The National Health Surveillance Agency (Anvisa) reported that, on Monday, 28, a meeting was held with technicians from the agency and the Butantan Institute to discuss the Butanvac vaccine against covid-19. According to the agency, the clinical research protocol is already approved, but there is still a lack of specific data to start the tests in humans.
In a note, the regulatory body states that the purpose of the meeting was to evaluate the information already presented by Butantan. “But for the vaccine to start being applied to human beings, it is necessary to present specific data, which are still being generated by Butantan”, he says. According to Anvisa, an example of the missing data refers to the inactivation of the virus used in the vaccine.
On June 9, the agency authorized the start of clinical research on the immunizing agent. At the time, Anvisa said that 400 people over 18 should participate in the first stage of the study. In the others, 6,000 volunteers are expected to receive the vaccine. The administration of Butanvac, which takes place in two doses with an interval of 28 days, will take place at the Hospital das Clínicas (FMUSP) and at the Hospital das Clínicas of the Faculty of Medicine of Ribeirão Preto.
On June 14, São Paulo Governor João Doria (PSDB) stated that clinical trials of the Butanvac vaccine should begin by the end of the month. According to Doria, the three phases of clinical trials should be completed in 120 days. After that, the data is submitted to a new evaluation by Anvisa.
Butantan’s press office informed that the data requested by Anvisa are being provided and that, in the meantime, the pre-registration for volunteers remains open. More than 93,700 people signed up on the Butanvac website to participate in the vaccine trials.
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