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 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.

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 AEFIs active surveillance projects as vaccinovigilance traineeship: Puglia (Italy) experience

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
P Stefanizzi ◽  
V Bavaro ◽  
G Spinelli ◽  
D Anona ◽  
P Stella ◽  
...  
Keyword(s):  
Active Surveillance ◽  
Surveillance System ◽  
Causality Assessment ◽  
Reporting Rate ◽  
Passive Surveillance ◽  
Important Concern ◽  
National Drug ◽  
Italian Regions ◽  
Passive Surveillance System ◽  
Before And After

Abstract Surveillance of Adverse Events Following Immunization (AEFIs) is a crucial part of vaccination strategies because the most important concern of “No-vax group” is the safety of vaccination. According to UE laws, in Italy a passive surveillance system of AEFIs is established by law and managed by National Drug Authority (AIFA) and Regional Health Governments. The performance of surveillance system is different in the 21 Italian Regions and in some Region, such as Puglia, the AEFIs reporting rate has been, for several years, lower than National figure. The implementation of AEFIs active surveillance projects could increase the performance of AEFIs surveillance system, also after the end of the project. In Puglia, since 2017, May to 2018, November, an active surveillance of AEFIs has been established, focused on MMRV vaccine. In this study, we analysed the AEFIs general picture in Puglia in 2016 and 2019, before and after active surveillance project. The source of data is the AIFA database; data were reported as number of AEFI and rate for Puglia population (reporting rate RR). The AEFIs were classified as serious, not serious and unclassifiable and causality assessment was performed according to WHO recommendations. The number of AEFIs detected by the passive surveillance system is 91 for 2016 (RR 2,2 per 100.000 people), and 168 for 2019 (RR 4,2 per 100.000 people). The percentage of serious AEFIs was 23.1% (21/91) in 2016 and 31% (52/168) in 2019 and unclassifiable AEFIs were 22% (20/91) in 2016 and 0 in 2019. The percentage of serious AEFIs for which the result of causality assessment was “consistent” is 23,8% (5/21) in 2016 and 55,8% (29/52) in 2019. The experience of AEFIs active surveillance project increase the performance of AEFIs surveillance system. From 2016 (pre-project time) to 2019 (post-project time) the number of AEFIs detected was doubled, the number of unclassifiable AEFIs (proxy of poor reliability of the system) was reduced to zero. Key messages AEFIs passive surveillance system could be affected by underreporting and lack of quality. The AEFIs active surveillance project are an important occasion of traineeship for vaccinovigilance system, that could increase the sensibility and the reliability.

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 A hospital-based birth defects surveillance system in Kampala, Uganda

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Daniel Mumpe-Mwanja ◽  
Linda Barlow-Mosha ◽  
Dhelia Williamson ◽  
Diana Valencia ◽  
Robert Serunjogi ◽  
...  
Keyword(s):  
Birth Defects ◽  
Demographic Data ◽  
World Health ◽  
Surveillance Program ◽  
Spontaneous Abortions ◽  
Middle Income ◽  
Electronic Data Collection ◽  
Resource Limited ◽  
Talipes Equinovarus ◽  
Surveillance Programs

Abstract Background In 2010, the World Health Assembly passed a resolution calling upon countries to prevent birth defects where possible. Though birth defects surveillance programs are an important source of information to guide implementation and evaluation of preventive interventions, many countries that shoulder the largest burden of birth defects do not have surveillance programs. This paper shares the results of a hospital-based birth defects surveillance program in Uganda which, can be adopted by similar resource-limited countries. Methods All informative births, including live births, stillbirths and spontaneous abortions; regardless of gestational age, delivered at four selected hospitals in Kampala from August 2015 to December 2017 were examined for birth defects. Demographic data were obtained by midwives through maternal interviews and review of hospital patient notes and entered in an electronic data collection tool. Identified birth defects were confirmed through bedside examination by a physician and review of photographs and a narrative description by a birth defects expert. Informative births (live, still and spontaneous abortions) with a confirmed birth defect were included in the numerator, while the total informative births (live, still and spontaneous abortions) were included in the denominator to estimate the prevalence of birth defects per 10,000 births. Results The overall prevalence of birth defects was 66.2/10,000 births (95% CI 60.5–72.5). The most prevalent birth defects (per 10,000 births) were: Hypospadias, 23.4/10,000 (95% CI 18.9–28.9); Talipes equinovarus, 14.0/10,000 (95% CI 11.5–17.1) and Neural tube defects, 10.3/10,000 (95% CI 8.2–13.0). The least prevalent were: Microcephaly, 1.6/10,000 (95% CI 0.9–2.8); Microtia and Anotia, 1.6/10,000 (95% CI 0.9–2.8) and Imperforate anus, 2.0/10,000 (95% CI 1.2–3.4). Conclusion A hospital-based surveillance project with active case ascertainment can generate reliable epidemiologic data about birth defects prevalence and can inform prevention policies and service provision needs in low and middle-income countries.

Current updates on COVID-19 - A review

2020 ◽  
Vol 10 (1) ◽  
pp. 1-8
Author(s):  
Ghotekar D S ◽  
Vishal N Kushare ◽  
Sagar V Ghotekar
Keyword(s):  
World Health Organization ◽  
Common Cold ◽  
Respiratory Diseases ◽  
Gastrointestinal Diseases ◽  
Hubei Province ◽  
World Health ◽  
The World ◽  
The Common ◽  
Novel Coronavirus ◽  
Health Organization

Coronaviruses are a family of viruses that cause illness such as respiratory diseases or gastrointestinal diseases. Respiratory diseases can range from the common cold to more severe diseases. A novel coronavirus outbreak was first documented in Wuhan, Hubei Province, China in December 2019. The World Health Organization (WHO) has declared the coronavirus disease 2019 (COVID-19) a pandemic. A global coordinated effort is needed to stop the further spread of the virus. A novel coronavirus (nCoV) is a new strain that has not been identified in humans previously. Once scientists determine exactly what coronavirus it is, they give it a name (as in the case of COVID-19, the virus causing it is SARS-CoV-2).

Hip surgery and radiology reporting for children with cerebral palsy prior to initiation of a hip surveillance program

2021 ◽  
pp. 1-7
Author(s):  
Kyra Kane ◽  
Marshall Siemens ◽  
Shane Wunder ◽  
Jacqueline Kraushaar ◽  
J. Alexandra Mortimer ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Retrospective Chart Review ◽  
Surveillance Program ◽  
Radiology Reporting ◽  
Reporting Practices ◽  
Hip Displacement ◽  
Primary Surgery ◽  
Radiology Reports ◽  
Children With Cerebral Palsy ◽  
Surveillance Programs

PURPOSE: Hip displacement impacts quality of life for many children with cerebral palsy (CP). While early detection can help avoid dislocation and late-stage surgery, formalized surveillance programs are not ubiquitous. This study aimed to examine: 1) surgical practices around pediatric hip displacement for children with CP in a region without formalized hip surveillance; and 2) utility of MP compared to traditional radiology reporting for quantifying displacement. METHODS: A retrospective chart review examined hip displacement surgeries performed on children with CP between 2007–2016. Surgeries were classified as preventative, reconstructive, or salvage. Pre- and post-operative migration percentage (MP) was calculated for available radiographs using a mobile application and compared using Wilcoxon Signed Ranks test. MPs were also compared with descriptions in the corresponding radiology reports using directed and conventional content analyses. RESULTS: Data from 67 children (115 surgical hips) was included. Primary surgery types included preventative (63.5% hips), reconstructive (36.5%), or salvage (0%). For the 92 hips with both radiology reports and radiographs available, reports contained a range of descriptors that inconsistently reflected the retrospectively-calculated MPs. CONCLUSION: Current radiology reporting practices do not appear to effectively describe hip displacement for children with CP. Therefore, standardized reporting of MP is recommended.

scholarly journals Epidemiologic Measures for Quantifying the Incidence of Concussion in National Collegiate Athletic Association Sports

2017 ◽  
Vol 52 (3) ◽  
pp. 167-174 ◽  
Author(s):  
Zachary Y. Kerr ◽  
Karen G. Roos ◽  
Aristarque Djoko ◽  
Sara L. Dalton ◽  
Steven P. Broglio ◽  
...  
Keyword(s):  
Student Athletes ◽  
National Collegiate Athletic Association ◽  
Injury Surveillance ◽  
Ice Hockey ◽  
Surveillance Program ◽  
Injury Rates ◽  
Policy Makers ◽  
Sports Concussion ◽  
Women's Basketball ◽  
Surveillance Programs

Context: Injury rates compare the relative frequency of sport-related concussions across groups. However, they may not be intuitive to policy makers, parents, or coaches in understanding the likelihood of concussion. Objective: To describe 4 measures of incidence (athlete-based rate, athlete-based risk, team-based rate, and team-based risk) during the 2011–2012 through 2014–2015 academic years. Design:  Descriptive epidemiology study. Setting: Aggregate injury and exposure data collected from the National Collegiate Athletic Association Injury Surveillance Program in 13 sports (men's baseball, basketball, football, ice hockey, lacrosse, soccer, and wrestling and women's basketball, ice hockey, lacrosse, soccer, softball, and volleyball). Patients or Other Participants: Collegiate student-athletes. Main Outcome Measure(s): Sport-related concussion data from the National Collegiate Athletic Association Injury Surveillance Program during the 2011–2012 through 2014–2015 academic years were analyzed. We calculated concussion rates per 1000 athlete-exposures (AEs), concussion risk, average number of concussions per team, and percentage of teams with at least 1 concussion. Results: During the 2011–2012 through 2014–2015 academic years, 1485 concussions were sustained by 1410 student-athletes across 13 sports. Concussion rates ranged from 0.09/1000 AEs in men's baseball to 0.89/1000 AEs in men's wrestling. Concussion risk ranged from 0.74% in men's baseball to 7.92% in men's wrestling. The average ± SD number of concussions per team ranged from 0.25 ± 0.43 in men's baseball to 5.63 ± 5.36 in men's football. The percentage of teams with a concussion ranged from 24.5% in men's baseball to 80.6% in men's football. Conclusions Although men's wrestling had a higher concussion rate and risk, men's football had the largest average number of concussions per team and the largest percentage of teams with at least 1 concussion. The risk of concussion, average number of concussions per team, and percentage of teams with concussions may be more intuitive measures of incidence for decision makers. Calculating these additional measures is feasible within existing injury surveillance programs, and this method can be applied to other injury types.

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

scholarly journals Motion – Screening and Surveillance of Barrett’s Epithelium Is Practical and Cost Effective: Arguments against the Motion

2002 ◽  
Vol 16 (8) ◽  
pp. 541-545 ◽  
Author(s):  
Naoki Chiba
Keyword(s):  
Cost Effective ◽  
World Health ◽  
Endoscopic Screening ◽  
Effective Screening ◽  
Screening And Surveillance ◽  
Screening Protocol ◽  
Surveillance Programs ◽  
Prolongation Of Life ◽  
Health Organization ◽  
Very High

The issue of whether to screen individuals for Barrett’s esophagus (BE) to prevent esophageal adenocarcinoma (EAC) is highly controversial. Important considerations are that BE is not highly prevalent in the general population and that not many patients with BE develop or die from EAC. Studies that suggest an improved prognosis from surveillance programs are susceptible to lead-time bias. Most of the principles for effective screening, as outlined by the World Health Organization, are not met by endoscopic screening and surveillance protocols. The diagnosis of BE (and dysplasia) is often unclear. Most patients with BE are not identified by screening, and few deaths would be prevented by surveillance. A decision analysis found that the most cost effective screening protocol would be every five years, but the costs associated with prolongation of life are very high, even if a group at high risk for EAC could be identified.

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