Brazil finally approved the import and use of the Sputnik V vaccine

The Brazilian National Health Surveillance Agency (ANVISA), the ANMAT pair in Brazil, finally approved the license for the import and use of the Sputnik V. He did so on the basis of the technical report provided by the Ministry of Health of the Russian Federation.

The Russian Direct Investment Fund (RDIF, the sovereign wealth fund of the Russian Federation) announced ANVISA’s decision to approve a license for the import and use of the Russian vaccine in several states of the country.

This is the second time that the agency has met to assess a possible exceptional approval for the importation of these vaccines. In March, ANVISA rejected a request from the Department of Health to import Covaxin. Among the reasons was the lack of minimum data required for analysis and a certificate of good manufacturing practice.

A negative opinion was also given at the end of April to the requests formulated by ten States to import Sputnik V. At the time, however, in addition to the lack of data, the agency pointed to technical flaws in the studies. and in the production of the vaccine which could pose risks to the safety and quality of the immunizing agent.

Now with approval, Brazil is the 67th country to approve the “Sputnik V” vaccine. The total population of these countries exceeds 3.4 billion people. In terms of the number of approvals received by government regulators, the “Sputnik V” vaccine ranks second in the world.

The news comes the same day Alberto Fernández announced during a video conference with Vladimir Putin that Argentina would start producing the Sputnik V vaccine. “On Sunday, God willing, a plane will leave Moscow with the active ingredient to immediately start production in Argentina. With him will come vaccines for Argentina and also for Paraguay “, declared the head of state on Friday.

Alberto Fernández delivered a very laudatory speech to the Gamaleya Institute and to Vladimir Putin, stressing the help that Russia has given to Argentina in the vaccination operation: “Friends know each other in difficult times and the President of Russia, the Gamaleya Institute, he was next to the Argentines helping us to obtain the vaccines that the world did not give us ”.

The authorization to import and use the vaccine by Brazilian states was accepted after review of a technical report submitted to ANVISA by the Russian Ministry of Health. In addition, the Russian side previously provided the regulator with additional data confirming the absence of replicated adenoviral vectors (RCA). Data from several countries using “Sputnik V” confirm the high safety and efficacy of the Russian vaccine.

Kirill Dmitriev, Executive Director (CEO) of RDIF, expressed “ANVISA’s decision to approve the use of the ‘Sputnik V’ vaccine in several Brazilian states will open up access to one of the best coronavirus drugs in the world. All the necessary documents were presented from the first moment to ANVISA, and subsequently none of the questions posed by the regulator went unanswered following the decision to postpone the approval of “Sputnik V”.

And he added: “Brazil will become the most populous country in South America, in which the use of the Russian vaccine is approved. We are ready to step up cooperation with partners in the country to save lives and overcome the pandemic ”.

The efficacy of the vaccine was97.6%, according to the result of the analysis of data on the incidence of coronavirus in Russians vaccinated with both components of the drug between December 5, 2020 and March 31, 2021. As we know, this vaccine is based on a platform of human adenoviral vectors that cause colds and which humanity has faced for millennia.

The safety, efficacy and absence of long-term adverse effects of adenoviral vaccines have been demonstrated in more than 250 clinical studies carried out over two decades.

Brazil has so far 470,000 deaths and nearly 17 million cases of COVID-19 since the start of the pandemic.

For the moment, ANVISA has only authorized the import of a first batch for this month of June, with doses for the states in the northeast of the country which had expressed their interest in the vaccine: Bahia; Maranhão, Sergipe; Ceará; Pernambuco and Piauí.

To authorize the import, Anvisa has established several conditions: the batches of vaccines intended for Brazil must come from factories already inspected by this agency, Generium and Pharmstandard UfaVita. In addition, vaccines must be accompanied by certificates demonstrating the absence of replicated adenoviruses, as well as reports of microbiological sterility.

The most serious question ANIVSA has asked about the Sputnik V vaccine is it from samples that they analyzed, the second injection (the adenovirus 5 component) was “able to replicate”. This means that once inside the body, the adenovirus can continue to multiply.

End of April, in dialogue with Infobae, Oscar Cingolani, cardiologist and researcher at 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 in times of pandemic is a way of working together to achieve transparent scientific information, and for the greatest number.“, He said Cingolani

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

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

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