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The president-director of the National Health Surveillance Agency (Anvisa), Antônio Barra Torres, wished “good luck” to the Governor of São Paulo, João Doria (PSDB), after anticipating the agency and announcing the start date of the vaccination against covid-19 in the state.
“None of the four [vacinas em desenvolvimento no Brasil] archived in registration documents, so we don’t even have the protocols to analyze. Before verifying these registration protocols, we must access the clinical trial documents for phase 3 of the trials. However, these studies have not yet been completed. To register the coronavirus vaccine, we need at least 60 days to analyze the documents, “said Barra Torres, without mentioning Doria by name, during an interview with Jovem Pan radio.
“Despite the prediction, I am not going to create expectations in the population that is already so affected by the pandemic with contradictory news. It is terrible to create an expectation that may not materialize. that is, there may be glitches and problems that can change the entire calendar. We can have the grateful joy that, right at the turn of the year, we have a concrete possibility of distributing the vaccine or, even in 2020, we approve the emergency use. it can happen, but we should not set deadlines, “
Doria previously announced that the PEI (State Immunization Plan) against covid-19 will start with health professionals and people over 60 years old. The campaign is expected to start on January 25, but this still depends on the approval of the CoronaVac vaccine by Anvisa (National Health Surveillance Agency).
At a press conference at the Palácio dos Bandeirantes, Doria also reported that the São Paulo government will offer 4 million doses to other states, enough to vaccinate 2 million people, since two doses per person will be needed. However, he did not reveal which governors asked their states for the vaccine; He only cited two mayors.
“In the state of São Paulo, the start of vaccination is scheduled for January 25. Phase 1 will be aimed at health professionals and people over 60 years of age. The choice of the target audience took into account the incidence of deaths , a total of 77% of the deaths due to covid were concentrated in people over 60 years old, ”said Doria.
CoronaVac is the vaccine developed and tested by the Chinese laboratory Sinovac, in partnership with the Butantan Institute, linked to the São Paulo government. Phase 3, clinical trials, ended two weeks ago, but the effectiveness rate has not yet been published.
“[A vacina] it will be free for everyone. The São Paulo government will also make the total of 4 million doses of CoronaVac vaccine available to other states to states that request it. The objective is that these states can begin to immunize their health professionals, a priority public in the fight against covid-19, recognizing the sacrifice of those who risk their lives to save lives, “said Doria.
The São Paulo government has already signed an agreement to have 46 million doses of the immunizer, which is enough to vaccinate 23 million people, since two doses are needed.
The first phase of vaccination, announced today, should have 18 million doses (that is, for 9 million people). The estimated time between the first and second doses is 21 days.
The forecast for January 25 depends on Anvisa
However, the state plan still depends on Anvisa’s approval. According to the Butantan Institute, documents with the latest testing phase will be sent to the regulatory body next week, on December 15. These documents include, in particular, the result of the efficacy test.
Anvisa has a maximum response time until January 15. There is no guarantee that the vaccine will be approved, but the São Paulo government is confident. According to Dimas Covas, director of the Butantan Institute, the planning for the 25th includes possible complications with the agency.
Originally, Doria had announced the start of immunization for December. “Amendment 15 [de dezembro] a 25 [de janeiro] it is because reality has imposed it. We are in the process of producing the vaccine and in the process of completing the efficacy evaluation of the clinical study, as well as [a avaliação pelo órgão] the factory there in China. These are the three elements that make up the album. This date is compatible with these three elements. It is an initial date and it is very likely that it will happen as planned, “said Covas, at the press conference.
In Brazil, four vaccines against covid-19 are being tested, but none have been officially registered by Anvisa.
