Pharmacovigilance of COVID-19 Vaccines in Brazil: Actions Taken, Lessons Learned, and Next Steps

Objective: To document the actions taken by Brazil's National Immunization Program for the pharmacovigilance of COVID-19 vaccines. Methods: Documentary research on the period 2020 to 2023. Documentary sources from the national Ministry of Health during COVID-19 vaccination were used to analyze and interpret the actions taken. The analysis was split into two stages: preparation and operationalization. The publications were organized according to title, date of publication, description, and URL. Results: A total of 86 documents published during the preparation and operationalization of vaccination were found and evaluated. In the preparation phase, a technical advisory board on immunization was set up and specific technical notes were published for COVID-19 vaccines and the introduction of a new information system. In the operationalization stage, the Interinstitutional Committee for Pharmacovigilance of Vaccines and other Immunobiologicals was created. Also, hospital sentinel surveillance systems were established for adverse events of special interest, and surveillance of COVID-19 vaccination safety in pregnant women was implemented. Conclusion: Pharmacovigilance was strengthened in the context of COVID-19 vaccination in Brazil. Given the gaps in knowledge about the new vaccines, as well as the infodemic surrounding them, it was necessary to adopt strategies to complement the passive surveillance system for monitoring vaccination safety. Inter-institutional collaboration, the availability of additional resources, and flexible and timely information systems all contributed to a comprehensively effective preparation and response in the pharmacovigilance of COVID-19 vaccines in Brazil.