Medical Products Agency

To evaluate the possible influence of gender and specialty on adverse drug reaction (ADR) reporting among physicians before and after the COVID-19 pandemic. This retrospective nationwide register study analysed all ADR reports submitted by physicians to the Swedish Medical Products Agency during 2017 and 2023 (n = 4079 and 3740, respectively). The reporting rates were calculated and stratified by gender and specialty. The highest reporting rate among physicians was observed in medical specialties, followed by primary care and psychiatry (27, 10, and 12, reports/100 physicians in 2017; 18, 15, and 9 in 2023). The lowest reporting rates were observed for surgical and hospital service specialties (8 and 1 in 2017; 6 and 1 in 2023). Male and female physicians reported ADRs to a similar extent and both reported more frequently on female patients. Gender concordance between physician and patient was associated with significantly higher reporting (p < 0.001 in 2017; p = 0.041 in 2023). Reporting varied across specialties, and gender concordance emerged as a previously unrecognized factor influencing ADR reporting. These findings provide new opportunities for targeted interventions to enhance physician participation in pharmacovigilance.

The Inno4Vac consortium, funded under the Innovative Medicines Initiative 2 Joint Undertaking, was launched in September 2021. Among its four key objectives is the development of an open-source, in silico simulation platform designed to support the design, scale-up, operation, and technology transfer of vaccine manufacturing processes, including stability testing. A workshop was held on May 27, 2025, in Brussels, Belgium, which provided an opportunity for modellers to show the progress made, and have an open dialogue with regulatory health authorities' representatives. Regulators are increasingly open to advanced kinetic modelling and other modelling approaches for predicting vaccine stability and shelf-life, provided they are transparent, scientifically justified, and validated with real-time data. Initial claims can rely on accelerated studies and modelling simulating worst-case scenarios, with extensions supported by additional data. In urgent contexts, extrapolation from similar products or processes may be accepted if scientifically sound. Platform-based extrapolation requires strong similarity, but product-specific data remain critical, as small formulation changes can alter stability. Simulation studies that demonstrate robustness and predictive accuracy enhance confidence. Projects like Inno4Vac highlight Bayesian methods for formulation design, though formal guidance is limited. Regulatory scrutiny depends on model risk, with low-risk models probably still requiring justification. Transparent data practices, including justified handling of outliers, are essential. Collaboration between regulators, industry, and academia remains key to advancing science-based innovation while ensuring product quality.

Antipsychotics are mainly used for severe psychiatric disorders. Risperidone is the only antipsychotic approved for younger children. Aripiprazole is approved for older children, ziprasidone and lurasidone for adolescents. To describe paediatric utilisation of antipsychotic drugs in Sweden. Dispensations of antipsychotic drugs to children aged 5-17 years from 2008 to 2021 were analysed using the National Prescribed Drug Register and recorded diagnoses were obtained from the National Patient Register. Overall, dispensations of antipsychotics to children increased from 16.7 to 36.9/10,000 between 2008 and 2021. The increase was larger in girls, from 12.3 to 36.6/10,000. New users of antipsychotics increased by 121% in the same period, from 7.9 to 17.5/10.000. In 2019, in children aged 12-17, 63% of girls and 71% of boys were dispensed had at least three dispensations of antipsychotics, while the corresponding proportion in children aged 5-11 were 52% for girls and 63% for boys. Risperidone was the most common drug in boys of all ages and in girls aged 5-11. In girls aged 12-17, aripiprazole and quetiapine were most common. The proportion of on-label antipsychotic use was 21% in girls and 15% in boys based in authorised product information and increased to 37% and 45%, respectively, when aligning with national guidelines. The use of antipsychotics has increased, with the proportion of girls starting treatment at the end of study period exceeding that of boys. A considerable proportion of prescriptions was off-label, even when considering national guidelines.

We estimated vaccine effectiveness (VE) of Omicron JN.1-adapted COVID-19 vaccines administered during the 2024 autumnal vaccination campaign against COVID-19 hospitalisation and death among eligible individuals aged ≥65 years. The study period was October 2024-January 2025. Using a common protocol across six EU/EEA study sites, we linked electronic health records to construct retrospective cohorts and applied Cox modelling to estimate VE via confounder-adjusted hazard ratios. The majority of vaccines administered during the study period were Omicron JN.1-adapted COVID-19 vaccines (99 %). VE against hospitalisation was 60 % (95 % Confidence Interval: 48-70 %) and against COVID-19-related death was 78 % (95 %CI: 64-87 %) among individuals aged 65-79 years; 58 % (95 %CI: 48-66 %) and 62 % (95 %CI: 32-79 %) among those aged ≥80 years. These results indicate high effectiveness in the initial months of the campaign. Continued monitoring is necessary to confirm these results, including estimates of VE in those with longer time since vaccination and during different variant predominance periods.