Collaboration within the global vaccine safety surveillance ecosystem during the COVID-19 pandemic: lessons learnt and key recommendations from the COVAX Vaccine Safety Working Group.

This analysis describes the successes, challenges and opportunities to improve global vaccine safety surveillance as observed by the Vaccine Safety Working Group from its role as a platform of exchange for stakeholders responsible for monitoring the safety of vaccines distributed through the COVAX mechanism. Three key elements considered to be essential for ongoing and future pandemic preparedness for vaccine developers in their interaction with other members of the vaccine safety ecosystem are (1) the availability of infrastructure and capacity for active vaccine safety surveillance in low-income and middle-income countries (LMICs), including the advancement of concepts of safety surveillance and risk management to vaccine developers and manufacturers from LMICs; (2) more comprehensive mechanisms to ensure timely exchange of vaccine safety data and/or knowledge gaps between public health authorities and vaccine developers and manufacturers; and (3) further implementation of the concept of regulatory reliance in pharmacovigilance. These aims would both conserve valuable resources and allow for more equitable access to vaccine safety information and for benefit/risk decision-making.

Progress in Immunization Safety Monitoring - Worldwide, 2020-2022.

Effective surveillance of adverse events following immunization (AEFIs) primarily relies on the collaboration of two partners: national regulatory authorities (NRAs) and national expanded programs on immunization (EPIs). In December 2020, the World Health Organization (WHO) Global Advisory Committee for Vaccine Safety recommended a new case-based indicator of national capacity to monitor immunization safety: at least one serious AEFI reported per 1 million total population per year. To achieve this indicator, WHO-affiliated countries and territories (WHO countries) rely upon data generated from functional AEFI surveillance systems.

Smartphone-based mobile applications for adverse drug reactions reporting: global status and country experience.

Background: Smartphone technology can support paperless reporting of adverse drug reactions (ADRs). The aims of this study were to systematically assess smartphone ADR-reporting applications, understand their qualitative and quantitative impact on ADR reporting, and garner key lessons from owners and developers.

Methods: This study had three components: (1) An assessment of ADR-reporting apps, (2) an online survey on the impact of app implementation on ADR reporting and the experiences of app developers and owners, and (3) a search of VigiBase, the World Health Organization global database of individual case safety reports (ICSRs), to observe trends in the number of ADR reports targeting countries where the apps were implemented.

Vaccine safety in the next decade: why we need new modes of trust building.

Among the realm of highly varied vaccine perceptions and concerns expressed by publics around the world, vaccine safety is the most frequently cited. While many of the safety questions raised have substantial evidence to address the concerns, vaccines do have small risks, and need vigilant and responsive systems to address them. With more and more new vaccines, combinations of vaccines and new technologies to develop and deliver them, new safety concerns will arise that need attention.

Immunization stress-related response - Redefining immunization anxiety-related reaction as an adverse event following immunization.

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 describe a range of symptoms and signs that may arise after immunization that are related to "anxiety" about the immunization. However, the term "anxiety" does not adequately capture all the elements of this cause specific AEFI.

Use of a new global indicator for vaccine safety surveillance and trends in adverse events following immunization reporting 2000-2015.

Reporting of adverse events following immunization (AEFI) is a key component for functional vaccine safety monitoring system. The aim of our study is to document trends in the AEFI reporting ratio globally and across the six World Health Organization (WHO) regions. We describe the number of AEFI reports communicated each year through the World Health Organization/United Nations Children's Fund Joint Reporting Form on Immunization from 2000 to 2015.

An approach to death as an adverse event following immunization.

Co-incidental death occurring proximate to vaccination may be reported as an adverse event following immunization. Such events are particularly concerning because they may raise community and health provider concerns about the safety of the specific vaccine and often the immunization programme in general. Coincidental events need to be differentiated from vaccine reactions, such as anaphylaxis, which may very rarely result in death.

Strengthening of causality assessment of adverse events following immunization in the WHO South East Asia and Western Pacific regions: Lessons from the 2014 SEAR inter-country workshop.

Background: Poorly managed AEFI undermine immunization programs. Improved surveillance in SEAR countries means more AEFIs but management varies. SEAR brought countries together to share AEFI experiences, and learn more about causality assessment.

Assessment of causality of individual adverse events following immunization (AEFI): a WHO tool for global use.

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 coincidental presentation, rather than caused by the administered vaccines. Given its priority, the Global Advisory Committee for Vaccine Safety (GACVS) commissioned a group of experts to review the previously published World Health Organization (WHO) Adverse Event Following Immunization (AEFI) causality assessment methodology and aide-memoire, and to develop a standardized and user friendly tool to assist health care personnel in the processing and interpretation of data on individual events, and to assess the causality after AEFIs.

Effective vaccine safety systems in all countries: a challenge for more equitable access to immunization.

Serious vaccine-associated adverse events are rare. To further minimize their occurrence and to provide adequate care to those affected, careful monitoring of immunization programs and case management is required. Unfounded vaccine safety concerns have the potential of seriously derailing effective immunization activities.

South-East Asia Regional update on measles mortality reduction and elimination, 2003-2008.

In 2005, the World Health Assembly endorsed a global goal of 90% reduction in measles mortality from 2000 to 2010. Substantial progress has been made toward achieving this goal in countries of the South-East Asia Region (SEAR). More than 120 million children received a second dose of measles-containing vaccine during supplemental immunization activities conducted from 2000 to 2008; routine first-dose measles-containing vaccine coverage increased from 63% in 2000 to 75% by 2008; and measles surveillance is supported in all countries by the Measles-Rubella Laboratory Network.