Publisher Health

After reports of smart phone and watch interference with implanted medical devices, investigators affiliated with the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration conducted a study that supports the FDA recommendation that patients keep any consumer electronic devices that may create magnetic interference, including cell phones and smart watches, at least six inches away from implanted medical devices, in particular pacemakers and cardiac defibrillators. Their findings appear in Heart Rhythm, the official journal of the Heart Rhythm Society, the Cardiac Electrophysiology Society, and the Pediatric & Congenital Electrophysiology Society, published by Elsevier.
“Ensuring the safety of our nation’s medical devices is a cornerstone of our consumer protection mission, especially as technology continues to advance,” explained lead investigator Seth J. Seidman, MS, Research Electrical Engineer and EMC Program Advisor with the CDRH. “As part of this work, the agency reviewed recently published articles describing the possibility that certain newer cell phones, smart watches, and other consumer electronics with high field strength magnets may temporarily affect the normal operation of implanted electronic medical devices, such as pacemakers and implantable defibrillators. Based on our review, we decided to conduct our own testing to confirm and help inform appropriate recommendations for patients and consumers.”
Cardiac implanted electronic devices are intended to support heart rhythm disorders, such as slow or fast heart rates. Implantable pacemakers and cardioverter defibrillators (ICDs) include a “magnet mode” designed to be used when a patient is undergoing a procedure where electromagnetic interference is possible, or when suspension of the device is necessary for medical treatment. However, this feature can also be triggered accidentally from strong magnetic fields greater than 10G, which can change how the device works and could result in serious harm to the patient.
Historically, magnets strong enough to trigger this magnet mode were very large and identifiable, such as stereo speakers or electronic motors in cordless tools. With the advent of small rare-earth magnets, however, strong magnetic fields can be found in headphones, door locks, or small phone speakers.
The investigators tested the magnetic field output of all iPhone 12 and Apple Watch 6 models at varying distances from the devices. They found that all the devices have static magnetic fields significantly greater than 10G in close proximity, high enough to place implanted cardiac devices into magnet mode. However, when a separation distance of six inches or more is maintained, the phones and watches will not trigger magnet mode.
“Because of these results, we are taking steps to provide information for patients and healthcare providers to ensure they are aware of potential risks and can take simple proactive and preventive measures like keeping consumer electronics, such as certain cell phones and smart watches, six inches away from implanted medical devices and not carrying consumer electronics in a pocket over the medical device,” advised Mr. Seidman.
“We believe the risk to patients is low and the agency is not aware of any adverse events associated with this issue at this time. However, the number of consumer electronics with strong magnets is expected to increase over time. Therefore, we recommend people with implanted medical devices talk with their healthcare providers to ensure they understand this potential risk and the proper techniques for safe use. The FDA will continue to monitor the effects of consumer electronics on the safe operation of medical devices,” noted Mr. Seidman.
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Genomics, proteomics, metabolomics, transcriptomics — rapid advances in high-throughput biomedical technologies has enabled the collection of data with unprecedented detail from the growing number of omics. But, how best to take advantage of the interactions and complementary information in omics data?
To fully utilize the advances in omics technologies to achieve a more comprehensive understanding of the biological processes underlying human diseases, researchers from Regenstrief Institute and Indiana, Purdue and Tulane Universities have developed and tested MOGONET, a novel multi-omics data analysis algorithm and computational methodology. Integrating data from various omics provides a more holistic view of biological processes underlying human diseases. The creators have made MOGONET open source, free and accessible to all researchers.
In a study published in Nature Communications, the scientists demonstrated that MOGONET, short for Multi-Omics Graph cOnvolutional NETworks, outperforms existing supervised multi-omics integrative analysis approaches of different biomedical classification applications using mRNA expression data, DNA methylation data, and microRNA expression data.
They also determined that MOGONET can identify important omics signatures and biomarkers from different omics data types.
“With MOGONET, our new AI [artificial intelligence] tool, we employ machine learning based on a neural network, to capture complex biological process relationships. We have made the understanding of omics more comprehensive and also are learning more about disease subtypes that biomarkers help us differentiate,” said Regenstrief Institute Research Scientist Kun Huang, PhD, who led the study. “The ultimate goal is to improve disease prognosis and enhance disease-outcome predictions.” A bioinformatician, he credits the diversity of the MOGONET research group, which included computer scientists as well as data scientists and bioinformaticians, with their varying perspectives, as instrumental in its development and success. He serves as director of data sciences and informatics for the Indiana University Precision Health Initiative.
The researchers tested MOGONET on datasets related to o Alzheimer’s disease, gliomas, kidney cancer and breast invasive carcinoma as well as on healthy patient datasets. They determined MOGONET handily outperformed existing supervised multi-omics integration methods.
“Learning and integrating intuitive recognition, MOGONET could generate new biomarker disease candidates,”said study co-author Regenstrief Institute Affiliated Scientist Jie Zhang, PhD, a bioinformatician. “MOGONET also could predict new cancer subtypes, tumor grade and disease progression. It can identify normal brain activity versus Alzheimer’s disease.”
Drs. Huang and Zhang plan to expand this work beyond omics to include imaging data, noting the abundance of brain images for AD and cancer-related pathology images which can teach MOGONET to recognize even cases it had not previously encountered. Both scientists note that following rigorous clinical studies, MOGONET could support improved patient care in many areas.
In addition to Drs. Huang and Zhang, authors of “MOGONET integrates multi-omics data using graph convolutional networks allowing patient classification and biomarker identification” are Tongxin Wang, PhD, and Haixu Tang, PhD, of Indiana University, Wei Shao, PhD, of IU School of Medicine; Zhi Huang of IU School of Medicine and Purdue University; and Zhengming Ding, PhD of Tulane University. Dr. Wang worked in Dr. Huang’s laboratory. Dr. Ding, formerly of Indiana University, is an expert in the field of machine learning.
The development and testing of MOGONET was supported by National Institutes of Health grants R01EB025018 and U54AG065181 and the Indiana University Precision Health Initiative.
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Vaccination remains the best defense, health experts say. But some infections occur regardless, and can come as a traumatic surprise.For Moira Smith and her mother, July promised a glimmer of normalcy after months of isolation. The two flew from Alaska to Houston and visited family, celebrating the first birthday of their cousin’s granddaughter. Ms. Smith’s mother bought a patterned pink onesie to give as a gift, and they all snapped photos of the baby’s face smeared with chocolate.Ms. Smith, 46, knew that her cousin’s family was not vaccinated but tried not to dwell on that. She and her mother had both received their Pfizer shots months earlier. In the hotel room one evening, Ms. Smith’s mother made an offhand comment to her relatives: “You can take your masks off but you have to promise to get vaccinated,” she chided them.The next morning Ms. Smith and her mother were headed home, on a layover in the Seattle airport, when they got the phone call: Their relative’s baby had come down with a fever and tested positive for Covid-19.Two days later, Ms. Smith woke up feeling like she had been “hit by a Mack truck,” with body aches and a sore throat, and tested positive for the coronavirus. The next week, her mother, who is 76 and has lung cancer, texted her an emoji of a thermometer indicating she, too, had spiked a fever, and she later wound up in the emergency room with Covid.Ms. Smith and her mother are part of a wave of Americans falling sick with Covid even though they are fully immunized, in what are known as breakthrough infections.Public health experts continue to believe that breakthrough infections are relatively uncommon, and rarely result in severe illness or hospitalizations. The vaccines available in the United States offer powerful protection from serious Covid illness, hospitalization and death. A recent analysis of state-reported data from the Kaiser Family Foundation found that more than nine in 10 Covid-19 cases that resulted in hospitalization and death occurred among people who were not fully vaccinated.“We always anticipated that there would be some breakthrough infections because the vaccines at their very best were 95 percent effective,” said Dr. William Schaffner, professor of infectious disease at Vanderbilt. “The vaccines were designed to prevent severe illness, and they’re spectacularly successful at that.”But as the more transmissible Delta variant becomes dominant in the United States, rising numbers of breakthrough cases are being reported, although most are mild.“Delta is vastly more contagious, so as it is spreading among the unvaccinated there is spillover into the vaccinated population,” Dr. Schaffner said. “The unvaccinated are a big highway of transmission. The vaccinated are a little side street.”Elaina Cary-Fehr’s father Isaac was transferred to long-term care facility after being hospitalized with Covid in June.“I hate that this had to happen to my family,” she said.Cindy Elizabeth for The New York TimesBecause people infected with the Delta variant have far more of the virus in their nose and upper respiratory tract, the importance of mask-wearing has become paramount. After the Centers for Disease Control and Prevention shifted its guidance on masking, recommending that vaccinated people in hot-spot areas resume wearing masks in public indoor spaces, millions of Americans who are fully immunized struggled to adjust their expectations for autumn months that had seemed to offer some semblance of festivity. And a small subset of Americans has already seen their routines upended by breakthrough infections.Spurred by concerns about breakthrough infections, federal health officials recently recommended that Americans who received the Pfizer or Moderna vaccines receive a third dose in the coming months. This week Johnson & Johnson reported that a booster shot of its vaccine raised levels of antibodies against the coronavirus.For some, breakthrough infections have felt like mild allergies, coming with symptoms including a cough, sniffles and a scratchy throat. Others have had more severe cases, where they are bedridden with body aches, fevers and chills. And still others have had some of the telltale signs of Covid such as loss of taste and smell, “Covid rash” and brain fog.“We were calling it floaty-head syndrome,” said Molly O’Brien-Foelsch, 47, a marketing executive in Pennsylvania who tested positive for Covid after a trip to the British Virgin Islands with her husband last month. “It felt like there was a huge marshmallow on my head.”Scientists believe that breakthrough infections rarely result in severe illness, but there have been cases of prolonged hospitalizations. Elaina Cary-Fehr’s father Isaac, a 64-year-old Uber driver in Austin, was transferred to a long-term care facility after being hospitalized with Covid pneumonia in June and later receiving a tracheotomy tube. He was released from the facility this week.“I believe in the vaccine, I kept holding on to hope that it would work and it did,” Ms. Cary-Fehr said. “But I hate that this had to happen to my family.”Dr. Rebecca Hughes, 32, works as an emergency medicine resident in Boston, so she had spent the last year with a simmering sense of anxiety about Covid exposure. She can still recall the fear she felt the first time she treated a coding Covid patient and wondered for hours whether her mask might have slipped and put her at risk. But all year she was kept safe by her protective equipment.Then, last month, her family took a vacation to visit her grandparents in Utah. It was a trip they had hoped to take last February but postponed as Covid case rates rose. Four days after they landed, Dr. Hughes felt her throat becoming scratchy. She was certain it was allergies but took a Covid test just in case; it came back positive. Shortly afterward her newborn, who was 9 weeks old, started sneezing and tested positive too, along with Dr. Hughes’s three other children, ages 8, 6 and 3.Jimmy Yoder, right, and his partner, Kyle Smith, felt ill after a weekend in Provincetown last month. “In the back of my mind I was like, ‘There is no way I’m going to get Covid,’ “ Mr. Yoder said.Gabriela Bhaskar/The New York Times“It felt ironic after I spent so long caring for Covid positive patients on every single shift since the pandemic started,” Dr. Hughes said. “My 8-year-old knows I’ve been seeing people die from this. She looked at me and said, ‘Am I going to be OK?’”Although some breakthrough infections like Dr. Hughes’s are difficult to trace to a precise exposure event, other Americans have found their vacation plans intersecting with well-known outbreaks..css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-3btd0c{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:1rem;line-height:1.375rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-3btd0c{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-3btd0c strong{font-weight:600;}.css-3btd0c em{font-style:italic;}.css-w739ur{margin:0 auto 5px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-w739ur{font-size:1.25rem;line-height:1.4375rem;}}.css-9s9ecg{margin-bottom:15px;}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}.css-uf1ume{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-box-pack:justify;-webkit-justify-content:space-between;-ms-flex-pack:justify;justify-content:space-between;}.css-wxi1cx{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:column;-ms-flex-direction:column;flex-direction:column;-webkit-align-self:flex-end;-ms-flex-item-align:end;align-self:flex-end;}.css-12vbvwq{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-12vbvwq{padding:20px;width:100%;}}.css-12vbvwq:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-12vbvwq{border:none;padding:10px 0 0;border-top:2px solid #121212;}.css-12vbvwq[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-12vbvwq[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-12vbvwq[data-truncated] .css-5gimkt:after{content:’See more’;}.css-12vbvwq[data-truncated] .css-6mllg9{opacity:1;}.css-qjk116{margin:0 auto;overflow:hidden;}.css-qjk116 strong{font-weight:700;}.css-qjk116 em{font-style:italic;}.css-qjk116 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:visited{color:#326891;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:hover{-webkit-text-decoration:none;text-decoration:none;}Jimmy Yoder, 25, felt no trepidation as he and his boyfriend, both vaccinated, packed their bags to spend a weekend in Provincetown in July. And because their days and nights there were a blur of clubs and dancing, he assumed that the Monday morning fatigue that greeted him back in Brooklyn was just a bad hangover.“I was feeling a little rundown but attributed it to a weekend of partying,” Mr. Yoder said. “In the back of my mind I was like, ‘There is no way I’m going to get Covid, I’m immune.’ ”By Wednesday morning, Mr. Yoder no longer felt so confident. “I felt like I had a really bad flu,” he said, with a high fever and congested sinuses. He and his boyfriend both tested positive that day. Mr. Yoder slept for the next 18 hours, and when he and his boyfriend were both starting to feel better they ordered a celebratory pizza. They realized then that they had both lost their sense of taste and smell.Mr. Yoder was relieved to find that of all the people he had exposed — friends who had driven him home from Provincetown, an office full of colleagues — only one tested positive. “Obviously it shows the vaccines are still working a lot,” he added.As many Americans begin the familiar exercise of questioning and calling off plans, scientists are stressing the continued importance of mask-wearing to reduce transmission and infection.“If you get infected and breathe virus out, it will get trapped by your mask,” said Dr. John Moore, a professor of microbiology and immunology at Weill Cornell. “These viruses don’t have pairs of scissors that can cut through masks.”

Could all this really be a result of a urinary-tract infection?The 75-year-old man lay sprawled on the floor between the kitchen counter and the island, surrounded by a halo of pills. “What happened?” his wife asked as she hurried to his side, although she suspected she already knew.He wasn’t sure, he told her. One minute he was standing at the counter, getting ready to take his morning medications; the next, just like that, he was on the floor. She helped him sit up. When he was able to, he slowly rose to his feet. It was the third time he fainted in the last week and a half. The first spell came when his wife was out of town. He was dozing on the patio and woke up hot and sweaty. As he made his way into the house, he felt unsteady and braced himself on the wall. He made it to a chair but passed out a couple of times just sitting there. And when awake, he was confused. He was trying to read a text from his daughter but couldn’t remember how.The next time, a couple of days later, he woke to go to the bathroom. He got up, then suddenly found himself on the floor. A sharp pain in his forehead told him he’d clipped the bedside table on his way down. His wife helped him up and to the bathroom. He found that he’d been incontinent. He was embarrassed, in front of his wife of 53 years. He called his doctor’s office the next morning and arranged to come in the following day. He hadn’t been feeling well for the past couple of weeks, he told the young physician assistant. He’d woken up drenched with sweat a few times recently, and his wife told him he rattled the bed with his shivering. He felt feverish. Tired. No appetite. No ambition. Foggy. One night he wasn’t even able to remember the prayer he always said before bed. And urinating was strangely uncomfortable.After finishing her exam, the physician assistant sent him to the lab. This was probably a urinary-tract infection, she told him after reviewing his test results. These are not uncommon in older men, because an enlarging prostate can make it hard to urinate. She started him on an antibiotic often used to treat this kind of infection.That was just two days before this most recent episode. The P.A. told him to go to the hospital if he felt any worse. He definitely felt worse.A Highly Motivated ClinicianIn the emergency department of the Yale New Haven Hospital, it was clear that the elderly man was sick. He had a fever of 101, his heart was racing and his blood pressure was abnormally low, even though he hadn’t taken his hypertension medications that morning. Lab results confirmed that first impression. His kidneys were failing — though they were fine just two days earlier. He was given IV fluids and started on broad-spectrum antibiotics. The drug he’d been taking for the past couple of days didn’t seem to be doing the job.On the floor, the first clinician the patient met was Alan Lee, who was in his last year of med school and serving as an intern. Lee was excited to see this patient. Because the hospital was so crowded, thanks in part to the recent resurgence in Covid-19 cases, patients often spent hours, sometimes days, in the E.R. waiting for a bed. By the time they got onto a medical floor, they could already have a doctor assigned. This meant most of the thinking about the patient had been done, and the accepting physician usually just carried out the first doctor’s plan. This Sunday-morning admission came during a lull in the action, so Lee’s team would get the first crack at figuring out what was going on.The doctors in the E.R. were focused on the man’s failing kidneys, but what injured those kidneys? What caused the fever? These were the questions Lee had to answer for himself and for the patient. The young man entered the room accompanied by his supervising resident, Dr. Roger Ying. They introduced themselves, and Lee started asking questions. The patient told the story of his three episodes of fainting, how he felt feverish and sick and how he lost 10 pounds in the past week or so because he felt too sick to eat or drink.Once Lee finished his questions, Ying asked the patient if he had been bitten by a tick recently. Absolutely not, the man answered promptly. He often took his dog to wooded paths down by the Connecticut River, but once he got home, he was careful to check his body for ticks.Dr. Joseph Donroe, the attending physician, joined the trainees at the bedside. Lee acknowledged that a urinary-tract infection could have caused the man’s urinary problems as well as the fever. Those symptoms could make the patient not want to eat or drink, allowing him to become dehydrated. That, in turn, could have caused him to faint and could have even damaged his kidneys. But a 10-pound weight loss was not a common finding in a urinary-tract infection. Neither was night sweats. Could this be a tick-borne illness like Lyme?Photo illustration by Ina JangThe Most Likely DiagnosisDonroe agreed that these symptoms were atypical. It seemed likely the patient now had urosepsis — an infection that started in the urinary tract but then involved the entire body — and that the cause of his symptoms was a urinary infection. But because he was already on antibiotics, they probably wouldn’t see anything in the urine if they tested him now. Lee should call the patient’s primary-​care doctor Monday morning to get the results of the tests done before he had started the antibiotics.The next day, the patient was feeling a lot better. He’d gotten fluids and a good night’s sleep. No fever, no shaking chills. Maybe the antibiotics were working. Still, his kidneys were no better.After rounds, Lee called the patient’s doctor. The urine culture hadn’t grown anything at all. The only abnormality was that the urine contained a lot of blood. Now what? Lee went to the attending with the news. Together Lee and Donroe went over the data one more time. One of the labs ordered suggested that red blood cells were being destroyed somewhere in the body. Suddenly it all made sense.The man had been sick for nearly two weeks with fevers and chills, and he had something destroying his red blood cells. To Donroe that sounded like a tick-borne disease. Not Lyme, but a different disease carried by the same type of tick: a disease called babesiosis. They should order a test for Babesia as well as one for Lyme, ehrlichiosis and anaplasmosis — the most common tick-borne diseases in Connecticut.It was late afternoon when the first result came back. Inside many of the patient’s red blood cells, the lab tech had seen a single tiny dark circle — a parasite. The patient had babesiosis.A Circle or a CrossBabesia is a protozoan, a single-celled parasitic organism, carried by the deer tick. This arachnid picks up the bug while feeding on a white-footed mouse and delivers it to the next mammal it bites. Once the organisms enter the circulation, they invade red blood cells, where they multiply. Under the microscope the organisms look like either a circle or a cross depending on where they are in maturation and reproduction. Then progenitor and offspring burst out of the cell, enter neighboring red blood cells and the process continues.In the Northeast, the deer tick is best known as the carrier of Lyme disease. And in fact, up to 42 percent of ticks that carry Babesia also carry Lyme disease, according to a study from a Connecticut state lab. The following day, the team learned that it was true for the tick that bit this patient as well. He had both Lyme and babesiosis, and so needed to be treated with three medications — two for the Babesia and one for the Borrelia, the bacteria that cause Lyme disease. He would have to take them for about two weeks.The patient could feel the difference the day after he started taking the medications. His appetite was back. So was his energy. Now that he is back home, he is considering how to deal with those ticks. He knows they’re not going anywhere, but neither are he and his wife. He already uses a spray to discourage their bites. Clearly he will just have to look a lot harder after his walks with the dog. He’s not going to let the arachnids win.Lisa Sanders, M.D., is a contributing writer for the magazine. Her latest book is ‘‘Diagnosis: Solving the Most Baffling Medical Mysteries.’’ If you have a solved case to share with Dr. Sanders, write her at Lisa.Sandersmd@gmail.com.

Physical activity among young people can be improved by well-designed and delivered online interventions such as ‘exergames’ and smartphone apps, new research shows.
According to a review study carried out at the University of Birmingham, children and young people reacted positively in PE lessons to the use of exergames, which deliver physical activity lessons via games or personalised activities. Changes included increases in physical activity levels, but also improved emotions, attitudes and motivations towards physical activity.
The study, published in Physical Education and Sport Pedagogy is one of the first to examine not only the impact of online interventions on physical behaviours in non-clinical groups of young people but the effects of digital mediums on physical activity knowledge, social development and improving mental health.
The evidence can be used to inform guidance for health and education organisations on how they can design online interventions to reach and engage young people in physical activity.
The authors analysed 26 studies of online interventions for physical activity. They found three main mechanisms at work: gamification, in which participants progress through different levels of achievement; personalisation, in which participants received tailored feedback and rewards based on progress; and information, in which participants received educational material or guidance to encourage behavioural change.
Most of the interventions were focused on gamification or personalisation and the researchers found the majority of studies (70%) reported an increase and/or improvement in outcomes related to physical activity for children and young people who participated in online interventions. Primary school age pupils in particular who participated during PE lessons benefited.
Lead author Dr Victoria Goodyear, in the University of Birmingham’s School of Sport, Exercise and Rehabilitation Science, said: “We find convincing evidence that PE teachers can use online learning to boost attitudes and participation in physical activity among young people, particularly at primary school age. There’s a real opportunity here for the PE profession to lead the way in designing meaningful and effective online exercise opportunities, as well as an opportunity to embed positive approaches to exercise and online games and apps at an early stage.”
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Variations in the 16p11.2 region of the genome are associated with autism spectrum disorder. While people with genetic deletions in this region have larger heads (macrocephaly) and people with genetic duplications have smaller heads (microcephaly), both variation types affect brain development and function.
To study the effects of these variations and search for ways to minimize their impact, University of California San Diego School of Medicine researchers are using brain organoids — tiny, 3D cellular models generated in the lab from people with 16p11.2 variations.
The organoids, described in a paper publishing August 25, 2021 in Molecular Psychiatry, mimicked the differences in brain size seen in people. They also revealed new information about the molecular mechanisms that malfunction when the 16p11.2 region of the genome is disrupted, providing new opportunities for potential therapeutic intervention.
“Because our organoids recapitulate the head size of the patients, that tells us this can be a useful model,” said senior author Lilia Iakoucheva, PhD, associate professor of psychiatry at UC San Diego School of Medicine. “And we need better models to study autism spectrum disorder, especially during fetal development.”
Iakoucheva led the study with Alysson Muotri, PhD, professor of pediatrics and cellular and molecular medicine at UC San Diego School of Medicine.
The brain organoids were created using induced pluripotent stem cells derived from people who have 16p11.2 genomic variations — three people with deletions, three with duplications and three non-variant controls. Researchers obtained a skin sample from each person, gave the skin cells a molecular cocktail that converted them to stem cells, then treated the stem cells in a way that coaxed them into becoming brain cells, preserving each patient’s unique genetic background.
The organoids revealed that RhoA — a protein that plays a big part in many basic cellular functions, such as development and movement — is more active in both 16p11.2-deleted and 16p11.2-duplicated organoids than it is in organoids without these variations. Over-active RhoA led to a slowdown in neuronal migration, the process by which brain cells get to where they need to be for normal fetal development and function in adulthood.
When the team inhibited RhoA in the autism-like organoids, neuronal migration was restored to levels seen in the control organoids.
“Our work opens the possibility to therapeutically manipulate the RhoA pathway,” said Muotri, who is also director of the UC San Diego Stem Cell Program and a member of the Sanford Consortium for Regenerative Medicine. “The same pathway may be also damaged in other individuals with autism spectrum disorder who have macrocephaly or microcephaly. Considering this, we can potentially help millions of patients.”
Organoids aren’t perfect reproductions of the brain. They lack connections to other organ systems, such as blood vessels, and so don’t encapsulate full human biology. In addition, therapeutics tested on brain organoids are added directly. They don’t need to get across the blood-brain barrier, specialized blood vessels that keep the brain largely free of microbes and toxins.
The team plans to further test RhoA inhibitors in a mouse model with 16p11.2 variations or over-active RhoA for their ability to reverse defects associated with autism spectrum disorder.
Co-authors include: Jorge Urresti, Pan Zhang, Patricia Moran-Losada, Priscilla D. Negraes, Cleber A. Trujillo, Danny Antaki, Megha Amar, Kevin Chau, Akula Bala Pramod, Leon Tejwani, Sarah Romero, and Jonathan Sebat, all at UC San Diego; Nam-Kyung Yu, Jolene Diedrich, and John R. Yates III, Scripps Research.
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Materials provided by University of California – San Diego. Original written by Heather Buschman, PhD. Note: Content may be edited for style and length.

Congress appropriated $16 billion to ramp up Covid-19 countermeasures, but a new report found that the Biden administration had spent very little of it on expanding vaccine manufacturing capacity.WASHINGTON — President Biden, who has pledged to fight the coronavirus pandemic by making the United States the “arsenal of vaccines” for the world, is under increasing criticism from public health experts, global health advocates and even Democrats in Congress who say he is nowhere near fulfilling his promise.Mr. Biden has either donated or pledged about 600 million vaccine doses to other countries — a small fraction of the 11 billion that experts say are needed to slow the spread of the virus worldwide. His administration has also taken steps to expand Covid-19 vaccine manufacturing in the United States and India, and is supporting production in South Africa and Senegal to expand access to locally produced vaccines in Africa.But with the administration now recommending booster doses for vaccinated Americans starting next month, outraged public health experts and many Democrats on Capitol Hill are calling on the president to move more aggressively to scale up global manufacturing. In an analysis to be published on Thursday, the AIDS advocacy group PrEP4All found that the administration had spent less than 1 percent of the money that Congress appropriated for ramping up Covid-19 countermeasures on expanding vaccine manufacturing.Congress put a total of $16.05 billion in the American Rescue Plan this year, in two separate tranches, that could be used to procure and manufacture treatments, vaccines and tools for ending the pandemic. But PrEP4All found that all told, the administration had spent $145 million — just $12 million of it from the American Rescue Plan — to expand vaccine manufacturing. The bulk of that went to retrofitting production lines at Merck, the pharmaceutical giant, which is teaming up with Johnson & Johnson to produce one billion vaccine doses starting in early 2022.White House officials dispute the $145 million figure, but did not respond to repeated questions about how the administration planned to use the bulk of the $16 billion. Senator Patty Murray, Democrat of Washington and the chairwoman of the Senate health committee, has also asked for a more detailed accounting, her office said.On Capitol Hill, 116 Democrats, including Senator Elizabeth Warren of Massachusetts, have called for putting $34 billion to increase vaccine manufacturing capacity in the upcoming budget reconciliation act. This month, they wrote to the president asking him to endorse the idea, but have not gotten a response, said Representative Raja Krishnamoorthi, Democrat of Illinois, who is leading the effort in the House.“This lack of attention to executing a robust vaccination strategy abroad is arguably one of their biggest missteps with regard to Covid,” said Mr. Krishnamoorthi, who said he lost three members of his extended family in India to Covid-19..css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-3btd0c{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:1rem;line-height:1.375rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-3btd0c{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-3btd0c strong{font-weight:600;}.css-3btd0c em{font-style:italic;}.css-w739ur{margin:0 auto 5px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-w739ur{font-size:1.25rem;line-height:1.4375rem;}}.css-9s9ecg{margin-bottom:15px;}.css-uf1ume{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-box-pack:justify;-webkit-justify-content:space-between;-ms-flex-pack:justify;justify-content:space-between;}.css-wxi1cx{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:column;-ms-flex-direction:column;flex-direction:column;-webkit-align-self:flex-end;-ms-flex-item-align:end;align-self:flex-end;}.css-12vbvwq{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-12vbvwq{padding:20px;width:100%;}}.css-12vbvwq:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-12vbvwq{border:none;padding:10px 0 0;border-top:2px solid #121212;}.css-12vbvwq[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-12vbvwq[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-12vbvwq[data-truncated] .css-5gimkt:after{content:’See more’;}.css-12vbvwq[data-truncated] .css-6mllg9{opacity:1;}.css-qjk116{margin:0 auto;overflow:hidden;}.css-qjk116 strong{font-weight:700;}.css-qjk116 em{font-style:italic;}.css-qjk116 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:visited{color:#326891;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:hover{-webkit-text-decoration:none;text-decoration:none;}James Krellenstein, a founder of PrEP4All and the author of its report, was more pointed. “If they don’t change course pretty soon,” he said, “the Biden administration is going to be remembered in terms that the Reagan administration is remembered today in not dealing with the AIDS crisis.”Addressing the world’s coronavirus vaccine needs is a complicated endeavor, with many layers of challenges. Vaccine makers around the world, including those in Russia, China and India, have predicted a total of 12 billion doses by the end of 2021, according to Duke University’s Global Health Innovation Center, which tracks vaccine manufacturing and publishes the Launch & Scale Speedometer website. Eight months into the year, an estimated five billion have been delivered.Some manufacturers are falling behind. Novavax has had production problems. Johnson & Johnson, which initially planned for one billion doses this year, has made slightly more than 103 million, Mr. Krellenstein said, citing data from the scientific intelligence firm Airfinity. That is in part because its contract manufacturer, Emergent BioSolutions, ruined up to 15 million doses, prompting the Food and Drug Administration to shutter its Baltimore plant for three months.If 12 billion doses were indeed produced and equitably distributed by year’s end, the world’s needs could be met. But, the Duke institute wrote, “those are both big ifs.”Several other countries as well as the United States are already recommending booster shots, which will cut into the supply. And the virus changes shape so rapidly — the highly infectious Delta variant is now dominant around the globe — that the vaccines developed last year may soon be outdated, said Dr. Richard Hatchett, the chief executive of the Coalition for Epidemic Preparedness Innovations, which helps lead the international vaccine effort known as Covax.In the short term, poor nations need doses, and Mr. Biden is correct when he says the United States has donated more than any other country. The United States has already donated 115 million surplus doses from the nation’s own supply, and has purchased 500 million doses from Pfizer and BioNTech to be distributed through Covax. With the United States planning for booster shots, one official said, there is no surplus right now.“Their financial contributions are huge — no other country has pledged as much as the U.S.,” Dr. Hatchett said. But, he added, “it’s not to say that they can’t and shouldn’t do more.”Dr. Hatchett said he would like to see a more nuanced discussion of the logistics of not only making vaccines for poor and middle-income nations, but also administering them. The New York Times recently reported that Covax was having trouble getting those shots into people’s arms. Unused doses are sitting idle on airport tarmacs in poor nations that lack the money and capacity to buy fuel to transport doses to clinics, to train people to give the shots — and to persuade people to take them.Mr. Biden took his first steps to address the vaccine shortage in March, when the White House announced the Merck deal as well as a partnership with Japan, India and Australia aimed at expanding manufacturing capacity. That included a pledge to help Biological E, an Indian manufacturer, produce one billion doses by the end of 2022.A White House official said the United States International Development Finance Corporation, which is making the investment, “expects to begin disbursing funds within the next several weeks.” The official did not offer specifics, or an amount.Mr. Biden promised in June that the United States would begin an “entirely new effort” to increase vaccine supply and vastly expand manufacturing capacity, most of it in the United States. He also put Jeffrey D. Zients, the White House coronavirus response coordinator, in charge of developing a global strategy. Mr. Zients pledged to work with U.S. manufacturers to “vastly increase supply for the rest of the world in a way that also creates jobs here at home.”.css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-3btd0c{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:1rem;line-height:1.375rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-3btd0c{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-3btd0c strong{font-weight:600;}.css-3btd0c em{font-style:italic;}.css-w739ur{margin:0 auto 5px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-w739ur{font-size:1.25rem;line-height:1.4375rem;}}.css-9s9ecg{margin-bottom:15px;}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}.css-uf1ume{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-box-pack:justify;-webkit-justify-content:space-between;-ms-flex-pack:justify;justify-content:space-between;}.css-wxi1cx{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:column;-ms-flex-direction:column;flex-direction:column;-webkit-align-self:flex-end;-ms-flex-item-align:end;align-self:flex-end;}.css-12vbvwq{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-12vbvwq{padding:20px;width:100%;}}.css-12vbvwq:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-12vbvwq{border:none;padding:10px 0 0;border-top:2px solid #121212;}.css-12vbvwq[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-12vbvwq[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-12vbvwq[data-truncated] .css-5gimkt:after{content:’See more’;}.css-12vbvwq[data-truncated] .css-6mllg9{opacity:1;}.css-qjk116{margin:0 auto;overflow:hidden;}.css-qjk116 strong{font-weight:700;}.css-qjk116 em{font-style:italic;}.css-qjk116 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:visited{color:#326891;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:hover{-webkit-text-decoration:none;text-decoration:none;}But since then, the Delta variant has shifted the focus to the new domestic crisis. Dr. Krishna Udayakumar, the director of the center at Duke, faulted Mr. Biden for pursuing an approach that “continues to be piecemeal” — an assessment echoed by J. Stephen Morrison, a global health expert at the Center for Strategic and International Studies in Washington.“They don’t have a strategy, nor do they have a structure to execute it,” Mr. Morrison said.White House officials say that it is not possible for them to scale up production quickly, in part because of a scarcity of raw materials, and that doing so would take three to five years — an assertion that Dr. Tom Frieden, who directed the Centers for Disease Control and Prevention during the Obama-Biden administration, dismissed as “nonsense.”Dr. Frieden, now the president of Resolve to Save Lives, a health nonprofit, pointed to Lonza, a Swiss biotechnology company, which entered into an agreement with the vaccine maker Moderna in May 2020, retrofitted its facility in Portsmouth, N.H., and was producing vaccine six months later.“People say, ‘Oh, it’s going to take months,’” Dr. Frieden said. “Well, Covid is with us for years. The best time to plant a tree is 20 years ago. The second best time is today.”Dr. Frieden and others also want the Biden administration to lean more heavily on Pfizer and Moderna to transfer their technology to manufacturers around the globe. The Financial Times reported this week that South Korean vaccine makers are poised to expand, but are struggling to secure intellectual property licensing deals with the two companies.Mr. Biden is likely to make some kind of announcement about addressing the pandemic when the United Nations General Assembly convenes in New York for its annual meeting in September. The administration is considering creating a government-owned manufacturing plant that would be run by a private contractor — a plan endorsed by PrEP4All. But a person familiar with the proposal said it was only a possibility at this point.There are challenges with such an approach, particularly if experienced vaccine makers do not participate, as the situation with Emergent BioSolutions demonstrated.Mr. Krishnamoorthi said the Democrats’ plan was modeled on PEPFAR, the President’s Emergency Plan for AIDS Relief, an initiative started by President George W. Bush that has invested $85 billion to address the global AIDS epidemic.Public Citizen, the nonprofit consumer advocacy organization, has a plan calling for the government to invest $25 billion in developing regional manufacturing hubs around the world, which it says would produce enough vaccine for low- and middle-income countries in a year.“He’s said, ‘We’ll be an arsenal for the world’ — that’s a little vague,” said Peter Maybarduk, who directs Public Citizen’s Access to Medicines program. “What we see instead are dribs and drabs, like the excess of the U.S. supply, maybe if we’re not using it for third shots at home.”

The Food and Drug Administration will evaluate the new data as the Biden administration pushes a booster shot strategy.As vaccine makers set their sights on boosters, new studies unveiled on Wednesday from Johnson & Johnson and Pfizer-BioNTech demonstrated that extra shots can dramatically raise antibodies against the coronavirus.The companies said they were submitting the new data to the Food and Drug Administration for evaluation, and Pfizer has formally asked the agency to authorize a booster shot. The Biden administration said last week that it wants to provide booster shots for all Americans eight months after vaccination.The Johnson & Johnson one-shot vaccine was absent from the government’s booster plan announced last week. But with the new data, the company hopes to be part of the initial distribution of additional shots, which could happen as early as September.“We look forward to discussing with public health officials a potential strategy for our Johnson & Johnson Covid-19 vaccine, boosting eight months or longer after the primary single-dose vaccination,” Dr. Mathai Mammen, the global head of Janssen Research & Development at Johnson & Johnson, said in a statement.In February, the F.D.A. gave emergency authorization to Johnson & Johnson for its shot, which showed a 72 percent efficacy against infection in its U.S. clinical trial. That study was done before the Delta variant became widespread. But in another study released earlier this month, South African researchers found that the vaccine was up to 95 percent effective against death from Delta, and reduced the risk of hospitalization by 71 percent.In its new study, Johnson & Johnson tracked 17 volunteers from last year’s clinical trial. When given a booster shot at six months, their antibodies against the coronavirus jumped nine times as high as after the first dose. The data has not yet been published in a scientific journal.Small studies of Moderna and Pfizer-BioNTech booster shots have found comparable jumps in antibody levels, as the companies reported on recent earnings calls.On Wednesday, Pfizer and BioNTech released new data from 306 people showing that a third dose given five to eight months after the second caused a strong immune response. The level of antibodies against the coronavirus in the volunteers more than tripled, the companies reported.The side effects of a third injection were about the same as after the initial two doses, the companies said. The underlying data was not included in the news release, nor were the dates or location of the study specified. The companies said they were preparing a scientific publication describing the research.Pfizer and BioNTech said they were now applying to the F.D.A. for supplemental approval of a coronavirus vaccine booster shot for those aged 16 and up, and will submit all their supporting data by the end of this week.The news of the booster application came two days after the F.D.A. fully approved the companies’ two-dose vaccine for those 16 and older, making it the first to move beyond emergency use status.Because booster shots from different companies have not been tested in a head-to-head comparison, it’s not possible to determine which one provides the biggest boost.It’s also hard to say if these big jumps in antibodies will translate into a highly effective booster shot.A number of studies have suggested that higher levels of antibodies provide better protection, especially against the Delta variant. But other parts of the immune system, such as T cells, are also important. So this data cannot give a precise estimate of how effective a booster shot will be against Covid-19.“It’s too early to guesstimate protection,” said Dr. Dan Barouch, a virologist at Beth Israel Deaconess Medical Center in Boston, who has led some studies for Johnson & Johnson but was not involved in the booster trial.The new data from Johnson & Johnson may lay to rest some early concerns about whether more than one dose of the vaccine could be effective. The Johnson & Johnson vaccine uses an adenovirus to deliver coronavirus genes into cells. When the company launched its trials, some experts wondered if people would make antibodies against the adenoviruses, which might render a booster useless.“Something we previously would have considered to be a major barrier may not be such a huge barrier,” said Lynda Coughlan, a virologist at the University of Maryland School of Medicine, who was not involved in the study.The Johnson & Johnson vaccine is the only shot in the United States or Europe authorized as a single dose. Since November, the company has been running a clinical trial to look at how much protection people get from two doses, two months apart. That trial is expected to deliver results in the next few weeks.After the volunteers in that trial received the second dose, their antibody levels rose by a factor of three. The much bigger increase in the new booster study is likely because of the longer wait between doses: A six-month pause gives the immune system time to develop a more mature response to the coronavirus.Only eight percent of vaccinated Americans — or about 14 million people — have received a Johnson & Johnson vaccine, according to the Centers for Disease Control. A federal official said that the government had sufficient supplies in reserve to give boosters to everyone who received a first dose of Johnson & Johnson, should it be authorized.The news of potential Johnson & Johnson boosters for Americans may sting in other countries that are still waiting for first doses of the vaccine. South Africa, for example, has ordered 31 million doses of the vaccine, but only two million people there have received it.It remains to be seen how long the high antibody levels produced by boosters will last. “We don’t have long-term human studies, but my prediction would be that those responses should be maintained after the boost,” Dr. Coughlan said.Noah Weiland

The research did not assess the risks specifically for young males, who are the most likely to develop the rare side effect.The Pfizer-BioNTech Covid-19 vaccine is associated with an increased risk of myocarditis, an inflammation of the heart muscle, a large new study from Israel confirms. But the side effect remains rare, and Covid-19 is more likely to cause myocarditis than the vaccine is, scientists reported on Wednesday.The research, which is based on the electronic health records of about two million people who are 16 or older, provides a comprehensive look at the real-wold incidence of various adverse events after both vaccination and infection with the coronavirus.Although the study did not break down the myocarditis risks by age or by sex, the median age of people who developed the condition after vaccination was 25, and 19 of the 21 cases were in males, the researchers reported.In addition to myocarditis, the Pfizer vaccine was also associated with an increased risk of swollen lymph nodes, appendicitis and shingles, although all three side effects remained uncommon in the study. Coronavirus infection was not associated with these side effects, but it did increase the odds of several potentially serious cardiovascular problems, including heart attacks and blood clots.“Coronavirus is very dangerous, and it’s very dangerous to the human body in many ways,” said Ben Reis, a co-author of the new study and the director of the predictive medicine group at the Boston Children’s Hospital Computational Health Informatics Program.He added, “If the reason that someone so far has been hesitating to get the vaccine is fear of this very rare and usually not very serious adverse event called myocarditis, well, this study shows that that very same adverse event is actually associated with a higher risk if you’re not vaccinated and you get infected.”The data arrived in the middle of an intense discussion among federal regulators about the risks of myocarditis and pericarditis, which is inflammation of the lining around the heart, in younger recipients of both the Pfizer-BioNTech and the Moderna vaccines, concerns that very likely led the Food and Drug Administration to negotiate larger pediatric trials with the vaccine makers this summer in the hopes of adequately assessing the risks before a possible emergency authorization for younger children. The companies are studying lower dosing in children to alleviate some of the risk.In their review of the Pfizer-BioNTech vaccine, regulators paid close attention to an American health care claims database, which found that the risk of the conditions in 16- and 17-year-old vaccinated boys could be as high as 1 in 5,000. The cases in the database were unconfirmed, the F.D.A. cautioned in an analysis published this week, but they were considered a reasonable estimate of the possible risk. Even in the worst-case scenarios of post-vaccination myocarditis and pericarditis modeled by the F.D.A., the benefits of vaccination still outweighed the risks, the analysis said.The study was one reason the F.D.A. said this week that after its licensure of Pfizer-BioNTech’s vaccine, Pfizer would conduct studies of myocarditis and pericarditis risks in people who received the shot, including long-term outcomes for those who fall ill after vaccination.Israel’s vaccination campaign, which relied on the Pfizer vaccine, got off to a fast start; by May 24, nearly five million people, or roughly 55 percent of the nation’s population, had received both doses of the vaccine.The new study, which was published in the New England Journal of Medicine, is based on an analysis of the electronic health records of Clalit Health Services, the nation’s largest H.M.O.The researchers assembled a group of roughly 880,000 people, age 16 or older, who had been vaccinated by May 24. To create a control group, they matched each of those individuals to an unvaccinated person who was medically and demographically similar.“You can think about them as pseudo twins,” said Dr. Ran Balicer, the chief innovation officer for Clalit Health Services and the lead author of the new study.Then the researchers calculated the incidence of 25 different potential adverse events in each group. In a second round of analysis, they calculated the incidence of the same potential side effects in a group of 170,000 people who had tested positive for the coronavirus and in a similar group of uninfected controls.They found that although myocarditis remained rare, it was more common in the vaccinated group than the unvaccinated one. There were an extra 2.7 cases of myocarditis for every 100,000 people in the vaccinated group, compared with the unvaccinated one, the researchers found..css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-3btd0c{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:1rem;line-height:1.375rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-3btd0c{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-3btd0c strong{font-weight:600;}.css-3btd0c em{font-style:italic;}.css-w739ur{margin:0 auto 5px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-w739ur{font-size:1.25rem;line-height:1.4375rem;}}.css-9s9ecg{margin-bottom:15px;}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}.css-uf1ume{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-box-pack:justify;-webkit-justify-content:space-between;-ms-flex-pack:justify;justify-content:space-between;}.css-wxi1cx{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:column;-ms-flex-direction:column;flex-direction:column;-webkit-align-self:flex-end;-ms-flex-item-align:end;align-self:flex-end;}.css-12vbvwq{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-12vbvwq{padding:20px;width:100%;}}.css-12vbvwq:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-12vbvwq{border:none;padding:10px 0 0;border-top:2px solid #121212;}.css-12vbvwq[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-12vbvwq[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-12vbvwq[data-truncated] .css-5gimkt:after{content:’See more’;}.css-12vbvwq[data-truncated] .css-6mllg9{opacity:1;}.css-qjk116{margin:0 auto;overflow:hidden;}.css-qjk116 strong{font-weight:700;}.css-qjk116 em{font-style:italic;}.css-qjk116 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:visited{color:#326891;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:hover{-webkit-text-decoration:none;text-decoration:none;}But the risks were even higher among those who had contracted the virus. There were an extra 11 cases of the condition for every 100,000 people who had been infected with the coronavirus, compared with those who had not.The study provides critical context for understanding the risks and benefits of vaccination, said Dr. Brian Feingold, an expert on heart inflammation in children at the UPMC Children’s Hospital of Pittsburgh who said he fields calls from parents who are concerned about the myocarditis risk.“And nobody’s blowing that off, but I think you just have to look at that in context,” he said. “Those risks related to Covid are higher than the risks related to the vaccine.”In addition to myocarditis, coronavirus infection was also associated with an increased risk of heart attacks, irregular heart beat, blood clots in the lungs or legs, kidney injury and bleeding inside the skull. For every 100,000 infections, there were an extra 25 heart attacks and 62 cases of blood clots in the lungs, for instance.“When you try to make your decision on whether or not you should take the vaccine, one of the things to ask is not only what are the potential adverse events associated with taking the vaccine, but also what am I risking when I think about Covid-19 as the other option,” Dr. Balicer said.Although the study is reassuring, it is important to continue collecting data on the myocarditis risks in young males in particular, scientists said.“But we’re at this red hot moment,” said Dr. Sean O’Leary, a pediatric infectious disease expert at the University of Colorado Anschutz Medical Campus. “This is what we’ve got, and the benefits still consistently appear to greatly outweigh the risks.”In one recent study, which has not yet been published in a peer reviewed journal, researchers calculated that 12- to 17-year-old boys were about six times as likely to develop myocarditis after infection with the virus than after receiving one of the mRNA vaccines.