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SAO PAULO (Reuters) – The Butantan Institute will request authorization from the National Health Surveillance Agency (Anvisa) on Friday to start human tests of a possible vaccine against Covid-19 developed by the institute linked to the São Paulo state government. two sources familiar with the matter told Reuters.
The Phase 1 and 2 studies will have 1,800 volunteers. The potential vaccine, called Butanvac, is an initiative of an international consortium led by Butantan, and the immunizer will be 100% developed in Brazil, one of the sources said. The São Paulo institute will have 85% of the total production capacity among the consortium members and, in addition to Brazil, the idea is to supply low- and middle-income countries from Butanvac.
The official announcement will be made at a press conference scheduled for 8 a.m. this morning at the Butantan headquarters, in the west of São Paulo, with the presence of the state governor, João Doria (PSDB), and the president of the institute, Dimas Covas. . The information was initially published Thursday night by the daily Folha de S.Paulo and later confirmed to Reuters by sources, who spoke on condition of anonymity.
The vaccine will use inactivated virus technology, which is dominated by Butantan, and the expectation is that it can begin to be produced on a larger scale – in addition to the doses used in the tests – from May, when the institute concludes the production of doses of the flu vaccine for the immunization campaign against the disease, said one of the sources.
The development of the new vaccine, according to this source, does not alter the agreement that Butantan has with the Chinese laboratory Sinovac for the packaging and future production in Brazil of CoronaVac. Not even construction work on a new factory for full production of the Chinese vaccine from January will be affected, at least for now.
The objective, he said, is to increase the supply of vaccines and guarantee the independence of Brazil in the supply of immunizers, without depending on purchases abroad.
Doria posted a video and text message on her Twitter account Thursday night in which she reported on the press conference on Friday morning.
“Once again, science fills us with hope in the fight against Covid-19,” he said without going into details of the announcement to be made.
The first two phases of human testing of a vaccine are carried out with a small number of volunteers and aim to verify that the immunizer is safe and induces the body to produce the expected immune response. In Phase 3, carried out on a larger number of volunteers, the efficacy of the vaccine is tested.
Butantan conducted CoronaVac Phase 3 tests in Brazil. The institute has already delivered 27.8 million doses of the vaccine to the National Immunization Program (PNI) of the Ministry of Health.
Butantan’s contract with the ministry foresees the delivery of a total of 100 million doses of CoronaVac by the end of September, a deadline that Butantan promises to advance until August.
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