International collaboration to assess the risk of Guillain Barré Syndrome following Influenza A (H1N1) 2009 monovalent vaccines.

BACKGROUND: The global spread of the 2009 novel pandemic influenza A (H1N1) virus led to the accelerated production and distribution of monovalent 2009 Influenza A (H1N1) vaccines (pH1N1). This pandemic provided the opportunity to evaluate the risk of Guillain-Barré syndrome (GBS), which has been an influenza vaccine safety concern since the swine flu pandemic of 1976, using a common protocol among high and middle-income countries. The primary objective of this project was to demonstrate the feasibility and utility of global collaboration in the assessment of vaccine safety, including countries both with and without an established infrastructure for vaccine active safety surveillance. A second objective, included a priori, was to assess the risk of GBS following pH1N1 vaccination. METHODS: The primary analysis used the self-controlled case series (SCCS) design to estimate the relative incidence (RI) of GBS in the 42 days following vaccination with pH1N1 vaccine in a pooled analysis across databases and in analysis using a meta-analytic approach. RESULTS: We found a relative incidence of GBS of 2.42 (95% CI 1.58-3.72) in the 42 days following exposure to pH1N1 vaccine in analysis of pooled data and 2.09 (95% CI 1.28-3.42) using the meta-analytic approach. CONCLUSIONS: This study demonstrates that international collaboration to evaluate serious outcomes using a common protocol is feasible. The significance and consistency of our findings support a conclusion of an association between 2009 H1N1 vaccination and GBS. Given the rarity of the event the relative incidence found does not provide evidence in contradiction to international recommendations for the continued use of influenza vaccines.

Pharmacoeconomic assessment of implementing a universal PCV-13 vaccination programme in the Valencian public health system (Spain).

BACKGROUND: Heptavalent pneumococcal conjugate vaccine (PCV-7) was licensed to provide immunity against pneumococcal disease caused by seven serotypes of S. pneumoniae. Thirteen-valent pneumococcal conjugate vaccine (PCV-13) includes 6 additional serotypes for preventing invasive pneumococcal disease. OBJECTIVE: The objective of this study was to estimate the potential health benefits, costs, and cost-effectiveness of vaccination with PCV-13 in the Community of Valencia and to generate valuable information for policy makers at regional and country levels. METHODS: A decision tree was designed to determine the health and economic outcomes in hypothetical cohorts of vaccinated and unvaccinated children followed over their lifetime. Information about disease incidence and serotype distribution were gathered from local databases and from published and unpublished local records. PCV-13 effectiveness was extrapolated from PCV-7 efficacy data. A 5% of herd effect and a serotype replacement of 25% were considered for the base case scenario. Only direct costs were taken into account and results were expressed in terms of life-years gained (LYG) and quality adjusted life years (QALY). RESULTS: Implementing a universal PCV-13 vaccination program in the Community of Valencia would decrease the number of hospital admitted pneumonia to less than 4571 cases while avoiding 310 cases of IPD and 82,596 cases of AOM throughout the cohort lifetime. A total of 190 S. pneumoniae related deaths would be averted over the same period. Total medical costs of non-vaccinating the cohort of newborns would reach up to 403,850.859€ compared to 438,762.712€ that would represent vaccinating the cohort. The incremental cost of vaccinating the children was estimated in 12,794€/LYG and 10,407€/QALY, respectively. CONCLUSIONS: A universal PCV-13 vaccination program in the Community of Valencia would be a cost-effective intervention from the payer perspective after preventing for pneumococcal infections and for decreasing its associated mortality and morbidity.

Antibody persistence 12 months after a booster dose of meningococcal-C conjugated vaccine in the second year of life.

We report on the results of the 12-month follow-up of children aged 14 to 18 months who received primary and booster vaccinations with either a meningococcal-C vaccine conjugated to tetanus toxoid or CRM197. Seroprotection (92.8%) and geometric mean titers/serum bactericidal activity (410.5; 95% CI: 273.4-616.3) were higher in children receiving the meningococcal serogroup C tetanus toxoid conjugate, compared with 61.5% and serum bactericidal antibody geometric mean titer of 45.1 (95% CI: 28.5-71.3) when MenC-CRM197 conjugate was used.

Nosocomial rotavirus gastroenteritis in Spain: a multicenter prospective study.

BACKGROUND: The objective of this study was to assess the incidence of nosocomial rotavirus gastroenteritis among children <2 years of age. METHODS: We conducted a prospective active surveillance for acute gastroenteritis (AGE) in the pediatric wards of 3 representative hospitals in Valencia (Spain) from October 2006 to March 2007, among children between 1 and 23 months of age with acute diarrhea. Children were followed up for 3 days after discharge. We obtained clinical and demographic information from participants and tested their stool specimens for rotavirus. RESULTS: A total of 1576 children were hospitalized at the 3 hospitals and 1300 (82.5%) were followed up as the study cohort. In 69 children, AGE started 48 hours after admission and were considered nosocomial infections. In 35 of the 59 cases where stool samples were obtained, rotavirus (RV) was present (59%), and in 12 of them symptoms started after discharge. The accumulated incidence of nosocomial rotavirus disease during the study period was 2.8 cases per 100 inpatients (95% CI: 1.9-3.8), and the incidence rate was 4.8 cases per 1000 hospital days (95% CI: 3.2-6.5). The most commonly found genotype in nosocomial infection was G9P[8], in 23 cases (66%), followed by G1P[8] in 4 cases (11%). The total economic cost was 883 euro per case. CONCLUSION: Active surveillance demonstrated that the burden of nosocomial rotavirus disease is substantial, and G9P [8] was the genotype found most frequently. Following up children after discharge from hospital allowed the discovery of cases of nosocomial RVAGE which are missed in most other studies.