Galanakis E.,University of Crete |
D'Ancona F.,National Center for Epidemiology |
Jansen A.,U.S. Center for Disease Control and Prevention |
Lopalco P.L.,VENICE National Gatekeepers
Expert Review of Vaccines | Year: 2014
Mandatory policies have occasionally been implemented, targeting optimal vaccination uptake among healthcare workers (HCWs). Herein, we analyze the existing recommendations in European countries and discuss the feasibility of implementing mandatory vaccination for HCWs. As reflected by a survey among vaccine experts from 29 European countries, guidelines on HCW vaccination were issued in all countries, though with substantial differences in targeted diseases, HCW groups and type of recommendation. Mandatory policies were only exceptionally implemented. Results from a second survey suggested that such policies would not become easily adopted, and recommendations might work better if focusing on specific HCW groups and appropriate diseases such as hepatitis B, influenza and measles. In conclusion, guidelines for HCW vaccination, but not mandatory policies, are widely adopted in Europe. Recommendations targeting specific HCW groups and diseases might be better accepted and facilitate higher vaccine uptake than policies vaguely targeting all HCW groups. © Informa UK, Ltd.
Ganesh B.,Indian National Institute of Cholera and Enteric Diseases |
Banyai K.,Hungarian Academy of Sciences |
Banyai K.,National Center for Epidemiology |
Martella V.,University of Bari |
And 3 more authors.
Reviews in Medical Virology | Year: 2012
Picobirnaviruses (PBVs) are small, non-enveloped, bisegmented double-stranded RNA genomic viruses of vertebrate hosts. Since their discovery in the late 1980s in clinical specimens from outbreaks of acute gastroenteritis in children, significant efforts have been made to investigate the role of PBV in diarrheic diseases. PBV has been detected in sporadic episodes of diarrhea as sole pathogen or coinfection as well as in outbreaks of acute gastroenteritis and in immunocompromised patients with diarrhea. However, PBV is frequently detected in non-diarrheic healthy hosts, and prolonged shedding has been observed in some individuals. Of interest, similar patterns of PBV infection have also been observed in pigs and other animal hosts. The increasing amount of PBV sequence data gathered from molecular epidemiological studies has evidenced a great sequence diversity of PBVs in various hosts and environmental samples. Importantly, evidence has been found for genetic relatedness between human and animal PBV strains, suggesting extant crossing points in the ecology and evolution of heterologous PBV strains. At present, no cell culture and animal model exists for PBVs. Well-structured epidemiological studies are still the only alternative to demonstrate the potential etiological role of PBVs in acute gastroenteritis or other diseases. This review aims to analyze the public health aspects of PBV infection, especially its possible association with zoonosis. © 2012 John Wiley & Sons, Ltd.
Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009-10 influenza season: a multicentre, randomised controlled trial
Vajo Z.,Debrecen University |
Tamas F.,State Primary Care Center |
Sinka L.,State Primary Care Center |
Jankovics I.,National Center for Epidemiology
The Lancet | Year: 2010
Background: With the ongoing 2009 pandemic of influenza A H1N1, development of pandemic influenza vaccines has generated much interest. We investigated the safety and immunogenicity of a whole-virion, inactivated, adjuvanted pandemic H1N1 vaccine in adult and elderly volunteers, given without or simultaneously with the 2009-10 seasonal trivalent influenza vaccine. Methods: This prospective, randomised study was undertaken in two centres in Hungary. 355 participants, including 203 adults (18-60 years) and 152 elderly people (>60 years), were assigned by stratified randomisation to either 0·5 mL of the pandemic vaccine (Fluval P, a monovalent vaccine with 6 μg haemagglutinin per 0·5 mL content and aluminium phosphate gel adjuvant; n=178) or 0·5 mL of the pandemic vaccine and 0·5 mL of the seasonal trivalent vaccine (Fluval AB, a trivalent inactivated whole-virion influenza vaccine; n=177). All vaccinations were done by specific study personnel, who did not take part in the assessment of safety or immunogenicity. Co-primary objectives were safety and immunogenicity by haemagglutinin inhibition testing. All analyses were done according to a pre-established analysis plan. This study is registered with ClinicalTrials.gov, number NCT01010893. Findings: Two participants receiving the pandemic vaccine only (group 1) and one receiving pandemic and seasonal vaccines (group 2) were lost to follow-up. Participants in both groups developed antibody responses against the pandemic influenza A H1N1 virus (group 1: seroconversion for adults 74·3%, 95% CI 64-6-82·4 and for elderly people 61·3%, 49·1-72·4; group 2: 76·8%, 67·2-84·7 and 81·8%, 71·4-89·7, respectively). Single doses of 6 μg fulfilled European Union and US licensing criteria for interpandemic and pandemic influenza vaccines. Simultaneously, participants in group 2 developed the immune responses needed for licensing for all three seasonal strains in the seasonal vaccine for the 2009-10 season. All adverse events were rare, mild, and transient; the most frequent were pain at injection site (eight cases in group 1 vs 18 in group 2) and fatigue for 1-2 days after vaccination (three vs five cases). Interpretation: The present pandemic vaccine is safe and immunogenic in healthy adult and elderly patients, and needs low doses and only one injection to trigger immune responses to comply with licensing criteria. It can be safely co-administered with the 2009-10 seasonal influenza vaccine. Funding: Omninvest, Hungary. © 2010 Elsevier Ltd. All rights reserved.
Nohynek H.,Finnish National Institute for Health and Welfare |
Wichmann O.,Robert Koch Institute |
Dancona F.,National Center for Epidemiology
Clinical Microbiology and Infection | Year: 2013
During the twenty-first century, the development of national immunization programmes (NIP) has matured into robust processes where evidence-based methodologies and frameworks have increasingly been adopted. A key role in the decision-making and recommending processes is played by National Immunization Technical Advisory Groups (NITAGs). In a survey performed among European Union member states, Norway and Iceland, in February 2013, 85% of the 27 responding countries reported having established a NITAG, and of these, 45% have formal frameworks in place for the systematic development of vaccination recommendations. Independent of whether a formal framework is in place, common key factors are addressed by all NITAGs and also in countries without NITAGs. The four main factors addressed by all were: disease burden in the country, severity of the disease, vaccine effectiveness or efficacy, and vaccine safety at population level. Mathematical modelling and cost-effectiveness analyses are still not common tools. Differences in the relative weighting of these key factors, differences in data or assumptions on country-specific key factors, and differences in existing vaccination systems and financing, are likely to be reasons for differences in NITAG recommendations, and eventually NIPs, across Europe. Even if harmonization of NIPs is presently not a reasonable aim, systematic reviews and the development of mathematical/economic models could be performed at supranational level, thus sharing resources and easing the present work-load of NITAGs. Nevertheless, it has been argued that harmonization would ease central purchase of vaccines, thus reducing the price and increasing access to new vaccines. © 2013 European Society of Clinical Microbiology and Infectious Diseases.
Scaravelli G.,National Center for Epidemiology
Placenta | Year: 2011
The application of the European Tissues and Cells Directive requires that a high standard of quality and safety be applied to all tissue establishments, including that of assisted reproductive centres. In the countries where the Directive has been implemented, changes in the ART clinic and laboratory procedures have been made. However, many requirements stipulated in the Directive are already in place in some European countries and are mandatory by the country specific laws, while some other requirements have been recently implemented. In this article the benefits and the potential risks of the Directive implementation on the efficacy, safety and cost of all the different assisted reproductive technologies performed, including cryopreservation techniques and storage policies have been widely analysed. The feasibility of the implementation of some of the specific requirements when considering the delicate issues of reproductive cells in contrast to other cells or tissues covered by the Directive has been evaluated. © 2011 Elsevier Ltd. All rights reserved.