The National Health Surveillance Agency (Anvisa) authorized, on Wednesday (24), the start of human trials of the anti-covid serum produced by Butantan Institute. The authorization comes after several criticisms of the regulatory body, including by the governor of the State of São Paulo, João Dória, about the delay in the bureaucratic process. Dimas Covas, president of the Butantan Institute, says that the request had been circulating since December; ANVISA, in turn, countered saying that the official documents were only sent at the beginning of this month. 3n161p
In the midst of the discussions, Anvisa also released its order history, which states that the Butantan Institute did not send “basic documents” – the agency’s own terminology – for the approval of the serum responsible for fighting COVID-19. Better late than never, testing the first humans with the anti-Covid serum was approved, upon submission of “complementary documents” by Butantan. According to the official note from Anvisa:
The authorization was conditional on a Term of Commitment which provides for the delivery of additional information. This means that, for the beginning of the study, Butantan will still have to present the complementary information that was not fully made available. For this, an official letter will be sent with a note of pending issues to Butantan, which was already agreed between Anvisa and the Institute.
This will be the first time that the Butantan serum will be tested on people, which required the Agency to carefully assess the technical and safety aspects of the product. So far, the serum has only been tested on animals.
Official note on the Anvisa website
The authorization arrives in good time, given that COVID-19 cases in the country are on the rise and daily deaths reach worrying levels. Considering the lack of management in all governmental spheres, it remains to be hoped that Brazilian science and research will overcome these adversities and be able to fight the virus in the best possible way, even if they have to face denialism and the inability of certain sectors of society.
Everything you need to know about Butantan's anti-Covid serum 3a4g31
The estimate is that the anti-Covid serum will be applied to the first human patients already this week or, at most, in the next. But the questions that remain for many are:
- How does it work?
- Where he came from?
- Is he effective?
First, it is important to explain what a serum is and how it differs from a vaccine. To this end, the showmetech asked for expert opinion Ian Soares Ribeiro, laboratory analyst in Microbiology at Fleury Medicina e Saúde, in Brasília.
The serum is the ready antibody, that is, it will be injected into the human being to fight the pathogen/molecule that is causing damage. For example, the antivenom serum, which has an immediate action against the snake venom molecule. He has an antibody ready to fight precisely this molecule. A preparation process is carried out, usually in large animals, such as horses, with blood removal and antibody separation. Thus, it will fight the pathogen and will be discarded from the organism – there is no memory of it.
This means, in practice, that if you are bitten by a snake, you will have to take the serum again, considering that it works as an instant remedy. Ian also explained the difference about the vaccine process as well:
The vaccine, on the other hand, is a compound made to create a cellular memory in the body that will generate the creation of antibodies. For this, the inactivated pathogen, weakened or only one of its parts (the one that produces the recombinant vaccine, which is the best one) is injected into the body, which will consider the molecule as a threat and will fight against it. From this, there is a whole chain of events that happens in the body that stimulates the creation of antibodies – therefore, it is a longer process.
What is it and how does it work? 6o3o71
It is important to mention that the clinical studies will be carried out in partnership with the Faculty of Medicine of the University of São Paulo (USP) and with the Hospital do Rim e Hipertensão, both in São Paulo. The studies will 3 phases – the first will have some patients selected for the test; the second aims to determine the precise amount of serum to enable the treatment; and the third intends to analyze the effectiveness of the dose.
Having done this analysis, the question that remains is how the anti-Covid serum from the Butantan Institute works. To this end, it is also interesting to show how it was produced: researchers inject inactivated viruses, that is, incapable of generating the disease, into horses — studies show that these animals have a much more concentrated and stronger antibody load than humans. Even inactivated, they have the same molecular structure, which stimulates the production of antibodies in the body of horses, such as.
After this step, the scientists remove the blood plasma of the animal - ing that the plasma constitutes about 55% of the blood and it is in it that the white blood cells (linked to the immune response), red and platelets are located - and, through a filtering process, they remove all the plasma components, with the exception of of antibodies, as Ian explained above. These antibodies are what make up the anti-Covid serum, which will act directly on the recipient organism.
According to an official note from the Butantan Institute about the anti-Covid serum:
The research will be conducted by infectologist Esper Kallás, from USP, and by nephrologist José Medina, both of the state government's Coronavirus Contingency Center.
The serum is made from a virus inactivated by radiation, in collaboration with IPEN (Instituto de Pesquisas Energéticas e Nucleares), also from USP, and applied to horses, which produce IgG antibodies, extracted from the blood and purified with a technique used for decades at Butantan.
Patients who will receive the anti-Covid serum first will be those most likely to develop severe disease, such as immunosuppressed patients, who have recently undergone transplantation and others in the highest risk group. Then, the effectiveness of the drug will be measured in people who have recently contracted the virus, to prevent the disease from getting worse.
Is that you? already done the pre-registration for vaccination in São Paulo?
Sources: CNN | UOL | G1 | Butantan Institute Facebook | Butantan Institute Twitter | Butantan Institute website | Butantan Channel
