ButanVac must receive authorization from Anvisa only in September

The Butantan Institute announced, this Friday (23), that ButanVac, the 100% Brazilian vaccine against covid-19, should be ready to receive emergency authorization from Anvisa only in September 2021. Previously, there was an expectation that the immunizing agent could begin to be applied in the population in July.

Butantan filed today with Anvisa the request to carry out studies of phases 1 and 2 of the vaccine. Only after the approval of the country’s health agency can scientific tests on humans begin.

According to Dimas Covas, president of Butantan, the study should last around 20 weeks. Around the 16th week, in the 4th month of research, it will be possible to request emergency authorization for Anvisa, explained Covas.

In a press conference at Palácio dos Bandeirantes, seat of the government of São Paulo, the president pointed out that ButanVac’s research will be of “comparability”.

“Since there are already vaccines being applied, the idea behind the study is to compare the safety and immunogenicity response of this new vaccine with the others and thus demonstrate its efficiency,” he said.

The studies of phases 1 and 2 of ButanVac will have about 1,800 volunteers, jumping to 9,000 volunteers in phase 3. People over 18 years old will be the target audience of the vaccine.

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