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US FDA approves expanded use of Moderna's RSV vaccine for at-risk adults
US FDA approves expanded use of Moderna's RSV vaccine for at-risk adults

Straits Times

time13-06-2025

  • Health
  • Straits Times

US FDA approves expanded use of Moderna's RSV vaccine for at-risk adults

Moderna's RSV shot, mRESVIA, was the first non-Covid-19 messenger RNA-based vaccine to be approved in the United States. PHOTO: REUTERS US FDA approves expanded use of Moderna's RSV vaccine for at-risk adults MARYLAND - The US Food and Drug Administration on June 12 expanded the use of Moderna's respiratory syncytial virus vaccine to a lower group of adults aged 18 to 59 years at increased risk for disease. Moderna's RSV shot, mRESVIA, was the first non-Covid-19 messenger RNA-based (mRNA) vaccine to be approved in the United States. The shot, the company's second product, is already approved for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 or older. While the FDA approval is a necessary step, the US Centres for Disease Control and Prevention (CDC) still has to recommend the shots before they are available for the age group. The CDC currently recommends the vaccine for adults aged 75 and older, as well as for adults aged 60 to 74 who are at increased risk of infection. In April, the CDC's panel of outside experts recommended the use of approved RSV vaccines in at-risk adults aged 50 to 59. Health Secretary Robert F. Kennedy Jr. on June 11 named eight new members to serve on the key panel of vaccine advisers, known as the Advisory Committee on Immunisation Practices, after previously firing all 17 of its members, saying it would 're-establish public confidence in vaccine science'. However, public health experts warn that this could undermine public confidence in available vaccines. Some of the new appointees have openly expressed anti-vaccine views, including against the mRNA vaccine technology. The panel, which provides guidance to the CDC on which groups of people would most benefit from an already-approved vaccine, is scheduled to meet later this month. RSV typically causes cold-like symptoms, but is also a leading cause of pneumonia in toddlers and older adults. The CDC estimates 15,000 to 20,000 annual RSV-associated hospitalisations in the US in adults aged 50 to 59. The FDA's approval for mRESVIA was based on results from a late-stage trial where the shot helped initiate significant immune responses in adults aged 18 to 59 years with underlying health conditions. The vaccine was well-tolerated with no safety concerns, the company said. The FDA approved mRESVIA in adults aged 60 or older in 2024 , but with a lower efficacy label indicating the shot was 79 per cent effective at preventing at least two symptoms of RSV, such as cough and fever. Moderna had said the shot was shown to be 83.7 per cent effective in a late-stage trial. All currently approved shots against RSV, including Pfizer's Abrysvo and GSK's Arexvy, are for adults aged 60 years and above. Arexvy and Abrysvo are also approved to prevent RSV-associated disease in at-risk adults aged 50 to 59 and 18 to 59, respectively. REUTERS Join ST's Telegram channel and get the latest breaking news delivered to you.

Newly approved antibody could offer another option for protecting infants from RSV, a common infection that can be deadly
Newly approved antibody could offer another option for protecting infants from RSV, a common infection that can be deadly

CNN

time12-06-2025

  • Health
  • CNN

Newly approved antibody could offer another option for protecting infants from RSV, a common infection that can be deadly

The United States could soon have another tool in the fight against respiratory syncytial virus, an illness that's the No. 1 cause of hospitalization in infants. The US Food and Drug Administration has approved a new monoclonal antibody to help prevent infection, according to an announcement late Monday from drugmaker Merck. Enflonsia is designed to be given in a single 105-milligram shot to protect newborns and infants from mild, moderate or severe RSV through all five months of their first virus season, which typically starts in the fall and goes through the next spring. Study materials that Merck submitted to the FDA for its approval showed that the antibody had a similar safety profile as a placebo. The most common adverse reactions from Enflonsia were mild and included injection-site swelling and a rash in a small number of infants. In a mid- to late-stage trial, Enflonsia reduced RSV-associated hospitalizations in infants more than 84% compared with a placebo. RSV can sometimes turn into serious lower respiratory infections like pneumonia, but the shot also reduced lower respiratory infections that needed medical attention by more than 60% compared with a placebo. 'Enflonsia provides an important new preventive option to help protect healthy and at-risk infants born during or entering their first RSV season,' Dr. Dean Y. Li, president of Merck Research Laboratories, said in a news release. 'We are committed to ensuring availability of Enflonsia in the US before the start of the upcoming RSV season to help reduce the significant burden of this widespread seasonal infection on families and health care systems.' Merck says it hopes Enflonsia will be available before the start of the 2025-26 respiratory virus season. First, it needs to be recommended by the US Centers for Disease Control and Prevention, and that means going in front of the agency's Advisory Committee on Immunization Practices. It's on the agenda for the panel's meeting this month, but US Health and Human Services Secretary Robert F. Kennedy removed all the members of that committee Monday. He says he will appoint new ones, but it's unclear how long that process will take. Doctors say another tool to prevent RSV cannot come soon enough. RSV is ubiquitous, one of the most common causes of childhood illness. Most kids will catch this highly contagious respiratory virus at some point before they turn 2, according to the CDC. For many healthy adults and older kids, RSV causes a mild illness like a cold. Typically, symptoms can be managed at home, and they often go away on their own. But for infants and the elderly, it can be a different story. Very young children's immune systems are just starting to learn how to fight infections, and infants have tiny airways. RSV inflames those airways, making it difficult to breathe, and can turn into a serious lower respiratory illness like bronchiolitis or pneumonia. Some of these RSV infections can be deadly. Two to three percent of infants under 6 months are hospitalized with RSV in the US every year, according to the CDC. Among children younger than 5, about 58,000 to 80,000 are hospitalized due to RSV. There's no specific medicine to treat RSV. Doctors can give an infant supportive care and oxygen, and then they essentially wait until their oxygen levels get back to normal, said Dr. Amy Edwards, director of pediatric infection control at UH Rainbow Babies and Children's Hospital in Cleveland. 'I hate RSV,' said Edwards, who was not connected with the Merck trial. 'Just to watch them struggle to breathe, and then they get scared, and then they cry, which of course makes the breathing worse, and their little lips turn blue. It's just so hard to watch.' Enflonsia joins a handful of other tools recently made available to protect babies from, although the FDA put RSV vaccine trials involving infants and young children ages 2 to 5 on hold last year after some developed severe illness. To prevent RSV in infants, the CDC currently recommends an RSV antibody made by Sanofi and AstraZeneca, called Beyfortus, which was approved in 2023. It was in short supply during that year's RSV season, although Edwards said supply started to catch up with demand in her health care system last season, and the company pledged to produce more. The other option to protect an infant is a vaccine that a person can get during pregnancy. Together, Beyfortus and the vaccine have made a difference. A CDC study published in March found that RSV-associated hospitalization rates among infants up to 7 months during 2024-25 season were lower than in seasons when those things weren't available. Edwards just hopes people will get protection for their infants. 'Every RSV season fills us to the gills,' she said. 'This should theoretically empty us out, if we have good uptake.' Correction: A previous version of this story incorrectly described the newly approved monoclonal antibody as a therapy.

Newly approved therapy could offer another option for protecting infants from RSV, a common infection that can be deadly
Newly approved therapy could offer another option for protecting infants from RSV, a common infection that can be deadly

Yahoo

time10-06-2025

  • Health
  • Yahoo

Newly approved therapy could offer another option for protecting infants from RSV, a common infection that can be deadly

The United States could soon have another tool in the fight against respiratory syncytial virus, an illness that's the No. 1 cause of hospitalization in infants. The US Food and Drug Administration has approved a new monoclonal antibody to help prevent infection, according to an announcement late Monday from drugmaker Merck. The therapy, Enflonsia, is designed to be given in a single 105-milligram shot to protect newborns and infants from mild, moderate or severe RSV through all five months of their first virus season, which typically starts in the fall and goes through the next spring. Study materials that Merck submitted to the FDA for its approval showed that the antibody had a similar safety profile as a placebo. The most common adverse reactions from Enflonsia were mild and included injection-site swelling and a rash in a small number of infants. In a mid- to late-stage trial, Enflonsia reduced RSV-associated hospitalizations in infants more than 84% compared with a placebo. RSV can sometimes turn into serious lower respiratory infections like pneumonia, but the shot also reduced lower respiratory infections that needed medical attention by more than 60% compared with a placebo. 'Enflonsia provides an important new preventive option to help protect healthy and at-risk infants born during or entering their first RSV season,' Dr. Dean Y. Li, president of Merck Research Laboratories, said in a news release. 'We are committed to ensuring availability of Enflonsia in the US before the start of the upcoming RSV season to help reduce the significant burden of this widespread seasonal infection on families and health care systems.' Merck says it hopes Enflonsia will be available before the start of the 2025-26 respiratory virus season. First, it needs to be recommended by the US Centers for Disease Control and Prevention, and that means going in front of the agency's Advisory Committee on Immunization Practices. It's on the agenda for the panel's meeting this month, but US Health and Human Services Secretary Robert F. Kennedy removed all the members of that committee Monday. He says he will appoint new ones, but it's unclear how long that process will take. Doctors say another tool to prevent RSV cannot come soon enough. RSV is ubiquitous, one of the most common causes of childhood illness. Most kids will catch this highly contagious respiratory virus at some point before they turn 2, according to the CDC. For many healthy adults and older kids, RSV causes a mild illness like a cold. Typically, symptoms can be managed at home, and they often go away on their own. But for infants and the elderly, it can be a different story. Very young children's immune systems are just starting to learn how to fight infections, and infants have tiny airways. RSV inflames those airways, making it difficult to breathe, and can turn into a serious lower respiratory illness like bronchiolitis or pneumonia. Some of these RSV infections can be deadly. Two to three percent of infants under 6 months are hospitalized with RSV in the US every year, according to the CDC. Among children younger than 5, about 58,000 to 80,000 are hospitalized due to RSV. There's no specific medicine to treat RSV. Doctors can give an infant supportive care and oxygen, and then they essentially wait until their oxygen levels get back to normal, said Dr. Amy Edwards, director of pediatric infection control at UH Rainbow Babies and Children's Hospital in Cleveland. 'I hate RSV,' said Edwards, who was not connected with the Merck trial. 'Just to watch them struggle to breathe, and then they get scared, and then they cry, which of course makes the breathing worse, and their little lips turn blue. It's just so hard to watch.' Enflonsia joins a handful of other tools recently made available to protect babies from, although the FDA put RSV vaccine trials involving infants and young children ages 2 to 5 on hold last year after some developed severe illness. To prevent RSV in infants, the CDC currently recommends an RSV antibody made by Sanofi and AstraZeneca, called Beyfortus, which was approved in 2023. It was in short supply during that year's RSV season, although Edwards said supply started to catch up with demand in her health care system last season, and the company pledged to produce more. The other option to protect an infant is a vaccine that a person can get during pregnancy. Together, Beyfortus and the vaccine have made a difference. A CDC study published in March found that RSV-associated hospitalization rates among infants up to 7 months during 2024-25 season were lower than in seasons when those therapies weren't available. Edwards just hopes people will get protection for their infants. 'Every RSV season fills us to the gills,' she said. 'This should theoretically empty us out, if we have good uptake.'

U.S. FDA Approves Merck's ENFLONSIA™ (clesrovimab-cfor) for Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants Born During or Entering Their First RSV Season
U.S. FDA Approves Merck's ENFLONSIA™ (clesrovimab-cfor) for Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants Born During or Entering Their First RSV Season

Business Wire

time09-06-2025

  • Health
  • Business Wire

U.S. FDA Approves Merck's ENFLONSIA™ (clesrovimab-cfor) for Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants Born During or Entering Their First RSV Season

BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved ENFLONSIA™ (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season. ENFLONSIA is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with the same 105 mg dose regardless of weight. A typical RSV season usually spans autumn to spring of the next year. 'RSV disease is the leading cause of infant hospitalization in the U.S. and can lead to serious respiratory conditions like bronchiolitis and pneumonia,' said Dr. Octavio Ramilo, chair of the Department of Infectious Diseases at St. Jude Children's Research Hospital and investigator for the CLEVER (MK-1654-004) and SMART (MK-1654-007) trials. 'ENFLONSIA combines dosing convenience with strong clinical data showing significant reductions in RSV disease incidence and hospitalizations, making it a promising new intervention to help protect infants from RSV.' ENFLONSIA should not be administered to infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA. See additional Selected Safety Information below. The approval is based on results from the pivotal Phase 2b/3 CLEVER trial (MK-1654-004) evaluating a single dose of ENFLONSIA administered to preterm and full-term infants (birth to 1 year of age). The trial met its primary and key secondary endpoints, as outlined below. ENFLONSIA demonstrated a reduction in incidence of RSV-associated medically attended lower respiratory infections (MALRI) requiring ≥1 indicator of lower respiratory infection (LRI) or severity compared to placebo through 5 months (primary endpoint) by 60.5% (95% CI: 44.2, 72.0, p<0.001) (incidence rates: ENFLONSIA, 0.026; placebo, 0.065). ENFLONSIA demonstrated a reduction in RSV-associated hospitalizations through 5 months (key secondary endpoint) by 84.3% (95% CI: 66.7, 92.6, p<0.001) (incidence rates: ENFLONSIA, 0.004; placebo, 0.024), showing increasing efficacy with increasing disease severity. The approval is also supported by results from the Phase 3 SMART trial (MK-1654-007) evaluating the safety and efficacy of ENFLONSIA versus palivizumab in infants at increased risk for severe RSV disease. 'ENFLONSIA provides an important new preventive option to help protect healthy and at-risk infants born during or entering their first RSV season with the same dose regardless of weight,' said Dr. Dean Y. Li, president, Merck Research Laboratories. 'We are committed to ensuring availability of ENFLONSIA in the U.S. before the start of the upcoming RSV season to help reduce the significant burden of this widespread seasonal infection on families and health care systems.' The U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for the use of ENFLONSIA in infants. Ordering is anticipated to begin in July, with shipments delivered before the start of the 2025-2026 RSV season. About ENFLONSIA™ (clesrovimab-cfor) ENFLONSIA (clesrovimab-cfor) is Merck's extended half-life monoclonal antibody (mAb) indicated for passive immunization for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season. ENFLONSIA is administered using non-weight-based dosing and is designed to provide direct, rapid and durable protection through 5 months, a typical RSV season. For infants born during the RSV season, ENFLONSIA is to be administered starting from birth. For infants born outside of the RSV season, ENFLONSIA should be administered prior to the start of their first RSV season. For infants undergoing cardiac surgery with cardiopulmonary bypass during or entering their first RSV season, an additional 105 mg dose is recommended as soon as the infant is stable after surgery. Selected Safety Information for ENFLONSIA (clesrovimab-cfor) Do not administer ENFLONSIA to infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA. Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, initiate appropriate medications and/or supportive therapy. The most common adverse reactions were injection-site erythema (3.8%), injection-site swelling (2.7%) and rash (2.3%). About Clinical Trials and Data Supporting U.S. FDA Approval The CLEVER trial (MK-1654-004) (NCT04767373) was a Phase 2b/3, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of ENFLONSIA in early and moderate preterm infants (≥29 to <35 weeks gestational age [GA]) and late preterm and full-term infants (≥35 weeks GA) entering their first RSV season. Participants were randomized 2:1 to receive a single 105 mg dose of ENFLONSIA (N=2,411) or saline placebo (N=1,203) by intramuscular (IM) injection. The primary endpoint was the incidence of participants with RSV-associated medically attended lower respiratory infection (MALRI) characterized as cough or difficulty breathing and requiring ≥1 indicator of LRI (wheezing, rales/crackles) or severity (chest wall in-drawing/retractions, hypoxemia, tachypnea, dehydration due to respiratory symptoms) from Day 1 through Day 150 (5 months) after dosing. Medically attended includes all health care provider visits in settings such as outpatient clinic, clinical study site, emergency department, urgent care center and/or hospital. The key secondary endpoint was RSV-associated hospitalization through Day 150 (5 months). The trial demonstrated that the safety profile of ENFLONSIA in infants entering their first RSV season was generally comparable to placebo. The most common adverse reactions were injection-site erythema occurring within 5 days post-dose (ENFLONSIA: 3.8%; placebo: 3.3%), injection-site swelling occurring within 5 days post-dose (ENFLONSIA: 2.7%; placebo: 2.6%) and rash occurring within 14 days post-dose (ENFLONSIA: 2.3%; placebo: 1.9%). Participants were monitored for serious adverse events (SAEs) through the duration of their participation for up to 365 days post-dose. Most (≥97%) of the adverse reactions were toxicity grade 1 (mild) or grade 2 (moderate). The SMART trial (MK-1654-007) (NCT04938830) was a Phase 3, randomized, partially-blind, palivizumab-controlled, multi-site trial to evaluate the safety and efficacy of ENFLONSIA in infants at increased risk of severe RSV disease, including early (<29 weeks GA) or moderate preterm infants (≥29 to ≤35 weeks GA) and infants with chronic lung disease of prematurity or congenital heart disease of any GA. Participants were randomized 1:1 to receive ENFLONSIA (N=446) or palivizumab (N=450) by IM injection. Among infants at increased risk of severe RSV disease and entering their first RSV season, the trial demonstrated that the safety profile of ENFLONSIA was generally comparable to palivizumab and consistent with the safety profile of ENFLONSIA in infants in the CLEVER trial. The efficacy of ENFLONSIA in infants at increased risk for severe RSV disease was established by extrapolation of efficacy of ENFLONSIA from the CLEVER trial to the SMART trial based on similar pharmacokinetic exposure. The incidence rates of RSV-associated MALRI requiring ≥1 indicator of LRI or severity and RSV-associated hospitalization were generally comparable between ENFLONSIA (3.6%, 95% CI: 2.0, 6.0 and 1.3%, 95% CI: 0.4, 2.9, respectively) and palivizumab (2.9%, 95% CI: 1.5, 5.2 and 1.5%, 95% CI: 0.5, 3.2, respectively) through Day 150 (5 months). In clinical trials, when ENFLONSIA was given concomitantly with routine childhood vaccines, the safety profile of the co-administered regimen was generally comparable to the safety profile when ENFLONSIA and childhood vaccines were administered alone. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( Please see Prescribing Information for ENFLONSIA (clesrovimab-cfor) at / enflonsia_pi.pdf and Patient Information/Medication Guide for ENFLONSIA at / enflonsia_ppi.pdf.

Bronchiolitis in Late Spring? Think Human Metapneumovirus
Bronchiolitis in Late Spring? Think Human Metapneumovirus

Medscape

time14-05-2025

  • Health
  • Medscape

Bronchiolitis in Late Spring? Think Human Metapneumovirus

It is mid-April in a pediatrician's office in the southeastern United States. A worried mother holds a 3-month-old on her lap. The baby has audible wheezes, clear nasal discharge, and mild nasal flaring. The symptoms began shortly after the child started group childcare. Kristina A. Bryant, MD 'This can't be RSV,' the mother insisted. 'She had the RSV shot before she left the newborn nursery, and you shared with me how effective that is.' The pediatrician consulted the electronic health record and confirmed that the baby had received nirsevimab on the second day of life. During a discussion with the family during a prenatal consultation, he had shared the results of a study conducted by the Centers for Disease Control and Prevention's (CDC's) New Vaccine Surveillance Network during the 2023-2024 respiratory virus season. Among infants entering their first respiratory syncytial virus (RSV) season, nirsevimab was 90% effective at preventing RSV-associated hospitalization. The pediatrician affirmed that nirsevimab protects most babies from getting sick enough to be hospitalized with RSV but gently reminded the mom that it might not prevent every infection. 'Surely this isn't flu,' the mother said. 'I had the flu shot during my pregnancy. That's supposed to protect my baby during the first 6 months of life.' The pediatrician recalled a paper published in JAMA Pediatrics that found that a flu shot during pregnancy reduced the risk for flu in babies younger than 6 months of age by one third. Flu hospitalizations were reduced by approximately 40%. While praising the mom for doing everything she could to protect her baby against viral infections, he noted that vaccination reduced but did not completely eliminate the risk for infection, and influenza, especially influenza B, was still circulating in the community. He recommended testing for RSV, flu, and COVID-19. The mother was relieved when the test was negative. The baby was discharged home with supportive care and the diagnosis of viral bronchiolitis. The following day, the baby worsened and presented to a local emergency department. An extended viral panel performed on a nasal swab revealed the diagnosis: human metapneumovirus (hMPV). Like RSV, hMPV is a member of the Pneumoviridae family, and clinical manifestations are often similar. Just like RSV, hMPV is a common cause of bronchiolitis in children. It can also cause upper respiratory tract infections, croup, pneumonia, otitis media, and asthma exacerbations. hMPV infections are common, if less well known to parents than RSV and influenza. Nearly all children are infected at least once by age 5. According to the American Academy of Pediatrics, the incidence of hospitalizations attributable to hMPV in young children is lower than RSV but similar to influenza and human parainfluenza type 3 (hPIV3). Children hospitalized with hMPV tend to be older than those hospitalized with RSV. Prior to the COVID-19 pandemic in the US, hMPV typically circulated from early January to early June, peaking in late March. By comparison, RSV season started earlier (typically late October), peaked in late December, and trailed off in April. There was considerable overlap with RSV circulation. Co-infections with these two viruses are well-described and may be associated with more severe disease. Seasonality for both hMPV and RSV was disrupted during the pandemic, and according to a recent CDC report that analyzed data from the National Respiratory and Enteric Virus Surveillance System (NREVSS), less than 5 weeks of co-circulation of RSV and hMPV occurred in most regions of the US during the 2022-2023 and 2023-2024 seasons. Notably, typical hMPV patterns have returned. Clinicians curious about hMPV circulation in their region can check out the NRVESS interactive dashboard at Ultimately, the baby with hMPV returned to the pediatrician for follow-up and the mother wanted to talk about what might have been done to prevent this infection. No vaccines are currently available to prevent hMPV, but candidate vaccines are being studied in adults and children. The safety and immunogenicity of an investigational combination mRNA vaccine targeting both hMPV and hPIV3 was recently evaluated in a phase 1b study. In children 12-59 months who were seropositive for both viruses at baseline, the investigational vaccine was well tolerated and boosted antibody levels. A study comparing two investigational live attenuated hPIV3/hMPV vaccines in children aged ≥ 24 months to < 60 months of age is ongoing. For now, the best ways to prevent hMPV are the commonsense approaches recommended for the prevention of all viral respiratory tract infections. Wash hands frequently with soap and water. Avoid touching your eyes and mouth (or the eyes and mouth of your baby) with unwashed hands. Clean surfaces regularly that might be contaminated with hMPV, such as shared toys. Finally, stay away from sick people if you can. That recommendation, the mom and the pediatrician agreed, is the one that often seems impossible.

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