Karina A. Top

The impact of the meningococcal serogroup C conjugate vaccine in Canada between 2002 and 2012

BACKGROUND Before 2001, the incidence of invasive meningococcal disease (IMD) in Canada was 1.0 per 100 000 per year, with 40% of cases caused by serogroup C organisms. During 2001-2005 all provinces introduced the meningococcal serogroup C conjugate vaccine (MCCV) into their routine infant immunization schedule. METHODS Active, prospective, population-based surveillance of IMD in children and adults was conducted by the Canadian Immunization Monitoring Program, ACTive (IMPACT) during 2002-2012. Inclusion criteria were admission to hospital and identification of Neisseria meningitidis from a sterile site. Incidence was estimated using population census data from Statistics Canada. RESULTS Prior to MCCV introduction, serogroup C disease incidence was 0.07-0.25 per 100 000 per year depending on the province. Following vaccine introduction, serogroup C disease decreased to <0.05 per 100 000 per year, with a reduction of 14% per year (P = .0014). A decrease occurred in all provinces, despite differing schedules being implemented. The largest decrease of 83% (from 0.27 to 0.05 per 100 000 per year) occurred in the 15-24 year age group (P = .0100) who were not vaccinated in all provinces. There was no impact on the incidence of nonserogroup C disease over the same period (P = .9811). CONCLUSIONS MCCV dramatically reduced the incidence of serogroup C IMD in Canada through both direct and indirect effects. The observation that disease incidence decreased with different schedules suggests that the doses at 12 months (common to all provinces) and adolescence (7 of 8 provinces studied) were critical in achieving disease control.

Vasculitis as an adverse event following immunization - Systematic literature review.

BACKGROUND Several types of vasculitis have been observed and reported in temporal association with the administration of various vaccines. A systematic review of current evidence is lacking. OBJECTIVE This systematic literature review aimed to assess available evidence and current reporting practice of vasculitides as adverse events following immunization (AEFI). METHODS We reviewed the literature from 1st January 1994 to 30th June 2014. This review comprises randomized controlled trials, observational studies, case series, case reports, reviews and comments regardless of vaccine and target population. RESULTS The initial search resulted in the identification of 6656 articles. Of these, 157 articles were assessed for eligibility and 75 studies were considered for analysis, including 6 retrospective/observational studies, 2 randomized controlled trials, 7 reviews, 11 case series, 46 case reports and 3 comments. Most of the larger, higher quality studies found no causal association between vaccination and subsequent development of vasculitis, including several studies on Kawasaki disease and Henoch-Schönlein purpura (IgA vasculitis). Smaller case series reported a few cases of vasculitis following BCG and vaccines against influenza and hepatitis. Only 24% of the articles reported using a case definition of vasculitis. CONCLUSIONS Existing literature does not allow establishing a causative link between vaccination and vasculitides. Further investigations were strengthened by the use of standardized case definitions and methods for data collection, analysis and presentation to improve data comparability and interpretation of vasculitis cases following immunization.

Neonatal infections: case definition and guidelines for data collection, analysis, and presentation of immunisation safety data.

Maternal vaccination is an important area of research and requires appropriate and internationally comparable definitions and safety standards. The GAIA group, part of the Brighton Collaboration was created with the mandate of proposing standardised definitions applicable to maternal vaccine research. This study proposes international definitions for neonatal infections. The neonatal infections GAIA working group performed a literature review using Medline, EMBASE and the Cochrane collaboration and collected definitions in use in neonatal and public health networks. The common criteria derived from the extensive search formed the basis for a consensus process that resulted in three separate definitions for neonatal blood stream infections (BSI), meningitis and lower respiratory tract infections (LRTI). For each definition three levels of evidence are proposed to ensure the applicability of the definitions to different settings. Recommendations about data collection, analysis and presentation are presented and harmonized with the Brighton Collaboration and GAIA format and other existing international standards for study reporting.

Risk of Recurrence of Adverse Events Following Immunization: A Systematic Review

This systematic review presents the risk of recurrence of AEFIs in patients who receive subsequent doses of vaccine. CONTEXT: Reimmunizing patients who had an adverse event following immunization (AEFI) is sometimes a challenge because there are limited data on the risk and severity of AEFI recurrence. OBJECTIVE: To summarize the literature on the risk of AEFI recurrence. DATA SOURCES: PubMed, Embase, and Cochrane library. STUDY SELECTION: We included articles in English or French published before September 30, 2016. Articles were selected if they estimated the risk of AEFI recurrence in at least 5 individuals. Studies with experimental vaccines were excluded. DATA EXTRACTION: Data on study design, setting, population, vaccines, and AEFI recurrence were extracted. RESULTS: Twenty-nine articles were included. Among patients with a history of hypotonic hyporesponsive episode (n = 398), anaphylaxis (n = 133), or seizures (n = 60) who were reimmunized, events recurred in 0% to 0.8%. Allergic-like events recurred in 30 of 594 reimmunized patients. Fever recurred in 0% to 84% of 836 reimmunized patients, depending on the vaccine and dose number. Among children with extensive limb swelling after the fourth dose of diphtheria-tetanus-acellular pertussis vaccine, recurrence was higher when the fifth dose was given withthe full-antigen formulation (78%) compared with the reduced-antigen formulation (53%, P = .02) LIMITATIONS: Many studies, included few patients, and those with severe AEFIs were often not reimmunized. CONCLUSIONS: Despite vaccines being administered to millions of people annually, there are few studies in which researchers evaluated AEFI recurrence. Published studies suggest that reimmunization is usually safe. However in these studies, severe cases were often not reimmunized.

Kawasaki disease and immunisation: Standardised case definition & guidelines for data collection, analysis

http://dx.doi.org/10.1016/j.vaccine.2016.09.025 0264-410X/ 2016 Published by Elsevier Ltd. Abbreviations: ADR, adverse drug reaction; AHA, American Heart Association; ALT, alanine transaminase; AST, aspartate transaminase; BCG, Bacillus Calmette (vaccine); CAAs, coronary artery aneurysms; CMRA, cardiac magnetic resonance angiography; CRP, C-reactive protein; DTP, diphtheria, tetanus, pertussis diphtheriatetanus, acellular pertussis; EBV, Epstein Barr Virus; ESR, erythrocyte sedimentation rate; GGT, gamma glutamyl transferase; HHV, human herpes vi Haemophilus influenza type b; HPF, high powered field; HSP, heat shock protein; IVIG, intravenous gamma globulin; JMoH, Japanese Ministry of Health; KD, Kawasaki LAD, left anterior descending; LV, left ventricular; MRI, magnetic resonance imaging; MSCT, multi, slice computed tomography; PAN, polyarteritis nodosa; PCV, pneum conjugate vaccine; PCR, polymerase chain reaction; RCA, right coronary artery; RMSF, Rocky Mountain Spotted Fever; RTPE,, recurrent toxin, mediated perineal er sJIA, systemic juvenile idiopathic arthritis; SPECT, single photon emission computed tomography; TSS, toxic shock syndrome; TST, tuberculin skin test; WBC, wh cells. ⇑ Corresponding author at: The Brighton Collaboration Foundation, c/o Universitäts-Kinderspital beider Basel, Spitalstrasse 33, 4056 Basel, Switzerland. E-mail address: contact@brightoncollaboration.org (J. Bonhoeffer). 1 Brighton Collaboration homepage: http://www.brightoncollaboration.org.

Effect of package insert language on health-care providers' perceptions of influenza vaccination safety during pregnancy

www.thelancet.com/lancetgh Vol 4 October 2016 e690 We enrolled 141 maternal healthcare providers from 49 countries in all six WHO regions; 105 (74%) respondents were from low-income and middle-income countries (LMICs). 24 (17%) participants were recruited from the teaching programmes Eff ect of package insert language on health-care providers’ perceptions of infl uenza vaccination safety during pregnancy

Adverse event following immunization surveillance systems for pregnant women and their infants: a systematic review

The World Health Organizations Strategic Advisory Group of Experts on Immunization has declared that maternal immunization is a key priority. Robust adverse event following immunization (AEFI) surveillance systems that capture outcomes in pregnant women and their infants are needed to ensure the safety of maternal immunization programs. We sought to identify the active and passive AEFI surveillance systems for pregnant women and their offspring described in the literature.

Immunizing Patients With Adverse Events After Immunization and Potential Contraindications to Immunization: A Report From the Special Immunization Clinics Network.

Background: For patients who have experienced adverse events following immunization (AEFI) or who have specific medical conditions, there is limited evidence regarding the best approach to immunization. The Special Immunization Clinics (SICs) Network was established to standardize patient management and assess outcomes after reimmunization. The study objective was to describe the first 2 years of the network’s implementation. Methods: Twelve SICs were established across Canada by infectious diseases specialists and allergists. Inclusion criteria were as follows: local reaction ≥ 10 cm, allergic symptoms < 24 hours postimmunization, neurologic symptoms and other AEFI or medical conditions of concern. Eligible patients underwent a standardized evaluation, causality assessment was performed, immunization recommendations were made by expert physicians and patients were followed up to capture AEFI. After individual consent, data were transferred to a central database for analysis. Results: From June 2013 to May 2015, 151 patients were enrolled. Most were referred for prior AEFI (132/151, 87%): 42 (32%) for allergic-like reactions, 31 (23%) for injection-site reactions, 20 (15%) for neurologic symptoms and 39 (30%) for other systemic symptoms. Nineteen patients (13%) were seen for underlying conditions that complicated immunization. Reimmunization was recommended for 109 patients, 60 of whom (55%) were immunized and followed up. Eleven patients (18%) experienced recurrence of their AEFI; none were serious (eg, resulting in hospitalization, permanent disability or death). Conclusions: The most frequent reasons for referral to a SIC were allergic-like events and injection site reactions. Reimmunization was safe in most patients. Larger studies are needed to determine outcomes for specific types of AEFI.

Kawasaki disease and immunisation: A systematic review.

BACKGROUND Kawasaki disease is a complex and potentially serious condition. It has been observed in temporal relation to immunisation. METHODS We conducted a systematic literature review using various reference sources to review the available evidence published in the literature. RESULTS We identified twenty seven publications reporting a temporal association between immunisation and Kawasaki disease. We present a systematic review of data drawn from randomised controlled trials, observational studies, case series and reports, and reviews. Overall there was a lack of standardised case definitions, making data interpretation and comparability challenging. CONCLUSIONS Although a temporal relationship between immunisation and Kawasaki disease is suggested, evidence for an increased risk or a causal association is lacking. Implementation of a standardised Kawasaki disease case definition would increase confidence in the findings and add value to future studies of pre- or post-licensure vaccine safety studies.

Immunization practices in acute lymphocytic leukemia and post-hematopoietic stem cell transplant in Canadian Pediatric Hematology/Oncology centers

ABSTRACT There are no Canadian immunization guidelines for children treated for malignancy. Guidelines do exist for patients who underwent hematopoietic stem cell transplant (HSCT), but they provide broad timeframes for initiating vaccination; there is no standard schedule. The optimal approach to immunization in these populations is unclear. We sought to describe immunization practices at Canadian Pediatric Hematology/Oncology centers. A 43-item online questionnaire was distributed to the 16 programs in the C17 research network of pediatric hematology/oncology centers to capture information on timing and criteria for immunization of patients with acute lymphocytic leukemia (ALL) and those who have undergone HSCT. At each center, 1–2 physicians or pharmacists completed the survey to reflect center-wide immunization practices. Responses were received from 11/16 (69%) programs; 11 respondents reported on practices for patients with ALL and 9 reported on practices for patients who are post-HSCT. In 5/11 ALL programs (45%) re-immunization is recommended routinely after chemotherapy, starting 3–6 months post-chemotherapy. In HSCT programs, timing of pneumococcal conjugate vaccination (PCV) varied from 3 months post-HSCT (4 programs) to 12 months post-HSCT (4 programs). Live vaccines were administered 24 months post-HSCT in 8/9 programs. All HSCT programs considered graft-versus-host-disease and 7 considered discontinuation of immunosuppression in immunization decisions. Pediatric hematology/oncology programs were divided in regards to re-immunization of patients with ALL post-chemotherapy. After HSCT, timing of PCV administration varied, with 4 programs initiating immunization later than Canadian guidelines recommend (3–9 months post-HSCT). These findings suggest a need to standardize immunization practices in these populations.