Vaccine Safety

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

The fulfillment of this goal requires, among other activities, to focus on monitoring the safety of vaccines and vaccination, in order to guarantee the availability of a supply chain of quality and highly effective vaccines and supplies, which are articulated in a service delivery system based on primary care.

In the Region of the Americas, vaccines have reached quite high levels of acceptance and confidence, compared to other areas of the world, as a very effective intervention to reduce the frequency and impact of many infectious diseases. However, the general 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, under emergency authorization schemes, the emphasis placed on activities that guarantee the Vaccine safety, including in a very relevant way, the surveillance of Events Supposedly Attributable to Vaccination or Immunization (ESAVI).

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

Key facts
All the countries of 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 most of the countries of the Region, specifically in 17 countries (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 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 mainly generates useful information on rare and very rare adverse events, and on risks related to the quality and problems in the handling of vaccines. This information is used to minimize its recurrence and impact on the health of the population.
 
Generating reliable information from ESAVI allows an objective and timely response to questions from the general public and questions from national authorities about the use of vaccines.