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The governor of São Paulo, João Doria (PSDB), said on Monday, at a press conference, that the delivery of the conclusive study of Butantan in CoronaVac on the 23rd of this month, and the request for definitive registration, the same day. , to the National Sanitary Surveillance Agency (Anvisa), its objective is to ensure agility in the certification process not only in Brazil, but also in other international organizations.
With this strategy, the vaccine should not be certified for emergency use, but rather definitive and can be exported to other countries. The same request, for final registration, will also be taken to the NMPA (National Medical Products Administration), a Chinese institution responsible for regulating medicines.
“The Brazilians want agility, they want vaccines and their protection. They cannot bear living in the midst of a pandemic that kills more than 600 Brazilians today, ”said the governor of São Paulo. “The faster we plan and safely vaccinate, the more lives will be saved in Brazil. We are going to vaccinate immediately, starting in January and with the vaccines that are available, regardless of their origin ”, he amended.
According to the governor, the decision responds to a recommendation of the independent international committee that accompanies the research carried out in partnership between the Butantan Institute and the biopharmaceutical company Sinovac Biotech, from China. He reported that the Brazilian institute and the Chinese company decided to end phase three of the clinical study in the country this week, since the ideal level of 154 volunteers with a positive diagnosis of coronavirus was exceeded.
According to information from the São Paulo government, today phase 3 of Butantan registers 170 contaminated volunteers. The conclusive study will measure the effectiveness rate of the immunizer by comparing how many received the harmless substance and how many took the vaccine. The minimum rate recommended by Anvisa itself is 50% as a protection parameter.
The expectation of the Doria government is to obtain the registration of the Butantan vaccine by the end of this year. “The State Immunization Plan foresees the start of the campaign on January 25, with the authorization of Anvisa or equivalent international organizations, as provided for in Brazilian legislation,” says the São Paulo government.
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