Depuis la publication en 2013 de l’« Évaluation du lien de causalité pour les manifestations postvaccinales indésirables (MAPI), Manuel d’utilisation de la classification OMS révisée », l’adoption de la nouvelle méthode révisée...

This website gives access to 4 WHO certified courses on vaccine safety and AEFI ( 1. Vaccine Safety Basics, 2. AEFI data management basics, 3. AEFI investigation and 4. AEFI causality assessment), as well as guidance on the topic and access to the...

Since November 2014, the pentavalent (Diptheria+Tetanus+Pertussis and Hepatitis B and Hib or DTP-HB- Hib) vaccine has been integrated into the Iranian national vaccination programme. This research conducts a prospective study in Zahedan in the...

The consolidated answers to the questions asked during and after Session #08 of the 'COVID-19 Vaccination: Building Global Capacity' webinar series for Health workers. The session was entitled '08: Reporting on COVID-19 vaccines (monitoring and...

Reducing pain during vaccination is becoming increasingly relevant as more vaccines become available and two or more vaccines may need to be administered simultaneously. While in some countries, up to four injectable vaccines have been...

The Council for the International Organizations of Medical Sciences (CIOMS) and WHO working group on pharmacovigilance defines five cause specific AEFI which includes an immunization anxiety-related reaction. Historically this term has been used to...

Monitoring of adverse events following immunization (AEFI) is an essential strategy for ensuring the safety of vaccines. This new manual provides guidance on setting-up AEFI surveillance systems with standardized methodologies and tools. It...

The second edition of the manual was developed by the WHO with support from the Global Advisory Committee for Vaccine Safety (GACVS) based on the findings of a scientific study conducted in April 2017, “Indo- Zimbabwe inter-country study to assess...

Background: A 9-valent human papillomavirus (HPV6/11/16/18/31/33/45/52/58; 9vHPV) vaccine was developed to expand coverage of the previously developed quadrivalent (HPV6/11/16/18; qHPV) vaccine. Methods: Efficacy, immunogenicity, and safety outcomes...

BACKGROUND: Vaccines should be stored and handled according to manufacturer specifications. Inadequate cold chain management can affect potency; but, limited data exist on adverse events (AE) following administration of vaccines kept outside of...

New vaccines designed to prevent diseases endemic in low and middle-income countries are being introduced without prior utilization in countries with robust vaccine pharmacovigilance systems. Our aim was to build capacity for active surveillance of...

Rotavirus is the most common cause of moderate-to-severe infant diarrhoea in developing countries, resulting in enormous morbidity, mortality, and economic burden. A bovine-human reassortant pentavalent rotavirus vaccine (BRV-PV) targeting the...

For vaccines to be fully effective and induce long-term protective immunity, individuals should receive all recommended doses. Vaccine recipients who experienced an adverse event following immunization (AEFI) are sometimes afraid that the adverse...

In 2013, the Council for International Organizations of Medical Sciences (CIOMS) created a Working Group on Vaccine Safety (WG) to address unmet needs in the area of vaccine pharmacovigilance. Generating reliable data about specific vaccine safety...

Introduction: Two types of Japanese encephalitis (JE) vaccines, inactivated JE vaccine (JE-I) and live-attenuated JE vaccine (JE-L), are available and used in China. In particular, one JE-L, produced by a domestic manufacturer in China, was...

On April 23, 2016, the Democratic Republic of the Congo (DRC) Ministry of Health reported an outbreak of yellow fever. As of May 24, 2016, among 41 confirmed yellow fever cases, 31 (75.6%) had occurred in Kongo Central Province, in the western part...

The yellow fever outbreak declared in Angola in January 2016 soon became the largest recorded yellow fever outbreak in the country’s history. In response, the Angola Ministry of Health, supported by the World Health Organization (WHO), conducted...

Background: Each year, rotavirus gastroenteritis is responsible for about 37% of deaths from diarrhea among children younger than 5 years of age worldwide, with a disproportionate effect in sub-Saharan Africa. Methods: We conducted a randomized,...

INTRODUCTION: BCG vaccination has been associated with beneficial non-specific effects on child health. Some immunological studies have reported heterologous effects of vaccines on antibody responses to heterologous vaccines. Within a randomised...

In a single-center study, 66 healthy volunteers aged between 18 and 50years were randomized to be immunized against rabies with three different injection routes: intradermal with DebioJect™ (IDJ), standard intradermal with classical needle (IDS),...

Background: Kawasaki disease is a complex and potentially serious condition. It has been observed in temporal relation to immunisation. Methods: We conducted a systematic literature review using various reference sources to review the available...

Background: Limited data are available describing the post-licensure safety of meningococcal vaccines, including Menveo®. We reviewed reports of adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS) to assess safety in all age...

The 9th African rotavirus symposium was held in Maputo, Mozambique from the 8th to 10th of December 2015, including a total of 101 delegates from 17 countries, 15 of which were African countries. This forum brought together participants with various...

Vaccines are extremely safe and harm is rare. Worldwide, more than 30 000 vaccine doses are delivered per second through routine immunization programs, which, in turn, prevent an estimated 2 million to 3 million deaths annually. The occurrence of...

BACKGROUND: Meningococcal conjugate vaccination is recommended in the United States. This study evaluates the safety of quadrivalent meningococcal conjugate vaccine in a cohort aged 11 to 21 years. METHODS: This cohort study with self-controlled...

The Canadian National Vaccine Safety network (CANVAS) gathers and analyzes safety data on individuals receiving the influenza vaccine during the early stages of annual influenza vaccination campaigns with data collected via participant surveys...

INTRODUCTION On-going post-licensure surveillance of adverse events following immunisation (AEFI) is critical to detecting and responding to potentially serious adverse events in a timely manner. SmartVax is a vaccine safety monitoring tool that...

This guide enables effective planning and implementation of proactive communication actions to promote understanding of the importance of vaccines in preventing illness and preventable deaths, and raises awareness of vaccine risks and perceptions of...

Background: The prevention of child mortality through immunization is one of the most cost-effective and widely applied public health interventions. In Ethiopia, the Expanded Program on Immunization (EPI) schedule is rarely completed as planned and...

The Global Advisory Committee on Vaccine Safety (GACVS), an independent expert clinical and scientific advisory body, provides WHO with scientifically rigorous advice on vaccine safety issues of potential global importance. GACVS held its 34th...

A WHO guideline on how to conduct AEFI

There is now clear evidence that the simplistic conventional model of immunization is invalid [1]. We can no longer assume that a vaccine acts independently of other vaccines, or that it influences only infections caused by the target disease....

To assess the performance of SmartVax, a prototypic active monitoring system for adverse events following immunisation (AEFI) using short message service (SMS) text messages and clinical data extracted from commercially available medical practice...

To facilitate introduction of live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) into the National Immunization Programme of Sri Lanka, we evaluated the safety and immunogenicity of co-administration of LJEV and measles vaccine at 9...

ACKGROUND: Concerns about vaccine safety have led some parents to decline recommended vaccination of their children, leading to the resurgence of diseases. Reassurance of vaccine safety remains critical for population health. This study...

BACKGROUND: Healthcare provider spontaneous reporting of suspected adverse events following immunisation (AEFI) is central to monitoring post-licensure vaccine safety, but little is known about how healthcare professionals recognise and report to...

In order to successfully control and eliminate vaccine-preventable infectious diseases, an appropriate vaccine coverage has to be achieved and maintained. This task requires a high level of effort as it may be compromised by a number of barriers....

The surveillance of vaccine safety is an essential requirement in vaccination programmes. Computerized immunization registries such as the Vaccination Information System (SIV) of Valencian Community (Spain) offer the opportunity to estimate the...

Adverse events following immunisation (AEFIs) with qHPV reported to the Slovenian AEFI Registry for the first four school years of the vaccination programme were analysed. We calculated annual reporting rates for 11–14 year-old vaccinees with...

Many events occurring after vaccination have been attributed to vaccines, when in fact the association was often due to chance.1 However, as with any medical intervention, there are times when adverse events are caused by immunizations.2...

It is critical to distinguish events that are temporarily associated with, but not caused by, vaccination from those caused by vaccination during mass immunization. The researchers performed a literature search in China National Knowledge...

The Japanese Ministry of Health, Labour, and Welfare (MHLW) partially suspended the human papillomavirus (HPV) vaccination programme in June, 2013. Although HPV vaccination has just been included in the routine vaccination schedule and publicly...

Parents commonly perceive and report that their child has experienced an AEFI. In this group of parents the subsequent expectation of an AEFI and vaccine safety concerns may be heightened. Further research should investigate parental understandings...

Serious illnesses or even deaths may rarely occur after childhood vaccinations. Public health programs are faced with great challenges to establish if the events presenting after the administration of a vaccine are due to other conditions, and hence...

A contentious theory espoused by some parents is that regressive-onset of autism spectrum disorder (ASD) is triggered by vaccines. If this were true, then vaccine receipt should be higher in children with regressive-onset ASD compared with other...

As 13-valent pneumococcal conjugate vaccine (PCV13) is introduced, children who began vaccination with 7-valent pneumococcal conjugate vaccine (PCV7) may complete their vaccination with PCV13. This open-label phase 3 study evaluated immunogenicity...

Studies from low-income countries indicate that co-administration of inactivated diphtheria–tetanus–pertussis (DTP) vaccine and live attenuated measles vaccine (MV) is associated with increased mortality compared with receiving MV only....

In this safety surveillance study of more than 200,000 DTaP–IPV vaccine recipients, there was no evidence of increased risk for any of the pre-specified adverse events monitored. Continued surveillance of DTaP–IPV vaccine safety may be warranted...

The demand for vaccination against infectious diseases involves a choice between vaccinating and not vaccinating, in which there is a trade-off between the benefits and costs of each option. The aim of this paper is to investigate these trade-offs...