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BRASILIA – A Oswaldo Cruz Foundation (Fiocruz), public laboratory linked to Ministry of Health, you must apply until next week to register the vaccine developed by Oxford University and the pharmaceutical group AstraZeneca. The immunizing agent is the federal government’s main bet to fight the pandemic. Fiocruz intends to deliver 210.4 million doses in the country throughout 2021, enough to vaccinate more than 105 million people.
The idea of taking the request to the National Health Surveillance Agency (Anvisa) between the end of 2020 and the beginning of the following year had already been announced by Fiocruz and cited by the Ministry of Health. In an interview with Rádio Gaúcha, this Monday, February 28, the vice president of Production and Health Innovation of the foundation, Marco Krieger, confirmed that the calendar is being maintained.
Fiocruz intends, in early January, to begin producing doses of the vaccine. The forecast is to receive the Anvisa registration until February and, subsequently, release the doses already manufactured. Health Minister Eduardo Pazuello says vaccination in Brazil should begin in mid-February.
The Brazilian laboratory will request the definitive registration of the product. With this type of guarantee it is possible to deliver the doses in bulk to the population and even use them in the private network. Fiocruz, however, sells its doses only to the public network. Anvisa has up to 60 days to evaluate the registration request. The expectation of the public laboratory is that the analysis will be faster, since the initial data (phases 1 and 2) on the development of the immunizer has already been delivered to the agency.
One option is to test approval for temporary and emergency use of the vaccine. In this case, Anvisa estimates to finish the analysis in up to 10 days, but the product could only be applied in small groups, such as health professionals. Fiocruz should not attempt this type of authorization.
Krieger told the Status that documentation will only be brought to the agency after the release of the final data (phase 3) of the immunization development research. He said the order will be placed “at the latest” next week. AstraZeneca claims to have found, after further research, “the winning formula” for its COVID-19 vaccine. In an interview with the Sunday Times, the chief executive of the pharmaceutical company, Pascal Soriot, said that the immunizer guaranteed “100% protection” against severe forms of COVID-19.
The percentage cited by Soriot refers to the power to avoid the severe form of covid-19. The data on the effectiveness of the vaccine, that is, the prevention of the development of the disease based on the protection created by the product, are still unknown. The vaccines developed by Pfizer / BioNTech and Moderna were 95% and 94% effective, respectively.
“We haven’t seen this data yet, but the CEO of the company was the one who spoke. My belief was that this evolution would happen. I didn’t imagine it would be that fast,” Krieger said. Status on Soriot’s speech.
The representative of Fiocruz also says that the new vaccines are a “revolution” in the fight against infectious diseases. “There is anxiety, but the outlook is good. Brazil may have more than one vaccine in a short time. We are excited about the results of these new technologies,” Krieger said.
Anvisa has already certified the AstraZeneca plant, located in China, which produces the pharmaceutical input delivered to Fiocruz. The Brazilian laboratory, in the first semester, must carry out the final stages of preparation of the vaccine. The idea is that all the product is manufactured in Brazil as of the second half of 2021.
According to the national immunization plan of the Ministry of Health, the production of doses in Fiocruz is expected to begin in January. The first batch of 15 million doses will be delivered the following month. In the first half, the idea is to manufacture 100.4 million. In the second semester, more than 110 million doses with entirely national production. The vaccination schedule for the priority groups was developed based on the forecast of available doses of this vaccine in 2021.
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