Surveillance Of Adverse Events Research Articles

Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev®) in South Korea, 2015-2019.

IntroductionThe live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV; Imojev®) has been approved in South Korea for use in subjects aged ≥ 12 months since 2015. As part of the license agreement, a post-marketing surveillance study was undertaken to actively monitor the safety profile of JE-CV in the Korean population.MethodsAn observational, active safety surveillance study was conducted from 3 April 2015 through to 2 April 2019 at 12 centers in South Korea. Subjects aged ≥ 12 months who received a single dose of JE-CV (primary or booster) during a routine healthcare visit were recruited and followed up for solicited reactions (7 and 14 days for injection site and systemic reactions, respectively), non-serious unsolicited adverse events and serious adverse events within 42 days after vaccination.ResultsOverall, 810 subjects who received JE-CV were included in our analysis, the majority received the vaccine as a primary vaccination (94.9%; 769/810). There were 179 solicited reactions reported by 111 subjects; the majority of solicited reactions occurred within 0–3 days (80.4%; 144/179), were of 1–3 days’ duration (79.3%; 142/179) and of grade 1 intensity (70.9%; 127/179). There were three grade 3 adverse reactions (irritability, pyrexia and malaise); all resolved within a few days. The incidence of solicited reactions were highest in those aged 12 to < 24 months (34.7% [52/150] subjects; 107 events) and 2 to < 10 years (17.8% [8/45] subjects; 14 events). All unsolicited adverse events (serious and non-serious) were unrelated to vaccination. There were no discontinuations due to adverse reactions/events.ConclusionJE-CV has a good safety profile under practice conditions in South Korea. No new safety issues were identified.Trial registrationClinicalTrials.gov identifier, NCT02933710Electronic supplementary materialThe online version of this article (10.1007/s40121-020-00305-6) contains supplementary material, which is available to authorized users.

Hospital Adverse Event Reporting Systems: A Systematic Scoping Review of Qualitative and Quantitative Evidence.

Reducing the incidence of reportable events with undesirable effects (REUE) is a priority in the hospital environment, which is why reporting systems have been implemented to identify and manage them. Information is required regarding the performance of reporting systems, barriers, or facilitators for reporting and strategies that improve passive reporting. Systematic scoping review of the literature that included studies performed in the population exposed to the occurrence of REUE in the health system (teams, patients, and family). A search was performed in Cochrane Database of Systematic Reviews, Epistemonikos, MEDLINE (PubMed), MEDLINE In-Process and MEDLINE Daily Update, EMBASE, LILACS, and databases of the World Health Organization and Pan-American Health Organization. Fifteen studies were found, 1 systematic review, 2 clinical trials, 8 observational studies, 3 qualitative studies, and 1 mixed study. In 4 of them, the effectiveness of active versus passive reporting systems was compared. The measures to improve the passive systems were education about REUE, simplification of the reporting format, activities focused on increasing the motivation for self-report, adoption of self-report as an obligatory institutional policy, and using specific report formats for each service. There is information that allows to find differences between the performance of the active and passive reporting systems. The reviewed research articles found that passive techniques significantly underreported adverse events. It is recommended that institutions adopt both active and passive techniques in adverse event surveillance. New studies should be directed to answer the comparative efficiency of the reporting systems.

Subcutaneous nodules following immunization in children; in Victoria, Australia from 2007 to 2016

BackgroundSubcutaneous nodules are a rare adverse event following immunization (AEFI). We aimed to describe nodules at the injection site reported to SAEFVIC (Surveillance of Adverse Events Following Vaccination in the Community) using the Brighton Collaboration Case Definition (BCCD), management and recurrence following subsequent immunizations. MethodWe assessed 58 cases (<18 years of age) of ‘nodule at injection site’ reported to SAEFVIC, Melbourne, Australia, between May 2007 and June 2016. Case details were analyzed from records and phone interview follow-up. The Australian Immunization Registry was reviewed for immunization status. Results71% (41/58 reported cases) were consistent with the BCCD for subcutaneous nodule, 14% (8 cases) were ‘possible subcutaneous nodules’, 10% (6 cases) were nodules associated with BCG immunization and 5% (3 cases) were attributable to an alternative diagnosis. The median age at immunization was 12 months, (range 1 month–12 years); 54% male (22/41 cases). 17% (7 cases) had multiple nodules. Nodules were associated with immunizations containing aluminum (74%, 36/49 nodules), no aluminum (8%, 4 nodules) and unknown (18%, 9 nodules). Most cases developed symptoms within 3 days post-immunization (59%, 24 cases) and in the thigh (59%, 29 nodules). Pruritus was associated in 41% (17 cases). Around 1/3 (34%) of nodules resolved 6 months post immunization, 2/3 (68%) by 12 months, however 1/4 (24%) remained persistent for >24 months. 5 cases had prior nodules and 1 case had recurrence with subsequent immunization. 83% (34 cases) were fully immunized for age at follow-up. ConclusionSubcutaneous nodules at the injection site may occur following a wide range of vaccines, including vaccines without aluminum. All cases require careful review and where possible, specialist management and to support subsequent immunizations.

Post-marketing surveillance of adverse events following measles, mumps, rubella and varicella (MMRV) vaccine: retrospecive study in apulia region (ITALY), 2009-2017

ABSTRACT Since 2006, some Italian Regions introduced the active offer of measles, mumps, rubella, and varicella (MMRV) vaccine for all newborns during the second years of life. In 2011, Italian Drug Authority (AIFA) recommended the discontinuation of the MMRV use for an increased risk of febrile seizures following vaccination; furthermore, some Regions (such as Apulia, that introduced MMRV offer in 2009) chose to continue the use of MMRV and Ministry of Health recommended to guarantee supplemental monitoring of safety of the vaccine. In Italy, the surveillance of Adverse Events following immunization (AEFIs) is currently carried out by AIFA and Regional Health Authorities; this paper aims to summarize the results of MMRV-vaccine surveillance of AEFIs program carried out in Apulia. From the AIFA database, we selected MMRV AEFIs that occurred in Apulia (about 4,000,000 inhabitants) from 2009 to 2017. For serious AEFIs, we applied the WHO causality assessment algorithm, using for cases hospitalized information from individual medical records. In the 8 years of observation, 155 MMRV-AEFIs (reporting rate: 37.9×100,000 doses) occurred of which 26 were classified as serious (6.3×100,000 doses) and 22 led to hospitalization. Performing causality assessment, for 10 the classification was “consistent causal association to immunization” (reporting rate: 2.4×100000 doses), for 2 indeterminate, for 13 “inconsistent causal association to immunization” and for 1 not-classifiable. No case of febrile seizure resulted consistent to vaccination. All consistent serious AEFIs were completely resolved at subsequent follow-up.

Surveillance of adverse events following immunisation in Australia: annual report, 2018.

This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2018 reported to the Therapeutic Goods Administration and describes reporting trends over the 19-year period 1 January 2000 to 31 December 2018. There were 4221 AEFI records for vaccines administered in 2018, an annual AEFI reporting rate of 16.9 per 100,000 population. There was a 2.9% increase in the overall AEFI reporting rate in 2018 compared to 2017. This slight increase in reported adverse events in 2018 was likely due to new additions to the National Immunisation Program schedule, namely meningococcal ACWY vaccination for children aged 12 months, enhanced immunogenicity trivalent influenza vaccines for adults aged ≥65 years, and state- and territory-funded seasonal influenza vaccination programs for children aged 6 months to <5 years. AEFI reporting rates for most individual vaccines in 2018 were similar to 2017. The most commonly reported adverse events were injection site reaction (34%), pyrexia (15%), rash (15%), vomiting (8%), headache (6%) and pain (6%). Two deaths were reported to the TGA but no clear causal relationship with vaccination was found.

Chlorhexidine Gluconate Utilization for Infection Prevention in the NICU: A Survey of Current Practice.

Central-line-associated bloodstream infection (CLABSI) contributes to significant morbidity and mortality in the neonatal intensive care unit (NICU). Disinfection of skin is part of bundled cares aimed at prevention of CLABSI. While considered an essential component of insertion and maintenance bundles, the optimal solution to disinfect neonatal skin remains controversial. The purpose of this project was to survey neonatal nurse practitioners and nursing leaders across NICUs regarding the current use of chlorhexidine gluconate (CHG) in term and preterm infants. This descriptive study involved the collection of survey data to determine NICU practices related to the use of CHG in their infant population. The sample was composed of nursing directors of NICUs and neonatal nurse practitioners who completed an electronic survey via a provided link. Chlorhexidine was reported to be used in 53 (82.81%) of the NICUs and was the primary agent used to prepare the skin for central vascular catheter insertion (53.23%) followed by povidone-iodine (45.16%), and 70% isopropyl alcohol (1.61%). Gestational age or birth weight restrictions for CHG use were reported in 43 (82.69%) NICUs. Trends in the data demonstrated nursing's role in using CHG in the NICU. Adverse events reported from CHG included burns, redness, dermatitis, and other irritations. Concerns included risk of absorption, burns, skin irritation, lack of evidence, and overall safety. Systematic monitoring by nurse leaders is needed to identify evidence related to skin disinfection and CHG in neonates. Targeted education for nursing staff related to directed to developmental maturation of the skin, safe use of CHG, review of best evidence, rationale for usage of CHG, and potential iatrogenic effects is recommended. Research is needed to evaluate the impact of educational offerings and surveillance for adverse events on CLABSI rates.

Timeliness of signal detection for adverse events following influenza vaccination in young children: a simulation case study

ObjectivesTo determine how soon after commencement of the seasonal influenza vaccination programme, the AusVaxSafety active vaccine safety surveillance system, currently in use across Australia, would have detected a safety signal...

Surveillance of adverse events following immunization in the late 2010s: an overview of the importance, tools, and challenges.

Immunization is one of the most effective measures to protect individuals and the population against vaccine-preventable diseases. Vaccines are safe and effective products, but like any other drug they can cause adverse events, which tend to become more visible as the diseases are controlled, eliminated, or eradicated. This study analyzed activities in the surveillance of adverse events following immunization (AEFI) based on data from the scientific literature, websites of immunization programs and health andregulatory agencies, and the authors' expertise in the areas of immunizations and pharmacovigilance. With the increase in the number of vaccines in the basic immunization schedule and expansion of the population's access, it has become essential to establish an efficient surveillance system for AEFI in Brazil. However, underreporting of cases in Brazil and in other countries hinders the detection of AEFI, especially rare events. Constantly updated information on vaccines' risks and benefits allows immunization programs to provide rapid and clear responses to rumors of AEFI. This ensures the system's reliability, especially in the face of the growing antivaccine movement and the increasing influence of social media in public opinion.

Updates on Vaccine Safety and Post-Licensure Surveillance for Adverse Events Following Immunization in South Korea, 2005-2017.

PurposeVaccine hesitancy is among the top ten threats to global health, and access to precise data on adverse events following immunization (AEFIs) is imperative to alleviate public concerns surrounding vaccines. This study aimed to present the overall trends of AEFIs reported in South Korea.Materials and MethodsWe evaluated the trends of AEFIs using the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System database between January 2005 and December 2017. AEFIs were classified into five categories to evaluate associations between vaccines and AEFIs through a case-non-case study: neurologic reactions, general systemic reactions, local reactions, allergic reactions, and others.ResultsAmong 54378 reported adverse events (AEs) associated with all vaccines approved in South Korea, more than half (56.7%) occurred following influenza vaccination, followed by the pneumococcal (11.6%) and Bacillus Calmette-Guérin (BCG) vaccines (5.0%). After immunization with most vaccines, general systemic reactions were most common, followed by local and neurologic reactions. Adjusted reporting odds ratios were calculated for all neurologic, general, local, and allergic reactions: of all vaccines, rotavirus [neurologic 2.43, 95% confidence interval (CI), 2.25–2.62], BCG (general; 2.20, 95% CI, 1.91–2.53), BCG (local; 3.15, 95% CI, 2.69–3.68), and Japanese encephalitis (allergic 2.38, 95% CI, 1.98–2.87) vaccines showed the highest values.ConclusionThe majority of reported AEFIs were non-serious and mostly general systemic reactions. Sufficient knowledge on the AEFIs would secure public confidence on the safety of vaccines, thereby reducing public health burden from vaccine-preventable diseases.

Use of an electronic system in the surveillance of adverse events following immunization (AEFI) in Sri Lanka: a pilot study

The Sri Lanka Journal of Bio-Medical Informatics (SLJBMI) is the official journal publication of the Health Informatics Society of Sri Lanka. It is the only academic publication in Sri Lanka which focuses on the emerging field of health informatics. SLJBMI was launched in 2010 as an open access and peer reviewed e-journal. It was temporarily paused publishing since June 2015 and relaunched in 2019 with an improved reader friendly format .The mission of SLJBMI is to publish high-quality original research and other relevant publications that would contribute to the promotion of digital health and health informatics. It aspires to be the most prominent publishing spotlight related to health informatics in the region and to be the gathering platform of the renowned experts and enthusiasts worldwide.

Near Real-Time Surveillance to Assess the Safety of the 9-Valent Human Papillomavirus Vaccine.

Human papillomavirus is the most common sexually transmitted infection in the United States and causes certain anogenital and oropharyngeal cancers. The 9-valent human papillomavirus vaccine (9vHPV) provides protection against additional types not included in the quadrivalent vaccine. We conducted near real-time vaccine safety surveillance for 24 months after the vaccine became available in the Vaccine Safety Datalink. Immunizations and adverse events were extracted weekly from October 2015 to October 2017 from standardized data files for persons 9 to 26 years old at 6 Vaccine Safety Datalink sites. Prespecified adverse events included anaphylaxis, allergic reaction, appendicitis, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, injection site reaction, pancreatitis, seizure, stroke, syncope, and venous thromboembolism. The observed and expected numbers of events after 9vHPV were compared weekly by using sequential methods. Both historical and concurrent comparison groups were used to identify statistical signals for adverse events. Unexpected signals were investigated by medical record review and/or additional analyses. During 105 weeks of surveillance, 838 991 doses of 9vHPV were administered. We identified unexpected statistical signals for 4 adverse events: appendicitis among boys 9 to 17 years old after dose 3; pancreatitis among men 18 to 26 years old; and allergic reactions among girls 9 to 17 years old and women 18 to 26 years old after dose 2. On further evaluation, which included medical record review, temporal scan analysis, and additional epidemiological analyses, we did not confirm signals for any adverse events. After 2 years of near real-time surveillance of 9vHPV and several prespecified adverse events, no new safety concerns were identified.

An Introduction of the Active Vaccine Safety Surveillance System in Foreign Countries

Vaccines require higher safety standards than most other medicinal products because they are given to healthy individuals, including infants, children, and elderly. Despite various activities by national agencies, public concern about vaccine safety often arises. Post-marketing activities for vaccine safety can be broadly classified into passive and active surveillances. Many countries as well as Korea operate passive vaccine safety surveillance systems that report adverse events related to vaccines. However, the active surveillance systems operate only in several countries, such as the United States of America (USA), Europe, Canada and Australia. In the US, Vaccine Safety Datalink (VSD) and Post-Licensure Rapid Immunization Safety Monitoring (PRISM) were developed in 1990 and 2009 respectively for monitoring vaccine actively. In the case of Europe, the Vaccine Adverse Event Surveillance and Communication (VAESCO) consortium was launched in 2008. After the end of VAESCO, the Accelerated Development of VAccine beNefit-risk Collaboration in Europe (ADVANCE) was organized to establish a vaccine benefit-risk monitoring framework in 2013. Canada has been operating a vaccine active monitoring system known as the Canadian Immunization Monitoring Program, ACTive (IMPACT) since 1991. The objective of this review was to describe and compare background, databases, and analysis systems of various vaccine active surveillance systems in the US, Europe, and Canada. We described the examples of studies on the safety of influenza A (H1N1) vaccines carried out in each system. This review could help provide directions for the future development of the ideal active vaccine safety surveillance system in Korea. Key words: Vaccine, Safety, Active vaccine surveillance system, Database, H1N1 influenza virus vaccine

PCN149 COST-EFFECTIVENESS ANALYSIS OF DABRAFENIB+TRAMETINIB VERSUS WATCHFUL WAITING IN THE ADJUVANT TREATMENT OF PATIENTS WITH RESECTED BRAF V600 POSITIVE STAGE III MELANOMA : A FRENCH PERSPECTIVE

A cost-effectiveness model was developed to estimate the ICER of dabrafenib+trametinib (D+T) compared to watchful waiting (WW) in BRAF+ adjuvant melanoma, from a French healthcare perspective. Methods were based on HAS guidelines and international good research practices for modelling. A non-homogeneous semi-Markov cohort model was used with states defined on recurrence and death, including: Relapse-free survival (RFS), locoregional recurrence, distant recurrence (1st line and 2nd line) and death. A lifetime horizon was used, from treatment initiation. Marginal parametric distributions were fitted on individual data from the COMBI-AD trial to extrapolate time spent in each health state. Distributions were distinguished between therapeutic classes for 1st line distant melanoma. Overall survival was corrected with general population mortality for locoregional melanoma and long-term survivors with distant melanoma. Health-state utilities were estimated using EQ-5D data from COMBI-AD. Resource utilization and costs included drug acquisition and administration, routine surveillance and management of adverse events, melanoma recurrences and end-of-life. In the COMBI-AD trial and after extrapolation, D+T showed significant advantage in reducing the risk of recurrence vs. WW (respectively 47% and 56% of patients developed a distant melanoma over lifetime). D+T was associated with lower costs (Δ=-20,140€) and higher QALYs (Δ=+1.68) than WW. Deterministic and probabilistic sensitivity analyses showed consistency with base case findings. Results were mainly sensitive to variations in extrapolation of the RFS and therapeutic patterns defined for each arm in metastatic setting. D+T represents a clinically significant advancement for adjuvant treatment of resected BRAF V600 mutation-positive high-risk stage III melanoma. D+T dominates WW with gains in QALYs and a lower cost. New melanoma adjuvant treatments including immune checkpoint inhibitors have shown great results vs. WW by delaying recurrences and increasing the proportion of patients cured. The relative positioning of these new strategies still needs to be defined.

Participant-Centered Online Active Surveillance for Adverse Events Following Vaccination in a Large Clinical Trial: Feasibility and Usability Study.

BackgroundActive participant monitoring of adverse events following immunization (AEFI) is a recent development to improve the speed and transparency of vaccine safety postmarketing. Vaxtracker, an online tool used to monitor vaccine safety, has successfully demonstrated its usefulness in postmarketing surveillance of newly introduced childhood vaccines. However, its use in older participants, or for monitoring patients participating in large clinical trials, has not been evaluated.ObjectiveThe objective of this study was to monitor AEFIs in older participants enrolled in the Australian Study for the Prevention through the Immunisation of Cardiovascular Events (AUSPICE) trial, and to evaluate the usefulness and effectiveness of Vaxtracker in this research setting.MethodsAUSPICE is a multicenter, randomized, placebo-controlled, double-blinded trial in which participants aged 55 to 61 years were given either the pneumococcal polysaccharide vaccine (23vPPV) or 0.9% saline placebo. Vaxtracker was used to monitor AEFIs in participants in either treatment arm through the administration of two online questionnaires. A link to each questionnaire was sent to participants via email or short message service (SMS) text message 7 and 28 days following vaccination. Data were collated and analyzed in near-real time to identify any possible safety signals indicating problems with the vaccine or placebo.ResultsAll 4725 AUSPICE participants were enrolled in Vaxtracker. Participant response rates for the first and final survey were 96.47% (n=4558) and 96.65% (n=4525), respectively. The online survey was completed by 90.23% (4083/4525) of Vaxtracker participants within 3 days of receiving the link. AEFIs were reported by 34.40% (805/2340) of 23vPPV recipients and 10.29% (240/2332) of placebo recipients in the 7 days following vaccination. Dominant symptoms for vaccine and placebo recipients were pain at the injection site (587/2340, 25.09%) and fatigue (103/2332, 4.42%), respectively. Females were more likely to report symptoms following vaccination with 23vPPV compared with males (433/1138, 38.05% versus 372/1202, 30.95%; P<.001).ConclusionsVaxtracker is an effective tool for monitoring AEFIs in the 55 to 61 years age group. Participant response rates were high for both surveys, in both treatment arms and for each method of sending the survey. This study indicates that administration of 23vPPV was well-tolerated in this cohort. Vaxtracker has successfully demonstrated its application in the monitoring of adverse events in near-real time following vaccination in people participating in a national clinical trial.Trial RegistrationAustralian New Zealand Trial Registry Number (ACTRN) 12615000536561; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368506

Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report.

The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events.The aim of this prospective study was to evaluate the frequency and severity of adverse events to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new (i.e. bedaquiline, delamanid) and repurposed (i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1-2) and 57 (11.3%) as serious (grade 3-5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone.The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care.

Adverse Events Following Measles-Mumps-Rubella-Varicella Vaccination and the Case of Seizures: A Post Marketing Active Surveillance in Puglia Italian Region, 2017-2018.

Since 2012, the Italian Ministry of Health has recommended to improve the surveillance of adverse events following the measles-mumps-rubella-varicella (MMRV) tetravalent vaccine that was provided in the official immunization schedule of some Italian regions for children during the second year of life. This recommendation was based on data from some surveys that showed an additional risk of seizure following the administration of this vaccine. Responding to the Ministry commitment, the Puglia Region launched, from May 2017 to November 2018, a post-marketing active surveillance program of adverse events following MMRV immunization (AEFIs). Immunized children (second year of life) were enrolled on a voluntary basis, AEFIs diaries were used, and their parents were interviewed 25 days after the immunization. There were 2540 children enrolled; 2149/2540 (84.6%) completed the post-vaccination follow-up. Of these, 992 AEFIs were registered with a reporting rate of 46.2 × 100 doses: 883/992 (89.0%) AEFIs were not serious, while 109/992 (11.0%) were serious. For serious AEFIs, the evaluation of causality assessment was performed using the algorithm proposed by the World Health Organisation (WHO): 82/109 consistent causal associations to MMRV immunization were detected (reporting rate of consistent AEFIs: 3.8 × 100 follow-up). All serious AEFIs consistently associated with immunization resulted completely resolved at the follow-up. The reporting rate of seizure consistently associated with immunization was 0.05 × 100, lower than data previous published in the literature that did not report the causality assessment. Because no emerging signals were detected, our data from the active surveillance program confirmed the safety profile of the MMRV vaccine.

Rollout of ShangRing circumcision with active surveillance for adverse events and monitoring for uptake in Kenya.

Since 2011, Kenya has been evaluating ShangRing device for use in its voluntary medical male circumcision (VMMC) program according to World Health Organization (WHO) guidelines. Compared to conventional surgical circumcision, the ShangRing procedure is shorter, does not require suturing and gives better cosmetic outcomes. After a pilot evaluation of ShangRing in 2011, Kenya conducted an active surveillance for adverse events associated with its use from 2016-2018 to further assess its safety, uptake and to identify any operational bottlenecks to its widespread use based on data from a larger pool of procedures in routine health care settings. From December 2017 to August 2018, HIV-negative VMMC clients aged 13 years or older seeking VMMC at six sites across five counties in Kenya were offered ShangRing under injectable local anesthetic as an alternative to conventional surgical circumcision. Providers described both procedures to clients before letting them make a choice. Outcome measures recorded for clients who chose ShangRing included the proportions who were clinically eligible, had successful device placement, experienced adverse events (AEs), or failed to return for device removal. Clients failing to return for follow up were sought through phone calls, text messages or home visits to ensure removal and complete information on adverse events. Out of 3,692 eligible clients 1,079 (29.2%) chose ShangRing; of these, 11 (1.0%) were excluded due to ongoing clinical conditions, 17 (1.6%) underwent conventional surgery due to lack of appropriate device size at the time of the procedure, 97.3% (1051/1079) had ShangRing placement. Uptake of ShangRing varied from 11% to 97% across different sites. There was one severe AE, a failed ShangRing placement (0.1%) managed by conventional wound suturing, plus two moderate AEs (0.2%), post removal wound dehiscence and bleeding, that resolved without sequelae. The overall AE rate was 0.3%. All clients returned for device removal from fifth to eleventh day after placement. ShangRing circumcision is effective and safe in the Kenyan context but its uptake varies widely in different settings. It should be rolled out under programmatic implementation for eligible males to take advantage of its unique benefits and the freedom of choice beyond conventional surgical MMC. Public education on its availability and unique advantages is necessary to optimize its uptake and to actualize the benefit of its inclusion in VMMC programs.

Surveillance of adverse events following immunisation in Australia annual report, 2017

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2017 reported to the Therapeutic Goods Administration and describes reporting trends over the 18-year period 1 January 2000 to 31 December 2017. There were 3,878 AEFI records for vaccines administered in 2017; an annual AEFI reporting rate of 15.8 per 100,000 population. There was a 12% increase in the overall AEFI reporting rate in 2017 compared with 2016. This increase in reported adverse events in 2017 compared to the previous year was likely due to the introduction of the zoster vaccine (Zostavax®) provided free for people aged 70–79 years under the National Immunisation Program (NIP) and also the state- and territory-based meningococcal ACWY conjugate vaccination programs. AEFI reporting rates for most other individual vaccines in 2017 were similar to 2016. The most commonly reported reactions were injection site reaction (34%), pyrexia (17%), rash (15%), vomiting (8%) and pain (7%). The majority of AEFI reports (88%) described non-serious events. Two deaths were reported that were determined to have a causal relationship with vaccination; they occurred in immunocompromised people contraindicated to receive the vaccines.

Immunization Campaigns and Strategies against Human Papillomavirus in Italy: The Results of a Survey to Regional and Local Health Units Representatives.

Objective. The study aimed to assess the impact of HPV immunization campaigns organizational aspects, the characteristics of immunization program (vaccination targets and type of offer), and communicative strategies adopted by four Italian administrative regions on vaccination coverage observed. Methods. From November 2017 to March 2018, regional and Local Health Units (LHUs) representatives were invited to complete an online survey including 54 questions evaluating vaccination invite systems, access systems to vaccination centres, reminder and recall systems, and adverse events surveillance. An overall descriptive analysis was conducted. Since observed vaccine coverage (VC) obtained in females (2002-2004 birth cohorts) was lower than objectives fixed by the Italian Ministry of Health, variables were assessed using the national VC mean obtained in the 2003 girls birth cohort as outcome. Results. Twenty-six LHUs belonging to 4 Northern and Southern Italian regions participated in the study. Organizational aspects significantly related to VC lower than the national mean were access to vaccine centres without appointment and parents' reservation as appointment planning system. Recall systems for both the first and the second dose, including the appointment in the invitation letter, the availability of regional immunization registry, and education of healthcare workers on universal HPV immunization strategies, instead, were related to higher VC. As regards preadolescent immunization strategies, both VC obtained in girls and boys were far from the Ministerial goals. Only 20% of LHUs introduced multicohort female strategies while all LHUs adopted copayment targeting both men and women. Immunizations strategies targeting subjects at risk were implemented only in half of participating LHUs. Conclusions. VC observed in participating LHUs are largely lower than the national objectives in all anti-HPV vaccine targets. Both organizational and educational strategies have to be implemented to improve the VC goals.

Study of a multisite prospective adverse event surveillance system

BackgroundWe have designed a prospective adverse event (AE) surveillance method. We performed this study to evaluate this method’s performance in several hospitals simultaneously.ObjectivesTo compare AE rates obtained by prospective AE...