Latest news with #nirsevimab

ABC News
2 days ago
- Health
- ABC News
Mothers in Victoria write to health minister amid confusion about RSV injection
A group of Victorian mothers have written to the health minister after struggling to get their children an antibody nirsevimab injection as part of the state's free RSV vaccination program. When Alissa Holder took her six-month-old baby to get a routine vaccination in April, she had no idea the ordeal she and her child was about to endure. Respiratory syncytial virus (RSV) is a highly infectious illness that infects up to 90 per cent of children in their first two years. It is one of the most common causes of hospitalisation of infants in Australia. This year the Victorian government introduced a program to provide free antibody nirsevimab injections, or the RSV shot, to eligible women and infants until late September 2025. Ms Holder saw seven doctors and five nurses in an effort to get her baby protected against RSV but said she was repeatedly denied the shot despite being eligible. A nurse from one clinic later confirmed her baby was eligible but that the clinic did not offer nirsevimab. She was advised to "doctor shop". On June 7, Ms Holder called triple-0 because her baby was coughing and struggling to breathe. Five days later, Ms Holder's baby tested positive for RSV. Ms Holder is now part of a group of 10 Ballarat parents with similarly confounding experiences that have written to Health Minister Mary-Anne Thomas about "the inequitable, confusing and ultimately dangerous … roll-out of the program in [the Ballarat] area". Amy Fuller contributed to the letter to Ms Thomas, detailing her month-long "stressful" process to get her newborn the nirsevimab shot. "We were originally told by the maternal child health nurse when we went for our normal vaccinations that we weren't eligible." Ms Fuller was later told by a GP that her baby was eligible, but that the clinic did not have any nirsevimab medicine. "We rang around Ballarat looking for vaccines and most places didn't have them," she said. Ms Fuller eventually found two clinics that offered the shot but was denied access because they were not "regular patients" at those clinics. She only recently got her child protected against the virus at a clinic but said there was still confusion. "They weren't entirely sure [about the injection]," Ms Fuller said. "One of them told us it was a live vaccine, one told us it wasn't, and they weren't sure if we had to wait 15 minutes or not [afterwards]." In the letter to the health minister, one mother said their doctors advised them the RSV injection "did not exist" and other parents said that some clinics could only order one dose per week or per month. Ms Thomas's office did not respond to a request for comment for this article, instead referring the ABC to the Department of Health. Under the Victorian RSV Mother and Infant Protection Program: The ABC understands the Department of Health is aware of the confusion about the RSV program within Victorian clinics and has since redistributed information and literature. "There is no shortage of nirsevimab in Victoria," a department spokesperson said. "Providers have been advised to order only what they need for scheduled appointments to ensure fair and efficient distribution. "Order limits have been relaxed as the respiratory illness season has progressed." The department said it had proactively sought to support health providers with additional information and guidance, including direct engagement with GP clinic staff. It said 46,000 doses of maternal RSV vaccine Abrysvo and more than 23,000 doses of nirsevimab had been distributed in Victoria. Ramya Raman, a practising GP and the Royal Australian College of GPs vice-president, said her patients had voiced confusion about the RSV injection. "The rate at which the public policy has been rolled out has been a little bit staggered and different between the states, and that's probably contributed a little bit to the confusion," Dr Raman said. She advised against doctor shopping. "It's important to have a regular GP because it means that that doctor will know exactly the family history, the mum's history, and will be able to advise appropriately whether they are eligible or not eligible," Dr Raman said. The day after her baby tested positive for RSV, Ms Holder got a call from the first nurse she met with, who apologised. The nurse went on to say that her baby was in fact eligible for RSV protection and she had since begun administering the jab to other infants as a result of multiple parents asking questions. "When it comes to health care it's important [governing bodies] don't leave any room for misinterpretation … because it can lead to illness and potentially death," Ms Holder said. "Make it really clear and simple and in plain English so that anyone can understand it." Editorial note 4/7/2025: The nirsevimap injection is not a vaccine, but a is a long-acting monoclonal antibody that can be given to infants to protect them from severe Respiratory Syncytial Virus disease. There is an RSV vaccine available for pregnant women, Arexvy and Abrysvo.


Medscape
26-06-2025
- Health
- Medscape
ACIP's New Class Endorses RSV, Talks COVID
A second monoclonal antibody to prevent respiratory syncytial virus (RSV) in infants has been recommended by the CDC's Advisory Committee on Immunization Practices (ACIP). Five voting members said no to recommending clesrovimab, a recently approved monoclonal antibody, for prevention of RSV in newborns and infants, based on safety concerns. Clesrovimab joins nirsevimab, a long-acting monoclonal antibody approved in 2023, in the arsenal to help protect infants and children against RSV. RSV remains a substantial burden among children younger than 5 years of age in the United States, and in the absence of prevention products, approximately 97% of infants develop RSV infections before age 2 years, said Adam MacNeil, PhD, of the CDC's National Center for Immunization and Respiratory Diseases, in his presentation. The current strategies for prevention of RSV in children and pregnant women are safe and effective, and the addition of a second option for children should increase access and address issues of supply, said MacNeil. Clesrovimab was recently approved by the FDA for prevention of RSV in infants younger than 8 months of age who were born during or entering their first RSV season. The ACIP previously recommended nirsevimab for prevention of RSV in this population and in children aged 8-19 months at increased risk of severe RSV disease and entering their second RSV season. For pregnant women, the CDC and ACIP continue to recommend a single dose of RSV vaccine (ABRYSVO) between 32 and 36 weeks' gestation. The development of monoclonal antibody products to prevent RSV in infants is 'a spectacular accomplishment,' said ACIP Panelist Cody Meissner, MD, a professor of pediatrics at Dartmouth Geisel School of Medicine, Hanover, New Hampshire, in a comment during the meeting. Providing data from clinical trials to inform recommendations 'is something the CDC does very well,' he said. The majority the public commentators during the first day of the meeting were clinicians who expressed support for the safety and effectiveness of vaccines. 'I have seen what vaccine preventable diseases can do to children,' said Caroline Brown, MD, a pediatrician in private practice in North Carolina, during the public comment. Thanks to vaccines, most children today are spared devastating outcomes, she said. However, Brown noted that she has been fielding calls from panicked parents with the appearance of measles in her area and emphasized that approved vaccines for children, including the measles vaccine, have been extremely well-researched and found to be safe and effective. Keeping the RSV Prevention Momentum Going Continued recommendation of the RSV vaccine is important, as the availability of both maternal vaccines and infant monoclonal antibodies for the past two seasons have resulted in reductions in hospitalizations and outpatient RSV visits, said Lori Handy, MD, MSCE, associate director of the Vaccine Education Center at the Children's Hospital of Philadelphia, Pennsylvania, and assistant professor of clinical pediatrics at the Perelman School of Medicine, in an interview. 'As all infants are at risk of RSV infection, multiple prevention products ensure that all families can access prevention and make informed choices about which prevention is best for their own circumstances,' said Handy. 'Continuing to offer safe and effective preventive options in the forms of maternal vaccines and infant monoclonal antibodies will ensure the success of the past two seasons will be enjoyed for newborns to come,' she emphasized. When it comes to vaccine information, clinicians continue to be the most trusted messengers, Handy told Medscape. Clinicians are in the best positions to have conversations with families and provide a strong recommendation to choose either maternal vaccine or monoclonal antibody for RSV prevention, she said. 'Direct patients and families to trusted resources developed by organizations with long-standing commitments to protecting the health of mothers and infants, such as ACOG, the Vaccine Education Center, and the American Academy of Pediatrics,' Handy added. The AMA Weighs In In advance of the ACIP meeting, the American Medical Association (AMA) posted an open letter to the American people with its position on respiratory vaccines. The letter acknowledged concerns in the medical and public health communities about the recent upheaval in ACIP membership and called on physicians to continue to provide 'clear, evidence-based guidance' to patients. 'We commit to working together to promote public understanding and confidence in the use of vaccines to avoid another severe respiratory virus season and resurgence of vaccine-preventable illnesses and deaths,' the AMA said in the statement. COVID-19 Here to Stay Although no voting related to COVID-19 vaccination occurred, the meeting began with a review of the latest data on COVID-19 epidemiology, followed by safety and efficacy reviews of former and current versions of the vaccine and a summary of the CDC's current recommendations. MacNeil noted in a separate presentation that although COVID-19 rates have decreased over the past several years, cumulative rates remain high among adults aged 75 years and older. He also noted that the risk of hospitalization from COVID-19 persists year-round, especially in vulnerable populations.


France 24
26-06-2025
- Health
- France 24
US panel replaced under Trump backs new shot for kids
The vote marked the first by the Advisory Committee on Immunization Practices (ACIP) since Kennedy dismissed all members of the influential group of independent experts and replaced them with his own nominees, a move that made this decision a test of the new panel's intentions. Clesrovimab was recently approved by the Food and Drug Administration as a shot for newborns and young babies experiencing their first respiratory syncytial virus (RSV) season. Marketed under the name Enflonsia by its manufacturer Merck, it was shown in clinical trials to be safe and effective at significantly reducing RSV infections and hospitalizations among infants. The ACIP panel was asked to adjudicate the next step after approval -- namely, whether it should now be recommended for infants under eight months old entering their first RSV season who are not already protected by an RSV vaccine administered to their mother during pregnancy. They voted 5-2 in favor. The two dissenters were Retsef Levi, a professor of operations management at MIT who has questioned the safety of Covid-19 vaccines, and Vicky Pebsworth, a nurse and member of the anti-vaccine National Vaccine Information Center (NVIC). "I don't feel this is ready to be administered to all healthy babies. I think we should take a more precautionary approach," said Levi, explaining his "no" vote. Pebsworth did not offer comments, but the NVIC previously opposed the earlier-approved RSV antibody, nirsevimab. Kennedy -- who spent decades spreading vaccine misinformation before becoming President Donald Trump's top health official -- abruptly fired all 17 members of the ACIP earlier this month, accusing them of conflicts of interest.


Medscape
26-05-2025
- Health
- Medscape
Nirsevimab Cuts RSV Hospitalizations in Spanish Study
The introduction of universal passive immunisation with nirsevimab, a long-acting monoclonal antibody, led to significant reductions in hospitalizations and paediatric intensive care admissions for respiratory syncytial virus–associated lower respiratory tract infections (RSV-LRTIs), particularly benefiting infants younger than 6 months. METHODOLOGY: Researchers carried out a prospective observational study at a tertiary hospital in Spain to examine if universally administering nirsevimab could reduce hospitalizations and paediatric intensive care admissions due to RSV-LRTIs in children younger than 5 years. They analysed 311 patients (median age, 4.9 months; 57.5% boys), comparing hospitalization rates during the October 2023-March 2024 RSV season — when nirsevimab was administered — with those during two pre-pandemic seasons (2018-2019 and 2019-2020) and one post-pandemic season (2022-2023). Nirsevimab immunoprophylaxis was given to all newborns with a gestational age of at least 35 weeks, to infants younger than 6 months, and to high-risk children younger than 2 years. TAKEAWAY: RSV-LRTI hospitalizations in infants younger than 6 months declined by 83.3% (95% CI, 70.9-95.8) during the period when nirsevimab was administered compared with those in the pre-pandemic periods and declined by 90.8% (95% CI, 83.6-98.0) compared with those in the post-pandemic period. Additionally, paediatric intensive care admissions declined by 73.3% during the period when nirsevimab was administered compared with those in the pre-pandemic periods and by 87.9% compared with those in the post-pandemic period. The median age of hospitalized patients significantly increased during the nirsevimab period, rising to 15.6 months, whereas it was 4 months and 3.4 months in the pre- and post-pandemic periods, respectively ( P < .001). < .001). Additionally, hospital stays were shorter during the nirsevimab period, with a median of 4 days, whereas they lasted a median of 6 days and 5 days in the pre- and post-pandemic periods, respectively ( P = .003). IN PRACTICE: "These findings are encouraging, and it is anticipated that in the coming years, nirsevimab prophylaxis will mitigate the significant burden on healthcare services during the winter season," the authors wrote. SOURCE: The study was led by Lorena Bermúdez-Barrezueta, Faculty of Medicine, Valladolid University, Valladolid, Spain. It was published online on May 16, 2025, in the European Journal of Pediatrics . LIMITATIONS: This was a single-centre study with a limited sample size. DISCLOSURES: The study was supported by FEDER European Funds and the Junta de Castilla y León under the Research and Innovation Strategy for Smart Specialization and partially funded by the Ernesto Sanchez Villares Foundation.