Butantan has 1 million vaccines ready and waiting for Anvisa

The agency received a request to register the vaccine on February 6. Since then, three technical demands have been made to the laboratory team to evaluate the vaccine: one on February 14th (answered on March 7th), one on May 22nd (answered on June 13th) and the last on October 2nd (answered on the 14th of the same month).

Anvisa and Butantan have also held two meetings to answer questions about the vaccines. These questions arose following a technical panel with external consultants on July 31, in which they discussed the data received from the vaccine.

Technical requirements are requests for documents that help clarify these doubts and “a common dynamic in the analysis of vaccines and medicines”, says Anvisa. The agency stressed that its teams and those at Butantan maintain a constant channel of communication and that requests are made to the laboratory “requiring explanations or additional data” when Anvisa believes that data is missing in the studies presented.

Anvisa is committed to evaluating the effectiveness and safety of the vaccine, so that its analysis takes place in the shortest possible time. In addition to analyzing and registering dengue vaccines, the agency is also responsible for regulating and monitoring the safety and quality of products such as repellents and tests to detect the disease. Anvisa, in a note to Facto News

After the possible approval of the registration by Anvisa, the price is defined. Butantan must send a request for price authorization to CMED (Medicine Market Regulation Chamber). The organ is made up of a advice of ministers that analyzes and establishes the maximum price that a medicine can be sold in Brazil. The step is mandatory even if the vaccine is made available free of charge by the government.

Then comes the analysis to incorporate the vaccine into the SUS. THE Conitec (National Commission for the Incorporation of Technologies in the Unified Health System) will study this possibility considering points such as relevant results, long-term benefits and risks and potential for technological innovation. At this point, Anvisa has no management.