The National Health Surveillance Agency (Anvisa) authorized this Wednesday, the 7th, the start of the vaccination of volunteers in the clinical study of Butanvac, a vaccine with 100% Brazilian production. The decision was taken after a meeting between Anvisa’s technical team and the Butantan Institute, which presented the pending data for the beginning of the application of tests on volunteers.
Butanvac’s clinical research had already been approved by Anvisa about a month ago, on June 9th. However, the beginning of the application in volunteers still depended on the resolution of pending information about the data generated by Butantan regarding the inactivation of the virus.
This Wednesday, this information was presented and Anvisa’s technical team considered the data sufficient for tests on volunteers to start being carried out.
The director of the Butantan Institute, Dimas Covas, even evaluated as “precious” the demand made by Anvisa to carry out an additional test so that the Butanvac vaccine starts testing in humans. “Right now, what we have to do is really get this authorization to apply the vaccine,” said Covas at the end of June.
Butantan, furthermore, indicated that it intends to shorten Butanvac’s testing time. For this, it must request the emergency use of the immunizing agent without the classic efficacy results – obtained in phase 3 of the research, based on data from infections and hospitalizations of study participants. Anvisa, however, still sees a lack of consensus on the new method.
The experimental application of Butanvac will be conducted through clinical phases 1 and 2 and will be divided into three stages: A, B and C. At the moment, only stage A is authorized.
Butantan will begin clinical trials of the new vaccine against covid-19 using groups that will receive a placebo. In the first stage of the studies with humans, 418 volunteers will be called. The requirement is to be over 18 years old, not have had the covid vaccine, or have been infected. Volunteers in Ribeirão Preto (SP) will preferably be selected.
This is because the study is expected to be carried out at the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo (HCFMUSP) and at the Hospital das Clínicas of the Faculty of Medicine of Ribeirão Preto (HCFMRP).
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