Nirsevimab

The CDC now recommends the use of Merck’s recently-approved RSV antibody in infants, after advisors to the agency voted in favor of the product in June. CDC Director Susan Monarez adopted the recommendation of the Advisory Committee on Immunization Practices on Monday after taking the helm of the agency last week. Merck’s Enflonsia was approved by the FDA earlier in June to prevent RSV lower respiratory tract disease in infants entering their first respiratory virus season. Inclusion of the antibody in CDC’s guidelines was the final step for Merck as it challenges Sanofi and AstraZeneca’s Beyfortus in the market. Beyfortus raked in almost $2 billion in sales in 2024 after being approved in 2023. The June ACIP meeting was the first since HHS Secretary Robert F. Kennedy Jr. fired and replaced the committee’s roster of members. Two of the seven new members had voted against the drug, raising safety concerns with the RSV antibodies. Retsef Levi, a supply chain professor at MIT, had issues with what he believed was an imbalance in deaths, specifically highlighting Beyfortus’ clinical trial data despite that product not being up for recommendation. Cody Meissner, the only former ACIP member to be included in the rebuilt panel, voted for the drug and underscored the real-world benefit that Beyfortus and Pfizer’s maternal RSV vaccine had demonstrated so far. “This is a truly spectacular accomplishment,” Meissner said at the meeting. Kennedy last month adopted guidance made by the previous ACIP panelists in April, recommending adult RSV vaccines for people 50 to 59 at higher risk of severe disease. Kennedy also recently adopted a June recommendation from the rebuilt ACIP panel to continue annual flu shots but remove thimerosal from them . That ingredient has been a source of consternation from people hesitant or skeptical about vaccination, and its alleged risks have been pushed by Children’s Health Defense, an organization Kennedy used to run. But the FDA notes that vaccines without thimerosal are available and that a “robust body of peer-reviewed scientific studies” have concluded that vaccines with the ingredient are safe.

The NHS’s top midwife is urging newly eligible pregnant mothers that “now is the time to act” and get the RSV vaccine to protect their baby ahead of this winter. Respiratory syncytial virus (RSV) is a leading cause of infant mortality around the world and a main cause of child hospitalisations every year – with almost 7,000 bed days taken up by children with RSV last winter in England (6,815 from 25 November 2024 – 30 March 2025). The Australian winter is often a good predictor of how viruses will spread in England, and following the highest number of RSV cases on record last year in Australia, cases have been steadily increasing since the start of 2025 in many areas, with almost half of RSV cases in children aged 0 to 4 years. England’s chief midwife is today urging eligible pregnant women from 28 weeks to speak to their maternity services about getting vaccinated to ensure their babies are protected ahead of their first winter months. Kate Brintworth, chief midwifery officer for NHS England, said : “While for most adults RSV only causes mild, cold like symptoms, for older adults and young children it can lead to serious breathing problems that can end up in hospitalisation. “Getting vaccinated while pregnant is the best way to protect your baby from the moment they are born, and now is the time for mums to act, to make sure their babies are protected ahead of their first few months this winter, when there tends to be more bugs circulating.” The RSV vaccine was offered to pregnant women in England for the first time last September and has now helped to protect more than 300,000 mothers and babies. Thanks to the hard work of GP and maternity services, vaccination teams and pharmacies across the country, NHS staff have now delivered more than two million RSV vaccinations to eligible people since the rollout kicked off (2,061,474). Pregnant mums from 28 weeks onwards can access the RSV jab through their maternity services or via their local GP practice. Older adults aged 75 to 79 years old are also eligible, and across the coming weeks NHS England will send invites to over one million people via letter, text, email or NHS App notifications, to remind those eligible to come forward. Health Minister Karin Smyth said : “I am proud that this government introduced the RSV vaccination programme for pregnant women last year, to protect babies against this disease. “Getting the RSV vaccine while pregnant is the most effective way to protect your newborn from getting seriously ill with RSV in their first few months of life. “That is why I encourage everyone who is eligible for the vaccine to come forward when asked, or contact your maternity service or GP practice to make an appointment from week 28 of pregnancy, to help give your child the best possible start in life.” New research from the UK Health Security Agency (UKHSA) has found the RSV vaccine is around 82% effective in preventing older people being hospitalised with an RSV infection, and another study by NHS paediatricians found that the maternal vaccine is 72% effective in preventing hospitalisation for newborns whose mothers are vaccinated more than 14 days before delivery. Greta Hayward, Consultant Midwife at the UK Health Security Agency, said : “Having the RSV vaccine during every pregnancy is the best way for women to protect their newborn against RSV, as the vaccine boosts their immune system to produce more antibodies against the virus, and these then pass through the placenta to help protect their baby from the day they are born. RSV infects around 90% of children in their first two years of life. “The RSV season usually starts in October and while there is no risk-free birth month, babies born in late summer or the autumn are most likely to be admitted to hospital. Hundreds of babies attend Emergency Departments each day for bronchiolitis through most of November and December. That is why it is so important that over the summer pregnant women reaching 28 weeks of pregnancy, ensure they are vaccinated as soon as possible.” Vaccinations to protect against flu and whooping cough are also recommended to women during pregnancy to further protect the health of the mother and their baby. Around 100 community pharmacies in the East of England and the Midlands are also now delivering the RSV vaccine, with NHS England planning to expand this offer to up to 150 additional pharmacies across the country, focusing on areas where access is limited to make it as easy as possible for eligible people to receive their jabs. Many of the additional community pharmacy sites will also be offering the pertussis (whooping cough) vaccine to eligible pregnant women, helping to improve uptake and free up GP appointments each year. National Childbirth Trust (NCT)’s Head of Service Development, Maxine Palmer, said : “It’s positive to see the NHS taking action to raise awareness of the risks of RSV to newborn babies. “Expectant parents need clear and accurate information about vaccinations during pregnancy, so they can make their own informed decisions about their health and the health of their baby. “We recommend all parents speak to their midwife or doctor to discuss their options and to learn more about preventing, recognising, and treating illness and infection during pregnancy.” NHS England is rolling out the one-off injection medication, nirsevimab, from late September to provide protection against RSV for eligible high-risk and very preterm babies who are born too early to be protected by the RSV vaccine offered to pregnant women. Parents should also ensure their children are up to date with their routine NHS vaccinations to protect against infections including HPV, meningitis and measles, mumps and rubella (MMR). For children and young adults up to 25 years old, please speak to your GP about catch-up vaccination options. Case study Student midwife Yusra Osman is all too aware of the danger of RSV, as her first child developed bronchiolitis when he was just three months old. Yusra had gone to get her son up out of bed and found he had a fever and was gasping for breath. She rang NHS 111 for advice and was told to call 999 immediately for an ambulance. Yusra said: “I wasn’t a healthcare professional back then, but as a mum your instincts take over. Everything was a blur, but I remember his chest was caving in and out and he was really struggling to catch his breath.” Hospital staff said her son’s oxygen levels were dangerously low. Yusra continues, “That was one of those things you don’t want to hear as a mum. He was crying, and we kept trying to put an oxygen mask on, but he was fighting to get it off and didn’t want to be touched. “We had to stay in hospital for three or four nights where he ended up on an oxygen and feeding tube.” Yusra had been breastfeeding, but her son was too poorly for her to continue. “We lost our sort of physical touch; we lost our bond, and I just felt helpless.” Fortunately, Yusra’s son recovered well. He loves sports and is now a big brother, but he has been diagnosed with asthma which flares up each time he is sick. “I’m so incredibly grateful for how far he’s come, but the memory never really leaves you,” says Yusra. “It’s a mum’s worst nightmare. I had another son about a year and a half later and had the RSV vaccine been available then, I’d definitely have had it.” Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. 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