Medicines and vaccines have transformed the prevention and treatment of diseases. In addition to their benefits, medicinal products may also have side effects, some of which may be undesirable and / or unexpected. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.
All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use. However, the clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time. Certain side effects may only emerge once these products have been used by a heterogenous population, including people with other concurrent diseases, and over a long period of time.
New course available in OpenWHO: Recognizing Anaphylaxis vs. Immunization Stress-Related Response
COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety (GACVS): updated statement regarding myocarditis and pericarditis reported with COVID-19 mRNA vaccines
Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on reports of Guillain-Barré Syndrome (GBS) following adenovirus vector COVID-19 vaccines
COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety (GACVS): updated guidance regarding myocarditis and pericarditis reported with COVID-19 mRNA vaccines
COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety (GACVS) reviews cases of mild myocarditis reported with COVID-19 mRNA vaccines
Statement of the COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety (GACVS) on safety signals related to the Johnson & Johnson/Janssen COVID-19 vaccine
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To improve reporting and stakeholder engagement, the Pharmacovigilance team in WHO has been supporting Low- and Middle-income Countries (LMICs) to implement a smart phone based adverse reactions reporting app, called the Med Safety App in collaboration with the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the WHO Collaborating Centre, Uppsala Monitoring Centre (UMC). As of March 2021, 12 LMICs have been supported in the implementation. In response to the COVID-19 pandemic, the Med Safety App has also been adapted to support the reporting of adverse events associated with medicines and vaccines used during the pandemic.
This Global Vaccines Safety Blueprint 2.0 (GVSB2.0) was developed through a step-wise consensus process to define the strategic priorities and objectives…
Thrombotic Thrombocytopenia Syndrome (TTS) has emerged as a new adverse event following immunization in individuals vaccinated with COVID-19 non-replicant…
The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicines and legal actions taken by regulatory authorities…
The module provides an overview of factors to consider when monitoring the safety of COVID-19 vaccines administered to pregnant and breastfeeding…
WHO has published the COVID-19 vaccines: safety surveillance manual to guide the processes for collecting, analysing and sharing safety data and information…
WHO has published the COVID-19 vaccines: safety surveillance manual to guide the processes for collecting, analysing and sharing safety data and information…
Anaphylaxis is an acute allergic reaction with multisystem involvement that can present as, or rapidly progress to, a life-threatening reaction. It may…
The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicines and legal actions taken by regulatory authorities…
Since the 2013 publication of the “Causality assessment of an adverse event following immunization (AEFI), user manual for the revised WHO classification”,…
The WHO Pharmacovigilance team strives to ensure safer use of medicines and vaccines throughout the life cycle of the products. We produce reliable, balanced information on the benefits and risks of medicines and vaccines, which enhances people’s care and safety.
Team Lead: Dr Shanthi Pal
Team Lead
Among our activities we are: