João Doria, governor of São Paulo, shows a box from ButanVac, the first immunizer against covid-19 produced in Brazil.MIGUEL SCHINCARIOL / AFP
"A 100% Brazilian vaccine."
This is how the governor of São Paulo, João Doria (Brazilian Social Democracy Party - PSDB), presented ButanVac, the first immunizer against covid-19 produced in Brazil.
The vaccine was developed by the Butantan Institute, which asked Anvisa (the country's regulatory agency) for authorization to start phases 1 and 2 of the tests, in which the safety and ability to promote the immune response will be evaluated with 1,800 volunteers.
Then, in phase 3, the immunizer will be applied to up to 9,000 volunteers to determine its effectiveness.
The vaccine, according to the institute, has already presented in preclinical studies, carried out in animals, a high immune response, which may indicate that a single dose will be necessary for complete immunization in humans, an advantage that only the immunizer, manufactured by Johnson & Johnson.
The expectation is that, if the tests are favorable, it will already be available to the population by the end of the first half of this year.
According to the president of the Butantan institute, Dimas Covas, the immunizer began to be produced in 2020. The vaccine was sent to India to be tested on animals and, according to him, had "excellent" results.
"Since then, it has been an intense fight, an energetic effort by the entire team, both from the point of view of production and international negotiations," he clarified.
Butantan is the main producer of ButanVac, with 85% of the vaccine supply capacity, in an international consortium that includes two other laboratories, one from Vietnam and the other from Thailand, where phase 1 has already started. is that the vaccine is supplied not only to Brazil, but also to other low- and middle-income countries, which have had a more difficult time buying the vaccines currently available.
Covas still plans to send a clinical development file this Friday to the National Health Surveillance Agency (Anvisa) to request authorization for the next phases of the studies.
Production of the vaccine should begin as early as May and the plan is to make 40 million doses available by July, says the Butantan institute spokesperson.
The ButanVac technology is the same that is used in the production of the flu vaccine, which is already manufactured at the institute, being produced in chicken eggs.
According to Dimas Covas, no other immunizer against covid-19 in the world uses this technology.
With this, according to him, it becomes cheaper and safer.
“This is generation 2.0 of the vaccine.
We have learned from previous vaccines and now we know which is a good vaccine for covid-19, and it already incorporates some of these modifications, ”explains Covas.
The immunizer technology uses the inactivated virus of an avian flu, called Newcastle disease, which contains the protein S (Spike) of the coronavirus in an integral way.
When introduced into the body, this protein stimulates the immune response to COVID-19.
This bird flu virus does not cause symptoms in humans, being a very safe alternative, according to Butantan.
According to Covas, ButanVac will already use the S protein of the Amazonian variant, the P.1, more transmissible and possibly more lethal.
Given that Butanvac uses a technology already widely used in the institute itself to manufacture the annual vaccine against the common flu, Covas believes that this will be an added factor to accelerate its development.
The fastest developing covid-19 vaccines in the world took less than six months to complete their phases 1 and 2. "But they were totally new," Covas said.
If the tests prove efficacy and the new vaccine is authorized, it will be an important complement for Brazil, which currently suffers from a shortage of immunizers due to the lack of organization of the federal government and which has so far vaccinated with a dose of less than 7% of the population.
And it becomes a new political asset for Governor João Doria, a political opponent of President Jair Bolsonaro, who insisted on being present on Friday morning at the press conference that announced the immunization.
The Butantan Institute, linked to the Government of São Paulo, already produces Coronavac with the Chinese laboratory Sinovac, responsible for most of the vaccination that is currently carried out in Brazil and that was initially despised by Bolsonaro.
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