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This is the Oxford vaccine, the University of Oxford and AstraZeneca; in Brazil, the tests are carried out by Unifesp and will be produced by Fiocruz
Anvisa begins the first review to register a vaccine against Covid-19
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01/10/2020 – 2:41 PM (Updated 01/10/2020 – 2:59 PM)
Anvisa (National Health Surveillance Agency) received the first request to register a vaccine against covid-19 in Brazil. It is the Oxford vaccine, developed by the University of Oxford, in the United Kingdom, and by the Swedish pharmaceutical AstraZeneca. In Brazil, it has tests coordinated by Unifesp (Federal University of the State of São Paulo) and will be produced by the Bio-Manguinhos laboratory, linked to Fiocruz (Oswaldo Cruz Foundation), in Rio de Janeiro.
Also read: Anvisa facilitates the registration of vaccines in the country
The body that regulates food and medicines in the country received the so-called “continuous shipment”, which means that the technical area of the agency has begun to evaluate the first package of data on the vaccine, which refer to non-clinical studies, as disclosed by Anvisa on this Thursday (1st).
“This does not mean that a conclusion can already be reached on the quality, safety and efficacy of the vaccine, as many data have not yet been analyzed,” he said in a statement.
The “continuous presentation” is a new procedure implemented by Anvisa and specific for vaccines against covid-19. The goal, according to the agency, is to expedite the registration process for these vaccines. In “continuous presentation”, manufacturers send information during the production process.
Typically, data on the efficacy, safety and quality of a drug should be presented at the beginning of the evaluation. In the case of “continuous delivery”, Anvisa will analyze the data as it becomes available.
“Large-scale clinical trials are being carried out with thousands of people and Brazil is participating in one of these studies. The results of these studies will provide information on the vaccine to protect people against covid-19 and will be evaluated in cycles of subsequent review. All available data on the quality of the vaccine will also be evaluated by the Agency, “he said.
“The ‘continuous filing’ will continue until sufficient evidence is available to support a formal application for registration,” he added.
The tests in Brazil will be carried out with 10,000 people and will begin on June 20. The global study was stopped on September 6 due to a serious adverse reaction in a volunteer in the UK, but was resumed three days later throughout the world except the United States.
If approved, Brazil will have access to 30 million doses between December and January and 70 million in the first half of 2021, according to an agreement signed with the Ministry of Health. Brazil is expected to produce 265 million doses by the end of 2021. The vaccine consists of chimpanzee adenovirus, which causes the weakened common cold, and fragments of the new coronavirus, to stimulate the body to produce antibodies.
