Anvisa Authorizes Clinical Trials of The Butanvac Vaccine against Covid

Butantan, however, must still send extra data before the start of the immunizing agent's tests, Doria's bet for the vaccination sequence in Brazil

Brasília and São Paulo

On Wednesday (9), Anvisa (National Health Surveillance Agency) granted authorization to carry out clinical trials (in humans) of the vaccine against Covid Butanvac, under development by the Butantan Institute.

Butanvac. REUTERS/Leonardo Benassatto - REUTERS

But, before starting the vaccination of volunteers, Butantan will still have to present some additional information about the ongoing tests, which are part of the so-called pre-clinical stage (in animals). "Soon after, Butantan should start the experimental application of Butanvac," informed the agency.

ANVISA gave authorization for human trials 75 days after the agency was notified of the existence of the immunizing agent and 48 days after the request was formalized.

The vaccine will be applied in two doses, with an interval of 28 days between them. Butantan's plan is to complete the initial stages, which verify the vaccine's safety and ability to generate an immune response in one month to advance to phase 3, which assesses efficacy in the following two months.

Translated by Kiratiana Freelon

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