Anvisa (National Health Surveillance Agency) 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.
“For this authorization, Anvisa analyzed data from previous stages of product development, including non-clinical ‘in vitro’ and animal studies, as well as preliminary data from ongoing clinical studies. of acceptable safety of the proposed vaccine”, said Anvisa, in a note.
Any clinical research involving human beings requires the approval of CEPs (Research Ethics Committees) and Conep (National Research Ethics Committee).
If 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.
Announced in March 2021 by former governor João Doria as the first 100% Brazilian vaccine, Butanvac actually has technology produced at Mount Sinai Hospital, in New York, and is a partnership to produce and test the vaccine in three countries: Brazil , Mexico and Thailand.
Initial vaccine results showed good antibody production in vaccinated individuals, according to a study done in Thailand.
So far, Butantan has not released the preliminary results of the phase 1 study conducted in the country. Some mishaps caused clinical studies to be delayed.
“Butanvac was delayed precisely because the dynamics of the pandemic changed, vaccination progressed and we had difficulties finding unvaccinated volunteers. We had to change the clinical trial with Anvisa. Now, it is no longer a first immunization vaccine, but a proposal as reinforcement”, said last Tuesday (29) the director of vaccine production at the institute, Ricardo Oliveira.
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