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Saúde / 27/03/2021


Butantan develops the first national vaccine against covid-19

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Butantan develops the first national vaccine against covid-19

Fonte AGENCIA BRASIL

The Butantan Institute announced today (26) that it has started to develop the pilot production of the first Brazilian vaccine against the new coronavirus. The expectation is that clinical trials of phases 1 and 2 in humans begin in April, which still needs authorization the National Health Surveillance Agency (Anvisa).

Called ButanVac, this would be a vaccine developed and produced entirely in Butantan, without the need to import the Active Pharmaceutical Ingredient (IFA). According to the government, the results of pre-clinical tests carried out on animals proved to be "promising", which would allow it to evolve into clinical studies in humans.

The pilot production of the compound has already been completed for application to human volunteers during the tests. The results of clinical research in humans will determine whether the vaccine is safe and has an immune response capable of preventing covid-19.

“This is a historic announcement for Brazil and the world. ButanVac is the first 100% national vaccine, fully developed and produced in Brazil by the Butantan Institute, which is a pride of Brazil. It has been in existence for 120 years, the largest producer of vaccines in the Southern Hemisphere, Brazil and Latin America and now placing itself internationally as a producer of vaccine against covid-19 ”, said the governor of São Paulo, João Doria.

Butantan develops the first national vaccine against covid-19

The Butantan Institute announced today (26) that it has started to develop the pilot production of the first Brazilian vaccine against the new coronavirus. The expectation is that clinical trials of phases 1 and 2 in humans begin in April, which still needs authorization the National Health Surveillance Agency (Anvisa).

Called ButanVac, this would be a vaccine developed and produced entirely in Butantan, without the need to import the Active Pharmaceutical Ingredient (IFA). According to the government, the results of pre-clinical tests carried out on animals proved to be "promising", which would allow it to evolve into clinical studies in humans.

The pilot production of the compound has already been completed for application to human volunteers during the tests. The results of clinical research in humans will determine whether the vaccine is safe and has an immune response capable of preventing covid-19.

“This is a historic announcement for Brazil and the world. ButanVac is the first 100% national vaccine, fully developed and produced in Brazil by the Butantan Institute, which is a pride of Brazil. It has been in existence for 120 years, the largest producer of vaccines in the Southern Hemisphere, Brazil and Latin America and now placing itself internationally as a producer of vaccine against covid-19 ”, said the governor of São Paulo, João Doria.

For the production of the vaccine, the institute should use technology already available in its flu vaccine factory, the cultivation of strains in chicken eggs, which generates inactivated doses of vaccines, made with fragments of dead viruses.

The new immunizer initiative is part of an international consortium of which the Butantan Institute is the main producer, responsible for 85% of the total capacity, according to the state government, and is committed to providing the vaccine to Brazil and the countries low and middle income.

Butantan's CEO, Dimas Covas, evaluated that the technology used in ButanVac is a way to take advantage of the knowledge acquired in the development of CoronaVac, a vaccine developed in partnership with the biopharmaceutical Sinovac, already available to the Brazilian population.

“We understand the need to expand the capacity to produce coronavirus vaccines and the urgency of Brazil and other developing countries to receive the product an institution with the credibility of Butantan. Due to the global scenario, we have opened the range of options to offer governments one more way to contribute to the control of the pandemic in the country and in the world ”, said Covas. According to him, the partnership with Sinovac will be maintained and there will be no change in the schedule of inputs China.

The forecast of the CEO of Butantan is that it will be possible to deliver the Brazilian vaccine later this year. “After the end of the production of the vaccine against Influenza, in May, we will be able to start the production of Butanvac immediately. Currently, our factory fills Influenza and CoronaVac. We are in full swing, ”he said.

Technology

ButanVac's technology uses a viral vector that contains the Spike protein the coronavirus in its entirety. The virus used as a vector in this vaccine is Newcastle disease, an infection that affects birds. For this reason, the virus develops well in embryonated eggs, which allows for productive efficiency in a process similar to that used in the influenza vaccine, as disclosed by Butantan and the state government.

“The Newcastle disease virus does not cause symptoms in humans, making it a very safe alternative in production. The virus is inactivated for the formulation of the vaccine, facilitating its stability and making the immunizer even safer ”, says Butantan.


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