Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age.

BACKGROUND: Safe and effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in young children. METHODS: We conducted a phase 1 dose-finding study and are conducting an ongoing phase 2-3 safety, immunogenicity, and efficacy trial of the BNT162b2 vaccine in healthy children 6 months to 11 years of age. We present results for children 6 months to less than 2 years of age and those 2 to 4 years of age through the data-cutoff dates (April 29, 2022, for safety and immunogenicity and June 17, 2022, for efficacy). In the phase 2-3 trial, participants were randomly assigned (in a 2:1 ratio) to receive two 3-µg doses of BNT162b2 or placebo. On the basis of preliminary immunogenicity results, a third 3-µg dose (≥8 weeks after dose 2) was administered starting in January 2022, which coincided with the emergence of the B.1.1.529 (omicron) variant. Immune responses at 1 month after doses 2 and 3 in children 6 months to less than 2 years of age and those 2 to 4 years of age were immunologically bridged to responses after dose 2 in persons 16 to 25 years of age who received 30 µg of BNT162b2 in the pivotal trial. RESULTS: During the phase 1 dose-finding study, two doses of BNT162b2 were administered 21 days apart to 16 children 6 months to less than 2 years of age (3-µg dose) and 48 children 2 to 4 years of age (3-µg or 10-µg dose). The 3-µg dose level was selected for the phase 2-3 trial; 1178 children 6 months to less than 2 years of age and 1835 children 2 to 4 years of age received BNT162b2, and 598 and 915, respectively, received placebo. Immunobridging success criteria for the geometric mean ratio and seroresponse at 1 month after dose 3 were met in both age groups. BNT162b2 reactogenicity events were mostly mild to moderate, with no grade 4 events. Low, similar incidences of fever were reported after receipt of BNT162b2 (7% among children 6 months to <2 years of age and 5% among those 2 to 4 years of age) and placebo (6 to 7% among children 6 months to <2 years of age and 4 to 5% among those 2 to 4 years of age). The observed overall vaccine efficacy against symptomatic Covid-19 in children 6 months to 4 years of age was 73.2% (95% confidence interval, 43.8 to 87.6) from 7 days after dose 3 (on the basis of 34 cases). CONCLUSIONS: A three-dose primary series of 3-µg BNT162b2 was safe, immunogenic, and efficacious in children 6 months to 4 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.).

Trained Immunity, BCG and SARS-CoV-2 General Outline and Possible Management in COVID-19.

The Bacillus Calmette-Guérin (BCG) vaccine has been in use for over 100 years. It protects against severe, blood-borne forms of tuberculosis. Observations indicate that it also increases immunity against other diseases. The mechanism responsible for this is trained immunity, an increased response of non-specific immune cells in repeated contact with a pathogen, not necessarily of the same species. In the following review, we present the current state of knowledge on the molecular mechanisms responsible for this process. We also seek to identify the challenges facing science in this area and consider the application of this phenomenon in managing the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic.

Vaccination Against Measles, Mumps, and Rubella in the Light of Current Epidemic Threats: Unjustified Postponement.

A worrying increase in the number of measles cases has been noted recently in Poland, which may have to do with a decreasing proportion of children vaccinated against measles, mumps, and rubella (MMR) in the second year of life (<95%). For many years, MMR vaccination in children has been associated with a fear of allergy to eggs. This study seeks to define the reason and justification for postponing MMR vaccination in a population of children referred to the outpatient specialist immunization clinic. One hundred and thirty eight (138) children, mean 24.5 ± 26.6 months, with a history of past allergies, in whom the first-time MMR vaccination was delayed by family doctors for fear of allergic reactions, were enrolled into the study. The mean delay in a vaccine shot was 12.3 ± 26.9 months. There were 101 children who displayed a distinct allergy to the egg proteins, among other accompanying types of allergy. All of the 138 children were found eligible to receive MMR vaccine at the visit to the clinic. No early allergic responses were noticed in any of the children. There were negligible delayed allergic responses in six children, all from the egg allergy group. We conclude that MMR vaccination in children with egg allergy is safe and can be conducted on the outpatient basis without any specific precautions or safety measures. Delays in vaccination were unjustified and may jeopardize children's health. There is a need for insightful education of primary care doctors concerning of MMR vaccination safety, particularly when allergy is suspected, to avoid unduly and potentially harmful delays.

[Why are preventive vaccinations still required?]

Vaccinations in Poland and other industrialized countries have been in the firing line for more than two decades. Members of the "anti-vaccine movement" and alternative medicine supporters are openly reluctant to this form of preventing infectious diseases, however their arguments are not based on reliable medical data. Contrary to false theories, the threat of infectious diseases is not lower than in the past. What is more, it has escalated in recent years as a result of the increasing number of parents who avoid vaccinations. Nevertheless, erroneous arguments find a breeding ground among parents or guardians of children covered by vaccination programs undermining trust in vaccines in general. In this situation, it is the responsibility of: physicians who provide preventive care for children, administrative bodies responsible for implementing immunization but also medical schools and other healthcare institutions, on the one hand to raise the level of social awareness about the meaning of vaccination, and on the other to effectively oppose the anti-vaccine propaganda. The way to achieve these goals is to thoroughly understand social needs and constantly improve the professional qualifications of primary care physicians, midwives, community nurses and doctors of different specialties who have daily contact with children and their parents. The key area of focus should also be to place greater emphasis on education about the prevention of infectious diseases among students of all medical school faculties.

Vaccination of preterm infants by polyvalent vaccines: immunogenicity and safety- review of literature.

The immunization of infants against infectious diseases still raises many controversies, not only with parents, but also among physicians. This refers particularly to preterm infants. Due to the increasing popularity of polyvalent vaccines, a number of studies has recently been conducted to verify their immunogenicity and safety in preterm infants. The aim of the present paper was to review the current literature dealing with the problem in question. The following recommendations regarding the use of polyvalent vaccines in preterm infants and neonates with low birth weight can be formulated on the basis of current evidence (1). Due to sufficient immunogenicity, polyvalent vaccines can be administered to preterm infants in accordance with their calendar age (2). Booster vaccination of preterm infants after completing 12 months of age is vital for achieving complete and persistent immunity against all vaccine antigens (3). In order to reduce the risk of adverse events after the administration of a polyvalent vaccine, it is essential to carefully consider the cardiorespiratory status of preterm infants during preimmunization examination, as well as their history of any cardiorespiratory dysfunctions. In such cases administering the first dose of the vaccine in a hospital setting is strongly advised.

New Insights on Respiratory Syncytial Virus Prevention.

Respiratory syncytial virus (RSV) is a well-known infant pathogen transmitted mainly by droplets. It is a leading cause of upper respiratory tract infections in children, usually with a mild course of illness. RSV has also been a threat to older people, especially those with underlying medical conditions. For a long time, prevention was limited to passive immunoprophylaxis with palivizumab for high-risk infants. There was a strong need to find other treatment or prevention methods against RSV infections. In addition, after the coronavirus disease 2019 (COVID-19) pandemic, some significant changes in RSV epidemiology have been observed. Researchers noticed the shift in RSV seasonality and age distribution and the increased number of cases in older infants and adults. All of these made the need to find other medical options even stronger. Fortunately, two protein-based vaccines against RSV have successfully passed all phases of clinical trials and have been approved for use by adults and older people. One of them is also approved for infants from birth to 6 months of age (after maternal immunisation during pregnancy) and for pregnant women between 24 and 36 weeks of pregnancy. Also, a new passive immunisation option named nirsevimab (a highly potent monoclonal antibody with a long half-life) is now available for the paediatric group. In this review, we will discuss the previous and current RSV prevention methods in the light of structural discoveries of RSV antigens.

Rotavirus Vaccination of Premature Newborns in the NICU: Evaluation of Vaccination Rates and Safety Based on a Single-Centre Study.

Preterm newborns are babies born before the end of the 36th week of gestational life. They are at increased risk of infection and death from infectious diseases. This is due, among other things, to the immaturity of the immune system and the long hospitalisation period. One common infectious disease in the paediatric population is rotavirus (RV) infection. We now have specific vaccines against this pathogen. The aim of this study was to evaluate the safety of rotavirus vaccination in the neonatal intensive care unit (NICU) setting and to determine the tolerance of this vaccine in low- and extremely low-weight children. The study carried out at a single centre, the University Hospital in Kraków, also allowed the assessment of vaccination trends during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. During the observation period, 126 premature newborns received the RV vaccine. We observed no adverse effects, and our analysis shows safety and good tolerance of the vaccine among preterm babies. In addition, we observed an increase in vaccination rates between 2019 and 2021, partly explained by parents' anxiety about infectious diseases in the era of pandemics and partly explained by a change in vaccination policy in Poland and the introduction of refunding for RV vaccination.

Immunogenicity and safety of a pentavalent meningococcal ABCWY vaccine in adolescents and young adults: an observer-blind, active-controlled, randomised trial.

BACKGROUND: Meningococcal serogroups A, B, C, W, and Y cause nearly all meningococcal disease, and comprehensive protection requires vaccination against all five serogroups. We aimed to assess the immunogenicity and safety of a pentavalent MenABCWY vaccine comprising two licensed vaccines-meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) and a quadrivalent meningococcal serogroup ACWY tetanus toxoid conjugate vaccine (MenACWY-TT)-compared with two doses of MenB-FHbp and a single dose of quadrivalent meningococcal serogroup ACWY CRM197-conjugate vaccine (MenACWY-CRM) as the active control. We previously reported the primary safety and immunogenicity data relating to the two-dose MenB-FHbp schedule. Here we report secondary outcomes and ad-hoc analyses relating to MenABCWY immunogenicity and safety. METHODS: We did an observer-blind, active-controlled trial at 68 sites in the USA, Czech Republic, Finland, and Poland. Healthy individuals (aged 10-25 years) who had or had not previously received a MenACWY vaccine were randomly assigned (1:2) using an interactive voice or web-based response system, stratified by previous receipt of a MenACWY vaccine, to receive 0·5 mL of MenABCWY (months 0 and 6) and placebo (month 0) or MenB-FHbp (months 0 and 6) and MenACWY-CRM (month 0) via intramuscular injection into the upper deltoid. All individuals were masked to group allocation, except staff involved in vaccine dispensation, preparation, and administration; and protocol adherence. Endpoints for serogroups A, C, W, and Y included the proportion of participants who achieved at least a four-fold increase in serum bactericidal antibody using human complement (hSBA) titres between baseline and 1 month after each vaccination. For serogroup B, secondary endpoints included the proportion of participants who achieved at least a four-fold increase in hSBA titres from baseline for each of four primary test strains and the proportion of participants who achieved titres of at least the lower limit of quantitation against all four test strains combined at 1 month after the second dose. Endpoints for serogroups A, C, W, and Y were assessed in the modified intent-to-treat (mITT) population, which included all randomly assigned participants who received at least one vaccine dose and had at least one valid and determinate MenB or serogroup A, C, W, or Y assay result before vaccination up to 1 month after the second dose, assessed in ACWY-experienced and ACWY-naive participants separately. Secondary endpoints for serogroup B were analysed in the evaluable immunogenicity population, which included all participants in the mITT population who were randomly assigned to the group of interest, received all investigational products as randomly assigned, had blood drawn for assay testing within the required time frames, had at least one valid and determinate MenB assay result after the second vaccination, and had no important protocol deviations; outcomes were assessed in both ACWY-experienced and ACWY-naive populations combined. Non-inferiority of MenABCWY to MenACWY-CRM and MenB-FHbp was determined using a -10% non-inferiority margin for these endpoints. Reactogenicity and adverse events were assessed among all participants who received at least one vaccine dose and who had available safety data. This trial is registered with Clinicaltrials.gov, NCT03135834, and is complete. FINDINGS: Between April 24 and November 10, 2017, 1610 participants (809 MenACWY-naive; 801 MenACWY-experienced) were randomly assigned: 544 to receive MenABCWY and placebo (n=272 MenACWY-naive; n=272 MenACWY-experienced) and 1066 to receive MenB-FHbp and MenACWY-CRM (n=537 MenACWY-naive; n=529 MenACWY-experienced). Among MenACWY-naive or MenACWY-experienced MenABCWY recipients, 75·5% (95% CI 69·8-80·6; 194 of 257; serogroup C) to 96·9% (94·1-98·7; 254 of 262; serogroup A) and 93·0% (88·4-96·2; 174 of 187; serogroup Y) to 97·4% (94·4-99·0; 224 of 230; serogroup W) achieved at least four-fold increases in hSBA titres against serogroups ACWY after dose 1 or 2, respectively, in ad-hoc analyses. Additionally, 75·8% (71·5-79·8; 320 of 422) to 94·7% (92·1-96·7; 396 of 418) of MenABCWY and 67·4% (64·1-70·6; 563 of 835) to 95·0% (93·3-96·4; 782 of 823) of MenB-FHbp recipients achieved at least four-fold increases in hSBA titres against MenB strains after dose 2 in secondary analyses; 79·9% (334 of 418; 75·7-83·6) and 74·3% (71·2-77·3; 605 of 814), respectively, achieved composite responses. MenABCWY was non-inferior to MenACWY-CRM (single dose) and to MenB-FHbp in ad-hoc analyses based on the proportion of participants with at least a four-fold increase in hSBA titres from baseline and (for MenB-FHbp only) composite responses. Reactogenicity events after vaccination were similarly frequent across groups, were mostly mild or moderate, and were unaffected by MenACWY experience. No adverse events causing withdrawals were related to the investigational product. Serious adverse events were reported in four (1·5%; 0·4-3·7) MenACWY-naive individuals in the MenABCWY group versus six (2·2%; 0·8-4·8) among MenACWY-experienced individuals in the MenABCWY group and 14 (1·3%; 0·7-2·2) in the active control group (MenACWY-experienced and MenACWY-naive individuals combined); none of these were considered related to the investigational product. INTERPRETATION: MenABCWY immune responses were robust and non-inferior to MenACWY-CRM and MenB-FHbp administered separately, and MenABCWY was well tolerated. The favourable benefit-risk profile supports further MenABCWY evaluation as a simplified schedule compared with current adolescent meningococcal vaccination programmes. FUNDING: Pfizer.

Status of immunity for vaccine--preventable diseases in children after hematopoietic stem cells transplantation.

INTRODUCTION: patients treated with hematopoietic stem cell transplantation (HSCT) lose immune memory accumulated through a lifetime. They are at increased risk of developing infections with microorganisms such as Haemophilus influenza, Streptococcus pneumoniae and others for which vaccines are available. Therefore, all patients after HSCT should be routinely revaccinated. Systemic reimmunization after HSCT is a relatively neglected area especially in countries which have not national recommendations and there is lack of systemic regulations in health care system. OBJECTIVE: the rate of immunization before transplantation and the persistence of vaccine-specific antibodies after HSCT was assessed. STUDY DESIGN: a group of38 children after stem cell transplantation (19 autologous, 19 allogeneic) was studied. RESULTS: only a few patients completed standard vaccination protocol before HSCT. At the median time of 29 (range: 6-67) months after autologous and 13 (range: 8-33) months after allogeneic HSCT, when the revaccination was commenced, the majority of children had concentration of antibody lower than the minimum protective thresholds. That was 82% for tetanus, 71% for Hib and varicella, 46% for HBV and 38% for diphtheria. CONCLUSIONS: all HSCT recipients should be routinely revaccinated to stimulate the immunity to the vaccine-preventable diseases.

Newborn screening and gene therapy in SMA: Challenges related to vaccinations.

Spinal muscular atrophy (SMA) affects one in 7,500-10,000 newborns. Before the era of disease-modifying therapies, it used to be the major genetic cause of mortality in infants. Currently, there are three therapies approved for SMA, including two molecules modifying the splicing of the SMN2 gene and one gene therapy providing a healthy copy of the SMN gene with a viral vector. The best effects of any of these therapies are achieved when the treatment is administered in the presymptomatic stage of the disease, therefore newborn screening programs are being introduced in many countries. Patients identified in newborn screening might be eligible for gene therapy. However, gene therapy and the associated administration of steroids in newborns might interfere with the vaccination schedule, which includes live immunization against tuberculosis in some countries. The timing of gene therapy in patients who received live vaccinations has not yet been addressed neither in the clinical trials nor in the existing international guidelines. The Polish Vaccinology Association has developed the first recommendations for gene therapy administration in newborns who received live vaccination against tuberculosis. Their statement was implemented in the current guidelines for Polish SMA patients identified in the newborn screening program and might be helpful for medical professionals in other countries where live vaccine against tuberculosis is still in routine use in newborns.

A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Impact of BCG Re-Vaccination on the Incidence and Severity of SARS-CoV-2 Infections among Symptomatic Healthcare Professionals during the COVID-19 Pandemic in Poland-Evaluation of Antibody Concentrations.

Tuberculosis (TB) was the predominant cause of death from a single infectious agent worldwide before the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) pandemic. Although TB vaccines have been successfully used for about 100 years, their full effect is still unknown. In previous studies, a reduced incidence and mortality from a coronavirus disease in TB-vaccinated populations were reported. In this article, we present the secondary analysis of a randomised controlled trial, reporting the results of a serological assessment evaluating the effect of the Bacillus Calmette-Guérin (BCG) vaccine on SARS-CoV-2. Participants-healthcare workers-were assessed 1-2 and 8 months after the second dose of the coronavirus disease 2019 (COVID-19) vaccine. We found no associations between antibody concentration, BCG revaccination, and additional characteristics, such as age, gender, or Body Mass Index. The effect of BCG vaccination on the immunological response against SARS-CoV-2 requires further research.

A Multi-Center, Randomised, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Impact of BCG Re-Vaccination on the Incidence and Severity of SARS-CoV-2 Infections among Symptomatic Healthcare Professionals during the COVID-19 Pandemic in Poland-First Results.

Tuberculosis vaccines (Bacillus Calmette-Guérin, BCG) were introduced 100 years ago and are still recommended by the World Health Organization to prevent the disease. Studies have shown that BCG vaccination can stimulate non-specific immune responses and reduce the incidence of certain diseases. At the beginning of the coronavirus disease 2019 (COVID-19) pandemic, it was hypothesised that the incidence of COVID-19 was lower in countries with BCG prevention. In an attempt to verify this thesis, we conducted a multicenter, randomised, double-blind, placebo-controlled study on a group of 695 health care workers aged 25 years and over in Poland. All participants in the study had a tuberculin test, after which those who were negative were randomised (1:1) and received either the BCG- or placebo vaccine. From then on, these people were subjected to three months of observation for the occurrence of COVID-19 symptoms. The statistical analysis did not reveal any significant correlation between the frequency of incidents suspected of COVID-19 and BCG-10 vaccination, the result of the tuberculin test and the number of scars. The only statistically significant feature was the type of medical profession-nurses became infected more often than doctors or other medical workers (p = 0.02). The results differ from similar trials in other countries. Perhaps this is due to the lack of an unvaccinated control group. The impact of BCG vaccination on the course of COVID-19 requires further research.

A phase 3 study to assess the immunogenicity, safety, and tolerability of MenB-FHbp administered as a 2-dose schedule in adolescents and young adults.

BACKGROUND: The MenB-FHbp vaccine is licensed to prevent meningococcal serogroup B disease on either a 2-dose (0, 6 months) or 3-dose (0, 1-2, 6 months) series. This phase 3 study further assessed the immunogenicity and safety of the 2-dose MenB-FHbp schedule. METHODS: Subjects 10-25 years of age received MenB-FHbp (months 0, 6) and the quadrivalent meningococcal conjugate vaccine MenACWY-CRM (month 0). Primary immunogenicity endpoints included percentages of subjects achieving ≥ 4-fold increases from baseline in serum bactericidal antibody using human complement (hSBA) titers for 4 diverse, vaccine-heterologous primary serogroup B test strains and titers ≥ lower limit of quantitation (LLOQ; 1:8 or 1:16) for all 4 primary strains combined (composite response) after dose 2; a titer ≥ 1:4 is the accepted correlate of protection. Percentages of participants with hSBA titers ≥ LLOQ for 10 additional vaccine-heterologous strains were also assessed; positive predictive values of primary strain responses for secondary strain responses were determined. Safety was assessed. RESULTS: Overall, 1057 subjects received dose 1 and 946 received dose 2 of MenB-FHbp. Percentages of participants achieving ≥ 4-fold increases in hSBA titers against each primary strain after dose 2 ranged from 67.4% to 95.0% and the composite response was 74.3%. Primary strain responses were highly predictive of secondary strain responses. Most reactogenicity events were mild-to-moderate in severity and did not lead to withdrawal from the study. Adverse events (AEs) considered by the investigator to be related to vaccination occurred in 4.2% (44/1057) of subjects, and there were no serious AEs or newly diagnosed chronic medical conditions considered related to vaccination. CONCLUSIONS: MenB-FHbp administered at 0, 6 months was well tolerated and induced protective bactericidal antibody responses against diverse serogroup B strains. Findings provide further support for the continued use of MenB-FHbp on a 2-dose schedule in this population.

Ten-year follow-up on efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine or one dose of monovalent varicella vaccine: Results from five East European countries.

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.

Who or What Influences the Individuals' Decision-Making Process Regarding Vaccinations?

Thanks to vaccines, many people are not exposed to the risks associated with vaccine-preventable diseases (VPDs). This, however, results in growing popularity of antivaccine movements and affects global and local epidemiological situation. Vaccine hesitancy has become a significant problem not only for epidemiologists but also for practitioners. Fortunately, the hesitant group seems to be vulnerable to intervention, and studies indicate that these patients can be persuaded to undergo vaccinations. The aim of the present study was to determine the factors most strongly affecting vaccination-related attitudes and decisions. An anonymous, self-administered survey consisting of demographic data and single select multiple-choice questions regarding vaccination was conducted. The voluntary study included secondary school pupils, medical and nonmedical students, healthcare professionals, hospital and clinic patients as well as parents. A total of 7950 survey forms were distributed between January 2018 and June 2019 in south-eastern Poland. A total of 6432 respondents (80.2%) completed a questionnaire that was eligible for analysis. The positive attitude toward vaccination was significantly affected by older age, by the fact of obtaining information on vaccinations from a physician, this information's higher quality (assessed in school grade scale), higher level of knowledge on vaccines and by the fact of denying the association between vaccination and autism in children (p < 0.001). The probability of supporting vaccinations was almost eight-fold lower among respondents believing the vaccine-autism relationship. Chance of supporting vaccination doubled in the group with a higher knowledge level. The individuals not provided with expert information on vaccination were twice as often unconvinced. Age, education and having children significantly affected the attitude toward influenza immunization (p < 0.001). Older, better educated respondents and those having children were more positive about vaccinations. The medical community still exert decisive effects on attitudes toward vaccinations. High-quality information provided by them is of great importance. Skillful and competent provision of evidence-based information disproving the myth about vaccine-autism connection and proper education of medical staff is essential in molding positive attitudes toward vaccinations.

Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) compared to the licensed 7vCRM vaccine.

BACKGROUND: The immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) was assessed and compared with the 7-valent pneumococcal conjugate vaccine (7vCRM). METHODS: Healthy subjects (1650) were randomized to be vaccinated with 3 doses of PHiD-CV or 7vCRM (Prevenar/Prevnar) at 2-3-4 months of age and a fourth booster dose at 12-18 months. Serotype-specific pneumococcal responses (GlaxoSmithKline's ELISA with 22F-inhibition) and opsonophagocytic activity (OPA) were measured 1 month after primary and booster vaccinations. RESULTS: The primary objective to demonstrate noninferiority of PHiD-CV versus 7vCRM (in terms of percentage of subjects with antibody concentration >or=0.2 microg/mL) for at least 7 of the 10 vaccine serotypes was reached as noninferiority was demonstrated for 8 serotypes. Although, noninferiority could not be demonstrated for ELISA responses against serotypes 6B and 23F, a post-hoc analysis of the percentage of subjects with OPA titers >or=8 suggested noninferiority for the 7 serotypes common to both vaccines including 6B and 23F.Priming of the immune system against all vaccine serotypes was confirmed by robust increases in ELISA antibody levels ( approximately 6.0-17 fold) and OPA titers ( approximately 8-93 fold) after a fourth consecutive dose of PHiD-CV. CONCLUSIONS: PHiD-CV induces ELISA and functional OPA antibodies for all vaccine serotypes after primary vaccination and is noninferior to 7vCRM in terms of ELISA and/or OPA threshold responses. Effective priming is further indicated by robust booster responses.

Central European Vaccination Advisory Group (CEVAG) guidance statement on recommendations for the introduction of HPV vaccines.

Vaccines against human papillomavirus (HPV), the primary causative agent in cervical cancer, are licensed. This paper contains the Central European Vaccination Advisory Group (CEVAG) guidance statement on the introduction of HPV vaccines in central Europe. Eight countries currently have medical representatives on CEVAG: the Czech Republic, Estonia, Hungary, Lithuania, Poland, Romania, Slovakia and Turkey. By raising awareness and disseminating information, CEVAG aims to promote the efficient and safe use of vaccines to prevent, control and if possible eliminate infectious diseases. In January 2008, the European Centre for Disease Prevention and Control published a report entitled Guidance for the Introduction of HPV Vaccines in EU Countries. Members of CEVAG have taken the information relevant to their countries from this report and, with consideration of local issues, produced these guidance recommendations for the introduction of HPV vaccines in the CEVAG region, which may be adapted for use in individual countries.

[What is parents' and medical health care specialists knowledge about vaccinations?]. / Co na temat szczepien ochronnych wiedza rodzice i pracownicy ochrony zdrowia?

AIM: The aim of the study was to become familiar with parents' and Medical Health Care specialists knowledge and attitude towards vaccinations. The influence of information, provided to patients from various sources, on general opinion about immunization and its coverage within the last year were evaluated. MATERIALS AND METHODS: Analysis of questionnaires about vaccinations performed among 151 parents and 180 Medical Health Care specialists. RESULTS: Medical Health Care specialists knowledge was considerably higher in comparison to questioned parents. Surprisingly enough, only approximately 90% of Medical Health Care workers knew about prophylaxis of Hib infections. A doctor is the main and the most reliable source of information for parents. Significant impact on parents' attitude to vaccinations is made not only by campaigns promoting vaccinations, but also by widespread opinions about their harmfulness. CONCLUSIONS: The doctor is the major source of reliable information about vaccinations for parents. Therefore, there is the need of continuous improvement of Medical Health Care specialists knowledge, but also the ability of successfully communicating it to parents.

[Controversies around vaccinations]. / Kontrowersje wokól szczepien.

Controversies on vaccinations refer to two fundamentally different areas. The public contestation refers first of all to the objective need, efficiencies and the safety of vaccinations. Results of reliable research and their metaanalyses published over the recent years confirmed none of claimed by antivaccinists dispraise including causalities among the vaccination and the autism, autoimmune or allergic diseases. The second area, wherein one observes disagreements on the subject of vaccinations, is discussions on of the efficiency of each vaccine, schemata of vaccinations, or else economic advantages from their usage. Result these discussions is the progress in the optimization of schemata, efficiencies and safeties of vaccinations. The more and more greater attention it goes at the standardization of the definition of events and the supervision over undesirable connected symptoms with the usage of vaccinations.

[Why should we revaccinate children after stem cell transplantations?]. / Dlaczego trzeba szczepic pacjentów po przeszczepieniach komórek krwiotwórczych?

Stem cell transplantation is a procedure often used in treatment of proliferative and non-prolifarative diseases. Recipient's immunological system has been damaged during pretransplant and conditioning therapy: deprived from B- and T-cell mediated immunological response and memory cells. One of the prophylactic procedures against post-transplant infections in recipients is efficient and safe revaccination. In Poland so far there is no uniform revaccination schedule for stem cell transplantation recipients.