The approval refers to the Phase II/III clinical trial of the covid-19 vaccine developed by the Butantan Institute; it is expected to include an additional 4,400 attendees
THE National Health Surveillance Agency (Anvisa) authorized the advancement of human trials of Butanvacpotential covid-19 vaccine developed by Butantane Institute🇧🇷 This new stage, divided into two phases (II and III), is expected to include over 4,400 participants.
A bet of the Butantan Institute for Supplementary Vaccination in BrazilButanvac is a recombinant inactivated virus vaccine whose production uses a low-cost process, similar to the one currently used for inactivated influenza virus vaccine.
Tests with Butanvac started in 2021, when Anvisa authorized the start of Phase I in June last year. COVID-19🇧🇷 Therefore, for later stages, the immunizer is treated as a booster dose.
With Anvisa’s approval, Butantan is authorized to begin Phase II clinical trials and, after submission and evaluation of the results, can proceed to Phase III. In these later stages, the researchers intend to evaluate immunogenicity, which is the ability of the vaccine to stimulate the production of antibodies within the body.
In phase II of the human trial, another 400 participants, aged 18 or over, will be included, of which 50% must be elderly (over 60), regardless of their coronavirus infection status. In phase III, another 4,000 volunteers will take part in the tests, this time with 20% of the participants being elderly.
“Father of Coronavac” in Brazil, Dimas Covas leaves the presidency of Butantan to take over the direction of the foundation
According to the agency, meetings were also held with the Butantan Institute, with the aim of aligning all the technical requirements necessary for carrying out these tests and evaluating the evidence already presented.
In order to carry out any clinical research involving humans, the approval of the Research Ethics Committees (CEPs) and/or gives National Research Ethics Committee (Conep)🇧🇷
There is no forecast yet for the completion of clinical trials. If at the end of all stages there is evidence that the benefits of the vaccine outweigh the risks, Butanvac can be registered by Anvisa and manufactured by Butantan for use in the Brazilian market.
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Source: Terra
Camila Luna is a writer at Gossipify, where she covers the latest movies and television series. With a passion for all things entertainment, Camila brings her unique perspective to her writing and offers readers an inside look at the industry. Camila is a graduate from the University of California, Los Angeles (UCLA) with a degree in English and is also a avid movie watcher.
