Measles in Poland in 2020.

INTRODUCTION: Measles is a disease under the elimination program coordinated by the World Health Organization (WHO). The elimination of measles in the country is possible provided that 95% of the population is vaccinated with two doses of the vaccine, the epidemiological situation is monitored, all suspected cases of measles are recorded, and laboratory diagnostics are conducted by the WHO Reference Laboratory. Polish Reference Laboratory is located at the Department of Virology NIPH NIH - NRI. OBJECTIVE: The aim of the article is to analyze the epidemiological situation of measles in Poland in 2020 with presenting the measles vaccination coverage and the progress of the measles elimination programme in Poland. MATERIAL AND METHODS: The epidemiological situation of measles in Poland was analyzed on the basis of the case-based questionnaires of cases suspected of measles sent to NIPH NIH - NRI by the Sanitary and Epidemiological Stations, data from the publications: "Infectious diseases and poisonings in Poland in 2020" and "Vaccinations in Poland in 2020". RESULTS: In 2020, 29 cases of measles were notified to the surveillance system in Poland (incidence 0.08 per 100,000 population). The highest incidence was observed in the aged 0-4 was estimated at 0.42 per 100,000 population. Out of all cases, 9 (31%) were hospitalized. No fatal cases due to the measles were reported. CONCLUSIONS: The epidemiological situation of measles in 2020 in comparison with the situation in 2019, has improvement. This was a trend in throughout Europe.

Rubella in Poland in 2020.

INTRODUCTION: Since 2005, rubella has been included in the eradication program coordinated by the World Health Organization (WHO). The elimination of rubella in the country is possible provided that it is achieved by min. 95% immunization status and monitoring of the epidemiological situation, including the recording all suspicions of rubella and conducting laboratory diagnostics in the WHO Reference Laboratory. AIM OF THE STUDY: The aim of the study is to assess the epidemiological situation of rubella in Poland in 2020, taking into account the assessment of rubella vaccination status and the degree of implementation of the WHO rubella elimination program in Poland. MATERIAL AND METHODS: Assessment of the epidemiological situation of rubella in Poland based on aggregated reports of suspected rubella cases sent to the National Institute of Public Health NIH - National Research Institute by the Voivodeship Sanitary and Epidemiological Stations, data from the bulletin "Infectious diseases and poisoning in Poland in 2020" and data from the Epibaza system and the bulletin "Preventive vaccination in Poland in 2020". RESULTS: In 2020, 98 cases of rubella were registered, 187 cases less than in 2019 (285 cases). There was also a decrease in the incidence to 0.26 per 100,000, compared to 0.74 per 100,000 in 2019. The highest incidence, iregardless of gender and place of residence, was recorded in the 0-4 age group (2.98 per 100,000). In 2020, no cases of congenital rubella syndrome were reported. In 2020, only one case (1.02%) was classified as a case confirmed in a laboratory test. The remaining 98.98% (97 cases) were diagnosed on the basis of clinical symptoms. SUMMARY AND CONCLUSIONS: In 2020, in Poland, a decrease in the number of rubella was observed. Rubella was registered in 99% on the basis of a general diagnosis, without the required laboratory confirmation, which means that other rash diseases can be registered as rubella.

Tetanus in Poland in 2018-2019.

BACKGROUND: Tetanus is an acute disease of the nervous system caused by tetanus toxin (neurotoxin) produced by tetanus bacilli (Clostridium tetani). This disease can be prevented by vaccination. In Poland, thanks to obligatory vaccinations of children and adolescents and high vaccination coverage, the disease has been practically eliminated. Less than 20 cases are recorded each year. AIM: The aim of the work is to analyze the epidemiological indicators of tetanus in Poland in 2018-2019. METHODS: The analysis of the Polish tetanus epidemiological situation in 2018-2019 was based on a review of data from the bulletins "Infections diseases in Poland in 2018", "Infections diseases in Poland in 2019" and the analysis of the population immunization was made on the basis of data from the bulletins "Protective Vaccination in Poland in 2018", "Protective Vaccination in Poland in 2019". RESULTS: There are 17 tetanus cases registered in 2019, in 2018 8 cases. The total incidence rate was 0.044 per 100 thousand population and was higher compared to 2018 (0.021). All reports involved hospitalized individuals. SUMMARY: The few cases of tetanus in Poland occur mainly in people over 60 years of age. These can be linked to the lack of tetanus booster vaccination of adults.

Rubella in Poland in 2019.

INTRODUCTION: Rubella has been included in the elimination program coordinated by the World Health Organization (WHO) since 2005. Elimination of rubella in the country is possible provided that min. 95% of the vaccination status of the population and monitoring the epidemiological situation, including recording all suspected rubella and conducting laboratory diagnostics at the WHO Reference Laboratory. AIM: The aims of the present article are to analyze the epidemiological situation of rubella in Poland in 2019 and to discuss the rubella vaccination coverage. MATERIAL AND METHODS: The assessment of the epidemiological situation of rubella in Poland was conducted on the basis of aggregated reports of suspected rubella cases sent to the National Institute of Public Health - National Institute of Hygiene by Voivodeship Sanitary and Epidemiological Stations, and data from the bulletin "Infectious diseases and poisoning in Poland in 2019" and "Vaccinations in Poland in 2019 ". RESULTS: In 2019, there was a decrease in the number of rubella cases with registered 285 cases (in 2018 - 37 cases), and a decline in incidence (from 1.1 per 100,000 to 0.74). The highest incidence rate, regardless of gender and the environment, was observed among children agded 0-4 years (6.4 per 100,000). In 2019, no cases of congenital rubella syndrome were registered. In 2019, only 3 (1.05%) cases were classified as laboratoryconfirmed cases. The remaining 98.9% (282 cases) were diagnosed on the basis of clinical symptoms. CONCLUSIONS: In 2019, there was a decrease in the number of rubella cases. In Poland rubella in reported exclusively on the basis of the clinical picture. The proportion of laboratory tests confirming/excluding rubella infection is still very low in Poland.

Measles in Poland in 2019.

INTRODUCTION: Since 1998 Poland has endorsed measles elimination programme which is coordinated by the World Health Organization (WHO). To accomplish measles elimination in the country, achievement of vaccination coverage at 95% in the population is needed, as is the monitoring of the epidemiological situation, i.e.: reporting on cases suspected of measles and conducting laboratory diagnostics in WHO Reference Laboratory. Polish Reference Laboratory is located at the Department of Virology NIPH NIH - NRI. OBJECTIVES: The aim of the article is to analyze the epidemiological situation of measles in Poland in 2019 with presenting the measles vaccination coverage and the progress of the measles elimination programme in Poland. MATERIAL AND METHODS: The epidemiological situation of measles in Poland was analyzed on the basis of the case-based questionnaires of cases suspected of measles sent to NIPH NIH-NRI by the Sanitary and Epidemiological Stations, data from the publications: "Infectious diseases and poisonings in Poland in 2019" and "Vaccinations in Poland in 2019". RESULTS: In 2019, 1,502 cases of measles were notified to the surveillance system in Poland (incidence 3.91 per 100,000 population, more than four times more than in 2018). The highest incidence was observed in the aged 35-39 was estimated at 11.36 per 100,000 population. Out of all cases, 772 (51.4%) were hospitalized. No fatal cases due to the measles were reported. In 2019 the maintenance of high vaccination coverage among children aged 2 and 12 years old was observed - from 92.6% to 99.5% (primary vaccination, children born in 2009-2017). CONCLUSIONS: The epidemiological situation of measles in 2019 in comparison with the situation in 2018, has deteriorated. This was a trend in throughout Europe.

BCG Moreau Vaccine Safety Profile and NK Cells-Double Protection Against Disseminated BCG Infection in Retrospective Study of BCG Vaccination in 52 Polish Children with Severe Combined Immunodeficiency.

OBJECTIVES: The aim of the study was to estimate the rate of adverse reactions to live BCG Moreau vaccine, manufactured by Biomed in Poland, in severe combined immunodeficiency (SCID) patients. MATERIAL: The profiles of 52 SCID patients vaccinated at birth with BCG, hospitalized in Children's Memorial Health Institute, Warsaw (CMHI), in the years 1980-2015 were compared with those of 349 BCG-vaccinated SCID patients from other countries analyzed by Beatriz E. Marciano et al. in a retrospective study (Marciano et al. J Allergy Clin Immunol. 2014;133(4):1134-1141). RESULTS: Significantly less disseminated BCG infections (10 out of 52 SCID, 19%) occurred in comparison with Marciano study-119 out of 349, 34% (p = 0.0028), with no death in patients treated with SCID anti-TB drug, except one in lethal condition. In our study, disseminated BCG infection was observed only in SCID with T-B+NK- phenotype and significantly lower NK cell counts (p = 0.0161). NK cells do not influence on the frequency of local BCG reaction. A significantly higher number of hematopoietic stem cells transplantations (HSCT) were performed in CMHI study (p = 0.0001). Anti-TB treatment with at least two medicines was provided. CONCLUSION: The BCG Moreau vaccine produced in Poland, with well-documented genetic characteristics, seems to be safer than other BCG substrains used in other regions of the world. Importantly, NK cells seem to play a role in protecting SCID patients against disseminated BCG complications, which NK- SCID patients are more prone to. HSCT and TB therapy could be relevant due to the patients' survival and the fact that they protect against BCG infection.

Rubella in Poland in 2018.

INTRODUCTION: Rubella is the disease subject to the elimination programme coordinated by the World Health Organization (WHO). Generally, rubella is an infection of mild course among children but in the case of pregnant women, who are not immunized, the probability of the occurrence of severe congenital abnormalities (congenital rubella syndrome) may amount to 95%. The strategy of the countries belonging to the WHO European Region is directed to the interruption of the rubella virus transmission in the environment in order to prevent the cases of congenital rubella syndrome (CRS). OBJECTIVES: The aims of the present article are to analyze the epidemiological situation of rubella in Poland in 2018 and to discuss the rubella vaccination coverage. MATERIAL AND METHODS: The epidemiological situation of rubella in Poland was analyzed on the basis of publications: "Infectious diseases and poisonings in Poland in 2018" and "Vaccinations in Poland in 2018". RESULTS: In 2018, there was a decrease in the number of rubella cases - with registered 437 cases (in 2017 - 476 cases) - and a decline in incidence (from 1.2 per 100 000 to 1.1). The highest incidence rate, regardless of gender and the environment, was observed among children aged 0-4 years (9.8 per 100,000). In 2018, no cases of congenital rubella syndrome were registered. SUMMARY AND CONCLUSIONS: In 2018, there was a decrease in the number of rubella cases. In Poland Rubella is reported exclusively on the basis of the clinical picture. The proportion of laboratory tests confirming/excluding rubella infection is still very low in Poland.

Measles in Poland in 2018.

INTRODUCTION: Since 1998 Poland has endorsed measles elimination programme which is coordinated by the World Health Organization (WHO). To accomplish measles elimination in the country, achievement of vaccination coverage at 95% in the population is needed, as is the monitoring of the epidemiological situation, i.e.: reporting on cases suspected of measles and conducting laboratory diagnostics in WHO Reference Laboratory. Polish Reference Laboratory is located at the Department of Virology NIPH-NIH. OBJECTIVES: The aim of the article is to analyze the epidemiological situation of measles in Poland in 2018 with presenting the measles vaccination coverage and the progress of the measles elimination programme in Poland. MATERIAL AND METHODS: The epidemiological situation of measles in Poland was analyzed on the basis of the case-based questionnaires of cases suspected of measles sent to NIPH-NIH by the Sanitary and Epidemiological Stations, data from the publications: "Infectious diseases and poisonings in Poland in 2018" and "Vaccinations in Poland in 2018". RESULTS: In 2018, 359 cases of measles were notified to the surveillance system in Poland (incidence 2.94 per 100 000 population). The highest incidence was observed in the age 1 and was estimated at 4.06 per 100 000 population. Out of all cases, 209 (58.2%) were hospitalized. No fatal cases due to the measles were reported. In 2018 the maintenance of high vaccination coverage among children aged 2 and 12 years old was observed - from 92.9% to 99.3% (primary vaccination, children born in 2008-2016) and from 92.4% to 97.8% (booster vaccination, children born in 2005-2010). CONCLUSIONS: The epidemiological situation of measles in 2018 in comparison with the situation in 2017, has deteriorated. This was a trend in throughout Europe.

The safety and effectiveness of vaccination against influenza and pertussis in pregnant women

In recent years a large amount of data has become available with regard to vaccinating women during pregnancy against influenza and against pertussis. The data comes from observational studies conducted when vaccine was administered as a part of a vaccination campaign, retrospective evaluations of databases and surveillance of the adverse post-vaccination events. Popularization of knowledge about the importance of immunization in this group and educating pregnant women about vaccination should be an essential element of health promotion and prevention programs.

[Genotyping Clostridium perfringens strains isolated from patients with symptoms of food poisoning and food samples].

INTRODUCTION: Clostridium perfringens strains that produce enterotoxin often cause outbreaks of food poisoning or epidemic, therefore is essential to develop and adapt methods useful in epidemiological investigations. The aim of the study was to assess the genetic diversity of C. perfringens strains isolated from patients with symptoms of food poisoning and food samples. METHODS: In this study it has been determined the genetic diversity of the pilot group of epidemiologically non- related 39 C. perfringens strains using RAPD (Random Amplified Polymorphic DNA), rep-PCR (Repetitive DNA Element Based PCR) and PFGE (Pulsed Field Gel Electrophoresis) methods. RESULTS AND CONCLUSIONS: It has been obtained comparable results of differentiation of C. perfringens strains isolated from patients with symptoms of food poisoning and food samples using RAOD and rep-PCR methods. It has been also confirmed a wide genetic diversity among C. perfringens strains isolated from different sources epidemiologically non-related using PFGE.

Application of the MALDI-TOF for identification of Clostridium perfringens strains.

INTRODUCTION: The anaerobic bacilli Closfridium perfringens are commonly found in soil and sewage and are also part of the gastrointestinal tract of humans and animals. Food poisoning caused by C. perfringens are regarded the most common diseases transmitted by contaminated food in the world. Bacteria of this species due to their pathogenic properties sustain the constant object of studies in order to elucidate mechanisms of toxinogenesis, to determine the roads of transmission and to develop better diagnostic tools. The objective of the study was to verify, the suitability of the MALDI-TOF method for the identification of C. perfringens species. METHODS: In order to identify anaerobic bacteria C. perfringens MALDI-TOF method, sequencing of 16S rRNA and detection of cpe and cpa gene by duplex PCR were used. RESULTS: MALDI-TOF confirmed C. perfringens identification in 39 isolates out of 41 archival isolates under study. The correctness of the results was verified by 16S rRNA sequencing and cpa gene detection. CONCLUSIONS: The study confirmed the usefulness of MALDI-TOF method in rapid identi- fication of anaerobic bacteria C. perfringens and thereby its applicability epidemiological investigations.

Consistency of Bordetella pertussis vaccine seed strains and potency of whole-cell pertussis vaccine still in use in Poland.

In Poland, where the wP vaccine has been used since 1960, pertussis rates increased in the mid-1990s. In 2012, the rate of pertussis recognised by surveillance was unexpectedly found to be two-fold higher than in the previous decade. Quality measures on potency and vaccine working seeds were introduced, to confirm the possible impact of manufacturing inconsistency or potency lowering on the observed increase in pertussis. Shewhart charts on potency values for lots released between 2001 and 2013 did not reveal any significant fluctuations. Working seeds of three vaccine strains used within last decade for wP manufacturing belong to the PFGE group III and were highly related. According to PFGE and SDS-PAGE data, all vaccine strains were found consistent according profiling on the genomic and protein levels. According to the sequencing data, they harboured ptxA2, ptxC1, prn1, fim2-1, fim3-1, tcfA2, ptxP1 and were assigned as MLST-2 type. Other factors apart from vaccine manufacturing inconsistency might be responsible for the increase in pertussis noted in 2012 in Poland.

PCR-based genomic deletion analysis of RD-regions in the identification of mycobacteria isolated from adverse events following BCG vaccination or TB suspected cases.

Early identification of mycobacterial species is crucial for early diagnosis. PCR-multiplex method performed on randomly chosen 54 mycobacteria isolates originating from clinical samples was found to be an inexpensive, quick and reliable alternative for commercially available diagnostics tests. Although the results of gene probes identification performed by NTLDR were generally consistent with multiplex PCR, two mixed Mycobacterium bovis BCG/Mycobacterium tuberculosis infections and a single misdiagnosis of M. tuberculosis with M. bovis were found. The routine application of multiplex-PCR has the potential to make diagnostics surveillance studies feasible.

Effectiveness of experimental whole-cell pertussis vaccines in murine model.

INTRODUCTION: Since the 1990s pertussis re-emergence has been observed in many highly immunized countries. Genetic divergence between circulating B. pertussis isolates and vaccine strains has been suggested as one of the reasons responsible for the resurgence of pertussis. This divergence was observed in some studies to affect the effectiveness of pertussis vaccine when tested in murine model. In the study, using the murine intranasal challenge model we evaluated the effectiveness of four experimental wP vaccines, prepared with B. pertussis isolates belonging to different PFGE groups, in the elimination of the bacterial infection induced with mixture of the four B. pertussis isolates. METHODS: The experimental wP vaccines were prepared with clinical isolates belonging to PFGE groups V, IVγ and C, used individually or together. The mixture of four isolates classified to PFGE groups V, IVγ, III and C was used as intranasal mice challenge. The chosen strains represent PFGE groups characteristic for isolates currently circulating in Europe (PFGE groups IV and V), specific for Poland (PFGE group C) and vaccine strains of Polish wP vaccine (PFGE group III). Additionally, to study bacterial fitness, changes in the proportions of four isolates used as the challenge within the course of infection in mice lungs were monitored. RESULTS AND CONCLUSIONS: All experimental wP vaccines were found to be equally effective in eliminating B. pertussis from mice lungs. Their effectiveness was independent on PFGE group of vaccine strain. The results on bacterial fitness during mixed infections induced in the non-immunized mice found the isolate of PFGE group IVγ dominating among the other isolates used in the mixture belonging to PFGE group III, V, and C. This data might suggest that the isolates belonging to PFGE group IV, so commonly seen in Europe, might be more fitted to explore in conditions of waning immunity.

Improving Vaccine Assessment Pathways and Decision Making in the Polish Immunization Program.

This study examines the vaccine market access pathway in Poland to evaluate its efficiency and propose recommendations for its improvement. The research spans a comprehensive analysis of the vaccine assessment process, ranging from pre-registration to sustainability, encompassing critical components such as national immunization technical advisory groups (NITAGs), health technology assessments, resource evaluations, and decision making. This investigation utilizes a multi-phase approach. Initial desk research aimed to collect accumulated evidence about each step of the vaccine access pathway. This constituted the background for an expert panel discussion (n = 13) and a final online questionnaire (n = 12), evaluating the timeframes, inclusiveness, transparency, and consistency of the elements of the process. Poland is a late adopter of new vaccines. The country faces budget constraints and lacks a formalized framework for the inclusion of vaccines into the national immunization program. Notably, NITAGs play a crucial role, yet their limited resources and dependence on public health stakeholders diminish their impact. A formal and well-supported advisory body may become a foundation for decision-making processes. The health technology assessment conducted by the national agency is recognized for its timeliness and transparency, though the absence of fiscal analyses in vaccine assessments is identified as a gap that limits the understanding of the value of vaccinations. Resources are key drivers of decision making, and recent changes in legislation offer increased flexibility in financing vaccines. Challenges in the procurement process include a limited consideration of non-acquisition costs and an increased absence of a documented general strategy for immunization program development in Poland, pointing to a need for strategic planning. In conclusion, this study recommends the establishment of a robust NITAG with enhanced resources, incorporating fiscal analyses, transparent resource allocation, and strategic planning for immunization program development. Addressing these recommendations is crucial for optimizing Poland's vaccine market access pathway, ensuring timely and efficient population-wide vaccine access.

[The studies of elimination of nontypeable Haemophilus influenzae strains using the animal model of infection]. / Badania eliminacji nietypowalnych szczepów Haemophilus influenzae na modelu zwierzecym.

INTRODUCTION: The intranasal immunization is considered the effective method to induce immunological response in the mucosa and the model useful to develop the vaccine against otitis media due to nontypaeble Haemophilus influenzae infections. In the study, elimination of NTHi strains isolated from healthy and carrier individuals, varying with several genetic determinants, from mice nasopharynx, lungs and ears tissues and the interactions among strains during mixed infections were evaluated. METHODS: Mice were infected with single and mixture of NTHi strains previously identified as non or potentially invasive. The curves of infections were drown from the averages of log cfu/mg values obtained for nasopharynx or ears leavages or lungs homogenates coupled with standard deviation at each time point using 5 mice. The significance of the differences was confirmed using ANOVA method. RESULTS: The course of infections induced with a single noninvasive or potentially invasive strains in the mice nasopharynx, ear or lung tissues were not found to differ in respect to the level and duration. Regardless the strain used, higher elimination rates in the ear and lung tissues in comparison with nasopharynx were fund. Different rate of elimination was found in the case of mixture infections where the strain, determined in the previous study as potentially invasive, was dominating. CONCLUSION: The concurrence model among not-invasive and potentially invasive NTHi strains in the host niche was thus confirmed using in vivo model of infection.

Feminized vaccine? Parents' attitudes toward HPV vaccination of adolescents in Poland: A representative study.

In 2023, the process of gradually introducing universal, free HPV vaccination into the vaccination program for children in Poland began. For this reason, the attitudes of parents of adolescents toward these vaccinations were examined in this study. The survey was conducted among 360 parents of children (girls and boys) aged 9-15. To achieve the best possible representativeness of the sample, parents were selected for the survey using a random-quota method. The survey was carried out using the CATI. The surveyed parents declared a high level of knowledge about HPV and awareness of HPV vaccination (74.2% of parents had heard of HPV, and 61.4% had heard of the HPV vaccine). The study showed a statistically significant relationship between parents' education and knowledge of HPV infection - the higher the parent's (mother or father) education, the higher the declared knowledge. Education was also a statistically significant factor influencing the declaration of vaccinating a child against HPV. In addition to parental education, the gender of the child was also a significant factor influencing willingness to vaccinate against HPV. Parents of boys were significantly more likely - than parents of girls - to declare that they would not vaccinate their sons against HPV. A significant factor influencing declarations to vaccinate against HPV was the child's vaccination against COVID-19. The study results indicate a strong correlation between parental education and parental knowledge and attitudes about HPV and the HPV vaccine.

Trust in Physicians in the Context of HPV Vaccination of Children from the Perspective of Social Exchange Theory: A Representative Study of Polish Parents.

The vaccination of children against human papillomavirus (HPV) effectively prevents HPV infection and HPV-related cancers in women and men. However, HPV vaccination programs are met with vaccine hesitancy, which varies between countries. The coverage in Poland is low, although introducing nationally funded HPV vaccination for girls aged 12-13 in mid-2023 may increase it. The uptake of the HPV vaccine in adolescents is highly affected by parental decisions, which in turn can be influenced by interactions with the physician. The present representative study aimed to analyze the acceptance of the HPV vaccine among Polish parents (n = 360) and the level of trust in HPV vaccination in the pediatrician/general practitioner who takes care of their children aged 9-15 years. The data were gathered in September 2022 using computer-assisted telephone interviews. Most surveyed parents reported trusting their child's physician regarding vaccine recommendations (89.2%) and vaccinated their child with all or most of the vaccines recommended by a national vaccination guideline (94.7%). However, 13.3% declared themselves as moderate or strong vaccine opponents, a group characterized by high (83.4%) distrust in physicians. There was no difference in the awareness of HPV in groups varying in trusting the physicians, but parents who trusted them were more frequently aware of the HPV vaccine. Parental willingness to vaccinate their child against HPV was highly differentiated by the level of trust in the child's physician. The results highlight that trust in physicians is a critical factor shaping decisions for children's vaccination, stressing a continuous need to improve strategies to communicate with patients.

The capacity of Mycobacterium tuberculosis complex species and M. bovis BCG substrains specific identification - implications for optimized PCR-based diagnostics in adverse events following vaccination suspected cases.

The capacities of differentiation of Mycobacterium bovis BCG from other members of M. tuberculosis complex species using PCR-RFLP, multiplex PCR, and PCR-based genomic deletion analysis approaches were compared. In the study, mycobacteria isolated from patients suspected of adverse events following vaccination with BCG, primarily classified according presence of RD1 marker as virulent and avirulent mycobacteria, were used. The PCR-based genomic deletion analysis was found the best option for mycobacteria diagnostics improvement, as it was capable precisely differentiate virulent and avirulent mycobacteria or virulent species of M. tuberculosis complex. The routine confirmation of mycobacteria species in the cases of adverse events following BCG vaccination is highly expected, especially in clinical practice of patients with primary immunodeficiency.

[Detection of the adventitious agents in the evaluation of vaccine safety]. / Wykrywanie zanieczyszczen czynnikami zewnatrzpochodnymi w ocenie bezpieczenstwa szczepionek.

In the study current recommendations of the European Pharmacopeia and European Medicines Agency on vaccine safety evaluation in respect to adventitious contaminating agents, e.g., viral originating from biological substances used for vaccine manufacturing were presented and discussed. According current recommendations, adventitious contaminating agents testing include viral identification by in vivo and in vitro infectivity, PCR, and electron transmission microscopy. The scope of safety tests might be however not sufficient in some cases. Improvement of adventitious testing, mostly viral, might be achieved by application of newly developed and validated analyses of vaccine metagenome, and/or introduction of next generation sequencing methods, DNA microarrays, real-time PCR or mass-spectrometry. Currently, the new generation tools were found useful in the practical detection of PCV1 and PCV2 circoviruses specific DNA sequences in the content of rotaviruses vaccines. Routine application of the widen safety measures for adventitious content agents testing will rely on their approval by competent authorities.