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ButanVac, a candidate vaccine advertised by the Butantan Institute as the first 100% national immunizer, was developed in the United States at the Mount Sinai Institute’s Icahn School of Medicine, the institution told the leaf.
The information, delivered to the report of the director and professor of the institute’s microbiology department, Peter Palese, also appears in a study published in December 2020 signed by researchers from Mount Sinai and the University of North Carolina School of Medicine at Chapel. Hill.
“We have carried out successful experiments with our vaccine based on the Newcastle disease virus [NVD, um tipo de gripe aviária]. In the meantime, we have started phase 1 trials in Vietnam and Thailand with our new (improved) generation of Covid vaccine. We are conducting a phase 1 trial here at Mount Sinai, “the director wrote in an email.
“Yes, we also have an agreement with the Butantan Institute to enter clinical trials in Brazil using our NVD vaccine vector. We are also developing vaccines for Covid-19 variants based on the South African and Brazilian versions for the Butantan Institute.”
Wanted for leaf, the director of Butantan, Dimas Covas, affirmed that “Butantan is doing the integral development of the vaccine based on alliances that we have and with an international consortium.” Mount Sinai, he explained, was allegedly sought out by Butantan to supply the vaccine vector.
He said that there are “innumerable associations”, but that they will only be announced when the respective agreements are signed: “The joint announcements of the associations will be made at the appropriate time by each institution of the consortium.”
Palese and another research director at Mount Sinai, Adolfo García Sastre, have patented the Newcastle disease virus vaccine model in the European patent registry since 2018.
The governor of São Paulo, João Doria (PSDB), said on Thursday (25) to leaf and this Friday (26) to the journalists who participated in a press conference at the institute’s headquarters that the vaccine was the first made with national technology to be applied for human tests.
At no point did Doria and Dimas Covas mention the association with Mount Sinai Hospital.
The vaccine is produced from a virus that causes Newcastle disease (an avian flu) modified to express the Spike protein S (or spike, the hook used by the coronavirus to infect and invade human cells) of the Sars-CoV coronavirus. -two.
After being inoculated into embryonated chicken eggs, the virus is inactivated, the protein is purified, and the final version of the vaccine uses only the protein, without the virus, which also does not infect humans.
In addition to retaining the knowledge of the technology patent, the Mount Sinai Hospital, according to Palese, was in charge of conducting the preclinical tests, performed on animals in the laboratory, which precede the tests in humans.
The technology, therefore, is American, and was published in two publications in scientific journals in 2020, one in EBioMedicine magazine, in November, and another in Vaccines magazine, in December.
Phase 1 clinical trials of the new candidate for immunization, the first to be tested in humans, have already begun in Thailand and Vietnam with an improved version of the vaccine, which is called second generation because it uses parts of the virus, not all. ., to induce an immune response. They were led up Mount Sinai, Palese said.
In Brazil, the Butantan Institute announced that on Friday (26) in Anvisa (National Health Surveillance Agency), it would request to start human tests and that, if authorized, it could start these tests in April. The government of São Paulo has announced that it will do a combined 1/2 phase in humans with 1,800 participants,
The vaccine has an advantage over the other two produced in the country: Coronavac, developed by China’s Sinovac and produced by Butantan itself, and Covishield, developed by the pharmaceutical company Astrazeneca with the University of Oxford and produced in association with Fiocruz. It will have 100% national supplies, while the rest will depend on the imported active pharmaceutical ingredient (API).
ButanVac could also do a rapid, large-scale production after the tests are completed, as there is the possibility of using embryonated eggs, a much cheaper technology present in influenza vaccine production plants around the world, as is the case. from the Butantan factory. .
According to Dimas Covas, the vaccine is intended for low- and middle-income countries, and there have also been advances in the immunizer in Vietnam and Thailand, but each will have its own drug.
Following the publication of this report, Butantan refuted the fact that the statements about Mount Sinai’s involvement were, in his view, “an unofficial statement by a researcher from a US institution. The institution did not authorize the release of his name in statements to Butantan officials on the new vaccine “.
Palese, however, responded to the report’s questions in his corporate email, as well as being the vector’s patent holder and responsible for the development of the vaccine at the hospital.
Butantan also stated that “it is important to highlight that ButanVac is and will be developed entirely in the country, and the international consortium has a very important role in the design of technology and in technical support for the development of immunobiologicals, something fundamental for a safe vaccine and effective “.
“In Brazil, the developer of the vaccine is the Butantan Institute. The vaccine, therefore, is Brazilian and from Brazilians,” the institute repeated.
