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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... more
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... more
Accessed December 2017
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... more
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... more
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... more
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... more
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... more
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 ... more
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... more
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... more
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... more
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 ... more
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... more
July 2021
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... more
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... more
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... more