Clesrovimab

Speaking on the first day of this year's JP Morgan Healthcare Conference, Sanofi CEO Paul Hudson highlighted the significant role Beyfortus (nirsevimab) can play in preventing respiratory syncytial virus (RSV) in newborn infants, and described the current US administration as having "a particular sensitivity around vaccination.""Preferring to give the parents the choice is a very delicate line to walk because not everybody is well informed," Hudson said of paediatric vaccination. "When you're trying to protect communities, it leaves too much open to variability." Earlier this month, the Department of Health and Human Services (HHS) said it will pare back the number of vaccines recommended for children to align its childhood vaccination schedule more closely with Denmark's (see – ViewPoints: 'It's only going to get worse' — Offit's 2026 vaccine outlook).Despite considerable evidence supporting the efficacy and safety of Beyfortus and Merck & Co.'s newer Enflonsia (clesrovimab-cfor), HHS has promised to "rigorously" review the data on both long-acting mAbs, which are designed to protect young children during their first RSV season."We think the half-life [of Beyfortus] guarantees it can project the baby for the entire RSV season," said Hudson, suggesting that Merck has yet to demonstrate Enflonsia can offer the same durability of effect.Pushed on the impact of US vaccine policy changes instigated by HHS secretary Robert F. Kennedy Jr., Hudson was pragmatic."I'm asked all the time, 'What are you going to do to fix this?' And the truth is, we just need to stay extremely objective and keep presenting the evidence," he said. "There's really very little else we can do." Hudson suggested that the pending mid-term elections could bring pushback against recent policy changes and sounded hopeful that in the longer-term they would be reversed, noting that, "for most of our work, we plan for longer than three years."From a financial perspective, Beyfortus can offer unique benefits to healthcare systems. Priced like "a premium vaccine," despite being a mAb, it provides "payback in the same fiscal year, which has surprised everyone," Hudson told delegates in San Francisco."Access is within reach for almost every baby that needs protection, and there are 50,000-plus newborns with RSV who go into intensive care units in the US each year in very distressing circumstances, many with longer-term implications," Hudson noted, adding that the launch of Beyfortus reduced this number by between 80% and 90%.  "The real-world evidence that has been accumulated shows that it absolutely pays back within the current year and protects those babies, and that is just a gift to parents," Hudson posited. "But it's also a gift to healthcare systems."Analysis – Physician Views Preview: Will changes to US childhood vaccine recommendations move the needle in clinical practice?

The US will pare back the number of vaccines recommended for children, the Department of Health and Human Services (HHS) announced on Monday, moving to align its childhood vaccination schedule more closely with Denmark's. Instead of a singular, universal vaccine policy, the Centers for Disease Control and Prevention (CDC) has divided its schedule into three segments: diseases for which all children should be vaccinated against, shots recommended only for certain high-risk groups, and vaccines that can be given "based on shared clinical decision-making."While the agency's schedule in 2024 and at the start of 2025 recommended all children be vaccinated against 18 diseases, it now only supports shots for 11: diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, pneumococcal conjugate, polio, measles, mumps, rubella, chickenpox and HPV — and only one dose of the latter, rather than the two it has recommended previously. According to HHS Secretary Robert F. Kennedy Jr., the changes were based on a scientific assessment that "compared US childhood immunisation recommendations with those of peer nations, analysed vaccine uptake and public trust, evaluated clinical and epidemiological evidence and knowledge gaps, [and] examined vaccine mandates."However, American Academy of Pediatrics (AAP) President Andrew Racine condemned the changes as "dangerous and unnecessary." “The United States is not Denmark, and there is no reason to impose the Danish immunisation schedule on America’s families," he said in a statement. "America is a unique country, and Denmark’s population, public health infrastructure, and disease-risk differ greatly from our own."Racine confirmed the AAP will continue to publish its own childhood vaccine recommendations, and reaffirmed the organisation's support for the eliminated shots "for good reason; thanks to widespread childhood immunisations, the United States has fewer paediatric hospitalisations and fewer children facing serious health challenges than we would without this community protection."Taken off the scheduleThe major overhaul comes shortly after the CDC first started eliminating certain vaccines from the childhood schedule. In May of last year, the agency removed its recommendation for all children aged six months and older to be vaccinated against COVID-19, a decision disputed by medical groups. The AAP filed suit against the HHS to block the policy change and issued its own guidance for all children between the ages of 6 months and 23 months to receive COVID-19 shots.The CDC's Advisory Committee on Immunization Practices (ACIP) also voted last month to ditch a decades-old policy for all babies to be vaccinated against hepatitis B at birth. Now, the shot is only recommended for babies whose mothers either test positive for hepatitis B surface antigen (HBsAg) or whose status is unknown; if a mother is HBsAg-negative, parents are advised to consult with a doctor about whether to administer the hepatitis B vaccine at birth or to skip it entirely. Further, if they opt for vaccination, they should wait until the baby is at least two months old before beginning the series.Similar to Monday's major overhaul, the inspiration behind the CDC's reversal on the universal hepatitis B birth dose was also Denmark. However, during the December ACIP meeting, Adam Langer — the CDC's acting principal deputy director and the associate director for science at the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention — cautioned against comparing the US's vaccine schedule with that of Denmark."More than 95% of pregnant women in Denmark are screened for hepatitis B. This is far higher than the number in the United States. Prenatal care is free for both citizens and refugee or asylum seekers in Denmark. We all know this is not the case in the United States," Langer said. "In Denmark, pregnant women who screen positive for surface antigen are followed up and their infants are followed up to ensure that they are vaccinated and tested for hepatitis B. In the United States, many of these infants are lost to follow up as soon as they leave the hospital. Denmark, and for that matter virtually all other high-income countries, are not really peer nations."Under the CDC's new tiered schedule, parents can still choose to vaccinate their children against COVID-19 and hepatitis B under the shared decision-making framework, along with rotavirus, influenza, meningococcal disease and hepatitis A. For high-risk children, the CDC is recommending preventative treatments for respiratory syncytial virus (RSV), hepatitis A and B, dengue and meningococcal disease. Despite mounds of evidence supporting the safety of RSV therapies such as Sanofi and AstraZeneca's Beyfortus (nirsevimab-alip) and Merck & Co.'s newer Enflonsia (clesrovimab-cfor), HHS has promised to "rigorously" review the data on both long-acting monoclonal antibodies, which are designed to protect young children during their first RSV season.