In many countries neonatal tetanus is responsible for half of all neonatal deaths due to vaccine-preventable diseases and for almost 14% of al¡ infant deaths. It is estimated that in the 1970s more than 10,000 newborns died annually from neonatal tetanus in the Americas. Neonatal tetanus is prevent...ed by immunization and/or assuring clean delivery and post-delivery practices.
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This is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programmes. A number of WHO publica...tions are available that provide a background to pharmacovigilance and, as far as possible, that material will not be repeated here. Health officials, planners, the staff of Pharmacovigilance Centres, public health teams and all health workers should become familiar with these publications, which are: • Safety of Medicines: A guide to detecting and reporting adverse drug reactions
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There is an urgent need for safer, simpler, more efficacious and accessible treatment regimens for all forms of TB. The development of Target Product Profiles for TB treatment regimens (referred to as Target Regimen Profiles or TRPs) seeks to guide the drug development process towards important regi...men characteristics corresponding to the needs of end-users.
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This document builds on the Background document prepared for the September 4-5, 2014 Consultation. It includes proposed elements to consider during the development of a framework to assist decision-making at global and national level.
The aim of the document is to assist Member States and releva...nt partners in their discussions to identify the best approaches to ensure the accelerated evaluation and use of available or near-term therapies and vaccines for the treatment and prevention of EVD. The document calls for a coordinated effort by the international community to remove unnecessary obstacles towards this goal.
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The WHO South-East Asia (SEA) Region bears a high burden of tuberculosis (TB) and MDR-TB. In 2015, the Region accounted for nearly 200 000 or 35% of the global estimated new RR/MDR-TB cases eligible for treatment. Extensively drug-resistant TB (XDRTB) has also been reported from s...ix countries of the SEA Region. MDR-TB could potentially replace drug-susceptible TB, and constitutes a threat to global public health security. The South- East Asia Regional Response Framework for DR-TB 2017–2021 complements the Ending TB in the South-East Asia Region: Regional Strategic Plan 2016–2020” and outlines key strategies for reducing morbidity, mortality and transmission of DR-TB.
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Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effective consumer reporting system within their pharmac...ovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
The Pharmacovigilance team in WHO aims to assure the safety of medicines and vaccines by ensuring reliable and timely exchange of information on safety issues, promoting pharmacovigilance activities throughout the Organization and encouraging participation in the WHO Programme for International Drug... Monitoring. This text was developed in consultation with the WHO Collaborating Centre for International Drug Monitoring and the national pharmacovigilance centres participating in the WHO Programme for International Drug Monitoring.
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3 February 2021
Vaccine- and vaccination-related crises require a communication response that is different from the communication strategies used to promote the benefits and importance of vaccines in general. This document presents the technical guidance needed to develop a communication plan that ...is appropriate for managing crises related to vaccine safety. This guidance will be useful for managers in the areas of immunization and vaccine and vaccination safety. They will also help preparedness and response teams working in safety crises to optimize their communication plans in order to regain, maintain, or strengthen trust in vaccines, vaccination, and immunization programs in general.
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COVID-19 Vaccines: 1 Safety Surveillance 2 Manual
While there is no indication that pregnant women have an increased susceptibility to infection with SARS-CoV-2, there is evidence that pregnancy may increase the risk of severe illness and mortality from COVID-19 disease in comparison with non-pregn...ant women of reproductive age. As seen with non-pregnant women, a high proportion of pregnant women have asymptomatic SARS-CoV-2 infection and severe disease is associated with recognized medical (e.g., high body-mass index (BMI), diabetes, pre-existing pulmonary or cardiac conditions) and social (e.g., social deprivation, ethnicity) risk factors. Pregnant women with symptomatic COVID-19 appear to have an increased risk of intensive care unit admission, mechanical ventilation and death in comparison with non-pregnant women of reproductive age, although the absolute risks remain low. COVID-19 may increase the risk of preterm birth, compared with pregnant women without COVID-19, although the evidence is inconclusive.
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The internationally recognized criteria for diagnosis of neurocysticercosis include a requirement for neuroimaging techniques, such as computerized tomography (CT) and/or magnetic resonance imaging (MRI), ideally supported by serology. These facilities are not available in all settings, especially i...n rural areas of low-income countries, making it difficult to identify and treat patients. Additionally, there is controversy about the role, type and duration of anthelmintic, antiinflammatory and antiepileptic drug (AED) treatments for different forms of neurocysticercosis.
These guidelines were developed to assist health-care providers in appropriate, evidence-based management of parenchymal neurocysticercosis. The guidelines do not address other forms of neurocysticercosis and do not include management of extraparenchymal disease (including cysticerci in the cerebral ventricles or subarachnoid space). The aim of the guidance is to improve decision-making to ensure appropriate patient care and to avoid misdiagnoses and inappropriate treatment of patients with neurocysticercosis.
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Development of one or more vaccines for Neisseria gonorrhoeae is an important objective for sexual and reproductive health worldwide, and for the fight against antimicrobial resistance.
WHO preferred product characteristics (PPCs) provide strategic guidance as to WHO’s preferences for new vacci...nes in priority disease areas. PPCs are intended to encourage innovation and development of vaccines for use in settings most relevant to the global unmet public health need.
Gonococcal vaccine PPCs describe global public health goals for gonococcal vaccines and preferred parameters pertaining to vaccine indications and target populations, safety and efficacy considerations, and immunization strategies.
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Weekly Epidemiological Record No 9, 2022, 97, 61–80
This position paper supersedes the 2016 publication, “Malaria vaccine: WHO position paper-2016.”1 It includes the updated WHO recommendations on the wider use of the RTS,S/AS01 vaccine for the reduction of malaria morbidity and mortality in ...children living in areas of moderate to high malaria transmission. It also incorporates findings from the evaluation of the WHO-coordinated Malaria Vaccine Implementation Programme (MVIP), recommended by SAGE and MPAG in 2015, and from additional studies since 2015.
This paper does not include findings on vaccine efficacy in infants first vaccinated at 6–12 weeks of age. Because of the lower vaccine efficacy observed in this age category, WHO did not recommend pilot implementation or RTS,S/AS01 vaccine introduction for these young infants. Recommendations2 on the use of RTS,S/AS01 vaccine were discussed by SAGE and MPAG during a joint session in October 2021; evidence presented at the meeting can be accessed at https://terrance.who.int/mediacentre/data/ sage/SAGE_eYB_Oct2021.pdf
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Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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Arsenical monotherapies were previously very successful for treating human African trypanosomiasis (HAT).
Melarsoprol resistance emerged as early as the 1970s and was widespread by the late 1990s.
Melarsoprol resistance represents the only example of widespread drug resistance in HAT patients wher...e the genetic mechanism has been established.
The current goal of elimination of HAT as a public health problem by 2020 may be undermined by the emergence and spread of resistance to current or new drugs.
Insights into potential resistance mechanisms for current and new drugs will facilitate predictions of the likelihood of resistance and will also facilitate rational approaches to minimizing, monitoring, and tackling the future emergence of resistance.
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Smallpox eradication was certified in 1980. Mpox has been endemic in Central and West African countries since it was first detected in 1958 . It is a zoonosis; cases are often found close to tropical rainforests where various animals carry the orthopoxvirus that causes the disease. In endemic countr...ies, most mpox infections in humans result from a primary animal-to-human transmission. Human-to-human transmission can result from close contact with respiratory secretions, skin lesions of an infected person, or recently contaminated objects. Transmission can also occur via the placenta from mother to fetus or through close contact during and after birth.
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Introduction Pharmacovigilance (PV) systems to monitor drug and vaccine safety are often inadequate in sub-Saharan
Africa. In Malawi, a PV enhancement initiative was introduced to address major barriers to PV.
Objective The objective of this initiative was to improve reporting of adverse events (A...Es) by strengthening passive safety
surveillance via PV training and mentoring of local PV stakeholders and healthcare providers (HCPs) at their own healthcare
facilities (HCFs).
Methods An 18-month PV training and mentoring programme was implemented in collaboration with national stakeholders,
and in partnership with the Ministry of Health, GSK and PATH. Two-day training was provided to Expanded Programme on
Immunisation coordinators, identified as responsible for AE reporting, and four National Regulatory Authority representa-
tives. Abridged PV training and mentoring were provided regularly to HCPs. Support was given in upgrading the national
PV system. Key performance indicators included the number of AEs reported, transmission of AE forms, completeness of
reports, serious AEs reported and timeliness of recording into VigiFlow.
Results In 18 months, 443 HCPs at 61 HCFs were trained. The number of reported AEs increased from 22 (January 2000 to
October 2016) to 228 (November 2016 to May 2018), enabling Malawi to become a member of the World Health Organization
Programme for International Drug Monitoring. Most (98%) AE report forms contained mandatory information on reporter,
event, patient and product, but under 1% were transmitted to the national PV office within 48 h.
Conclusion Regular PV training and mentoring of HCPs were effective in enhancing passive safety surveillance in Malawi,
but the transmission of reports to the national PV centre requires further improvement.
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