Special Section: Latin America
two hands, one with a medical symbol and the other with a scale
Pharmacovigilance Systems in Latin America for COVID-19 Vaccines: Brazil, Chile, Costa Rica, and Mexico
Josué Bautista Arteaga
Global Pharmacovigilance Society (GPS)
Americas Region Chairman & LATAM Ambassador

ne of the greatest challenges to pharmacovigilance in Latin America has been the awareness and willingness of the population (patients) and healthcare professionals to report adverse events. With vaccination serving as one of the key instruments in combatting the COVID-19 pandemic, are these pharmacovigilance systems positively influencing this awareness and willingness to be an active part of the surveillance of these vaccines during this public health emergency?

Pharmacovigilance in Latin America works through four steps to examine whether the information obtained through these real-life (or real-world) reports is in accord with previous knowledge of these vaccines or if they present new relevant safety information that demands action: Analyze risk, understand risk, communicate risk, and mitigate risk. This article overviews the state of COVID-19 vaccinations and the systems established to analyze, understand, communicate, and mitigate their risk in Brazil, Chile, Costa Rica, and Mexico.


As reported at the XV Mexican Pharmacovigilance Congress in October 2021, an estimated 300 million doses of four available vaccines were planned to be administered in Brazil by the end of November 2021. The National Drug Monitoring Center, which was established as part of the Brazilian regulatory agency (ANVISA) in 2001, conducts safety surveillance of these vaccines based on five operational pillars:

  • Daily evaluation of incoming notifications
  • Signal detection
  • Risk management plan
  • Monthly executive summary of adverse events
  • Periodic quarterly benefit and risk assessment reports.

Individual reports are received and collected through VigiMed/VigiFlow for evaluation by the ANVISA pharmacovigilance team, and their information is subsequently shared with the WHO database, VigiBase. Another platform, E-SUS Notifica, also collects individual reports. ANVISA has reported that approximately 17,000 notifications had been registered in VigiMed and about 135,000 in E-SUS Notifica by the end of September 2021. Access to VigiMed is available on ANVISA’s home page, and descriptive statistics of these individual reports are available in the PV section of the ANVISA website, which highlights how deeply ANVISA understands the importance of communicating adverse events.

In June 2021, ANVISA launched a social network pharmacovigilance campaign, including videos and other illustrative materials, to educate and encourage the public to learn more about pharmacovigilance and safety for medicines in general and COVID-19 vaccines in particular. In addition, several medical societies have signed and published a public letter of commitment to extol and corroborate their organization’s commitment to pharmacovigilance and patient safety. ANVISA had also published several communiqués (seven in total) to inform the population of known and new risks associated with COVID-19 vaccines available in the country. The most recent one addressed the risk of Guillain-Barr syndrome.


Approximately 35 million doses of four available vaccines had been administered in Chile by the end of November 2021.

The first pharmacovigilance regulations in Chile were published in 2010 and established the Subdepartment of Pharmacovigilance (SDFV) team responsible for coordinating pharmacovigilance activities as part of the Chilean regulatory agency (ISP). During the pandemic, ISP considered the approach of the EMA and other regulators and in December 2020 published Implementation of Pharmacovigilance for SARS-CoV-2 vaccines in Chile to provide technical and regulatory guidance along these pillars:

  • Legal basis for case reporting
  • Report prioritization, investigation, and evaluation
  • Risk management plans
  • Monthly periodic reports.

In addition to this framework, the regulator implemented a system of stimulated passive surveillance, a series of virtual surveys of patients vaccinated against COVID-19 sent to the patient’s email address at three points in time: 48 hours after administration of each dose (inoculation), 7 days later, and finally 42 days after inoculation.

ISP collects individual safety reports through two main channels, ESAVI online and RAM Network. Manual reports may also be emailed to esavi@ispch.cl for the SDFV to evaluate and share in the WHO VigiBase. Approximately 14,000 notifications were received from December 2020 to November 2021. ISP also publishes periodic reports, which include such statistics as severity, gender, age, nature of the event, number of reports per vaccine, and number of reports per number of doses applied, among other elements, from these collected reports. The regulator also communicates the safety and benefit of COVID-19 vaccines to the general public on its own website and other social networks.

Costa Rica

The National Center for Pharmacovigilance was established in Costa Rica in 1998 and was incorporated within the Ministry of Health of Costa Rica in 2005.

As reported at the XV Mexican Pharmacovigilance Congress, a National Technical Working Committee was built by the Costa Rican Social Security Fund, the Ministry of Health (including representation from the National Center of Pharmacovigilance), and other specialists, with the objective of identifying possible risks associated with vaccination against COVID-19. This surveillance scheme for COVID-19 vaccines consists of these pillars:

  • Spontaneous notification
  • Risk management plans
  • Monthly safety reports.

By the end of October 2021, approximately 7 million doses of two available vaccines had been administered. Spontaneous safety reports are collected through four main channels: the regional database Noti-FACEDRA, the Yellow Card, the CCSS Notification Card, and the dedicated telephone line. These channels received approximately 6,000 reports from December 2020 through October 2021. The National Center for Pharmacovigilance publishes periodic reports including such statistics as severity, gender, age, nature of the event, and number of reports per vaccine.


As of the end of November 2021, approximately 132 million doses of eight available vaccines had been administered in Mexico. COVID-19 vaccine safety surveillance in Brazil and Mexico has many similarities. Mexico’s National Pharmacovigilance Center, integrated into the national regulatory agency COFEPRIS in 2001, conducts safety surveillance of these vaccines based on three similar operational pillars:

  • Risk management plan
  • Evaluation of notifications received
  • Signal detection.
Patients and healthcare providers can submit individual safety or risk reports through VigiFlow. Other online resources for vaccine safety reporting, including common side effects and the technical monograph for each vaccine authorized in Mexico, are available on the COFEPRIS website and other websites. The National Pharmacovigilance Center team, which had begun collecting and evaluating safety information in August 2019 (pre-pandemic), has adapted these processes and shares the information collected in these vaccine safety reports with the WHO database, VigiBase.

From December 2020 through the end of October 2021, this team had received and evaluated approximately 31,000 vaccine safety notifications. COFEPRIS has issued monthly reports with statistics describing the seriousness, gender, age, locality, and nature of each reported event. COFEPRIS has also issued several health alerts (six in total) to inform the population about illegal and counterfeit COVID-19 vaccine sales and related issues.

Through these and other paths of action, Brazil, Chile, Costa Rica, and Mexico have adapted current infrastructures and created new ones to communicate relevant safety information to their respective populations with transparency and robustness to ensure that the benefits of COVID-19 vaccines continue to outweigh their risks. These significant system innovations, updates, and improvements have built confidence in the safety science tools that enable us to deal with a pandemic such as COVID-19.

The author gratefully acknowledges the work of Helaine Capucho (ANVISA), Verónica Vergara (ISP), and Xiomara Vega (Ministry of Health of Costa Rica) in preparing this report.