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Saúde / 15/04/2021


Brazilian vaccine could be effective for up to 12 years, says USP

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Brazilian vaccine could be effective for up to 12 years, says USP

The Brazilian vaccine developed by scientists USP Ribeirão Preto, called Versamune, can be effective for up to 12 years.

“Versamune has the ability to activate the entire immune system, which not only prevents SARS-CoV-2 entering cells, but also kills already infected cells. We believe that the immunizing agent generates an immunological memory of up to 12 years ”, said Celio Lopes Silva, professor of the Department of Biochemistry and Immunology, Celio Lopes Silva, in an interview with Jornal da USP.

The Ribeirão Preto School of Medicine (FMRP) developed Versamune, in partnership with Farmacore Biotecnologia and the North American PDS Biotechnology.

The consortium filed an order with Anvisa (National Health Surveillance Agency) on March 25 to start clinical tests on humans and expects a response the agency - the same day that the agency received a similar request Butanvac. (see below)

The Brazilian vaccine has already been tested on animals and, according to Helena Faccioli, CEO of Farmacore, pre-clinical tests show that the vaccine did not cause harm to animals.

"Studies show that Versamune is safe, has no toxic effects on animals, and has a great ability to activate antibodies, especially T cells (defense cells that help fight infectious agents)," she said.

The tests

The consortium requested authorization to carry out the phase 1 and 2 studies, to verify the safety and effectiveness of Versamune in humans.

If approved by Anvisa, the test will be done with 360 healthy volunteers, aged between 18 and 55 years old, and in a second moment, 55 to 75 years old.

In the period of 3 to 4 months the side effects will be evaluated and if the volunteers produced antibodies against the covid virus.

Based on good results, the request for phase 3 will be made. The last test stage will last about six months, and 10,000 volunteers will be tested.

If the answer is positive, the consortium intends to request the emergency use of the immunizer Anvisa in the beginning of 2022.

The vaccine

The pre-clinical phase showed that it is necessary to apply the Brazilian vaccine in two doses, with an interval of 21 days between them, for the immunizer to be effective.

The immunizer was developed by joining a replica of the S1 protein, which is a small piece of the spike protein, part of the SARS-CoV-2 responsible for the entry of the virus into human cells, with a nanoparticle.

This combination is injected into people's bodies and the expectation is that the immune system creates antibodies against this piece of the coronavirus and blocks its installation in cells.

In addition, this nanoparticle induces the action of T lymphocytes. So, even if the S1 protein does not produce the expected response, the activated lymphocytes would neutralize the new coronavirus.

"Unlike virus and adjuvant technologies, this vaccine generates a very specific, targeted and powerful immune response, with the capacity to generate immune memory in the body and prevent future reinfections", says Faccioli.


Farmacore did not say what Versamune's final price will be.

"The price will be determined in the industrial scaling phase, but it will have the average cost of the vaccines that are being used today in Brazil", he guaranteed.

The costs of producing the vaccine are about R $ 633 million. The company informed R7 of the amounts spent divided by the production phases.

“The initial investment by the federal government, exclusively for non-clinical research conducted under the coordination of the Ribeirão Preto School of Medicine, was approximately R $ 3 million. For the phase 1/2 clinical trial, the consortium is seeking funds the Federal Government, estimated at R $ 30 million. With certainty, the investment for phase 3, due to a greater number of volunteers and all the logistical issues that this process requires, should be around R $ 300 million (the values ​​are estimated and it is necessary to the quotations and budgets according to the number of participants in the clinical trials) ”, announced the consortium's press officer.


In addition to Versamune, Butantan also awaits Anvisa's response to begin clinical trials of Butanvac, another Brazilian vaccine produced by the Butantan Institute in partnership with the Icahn School of Medicine, at Mount Sinai, in New York (USA).

The Agency reported that there is still a lack of protocols for the preclinical studies of the two immunizers, so that they can be analyzed and, there, released.

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