Brazil has started production of Butanvac, its first vaccine against COVID-19

The Butantan Institute of São Paulo, one of the most prestigious medical research centers in Brazil and Latin America, Production of Butanvac, the first coronavirus vaccine developed in the country, began on Wednesday and that it has not yet passed the experimental phases in humans.

“Butantan today begins to produce the first batch of one million doses of Butanvac, which will be entirely produced” by the institute “without the need to import raw material from abroad”the governor of the country’s most populous state, Joao Doria, reported at a press conference.

Last Friday, the São Paulo entity asked the National Health Surveillance Agency (Anvisa), the country’s highest health authority, authorization to start phases 1 and 2 of human clinical trials.

However, Anvisa on Tuesday asked for additional information on the formula to be able to publish the realization of what will be the first study of Butanvac in humans, since so far it has only been tested in animals.

Despite everything, the São Paulo authorities wanted to anticipate this analysis by the control body and start the production of their candidate, with the forecast to have 18 million doses ready on June 15 beyond the eventual approval date.

“The doses already in production at the Butantan Institute will be stored and supplied to the population after the authorization of Anvisa, which should take place in the second half of the year”, the entity said in a statement.

The first batch of one million doses of Butanvac will be made from a shipment of 520,000 eggs, which will be used as input for the production of the drug. This methodology has been used by Butantan for decades for the production of the influenza vaccine.

The Butantan Institute already produces in Brazil the Coronavac vaccine, from the Chinese laboratory Sinovac, the most used in the country, one of the most affected by the pandemic with nearly 400,000 dead and more than 14.4 million people infected.

Brazil is also producing the vaccine for Anglo-Swedish firm AstraZeneca and the University of Oxford, but from the Oswaldo Cruz Foundation (FioCruz), an organization linked to the federal government.

The epidemiological situation, worsened by the circulation of more infectious variants, including two Brazilian known as P.1 and P.2, has improved slightly over the past two weeks, although it remains at very high levels. .

The country has averaged over 55,000 infections and nearly 2,500 daily deaths from the coronavirus in the past seven days, less than the 3,100 at the beginning of the month.

Brazilian variant P.1 of the coronavirus may be between 1.7 and 2.4 times more transmissible and able to evade immunity obtained by infection with other strains, according to a study using a model to investigate the situation in the city of Manaus during the second wave at the end of last year.

Researchers who publish their results in Science they warn that one must be “careful when extrapolating these results so that they are applicable elsewhere” beyond the Brazilian city of Manaus.

Research conducted by the University of Copenhagen suggests, depending on the epidemiological model used, that it is likely that the P.1 variant is also “Able to escape between 10 and 46% of the immunity obtained by infection with a non-P.1 coronavirus”.

“In Brazil, two variants of SARS-Cov-2 were detected, P.1 from Manaus and P.2 from Rio de Janeiro, although the one that worries the most is the first, which appeared at the end of 2020 in the capital of the State of Amazonas ”, indicates the study.

The team studied the evolution of the covid-19 pandemic in Manaus, which was so affected by the first wave, “that it was thought to be one of the few places in the world to have reached the group immunity “, but there was a second wave in November and December of this year.

The researchers analyzed the P.1 variant with an epidemiological model, which indicates that “it is probable” that this one is more transmissible than the preceding strains of coronavirus and that it can escape the immunity acquired by infection with other strains “according to lead author Samir Bhatt of the University of Copenhagen.

To characterize this variant and its properties, they used various datasets, including 184 DNA sequencing samples, and saw that it had acquired 17 mutations, including K417T, E484K and N501Y, in the spike protein, which is that used by the virus. to enter cells.

Analysis shows that P.1 appeared in Manaus around November 2020 and went from undetectable in genetic samples handled by the team to 87% positive in just seven weeks.

The researchers then used an epidemiological model to compare two different strains of the virus to see which best explained the scenario that unfolded in Manaus at the end of 2020. One of them was the “normal coronavirus” and the other was dynamically adjusted by machine learning to better adapt to real events in Brazil “, explained Bhatt.

While the group noted that caution should be exercised in attempting to extrapolate these results, they stressed that they “underscore the fact that greater surveillance for infections and different strains of the virus. is necessary in many countries to fully control the pandemic. “.

With information from EFE

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