Brazil’s Anvisa gives green light to start ButanVac testing pending some paperwork
Brazil’s National Health Surveillance Agency of Brazil (Anvisa) Wednesday authorized the Butantan Institute to carry out human tests of the locally-produced ButanVac immunizer.
São Paulo Governor Joao Doria celebrated the good news, because the ButanVac vaccine does not depend on inputs from other countries. Since 2020 Butantan imported and produces the Chinese Coronavac vaccines, but for weeks there has been a drop in the arrival of Active Pharmacological Supplies (IFA). Diplomatic documents revealed that this decrease in IFA shipments is a consequence of hostile statements by President Jair Bolsonaro, against the Chinese government.
The ButanVac vaccine will be applied in two doses, with an interval of 28 days. The test should be performed at two University of São Paulo hospitals: one in the state capital and the other in Ribeirão Preto.
Trials on volunteers are ready to start as soon as Butantan produces some additional information before beginning phase 1 and 2 of clinical trials. Each of these phases is divided into three steps. The first will involve 400 volunteers. And, at the end of phases 1 and 2, around 6,000 people must have participated in the study. All of them must be 18 years or older.
Butantan Director Dimas Covas said 7 million doses of the drug have already been produced, which will only be applied once the testing phases have been concluded and approved. Butantan has the most important vaccine production plant in the country.
After Wednesday’s decision, Brazil now has four vaccines under test. On April 8, Anvisa authorized studies of the immunizing agent manufactured by pharmaceutical companies Medicago, from Canada, and GSK, from the United Kingdom; on April 19, research was authorized by the Chinese laboratory Sichuan Clover Biopharmaceuticals; and, on May 13, Anvisa gave the green light for Covaxin tests, by the Indian company Bharat Biotech.
The eventual ButanVac vaccine was not developed exclusively in Brazil, since it has knowledge generated at Mount Sinai in New York, in the United States. To produce ButanVac, a virus, Newcastle, is used, which causes the disease in birds. Millions of eggs were used to produce this adenovirus, harmless to humans, a technique that is applied to manufacture flu vaccines.
Anvisa is still waiting for more information to allow studies on humans of Versamune, developed by Brazilian startup Farmacore, and UB-612, also by a Brazilian laboratory.