The Agency and the National Immunization Program (Programa Nacional de Imunizações – PIN) are responsible for epidemiological and health surveillance of adverse events after vaccination.
ANVISA’S PLAN FOR MONITORING
Anvisa has published the Plan for Monitoring Adverse Events of Drugs and Vaccines Post-Authorization for Emergency Use. The document defines the guidelines and strategies of the Agency for the confrontation of Covid-19 in Brazil.
Produced based on Anvisa’s experience in pharmacovigilance in previous epidemics and cooperation among regulatory authorities of several countries, the Plan is aligned to the actions of the World Health Organization (WHO) International Drug Monitoring Program.
The Plan details the strategic articulation promoted between the Agency and the National Immunization Program (PNI) for epidemiological and health surveillance of post-vaccination adverse events.
The Agency established the MonitoraCovid-19 Situation Room as one of the mechanisms to monitor the benefit-risk ratio of vaccine use and subsidize regulatory action. It is Anvisa’s responsibility to promote interventions that may range from restricting the use to specific age groups, changes in the package leaflet, withdrawal from circulation of specific batches of immunizers until the cancellation of the experimental use of the vaccine.
NATIONAL IMMUNIZATION PROGRAM (PIN)
The PIN is responsible for recording, investigating and analyzing the causality of occurrences reported by the public health network. The records of these events in the National Health System (SUS) are processed and incorporated to the base of VigiMed, one of Anvisa’s monitoring systems, to be sent to WHO.
Anvisa clarifies that a large volume of records of suspected adverse reactions is expected during the immunization against Covid-19 in Brazil and reinforces that these reactions are investigated to establish the existence of causality of the event to the use of the vaccine. The Sars-CoV-2 immunizer is a new drug and although research has indicated acceptable efficacy and safety during clinical trials, unpredictable or unknown events may occur.
The Plan for Monitoring Adverse Events of Drugs and Vaccines Post-Authorization for Emergency Use, published by Anvisa on January 15, can be consulted here (available only in Portuguese).
On 03/18/2020, Anvisa published a new regulation (RDC 348/2020), that defines the conditions of the priority review for the registration of covid-19 Vaccines .
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.