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The National Sanitary Surveillance Agency (Anvisa) temporarily authorized the emergency use of vaccines against covid-19 in Brazil. The decision was communicated by the Collegiate Board of the regulatory body on Thursday (10), during an extraordinary meeting.
According to the director of Anvisa, Alessandra Bastos Soares, the authorization for emergency use facilitates the availability and use of immunizers against the new coronavirus in priority audiences, even if they have not yet obtained registration with the agency. Therefore, it is necessary to meet minimum requirements for quality, safety and efficacy.
This means that the measure opens the way for companies interested in requesting an emergency authorization to place the order. However, Soares points out that no company involved in the manufacture of vaccines has so far sought the agency with this type of demand.
Four vaccines are in the last phase of clinical trials in Brazil.Source: Unsplash
Anvisa also highlighted that it can suspend, modify or even cancel this temporary authorization for the use of the immunizer in Brazil at any time, based on scientific and technical elements.
Vaccines with potential for use in Brazil
At the moment, four vaccines to combat the new coronavirus are in test phase 3 in Brazil. One of them is CoronaVac, developed by China’s Sinovac in association with the Butantan Institute, chosen by the São Paulo government to start immunization in the state from January.
The others are the vaccine developed by Pfizer in partnership with BioNTech, which is being applied in the UK, and the one developed by AstraZeneca and Oxford. Additionally, there are ongoing trials of Johnson’s vaccine.
If these companies want to request the emergency use of their immunizers, they must request it from Anvisa. To grant authorization, it will analyze case by case, considering data from clinical and non-clinical studies, provisional test results, monitoring and control strategies, and good manufacturing practices, among other evidence presented by pharmaceutical companies.
Companies interested in the application will also need to submit data demonstrating that the manufacturing and stability are adequate to ensure the quality of the immunizer. After analyzing all this information received, the decision to grant or not the emergency authorization will be left to the board of the regulatory agency.
