Vaccine Safety

ESAVI SURVEILLANCE COMMUNICATION QUALITY VACCINES DISTRIBUTION CHANNELS SAFE VACCINATION

The strategic priority of the 2030 Immunization Agenda is the development of immunization programs for primary health care and universal health coverage.

The fulfilment of this goal requires, among other activities, to focus on monitoring the safety of vaccines and vaccination, in order to guarantee a supply chain of high quality vaccines and supplies. This is articulated in a service delivery system based on primary care.

In the Region of the Americas, vaccines have reached high levels of acceptance and confidence in their effectiveness to reduce the frequency and impact of many infectious diseases, compared to other areas of the world. However, the public has expressed more doubts about the safety of vaccines than about their effectiveness.

In the current context of the emergency due to the COVID-19 pandemic, in which the rapid deployment of new vaccines has been required and have had to go through emergency authorization schemes, an emphasis has been placed on activities that guarantee the Vaccine safety. These include the surveillance of Events Supposedly Attributable to Vaccination or Immunization (ESAVI).

The safe vaccination system is made up of several components that must interact continuously and by activities carried out simultaneously by different institutions in all countries.

Vaccine Safety: An interinstitutional work

Key facts

	All the countries in the Region of the Americas have national ESAVI surveillance systems, with different levels of maturity that depend on a variety of actors within the health system.
	In 17 countries of the Region, (48.6%), the national immunization program (NIP) is responsible for reporting ESAVI data; In nine countries (25.7%), ESAVIs are reported jointly between the NIP and the National Regulatory Authority (NRA) and in only three countries (8.6%) the responsibility is solely of the NRA. Six countries (17.1%) of the Region have designated an institution other than the NRA or NIP to report these data
	The monitoring of adverse events after the administration of vaccines generates useful information on rare and very rare adverse events, and on risks related to the quality and handling of vaccines. This information is used to minimize its recurrence and impact on the health of the population.
	Generating reliable information from ESAVIs allows countries to form objectives and provide timely response to questions from the public and national authorities about the use of vaccines.

Fact sheet

An information system on vaccine safety is an essential tool to support decision-making, as the risks generated by the proposed interventions are being permanently evaluated.

Building public confidence in vaccines requires having relevant information about their safety and effectiveness that reliably answers questions and concerns.

Access to innovations in immunization, especially for public health emergencies (for example, caused by SARS-CoV-2), requires that we have information generation platforms that allow us to evaluate the effect that these innovations have on state of health and in mitigating the cause of the emergency.

It is essential to continue strengthening ESAVI surveillance systems with a strategy that manages to generate technical capacities from the local level to strengthen information systems and the use of technologies to carry out high-quality surveillance work.

What PAHO does

The Immunizations Unit in conjunction with the Medicines and Health Technologies Unit work together for the implementation of the regional system for the surveillance of ESAVI, which aims to monitor the security situation of vaccines in the region, in addition to measuring signal detection and population causality to analyse the relationship between observed adverse events and vaccines.

This system will serve as a platform for the development of research necessary for decision-making on regional and national immunization plans and policies. It will also indirectly contribute to global knowledge on vaccine safety and vaccination procedures. PAHO develops multi-country work initiatives that support many of the activities related to the safe vaccination cycle.

Guides, operational manuals, technical guidelines, and references to work networks have been developed among the countries of the region that support the implementation of all PAHO technical recommendations. A regional ESAVI surveillance training strategy is available, which covers the entire surveillance operational cycle and provides knowledge on the proper operation of the surveillance phases.

Along with training and capacity building, PAHO offers support to monitoring and surveillance activities by working directly with the countries in some of the operational activities.

seguridad-vacunas-ops-iniciativas-paises

Initiatives for countries

ESAVI Regional Surveillance Manual
Providing regional surveillance standards is the first step in the application of a regional surveillance system that allows permanent and real-time monitoring of vaccine safety through a multicentre information network.

Regional Surveillance System
Guidelines for the implementation of the regional ESAVI / AESI surveillance system in the context of COVID-19.

Health Personnel Training
Health personnel training in ESAVI surveillance, risk communication, among others.

Communication Support
Support for communication on vaccine safety with specific training and review of communication plans.

Regional Protocol
Regional protocol for the surveillance of ESAVI and EVADIE for the regional network of sentinel hospitals.

Back to menu

ESAVI SURVEILLANCE

ESAVI surveillance aims at early detection and analysis of adverse events to develop a rapid and appropriate response that minimizes the negative impact on the health of individuals and on the immunization program.

Manual for Surveillance of Events Supposedly Attributable to Vaccination or Immunization in the Region of the Americas

Preview / Download

Event Suspected to be Attributable to Vaccination or Immunization (ESAVI):

Any unfavorable and/or unintended health situation (sign, abnormal laboratory finding, symptom or disease) occurring after vaccination (or immunization) that does not necessarily have a causal relationship with the vaccination process or the vaccine.

They are classified as either non-serious (fever, local redness or pain, irritability, rash) or serious (aseptic meningitis, neurotropic disease, viscerotropic disease, thrombocytopenia, anaphylaxis, febrile convulsions, vaccine-associated poliomyelitis).

The application of a surveillance system varies according to the methods and mechanisms used for each phase of the process.

Passive Surveillance is based on voluntary and spontaneous notifications of those who identify the adverse event in the health institution or by notification of the vaccinated person.

Active Surveillance consists of the application of systematic search strategies for specific events in the community or in health institutions through a protocol with detailed instructions, to answer questions about the real frequency of an event and its association with the vaccine.

The general objective of ESAVI surveillance at the national level is the early detection, notification, and analysis of events presumably attributable to vaccination. As such, a rapid and effective response can be organized to minimize the negative impact on vaccination, the health of individuals and on the immunization program, and prevent the occurrence of additional events or their recurrence.

An essential component of the system is the communication component. Both crisis communication and risk communication decision makers and the community. With the information available from regulatory activities and from the surveillance vaccine safety, crises in the confidence of the population must be anticipated and managed appropriately, without negatively impacting the acceptability and the financing of the entire system.

The information generated by the ESAVI surveillance system gives tools to all those responsible for vaccine safety to identify any risks that may arise from the interaction of the biological product with the recipient's immune system. It also helps identify deviations from the process of use of the vaccine or quality problems in the production of the vaccine, as well as discriminating against those erroneously associated with vaccination, among others.

The principles of ESAVI surveillance will guide the actions of everyone involved, and direct them in situations where there is uncertainty or where there are no specific recommendations on how to proceed.

Humanization of surveillance
A focus on purpose
Quality of information
Confidentiality
Systemic approach
Interprogrammatic and interagency coordination
Optimal risk communication

An information systems development plan should be defined for vaccine safety in coordination with all the institutions involved. It should consider the necessary information technologies, the human, physical and economic resources, and the way to manage those resources.

It must also establish the flow of notifications and information, analysis procedures, decision-making, and communication.

Image labels are in Spanish only

Schematic representation of the structure for data exchange at subnational, national and global levels (spanish only)

Click to expand

representacion-esquematica-de-la-estructura-para-el-intercambio-de-datos-a-nivel-subnacional-nacional-mundial

ESAVI Surveillance Cycle

Detection and Notification

ESAVI is detected by health personnel who care for the affected person or their family members.

Very often it is detected in the first hours after its administration.

Attention must first be paid to the health condition of the person, ensuring an accurate diagnosis and effective treatment as well as rehabilitation measures if necessary.

The event must be notified to the public health surveillance system available in the country as soon as possible, ensuring that all relevant and verifiable clinical and epidemiological information is included.

Investigation

The investigation process aims to fully understand the events that occurred in order to verify the clinical diagnosis. The context and the factors related or contributing to the appearance of the event must also be considered.

Data Analysis -> Analysis Techniques

The analysis of aggregated data from ESAVI notifications and research aims to characterize the population affected by ESAVI and the event itself and identify patterns related to new associations between the vaccine and adverse events (signs), quality problems of the biological product, and systematic errors in the handling of vaccines or in vaccination (programmatic errors).

Finally, it also aims to evaluate the performance of the activities of the ESAVI surveillance system.

Causality analysis -> CMS Methodology

This analysis aims to establish the level of certainty in stating that the vaccine or the vaccination process was the origin or cause of the clinical picture and the symptoms or signs observed in the vaccinated person.

Feedback

With the conclusions of the event analysis, we proceed to formulate and implement corrective measures that reduce the probability of preventable events occurring, improve the safety of the activities of the National Immunization Program and the performance of ESAVI surveillance.

Pan American Committee for Safe Vaccination (COPAVASE)

Provide independent, authoritative, scientific advice to PAHO on vaccine safety issues.
Provide science-based recommendations to PAHO Member States to improve technical cooperation on vaccine safety.
Serve as a trusted body that generates and disseminates credible safety evidence to support PAHO's timely response to serious or unexpected ESAVIs.

Rigorously review individual cases of serious and unusual ESAVIs and other ESAVIs-related issues referred by the Secretariat of Health to assess a possible causal relationship between the event and the vaccine.
Provide scientific recommendations intended to assist PAHO in formulating policy regarding vaccine safety issues.
Review other important safety issues and issues of regional concern that may affect national immunization programs.

Angela Gentile (Argentina), president
Sarah Bennett (United States of America)
Jorge Cortés (Colombia)
Alejandro Cravioto (Mexico)
Tracy Evans-Gilbert (Jamaica)
Peter Figueroa (Jamaica)
Gloria Giraldo (Colombia)
Herminio Hernández (Peru)
Noni MacDonald (Canada)
Claudio Struchiner (Brazil)
María Teresa Valenzuela (Chile)
Verónica Vergara (Colombia)

DOWNLOAD BROCHURE

Back to menu

COMMUNICATION

Communication and community engagement activities on vaccine safety should be an essential component for immunization programs. Concerns about vaccine safety are strongly associated with doubts, acceptance and demand for vaccines and these concerns and perceptions influence the confidence of the public, health care workers and decision makers.

Therefore, supporting the ability of countries in the Region to communicate the safety aspects of vaccines, the risks and benefits of vaccines, and the diseases they prevent is critical to building trust and supporting the maintenance of optimal vaccination coverage.

Communicating about Vaccination-related Risks

This document seeks to help health communication professionals working on the topic of immunization more effectively communicate about Events Supposedly Attributed to Vaccination and Immunization (ESAVI) by building trust in National Immunization Programs, understanding risk perceptions related to vaccination, and responding to false information related to vaccination. It includes practical dos and don’ts regarding risk communication and community engagement processes and principles, messaging, risk perceptions, handling false information, collaborating with partners, and pharmacovigilance, as well as real-world examples.

You can access the material here

Interpersonal communication for healthcare workers

Although efforts to increase vaccination coverage or strengthen confidence in immunizations require close collaboration among all key players in the areas of immunization and communication, interpersonal communication between health care personnel and the individual (patient, parent, caregiver, child) is essential. Many studies have shown that healthcare workers and their interaction with the individual in the decision to vaccinate constitute the most reliable source of information.

Also, the right message to patients and caregivers at the right time can have a positive impact and maintain or increase confidence in vaccines, credibility in health authorities or all health personnel, and avoid a negative effect on the appreciation of vaccines, vaccination, and immunization.

PAHO has designed a support guide for health personnel to provide them with tools to support effective communication between them and the general population, answering common doubts and questions about vaccine-preventable diseases, vaccines and vaccination.

You can access the material here

Crisis communication

Crises related to vaccines and vaccination require a different communication response than communication strategies to promote the benefits and importance of vaccines in general. Timely and transparent crisis communication can help maintain and strengthen trust between the individual and the health care provider. It is important to note the impact that crisis events related to vaccination safety can have on vaccination coverage. On the other hand, institutional silence can fuel rumors and diminish credibility and trust in authorities and in vaccination.

PAHO has developed a material with guidelines so that countries and immunization programs in the Region can develop and update their crisis communication plans related to vaccine safety.

The material can be accessed here

Risk Communication

Vaccine safety risk communication should consider ongoing communication interventions to maintain public confidence and not be limited to a response during a vaccine safety crisis.

It is increasingly necessary to strengthen the risk communication component as an essential tool to adequately convey to the population all information on the immunization process, from clinical trials and the production of new vaccines to the introduction, distribution, and prioritization of groups to which one or more vaccines should be administered - depending on the definition and availability in each country - as well as universal access to them. PAHO, as part of its ongoing efforts to support the countries of the Americas, has developed guidelines to facilitate the development of a risk communication and community participation strategy for vaccination against COVID-19. Its purpose is to help strengthen the communication capacities and planning of ministries or secretariats of health, as well as other agencies responsible for communicating in COVID-19 vaccines in the Americas. Although this resource is focused on COVID-19 vaccines, it can be adapted for other vaccines.

The material can be accessed here

Videos

Vaccine Safety Surveillance for ESAVI (part 1)

Vaccine Safety: Surveillance for ESAVI (part 2)

Vaccine Safety: Surveillance for ESAVI (part 3)

Vaccine Safety: Surveillance for ESAVI part 1 (reduced version)

Vaccine Safety: Surveillance for ESAVI part 2 (reduced version)

Vaccine Safety: Surveillance for ESAVI part 3 (reduced version)

Communications materials

The Best Vaccine - Social media collection

Blood Clots and COVID-19 vaccines: Materials

Guillain-Barré Syndrome and COVID-19 vaccines: Materials

Heart inflammation and mRNA COVID-19 vaccines: Materials

Courses

Communication on vaccine safety: Guidance to support Health Care Workers

The aim is to provide health teams with tools that will aid them in communicating effectively with the general population, with the purpose of strengthenig or regaining trust in vaccines and immunization programs in the Americas.

Join the course

Courses

Surveillance of Events Supposedly Attributable to Vaccination or Immunization (ESAVI)

In order to achieve the 2030 Agenda for Immunization, it is required, among other activities, to focus on monitoring the safety of vaccines and vaccination, in order to ensure the availability of a supply chain of quality vaccines and supplies with high effectiveness, which are articulated in a service delivery system based on primary healthcare.

Join the course (in Spanish)

Courses

Crisis communication related to vaccine and vaccination safety: technical guidance

Vaccine and vaccination-related crises require a different communication response than communication strategies to promote the benefits and importance of vaccines in general.

Join the course (in Spanish)

Back to menu

QUALITY VACCINES

Taking care of the quality and safety of vaccines includes:

COVID-19 Vaccine Pharmacovigilance Dashboard

Throughout the so-called life cycle of the vaccine, there are different activities planned to verify compliance with clinical research, manufacturing, control, and regulatory practices.

Regulatory entities are responsible for carrying out said inspection.
For its part, the World Health Organization (WHO) provides international guidelines and recommendations for the application of these practices.

COVID-19 Vaccine Pharmacovigilance Dashboard

During the vaccine manufacturing process, there may be situations that lead to non-compliance with the rules of good manufacturing and manufacturing practices or with requirements, specifications and approved standard operating procedures, with the consequent risk for the recipients of the products.

The most common example is microbiological contamination of the vials where the biological product is stored, which can cause local and systemic infections in the recipient.

Functions of the National Regulatory Authority

The NRA must authorize the use of vaccines, define the regulatory and operational frameworks, post-authorization surveillance, evaluate risk management plans, and coordinate with the NIP and entities deemed necessary to create strategies for the management of potential associated risks. The NRA also participates in national committees for safe vaccination, and, in coordination with the NIP, trains all personnel in charge of health surveillance, provides safety data, conducts research, supports the collection of vaccine samples, and analyzes national data, to notify the ESAVI to the WHO collaborating centre, according to regulations.

One of the functions at the national level of the NRAs is: To evaluate the risk management plans of products presented by the manufacturers during the authorization processes and the periodic safety reports. Based on these inputs, the NRA coordinates with the NIP and the entities deemed necessary, the strategies for the management of potential risks associated with vaccines.

The regulatory framework of the countries must contain laws or policies that include:

authorizing the emergency use of medicines and other health technologies
a pandemic preparedness plan in which the emergency use is authorized
technical procedures that resort to the decisions of regulatory authorities of other jurisdictions and the recognition of trustworthy or reference authorities for the authorization of emergency use
a monitoring system for products whose sale has been authorized for emergency use.

Post-authorization Surveillance of Medical Products during a Pandemic Emergency, 21 July 2020
(File PDF / 520.8 KB)

Regulating clinical trials focuses on protecting the safety, well-being and rights of human subjects, ensuring that trials are appropriately designed to achieve sound scientific goals, and preventing fraud and falsification of data.

Considerations for Regulatory Oversight of Clinical Trials in the COVID-19 Pandemic-19
(Spanish Only / File PDF / 364 KB)

The release of batches constitutes one of the basic functions established by the World Health Organization (WHO) to be performed by an NRA and is required for vaccines and other biological drugs as they require special control due to their origin.

This process consists of the review of each batch of a product before giving approval for its release to the market or what is the same, the independent control of each batch ensuring that it has adequate quality and safety.

Lote Release (Spanish Only / File PDF / 825.82 KB)

Back to menu

DISTRIBUTION CHANNELS

Current cold chain and immunization supply chain operations have been one of the key elements in expanding the delivery of daily immunization services and enabling more people to be protected from vaccine-preventable diseases.