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The National Health Surveillance Agency (Anvisa) finished analyzing the documents already presented by AstraZeneca on the Covid-19 vaccine prepared in collaboration with the University of Oxford. In practice, the agency “is up to date” with what has been presented so far.
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A the analysis of phases 1, 2 and 3 has the status “completed”. Anvisa clarifies, however, that the company can still present more documents, if it considers it necessary.
Recently, the agency has simplified the information requirements that must be submitted for emergency use requests. Before, the pharmaceutical company had to present the number of doses available, and now Anvisa only asks for a forecast of the number of doses that will be available. In the case of registration, the number of available immunizers is not required.
Fiocruz will deliver the documents for the Oxford vaccine registration until January 15
On Wednesday (30), the president of the Oswaldo Cruz Foundation (Fiocruz), Nísia Trindade, affirmed that the final delivery of all documents for the registration of the Oxford vaccine in Brazil must take place before January 15.
“Our registry is already being presented with the prospect of the final delivery of the documents in mid-January, on January 15,” said the president.
The forecast is that the first batch with 1 million doses will be delivered between February 8 and 12.
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‘We look forward to the news of the AstraZeneca vaccine registration,’ says Fiocruz president
The Oxford vaccine has an efficacy that varies between 62% and 90% depending on the dose applied, according to a study published in early December in the scientific journal “Lancet.”
Among the main advantages of this vaccine over other immunizers is the fact that it is cheaper and easier to store, which also facilitates its distribution. Unlike the Pfizer / BioNTech vaccine, for example, it does not need to be kept at -70 ° C and can be kept at normal refrigeration temperatures of 2 ° C to 8 ° C.
On Tuesday (29), the Ministry of Health said that the forecast is to start vaccination against Covid-19 in Brazil between January 20 and February 10, but, for that, it is necessary to register the vaccine with Anvisa.
Argentina approved this Wednesday the emergency authorization for the Covid-19 vaccine developed by AstraZeneca and the University of Oxford.
The product, for which Argentina closed a manufacturing agreement, was registered in the “registry of emergency vaccines of health interest” for a period of one year, the agency indicated in its resolution.
The country’s regulatory agency says the product has “acceptable” risk-benefit.
