Dengue: Anvisa creates group to evaluate the safety of the Butantan vaccine
⚡ Quick Summary
The National Health Surveillance Agency (Anvisa) established this Tuesday (16) a working group to further evaluate the safety of the Butantan-DV dengue vaccine. According to Ordinance No.
The National Health Surveillance Agency (Anvisa) established this Tuesday (16) a working group to further evaluate the safety of the Butantan-DV dengue vaccine.
According to Ordinance No. 715/2026, the new board is responsible for coordinating and providing technical support to the activities of a panel of experts, responsible for analyzing clinical data on adverse events reported after the application of the vaccine.
Related news:
Butantan is maintaining a study on the dengue vaccine in the elderly.
Municipalities must store the Butantan vaccine until further decision.
See the symptoms to watch out for for those who received the Butantan vaccine.
According to the standard, the working group will work on evaluating additional information presented by the vaccine registration holder and consolidating the data necessary to review the risk and benefit profile of the product.
The initiative takes place in the context of continuous monitoring of vaccine safety, known as pharmacovigilance.
Composition
The group will be made up of representatives from different areas of Anvisa, including sectors responsible for biological products, pharmacovigilance, product monitoring and health inspection, in addition to the agency's directors.
Ministry of Health, as a guest at the activities.
The panel of experts will have a consultative nature and will be made up of professionals external to the agency, chosen based on criteria of technical qualification, professional experience and absence of conflict of interests. Participation will be voluntary and unpaid.
Decision
The ordinance establishes that the conclusions of the working group and panel of experts will serve as technical support for decisions by Anvisa's Collegiate Board, responsible for final deliberations.
The group will have an indefinite duration and may remain active as long as there is a need for monitoring and analysis related to the safety of the vaccine.
← Back