ButanVac: Brazil’s health regulator requests additional documents to authorize trials

The request was made on Monday, April 26th. In a note, the agency said that the "Butantan's authorization request, sent on April 23rd, and the clinical trial protocol sent last Friday, April 23rd, are still incomplete and do not meet the technical requirements for authorizing clinical trials of vaccines in humans."

RIO DE JANEIRO, BRAZIL - The Brazilian Health Regulatory Agency (ANVISA) announced that after the technical analysis of documents and data submitted for authorization of human trials, the so-called clinical trials, of the Covid-19 ButanVac vaccine, developed by the Butantan Institute, it has requested the São Paulo immunization development center for additional documents and information.

The request was made on Monday, April 26th. In a note, the agency said that the "Butantan's authorization request, sent on April 23rd, and the clinical trial protocol sent last Friday, April 23rd, are still incomplete and do not meet the technical . . .

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