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The National Sanitary Surveillance Agency (Anvisa) announced on Thursday (1st) that it will begin the analysis of the first application for registration of a vaccine against Covid-19 in Brazil. The agency will adopt a new procedure that it authorized on Tuesday (29): it reduced the initial documentation requirement and simplified the process of immunizers against the new coronavirus.
Two days after the easing, Astrazeneca submitted the first order. The pharmaceutical company is developing a vaccine in partnership with the University of Oxford, which should be produced in Brazil by the Oswaldo Cruz Foundation (Fiocruz). This is the initial step to authorize the application of a vaccine in the country – if it is approved in all the clinical trials, which are still ongoing.
- Anvisa reduces the requirements and simplifies the registration of vaccines against Covid-19
- Oxford vaccine for Covid-19 is safe and induces an immune response, preliminary results indicate
At the current stage, Anvisa technicians can already evaluate the first results of tests, including preclinical studies, which did not involve humans. The idea is to speed up the registration of the vaccine, if it presents positive results of safety and efficacy in the other phases of the studies.
On September 8, phase 3 testing of the AstraZeneca and Oxford University vaccines were to be temporarily halted. One volunteer experienced adverse reactions, but the studies were resumed four days later, on the 12th. The continuation of the investigation was published after the Medicines Health Regulatory Authority (MHRA) confirmed that it was safe to continue the investigation.
Purchase of 30 million doses
The British vaccine is considered one of the main bets for immunization against Covid-19 in Brazil.
The Brazilian government, through the Ministry of Health and Fiocruz, signed a memorandum of understanding with AstraZeneca that provides for the purchase of 30 million doses, with delivery in December of this year and January of next. There is also the possibility of acquiring an additional 70 million if the vaccine has proven efficacy and safety.
In addition, the initial agreement provides for the transfer of technology developed by the University of Oxford and the AstraZeneca laboratory for local production in Fiocruz, with the expected start, according to the ministry, still in the first half of 2021.
