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 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 COVID-19 Vaccination Perception and Attitude among Healthcare Workers in Egypt

2021 ◽  
Vol 12 ◽  
pp. 215013272110133
Author(s):  
Samar Fares ◽  
Merihan M. Elmnyer ◽  
Shimaa Sabry Mohamed ◽  
Radwa Elsayed
Keyword(s):  
Healthcare Workers ◽  
Study Groups ◽  
World Health ◽  
Vaccine Hesitancy ◽  
Accurate Information ◽  
P Value ◽  
Major Barrier ◽  
Vaccination Programs ◽  
The World ◽  
Health Organization

Introduction COVID-19 pandemic has affected the whole world, especially the frontline worriers. To get shielded through this war, the world is racing to reach and manufacture COVID-19 vaccines. Vaccination hesitancy is one of the significant obstacles to global health. Objectives This study aimed to assess the perception and attitude of healthcare workers in Egypt toward COVID-19 vaccines, acknowledge the determinants of their attitude, and the factors that could increase the acceptance of the vaccine. Methods an observational web-based anonymous survey was conducted on 385 Egyptian healthcare workers in different governorates. The questionnaire-based on Vaccine Hesitancy Survey Questions of the World Health Organization was available in Arabic and English languages and was tested for reliability. Results Regarding vaccination decision, 51% of the participants were undecided, 28% refused, and 21% accepted vaccination. Reasons for vaccine acceptance mainly were risks of COVID-19 (93%), safety (57.5%), and effectiveness (56.25%) of the vaccine. Simultaneously, the reasons for vaccine hesitancy were the absence of enough clinical trials (92.4%) and fear of side effects of the vaccine (91.4%). The leading factor that could increase vaccination acceptance among the participants was to get sufficient and accurate information about the available vaccines. The participants revealed a high mean level of concern for COVID-19 vaccines’ safety (3.8 of 5) that differs significantly among the different study groups ( P-value .002). Conclusion Despite the COVID-19 pandemic, only approximately 21% of Egyptian healthcare workers in our study accepted the COVID-19 vaccination. Vaccine hesitancy represents a major barrier to implementing vaccination programs.

scholarly journals Vaccination Coverage for Routine Vaccines and Herd Immunity Levels against Measles and Pertussis in the World in 2019

Vaccines ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 256
Author(s):  
Pedro Plans-Rubió
Keyword(s):  
Vaccination Coverage ◽  
Action Plan ◽  
Herd Immunity ◽  
World Health ◽  
Immunization Programs ◽  
National Immunization ◽  
The World ◽  
Measles Vaccination ◽  
The Mean ◽  
Health Organization

In 2012, the World Health Organization (WHO) established the Global Vaccine Action Plan with the objective to promote essential vaccinations in all countries and achieve at least 90% vaccination coverage for all routine vaccines by 2020. The study assessed the mean percentages of vaccination coverage in 2019 for 13 routine vaccines, vaccination coverage variation from 2015 to 2019, and herd immunity levels against measles and pertussis in 2019 in countries and regions of WHO. In 2019, the mean percentages of vaccination coverage were lower than 90% for 10 (78.9%) routine vaccines. The mean percentages of vaccination coverage also decreased from 2015 to 2019 for six (46.2%) routine vaccines. The prevalence of individuals with vaccine-induced measles immunity in the target measles vaccination population was 88.1%, and the prevalence of individuals with vaccine-induced pertussis immunity in the target pertussis vaccination population was 81.1%. Herd immunity against measles viruses with Ro = 18 was established in 63 (32.5%) countries but not established in any region. Herd immunity against pertussis agents was not established in any country and in any region of WHO. National immunization programs must be improved to achieve ≥90% vaccination coverage in all countries and regions. Likewise, it is necessary to achieve ≥95% vaccination coverage with two doses of measles vaccines and three doses of pertussis vaccines in all countries and regions.

scholarly journals Low-dose amikacin in the treatment of Multidrug-resistant Tuberculosis (MDR-TB)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Natasha F. Sabur ◽  
Mantaj S. Brar ◽  
Lisa Wu ◽  
Sarah K. Brode
Keyword(s):  
Hearing Loss ◽  
Adverse Events ◽  
Low Dose ◽  
Multidrug Resistant ◽  
Significant Rise ◽  
World Health ◽  
Therapeutic Drug ◽  
Successful Treatment Outcome ◽  
Mdr Tb ◽  
Health Organization

Abstract Background The World Health Organization recommends intravenous amikacin for the treatment of MDR-TB at a dose of 15 mg/kg. However, higher doses are associated with significant toxicity. Methods Patients with MDR-TB treated at our institution receive amikacin at 8–10 mg/kg, with dose adjustment based on therapeutic drug monitoring. We conducted a retrospective cohort study of patients with MDR-TB who received amikacin between 2010 and 2016. Results Forty-nine patients were included in the study. The median starting dose of amikacin was 8.9 mg/kg (IQR 8, 10), and target therapeutic drug levels were achieved at a median of 12 days (IQR 5, 26). The median duration of amikacin treatment was 7.2 months (IQR 5.7, 8), and median time to sputum culture conversion was 1 month (IQR 1,2). Six patients (12.2%) experienced hearing loss based on formal audiometry testing (95% CI 4.6–24.8%); 22.2% had subjective hearing loss (95% CI 11.2–37.1%) and 31.9% subjective tinnitus (95% CI 19.1–47.1%). Ten patients (23%) had a significant rise in serum creatinine (95% CI 11.8–38.6%), but only 5 patients had a GFR < 60 at treatment completion. 84% of patients had a successful treatment outcome (95% CI 84–99%). Conclusions Low dose amikacin is associated with relatively low rates of aminoglycoside-related adverse events. We hypothesize that low-dose amikacin can be used as a safe and effective treatment for MDR-TB in situations where an adequate regimen cannot be constructed with Group A and B drugs, and where careful monitoring for adverse events is feasible.

Reasons for Vaccine Rejection in 0 to 2 Years Old Children Registered to Family Health Centers in Konya

2021 ◽  
Vol 16 (02) ◽  
pp. 074-079
Author(s):  
Hasan Kucukkendirci ◽  
Fatih Kara ◽  
Gulsum Gulperi Turgut
Keyword(s):  
Health Personnel ◽  
Family Health ◽  
Cross Sectional Study ◽  
World Health ◽  
University Graduates ◽  
Cross Sectional ◽  
Vaccination Programs ◽  
Vaccine Preventable Diseases ◽  
Health Organization

AbstractObjective According to the 2017 report of the World Health Organization (WHO), ∼1.5 million people die from vaccine preventable diseases. The WHO is working to generate and popularize effective vaccination programs. However, the concept of “vaccine rejection,” which first started in Europe and United States, has started to make an impact in Turkey during the past 10 years. It is therefore seen as a growing danger in future. This study was conducted to determine, detect, and prevent the reasons of vaccine rejection that have increased in recent years.Methods A cross-sectional study was conducted between June and December at 2015. In all districts of Konya (n = 31), it was aimed to reach all 242 families who rejected vaccination to their 0 to 2 years old babies. Families having more than one child refused to vaccinate all of their children. A questionnaire consisting of 47 questions was prepared by the researchers, using the standard trainings of the Ministry of Health and the literature. A total of 172 families agreed to participate in this study. The questionnaire was applied to the parents using the telephone interview technique. Data were presented as mean ± standard deviation and percentage.Results About 41.3% (n = 71) of the mothers were high school graduates, 50.6% (n = 87) of their fathers were university graduates. About 82.6% (n = 142) of the participants received examination, treatment and follow-up services from family physicians and family health personnel. About 20.9% (n = 36) of the children were the only children of the family. About 55.8% (n = 96) of the families also refused the vaccination for other children. About 83.7% (n = 144) of the unvaccinated children had infants/children follow-up care. While all participants stated that vaccines had side effects, 31.4% (n = 54) of these believed that vaccines cause autism or paralysis in infants. About 62.2% (n = 107) of their mothers did not receive tetanus vaccine during pregnancy. The highest rate of nonvaccination was with the second dose of hepatitis A vaccine, which 96.5% (n = 166) refused. The most accepted vaccine was the first dose of hepatitis B vaccine, which was refused by 18.0% (n = 31). About 79.7% (n = 137) of the participants did not know the reason for the vaccination and 95.9% (n = 165) thought that the vaccines were not required. All participants received information from the health personnel about the vaccines. While 9.9% (n = 17) of the families thought that vaccines cause infertility, 44.8% (n = 77) did not receive vaccination because the vaccines were produced abroad.Conclusion A growing number of families refuse to have their babies vaccinated. The production of vaccines abroad is a major cause of insecurity. There are also beliefs that vaccines cause infertility. Vaccine production in Turkey should be accelerated and public education about vaccines should be reviewed. Training provided to families about vaccines should also be reviewed.

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 Development and Validation of Emotion Regulation Strategies in Germophobia Questionnaire in Iran

2020 ◽  
Vol 8 (4) ◽  
pp. 307-316
Author(s):  
Seyed Mohammadreza Alavizadeh ◽  
◽  
Mojgan Sepahmansour ◽  
Somaye Entezari ◽  
Mohammadreza Seirafi ◽  
...  
Keyword(s):  
Emotion Regulation ◽  
World Health ◽  
Snowball Sampling ◽  
Emotion Regulation Strategies ◽  
Study Results ◽  
The World ◽  
Valid Instrument ◽  
Regulation Strategies ◽  
Health Organization ◽  
Study Participants

Objective: The Coronavirus Disease-2019 (COVID-19) has recently been identified as a pandemic by the World Health Organization. The outbreak of the disease has caused numerous individuals around the world to become extremely frightened and subsequently present the signs of phobia. Fear is the basic emotion of anxiety disorders and individuals cope with their emotions by different strategies. The present study aimed at developing and validating Emotion Regulation Strategies for Germophobia Questionnaire (ERS-GPQ). Methods: The study participants were 99 individuals (74 females) of the Iranian population with concerns about germs who were selected with the snowball sampling method. They completed the ERS-GPQ and GPQ in the Google Forms platform. Results: The present study results illustrated that the ERS-GPQ has acceptable internal consistency with Cronbach’s alpha coefficient (a=0.61), reliability coefficients with split-half (0.70), and one-week test-retest (0.92); the ERS-GPQ also presented a moderate positive correlation with the contamination obsessions checklist of GPQ (r=0.44) as the convergent coefficient. Besides, the confirmatory factor analysis indicated 2 factors of the ERS-GPQ. Finally, the ERS-GPQ has 2 components with good convergent and discriminate validities and composite reliability. Conclusion: Based on the current research findings, the ERS-GPQ has acceptable and good psychometric properties; researchers can use the ERS-GPQ as a reliable and valid instrument for assessing ER strategies concerning germophobia. Furthermore, it has some considerations for practitioners in epidemic and pandemic crises, like COVID-19.

Alcohol Intoxication and Suicide by Hanging in Poland

2020 ◽  
Vol 55 (3) ◽  
pp. 278-283 ◽  
Author(s):  
Dorota Lasota ◽  
Witold Pawłowski ◽  
Paweł Krajewski ◽  
Anna Staniszewska ◽  
Krzysztof Goniewicz ◽  
...  
Keyword(s):  
Metropolitan Area ◽  
Alcohol Intoxication ◽  
World Health ◽  
Target Groups ◽  
Demographic Differences ◽  
Alcohol Group ◽  
Demographic Groups ◽  
Study Population ◽  
Health Organization ◽  
Medical University

Abstract Aims An integral part of the World Health Organization (WHO) plan to reduce suicide by 10% by 2020 is to identify areas and demographic groups, which should be priority target groups for preventive activities. This study aimed to present the demographic differences between victims of suicide by hanging in the Warsaw metropolitan area, in Poland, by examining the sobriety of victims. Methods Data for analysis were obtained from the documentation of the Department of Forensic Medicine (DFM) at the Medical University of Warsaw (MUW). The retrospective analysis included 358 out of 466 victims of suicides by hanging in the Warsaw metropolitan area, in Poland, recorded in the DFM documentation covering 2011–2013. The data gathered included age, gender, the cause of death, a post-mortem examination as well as the level of ethanol in the blood and muscles of victims. Results In both groups, men accounted for a larger percentage of victims than women, P = 0.068. In the no-alcohol group, the victims were older than in the alcohol group (47.52 ± 19.21 vs. 40.88 ± 12.77) (P &lt; 0.001). The majority of the studied population were victims aged 25–34 (22.90%), mainly men (20.95%). Young men were also the largest group among victims in the alcohol group (28.33%). The most numerous age group among no-alcohol group were older victims aged 55–64 (19.10%), especially men (16.29%). Conclusion Regardless of sobriety, men were the largest group of suicide victims in the study population, which means that men die suicide more often than women. Differences in gender proportions are related to age. In the studied population, it was primarily young victims, mainly men. These are the groups that should be priority target groups for preventive activities aimed at reducing the number of suicides. The presence of ethanol in more than half of the victims of suicide in the study population indicates that alcohol is an important suicidal risk factor.

Immunogenicity and Safety of the Measles Vaccine in HIV-Infected Children: An Updated Systematic Review

2019 ◽  
Author(s):  
Nicky J Mehtani ◽  
Lori Rosman ◽  
William J Moss
Keyword(s):  
Latin American ◽  
Prevalence Ratio ◽  
Vaccine Safety ◽  
World Health ◽  
Measles Vaccine ◽  
Serious Adverse Events ◽  
Increased Risk ◽  
Hiv Exposed ◽  
Health Organization ◽  
Reported Data

Abstract Children infected with human immunodeficiency virus (HIV) are at increased risk of measles morbidity and mortality. We searched abstracts from the PubMed, Embase, and Latin American and Caribbean Center on Health Sciences Information databases for articles published from the earliest date available through September 26, 2017. The primary outcome of interest was serological responses to measles vaccine, stratified by HIV infection status. A total of 2,858 potentially eligible articles were identified, and the final review included 12 studies published between 1992 and 2013, 9 of which reported data on vaccine safety. The studies we included represented 3,573 children, of whom at least 335 were infected with HIV, 788 were HIV-exposed but not infected, and 1,478 were unexposed to HIV. Four of the 12 studies found statistically significant reductions in seropositivity among HIV-infected children compared with HIV-uninfected children within 4 months of vaccination (prevalence ratio range, 0.44–0.70), and forest plots provided visual trends of decreasing immunity over time among HIV-infected children in 2 additional studies. No vaccine-related deaths or serious adverse events were reported. This updated review demonstrated limitations of the existing published literature but supported evidence of reduced immunogenicity of measles vaccine among HIV-infected children, supporting the World Health Organization recommendation to revaccinate HIV-infected children against measles following immune reconstitution with combination antiretroviral therapy.

scholarly journals HPV Vaccination: The Position Paper of the Italian Society of Colposcopy and Cervico-Vaginal Pathology (SICPCV)

Vaccines ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. 354 ◽  
Author(s):  
Andrea Ciavattini ◽  
Luca Giannella ◽  
Rosa De Vincenzo ◽  
Jacopo Di Giuseppe ◽  
Maria Papiccio ◽  
...  
Keyword(s):  
Hpv Vaccination ◽  
Local Treatment ◽  
Target Population ◽  
Italian Society ◽  
World Health ◽  
Quadrivalent Vaccine ◽  
Protein Antigens ◽  
Vaccination Programs ◽  
Bivalent Vaccine ◽  
Health Organization

Human papillomavirus (HPV) related cervical cancer represents an issue of public health priority. The World Health Organization recommended the introduction of HPV vaccination in all national public programs. In Europe, vaccines against HPV have been available since 2006. In Italy, vaccination is recommended and has been freely offered to all young girls aged 11 years since 2008. Three prophylactic HPV vaccines are available against high- and low-risk genotypes. The quadrivalent vaccine contains protein antigens for HPV 6, 11, 16, and 18. The bivalent vaccine includes antigens for HPV 16 and 18. The nonavalent vaccine was introduced in 2014, and it targets HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Clinical trials demonstrated the effectiveness of the three vaccines in healthy young women. Likewise, all vaccines showed an excellent safety profile. The bivalent vaccine provides two doses in subjects aged between 9 and 14 years and three doses in subjects over 14 years of age. The quadrivalent vaccine provides two doses in individuals from 9 to 13 years and three doses in individuals aged 14 years and over. The nonavalent vaccine schedule provides two doses in individuals from 9 to 14 years of age and three doses in individuals aged 15 years and over at the time of the first administration. Preliminary results suggest that the HPV vaccine is effective in the prevention of cervical squamous intraepithelial lesions even after local treatment. Given these outcomes, in general, it is imperative to expand the vaccinated target population. Some interventions to improve the HPV vaccine’s uptake include patient reminders, physicians-focused interventions, school-based vaccinations programs, and social marketing strategies. The Italian Society of Colposcopy and Cervico-Vaginal Pathology (SICPCV) is committed to supporting vaccination programs for children and adolescents with a catch-up program for young adults. The SICPCV also helps clinical and information initiatives in developing countries to decrease the incidence of cervico-vaginal and vulvar pathology.

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