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Anvisa (National Health Surveillance Agency) decided on Thursday (10) to grant a temporary authorization for the emergency use, on an experimental basis, of vaccines against Covid-19 and established rules for companies to request authorization. The decision was unanimous among the directors. At the beginning of December, Anvisa had already defined the requirements to request the use of emergency vaccines.
In practice, the measure opens the way for companies to make this emergency request. “Authorization for emergency use is a mechanism that can facilitate the availability and use of vaccines against Covid-19, even if they have not been evaluated under the scrutiny of the registry, as long as they meet the minimum requirements of safety, quality and effectiveness “, said Alessandra Bastos Soares, director of Anvisa.
The agency still did not receive any request for emergency use or request for immunization records. He also stressed that this request must be made by the company.
“Any authorization granted by Anvisa, any consent, will only be made upon request. The vaccine will only be authorized for experimental and emergency use if there is a claim made by a company”Soares said.
Anvisa indicates that it may modify, suspend or cancel the temporary authorization at any time, based on technical and scientific elements.
Four vaccines are in phase 3 trials in Brazil: Pfizer, Oxford, Johnson, and Sinovac.
The application of a vaccine against Covid-19 in Brazil depends on the approval for the use of the new drug. Permission can basically be obtained in two ways. The first is directly linked to the two types of registration (traditional or emergency) that the National Health Surveillance Agency (Anvisa) can give.
The second possibility, on the other hand, is based on the so-called “Covid Law”, which releases the use if the immunizer is endorsed by an external agency, regardless of the Anvisa registration.
- Anvisa – definitive record: the developers send the registration request to Anvisa only after completing the 3 vaccine testing phases. To speed up the process, the agency created the procedure for continuous data submission.
- Anvisa – emergency use: allows developers to submit data proving efficacy and safety before completing phase 3 of the vaccine;
- Lei Covid – It establishes that Anvisa will have a period of 72 hours to grant the authorization if the immunizer has managed to register in Japan, the USA, Europe or China. If the deadline is not met and Anvisa does not respond, the authorization is granted automatically.
