New phase of Butanvac vaccine clinical trial allowed to start

Brazil’s drug regulator Anvisa has authorized the second phase of clinical trials for Butanvac, a vaccine against COVID-19 produced by São Paulo’s Butantan Institute. In this stage, the consistency of booster doses, the immunization safety, and immunization capacity will be assessed.

According to an Anvisa announcement released Thursday (Dec. 1), the authorization was based on results obtained in the previous phase of studies, which demonstrated an acceptable safety profile for the vaccine. Data from non-clinical in vitro and animal studies were analyzed. 

Clinical trials are used by laboratories to test a new drug or vaccine experimentally in humans. During this phase, tests must demonstrate safety and health effectiveness. If it is proven that the benefits outweigh the risks, the inoculation may be registered and made available on the market.