scholarly journals Revised World Health Organization (WHO)’s causality assessment of adverse events following immunization—a critique

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 243 ◽  
Author(s):  
Jacob Puliyel ◽  
Pathik Naik
Keyword(s):  
Heart Disease ◽  
Adverse Events ◽  
Vaccine Safety ◽  
World Health Organisation ◽  
Epidemiological Studies ◽  
World Health ◽  
Causal Association ◽  
Risk Of Death ◽  
Post Marketing Surveillance ◽  
Definition Of

The World Health Organisation (WHO) has recently revised how adverse events after immunization (AEFI) are classified. Only reactions that have previously been acknowledged in epidemiological studies to be caused by the vaccine are classified as a vaccine-product–related-reaction. Deaths observed during post-marketing surveillance are not considered as ‘consistent with causal association with vaccine’, if there was no statistically significant increase in deaths recorded during the small Phase 3 trials that preceded it. Of course, vaccines  noted to have caused a significant increase in deaths in the control-trials stage would probably not be licensed. After licensure, deaths and all new serious adverse reactions are labelled as ‘coincidental deaths/events’ or ‘unclassifiable’, and the association with vaccine is not acknowledged. The resulting paradox is evident. The definition of causal association has also been changed. It is now used only if there is ‘no other factor intervening in the processes’. Therefore, if a child with an underlying congenital heart disease (other factor), develops fever and cardiac decompensation after vaccination, the cardiac failure would not be considered causally related to the vaccine. The Global Advisory Committee on Vaccine Safety has documented many deaths in children with pre-existing heart disease after they were administered the pentavalent vaccine. The WHO now advises precautions when vaccinating such children. This has reduced the risk of death. Using the new definition of causal association, this relationship would not be acknowledged and lives would be put at risk. In view of the above, it is necessary that the AEFI manual be revaluated and revised urgently. AEFI reporting is said to be for vaccine safety. Child safety (safety of children) rather than vaccine safety (safety for vaccines) needs to be the emphasis.

scholarly journals Revised World Health Organization (WHO)’s causality assessment of adverse events following immunization—a critique

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 243 ◽  
Author(s):  
Jacob Puliyel ◽  
Pathik Naik
Keyword(s):  
Heart Disease ◽  
Adverse Events ◽  
Vaccine Safety ◽  
World Health Organisation ◽  
Epidemiological Studies ◽  
World Health ◽  
Causal Association ◽  
Risk Of Death ◽  
Post Marketing Surveillance ◽  
Definition Of

The World Health Organisation (WHO) has recently revised how adverse events after immunization (AEFI) are classified. Only reactions that have previously been acknowledged in epidemiological studies to be caused by the vaccine, are classified as a vaccine-product–related-reaction. Deaths observed during post-marketing surveillance are not considered as “consistent with causal association with vaccine”, if there was no statistically significant increase in deaths recorded during the small Phase 3 trials that preceded it. Of course, vaccines that caused deaths in the control-trials stage would not be licensed. After licensure, deaths and all new serious adverse reactions are labelled as ‘coincidental deaths’ or ‘unclassifiable’, and the association with vaccine is not acknowledged. The resulting paradox is evident. The definition of causal association has also been changed. It is now used only if there is “no other factor intervening in the processes.” Therefore, if a child with an underlying congenital heart disease (other factor), develops fever and cardiac decompensation after vaccination, the cardiac failure would not be considered causally related to the vaccine. The Global Advisory Committee on Vaccine Safety has documented many deaths in children with pre-existing heart disease after they were administered the Pentavalent vaccine. The WHO now advises precautions when vaccinating such children and this has reduced the risk of death. Using the new definition of causal association, this relationship would not be acknowledged and lives would be put at risk. In view of the above, it is necessary that the AEFI manual be revaluated and revised urgently. AEFI reporting is said to be for vaccine safety. Child safety (safety of children) rather than vaccine safety (safety for vaccines) needs to be the emphasis.

scholarly journals Review on Machine Learning Techniques for Diagnosis of Heart Disease

2021 ◽  
Vol 9 (8) ◽  
pp. 1418-1420
Author(s):  
Harshal P. Sabale
Keyword(s):  
Machine Learning ◽  
Heart Disease ◽  
Human Health ◽  
World Health Organisation ◽  
Disease Diagnosis ◽  
Machine Learning Techniques ◽  
World Health ◽  
Learning Techniques ◽  
Machine Learning Approach ◽  
Heart Disease Diagnosis

Abstract: Now-a-days, heart disease is becoming a concern to human health. According to World Health organisation (WHO), heart disease is the number one killer among other fatal diseases. Excessive smoking, alcohol consumption and junk food are culprit for the heart disease. Physical inactivity is also a concerning to the human health. Heart disease is pretty hard to predict or diagnose using traditional methods like counselling. But, now-a-days, medical fields are using machine learning to predict or diagnose different diseases. Implementation of machine learning techniques provides faster and mostly accurate results. This can save many life. In this paper, different machine learning approach for heart disease diagnosis are reviewed. Keywords: Heart disease, CVD, Machine Learning

Use of the self-controlled case-series method in vaccine safety studies: review and recommendations for best practice

2011 ◽  
Vol 139 (12) ◽  
pp. 1805-1817 ◽  
Author(s):  
Y. G. WELDESELASSIE ◽  
H. J. WHITAKER ◽  
C. P. FARRINGTON
Keyword(s):  
Adverse Events ◽  
Best Practice ◽  
Good Practice ◽  
Case Series ◽  
Vaccine Safety ◽  
The Self ◽  
Series Method ◽  
Safety Studies ◽  
Definition Of ◽  
Study Designs

SUMMARYThe self-controlled case-series method was originally developed to investigate potential associations between vaccines and adverse events, and is now commonly used for this purpose. This study reviews applications of the method to vaccine safety investigations in the period 1995–2010. In total, 40 studies were reviewed. The application of the self-controlled case-series method in these studies is critically examined, with particular reference to the definition of observation and risk periods, control of confounders, assumptions and potential biases, methodological and presentation issues, power and sample size, and software. Comparisons with other study designs undertaken in the papers reviewed are also highlighted. Some recommendations are presented, with the emphasis on promoting good practice.

Personality and dietary correlates of coronary heart disease among Indians

1994 ◽  
Vol 7 ◽  
pp. 32-34
Author(s):  
S. Khanna ◽  
O. P. Sharma ◽  
B. L. Kotia
Keyword(s):  
Coronary Heart Disease ◽  
Heart Disease ◽  
Heart Attack ◽  
Saturated Fat ◽  
World Health Organisation ◽  
World Health ◽  
Eysenck Personality Questionnaire ◽  
Unsaturated Fat ◽  
Fat Consumption ◽  
Total Fat

98 cases of first heart attack were selected for the study. The group included 4 patients from business, 24 housewives and 70 from the service class. Ages ranged from 23 to 70 years. The Eysenck Personality Questionnaire (EPQ) and a Diet Inventory were administered. Diet variables included: (a) caffeine (b) saturated fat (c) unsaturated fat, (d) cooking fat, (e) type of milk used, and (f) total fat consumed. Patients were classified as neurotics (67.3% of cases), extroverts (19.4% of cases), and liars (13.3% of cases) on the basis of their EPQ scores (there were no patients classed as psychotics). The three groups differed on tea consumption, cooking fat consumption, and total fat consumption. Neuroticism was associated with “coronary heart disease;” extroversion and lying were related to “heart attack.”There is evidence from both sides of Atlantic that, with increasing wealth, there is increased consumption of meat, salt, vegetables, refined cereal and an increased intake of alcohol and tobacco (World Health Organisation, 1982). These increases are associated with increased incidence of degenerative diseases such as cardiovascular disease, coronary heart disease and hypertension, and all are common causes of death and disability in industrialized countries (World Health Organisation,1982).

scholarly journals Active surveillance of adverse events following immunization (AEFI): a prospective 3-year vaccine safety study

2019 ◽  
Vol 7 ◽  
pp. 251513551988900 ◽  
Author(s):  
Juny Sebastian ◽  
Parthasarathi Gurumurthy ◽  
Mandyam Dhati Ravi ◽  
Madhan Ramesh
Keyword(s):  
Adverse Events ◽  
Pediatric Population ◽  
Local Population ◽  
Vaccine Safety ◽  
World Health ◽  
Vaccination Programs ◽  
National Immunization ◽  
Study Population ◽  
Health Organization ◽  
Study Participants

Background: Vaccines used in national immunization programs are considered safe and effective but immunization safety has become as important as the efficacy of vaccination programs. The objective of the study was to detect adverse events following immunization (AEFIs) to all vaccines administered to a pediatric population in India. Methods: The prospective active vaccine safety surveillance study enrolled eligible children in the age group 0–5 years receiving vaccination from the immunization center at JSS Hospital, Mysuru. Study participants were monitored at the site for 30 min following vaccination and a telephonic survey was made after 8 days to identify all AEFIs. Causality assessment of the AEFIs were done using a new algorithm developed by the safety and vigilance department of the World Health Organization. Results: The incidence of reported AEFIs was 13.7%. The most frequently reported AEFI was fever ( n = 3095, 93.2%) with an incidence of 109.7 per 1000 doses of vaccine administered, followed by persistent crying ( n = 69, 2.4 per 1000 doses of vaccine) and diarrhea ( n = 57, 2.0 per 1000 doses of vaccine). The majorly implicated vaccine for AEFIs was Pentavac® followed by BCG. Consistent causal association to immunization was observed in 93.4% of cases. Conclusions: A high incidence rate of AEFI was observed in our study population when compared with previous published studies. AEFI surveillance studies help to detect changes in the frequency of adverse events, which may be an alert to consider vaccine quality or identify a specific risk among the local population.

scholarly journals The Microbial Hypothesis: Contributions of Adenovirus Infection and Metabolic Endotoxaemia to the Pathogenesis of Obesity

2016 ◽  
Vol 2016 ◽  
pp. 1-11 ◽  
Author(s):  
Amos Tambo ◽  
Mohsin H. K. Roshan ◽  
Nikolai P. Pace
Keyword(s):  
Massachusetts General Hospital ◽  
World Health Organisation ◽  
Systemic Circulation ◽  
Epidemiological Studies ◽  
World Health ◽  
Public Health Issue ◽  
Low Grade ◽  
Adenovirus Infection ◽  
The Impact ◽  
Low Grade Inflammation

The global obesity epidemic, dubbed “globesity” by the World Health Organisation, is a pressing public health issue. The aetiology of obesity is multifactorial incorporating both genetic and environmental factors. Recently, epidemiological studies have observed an association between microbes and obesity. Obesity-promoting microbiome and resultant gut barrier disintegration have been implicated as key factors facilitating metabolic endotoxaemia. This is an influx of bacterial endotoxins into the systemic circulation, believed to underpin obesity pathogenesis. Adipocyte dysfunction and subsequent adipokine secretion characterised by low grade inflammation, were conventionally attributed to persistent hyperlipidaemia. They were thought of as pivotal in perpetuating obesity. It is now debated whether infection and endotoxaemia are also implicated in initiating and perpetuating low grade inflammation. The fact that obesity has a prevalence of over 600 million and serves as a risk factor for chronic diseases including cardiovascular disease and type 2 diabetes mellitus is testament to the importance of exploring the role of microbes in obesity pathobiology. It is on this basis that Massachusetts General Hospital is sponsoring the Faecal Microbiota Transplant for Obesity and Metabolism clinical trial, to study the impact of microbiome composition on weight. The association of microbes with obesity, namely, adenovirus infection and metabolic endotoxaemia, is reviewed.

scholarly journals Evaluation of Vaccine Safety After the First Public Sector Introduction of Typhoid Conjugate Vaccine—Navi Mumbai, India, 2018

2021 ◽  
Author(s):  
Ashley T Longley ◽  
Kashmira Date ◽  
Stephen P Luby ◽  
Pankaj Bhatnagar ◽  
Adwoa D Bentsi-Enchill ◽  
...  
Keyword(s):  
Public Sector ◽  
Adverse Events ◽  
Conjugate Vaccine ◽  
Surveillance System ◽  
Large Scale ◽  
Safety Evaluation ◽  
Vaccine Safety ◽  
World Health ◽  
Post Vaccination ◽  
Health Organization

Abstract Background In December 2017, the World Health Organization (WHO) prequalified the first typhoid conjugate vaccine (TCV) (Typbar-TCV). While no safety concerns were identified in pre- and post-licensure studies, WHO’s Global Advisory Committee on Vaccine Safety recommended robust safety evaluation with large-scale TCV introductions. During July–August 2018, the Navi Mumbai Municipal Corporation (NMMC) launched the world’s first public sector TCV introduction. Per administrative reports, 113,420 children 9 months–14 years old received TCV. Methods We evaluated adverse events following immunization (AEFI) using passive and active surveillance via 1) reports from the passive NMMC AEFI surveillance system, 2) telephone interviews with 5% of caregivers of vaccine recipients 48 hours and 7 days post-vaccination, and 3) chart abstraction for adverse events of special interest (AESI) among patients admitted to 5 hospitals using the Brighton Collaboration criteria followed by ascertainment of vaccination status. Results We identified 222/113,420 (0.2%) AEFI through the NMMC AEFI surveillance system: 211 (0.19%) minor, 2 (0.002%) severe, and 9 (0.008%) serious. At 48 hours post-vaccination, 1,852/5,605 (33%) caregivers reported one or more AEFI, including injection site pain (n=1,452, 26%), swelling (n=419, 7.5%), and fever (n=416, 7.4%). Of the 4,728 interviews completed at 7 days post-vaccination, the most reported AEFI included fever (n=200, 4%), pain (n=52, 1%), and headache (n=42, 1%). Among 525 hospitalized children diagnosed with an AESI, 60 were vaccinated; no AESI were causally associated with TCV. Conclusions No unexpected safety signals were identified with TCV introduction. This provides further reassurance for the large-scale use of Typbar-TCV among children 9 months–14 years old.

scholarly journals Sexual education in the European countries

2018 ◽  
pp. 335-344
Author(s):  
Mirjana Rasevic
Keyword(s):  
Sex Education ◽  
World Health Organisation ◽  
European Countries ◽  
World Health ◽  
Planned Parenthood ◽  
Scientific Papers ◽  
The Status ◽  
Status Assessment ◽  
The Media ◽  
Definition Of

Sweden was the first country in Europe to introduce compulsory sex education into school curricula as early as 1955. It is nowadays integrated in the education systems of many European countries. Is the contemporary approach to sex education realistic in Serbia, as well? In other words, has the state modernised its education system and adapted it to the present-day requirements and needs in this field? With that respect, the paper considers a number of topics related to sex education: contemporary definition of the concept, respect of the relevant human rights, new needs for this type of information, the implementation principles, barriers and models in the European countries, the role of schools, health care institutions and the media, as well as the good practices in Europe. Besides the research results published in scientific papers, important inputs for consideration of the above topics were also taken from the relevant studies of the World Health Organisation, the International Planned Parenthood Federation and the European Society of Contraception and Reproductive Health. This has provided the basis for the status assessment and the formulation of expectations with regard to the implementation of youth sex education in Serbia. The emphasis is on working with youth as the key target group for education in this field, although sex education is significant in all stages of life.

scholarly journals Analysis of Serological Biomarkers of SARS-CoV-2 Infection in Convalescent Samples From Severe, Moderate and Mild COVID-19 Cases

2021 ◽  
Vol 12 ◽  
Author(s):  
Javier Castillo-Olivares ◽  
David A. Wells ◽  
Matteo Ferrari ◽  
Andrew C. Y. Chan ◽  
Peter Smith ◽  
...  
Keyword(s):  
Large Scale ◽  
World Health Organisation ◽  
Epidemiological Studies ◽  
Antibody Responses ◽  
Clinical Severity ◽  
World Health ◽  
Binding Assays ◽  
Neutralising Antibodies ◽  
Antibody Assays ◽  
Binding Antibody

Precision monitoring of antibody responses during the COVID-19 pandemic is increasingly important during large scale vaccine rollout and rise in prevalence of Severe Acute Respiratory Syndrome-related Coronavirus-2 (SARS-CoV-2) variants of concern (VOC). Equally important is defining Correlates of Protection (CoP) for SARS-CoV-2 infection and COVID-19 disease. Data from epidemiological studies and vaccine trials identified virus neutralising antibodies (Nab) and SARS-CoV-2 antigen-specific (notably RBD and S) binding antibodies as candidate CoP. In this study, we used the World Health Organisation (WHO) international standard to benchmark neutralising antibody responses and a large panel of binding antibody assays to compare convalescent sera obtained from: a) COVID-19 patients; b) SARS-CoV-2 seropositive healthcare workers (HCW) and c) seronegative HCW. The ultimate aim of this study is to identify biomarkers of humoral immunity that could be used to differentiate severe from mild or asymptomatic SARS-CoV-2 infections. Some of these biomarkers could be used to define CoP in further serological studies using samples from vaccination breakthrough and/or re-infection cases. Whenever suitable, the antibody levels of the samples studied were expressed in International Units (IU) for virus neutralisation assays or in Binding Antibody Units (BAU) for ELISA tests. In this work we used commercial and non-commercial antibody binding assays; a lateral flow test for detection of SARS-CoV-2-specific IgG/IgM; a high throughput multiplexed particle flow cytometry assay for SARS-CoV-2 Spike (S), Nucleocapsid (N) and Receptor Binding Domain (RBD) proteins); a multiplex antigen semi-automated immuno-blotting assay measuring IgM, IgA and IgG; a pseudotyped microneutralisation test (pMN) and an electroporation-dependent neutralisation assay (EDNA). Our results indicate that overall, severe COVID-19 patients showed statistically significantly higher levels of SARS-CoV-2-specific neutralising antibodies (average 1029 IU/ml) than those observed in seropositive HCW with mild or asymptomatic infections (379 IU/ml) and that clinical severity scoring, based on WHO guidelines was tightly correlated with neutralisation and RBD/S antibodies. In addition, there was a positive correlation between severity, N-antibody assays and intracellular virus neutralisation.

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