RIO DE JANEIRO, BRAZIL – The Brazilian Health Regulatory Agency (ANVISA) on Tuesday, May 25, authorized the start of trials of the anti-Sars-CoV-2 serum, developed by the Butantan Institute, in São Paulo.
With the decision, the Butantan Institute may begin to test the serum on trial volunteers. This will be the first time that the serum will be tested in humans.
On March 24, the agency had approved the research, but conditioned to the signing of a term of commitment that provided for the delivery of additional data, which were not available at that time.
Yesterday’s authorization was granted after Butantan supplied the agency with the new clinical protocol with the required adjustments so human trials could be initiated.
The serum is a concentrate of antibodies against the novel coronavirus and can be administered as soon as patients display clinical symptoms of the disease. In March, Butantan had announced that the clinical trial would include transplant patients from the Hospital do Rim (Kidney Hospital) and patients with comorbidities from the Clínicas Hospital, both in the city of São Paulo.
According to ANVISA, the agency conducted the full assessment of the trial proposal, with no involvement of other foreign agencies, since the serum’s initial clinical trial phases will be conducted only in Brazil. “As this is the first time that the Butantan serum will be tested in people, this demanded a careful assessment of the product’s technical and safety aspects,” it pointed out in an official statement. So far, the serum has only been tested on animals.
Also yesterday, ANVISA received a new request for importation from India of the Covaxin vaccine against Covid-19. The request is to import 20 million doses and was submitted by the Ministry of Health on Monday, May 24.