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The national government will announce today that the Russian Sputnik vaccine may be applied to people over 60 years of age, based on a recommendation of the National Administration of Drugs, Food and Medical Technology (ANMAT).
The Casa Rosada had received a dossier sent from Moscow, which was translated and analyzed in record time, in which the effectiveness of the drug developed by the Instituto Gamaleya.
Once the recommendation is published on the ANMAT official page, the Ministry of Health will issue an official resolution that will officially authorize the application of Sputnik V in the main risk group in Argentina: around 7,400,000 adults who are at mercy of COVID-19. Including the President.
Almost a month after the health ministry approved the emergency use of the Russian Sputnik V vaccine, on Wednesday the regulatory agency gave the go-ahead for its application in adults over 60 years of age.
The definition was expected sometime this week, as he had found out Infobae with high government sources after on Saturday a document of more than 200 pages had arrived from Moscow endorsing the efficacy and safety of the vaccine produced by the National Center of Epidemiology and Microbiology of Gamaleya in people of that age.
After the authorization of the Anmat, the next plane with vaccines from Russia will begin to be applied to people over 60 years old and residents of nursing homes together with the rest of the health workers and the security forces throughout the country. Then progress will be made with teachers, although the Ministry of Education of the Nation remarked that the beginning of the school year will not be subject to the vaccination of teachers.
The emergency authorizations – such as the one that had been granted in December to the formulation – that the treatments and vaccines against the new coronavirus SARS-CoV-2 receive are defined within the framework of the pandemic time that the world has been carrying out almost 12 months.
However, that authorization did not include those over 60. “The study is the same, what happens is that the number of cases of more than 60 years is a thousand something, so they want to expand it a little more, but they came out with the same effectiveness, with the same level of antibodiesIt went very well, but (the President) decided that until he can be vaccinated he does not want to make any image with this, “said the official Gines Gonzales Garcia, in a dialogue that could be seen during the official transmission of the vaccination.
But what did they say from Russia about the statements that went around the world? According to Alexei Kuznetsov, advisor to the Minister of Health of the Russian Federation currently, routine medical use of the Sputnik V vaccine is possible with patients between 18 and 60 years: “To raise the upper age limit, the developers of the vaccine, they are conducting additional clinical trials with volunteers over 60 years of age that are showing good preliminary results. In addition, clinical data are being analyzed and a report is being prepared that will be used by the Ministry of Health to decide on the use of the COVID-19 vaccine for older population groups ”.
The case of Sputnik V is part of Law No. 27573 and ANMAT acts within the framework of its powers; submits the report to the Ministry of Health who is the one that authorizes the emergency use.
The Russian vaccine showed 42 days after the first dose an efficacy of more than 95%. According to the data presented, the efficacy of Sputnik V after 28 days is 91.4%, a figure determined based on 18 thousand volunteers, among whom 39 cases of COVID-19 were detected. Of these, 31 belonged to the group that received the placebo, but the distribution is different because 75% of the participants received the vaccine (and not a 50-50 distribution, as is more usual).
The formulation that owes its name to the famous Russian satellite does not have any element of the coronavirus in its composition, is presented in lyophilized form, that is, as a powder that is mixed with an excipient to dissolve it and then administer it intramuscularly.
The drug uses a human adenovirus technology of two different vectors, Ad5 and Ad26, for a first and a second injection. However, Sputnik V does not contain live human adenoviruses, but human adenoviral vectors that are not capable of multiplying and are completely safe for health.
“Vectors” are vehicles that can introduce genetic material from another virus into a cell. The adenovirus gene, which is the cause of the infection, is removed and a gene encoding the protein of another virus is inserted in its place. The inserted element is safe for the body and helps the immune system to react and produce antibodies that protect us from infection.
The formula can be dispensed in lyophilized (dry) form, which requires common refrigeration, between 2 ° C and 8 ° C. That is an advantage shared with the Oxford / Astrazeneca formula, while the Pfizer and Moderna candidates, due to their type of development, require super-freezing that makes logistics difficult.
So things, The debate that in the meantime is being discussed at the small government table revolves around publishing -or not- the full scientific report that supports the application of the Russian vaccine to those over 60 years of age. And in the face of this discussion, the team of experts that advises the President has already given their vision tending to the full publication of the dossier to avoid a public trial in the media and social networks that affects the majority decision of adults over 60 years of age .
It is a dissemination strategy that tries to block a possible sequence against the massive application of Sputnik V. If the Gamaleya institute report is recommended by the Anmat and approved by the Health Ministry, but the content of the dossier that justifies its health efficacy, it could happen that thousands of eventual elderly patients decide to wait for the arrival of another vaccine when the second wave of COVID-19 has already started.