Non-Communicable Disease and Healthcare System Developments
EMA Medicine Safety and Availability
Injectable Iron — Review of Hypophosphataemia and Bone Complications
EMA’s Pharmacovigilance Risk Assessment Committee, meeting from 31 August to 3 September, opened a safety review of injectable iron-containing medicines after reports of severe hypophosphataemia and associated osteomalacia raised concerns about the effectiveness of existing risk minimisation measures. Some serious cases followed only one or two doses of ferric carboxymaltose in patients without recognised risk factors; delayed diagnosis was also reported. Similar reports with other injectable formulations prompted a review of the whole injectable class. Oral iron is outside its scope.
This is the start of a regulatory assessment, with any changes to marketing authorisations still to be determined. For Bulgarian services using intravenous iron, the immediate relevance is the possibility that bone pain and other symptoms following treatment may reflect an adverse effect requiring recognition; the announcement does not establish an identical risk across formulations or quantify the frequency of osteomalacia.
Visudyne — Supply Recovery Expected in 2027
On 4 September, EMA announced approval of new EU supply arrangements and manufacturing sites for Visudyne (verteporfin), used in photodynamic treatment of selected serious retinal conditions. Full restoration of EU supply is expected in 2027. The previous dependence on a single US active-substance manufacturing site contributed to supply vulnerability, and limited stocks have required controlled allocation between Member States. Bulgarian ophthalmology services therefore have a prospective supply improvement to plan around, while the announcement itself does not mean that current shortages or treatment prioritisation have ended.
Clinical Research Highlights
Digital Reminders and Statin Refilling
The ADHERE-ASCVD randomised trial, published in JAMA on 29 August, enrolled 20,604 adults with established atherosclerotic cardiovascular disease or high cardiovascular risk and recent statin nonadherence within Kaiser Permanente Northern California. Initial digital outreach increased refilling within fourteen days from 12.0% with usual communication to 14.4%, an adjusted difference of 2.3 percentage points (95% confidence interval 1.3–3.4). A second outreach improved refilling among initial nonresponders, but switching communication channels offered no clear advantage over repeating the same channel.
The finding is relevant to Bulgarian electronic prescribing and pharmacy follow-up: inexpensive communication can produce a measurable, modest improvement in medication collection. Follow-up lasted only twenty-eight days, however, and prescription refilling does not establish sustained medication use, LDL cholesterol reduction, or prevention of cardiovascular events. Transferability also depends on reliable patient contact details and access to digital communication.
Early Evolocumab After Myocardial Infarction
The AMUNDSEN trial, also published in JAMA on 29 August, randomised 2,161 patients with high-risk acute myocardial infarction undergoing percutaneous coronary intervention to evolocumab initiated before the procedure plus standard care, or standard care alone. At twelve months, LDL cholesterol below 55 mg/dL together with a reduction of at least 50% from baseline was achieved in 82% versus 40% of patients with available measurements (adjusted odds ratio 5.54, 95% confidence interval 4.50–6.82). The clinical endpoint of all-cause death or unplanned cardiovascular hospitalisation occurred in 14.6% versus 15.4% (adjusted odds ratio 0.94, 95% confidence interval 0.73–1.19).
Early treatment substantially improved lipid control, while the trial did not demonstrate a clinical benefit within one year. For Bulgarian cardiology and reimbursement discussions, those outcomes need separate interpretation: the biochemical result supports effective LDL lowering, whereas the clinical estimate remains compatible with both benefit and no benefit over the observed period.
Infectious Diseases: Global Perspective
Contact and Body-Fluid Transmission
Bundibugyo Ebola Disease — Democratic Republic of the Congo and Uganda
ECDC’s Week 35 bulletin recorded 5,794 confirmed Ebola cases and 2,786 related deaths in the Democratic Republic of the Congo through 26 August. The Week 36 bulletin reported 6,342 cases and 3,072 deaths through 2 September: increases of 548 cases and 286 deaths, with a crude cumulative case fatality ratio of 48.4%. Six provinces had been affected. These cumulative surveillance figures cannot by themselves separate new transmission from delayed ascertainment, and the deaths-to-cases ratio is not a completed-cohort estimate of prognosis.
WHO declared Uganda’s outbreak over on 25 August; ECDC distinguishes this from the national declaration on 28 July cited in the previous edition. ECDC continued to assess infection likelihood as very low for the EU/EEA population. For Bulgaria, the practical relevance remains recognition and isolation of a compatible illness in a traveller with an appropriate exposure history, despite the low likelihood of importation.
Infectious Diseases: European Union/European Economic Area
Vector-Borne Transmission
West Nile Virus, Chikungunya and Dengue
ECDC’s Week 36 report identified 144 West Nile virus affected areas in fifteen European countries as of 3 September, including nineteen in Greece and seventeen in Romania. These are geographic areas, not case counts. Bulgaria was absent from that particular European listing, although NCIPD had recorded one human notification nationally; the two outputs have different reporting and inclusion processes, and the national notification alone does not establish where infection was acquired.
As of 2 September, France had reported 46 locally acquired chikungunya cases, thirteen more than in the preceding update. Locally acquired dengue numbered five cases in France and three in Italy. These detections remain relevant to Bulgarian travel-associated surveillance and assessment of local vector exposure, without establishing local transmission in Bulgaria. Spain’s four reported locally acquired Crimean-Congo haemorrhagic fever cases were unchanged in the latest week and are included for regional surveillance continuity.
Airport-Associated Malaria in Frankfurt
By 28 August, six Plasmodium falciparum infections had been identified among Frankfurt International Airport workers without travel to malaria-endemic areas; two patients died. ECDC attributed the event to infectious mosquitoes transported by aircraft and reported no increased risk to the general population. For Bulgarian clinicians, airport work or proximity can be relevant exposure information when investigating otherwise unexplained fever, even in the absence of travel to an endemic country.
Respiratory and Droplet Transmission
Fatal Diphtheria in Italy and Early Respiratory Virus Increases
ECDC’s Week 35 report described fatal respiratory diphtheria in an unvaccinated four-year-old child in Palermo, with a second probable case in a cousin. Italy’s national institute confirmed Corynebacterium diphtheriae and the toxin gene on 25 August. The event is pertinent to Bulgarian assessment of missed childhood vaccinations, especially alongside continuing domestic measles notifications; it does not indicate widespread European diphtheria transmission.
The Week 36 respiratory summary, using Week 35 surveillance data, described low overall activity with increasing SARS-CoV-2 and influenza circulation in some countries; older adults accounted for much of the hospital detection burden. RSV remained at inter-seasonal levels. Bulgaria’s small COVID-19 notification counts cannot independently quantify community circulation, given their dependence on testing and reporting.
One Health: Animal Disease Events in the European Region
Foot-and-Mouth Disease Serotype SAT 1
WOAH’s 28 August assessment, drawing on WAHIS notifications through 26 August, described the geographic expansion of foot-and-mouth disease serotype SAT 1. First occurrences were reported in Israel, Cyprus, Palestine, China and Mongolia during 2026, while Türkiye, Lebanon and Greece reported its return during 2025–2026 after a prolonged absence. These are cumulative developments reviewed during the fortnight, rather than a set of newly occurring outbreaks confined to these two weeks.
For Bulgaria, the involvement of neighbouring Greece and Türkiye makes livestock movement surveillance and preparedness directly relevant. Foot-and-mouth disease threatens susceptible livestock, production and trade; it should be distinguished from the human anthrax notifications discussed below. The latter provide a separate example of an animal health event with documented human disease in the same district.
Infectious Diseases: Bulgaria
The NCIPD operational analyses and NCPHA district-level ZRZ bulletins both cover Week 35, 24–30 August, and Week 36, 31 August–6 September. The following comparisons use those national periods; ECDC’s correspondingly numbered bulletins cover 22–28 August and 29 August–4 September. As in previous editions, changes of at least 20% support signal selection, with cumulative excesses and unusual events considered separately. At small counts, percentage changes are descriptive and do not establish changes in underlying incidence.
Zoonotic Transmission
Anthrax — Three Confirmed Notifications in Lovech
NCIPD recorded three confirmed anthrax cases in Week 35, compared with none in Week 34, and no further notifications in Week 36. The cumulative total remained three, compared with zero in the corresponding period of 2025; a percentage increase from that baseline is undefined. NCPHA assigned all three notifications to Lovech.
The Lovech regional administration’s statement of 26 August documented an officially confirmed cattle anthrax outbreak in Stefanovo, following hospital admissions with suspected anthrax and an investigation of slaughtered livestock. The response included disinfection, animal movement restrictions and arrangements for vaccination of eligible animals; twenty-one exposed or contact persons were identified for clinical assessment. This establishes the animal and human investigation context, although the weekly tables do not provide individual exposure histories, clinical forms, or a case-by-case linkage for all three confirmed notifications.
Bacillus anthracis forms environmentally persistent spores, and exposure to infected animals or contaminated animal products can cause human disease. The district concentration therefore warrants interpretation as an unusual zoonotic signal despite the small count. One subsequent week without new notifications is insufficient to establish that all exposure-related illness has been excluded.
Respiratory and Droplet Transmission
Measles — Eighteen Notifications Across Four Districts
NCPHA recorded six measles notifications in Week 35: Vratsa (one), Lovech (one) and Pleven (four). Week 36 recorded twelve: Vratsa (one), Lovech (six), Pleven (four) and Sofia-grad (one). The increase was six cases, or 100.0%, after the decline from nine in Week 34 to six in Week 35 (33.3%). Across the fortnight, Pleven accounted for eight cases, Lovech seven, Vratsa two and Sofia-grad one.
The northwest and north-central concentration described in previous editions continued, but the Sofia-grad notification broadens the distribution of reporting districts. Residence or notification location does not establish the place of acquisition, and these aggregate data cannot determine whether the Sofia-grad case was linked to the other districts. The district bulletins do not provide a cumulative national measles total or a comparable 2025 cumulative figure, so a year-to-date percentage comparison cannot be independently updated from these tables.
Varicella — Weekly Rebound Without a Cumulative Excess
Varicella rose from thirty cases in Week 35 to fifty-five in Week 36, an increase of twenty-five (83.3%), following a decrease from fifty-two in Week 34. Week 36 comprised fifteen possible, thirty-six probable and four confirmed cases. The year-to-date total of 15,772 remained 4.1% below the 16,449 recorded in 2025. The weekly movement exceeds the inclusion threshold, but the cumulative comparison and low summer counts do not support characterising it as a national escalation.
Fecal-Oral and Bloodborne Transmission
Fecal-Oral Transmission
Campylobacteriosis and Rotavirus Gastroenteritis
Campylobacteriosis rose from fourteen confirmed cases in Week 35 to twenty-two in Week 36, an increase of eight (57.1%), after a sub-threshold decrease from sixteen in Week 34. The year-to-date total of 458 was 45.9% above the 314 recorded in 2025. Sofia-grad accounted for eleven Week 36 notifications, followed by Varna with four and Ruse with three. The persistent excess warrants attention, although notification concentration can also reflect differences in diagnostic access and testing practice; no shared food exposure is established by these tables.
Rotavirus gastroenteritis increased from twenty-seven confirmed cases in Week 35 to fifty-two in Week 36, a rise of twenty-five (92.6%), following forty cases in Week 34. The cumulative total was 651 versus 550 in 2025, an 18.4% increase. Varna contributed twenty-two Week 36 cases, Sliven eight and Sofia-grad seven. The weekly rise exceeds the reporting threshold even though the cumulative excess remains below 20%; age, vaccination status and institutional links are unavailable, limiting attribution to a particular outbreak or immunity gap.
Gastroenteritis and Enterocolitis — Context Below the Threshold
The broader gastroenteritis/enterocolitis category registered 333 cases in Week 35, up from 295 (12.9%), and 319 in Week 36, a decrease of fourteen (4.2%). The cumulative total of 6,897 was 2.7% above 2025’s 6,717. These movements are below the reporting threshold and are included as context for the pathogen-specific increases. Only eleven Week 36 cases were confirmed, alongside 121 possible and 187 probable cases; this predominantly syndromic category cannot be assumed to represent the same aetiological pattern as the laboratory-confirmed enteric infections.
Contact and Sexual Transmission
Syphilis, Gonorrhoea, Chlamydial Infection and Mpox
Syphilis increased from four confirmed cases in Week 35 to twenty in Week 36, an absolute increase of sixteen (400.0%), after ten cases in Week 34. The cumulative total reached 297 versus 236 in 2025, a 25.8% excess. The separate congenital and infant syphilis category recorded one probable case in Week 35 and two confirmed cases in Week 36, bringing its cumulative total to twenty-seven versus twenty-five in 2025 (8.0%). The latter is included because of its clinical significance despite the small absolute numbers; notification week does not identify the timing of maternal infection or permit an assessment of antenatal screening performance.
Gonorrhoea recorded seven confirmed cases in Week 35 and six in Week 36, a one-case decrease of 14.3%, below the weekly threshold; its cumulative total of 172 versus eighty in 2025 remained 115.0% higher. Urogenital chlamydial infection declined from four to three confirmed cases (25.0%), with 241 cumulatively versus 123 (95.9% higher). These persistent excesses retain their relevance despite modest weekly counts. Routine notifications provide no antimicrobial susceptibility data for Neisseria gonorrhoeae, and changes in screening or case ascertainment remain possible contributors.
Mpox registered no cases in Week 35 and one confirmed case in Week 36, bringing the cumulative total to three versus two in 2025. This is an additional sporadic notification, with no exposure history, clade or linkage information in the national analysis; it does not by itself establish a connected domestic transmission chain.