Anvisa (National Health Surveillance Agency) has authorized the advancement of human trials of Butanvac, the potential vaccine against Covid-19 developed by the Butantan Institute.
The endorsement was granted for phase 2 of the clinical trial. This step aims to demonstrate the safety and efficacy of the experimental vaccine. As the vast majority of the population has already been vaccinated, Butanvac is being tested as a booster dose.
The first phase of the study was authorized by Anvisa in June 2021 and started in July of the same year. The regulatory agency said that 4,400 participants aged at least 18 years should participate in the next two phases of the study, with 400 in the second phase and 4,000 in the third.
Once there is proof that the benefits outweigh the risks, the experimental drug may be registered by Anvisa, and made available in the Brazilian market, provided there is a request by the company.
Translated by Cassy Dias