NEWS
Study shows success of RSV maternal vaccine
A new UK Health Security Agency (UKHSA) study shows the maternal respiratory syncytial virus (RSV) vaccination programme is providing over 80% protection for newborn infants, including those born prematurely. The study – Maternal RSV
vaccination and reduced risk of hospitalisation for babies in England 2024/25 – found vaccination at least two weeks before the birth gave 81.3% protection. A narrow range of statistical uncertainty, 78.9% to 83.4%, means there is high confidence in the protective effect of the vaccine. Analysing data from the first year of
vaccine roll out (24/25), the study is believed to be the largest in the world evaluating the effect of maternal RSV vaccination in preventing infants being hospitalised for RSV chest infection. RSV causes bronchiolitis (infection and inflammation of the small airways of the lung) and is a major cause of hospital admission in infants. The maternal vaccination programme is offered to women from 28 weeks of pregnancy to protect newborns. Nearly 300,000 babies born between
September 2024 and March 2025 were followed, representing around 90% of all births in England during this period. Using routinely collected electronic health records, UKHSA researchers assessed the vaccine’s effectiveness in preventing hospital admissions. More than 4,500 hospitalisations occurred in this cohort, the vast majority in infants whose mothers had not been vaccinated. The study, which was presented at
ESCMID Global 2026, also found that premature babies – who are particularly vulnerable to RSV – can be well protected, provided there is at least two weeks between vaccination and birth.
New validation guidance for IVDs published
A newly published joint resource from IBMS, LabMed and MHRA, with input from UKAS, supports laboratories in validating and verifying IVDs in line with ISO 15189. Medical laboratories work with
diagnostic devices and methods that need local verification or full validation to ensure they are fit for purpose in their own environment. Validation Guidance for Medical Laboratories – which has been jointly produced by the Institute of Biomedical Science (IBMS), the Association for Laboratory Medicine (LabMed), and the Medicines and Healthcare products Regulatory Agency (MHRA) – provides a principles-based framework for doing so, aligned with ISO 15189 requirements for
quality, competence and patient safety. The guidance covers verification
of manufacturer performance claims, validation of modified or off-label use, integration into laboratory-developed testing, and the use of research-use-only reagents. It also applies the same risk- based validation principles to emerging technologies, including AI-driven laboratory systems and digital pathology platforms. A practical stepwise workflow and
quick-reference requirements matrix are included to support laboratories in planning, executing and documenting validation activities proportionate to clinical risk.
Gut microbiome changes may signal increased Parkinson’s risk
Analysis of microbes in the gut can reveal whether a person faces an elevated risk of Parkinson’s disease before they have developed any symptoms, suggests a new study led by University College London (UCL) researchers. The scientists found that people with
Parkinson’s disease have a distinctive makeup of gut microbes, as do healthy individuals who are genetically at risk of Parkinson’s disease, they report in the new Nature Medicine study. The researchers say their findings could help in developing tests to reveal a person’s risk of developing Parkinson’s disease, so that they can be offered early support, and potentially also lead to new ways to prevent Parkinson’s by targeting the gut. For the study, the international
team led by scientists at UCL used an innovative new method to analyse clinical and faecal data from study participants in the UK (at the Royal Free Hospital, London) and Italy. This included 271 people with Parkinson’s disease, 43 carriers of the GBA1 variant (a gene variant that can increase the risk of Parkinson’s disease by up to 30-fold) with no clinical symptoms, and 150 healthy control participants (as a comparison group). The scientists found that over a
quarter of the microbes making up the gut microbiome (the assortment of
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WWW.PATHOLOGYINPRACTICE.COM May 2026
microorganisms such as bacteria that live in our digestive tract) – 176 different species – differed in their abundance when comparing people with Parkinson’s disease and the healthy control participants. Some microbes were more common among those with Parkinson’s disease, while others were more common among healthy study participants. This patern was most noticeable among people in more advanced stages of Parkinson’s. Most of these microbes (142 species) also consistently differed in abundance when comparing healthy controls to people with the GBA1 gene variant who have not yet experienced any symptoms of Parkinson’s disease. The researchers say that the
makeup of the gut microbiome in people who are genetically at risk of Parkinson’s, but without any symptoms, resembled an intermediate patern between the healthy individuals and those with Parkinson’s. More research is still needed to
understand what other genetic or environmental factors are at play to determine whether someone develops Parkinson’s. Menozzi E, Ren Y, Geiger M, et al. Microbiome signature of Parkinson’s disease in healthy and genetically at-risk individuals. Nat Med. 2026 Apr 20. doi:10.1038/s41591-026-04318-5. Online ahead of print.
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