The National Health Surveillance Agency (Anvisa) informed, this Wednesday (10), that it received the request for emergency use of the vaccine by Convidecia, manufactured by the CanSino laboratory. The request was presented on Monday (8) by the Biomm laboratory, the representative in Brazil of the manufacturer of the vaccine produced in China.
According to Anvisa, the analysis period is seven working days. The period does not consider the process time in technical requirement status, which is when the laboratory needs to answer technical questions asked by the agency within the process.
CanSino’s vaccine is a single dose, as is Janssen’s immunizer. For emergency use requests, the first 24 hours are dedicated to screening the process to verify that the necessary documents are available. According to Anvisa, in the absence of important information, the agency may request additional data from the laboratory.
According to Anvisa, in this case, and exceptionally, the process was made available to the technical team on the 10th and therefore the initial screening should be completed this Thursday (11).
The analysis of the request for emergency use is carried out by a multidisciplinary team that involves specialists from the areas of registration, monitoring and inspection at Anvisa. For the evaluation, the information presented along with the application is used, as well as the information already verified through the continuous submission.
Reference: CNN Brasil
