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

Vaccines ◽  
2019 ◽  
Vol 7 (4) ◽  
pp. 140 ◽  
Author(s):  
Stefanizzi ◽  
Stella ◽  
Ancona ◽  
Malcangi ◽  
Bianchi ◽  
...  
Keyword(s):  
Adverse Events ◽  
Active Surveillance ◽  
Causality Assessment ◽  
Reporting Rate ◽  
Surveillance Program ◽  
Second Year Of Life ◽  
Post Marketing ◽  
Second Year ◽  
Active Surveillance Program

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.

scholarly journals Adverse events following measles-mumps-rubella-varicella vaccine: an independent perspective on Italian pharmacovigilance data

F1000Research ◽  
2021 ◽  
Vol 9 ◽  
pp. 1176
Author(s):  
Paolo Bellavite ◽  
Alberto Donzelli
Keyword(s):  
Active Surveillance ◽  
Causality Assessment ◽  
Varicella Vaccine ◽  
Febrile Seizures ◽  
Gastrointestinal Diseases ◽  
Reporting Rate ◽  
World Health ◽  
Surveillance Program ◽  
Multifactorial Diseases ◽  
Surveillance Programs

Vaccine surveillance programs are crucial for the analysis of the vaccine’s safety profile and the guidance of health policies. The Epidemiological Observatory of the Italian Apulia Region carried out an active surveillance program of adverse effects following immunization (AEFI) after the first dose of the measles-mumps-rubella-varicella (MMRV) vaccine, finding 462 AEFIs per 1000 doses, with 11% rated serious. Applying the World Health Organization (WHO) causality assessment algorithm, 38 serious AEFIs/1000 enrolled were classified as ‘consistent causal associations’ with MMRV immunization. Severe hyperpyrexia, neurological symptoms and gastrointestinal diseases occurred in 38, 20 and 15 cases/1000 enrolled, respectively. A projection of such AEFIs in an Italian birth cohort would give tens of thousands of serious AEFIs. These incidence data are much greater than the incidence of serious AEFIs reported by the Italian Medicines Agency (AIFA) for years 2017 and 2018, mainly based on passive (or mixed) pharmacovigilance. In a previous epidemiological study in the same Italian Region, during an eight year passive surveillance, the reporting rate of serious AEFI was 0.06/1000 doses, and no cases of febrile seizures were detected applying the WHO algorithm. Taken together, the data suggest that passive pharmacovigilance is utterly inadequate to document the real incidence of serious AEFIs and that current methods of assessing causality may be questioned. Active surveillance programs are required in representative population samples, with results presented separately from those of spontaneous reporting, and causality assessment should be performed carefully and using a correct technique for AEFIs presenting as complex and multifactorial diseases, like those with serious neurologic disorders.

scholarly journals Safety Profile of Recommended Vaccinations in Adolescents: Data from Surveillance of Adverse Events Following Immunization in Puglia (Italy), 2016–2020

Vaccines ◽  
2021 ◽  
Vol 9 (11) ◽  
pp. 1302
Author(s):  
Antonio Di Lorenzo ◽  
Francesco Paolo Bianchi ◽  
Andrea Martinelli ◽  
Sabrina Lattanzio ◽  
Antonella Carbonara ◽  
...  
Keyword(s):  
Adverse Events ◽  
Safety Profile ◽  
Causality Assessment ◽  
Real Life ◽  
Study Data ◽  
Reporting Rate ◽  
World Health ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Health Organization

Adolescence is a critical period for immunization, in which the adhesion rate to recommended vaccinations is often lower than desired. Since the safety of new vaccines is one of the most important factors determining vaccination hesitancy, post-marketing surveillance of adverse events following immunization (AEFIs) is recommended by the World Health Organization (WHO) to better understand the safety of these drugs. This report describes AEFIs notified in Puglia (Italy) after recommended vaccinations in adolescents aged 12 to 18 years in 2016–2020 to determine the safety profile of these products in a real-life scenario. This is a retrospective observational study. Data were gathered from the list of AEFIs notified in subjects between 12 and 18 years of age following administration of recommended vaccines in Puglia in 2016–2020. AEFIs were classified according to the WHO’s decisional algorithm, and causality assessment was carried out for serious AEFIs. From 2016 to 2020, 323,627 doses of vaccine were administered to adolescents in Puglia and 50 AEFIs were reported (reporting rate: 15.4 × 100,000 doses). Of these, 17 (34.0%) were classified as serious, and causality assessment identified 13 of them (76.5%) as vaccine related. The most common symptoms were local reactions, fever and neurological symptoms. No deaths were notified. The benefits of immunization in adolescents appear to be greater than the risk of AEFIs for all studied vaccines; in fact, AEFIs occur in less than 0.1‰ of patients and are generally mild and self-limiting.

scholarly journals Adverse events following measles-mumps-rubella-varicella vaccine: an independent perspective on Italian pharmacovigilance data

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 1176
Author(s):  
Paolo Bellavite ◽  
Alberto Donzelli
Keyword(s):  
Active Surveillance ◽  
Causality Assessment ◽  
Varicella Vaccine ◽  
Febrile Seizures ◽  
Gastrointestinal Diseases ◽  
Reporting Rate ◽  
World Health ◽  
Surveillance Program ◽  
Multifactorial Diseases ◽  
Surveillance Programs

Vaccine surveillance programs are crucial for the analysis of the vaccine’s safety profile and the guidance of health policies. The Epidemiological Observatory of the Italian Apulia Region carried out an active surveillance program of adverse effects following immunization (AEFI) after the first dose of the measles-mumps-rubella-varicella (MMRV) vaccine, finding 462 AEFIs per 1000 doses, with 11% rated serious. Applying the World Health Organization (WHO) causality assessment algorithm, 38 serious AEFIs/1000 enrolled were classified as ‘consistent causal associations’ with MMRV immunization. Severe hyperpyrexia, neurological symptoms and gastrointestinal diseases occurred in 38, 20 and 15 cases/1000 enrolled, respectively. A projection of such AEFIs in an Italian birth cohort would give tens of thousands of serious AEFIs. These incidence data are much greater than the incidence of serious AEFIs reported by the Italian Medicines Agency (AIFA) for years 2017 and 2018, mainly based on passive (or mixed) pharmacovigilance. In a previous epidemiological study in the same Italian Region, during an eight year passive surveillance, the reporting rate of serious AEFI was 0.06/1000 doses, and no cases of febrile seizures were detected applying the WHO algorithm. Taken together, the data suggest that passive pharmacovigilance is utterly inadequate to document the real incidence of serious AEFIs and that current methods of assessing causality may be questioned. Active surveillance programs are required in representative population samples, with results presented separately from those of spontaneous reporting, and causality assessment should be performed carefully and using a correct technique for AEFIs presenting as complex and multifactorial diseases, like those with serious neurologic disorders.

In vitro susceptibilities of bloodstream isolates of Candida spp.: results from a multicenter active surveillance program in Andalusia

2010 ◽  
Vol 28 (6) ◽  
pp. 405
Author(s):  
Carmen Flórez ◽  
Estrella Martín-Mazuelos ◽  
Maite Ruiz ◽  
José Miguel Cisneros ◽  
Marta Herrero ◽  
...  
Keyword(s):  
Active Surveillance ◽  
Surveillance Program ◽  
Candida Spp ◽  
Active Surveillance Program

Safety and tolerability of prescribed usage of Derise® (Darbepoetin Alfa, Hetero) in symptomatic anemia: A Post Marketing Surveillance Study

2020 ◽  
Author(s):  
Shubhadeep Sinha ◽  
Vamsi Krishna Bandi ◽  
Bala Reddy Bheemareddy ◽  
Pankaj Thakur ◽  
Sreenivasa Chary ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Adverse Events ◽  
Darbepoetin Alfa ◽  
P Value ◽  
End Of Treatment ◽  
Post Marketing Surveillance ◽  
Post Marketing

Abstract Background This post marketing surveillance, observational, prospective, safety study evaluated the safety, tolerability and long term immunogenicity of prescribed usage of Darbepoetin alfa, (DA-α, manufactured by Hetero Biopharma) in Indian patients with chronic kidney disease with anemia.Methods All patients with anemia of chronic kidney disease prescribed Hetero-Darbepoetin were the target patient population. The present study gathered the data from 503 Hetero-Darbepoetin alfa prescribed patients. This study collected information of patient demography, patient's medical history, concomitant medications, action taken with respect to Hetero-Darbepoetin-alfa, AE details (AE term, start date, stop date, severity, action taken, outcome and causality), periodic Hemoglobin (Hb) levels and abnormal laboratory tests results until treatment is discontinued or the patient is lost to follow-up. Immunogenicity data was collected in 121 patients at the end of treatment and after 1 year. Statistical analyses were performed to explore and analyze details of individual case safety reports of adverse events such as incidence, severity, seriousness, outcome, duration, action taken, and causality relationship of individual adverse event (AE) to the prescribed study drug. Results 87 AEs were reported in this study and most of them were mild to moderate in intensity. No deaths or serious adverse events (SAEs) were reported in this study. Anti-drug antibodies were not detected in any subject at the end of treatment phase and after 12 months long term follow up period. Baseline mean Hemoglobin value was 8.34 (SD 1.24) g/dL and last visit mean Hemoglobin value was 10.42 (SD 1.28) g/dL. The mean difference between baseline and last visit was 2.10 [2.00, 2.20], statistically significant (p-value <.0001). Conclusions The safety and tolerability of the usage of DA-α (manufactured by Hetero Biopharma) is similar to that reported in the published literature of the innovator. No patients showed anti-drug antibodies after treatment. Additionally, the patients also showed significant improvement in hemoglobin levels, compared to baseline.Clinical Trial Registry Number: CTRI/2017/04/008338 [Registered on CTRI http://ctri.nic.in/Clinicaltrials/login.php : 12/04/2017]; Trial Registered Retrospectively

Exploring classification of birth defects severity in national hospital discharge databases compared to an active surveillance program

2019 ◽  
Vol 111 (18) ◽  
pp. 1343-1355
Author(s):  
Jennifer L. Matas ◽  
Denny Fe G. Agana ◽  
George J. Germanos ◽  
Michael A. Hansen ◽  
Sanjukta Modak ◽  
...  
Keyword(s):  
Hospital Discharge ◽  
Active Surveillance ◽  
Birth Defects ◽  
Surveillance Program ◽  
National Hospital ◽  
Active Surveillance Program

In vitro susceptibilities of bloodstream isolates of Candida spp.: results from a multicenter active surveillance program in Andalusia

2009 ◽  
Vol 27 (9) ◽  
pp. 518-522 ◽  
Author(s):  
Carmen Flórez ◽  
Estrella Martín-Mazuelos ◽  
Maite Ruiz ◽  
José Miguel Cisneros ◽  
Marta Herrero ◽  
...  
Keyword(s):  
Active Surveillance ◽  
Surveillance Program ◽  
Candida Spp ◽  
Active Surveillance Program

Safety of Active Surveillance Program for Recurrent Nonmuscle-invasive Bladder Carcinoma

Urology ◽  
2009 ◽  
Vol 73 (6) ◽  
pp. 1306-1310 ◽  
Author(s):  
V. Hernández ◽  
M. Alvarez ◽  
E. de la Peña ◽  
N. Amaruch ◽  
M.D. Martín ◽  
...  
Keyword(s):  
Active Surveillance ◽  
Bladder Carcinoma ◽  
Surveillance Program ◽  
Active Surveillance Program
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