ButanVac: Brazil’s health regulator requests additional documents to authorize trials
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 requirements for authorizing clinical trials of vaccines in humans.”
The applications in trials relate to phases 1 and 2, the first in volunteers.
With the sending of the agency’s requirements, ANVISA’s analysis deadline is interrupted, once the agency depends on Butantan’s information to proceed with the technical analysis, says the report. In the same note, the agency listed 44 missing items in the requirements needed to secure authorization.
In a statement, the Butantan Institute said it was advised by ANVISA on Tuesday, April 27th, about the notes and that “it will maintain contact with the regulatory agency to enable the necessary clarifications to proceed with the authorization process for the ButanVac’s phases 1 and 2 clinical trials.”
The reference center stated that “it expects the regulatory agency to have the due sense of urgency and approve the beginning of trials as soon as possible so that the new vaccine, the first one to be produced in the country without the need to import active pharmaceutical ingredients (APIs), may be quickly made available to the Brazilian population.”
Source: Veja
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