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Background We assessed the 10-year efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV) or one dose of a monovalent varicella vaccine (V) in children from Czech Republic, Lithuania, Poland, Romania and Slovakia. Methods This was a phase IIIB follow-up of an observer-blind, randomized, controlled trial (NCT00226499). In phase A, healthy children aged 12–22 months from 10 European countries were randomized in a 3:3:1 ratio to receive two doses of MMRV (MMRV group), one dose of MMR followed by one dose of V (MMR + V group), or two doses of MMR (MMR; control group), 42 days apart. Vaccine efficacy (VE) against varicella (confirmed by viral DNA detection or epidemiological link and clinical assessment) was calculated with 95% confidence intervals using Cox proportional hazards regression model. Immunogenicity was assessed as seropositivity rates and geometric mean concentrations (GMCs). Solicited and unsolicited adverse events (AEs) and serious AEs (SAEs) were recorded. Results A total of 3705 children were vaccinated (1590, MMRV group; 1586, MMR + V group; 529, MMR group). There were 663 confirmed varicella cases (47, MMRV group; 349, MMR + V group; 267, MMR group). VE ranged between 95.4% (Lithuania) and 97.4% (Slovakia) in the MMRV group and between 59.3% (Lithuania) and 74% (Slovakia) in the MMR + V group. At year 10, seropositivity rates were 99.5%–100% in the MMRV group, 98%–100% in the MMR + V group and 50%–100% in the MMR control group, and the anti-VZV antibody GMCs were comparable between MMRV and MMR + V groups. The occurrence of solicited and unsolicited AEs was similar across groups and no SAE was considered as vaccination-related. No new safety concerns were identified. Conclusions Our results indicated that two doses of varicella zoster virus-containing vaccine provided better protection than one dose against varicella and induced antibody responses that persisted 10 years post-vaccination.

We collected data from 10 EU/EEA countries on 240 COVID-19 outbreaks occurring from July−October 2021 in long-term care facilities with high vaccination coverage. Among 17,268 residents, 3,832 (22.2%) COVID-19 cases were reported. Median attack rate was 18.9% (country range: 2.8–52.4%), 17.4% of cases were hospitalised, 10.2% died. In fully vaccinated residents, adjusted relative risk for COVID-19 increased with outbreak attack rate. Findings highlight the importance of early outbreak detection and rapid containment through effective infection prevention and control measures.

BackgroundThe emergence of a novel SARS-CoV-2 variant of concern called B.1.1.7 lineage sparked global alarm due to evidence of increased transmissibility, mortality, and uncertainty about vaccine efficacy, thus accelerating efforts to detect and track the variant. Current approaches to detect lineage B.1.1.7 include sequencing and RT-qPCR tests containing a target assay that fails or results in reduced sensitivity towards the B.1.1.7 variant.AimSince many countries lack robust genomic surveillance programs and failed assays detect multiple unrelated variants containing similar mutations as B.1.1.7, we sought to develop an RT-qPCR test that can accurately and rapidly differentiate the B.1.1.7 variant from other SARS-CoV-2 variants.MethodsWe used bioinformatics, allele-specific PCR, and judicious placement of LNA-modified nucleotides to develop a test that differentiates B.1.1.7 from other SARS-CoV-2 variants. We validated the test on 106 clinical samples with lineage status confirmed by sequencing and conducted a surveillance study of B.1.1.7 lineage prevalence in Slovakia.ResultsOur multiplexed RT-qPCR test showed 97% clinical sensitivity at detecting lineage B.1.1.7. The assay was used in a country-wide surveillance of B.1.1.7 lineage spread in Slovakia. Retesting nearly 7,000 SARS-CoV-2 positive samples obtained during three campaigns performed within a one month period, revealed pervasive spread of B.1.1.7 with an average prevalence of 82%.ConclusionLabs can easily implement this test to rapidly scale B.1.1.7 surveillance efforts and it is particularly useful in countries with high prevalence of variants possessing only the ΔH69/ΔV70 deletion because current strategies using target failure assays incorrectly identify these as putative B.1.1.7 variants.

In August 2017, an increased incidence of Salmonella Bareilly was detected in the Czech Republic. An investigation was conducted with Slovakia to confirm the outbreak and identify the source. Probable outbreak cases were defined as cases with laboratory-confirmed S. Bareilly reported in either of the national surveillance systems, and/or the Czech and Slovak National Reference Laboratory databases from July 2017. Confirmed cases had the pulsed-field gel electrophoresis (PFGE) outbreak pulsotype or up to 5 alleles difference from outbreak cluster members by core genome multilocus sequence typing (cgMLST). PFGE and whole genome sequencing were used for isolate comparison. The same trawling questionnaire was used in both countries. By the end of October 2018, 325 cases were identified. Among 88 human S. Bareilly isolates analysed by PFGE, 82 (93%) shared an identical pulsotype; cgMLST of 17 S. Bareilly human isolates showed 1–2 allele difference. The trawling questionnaire excluded consumption of unusual or imported foods. In September 2018, an isolate closely related to the outbreak isolates was identified in a powdered egg product. A spray dryer was recognised as the contamination source and the production plant was closed. Using molecular typing methods, we detected a diffuse cross-border outbreak caused by S. Bareilly.

In August 2017, an increased incidence of Salmonella Bareilly was detected in the Czech Republic. An investigation was conducted with Slovakia to confirm the outbreak and identify the source. Probable outbreak cases were defined as cases with laboratory-confirmed S. Bareilly reported in either of the national surveillance systems, and/or the Czech and Slovak National Reference Laboratory databases from July 2017. Confirmed cases had the pulsed-field gel electrophoresis (PFGE) outbreak pulsotype or up to 5 alleles difference from outbreak cluster members by core genome multilocus sequence typing (cgMLST). PFGE and whole genome sequencing were used for isolate comparison. The same trawling questionnaire was used in both countries. By the end of October 2018, 325 cases were identified. Among 88 human S. Bareilly isolates analysed by PFGE, 82 (93%) shared an identical pulsotype; cgMLST of 17 S. Bareilly human isolates showed 1–2 allele difference. The trawling questionnaire excluded consumption of unusual or imported foods. In September 2018, an isolate closely related to the outbreak isolates was identified in a powdered egg product. A spray dryer was recognised as the contamination source and the production plant was closed. Using molecular typing methods, we detected a diffuse cross-border outbreak caused by S. Bareilly.

Between January 2018 and May 2019, 349 cases of Candida auris were reported in the European Union/European Economic Area*, 257 (73.6%) colonisations, 84 (24.1%) bloodstream infections, seven (2.0%) other infections and one case of unknown infection/colonisation status (0.3%). Most cases (97.1%, n = 339) were reported from Spain or the United Kingdom, but also for the first time in Greece, the Netherlands and Poland. Laboratory capacity and preparedness has improved since January 2018.

We assessed the long-term persistence of humoral immunity against diphtheria in adults with childhood vaccination and the immunogenicity of a booster dose considering demographic, behavioural and vaccinating factors. We conducted a trial in 200 healthy Slovak adults aged 24&ndash, 65 years, immunised against diphtheria in childhood and against tetanus at regular 10&ndash, 15 year intervals, and receiving a dose of a tetanus-diphtheria toxoid vaccine. The response was determined by ELISA antibody concentrations of paired sera before and at 4 weeks post-vaccination. A seroprotection rate of 21% (95% confidence interval, CI 15.6&ndash, 27.3%) was found in adults up to 59 years since the last vaccination with seroprotective levels of antibodies against diphtheria &ge, 0.1 IU/mL and a geometric mean concentration of 0.05 IU/mL. Conversely, seropositive levels &ge, 0.01 IU/mL were observed in 98% of adults (95% CI 95&ndash, 99.5%). Booster-induced seroprotection was achieved in 78% of adults (95% CI 71.6&ndash, 83.5%) clearly depending on pre-booster antibody levels correlating with age and time since the last vaccination. Moreover, only 54.2% of smokers and 53.3% of patients on statins exhibited seroprotection. Booster vaccination against diphtheria was unable to confer seroprotection in all recipients of only childhood vaccination.

Objectives To provide valuable local data on the economic burden of rotavirus gastroenteritis (RVGE) for decision making on introduction of rotavirus vaccination in Central European countries. Methods We conducted a retrospective patient hospital chart review during the winter RVGE peak in the Czech Republic (n = 109), Hungary (n = 109), Poland, (n = 112), and Slovakia (n = 115) to estimate resource use and associated costs from the payer's perspective in children younger than 5 years with severe RVGE requiring hospitalization. Microcosting analysis was used to estimate the average costs of treating RVGE inpatients including pre- and posthospitalization costs. Results The average cost of treatment was €476, €316, €741, and €594 in the Czech Republic, Hungary, Poland, and Slovakia, respectively. Extrapolating these costs to the total number of RVGE hospitalizations gives annual cost estimates of €2.1 million, €1.5 million, €13.2 million, and €1.5 million, respectively. The main component of expenditure in all the four countries is the hospital stay, but wide variation among countries was observed (total cost of treating RVGE in hospital was almost 2.5-fold higher in Poland than in Hungary). In countries with diagnosis related group (DRG) costs available, the best agreement between real resource-use–driven costs and the DRG cost was found in the Czech Republic and Hungary, with differences of only €22 and €33, respectively. In Poland, the microcosting indicated higher overall costs incurred in hospital than the DRG cost, with a difference exceeding €190. Conclusions Hospitalization of children with RVGE represents a substantial economic burden for the national health systems in these countries.

The duration of protection provided by varicella vaccines is unclear. We assessed the 10-year vaccine efficacy of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV), one live attenuated varicella vaccine (V) dose given after one measles-mumps-rubella vaccine (MMR) dose (MMR + V), versus two MMR doses (control vaccine) for the prevention of confirmed varicella.This was a phase 3b follow-up of an observer-blinded, randomised, controlled trial. In phase a, children aged 12-22 months (at first vaccination) from Czech Republic (Czechia), Greece, Italy, Lithuania, Norway, Poland, Romania, Russia, Slovakia, and Sweden were randomly assigned by computer-generated randomisation list (3:3:1) to receive two doses of MMRV, one dose of MMR and one dose of varicella vaccine, or two doses of MMR, 42 days apart. Varicella cases were confirmed by detection of viral DNA, or epidemiological link and clinical assessment, by an independent data monitoring committee; disease severity was based on a modified Vázquez scale. Hazard ratios for MMRV and MMR + V versus MMR estimated in the per-protocol cohort using a Cox proportional hazards regression model were used to calculate vaccine efficacy and 95% CI. Serious adverse events were recorded throughout the study in all vaccinated children. Study objectives were secondary and descriptive. The trial is registered at ClinicalTrials.gov, number NCT00226499.Between Sept 1, 2005, and May 10, 2006, 5803 children (mean age 14·2 months, SD 2·5) were vaccinated. The per-protocol cohort included 2279 children from the MMRV group, 2266 from the MMR + V group, and 744 from the MMR group. From baseline to a median follow-up of 9·8 years, 76 (3%) children in the MMRV group, 469 (21%) in the MMR + V group, and 352 (47%) in the MMR group had varicella. Vaccine efficacy against all varicella was 95·4% (95% CI 94·0-96·4) for MMRV and 67·2% (62·3-71·5) for MMR + V; vaccine efficacy against moderate or severe varicella was 99·1% (97·9-99·6) for MMRV and 89·5% (86·1-92·1) for MMR + V. During phase b, serious adverse events were reported by 290 (15%) of 1961 children in the MMRV group, 317 (16%) of 1978 in the MMR + V group, and 93 (15%) of 641 in the MMR group. There were no treatment-related deaths.The 10-years vaccine efficacy observed, suggests that a two-dose schedule of varicella vaccine provided optimum long-term protection for the prevention of varicella by offering individual protection against all severities of disease and leading to a potential reduction in transmission, as observed in the US experience with universal mass vaccination.GlaxoSmithKline Biologicals.

During 2013–2017, 620 cases of Candida auris were reported in the European Union/European Economic Area – 466 (75.2%) colonisations, 110 (17.7%) bloodstream infections, 40 (6.5%) other infections and four cases (0.6%) of unknown colonisation/infection status – the majority from four large outbreaks. Survey results showed that several countries lacked laboratory capacity and/or information on the occurrence of cases at national level. To prevent further spread, adequate laboratory capacity and infection control preparedness is required in Europe.

Background Slovakia is well-known for tick-borne encephalitis alimentary (TBE) outbreaks in Europe for a long time. Since the first known and largest TBE alimentary outbreak in 1951 (at territory of Slovakia) until today, none of the European countries report a comparable number of TBE alimentary outbreaks with probable and laboratory confirmed food transmission factor as Slovakia. Methods We analyzed TBE outbreak confirmed cases reported in Slovakia from web-based Epidemiological Information System (EPIS) during the period 2007–2016. Results During years 2007–2016 we recorded 26 TBE alimentary outbreaks. In most outbreaks (22 out of 26) the probable transmission factor of TBE virus was identified within epidemiological context. In 4 outbreaks the transmission factor was laboratory confirmed. The most common probable and confirmed transmission factor of alimentary TBE outbreaks was milk and milk products of goat origin. Conclusion There should be more effort of laboratory clarification of TBE transmission factor in Slovakia. It is important to be aware of the issue of Slovakia from the point of tourism and prevention, but also due to potential risks of consumption of raw milk and its products that became popular in recent years not only in Slovakia.

Summary Background Rates of varicella have decreased substantially in countries implementing routine varicella vaccination. Immunisation is possible with monovalent varicella vaccine or a combined measles-mumps-rubella-varicella vaccine (MMRV). We assessed protection against varicella in naive children administered one dose of varicella vaccine or two doses of MMRV. Methods This study was done in ten European countries with endemic varicella. Healthy children aged 12–22 months were randomised (3:3:1 ratio, by computer-generated randomisation list, with block size seven) to receive 42 days apart (1) two doses of MMRV (MMRV group), or (2) MMR at dose one and monovalent varicella vaccine at dose two (MMR+V group), or (3) two doses of MMR (MMR group; control). Participants and their parents or guardians, individuals involved in assessment of any outcome, and sponsor staff involved in review or analysis of data were masked to treatment assignment. The primary efficacy endpoint was occurrence of confirmed varicella (by detection of varicella zoster virus DNA or epidemiological link) from 42 days after the second vaccine dose to the end of the first phase of the trial. Cases were graded for severity. Efficacy analyses were per protocol. Safety analyses included all participants who received at least one vaccine dose. This trial is registered with ClinicalTrials.gov, number NCT00226499. Findings Between Sept 1, 2005, and May 10, 2006, 5803 children (mean age 14·2 months, SD 2·5) were vaccinated. In the efficacy cohort of 5285 children, the mean duration of follow-up in the MMRV group was 36 months (SD 8·8), in the MMR+V group was 36 months (8·5) and in the MMR group was 35 months (8·9). Varicella cases were confirmed for 37 participants in the MMRV group (two moderate to severe), 243 in the MMR+V group, and 201 in the MMR group. Second cases occurred for three participants (all in the MMR+V group). Varicella cases were moderate to severe for two participants in the MMRV group, 37 in the MMR+V group (one being a second case that followed a mild first case); and 117 in the MMR group. Efficacy of two-dose MMRV against all varicella was 94·9% (97·5% CI 92·4–96·6), and against moderate to severe varicella was 99·5% (97·5–99·9). Efficacy of one-dose varicella vaccine against all varicella was 65·4% (57·2–72·1), and against moderate to severe varicella (post hoc) was 90·7% (85·9–93·9). The most common adverse event in all groups was injection-site redness (up to 25% of participants). Within 15 days after dose one, 57·4% (95% CI 53·9–60·9) of participants in the MMRV group reported fever of 38°C or more, by contrast with 44·5% (41·0–48·1) with MMR+V, and 39·8% (33·8–46·1) with MMR. Eight serious adverse events were deemed related to vaccination (three MMRV, four MMR+V, one MMR). All resolved within the study period. Interpretation These results support the implementation of two-dose varicella vaccination on a short course, to ensure optimum protection from all forms of varicella disease. Funding GlaxoSmithKline Vaccines.

The 17th meeting of the International Scientific Working Group on Tick-Borne Encephalitis (ISW-TBE), a group of neurologists, general practicioners, clinicians, travel physicians, virologists, pediatricians, and epidemiologists, was held under the title “Tick-borne encephalitis as a notifiable disease – status quo and the way forward”. The conference agenda was divided into three parts on the first day: “Epidemiology & Risk areas”, “Poster Walk: Epidemiological Update in Europe”, and “News in TBE Research”. On the second day, a World Cafe Working Session took place where the participants could choose three tables out of six to join for discussion. Key topics on current epidemiological developments and investigations, risk areas, cases, travel and mobility, TBE in children, vaccination rates, and latest news on vaccination were presented and extensively discussed.

The immunogenicity and reactogenicity of primary vaccination at 3, 4 and 5 months and boosting at 12-18 months with a new DTPw-HBV vaccine was compared with either licensed DTPw and HBV vaccines given separately or a licensed DTPw-HBV combination (Tritanrix-HepB) in this randomized, partially double-blind primary vaccination and single-blind booster vaccination study in healthy infants (n = 239; Trial DTPw-HBV-001/004). One month after primary vaccination with the new DTPw-HBV vaccine, seroprotection against diphtheria, tetanus, hepatitis B and vaccine response to B. pertussis was seen in 100%, 98.7%, 94.9% and 98.7% of subjects, respectively, compared to 100%,or =98.5%, 89.2% and 92.2% of subjects in the comparator groups, respectively. One month after the booster dose, a marked response to all vaccine antigens was observed, resulting in seroprotection against diphtheria, tetanus, hepatitis B in all DTPw-HBV recipients and response to B. pertussis in over 98.6%. After primary vaccination, there was evidence that feveror =38.0 degrees C (rectal route) occurred more frequently after the new vaccine (following 41.6% of doses, compared with 32.2% and 29.3% in the comparator groups, p0.05) and that pain and drowsiness occurred more frequently than after licensed DTPw-HBV (45.3% versus 35.1% and 37.1% versus 24.9%, respectively). However after primary and booster doses Grade 3 symptoms occurred at similar frequencies in the three groups suggesting these possible differences are of minimal clinical significance. In conclusion, within the framework of this study the immunogenicity and safety profiles of GSK Biologicals' new DTPw-HBV vaccine when used for primary and booster vaccination were acceptable.