Non-Communicable Disease and Healthcare System Developments
EMA February 2026: New Medicine Approvals and Notable Regulatory Actions
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended twelve medicines for marketing authorisation at its February 2026 plenary meeting, with several decisions carrying immediate clinical relevance for public health practice.
The most epidemiologically significant approval is mCombriax, the first combined messenger RNA vaccine designed to protect individuals aged 50 years and above simultaneously against COVID-19 and seasonal influenza. This represents a meaningful advance in vaccine delivery architecture: co-administration of two separately administered immunisations into a single formulation may meaningfully improve coverage rates in older adults, who are historically underserved by influenza vaccination programmes. The public health relevance is substantial given that seasonal influenza generates up to 50 million symptomatic cases annually in the European Economic Area, while the cumulative COVID-19 case burden in Europe has exceeded 281 million reported cases. Whether co-formulation translates into improved immunogenicity compared to concurrent separate vaccination in the 50+ age group will require post-authorisation effectiveness data, but the structural simplification of the vaccination visit alone has programme-level implications.
The CHMP granted a conditional marketing authorisation for Ojemda (tovorafenib) for paediatric low-grade glioma in patients aged six months and above. Low-grade glioma is the most common central nervous system tumour in children; current standards of care—surgery and chemotherapy—offer modest benefit for many patients and carry substantial toxicity. Tovorafenib is a once-weekly oral BRAF inhibitor representing the first new treatment option for a broad paediatric glioma population, and its conditional approval reflects both unmet clinical need and limited long-term outcome data.
Two further approvals carry global public health significance. Acoziborole (Acoziborole Winthrop) received a positive opinion via the EU-Medicines for All (EU-M4All) regulatory pathway for human African trypanosomiasis (sleeping sickness) caused by Trypanosoma brucei gambiense. This single-dose oral regimen simplifies treatment for both first- and second-stage disease, addressing a major barrier to treatment delivery in sub-Saharan Africa where intravenous therapy has historically constrained access. The accelerated assessment timeline underscores the Agency’s capacity to contribute to global health equity for neglected tropical diseases.
Among negative opinions, the CHMP declined to recommend Daybu (trofinetide) for Rett syndrome, a rare neurodevelopmental disorder, and Iloperidone Vanda Pharmaceuticals for schizophrenia and acute bipolar episodes, on grounds of insufficient benefit-risk balance. An application for Zumrad (sasanlimab), a PD-1 inhibitor in development for bladder cancer, was withdrawn prior to committee opinion.
Extended indications of note include Dupixent (dupilumab) for chronic spontaneous urticaria in children aged 2 to 11 years—the first approved biologic for this indication in pre-adolescent patients—and Jorveza (budesonide) in a paediatric formulation for eosinophilic oesophagitis, addressing documented off-label use of adult formulations in younger patients.
Infectious Diseases: Global Perspective
Respiratory and Droplet Transmission
Avian Influenza A(H5N1) — Cambodia
On 14 February 2026, Cambodia’s Ministry of Health confirmed a new human case of avian influenza A(H5N1) in an adult male from Teuk Chhou district, Kampot province—the first case reported from Cambodia in 2026. The patient developed fever, cough, and abdominal pain after exposure to dead backyard poultry; the carcasses had been prepared and consumed approximately three days before symptom onset. He subsequently made a full recovery. Close contacts received oseltamivir prophylaxis, and health education campaigns were initiated in affected villages.
Since 2003, Cambodia has reported 91 human A(H5N1) cases, of which 52 resulted in death (case fatality rate: 57%), placing it among the highest-burden countries globally. The globally accumulated toll since 2003 now stands at 994 confirmed human cases across 25 countries, with 476 deaths (CFR: 48%). Clade 2.3.2.1c continues to circulate among poultry in Cambodia and has been identified in all recent Cambodian human cases. No sustained human-to-human transmission has been documented. ECDC’s risk assessment for the general population in the EU/EEA remains low, predicated on the absence of adaptive mutations conferring efficient mammalian-to-mammalian transmissibility. Nonetheless, the clustering of severe cases in Asia and the Americas among individuals with unprotected contact with backyard poultry reaffirms the importance of personal protective equipment in high-exposure settings and reinforces the need for clinician awareness of travel-associated zoonotic influenza risk.
Avian Influenza A(H10N3) — China
An update was provided for a human case of avian influenza A(H10N3) in a 34-year-old man from Guangdong province, China, whose symptom onset was on 29 December 2025. The patient was hospitalised and was in stable condition as of 20 February 2026. Exposure to live poultry preceded illness. This represents the third A(H10N3) case reported in 2025, and the seventh case globally since 2021, all localised to different Chinese provinces. No human-to-human transmission has been documented for this subtype, and ECDC assesses the risk to human health in the EU/EEA as very low. The case is nonetheless notable as a reminder of the breadth of avian influenza subtypes capable of occasional zoonotic transmission, warranting continued integrated human-animal surveillance at the human-poultry interface.
Contact and Sexual Transmission
Mpox — Novel Clade Ib/IIb Recombinant Strain
On 14 February 2026, WHO published a Disease Outbreak News item reporting two human cases of mpox infected with a recombinant strain incorporating genomic elements of both clade Ib and clade IIb monkeypox virus (MPXV). The cases were identified in the United Kingdom and India, with symptom onset in December 2025 and September 2025 respectively; both individuals had international travel histories, though to different destinations. Phylogenetic analysis demonstrated greater than 99.9% genomic similarity between the two recombinant strains, confirming a shared lineage. Crucially, the Indian case is the earliest known detection of this recombinant, predating the UK detection by approximately three months. Transmission of the recombinant virus has now been confirmed in at least four countries across three WHO regions, though its geographic origin remains unknown.
The clinical presentation of both cases was consistent with that of non-recombinant clade I or clade II infection. ECDC notes that the emergence of recombinant MPXV strains is not unexpected given the concurrent circulation of both clades in multiple geographic and demographic settings where co-infection opportunities exist. However, the detection underscores two critical imperatives: the continued potential for MPXV to undergo evolutionary change, and the necessity of comprehensive genomic surveillance with deposit of sequences in publicly accessible repositories (ENA, SRA, GISAID EpiPox). Currently, no conclusions can be drawn regarding whether the recombinant strain exhibits altered transmissibility or clinical severity compared with parental clades.
Infectious Diseases: European Union/European Economic Area
Respiratory and Droplet Transmission
Influenza and Respiratory Virus Syndromic Activity
Based on ECDC Week 8 surveillance data (14–20 February 2026), influenza virus circulation across the EU/EEA remains elevated but has been declining from its seasonal peak since the beginning of the year. Primary care consultations for influenza-like illness (ILI) and acute respiratory infections (ARI) remain high in the majority of reporting countries, with a pooled influenza test positivity in primary care of 25% (median across Member States; IQR: 19–48%), compared to 21% in Week 6. In the hospital setting, influenza test positivity among severe acute respiratory illness (SARI) presentations stands at 22% (median 11%; IQR: 3.6–26%).
The dominant circulating subtype in primary care remains influenza A(H3), accounting for 61% of typed primary care detections in Week 7 of 2026, with A(H1)pdm09 contributing the remaining 39%. In hospitalised patients, this pattern is reversed: A(H1)pdm09 represents 64% of subtyped hospital influenza detections, with A(H3) at 36%. This divergence is consistent with well-established patterns of differential age-group susceptibility—A(H3N2) tends to cause more severe disease in older adults, who dominate primary care-seeking behaviour, while A(H1)pdm09 disproportionately impacts younger adults in hospital settings. At the subclade level, A(H3) subclade 2a.3a.1(K) accounts for 90% of all genetically characterised A(H3) viruses, confirming the dominance of this phylogenetic cluster throughout the 2025/26 season. Influenza B/Victoria strains represent only 0.3% of detections.
Hospitalisations due to influenza have been declining since early January 2026, with adults aged 65 years and above accounting for the majority of admissions cumulatively over the season. RSV circulation also remains elevated but variable by country; RSV-B represents 60% of typed RSV detections in primary care, and children under five years of age account for most cumulative hospital admissions. SARS-CoV-2 circulation remains at a low level across all age groups, with primary care test positivity at 2.2% and hospital test positivity at 1.6%. The XFG variant represents approximately 56% of SARS-CoV-2 detections, followed by NB.1.8.1 at 25%.
EuroMOMO continues to register elevated all-cause mortality compared to baseline, both overall and in the 65+ age group, consistent with the typical influenza season mortality signal. This excess mortality indicator contextualises the clinical significance of the continuing, if declining, respiratory virus co-circulation and should inform healthcare capacity planning as the season moves toward its conclusion.
Contact and Sexual Transmission
Mpox Clade Ib — Local Transmission Established in MSM Networks
The mpox clade Ib situation in the EU/EEA has entered a qualitatively new phase. Since 1 January 2026, 80 clade I cases were reported to TESSy by seven EU/EEA countries—Spain (36), Italy (19), Germany (10), France (8), the Netherlands (5), Czechia (1), and Ireland (1)—bringing the total to 185 clade I cases since August 2024 across 12 EU/EEA countries. The trajectory of monthly case counts is striking: from 8 in September 2025 to 12 in October, 20 in November, 37 in December, and 73 in January 2026. Spain, Italy, and Germany together account for the bulk of this acceleration, with Spain reporting 35 cases in January alone, Italy 16, and Germany 9.
The epidemiological profile has shifted materially compared to the initial phases of clade Ib importation. Of 91 cases with information available on sexual behaviour, 80 were among men who have sex with men (MSM), and the majority lack a direct travel link to a country with endemic clade Ib transmission. Fifty-nine of 75 MSM cases with travel information had locally acquired infection. This pattern indicates that autochthonous transmission within gay, bisexual and other MSM sexual networks is now established in multiple EU/EEA settings. Prior to October 2025, all EU/EEA clade Ib cases were imported or directly linked to imported cases through heterosexual or household transmission.
Vaccination uptake among cases remains suboptimal: of 72 MSM cases with vaccination information, 50 (69%) were unvaccinated. ECDC assesses the risk of mpox clade Ib as moderate for MSM and low for the general population, and reaffirms that pre-exposure vaccination, accessible testing, active contact tracing, and community engagement are the cornerstone response measures. Countries are urged to prioritise sequence deposition for all positive cases and to report clade I cases to both EpiPulse Events and TESSy on an expedited basis.
Infectious Diseases: Bulgaria
The following section presents data from the National Centre for Infectious and Parasitic Diseases (NCIPD) weekly surveillance report for Week 9, 2026 (23 February – 1 March 2026), supplemented with regional case distribution data from Week 8 (16–22 February 2026). Where week-over-week changes and year-over-year comparisons are cited, these are derived from the NCIPD dataset.
Bloodborne and Parenterally Transmitted Infections
Fecal-Oral Transmission
Gastroenteritis and Enterocolitis
Gastroenteritis and enterocolitis cases surged in Week 9, reaching 150—an increase of 30 cases (25%) compared to the previous week’s 120. This represents a statistically and epidemiologically meaningful week-over-week escalation, particularly in the context of the late winter period when gastrointestinal infection burden would typically be expected to plateau or decline. Case classification includes 62 possible, 79 probable, and 9 confirmed cases. Year-to-date incidence (1,205 cases) is modestly elevated relative to the same period in 2025 (1,160 cases), though the 4% year-over-year difference is less informative than the current directional trend. The 25% single-week increase warrants enhanced monitoring to determine whether this reflects isolated cluster activity, a broadening outbreak, or the emergence of a specific pathogen driving community-level transmission.
Rotavirus Gastroenteritis
Rotavirus gastroenteritis demonstrated a particularly sharp week-over-week increase in Week 9, with 20 confirmed cases recorded compared to 11 in the preceding week—an 82% increase. All reported cases were laboratory confirmed, and the cumulative year-to-date total of 118 cases remains below the 2025 comparator of 186 (a 37% year-over-year decrease), suggesting that the 2026 rotavirus season has been milder in aggregate but is now intensifying. Rotavirus predominantly affects children under five years, and the current trajectory should be monitored in the context of healthcare utilisation pressure in paediatric settings. The concurrent rise in both non-specific gastroenteritis and confirmed rotavirus infection suggests a genuine increase in enteric virus transmission, potentially facilitated by the post-winter school and daycare attendance patterns.
Campylobacteriosis
While campylobacteriosis case counts for Week 9 showed a decline compared to Week 8 (8 cases versus 16, a 50% decrease), the cumulative year-to-date burden remains dramatically elevated. Through Week 9, 84 campylobacteriosis cases have been registered in Bulgaria, compared to 33 cases at the same point in 2025—a 155% year-over-year increase. Campylobacter spp. infection, primarily acquired through consumption of undercooked poultry or contaminated water, is the most common bacterial cause of foodborne gastroenteritis in Europe. The sustained elevation in case numbers through nine consecutive reporting weeks suggests a structural shift in exposure conditions—potentially related to poultry supply chain hygiene, environmental contamination, or enhanced surveillance sensitivity—rather than a transient cluster phenomenon. This trend merits investigation in coordination with veterinary and food safety authorities.
Shigellosis
In Week 9, three confirmed cases of bacillary dysentery (shigellosis) were registered, compared to zero in the previous week. Year-to-date, six cases have been reported against two cases in 2025—a 200% year-over-year increase, though the absolute numbers remain small. Shigella spp. are transmitted via the fecal-oral route, with a very low infectious dose, making institutional transmission (daycare centres, schools, residential facilities) a primary concern. Given the concurrent elevation in non-specific gastroenteritis, the shigellosis cases should be reviewed for any clustering by institution or geographic area. Antimicrobial resistance among Shigella is an increasing global concern; clinical isolates should be subject to susceptibility testing.
Contact and Sexually Transmitted Infections
Gonorrhoea and Urogenital Chlamydial Infection
Sexually transmitted infections continue to demonstrate an upward trajectory in Bulgarian surveillance data that has persisted across the first nine weeks of 2026. Gonorrhoea (Neisseria gonorrhoeae) registered 6 confirmed cases in Week 9 (versus 4 in Week 8, a 50% week-over-week increase), but the year-over-year comparison is considerably more informative: 37 cases year-to-date in 2026 versus 13 cases at the same point in 2025, representing a 185% increase. Urogenital chlamydial infection (Chlamydia trachomatis) similarly recorded 12 confirmed cases in Week 9 (versus 9 the prior week, +33%), with cumulative 2026 incidence of 51 cases compared with 26 in the same period of 2025—a 96% year-over-year increase.
These parallel increases in two distinct bacterial STIs are unlikely to result from artefact or surveillance variation alone and suggest a genuine increase in unprotected sexual contact or, alternatively, enhanced diagnostic testing and ascertainment. Gonorrhoea is of particular concern given the global spread of antimicrobial-resistant N. gonorrhoeae strains, including those with reduced susceptibility to extended-spectrum cephalosporins. The absence of gonococcal resistance monitoring data from the NCIPD surveillance reports represents a gap in the actionable intelligence produced by these data. Clinicians managing gonorrhoea cases should adhere to current Bulgarian and ECDC treatment guidance and submit isolates for susceptibility testing to contribute to national resistance profiling.
Syphilis in Week 9 registered 5 confirmed cases, a modest decline of 1 from the prior week, with year-to-date incidence (61 cases) slightly below the 2025 comparator (72 cases, -15%). The concurrent elevation in gonorrhoea and chlamydia without a parallel syphilis increase may reflect differential diagnostic pathways or reporting completeness.
HIV
HIV notifications for Week 9 totalled 10 confirmed cases, compared to 4 in the previous week—a 150% week-over-week increase. The absolute numbers are small and the year-to-date total (41 cases) remains below the 2025 comparator (52 cases, -21%), suggesting that this spike reflects stochastic weekly variation rather than a sustained transmission acceleration. Nonetheless, the concurrent upward trends across gonorrhoea and chlamydia point to an epidemiological context in which HIV transmission opportunities may be elevated, warranting continued attention to HIV testing uptake, pre-exposure prophylaxis (PrEP) access, and linkage to care for newly diagnosed individuals.
Vaccine-Preventable Diseases
Varicella
Varicella remains highly prevalent in Week 9 surveillance, with 635 cases registered—a slight decline of 9 cases from the prior week. The cumulative year-to-date burden (5,345 cases) is marginally below the 2025 comparator (5,780 cases, -8%), consistent with the typical late winter-early spring seasonality of varicella in Bulgaria. The continued high weekly case counts reflect the endemic circulation of varicella-zoster virus in an incompletely vaccinated paediatric population. Regional Week 8 data confirm widespread geographic distribution, with the largest urban centres—Sofia (186 cases) and Plovdiv (37)—contributing the greatest absolute burden, alongside Varna (55), Stara Zagora (10), Targovishte (32), and Blagoevgrad (50).
Scarlet Fever
Scarlet fever registered 108 cases in Week 9, a marginal decrease of 3 cases from Week 8. The year-over-year comparison shows a substantial reduction in 2026 relative to 2025: 635 cases year-to-date versus 891 at the same point last year (-29%). This notable decline continues the trend observed in prior weeks and may reflect either natural cyclical variation in Group A Streptococcus transmission or a partial protective effect of accumulated population immunity following the 2025 surge. The current case levels, while still representing active community circulation, do not signal an emergent threat.
Vector-Borne and Zoonotic Infections
Lyme Borreliosis
Three confirmed cases of Lyme borreliosis were registered in Week 9—a decrease of 2 from the prior week. Year-to-date incidence (31 cases) modestly exceeds the 2025 comparator (26 cases, +19%). While this elevation falls below the 20% threshold for routine signal inclusion, the cumulative pattern through nine weeks suggests marginally above-baseline tick activity, possibly influenced by the relatively mild winter conditions in parts of Bulgaria. Surveillance for tick-borne diseases should be maintained as the spring season—when Ixodes ricinus activity intensifies—approaches.