Anvisa anuncia autorização para testes clínicos da Butanvac

SAO PAULO, BRAZIL - APRIL 23: An employee shows bottles of vaccine while working on the production line of CoronaVac, Sinovac Biontech's vaccine against COVID-19 at Butantan biomedical production center on April 23, 2021 in Sao Paulo, Brazil. While Butantan Institute works on developing its own vaccines, continues to produce the Chinese CoronoVac developed in partnership with the Chinese laboratory Sinovac Biontech. Brazil already announced that due to lack of vaccines, will finish inoculating high risks groups by September and not by May as it had been announced. The Butantan Institute requested authorization to the Sanitary Surveillance Agency (ANVISA) to start clinical tests with Butanvac, a new vaccine against COVID-19 100% developed in Brazil. (Photo by Alexandre Schneider/Getty Images)
SAO PAULO, BRAZIL - APRIL 23: An employee shows bottles of vaccine while working on the production line of CoronaVac, Sinovac Biontech's vaccine against COVID-19 at Butantan biomedical production center on April 23, 2021 in Sao Paulo, Brazil. While Butantan Institute works on developing its own vaccines, continues to produce the Chinese CoronoVac developed in partnership with the Chinese laboratory Sinovac Biontech. Brazil already announced that due to lack of vaccines, will finish inoculating high risks groups by September and not by May as it had been announced. The Butantan Institute requested authorization to the Sanitary Surveillance Agency (ANVISA) to start clinical tests with Butanvac, a new vaccine against COVID-19 100% developed in Brazil. (Photo by Alexandre Schneider/Getty Images)

A Agência Nacional de Vigilância Sanitária (Anvisa) anunciou hoje (1º) que autorizou a segunda fase de ensaios clínicos da Butanvac, vacina contra a covid-19 produzida pelo Instituto Butantan, em São Paulo. Nesta etapa, serão analisados a consistência de doses de reforço, a segurança do imunizante e a capacidade de imunização. 

De acordo com a Anvisa, a autorização foi baseada em resultados obtidos na fase anterior dos estudos, que demonstraram perfil de segurança aceitável da vacina. Foram analisados dados de estudos não-clínicos in vitro e em animais.

A primeira fase de desenvolvimento da Butanvac foi autorizada pela Anvisa em junho de 2021, quando os primeiros voluntários passaram a ser vacinados.

Fonte: bnews.com.br

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