New science demand for Brazil and Russia to resolve objections to Sputnik V’s security

Put in the alongside the accused the efficacy and safety of vaccines – the only scientific discovery to date capable of unraveling the effects of COVID-19 – threatens the certainty that the management of a global pandemic needs; which is characterized precisely by a disruption of daily life and health of people. However, it didn’t take long for scientific objections to appear.

This is how the decision taken by the National Health Surveillance Agency (Anvisa, the Brazilian regulatory body) gained in importance, which recommended that Brazil stop the import of the Sputnik V vaccine, to attribute complications in the technology used for its production and in the quality control of doses.

The most serious question that the Anvisa regulator poses to the Sputnik V vaccine is that from the samples analyzed, the second injection (the adenovirus 5 component) was “capable of replicating”. This means that once inside the body, the adenovirus can continue to multiply.

Consulted by Infobae, Oscar Cingolani, cardiologist and researcher at the Johns Hopkins University, did not hesitate to give an opinion and reflect on the scientific conflict on the safety of the Sputnik V vaccine between Brazil and Russia. “Engaging in these topics of debate raised by science during a pandemic is a way of working together to obtain transparent scientific information, and for the greatest number“, He said Cingolani of Maryland.

Based in the United States, Professor of Medicine and Director of the Center for Arterial Hypertension and the Cardiovascular Critical Care Unit (UCC) Johns Hopkins Hospital, one of the most recognized university hospitals in the world, has played a role of leading scientific disseminator during this period of pandemic: “Brazil and Russia must urgently resolve objections to the safety of the Sputnik V vaccine as it undermines the certainty that pandemic management needs.”

“And they have to do it together, in a sort of virtual scientific table, to expose the objections to the replication of the virus made by the Anvisa agency. And that for its part, the Gamaleya Institute can open all its scientific documentation so that, both the people who hope to receive this vaccine of Russian origin in the coming days; and among those who are already vaccinated with Sputnik V, they can rest quietly and not feel that their health is threatened. The millions of people vaccinated worldwide with the Sputnik V vaccine must be sure that the inoculation they have received is effective and safe, ”said the researcher from Hopkins a Infobae.

Added Cingolani to Infobae: “At this time of the conflict, I want to stay in the center, because I also want to stress that the best way for the Russian Scientific Institute Gamaleya to confront this information about its vaccine is to open its papers scientists who support the discovery and production processes of the Sputnik V vaccine, which is already exported to many countries around the world ”.

One of the guarantees of the criticisms made by the Brazilian agency Anvisa to Gamaleya is that it uses the same Standard of the most prestigious regulators in the world, the Food and Drug Administration (FDA) and the European EMA; both too and so far, they have refused final approval of Sputnik V in their home country. Also, there are geopolitical issues in the middle.

Details of objections

Remember that the Sputnik V vaccine is a vaccine with two different doses. It uses two different adenovirus vectors to perform this task of protecting the body against SARS-COV-2 virus: adenovirus type 26 (Ad26) for the first injection and adenovirus type 5 (Ad5) for the second injection.

Scientists at Anvisa said they analyzed samples from the second injection and found that it was “able to replicate”, which means that once inside the body, the adenovirus can continue to multiply. .

“The platform that uses the Sputnik V vaccine made in Gamaleya is a very safe production technology platform, and it has already been used effectively in the vaccine against the terrible Ebola virus,” Cingolani said.

To explain it simply, When a lab has a vial with the virus formulation, they do not replicate. And for this little bottle to scale and reproduce to vaccinate millions of people, it has to go through a process of genetic engineering. A series of filtrations, purification and sterilization of the formulations is carried out – with nuclear reactors in between – then it is ready to be inoculated, to inject a virus that does not reproduce or does not replicate in the vaccinated body.

“Now, if I or the producing lab does this process incorrectly, the possibility of a virus being incorporated is there. But the idea is that it be conducted in a manner that is appropriate, professionalized and with the scientific rigors of the case.Cingolani added. What the regulatory agency Anvisa Brasil objects to the Gamaleya Institute, the makers of Sputnik V, are precisely the vicissitudes of the filtering production process.

The problem centers on an “adenovirus vector”, a pathogen which normally causes mild respiratory disease but which is genetically modified in vaccines to prevent its replication. In addition, this pathogen is modified to carry the DNA instructions that allow human cells to develop the coronavirus spike protein, which causes the disease. This in turn trains the human system to prepare in case it later encounters the actual coronavirus.

History of a conflict

Russian health authorities and the Gamaleya Institute have also made their voices heard. And through a comprehensive statement, the Russian Direct Investment Fund (RDIF) on Anvisa’s decision to postpone the authorization of Sputnik V in Brazil said: “That they are bringing a libel action against the Brazilian regulator Anvisa for intentionally disseminating false and inaccurate information ”.

Anvisa has made statements without analyzing samples of the vaccine and ignoring official documents sent by the Gamaleya Institute on the absence of replicating adenoviruses. Anvisa has made incorrect and misleading claims without testing the Sputnik V vaccine. And regardless of the official letter from the Gamaleya Institute that there is no replication competent adenovirus (RCA, for its acronym in English). And that only non-replicating vectors with E1 deleted are used. Our legal team will be in touch, ”the Russian Federation said in the statement.

To add more confusion to the facts, the RDIF and Gamaleya appreciated that the Brazilian regulator finally dispelled the confusion it created, because Brazilian officials confirmed they did not generate evidence for the presence of a replication competent adenovirus (RCA) in the Russian vaccine, but they were concerned about Russia’s theoretical regulatory limit for this parameter.

With a critical look at Sputnik V, the prestigious Canadian virologist Angela Rasmussen He told various media outlets that this finding “raises questions about the integrity of manufacturing processes” and that it could pose a safety concern for people with weaker immune systems, if the problem is concluded. is generalized. The decision by the National Health Surveillance Agency (Anvisa) and Rasmussen’s amplified opinion continued to add voices from the scientific world. “This sort of thing calls into question the entire manufacturing and quality control process of the Sputnik V,” noted chemist Derek Lowe in Scientific magazine.

“The debate will end when the parties meet and each presents its arguments with scientific rigor, for example at a televised press conference around the world,” he suggested. Infobae the Argentinian cardiologist and researcher.

“Gamaleya is firm in his position that the virus does not replicate. There is certainly an acceptable replication threshold for the virus; but maybe Anvisa does not accept these settings. More than ever, this needs to be clarified to bring peace of mind to the world’s population, “Cingolani concluded at Infobae.

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