The National Health Surveillance Agency (Anvisa) announced today (1st) that it has authorized the second phase of clinical trials of Butanvac, a vaccine against covid-19 produced by the Butantan Institute, in São Paulo. At this stage, the consistency of booster doses, immunizer safety and immunization capacity will be analyzed. 
According to Anvisa, the authorization was based on results obtained in the previous phase of the 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 that test a new drug or vaccine experimentally in humans. During the clinical phase, trials must demonstrate safety and efficacy for health. If it is proven that the benefits outweigh the risks, the vaccine may be registered by Anvisa and made available on the market.
Butanvac’s first development phase was authorized by Anvisa in June 2021, when the first volunteers started to be vaccinated.
