scholarly journals Az új, csökkentett dózisú, hazai gyártású influenzavakcina (FluArt) forgalomba hozatalát követő első szezonjának biztonságossági vizsgálata

2017 ◽  
Vol 158 (49) ◽  
pp. 1953-1959
Author(s):  
Péter Vajó ◽  
Orsolya Gyurján ◽  
Ágnes Mira Szabó ◽  
László Kalabay ◽  
Zoltán Vajó ◽  
...  
Keyword(s):  
Adverse Events ◽  
Seasonal Influenza ◽  
Safety Data ◽  
Influenza Vaccines ◽  
European Medicines Agency ◽  
Fisher Exact Test ◽  
Exact Test ◽  
Reduced Dose ◽  
Safety Surveillance ◽  
Dose Vaccine

Abstract: Introduction: The currently licensed seasonal influenza vaccines contain split, subunit or whole virions, typically in amounts of 15 µg hemagglutinin per virus strain for adult and up to 60 µg in elderly patients. Aim: The present study reports safety data of the newly licensed, reduced dose vaccine with 6 µg of hemagglutinin per strain produced by Fluart (Hungary) after its first season on the market. The main objective of enhanced safety surveillance was to detect a potential increase in reactogenicity and allergic events that is intrinsic to the product in near real-time in the earliest vaccinated cohorts. Method: The study methods were based on the Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU by the European Medicines Agency. Statistics: We used the Fisher exact test with 95% confidence intervals. Results: We studied 587 patients and detected a total 24 adverse events, all of which have already been known during the licensing studies of the present vaccine. The frequencies of the adverse events were not different from what had been seen with the previously licensed 15 µg vaccine. Conclusions: Based on the results, the authors conclude that the new, reduced dose vaccine FluArt is safe and tolerable. Orv Hetil. 2017; 158(49): 1953–1959.

scholarly journals Real-time safety surveillance of seasonal influenza vaccines in children, Australia, 2015

2015 ◽  
Vol 20 (43) ◽  
Author(s):  
Alexis Pillsbury ◽  
Patrick Cashman ◽  
Alan Leeb ◽  
Annette Regan ◽  
Darren Westphal ◽  
...  
Keyword(s):  
Young Children ◽  
Adverse Events ◽  
Influenza Vaccine ◽  
Real Time ◽  
Surveillance System ◽  
Seasonal Influenza ◽  
Vaccine Safety ◽  
Influenza Vaccines ◽  
Safety Surveillance ◽  
Medical Attendance

Increased febrile reactions in Australian children from one influenza vaccine brand in 2010 diminished confidence in influenza immunisation, highlighting the need for improved vaccine safety surveillance. AusVaxSafety, a national vaccine safety surveillance system collected adverse events in young children for 2015 influenza vaccine brands in real time through parent/carer reports via SMS/email. Weekly cumulative data on 3,340 children demonstrated low rates of fever (4.4%) and medical attendance (1.1%). Fever was more frequent with concomitant vaccination.

scholarly journals Passive enhanced safety surveillance of GSK’s quadrivalent seasonal influenza vaccine in Belgium, Germany and Spain, an observational study: protocol for the 2018/2019 influenza season

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e028043 ◽  
Author(s):  
Gaël Dos Santos ◽  
Anne Yeakey ◽  
Vishvesh Shende ◽  
Katie Smith ◽  
Frederic Lin ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Influenza Vaccine ◽  
Study Protocol ◽  
Seasonal Influenza ◽  
Influenza Season ◽  
Age Groups ◽  
European Medicines Agency ◽  
Case Report Form ◽  
Safety Surveillance

IntroductionThe European Medicines Agency requires Marketing Authorisation Holders providing seasonal influenza vaccines in Europe to conduct enhanced safety surveillance accounting for the different age groups based on the vaccine indication, in order to detect any potential increase of local and systemic adverse reactions early in an influenza season. To comply with this requirement, a multicountry European passive enhanced safety surveillance study has been set up to capture and assess adverse events occurring within 7 days following seasonal influenza vaccination. Here we share our surveillance protocol for the 2018/2019 influenza season.MethodsNine healthcare professionals (HCPs) in Belgium, Germany and Spain have been recruited for this study. Cumulatively, approximately 1000 vaccinees will be provided with customised adverse event recording cards to report adverse events experienced within 7 days following vaccination with GSK’s split-virion inactivated quadrivalent influenza vaccine. The cards are to be returned to the HCPs and the events encoded using an electronic case report form. Adverse event reporting rates will be analysed weekly and cumulatively, throughout the study period. Event rates will be described by country, age group and by influenza morbidity/mortality risk status of vaccinees (based on HCP assessment).Ethics and disseminationEthics committee approval was obtained for all participating sites prior to enrolment of the study participants. At the end of the study, each participating site will receive their data, and the outputs from the research will be made available to regulatory authorities. We intend to seek publication in peer-reviewed journals. GSK has posted a summary of the study protocol before the start of the study and results will be posted within 12 months of statistical analysis completion, in line with the National Institutes of Health recommendations.Trial registration numberNCT03688620.

Comparative efficacy and safety of sorafenib in elderly versus non-elderly patients with advanced hepatocellular carcinoma (HCC) with varying liver dysfunction.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 430-430 ◽  
Author(s):  
Sukeshi Patel Arora ◽  
Norma S. Ketchum ◽  
Jonathan Gelfond ◽  
Joel Michalek ◽  
Devalingam Mahalingam
Keyword(s):  
Adverse Events ◽  
Age Groups ◽  
Safety Data ◽  
The Elderly ◽  
Rank Test ◽  
Advanced Hepatocellular Carcinoma ◽  
Efficacy And Safety ◽  
Exact Test ◽  
Advanced Hcc ◽  
Vein Thrombosis

430 Background: Sorafenib is the only FDA-approved systemic therapy for advanced HCC. The incidence of HCC increases with age, peaking above 70 years; however, we have limited efficacy and safety data in the elderly. Given the prevalence of HCC in South Texas, we assessed the efficacy and safety of sorafenib in the elderly. Methods: Retrospective analysis of HCC patients (pts) receiving sorafenib from 2008-2013. PFS and OS were estimated from Kaplan-Meier curves and groups were statistically compared with the log rank test. The magnitude of association between dichotomous factors and survival was estimated with the hazard ratio (HR). Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events version 4.0. Differences between age groups (65+, < 65) for dose reduction (yes, no), and AEs were analyzed using Fisher’s Exact Test. Results: A total of 118 pts were included. Median age 57 (range 41-93; 65+ 26%). males 81%. Hispanic 73%, Non-Hispanic White 24%. ECOG PS 0–1 93 %. Causes of cirrhosis: Hepatitis C 66%, Hepatitis B 4%, EtOH 58%. Portal vein thrombosis 36%, Extrahepatic disease 38%. Child-Pugh score: A 56%, B 44%. BCLC class: B 13%, C 87%. Among 113 pts 34% were started at 400 mg daily versus 66% started at 800 mg daily. mOS was 11.2 months (mo) (95% CI: 7.8-14.0), mPFS 5.2 mo (95% Cl: 3.9-7.1). In subgroup analysis, mOS for < 65 was 10.2 mo vs 13.5 mo for 65+ (HR 0.67, 95% CI: 0.39-1.16, p = 0.15). mPFS for < 65 was 4.6 mo vs 6.2 mo for 65+ (HR 0.92, 95% CI: 0.58-1.45, p = 0.71). Among 109 pts, dose reductions in < 65 vs 65+ were 64.6 vs 70% (P = 0.66); survival differences were not statistically significant. Among 75 pts there was a trend to improved survival in 65+ patients with AST/Platelet Ratio (APRI) < / = 1.68, but not statistically significant. Sorafenib was tolerated in the elderly. In regards to nausea, fatigue, diarrhea and hand foot syndrome, difference in toxicity was not statistically significant in < 65 versus 65+. Conclusions: In advanced HCC, elderly pts should be offered sorafenib, as it has efficacy and is tolerated in the elderly. Further prospective studies in the elderly are warranted, with evaluation of APRI as a prognostic marker.

scholarly journals Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: protocol of a pilot study in England

BMJ Open ◽  
2017 ◽  
Vol 7 (5) ◽  
pp. e015469 ◽  
Author(s):  
Simon de Lusignan ◽  
Gaël Dos Santos ◽  
Ana Correa ◽  
François Haguinet ◽  
Ivelina Yonova ◽  
...  
Keyword(s):  
Pilot Study ◽  
Seasonal Influenza ◽  
Influenza Vaccines ◽  
Safety Surveillance

scholarly journals Comparing the incidence of common adverse events of interest following influenza vaccination in the first season adjuvanted trivalent immunisation was introduced: English sentinel network annual report paper 2018/19 (Preprint)

2020 ◽  
Author(s):  
Simon de Lusignan ◽  
Ruby Tsang ◽  
Oluwafunmi Akinyemi ◽  
Jamie Lopez Bernal ◽  
Gayatri Amirthalingam ◽  
...  
Keyword(s):  
Adverse Events ◽  
Influenza Vaccine ◽  
Influenza Vaccination ◽  
Seasonal Influenza ◽  
Reference Group ◽  
Case Series ◽  
European Medicines Agency ◽  
Seasonal Effect ◽  
Sentinel Network ◽  
Relative Incidence

BACKGROUND Vaccination is the most effective form of prevention of seasonal influenza; the UK has a national influenza vaccination programme to cover targeted population groups. Influenza vaccines are known to be associated with some common minor adverse events of interest (AEIs), but it is not known if the adjuvanted trivalent influenza vaccine (aTIV, first offered in the 2018/19 season) would be associated with more AEIs than other types of vaccines. OBJECTIVE To determine the Relative Incidence (RI) of AEIs following seasonal influenza vaccination, and compare RIs between aTIV, quadrivalent influenza vaccine (QIV) and live attenuated influenza vaccine (LAIV). METHODS We carried out a retrospective cohort study using computerised medical record data from the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) sentinel network database. We extracted data on vaccine exposure and consultations for European Medicines Agency (EMA)-specified AEIs for the 2018/19 influenza season. We used a self-controlled case series design and computed relative incidence (RI) of AEIs following vaccination, and compared RI of AEIs associated with aTIV, QIV and LAIV. We also compared RI of AEIs for vaccinations that took place in a practice with those that took place elsewhere. RESULTS The majority of AEIs occurred within seven days following vaccination, with a seasonal effect observed. Using aTIV as the reference group, QIV was associated with a higher RI of AEIs (RI=1.46, 95% CI 1.41-1.52), whereas LAIV was associated with a lower RI of AEIs (RI=0.79, 95% CI 0.73-0.83). No effect of vaccination setting on RI of AEIs was observed. CONCLUSIONS Routine sentinel network data offer an opportunity to make comparisons between safety profiles of different vaccines. Evidence that supports the safety of newer types of vaccines may be reassuring for patients and could help improve uptake in the future.

scholarly journals Allergic adverse events following 2015 seasonal influenza vaccine, Victoria, Australia

2017 ◽  
Vol 22 (20) ◽  
Author(s):  
Hazel J Clothier ◽  
Nigel Crawford ◽  
Melissa A Russell ◽  
Jim P Buttery
Keyword(s):  
Adverse Events ◽  
Confidence Interval ◽  
Influenza Vaccine ◽  
Allergic Reaction ◽  
Seasonal Influenza ◽  
Vaccine Safety ◽  
Clinical Severity ◽  
Influenza Vaccines ◽  
Seasonal Influenza Vaccine ◽  
Initial Investigation

Australia was alerted to a possible increase in allergy-related adverse events following immunisation (AEFI) with 2015 seasonal trivalent influenza vaccines (TIV) by the Victorian state vaccine safety service, SAEFVIC. We describe SAEFVIC’s initial investigation and upon conclusion of the 2015 influenza vaccination programme, to define the signal event and implications for vaccine programmes. Allergy-related AEFI were defined as anaphylaxis, angioedema, urticaria or generalised allergic reaction. Investigations compared 2015 TIV AEFI reports to previous years as proportions and reporting risk (RR) per 100,000, stratified by influenza vaccine brand. The initial investigation showed an increased proportion of allergy-related AEFI compared with 2014 (25% vs 12%), predominantly in adults, with insufficient clinical severity to alter the programme risk-benefit. While overall TIV AEFI RR in 2015 was similar to previous years (RR: 1.07, 95% confidence interval (CI): 0.88–1.29), we identified a near-doubling RR for allergy-related AEFI in 2015 (RR: 1.78, 95% CI: 1.14­– 2.80) from 2011 to 2014 with no difference by vaccine brand or severity increase identified. This increase in generalised allergy-related AEFI, across all used vaccine brands, supports evidence of variable reactogenicity arising from influenza vaccine strain variations. This investigation underlines the importance of effective seasonal influenza vaccine pharmacovigilance.

scholarly journals Surveillance of adverse events following immunisation in Australia annual report, 2019

2021 ◽  
Vol 45 ◽  
Author(s):  
Aditi Dey ◽  
Han Wang ◽  
Helen Quinn ◽  
Alexis Pillsbury ◽  
Catherine Glover ◽  
...  
Keyword(s):  
Adverse Events ◽  
Seasonal Influenza ◽  
Annual Report ◽  
Injection Site Reaction ◽  
Clinical Findings ◽  
Reporting Rate ◽  
Influenza Vaccines ◽  
Causal Association ◽  
Site Reaction ◽  
Reporting Rates

This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2019 reported to the Therapeutic Goods Administration (TGA) and describes reporting trends over the 20-year period from 1 January 2000 to 31 December 2019. There were 3,782 AEFI records for vaccines administered in 2019, an annual AEFI reporting rate of 14.9 per 100,000 population. There was an 11.8% decrease in the overall AEFI reporting rate in 2019 compared to 2018 (16.9 per 100,000 population). This decrease in the AEFI reporting rate in 2019 was mainly attributable to a decline in reported adverse events related to the human papillomavirus (HPV), dTpa, meningococcal ACWY and seasonal influenza vaccines. AEFI reporting rates for most individual vaccines in 2019 were similar to 2018. The most commonly-reported adverse events were injection site reaction (35.8%), rash (16.6%), pyrexia (15.3%), vomiting (8.1%), urticaria (5.8%), pain (5.8%) and headache (5.7%). There were five deaths reported to the TGA. In one report, the timing and clinical findings were consistent with a causal association with vaccination. In the remaining four reports, no clear causal relationship with vaccination was found.

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

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e031851 ◽  
Author(s):  
Peter Jacoby ◽  
Catherine Glover ◽  
Chloe Damon ◽  
Parveen Fathima ◽  
Alexis Pillsbury ◽  
...  
Keyword(s):  
Young Children ◽  
Adverse Events ◽  
Influenza Vaccination ◽  
Vaccination Programme ◽  
Seasonal Influenza ◽  
Vaccine Safety ◽  
Public Confidence ◽  
Safety Signal ◽  
Seasonal Influenza Vaccination ◽  
Safety Surveillance

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 had it been operating in 2010 when there was an unprecedented number of febrile seizures in young children associated with one specific influenza vaccine brand, Fluvax (CSL Biotherapies).DesignSimulation study.SettingWestern Australian vaccine influenza coverage and adverse event surveillance data.Outcome measuresSimulated solicited responses from caregivers who would have received an SMS survey about adverse events experienced following seasonal influenza vaccination of their children aged 6 months to <5 years.ParticipantsNone.ResultsWe estimated a >90% probability of a safety signal being detected by AusVaxSafety based on solicited reports for either fever or medical attendance at or before the week ending 28 March 2010, 3 weeks after the start of vaccine distribution. Suspension of the national paediatric influenza vaccination programme as a result of the passive adverse events surveillance operating at the time did not occur until 23 April 2010.ConclusionsActive vaccine safety surveillance leading to rapid detection of a safety signal would likely have resulted in earlier suspension of Fluvax from the vaccination programme, prevention of many febrile convulsions and maintenance of public confidence in influenza vaccination for young children.

Anaphylaxis and anaphylactoid reactions associated with the insertion of peripherally inserted central catheters: A multiyear comparative retrospective cohort study

2019 ◽  
Vol 40 (11) ◽  
pp. 1215-1221
Author(s):  
Christina S. Thornton ◽  
Jody Dumanski ◽  
Cherylanne Margherit ◽  
Sandra Vaz-Gonsalves ◽  
Sheryl McDiarmid ◽  
...  
Keyword(s):  
Adverse Events ◽  
Tertiary Care ◽  
Fisher Exact Test ◽  
Peripherally Inserted Central Catheters ◽  
Vascular Access Devices ◽  
Exact Test ◽  
Ottawa Hospital ◽  
Study Results ◽  
Anaphylactoid Reactions ◽  
Central Catheters

AbstractObjective:Peripherally inserted central catheters (PICCs) are a mainstay of nonpermanent vascular access devices. In this study, we assessed patients displaying anaphylaxis or anaphylactoid reactions to the PowerPICC SOLO and Groshong PICC (Bard Access Systems) using the Sherlock tip locating system (TLS).Methods:Patients from 2 tertiary-care hospitals were systematically monitored over 4 years for adverse events following the insertion of a PICC using the Sherlock TLS. Insertion data were also collected using the BioFlo PICC (Angiodynamics)from a third hospital site and from The Ottawa Hospital over 4 years as an additional comparator. Three definitions of anaphylaxis and anaphylactoid reactions were utilized, and the Cohen κ was used to assess interrater agreement. Analysis of reactions among the patient cohorts was performed using the χ2 test with Yates correction or the Fisher exact test as appropriate.Results:Among 8,257 insertions using the TLS PICCs, 37 potential reactions (0.45%) were recorded. Using specific definitions for anaphylaxis or anaphylactoid reactions, 54.1%–91.9% met criteria. Comparator populations using data from Calgary (n = 491) and Ottawa (n = 7,889) using the BioFlo PICC insertion found no reactions. Anaphylactic or anaphylactoid reactions were significantly associated with the PowerPICC SOLO and Groshong PICC with the TLS compared to the BioFlo PICC (P < .0001) across all definitions. The largest subset of patients experiencing adverse reactions had cystic fibrosis (CF) (n = 4, 10.8%).Conclusion:Our study results demonstrate significant adverse events associated with the PowerPICC SOLO and Groshong PICC using the Sherlock TLS inserted across a range of patient populations. The incidence rate of anaphylaxis or anaphylactoid reactions in the CF population at our center is significantly higher than in non-CF patients (P < .001).

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