Pharmacovigilance and COVID-19 - vaccines - PAHO/WHO | Pan American Health Organization

On 30 January 2020, World Health Organization (WHO) declared that the outbreak of a disease known as COVID-19, caused by a novel coronavirus (SARS-CoV-2), constituted a public health emergency of international concern (PHEIC). One essential strategy to control this pandemic was the rapid development of safe and effective vaccines.

On 27-28 May 2020, the 42nd Global Advisory Committee on Vaccine Safety (GACVS) addressed pharmacovigilance preparedness for the introduction of future COVID-19 vaccines. One of its recommendations was that infrastructure and capacity for surveillance of the safety of COVID-19 vaccines should be in place in all countries, and that existing infrastructure should be reactivated and engaged before a vaccine is introduced.

Pharmacovigilance for COVID-19 vaccines dashboard

Regional vaccination dashboard

Periodic Update Reports on AEFI – COVID-19 vaccines

What PAHO is doing:

PAHO/WHO promotes the implementation of a regional system for adverse events following immunization (AEFI) surveillance, which will make it possible to monitor the safety of vaccines in the Region, detect signals, and conduct population-level causality analyses of the relationship between observed adverse events and the vaccines. This system serves as a platform for conducting the research needed for decision-making on regional and national immunization plans and policies, while indirectly contributing to global knowledge on vaccine safety and vaccination procedures.

PAHO/WHO supports the development of guidelines, operational manuals, technical documents, and references to networks linking the countries of the Region.

A regional AEFI surveillance training strategy is available, covering the entire surveillance operational cycle and providing knowledge on the proper operation of the various phases of surveillance.

PAHO promotes multi-country work initiatives that support many of the activities related to the safe vaccination cycle.

Country initiatives

En este manual se proporciona orientación sobre la introducción de las vacunas contra la COVID-19, y está destinado a gobiernos, personal de programas de vacunación a nivel nacional, regional y mundial, autoridades regulatorias, ministerios de salud, colaboradores y centros de farmacovigilancia, así como a los fabricantes de vacunas.

Enlace al recurso

Este manual provee normas regionales de vigilancia es el primer paso a la aplicación de un sistema de vigilancia regional que permita realizar el monitoreo permanente y en tiempo real de la seguridad de las vacunas y de la vacunación a través de una red de información multicéntrica.

Enlace al recurso

Este documento de referencia enumera y proporciona definiciones de casos estandarizadas internacionalmente de eventos adversos de especial interés y eventos adversos posteriores a la inmunización para las vacunas COVID-19.

Enlace al recurso

Training health personnel on AEFI surveillance, risk communication, etc.

Organización Mundial de la Salud

Autoaprendizaje on-line. Disponible en OpenWHO
Registro requerido
Idioma: Inglés
Duración: 5 horas

Enlace al curso

Autoaprendizaje on-line. Disponible en OpenWHO
Registro requerido
Idioma: Español/Inglés
Duración: 20 minutos

Enlace al curso

Autoaprendizaje on-line. Disponible en OpenWHO
Registro requerido
Idioma: Inglés
Duración: 1 hora

Enlace al curso

Organización Panamericana de la Salud

Curso de autoaprendizaje
*Pendiente de carga en la plataforma CVSP/OPS
Idioma: Español/Inglés
Duración: 20 minutos
Duración: 15 horas

Enlace al curso

Curso de autoaprendizaje
*Pendiente de carga en la plataforma CVSP/OPS
Idioma: Español/Inglés
Duración: 20 minutos
Duración: por confirmar

Enlace al curso

Curso de autoaprendizaje
*Pendiente de carga en la plataforma CVSP/OPS
Idioma: Español/Inglés
Duración: 20 minutos
Duración: por confirmar

Enlace al curso

Support for communication on safe vaccination with specific training and review of communication plans.

Communicating about Vaccine Safety

Guidelines to help health workers communicate with parents, caregivers, and patients

Link

Communication in Crises Related to Vaccine Safety: Technical Guidance

Support tool to prepare, implement and evaluate a communication response to the crisis

Link

Guide for the preparation of a risk communication strategy for COVID-19 vaccines: A Resource for the countries of the Americas

Guide to contribute to capacity building and risk communication planning

Link

Webinars

Vaccine Safety Communication: Guidelines for Health Care Workers

The main objective of this webinar is to introduce vaccine safety communication orientations and tools that Health Care workers working in the field of immunizations and in any other specialty can use when interacting with parents, caregivers, and patients.

Link

Crisis communications for vaccine safety

The main objective of this webinar was to introduce the new vaccine-related crisis communication guidelines that aim to help strengthen national communication capacities related to Events Supposedly Attributable to Vaccination or Immunization (ESAVI) and to provide a set of useful tools that they can use in this matter

Link

Publications

This document provides guidance to national regulatory authorities (NRAs) and regulatory systems on practical ways to implement reliance for emergency use of medicines and other health technologies in and around a pandemic.

Link to de publication

Link to the publication

This document presents guidance on the regulation of clinical trials to national regulatory authorities (NRAs) in order to promote the research and use of medicines and other health technologies that are safe and effective to meet health needs during the pandemic. of COVID-19. (only spanish)

Link to the publication

The objective of this document is to identify the main gaps in readiness for the introduction of COVID-19 vaccines and to propose the regulatory procedures needed to manage and reduce these gaps

Link to the publication

This document was prepared to provide recommendations and considerations that serve as a guide for the development of evaluation strategies for Risk Management Plans (PGR) and Periodic Safety Reports (IPS) requested as regulatory requirements for the authorization of use of vaccines against COVID-19, as well as for monitoring their safety once their use is authorized.

Link to the publication

This publication aims to provide recommendations on the notification and evaluation of serious adverse events, suspected unexpected serious adverse reactions and adverse events of special interest detected during clinical trials with COVID-19 vaccines, as well as their integration with security information from post-authorization surveillance.

Link to the publication

This document provides answers to questions related to regulatory issues related to the introduction and pharmacovigilance of vaccines against COVID-19.

Link to the publication

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