After completing data analysis, the National Health Surveillance Agency (Anvisa) requested additional information from the Butantan Institute on dengue vaccine.
The order involves technical data related to the three data packages presented by Butantan.
The analysis is part of the continuous submission process, which allows the agency to initiate the evaluation of technical data from the vaccine as it is generated.
According to Anvisa, there is no definite deadline for the institute's response.
THE CNN contacted the Butantan Institute, which reported that it received requests for information and complementary data.
The questions, according to the institute, “seek to deepen the discussion between Anvisa and the Butantan Institute to reach a product as secure as possible.”
Beginning of vaccine production before release
In January, the Butantan Institute had already begun the production of immunizers against dengue, even before the release of the National Health Surveillance Agency (Anvisa).
According to Butantan, the latest document package for the approval of the vaccine, named “Butantan DV”, was submitted to the agency in December last year, and if approved, it is expected to deliver 100 million doses by 2027.
The institute said the deadline for this analysis takes, on average, 90 days, being counted from the date of shipment.
*Under supervision
This content was originally published in Anvisa charges Butantan data on dengue vaccine on the CNN Brazil website.
Source: CNN Brasil