manufactured since October 2019, all of which are used to connect a ventilator to the Volara device.

https://www.fiercebiotech.com/medtech/baxter-warns-possible-drop-oxygen-levels-linked-hillrom-lung-expansion-therapy-device

Silent panic alarms could be coming to NY schools after ‘Alyssa’s Law’ passes

 Albany pols passed a law Saturday requiring school districts statewide to seriously consider installing silent panic alarms to alert law-enforcement authorities during emergencies.

The state Assembly approved “Alyssa’s Law,” named after 14-year-old Alyssa Alhadeff, who was shot and killed in 2018 during the Parkland, Florida school massacre.

“Schools should be a safe place for our kids to learn and grow,” said Assembly Speaker Carl Heastie in a statement announcing the bill’s passage.

Alyssa’s Law will force each school district’s safety teams to consider installing panic alarm systems and other direct communication technologies as part of their mandatory regular reviews of safety plans.

The measure had previously passed in the state Senate and now heads to the governor’s desk to be signed into law.

Assembly Speaker Carl Heastie said New York schools should be “safe” for students.

AP

Fabien Levy, a spokesman for Mayor Eric Adams, said the city currently doesn’t believe it needs panic buttons in Big Apple schools but will review the measure.

“Our children’s safety is our top priority, which is why all our public schools have School Safety Agents assigned to them,” Levy said in an email.

“SAAs are members of the NYPD and, thus, our schools already have a direct line to police in case of an emergency. We don’t believe there is a need for legislation to supplement the good work we’re already doing in New York City public schools, but we will review this legislation.”

The bill is named “Alyssa’s Law” after Alyssa Alhadeff, left, who died in the 2018 Parkland shooting.

AP

Alhadeff’s family had been pushing for the bill’s passage in New York for three years. It already exists in Florida and New Jersey.

Some schools in New York already use panic buttons.

https://nypost.com/2022/06/04/panic-alarms-could-be-coming-to-ny-schools-after-alyssas-law-passes/

Novel genetic experiment shrinks tough-to-treat cancer

 In a novel experiment, a woman with advanced pancreatic cancer saw her tumors dramatically shrink after researchers in Oregon turbocharged her own immune cells, highlighting a possible new way to someday treat a variety of cancers.

Kathy Wilkes isn’t cured but said what’s left of her cancer has shown no sign of growth since the one-time treatment last June.

“I knew that regular chemotherapy would not save my life and I was going for the save,” said Wilkes, of Ormond Beach, Fla., who tracked down a scientist thousands of miles away and asked that he attempt the experiment.

The research, published Wednesday in the New England Journal of Medicine, explores a new method of harnessing the immune system to create “living drugs” able to seek and destroy tumors.

“It’s really exciting. It’s the first time this sort of treatment has worked in a very difficult-to-treat cancer type,” said physician Josh Veatch of the Fred Hutchinson Cancer Research Center in Seattle, who wasn’t involved with the experiment.

It’s just a first step and far more research is needed, he cautioned — noting that Wilkes is one of only two people known to have tried this exact approach and it failed in the other patient.

Still, Veatch said the findings are “a proof of principle that this is possible” and that other researchers also are testing this type of immunotherapy.

T cells are key immune soldiers, able to kill off diseased cells — but too often cancer evades them. Doctors already have learned how to strengthen T cells to fight some types of leukemia and lymphoma. They add an artificial receptor to patients’ T cells so the immune fighters can recognize a marker on the outside of blood cancer cells, and attack.

But that CAR-T therapy doesn’t work against more common solid tumors, which don’t carry that same danger marker.

The new twist: At Oregon’s Providence Cancer Institute, researcher Eric Tran genetically engineered Wilkes’ T cells so they could spot a mutant protein that’s hidden inside her tumor cells — and only there, not in healthy cells.

How? Certain molecules sit on the surface of cells and give the immune system a sneak peek of what proteins are inside. If a complex receptor on the T cell recognizes both the person’s genetically distinct “HLA” molecule and that one of the protein snippets embedded in it is the targeted mutant, that immune fighter can latch on.

It’s an approach known as T cell receptor, or TCR, therapy. Tran stressed that the research remains highly experimental but said Wilkes’ remarkable response “provides me with optimism that we’re on the right track.”

Eric Rubin, the NEJM’s top editor, said the study raises the possibility of eventually being able to target multiple cancer-causing mutations.

“We’re talking about the chance to distinguish tumor cells from non-tumor cells in a way that we never could before,” he said.

Wilkes underwent chemotherapy, radiation and surgery for her pancreatic cancer. Later doctors discovered new tumors in her lungs — the pancreatic cancer had spread, a stage when there is no good treatment.

Wilkes knew researchers were testing immunotherapy to fight different hard-to-treat tumors, and a biopsy showed a specific mutation was fueling her cancer. Her search led to Tran, who in 2016 had co-authored a study about a subset of T cells that naturally harbored receptors able to spot that same so-called KRAS mutation.

Wilkes also had the right type of HLA molecule. So Tran and his colleague Rom Leidner, an oncologist, got Food and Drug Administration permission to reprogram her T cells to bear the special mutant-fighting receptor.

They culled T cells from Wilkes’ blood, genetically engineered them in the lab and then grew billions of copies. Six months after a transfusion of the altered cells, her tumors had shrunk by 72% — and Wilkes said recent checkups show her disease remains stable.

Tran said it’s not clear why the experiment failed in another patient, although lessons from that case that prompted some changes to Wilkes’ treatment.

The Oregon team has opened a small study to further test TCR therapy for patients with incurable cancers fueled by what Tran calls “hot-spot” mutations.

https://www.statnews.com/2022/06/01/novel-genetic-experiment-shrinks-pancreatic-cancer/

In Depp v. Heard, forensic psychiatry took the stand. Let’s correct the record

 Like millions of people around the world, we’ve found ourselves drawn to the Depp v. Heard trial. As forensic psychiatrists, we’ve had a professional interest as well as a pop culture interest, since members of our profession were in the spotlight in court.

In this unfortunate and complex clash between divorced actors, Johnny Depp sued Amber Heard for $50 million for defamation due to her 2018 Washington Post essay that implied Depp had perpetrated partner violence. Heard counter-sued Depp for $100 million for defamation, stemming from statements made by his attorney in 2020 that the abuse was a hoax. On Wednesday, the jury found that Depp had been defamed by the op-ed, and also that Heard had been defamed by Depp’s lawyer, and awarded large damages to each.

This live-streamed case has blurred lines between entertainment and the courtroom. It has also drawn attention to forensic psychiatry.

We often find it bizarre to see fictional forensic psychiatrists testify in court in movies or on television shows. Hannibal Lecter, one of the greatest villains of all time in film, is also a fictional forensic psychiatrist. A rare positive example is B.D. Wong’s portrayal of an New York Police Department forensic psychiatrist in “Law & Order: SVU.”

Seeing real-life psychiatrists in an internationally televised Virginia courtroom is even more curious, further blurring the lines between Hollywood and law. Memes were plentiful on the internet, comparing one of the psychiatrists to Doc Brown from the “Back to the Future” franchise, as well as other fictional characters.

Forensic psychiatry, which applies mental health knowledge to legal questions that could include evaluation of a possible crime or wrongdoing, is a subspecialty of psychiatry that interfaces with the law. A board-certified forensic psychiatrist is a physician who has completed medical school, a residency in general psychiatry followed by a fellowship in forensic psychiatry, and passed certification examinations.

Because most cases do not go to trial, forensic psychiatrists are often consultants who perform comprehensive psychiatric evaluations to help with a legal question relevant to psychiatry. In real life, forensic psychiatrists work with defendants with mental illness in forensic psychiatric hospitals (where they may be sent by the court if they are found insane or incompetent), assess other defendants and plaintiffs for court cases, and work in jails or prisons.

Forensic psychiatry plays an important role in consideration of insanity pleas, or whether someone is mentally fit to stand trial. It also plays a role in answering questions in contested wills or guardianship cases. Defamation cases are less common.

Forensic psychiatrists are commonly depicted in pop culture as evil, crazy, confused, dippy, activists, or hired guns — and rarely reputable. These depictions propagate a distorted view of what forensic psychiatrists do and this trial risks validating that skewed view.

In the final week of the Depp-Heard trial, two psychiatrists testified. We were surprised that neither one was a board-certified forensic psychiatrist nor had specific expertise in intimate partner violence. The psychiatrist retained by Heard’s team had proffered opinions about Depp’s mental health without the benefit of a clinical interview, raising two ethical questions: Was the American Psychiatric Association’s (APA) Goldwater Rule violated? And were the American Academy of Psychiatry and the Law (AAPL)’s practice guidelines for the forensic assessment followed?

More people have asked us about these two items in the last few days than during the entirety of our careers. The rebuttal psychiatrist retained by the Depp team explained his own understanding of the Goldwater rule and AAPL’s Practice Guidelines.

The Goldwater Rule is not generally a rule for the courtroom but for interactions with the media or the public at large. It states that psychiatrists should not give professional opinions about public figures whom they have not examined, and have not been granted authorization to share an opinion. This came about after a quite uncomfortable situation for organized psychiatry. In 1964, Fact magazine polled 12,000 psychiatrists about whether presidential candidate Barry Goldwater was fit to become president. More than 1,000 said he was not, and Fact published a special issue which highlighted this. Goldwater sued the magazine. The APA’s Principles of Medical Ethics eventually included the rule.

The Goldwater Rule had been little known outside of our field until it was raised during Donald Trump’s presidency, and then again during the Depp-Heard trial.

Just like other Americans, psychiatrists come from all sorts of political backgrounds, and one can easily envision a situation in which one psychiatrist gives an opinion about one political candidate, and another psychiatrist says the same about the opposition. The Goldwater Rule is the reason that when a psychiatrist is speaking to the media and is asked about the mental health of a public figure they haven’t evaluated, they ethically should not be giving a professional opinion.

Psychiatric opinions about an individual should not be given without appropriate effort to personally examine that individual. Nor should they be given lightly, inside or outside of a courtroom.

One paragraph of the lengthy AAPL practice guidelines says that if no interview had been conducted in a forensic assessment, that limitation should be discussed in both the report and the testimony, and the reasons why an interview was not completed should be indicated.

In this case, the court did not order Depp to comply with a psychiatric examination. The crux of his team’s argument was that the psychiatrist providing testimony on behalf of Heard did not outline the limitations of his opinion, which was made without a psychiatric examination of Depp.

Another tenet of forensic psychiatry that was not clearly presented in this trial is the concept of objectivity. According to AAPL ethics guidelines, forensic psychiatrists must strive for objectivity, no matter who is retaining them. Forensic psychiatrists are not supposed to be fact finders. Instead, their role is to aid and educate the court about the psychiatric question or questions involved. Failing to acknowledge biases compromises the integrity of the individual psychiatrists and the entire field. Over-reaching outside of areas of expertise, when it occurs, is cause for concern. Absolute opinions are rare in psychiatry and, in complicated cases such Depp v. Heard, can signal bias.

Forensic psychiatrists serve a small role in the outcome of a case. Jurors are tasked with understanding a multitude of information, as they needed to do in Depp v. Heard, and most of the time, the role of the forensic psychiatrist is narrow. Good or bad expert witnesses do not win or lose cases. However, experts who do not follow the guidelines of the field can threaten its reputation. Regardless, as exemplified by this highly publicized trial, the juxtaposition of the media with forensic psychiatry can easily distort the public perception of our field.

Susan Hatters Friedman is a psychiatrist and professor of forensic psychiatry at Case Western Reserve University. Renee Sorrentino is a psychiatrist and assistant professor of psychiatry at Harvard Medical School. Karen B. Rosenbaum is a psychiatrist and clinical assistant professor of psychiatry at New York University, Langone Medical Center.

https://www.statnews.com/2022/06/03/in-depp-v-heard-forensic-psychiatry-took-the-stand-lets-correct-the-record/

FDA: Novavax’s Covid-19 vaccine is effective, but also raise concerns

 Scientists at the Food and Drug Administration said the Covid-19 vaccine developed by the biotech Novavax was effective at preventing disease but questioned how effective it is against currently circulating strains — and raised concerns about the potential for a rare side effect.

Their analysis, laid out in briefing documents released Friday ahead of an advisory committee meeting on the vaccine, sent Novavax shares down more than 16%.

The FDA’s scientists raised concerns, in particular, about the risk of myocarditis and pericarditis associated with the vaccines. Both are types of inflammation of the heart or surrounding tissue that have also been associated with the mRNA-based Covid vaccines developed by Pfizer and its partner BioNTech and Moderna.

The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on June 7 to consider whether the Novavax vaccine should be authorized as another Covid vaccine option in the U.S. The agency is not bound by the recommendations of its outside advisory committees, but tends to follow them.

There has been interest in the Novavax vaccine because it is produced on a more traditional vaccine platform than the newer mRNA vaccines, which might convince some people who have not received a Covid vaccine to get one. The Novavax vaccine is composed of a key protein from the SARS-CoV-2 virus that is produced in insect cells and bolstered with another chemical, called an adjuvant, meant to produce an immune response. Similar technologies are used in some influenza vaccines.

But the FDA documents raise questions about how the vaccine, known as NVX-CoV2373, will be positioned if it is authorized.

“Relevant data to assess effectiveness of NVX-CoV2373 against the Omicron variant and sublineages, including observational data from use in other countries where the vaccine has been deployed, are currently unavailable,” the FDA wrote. “However, based on the efficacy estimate in the clinical trial of this vaccine, it is more likely than not that the vaccine will provide some meaningful level of protection against COVID-19 due to Omicron, in particular against more severe disease.”

It is also not clear how much a booster dose of the vaccine, currently given as a two-dose series, would increase protection.

Five of the cases of myocarditis and pericarditis in the Novavax trail were reported within two weeks of vaccination. One case may have been caused by Covid, not the vaccine, but there were no clear alternative explanations for the other cases. Four cases of heart inflammation occurred in young men, mirroring what is seen with the mRNA vaccines.

What’s more, the FDA scientists said, the identification of multiple vaccine-associated cases in a the safety database with the Novavax vaccine “raises concern that if causally associated, the risk of myocarditis following NVX-CoV2373 could be higher than reported during post-authorization use of mRNA COVID-19 vaccines.” The FDA scientists noted that myocarditis was not identified before the mRNA vaccines were authorized.

The FDA also said that an authorization of the Novavax vaccine would depend on information about the company’s manufacturing processes.

“Testing and submission of manufacturing and product information for the NVX-CoV2373 product intended for use under EUA were still in process at the time of this review,” the FDA scientists wrote.

https://www.statnews.com/2022/06/03/fda-scientists-say-novavaxs-covid-19-vaccine-is-effective-but-also-raise-concerns/

Heart inflammation found in one in eight patients after hospitalization with COVID-19

 One in eight people who were hospitalized with COVID-19 between May 2020 and March 2021 were later diagnosed with myocarditis, or heart inflammation, according to major new research into the clinical long-term effects of COVID-19.

The largest study of its kind to date was led by the University of Glasgow in collaboration with NHS Greater Glasgow and Clyde (NHS GGC), and followed for one year, in real time, 159 patients after they were hospitalized with COVID-19. The results, which show that patients hospitalized with COVID-19 between May 2020 and March 2021 have a number of ongoing health conditions, are published in Nature Medicine.

The study also looked at why some patients suffer long-term ill health after hospitalization with COVID-19. Until now it has been speculated that previous underlying health conditions may be linked to the severity of post-COVID long-term effects. However, this new landmark study suggests that it is the severity of the COVID-19 infection itself which is most closely correlated to the severity of a patient's long-COVID symptoms, rather than pre-existing health problems.

The CISCO-19 (Cardiac Imaging in SARS Coronavirus disease-19) study, which was funded in May 2020 as part of a Scottish Government Chief Scientist Office Rapid Research Response aimed at increasing the understanding of the coronavirus pandemic, followed patients in real time after hospitalization with COVID-19 and compared their health to those in a control group of individuals of similar age, sex and medical background. Assessments included blood tests, and CT and MRI scans of multiple organs, including the heart, kidneys and lungs, as well as measuring patients' own opinions on their own ongoing health via questionnaires. Clinical outcomes including survival, hospital readmission and referral to outpatient clinics were also assessed. The study is ongoing, supported by NHS GGC, and will continue to follow up with patients at 18 months and 5 years post hospitalization.

Hospitalization with COVID-19 was found to cause a number of long-term health problems. Researchers found 1 in 8 patients hospitalized with COVID-19 have heart inflammation, while inflammation across the body and damage to the other organs such as the kidneys was also common. These problems clustered in individuals pointing to the overall severity of COVID-19 as being the main driver of illness. Exercise capacity and health related quality of life were markedly impaired initially after discharge from hospital and remained reduced one to two months after discharge—this was especially the case in patients with heart inflammation.

During a period of 450 days after discharge from hospital, one in seven patients died or were readmitted to hospital, and two in three patients required NHS outpatient care.

Patients were given questionnaires on the same day they underwent blood tests and scans, before they had been given clinical results, in order to gain a true understanding of how they were feeling post hospitalization. From these questionnaires, having been hospitalized with COVID-19 was associated with a worse health-related quality of life as well as with anxiety and depression.

Professor Colin Berry, principle investigator of the CISCO-19 study and professor of Cardiology and Imaging at the University of Glasgow, said: "COVID-19 is a multi-system disease, and our study shows that injury on the heart, lungs and kidneys can be seen after initial hospitalization in scans and blood tests. These results bridge a vital knowledge gap between our current understanding of post-COVID-19 syndromes, such as Long COVID, and objective evidence of ongoing disease.

"One of the most important findings of the CISCO study is that it is the severity of a patient's COVID-19 infection—not their underlying health conditions—that is most closely correlated with the severity of any ongoing health outcomes post discharge. We found that previously healthy patients, without any underlying health conditions, were suffering with severe health outcomes, including myocarditis, post hospitalization.

"The reasons for this are unclear, but it may be that a healthy person who is hospitalized with COVID-19 is likely to have a worse COVID infection than someone with underlying health conditions who is hospitalized. More work needs to be done here to understand the risks, and also on how we can better support patients who have ongoing health outcomes after being hospitalized with COVID-19."

Long COVID has been found to predominately affect females. CISCO found that female sex was associated with myocarditis, which in turn was linked with lower mental and physical well-being. Researchers believe these findings provide some answers that could explain the physical limitations experienced by some female patients post COVID-19 hospitalization.

Considering clinical translation into healthcare, the results highlight the need for focused use of medical tests, new therapy development and rehabilitation. The results also highlight the importance of avoiding severe COVID-19 such as by vaccination.

Professor Julie Brittenden, Director of Research and Innovation at NHSGGC, said: "NHSGGC is pleased to have played an important role in this study, which has further enhanced our understanding of the long term effects of COVID-19 in patients who required to be hospitalized.

"I would like to thank all of our patients who have taken part in this study, as well as the wider research teams who continue to work to improve knowledge, develop treatment options and improve outcomes of patients with COVID-19 "

Professor David Crossman, Chief Scientist (Health) for Scotland at the time the study was funded, said: "This study provides important insight into the longer-term effects of COVID-19 infection, and will help inform approaches to treatment going forward. The Chief Scientist Office is pleased to have funded this research as part of the £5 million Rapid Research in COVID-19 program."

The CISCO study focuses on people hospitalized with COVID-19, however other studies looking at community COVID infections—infections not severe enough to result in hospitalization—have reported more encouraging data on long term health recovery. Patients in this study were enrolled during the first and second waves of the pandemic, until March 2021, and as a result they were mainly unvaccinated.

Among the patients enrolled in the study, risk factors for heart disease were common, including overweight or obesity, high blood pressure and pre-diabetes or diabetes.

Staff from several hospitals in the West of Scotland supported the project, including the Queen Elizabeth University Hospital and the Royal Infirmary in Glasgow, the Royal Alexandra Hospital in Paisley, Hairmyres Hospital in NHS Lanarkshire and the NHS Golden Jubilee in Clydebank.

Dr. Kenneth Mangion, clinical lecturer in cardiology at the University of Glasgow, and co-senior author, said: "We are grateful for the support from the Chief Scientist Office, NHS GG&C, NHS R&D. We are also grateful to all co-investigators, clinicians, research nursing staff, scientists, lab technicians radiographers, who have all worked together to help deliver this project."

The study, "Multisystem, cardio-renal investigation of post-COVID illness," is published in Nature Medicine.

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More information: "Multisystem, cardio-renal investigation of post-COVID illness," Nature Medicine (2022).

https://medicalxpress.com/news/2022-05-heart-inflammation-patients-hospitalization-covid-.html

Mystery hepatitis in children may have been here all along

 The children typically show up at hospitals scattered across the country, one or two at a time, with symptoms like unexplained vomiting, diarrhea and jaundice. These are the classic signs of hepatitis—inflammation of the liver—yet in many cases, no cause is ever identified.

That's why the nation's disease detectives are so intrigued by the evidence emerging from more than 200 pediatric hepatitis cases dating back to October, including a handful from Pennsylvania, New Jersey, and Delaware.

Close to half of the children, including an initial nine identified in Alabama, tested positive for an adenovirus—a type of virus not normally associated with hepatitis.

It's possible that the virus has been responsible all along for many of the cases for which no cause is ever identified, CDC officials said at a briefing. An investigation remains underway, in cooperation with officials in 32 other countries where cases have been reported. As of Friday, 650 cases are under investigation worldwide, the World Health Organization said.

The CDC also is investigating whether some sort of "co-factor" is involved, causing the children to become sicker from the adenovirus than would otherwise be the case. Among the early possibilities considered: the virus that causes COVID-19.

And investigators are looking for other possible causes of the hepatitis, such exposure to drugs, toxins, or food, but so far an adenovirus infection remains a leading theory, said Jay Butler, the CDC's deputy director for infectious diseases. The unusual cluster last fall in Alabama was the first clue.

"This is the type of shoe-leather epidemiology that our disease detectives are trained to do," he said.

Six of the U.S. children died, and 15 have needed liver transplants, whereas symptoms were moderate or mild in the rest. The CDC did not specify where the six deaths occurred in order to protect patient privacy, agency officials said.

St. Christopher's Hospital for Children has reported two cases to the Philadelphia Department of Public Health, said Janet Chen, section chief of infectious diseases at the North Philadelphia hospital. She noted that the likelihood that COVID plays a role in the unknown hepatitis seems to be weakening. But it's too soon to rule it out entirely.

"If the last two years have taught us anything, COVID is involved in a lot of things," she said.

The liver is a complex organ, ridding the body of toxins while making other substances that are essential for survival, among them proteins used in clotting blood. The organ also is involved in producing cholesterol, and it stores energy in the form of glucose.

Hepatitis is a catchall term for inflammation in the organ. And while other viruses are known to cause it (the hepatitis viruses A, B, and C are the most common), adenoviruses have been implicated only in cases where the child's immune system is compromised.

The unusual cluster last fall in Alabama pointed epidemiologists in the direction of the adenovirus.

In cases where the virus could be subjected to genetic testing, labs have identified a specific type called adenovirus 41.

For children whose samples are no longer available for viral testing, the other case details are still valuable in establishing the scope of disease, said Jim Squires, an associate professor of pediatrics in the division of gastroenterology and hepatology at UPMC Children's Hospital of Pittsburgh.

That hospital has identified several such cases that meet the CDC's broad definition for inclusion: children in whom a type of liver enzyme was elevated, he said.

"It's getting a denominator of how many cases are out there," said.

Still, Squires agreed with CDC officials that the adenovirus was a possible culprit in the recent cases.

Yet uncertainty remains. Generally, the adenovirus was not found in the children's livers, but in their blood.

As more and more hepatitis cases have been identified, COVID is looking less likely as a contributing factor. The percentage of cases in children who turned out to have a recent or current infection with the coronavirus has dipped below 20%, the CDC's Butler said.

If the adenovirus turns out to be the prime culprit, it could, in theory, be prevented with the same tool we've used against COVID: a vaccine.

A vaccine that protects against two other types of adenoviruses is recommended for members of the U.S. military, though no adenovirus vaccine is on the recommended schedule for children.

"I think everything's on the table," said Chen, of St. Christopher's Hospital for Children. "We have to kind of wait and see how this plays out."

https://medicalxpress.com/news/2022-06-mystery-hepatitis-children.html