ButanVac should receive authorization from Anvisa only in September


ButanVac: The Butantan Institute announced, on 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 immunization could start to be applied in the population in July.

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

According to Dimas Covas, president of Butantan, the study is expected to take about 20 weeks. By the 16th week, in the 4th month of research, it will be possible to request emergency authorization from Anvisa, explained Covas.

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

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

The studies of phases 1 and 2 of ButanVac will have about 1.8 thousand volunteers, jumping to 9 thousand volunteers in phase 3. People over 18 years will be the target audience of the vaccine.


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