However, the measure will only take effect if quality, safety and effectiveness are demonstrated, in accordance with technical and regulatory requirements.
Nov 19, Brasilia: Published this Wednesday (18), in the Official Gazette (DOU), Normative Instruction No. 77 aims to speed up the availability to the Brazilian population of vaccine records against Covid-19.
But, according to the National Health Surveillance Agency (Anvisa), the measure will only have an effect if it demonstrates quality, safety and effectiveness, in accordance with the technical and regulatory requirements in force.
The document provides for the procedure for the continuous submission of technical data for the registration of vaccines against coronavirus. In practice, it allows the optimization of the Agency's workforce. That is, as the vaccine technical data is being generated and presented, Anvisa is working on adding the information. Thus, it will not be necessary, therefore, to wait for the studies to be completed before sending the data to the federal regulatory agency. It is worth noting, however, that this procedure will only apply to Covid vaccines that are in phase 3 of clinical development.
“Today's publication is the formalization of a procedure that we had already defined last month, which is the possibility for the company, instead of waiting for all documents to be ready to request registration with Anvisa, it has the possibility to send these documents partially, in small packages, so that we can already do the analysis and already put our considerations, our doubts ", explains the general manager of Medicines at Anvisa, Gustavo Mendes.
Analysis time agility
According to the rule published in the Federal Official Gazette, for each protocol for adding vaccine data, Anvisa will analyze the documentation within 20 days, counting from the date of the protocol. The company will only be able to file a new amendment after the completion of the same previous type. The company will be notified by letter of the conclusion of the analysis of each amendment.
"We believe that if we manage to evaluate a large number of documents before the formal registration request, the analysis time for the registration request will be shorter", adds the manager of Anvisa.
Other leading regulatory authorities, such as the United States, Europe, Switzerland and China, already use the continuous submission in specific situations.
“Here in Brazil, we put this possibility specifically for Covid-19 vaccines because we understand that there is a priority in this election and also because we know that it requires an enormous effort by Anvisa to analyze all these small submission packages that are sent, ”reiterates Gustavo Mendes.
However, the manager explained that Anvisa will not give up any technical requirements. "We are not giving up any technical criteria, any scientific rigor necessary to approve a vaccine here in Brazil."
Vaccine development stages
To be marketed and made available in Brazil, a vaccine must follow several mandatory steps, which include basic research and non-clinical tests, three-phase clinical studies and registration.
The National Health Surveillance Agency is responsible for authorizing clinical trials of vaccines against the new coronavirus that are being studied. Currently, Brazil participates in four tests. Together, they have approximately 33,000 Brazilian volunteers, distributed among the following states: São Paulo, Rio de Janeiro, Rio Grande do Sul, Minas Gerais, Paraná, Federal District, Bahia, the Rio Grande do Norte, Mato Grosso and Mato Grosso southern.
Tests of vaccines authorized in Brazil: Oxford-Astrazeneca, from the United Kingdom; Coronavac (Sinovac-Instituto Butantã), from China; Pfizer-Wyeth, from the United States; and Johnson & Johnson (Janssen-Cilag), from Europe.
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