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 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 Decision Making and Implementation of the First Public Sector Introduction of Typhoid Conjugate Vaccine—Navi Mumbai, India, 2018

2020 ◽  
Vol 71 (Supplement_2) ◽  
pp. S172-S178
Author(s):  
Kashmira Date ◽  
Rahul Shimpi ◽  
Stephen Luby ◽  
Ramaswami N ◽  
Pradeep Haldar ◽  
...  
Keyword(s):  
Decision Making ◽  
Public Sector ◽  
Conjugate Vaccine ◽  
Low Income ◽  
Phase 1 ◽  
Vaccination Campaign ◽  
Economic Cost ◽  
World Health ◽  
Multiple Partners ◽  
Health Organization

Abstract Background Typhoid fever prevention and control efforts are critical in an era of rising antimicrobial resistance among typhoid pathogens. India remains one of the highest typhoid disease burden countries, although a highly efficacious typhoid conjugate vaccine (TCV), prequalified by the World Health Organization in 2017, has been available since 2013. In 2018, the Navi Mumbai Municipal Corporation (NMMC) introduced TCV into its immunization program, targeting children aged 9 months to 14 years in 11 of 22 areas (Phase 1 campaign). We describe the decision making, implementation, and delivery costing to inform TCV use in other settings. Methods We collected information on the decision making and campaign implementation in addition to administrative coverage from NMMC and partners. We then used a microcosting approach from the local government (NMMC) perspective, using a new Microsoft Excel–based tool to estimate the financial and economic vaccination campaign costs. Results The planning and implementation of the campaign were led by NMMC with support from multiple partners. A fixed-post campaign was conducted during weekends and public holidays in July–August 2018 which achieved an administrative vaccination coverage of 71% (ranging from 46% in high-income to 92% in low-income areas). Not including vaccine and vaccination supplies, the average financial cost and economic cost per dose of TCV delivery were $0.45 and $1.42, respectively. Conclusion The first public sector TCV campaign was successfully implemented by NMMC, with high administrative coverage in slums and low-income areas. Delivery cost estimates provide important inputs to evaluate the cost-effectiveness and affordability of TCV vaccination through public sector preventive campaigns.

scholarly journals Introducing Typhoid Conjugate Vaccine in South Asia: Lessons From the Surveillance for Enteric Fever in Asia Project

2020 ◽  
Vol 71 (Supplement_3) ◽  
pp. S191-S195
Author(s):  
Alice S Carter ◽  
Stephen P Luby ◽  
Denise O Garrett
Keyword(s):  
Conjugate Vaccine ◽  
Large Scale ◽  
Enteric Fever ◽  
World Health ◽  
Health Concern ◽  
Vaccine Introduction ◽  
The World ◽  
Health Organization ◽  
Drug Resistant Strains ◽  
Sanitation Infrastructure

Abstract Enteric fever remains a public health concern in communities lacking sanitation infrastructure to separate sewage from drinking water. To bridge the gap until large-scale civil-engineering projects are implemented in high-burden countries, typhoid conjugate vaccine presents a promising disease-prevention technology. A new typhoid conjugate vaccine was prequalified by the World Health Organization in 2017 and is beginning to be introduced in countries around the world. To help inform vaccine introduction, the Surveillance for Enteric Fever in Asia Project (SEAP) conducts prospective enteric fever surveillance in Bangladesh, Nepal, and Pakistan. This supplement presents findings from Phase II of the study (2016–2019) on burden of disease, clinical presentation, the growing spread of drug-resistant strains, and policy and economic ramifications. These findings are delivered to support policymakers in their deliberations on strategies to introduce typhoid conjugate vaccine as a preventive tool against enteric fever.

scholarly journals Quality Assessment of an Antimicrobial Resistance Surveillance System in a Province of Nepal

2021 ◽  
Vol 6 (2) ◽  
pp. 60
Author(s):  
Jyoti Acharya ◽  
Maria Zolfo ◽  
Wendemagegn Enbiale ◽  
Khine Wut Yee Kyaw ◽  
Meika Bhattachan ◽  
...  
Keyword(s):  
Antimicrobial Resistance ◽  
Surveillance System ◽  
Surveillance Data ◽  
World Health ◽  
Cross Sectional ◽  
Antimicrobial Resistance Surveillance ◽  
Data Collection Process ◽  
Data Compilation ◽  
Site Variation ◽  
Health Organization

Antimicrobial resistance (AMR) is a global problem, and Nepal is no exception. Countries are expected to report annually to the World Health Organization on their AMR surveillance progress through a Global Antimicrobial Resistance Surveillance System, in which Nepal enrolled in 2017. We assessed the quality of AMR surveillance data during 2019–2020 at nine surveillance sites in Province 3 of Nepal for completeness, consistency, and timeliness and examined barriers for non-reporting sites. Here, we present the results of this cross-sectional descriptive study of secondary AMR data from five reporting sites and barriers identified through a structured questionnaire completed by representatives at the five reporting and four non-reporting sites. Among the 1584 records from the reporting sites assessed for consistency and completeness, 77–92% were consistent and 88–100% were complete, with inter-site variation. Data from two sites were received by the 15th day of the following month, whereas receipt was delayed by a mean of 175 days at three other sites. All four non-reporting sites lacked dedicated data personnel, and two lacked computers. The AMR surveillance data collection process needs improvement in completeness, consistency, and timeliness. Non-reporting sites need support to meet the specific requirements for data compilation and sharing.

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.

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 Australian National Enterovirus Reference Laboratory annual report, 2017

2020 ◽  
Vol 44 ◽  
Author(s):  
Jason A Roberts ◽  
Linda K Hobday ◽  
Aishah Ibrahim ◽  
Bruce R Thorley
Keyword(s):  
Surveillance System ◽  
Disease Surveillance ◽  
Performance Criterion ◽  
World Health ◽  
Reference Laboratory ◽  
Surveillance Systems ◽  
Disease Surveillance System ◽  
Enterovirus A71 ◽  
Clinical Surveillance ◽  
Health Organization

Australia monitors its polio-free status by conducting surveillance for cases of acute flaccid paralysis (AFP) in children less than 15 years of age, as recommended by the World Health Organization (WHO). Cases of AFP in children are notified to the Australian Paediatric Surveillance Unit or the Paediatric Active Enhanced Disease Surveillance System and faecal specimens are referred for virological investigation to the National Enterovirus Reference Laboratory. In 2017, no cases of poliomyelitis were reported from clinical surveillance and Australia reported 1.33 non-polio AFP cases per 100,000 children, meeting the WHO performance criterion for a sensitive surveillance system. Three non-polio enteroviruses, coxsackievirus B1, echovirus 11 and enterovirus A71, were identified from clinical specimens collected from AFP cases. Australia established enterovirus and environmental surveillance systems to complement the clinical system focussed on children and an ambiguous vaccine-derived poliovirus type 2 was isolated from sewage in Melbourne. In 2017, 22 cases of wild polio were reported with three countries remaining endemic: Afghanistan, Nigeria and Pakistan.

scholarly journals Establishment of the South Korean national antimicrobial resistance surveillance system, Kor-GLASS, in 2016

2018 ◽  
Vol 23 (42) ◽  
Author(s):  
Hyukmin Lee ◽  
Eun-Jeong Yoon ◽  
Dokyun Kim ◽  
Seok Hoon Jeong ◽  
Jong Hee Shin ◽  
...  
Keyword(s):  
Antimicrobial Resistance ◽  
Surveillance System ◽  
Action Plan ◽  
World Health ◽  
Surveillance Systems ◽  
The South ◽  
South Korean ◽  
Antimicrobial Resistance Surveillance ◽  
The Status ◽  
Health Organization

Surveillance plays a pivotal role in overcoming antimicrobial resistance (AMR) in bacterial pathogens, and a variety of surveillance systems have been set up and employed in many countries. In 2015, the World Health Organization launched the Global Antimicrobial Resistance Surveillance System (GLASS) as a part of the global action plan to enhance national and global surveillance and research. The aims of GLASS are to foster development of national surveillance systems and to enable collection, analysis and sharing of standardised, comparable and validated data on AMR between different countries. The South Korean AMR surveillance system, Kor-GLASS, is compatible with the GLASS platform and was established in 2016 and based on the principles of representativeness, specialisation, harmonisation and localisation. In this report, we summarise principles and processes in order to share our experiences with other countries planning to establish a national AMR surveillance system. The pilot operation of Kor-GLASS allowed us to understand the national burden of specific infectious diseases and the status of bacterial AMR. Issues pertaining to high costs and labour-intensive operation were raised during the pilot, and improvements are being made.

Development of Herbal Ayurvedic Formulation as Digestive Tablets, Evaluation of it’s Pharmaceutical, Pharmacognostic Parameters and Screening of its Antioxidant Potential

2021 ◽  
pp. 5849-5855
Author(s):  
Vikas Sharma ◽  
Chandana Majee ◽  
Rahul Kaushik ◽  
Shivani Saxena ◽  
Salahuddin Salahuddin ◽  
...  
Keyword(s):  
Large Scale ◽  
Volatile Oil ◽  
Antioxidant Potential ◽  
World Health ◽  
Wet Granulation ◽  
Scale Production ◽  
Human Beings ◽  
Weight Variation ◽  
Health Organization ◽  
Average Size

Herbal digestive tablets are meant for treating indigestion problems. The indigestion problem is one of the major problems of all (the) ages of human beings. As trends for eating fast foods is increasing, simultaneously the improper digestion also tends to increase. There are a number of digestive tablets in the market but in attempt to improve their taste the actual motto behind their use is masked. To combat the indigestion problems, in the present study an attempt has been made to formulate, develop and evaluate herbal digestive tablets. The formula of the digestive tablet has been decided after deep review of Ayurvedic formulary of India. The ingredients of this formulation have been procured from authentic sources. The wet granulation method was used to prepare the granules for punching the tablets. After preparation, the herbal digestive tablets were subjected to various pharmaceutical evaluations and quality control evaluations as per the guidelines from World Health Organization (WHO). The formulation was also subjected to antioxidant screening using Phosphomolybdenum method. The digestive tablets are obtained as light brown-colored round tablets with pleasant odour and spicy taste with an average size of 8mm and smooth edges. Maximum extractive value was observed as 34% in methanol with a total ash value of 10.16%. Other parameters reported as bitterness value- 0.69 units, volatile oil content-8%, loss on drying- 12.3%, swelling and foaming index of 0.27 and less than 100 respectively. The tablets showed a total antioxidant potential of 0.51mg/mg as Ascorbic acid equivalent. Tablets also pass various pharmaceutical evaluation parameters like hardness, friability, weight variation, and disintegration test. Herbal digestive tablets have very excellent taste due to less bitter drugs. The tablet formula can be applied to prepare large scale production of digestive tablets.

scholarly journals Early Insights From Clinical Trials of Typhoid Conjugate Vaccine

2020 ◽  
Vol 71 (Supplement_2) ◽  
pp. S155-S159
Author(s):  
Kathleen M Neuzil ◽  
Buddha Basnyat ◽  
John D Clemens ◽  
Melita A Gordon ◽  
Priyanka D Patel ◽  
...  
Keyword(s):  
Clinical Trials ◽  
World Health Organization ◽  
Conjugate Vaccine ◽  
Trial Data ◽  
Early Data ◽  
World Health ◽  
Data Support ◽  
Health Organization

Abstract Clinical trials of typhoid conjugate vaccine (TCV) are ongoing in 4 countries. Early data confirm safety, tolerability, and immunogenicity of typhoid conjugate vaccine, and early efficacy results are promising. These data support World Health Organization recommendations and planned country introductions. Forthcoming trial data will continue to inform programmatic use of typhoid conjugate vaccine.

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