Medical Products Agency

Annual reformulation and approval of seasonal influenza vaccines necessitate yearly evaluation of their effectiveness. Regulatory agencies, including the European Medicines Agency (EMA), rely on timely, real-world evidence to inform product-specific benefit-risk assessments. We explored the feasibility of conducting annual, brand-specific influenza vaccine effectiveness studies in Denmark, Finland and Sweden, starting with the 2024/25 season. These countries maintain population-wide vaccination, clinical and laboratory registers, linkable via personal identification numbers and updated in near real-time. We discuss suitable study designs and document that cohort studies using a target trial emulation (TTE) framework are feasible in all three countries; register-based test-negative case-control design (TND) studies are currently only feasible in Denmark. Supplementary methods, including regression discontinuity and negative control outcome analyses, can address residual bias. This Nordic collaboration has proven capacity for large-scale register-based studies and its infrastructure is able to address EMA's requirements for timely, robust post-authorisation evidence to guide public health and regulatory decisions.

Abstract Marked differences in antidepressant prescribing have been reported across the Nordic countries, but existing reviews are based on older data and focus mainly on young people. We conducted an updated systematic review of antidepressant prescribing across all age groups in the Nordic countries. We searched Embase, PubMed, and Web of Science for observational studies reporting prevalence and/or incidence of antidepressant prescribing in general populations in the Nordic countries, published from 1 January 2000 to 1 October 2025. From 2728 screened articles, 30 studies with prescribing data from 1994–2021 were included. The rate of antidepressant prescribing was higher in Sweden compared to Denmark and Norway, and these differences increased in recent years, mainly due to large increases in Sweden. Findings were consistent across all age groups and both sexes, but were especially pronounced among children and adolescents, and particularly girls. The most recent data showed a 2–5 times higher prevalence and incidence of antidepressant prescribing among Swedish girls and boys as compared to their Danish and Norwegian peers, including relevant differences in absolute measures. The prevalence pattern was similar in adults, and while relative differences were smaller there were large absolute differences. Comparisons with Finland and Iceland were not feasible due to outdated data. The rate of antidepressant prescribing is consistently higher in Sweden compared to in Denmark and Norway, and these differences between countries have increased markedly over time. The pattern is observed across all age groups and both sexes but is especially strong among young females.

In May 2024 with a subsequent update in June 2025, the Swedish Medical Products Agency’s expert group revised guidelines on the management and treatment of respiratory syncytial virus (RSV) infection. This is an abridged version and commentary on the full recommendation including specific recommendations for the RSV-season 2025/2026. Key points are: (i) RSV is a seasonal, highly contagious infection. Almost all children are infected by age two, usually with mild illness; (ii) Some infants, children with underlying conditions, and frail elderly are at risk for developing severe disease requiring hospital care; (iii) Preventive measures—such as hand hygiene and avoiding contact with people with colds—are essential to protect infants and the elderly; (iv) Prophylactic treatment with monoclonal antibodies reduces the risk of infants developing severe RSV disease and requiring hospital care. The long-acting drug nirsevimab is preferred over the shorter-acting palivizumab; (v) Universal prophylaxis in infants reduce disease burden for both families and society; (vi) If supply is limited, children at highest risk should be prioritised for prophylaxis; (vii) Maternal vaccination during pregnancy lowers the risk of severe RSV in newborns, decreasing hospital admissions. The protective effect is considered to be equivalent to that of monoclonal antibodies. Recommendations and funding decision for maternal vaccination is under investigation during the autumn of 2025; (viii) In the elderly, vaccination is the most effective pharmacological prevention; (ix) There is no effective antiviral treatment for established RSV disease; management is symptomatic and supportive. Hospitalised children should not be subjected to measures with no proven effect, preferable minimal interventions, with treatment focused on ensuring adequate nutrition; (x) The Swedish recommendations state that during the RSV season 2025/2026, nirsevimab should be administered to prevent RSV infection in all infants aged 0–3 months during the RSV season and to infants under 12 months with increased risk of severe RSV and certain high risk children under 24 months.

BackgroundSwedish animal welfare requirements exceed those of EU, which may have contributed to decreased pig production in Sweden since joining EU. On request from stakeholders, the Swedish Board of Agriculture allowed testing effects of reduced welfare demands on pig production for one year. This included weaning before 28 days at individual level, temporary confinements of sows during farrowing and mating, and increased stocking density of growers. The intervention period lasted for one year, and the productivity was compared with the preceding year.ResultsA reduced mean weaning age from 32 to 27 days did not have a significant effect on piglet welfare measures but the annual number of piglets weaned per sow increased by 1.3. Temporary confinement of sows at farrowing had no significant effect on piglet mortality or productivity, but the confinement reduced sow welfare. Temporary confinement of sows during mating did not improve sow productivity. Instead, hygiene and welfare decreased due to the confinement. Decreased stocking density by 10% compared with Swedish requirements had no significant effect on welfare measures. Nor did weight gain differ from the previous year. However, increased batch size of fatteners increased the incidence of respiratory lesions at slaughter, impaired growth and feed conversion.ConclusionsSimulations assured that over 90% of the piglets were older than 25 days in batches weaned at a mean age of 28 days. As piglets mature from three to four weeks of age, this was important for piglet welfare. Short-term confinement of sows at farrowing or mating decreased sow welfare due to the confinement while no significant increase in piglet productivity was found. An increased stocking density by 10% of weaners and growers did not affect welfare measures but increased the number of potential disease transmissions between pigs by 22% due to increased batch sizes. When batch size increased, respiratory lesions at slaughter increased and productivity decreased. Based on the results, the Board of Agriculture allowed herds to wean at a mean age of 28 days provided they complied with special requirements. Except for this, the minimal legal requirements of pig welfare in Sweden remained unchanged.

Avian scavengers, such as vultures and condors, perform vital ecosystem services by rapidly consuming dead animals and removing infectious materials, thus reducing outbreak risk.However, the role of these scavengers in pathogen transmission dynamics is often overlooked in the One Health framework.

Hormonal therapy is widely used to treat different conditions in humans; a well-known indication being the relief of menopausal symptoms in women. Transdermal delivery of hormonal drugs is common and may pose a risk to humans and animals through secondary exposure. This report raises awareness of risks associated with secondary exposure to transdermal hormone-containing drugs, based on evidence from spontaneous reporting of suspected adverse events. Clinical signs in humans included precocious puberty, unresolved virilisation, accelerated growth rate, alopecia, foetal death, and female infertility. In animals, clinical signs included persistent oestrus, poor growth rate and birth defects. Risks of secondary exposure must be acknowledged when prescribing hormonal drugs and as a possible aetiology of clinical signs in humans and animals.

Background and ObjectivesReports of suspected adverse drug reactions are of a great importance for the safety monitoring of new vaccines to identify potential safety risks promptly and to ensure necessary measures for risk mitigation. We reviewed the reports of fatal adverse drug reactions after coronavirus disease 2019 (COVID-19) vaccination with Comirnaty®, Spikevax®, and Vaxzevria® during the national vaccination campaign in Sweden.MethodsSwedish reports of suspected adverse drug reactions with fatal outcomes after COVID-19 vaccines were retrieved from the EudraVigilance database. Vaccination data were obtained from the National vaccination register. Reporting rates were calculated by dividing the number of adverse drug reaction reports with fatal outcomes by the number of people exposed to at least one dose of the COVID-19 vaccines or by the number of vaccine doses given. A causality assessment of adverse drug reaction reports was performed by clinically qualified reviewers.ResultsMore than 26 million doses of COVID-19 vaccines were administered and 456 reports of suspected adverse drug reactions with fatal outcomes were reported during 27 December, 2020–31 May, 2023. The reporting rate was 5.7 fatal outcomes per 100,000 persons vaccinated with at least one dose of any COVID-19 vaccine or 1.7 per 100,000 vaccine doses given. Most of the fatalities were related to patients’ pre-existing conditions, predominantly among people aged 70 years or older. Only ten of the reported fatalities (0.1 per 100,000 persons vaccinated) were assessed as consistent with a causal association to COVID-19 vaccination.ConclusionsAdverse drug reactions with fatal outcomes after COVID-19 vaccines in Sweden were very rare. No new safety concerns were observed in this study.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40261-025-01466-3.