After announcing simplification measures in the vaccine registration against Covid-19, the National Health Surveillance Agency (Anvisa) will begin the analysis of the first request from register. The announcement was made on Thursday (1st), according to G1.
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The request was filed by the Astrazeneca, a pharmaceutical company that is developing a vaccine in partnership with the University of Oxford, which should be produced in Brazil by the Oswaldo Cruz Foundation (Fiocruz).
The British vaccine is considered one of the main bets for immunization against Covid-19 in Brazil, the portal published.
In the process to release the use of the vaccine in the country, this is the first step to be taken. But immunization can only be authorized after it has passed all clinical trials, which are still in progress.
With the application for registration with Anvisa, the agency’s technicians begin the analysis of the first Test results, even from pre-clinical studies, which do not involve human beings.
If the safety and efficacy results are positive in all phases of testing, the idea is that, with the analysis already advanced, the vaccine registration process will be streamlined.
Anvisa published, on the last 29, a new technique for the registration of the vaccine against Covid-19. The new process, called “continuous submission”, reduces initial documentation, simplifying registration. The goal is to speed up the analysis.
“Normally, all data on the efficacy, safety and quality of a drug and other necessary documents must be presented at the beginning of the assessment in a formal application for registration. In the case of ‘continuous submission’, Anvisa will analyze the data as it is when they become available “, explains the Agency.
Agreement between Government and AstraZeneca
The Ministry of Health and Fiocruz signed a memorandum of understanding with AstraZeneca providing for the purchase of 30 million doses of the vaccine. The forecast for the arrival of doses in Brazil is December this year and January next year, as published by G1.
There is also the possibility of purchasing another 70 million if the vaccine has proven efficacy and safety.
The initial agreement also provides for the transfer of technology developed by the University of Oxford and the AstraZeneca laboratory for local production at Fiocruz. The start forecast is still in the first half of 2021.