Last night, through the journalist Ricardo Benedetti, part of the internal file of the National Administration of Drugs, Food and Medical Technology (Anmat) that recommended to the Ministry of Health of the Nation the “emergency authorization” of the vaccine from the Russian Direct Investment Fund (RDIF), Sputnik V, that will begin to be applied to Argentine doctors tomorrow in the morning across the country.
THE NATION confirmed the veracity of the text through sources with access to the internal document of the Anmat and that exposes part of the information that the RDIF has not yet made public on total “phase 3” volunteers who had adverse effects and what were the same.
According to the text, the most frequent adverse event observed was a flu-like syndrome. Further, three adults over 60 years of age, one of the risk groups against SARS-CoV-2 and a priority in the vaccination line after medical personnel, suffered serious adverse effects after receiving the two doses of the Gam-COVID-Vac vaccine. But according to experts consulted by THE NATION, the latter would be effects that would not have directly to do with the application of the vaccine, although it is not made explicit in the filtered text.
The serious adverse events of Sputnik V are: renal colic, deep vein thrombosis, and a limb abscess. The government plans to start vaccination without warning those who may be harmed. Manuel Limeres knew about this, and also recommended approval [R]
&- Ricardo R Benedetti (@RicBenedetti)
December 27, 2020
Titled: “Drug Evaluation and Registration Directorate Report“, the five-page text is dated December 23 at 11.13.04, is part of the file: NO-2020-89948949-APN-DERM # ANMAT and is signed by Nélida Agustina Bisio, technical analyst and head of the Directorate of Evaluation and Registration of Medicines. As this medium learned, she was not one of the four Anmat technicians who traveled to Moscow together with Carla Vizotti, Secretary of Access to Health of the Nation.
The document is directed Marcelo Alberto Carignani, head of the National Institute of Medicines (INAME); and to Manuel Limeres, head of the Anmat and his second head of the organization, Valeria Teresa Garay.
The report arrived two hours before the Ministry of Health gave the green light to Sputnik V, an attribution that is framed in law 27,573, which was approved by Congress during the pandemic, and there the Anmat acts “within the framework of its powers”, which is to submit a report to the Ministry of Health of the Nation with the recommendation to approve or not. That report, a page and a half, was the one that was known during Christmas and that raised some doubts due to its conciseness.
“It is a favorable report”
“The Anmat did a correct analysis and is favorable to the vaccine“, said to THE NATION, Eduardo López, infectious disease doctor and head of the Department of Medicine of the Ricardo Gutiérrez Children’s Hospital after reading the document.
The text explains that Anmat’s analysis was based on information sent from Gamaleya on 12,296 volunteers, between 18 and 87 years old, of the 40,000 who will participate in Phase 3 of the clinical trial. 10,900 participants were up to 60 years old and the 1,369 over that age. Of these people, as of December 10, 9258 had received the Gam-COVID-Vac vaccine and 3038 a placebo. That is, three out of four volunteers received Sputnik V.
“They propose an efficiency of 96% for this first group and, when it is expanded to the 22,714 reported by the RDIF on December 14, it drops to 92%. The data in both cases are sustainable and coherent, “said López when comparing the Anmat document and the press reports released by RDIF that have not yet published the details of the these “interim analyzes” of phase 3 that will end in May next year.
In the document of the Anmat It was detailed that of the 1,369 volunteers over the age of 60, only two cases of positive Covid-19 were confirmed among the 340 volunteers who received the placebo and none among those who received the vaccine. However, it did not recommend its application in people over 60 because “due to the small number of cases, it did not reach a level of statistical significance (p = 0.062) “.
On this point, López explained: “Due to the smallness of that sample and the few cases of Covid-19 that It occurred among the volunteers, it is not allowed to obtain, in this cut, a conclusive statistical result, but it has a tendency to show that it is effective, since it is very close to that 0.062. This means that with a greater number of people analyzed, they could reach this floor. “
“The data that the Anmat analyzed are very consistent with the data it released, Through a statement, the people of RDIF in the third interim analysis. The one who analyzed the Anmat was the second one, “said López.
Adverse effects in detail
Among the more detailed information contained in the document within the Anmat file is the “security analysis”. Which indicated that of the 12,296 volunteers, there were 8,704 minor adverse effects out of a total of 4401. “The most frequent adverse event observed was flu-like syndrome in people who received the vaccine compared to placebo. In addition, local reactions were recorded at the injection site more frequently than in the placebo group,” says Bisio’s text.
Over the “serious adverse effects”, details that there were 12 in total and that three of them occurred in adults over 60 years of age. “Renal colic, deep vein thrombosis and a limb abscess”, were the complications suffered by three of the volunteers in the risk group.
“They are probably not related to the vaccine. Almost certainly. An abscess is unlikely to be related to the vaccine. The same as renal colic and thrombosis. Not common. It is unlikely to be linked to the vaccine. If the Anmat does not mark it, it is because it considers that it is not critical“Lopez analyzed.
In the considerations, the document detailed that “an acceptable safety profile is reported, there were no unexpected adverse events until the moment of analysis.”
Then he makes a distinction between those under and over 60 years old. In the first group, the efficacy reaches 96% with a “statistically significant difference with respect to the placebo group”.
Meanwhile, for those over 60, “Considering that 1029 subjects were exposed to the product under investigation, a new safety analysis is suggested and the expectation of adverse events that could be observed in a greater number of exposed subjects“.
The document closes: “Based on these data for people over 60 years of age, it is recommended to wait for a report of more data on efficacy, immunogenicity and safety“.
“The decision of the Anmat was correct, with the data available, not to suggest the application in people over 60 years because it lacks more data on the percentage of effectiveness. It is not that it is not effective, but that it needs to be tested on more people, “said López on this point.
The infectologist who is part of the expert committee that advises the Government of Alberto Fernández, added: “The Anmat analysis, which is interim. It was correct. Here is what the Gamaleya Institute sent him“.
López later recalled that the adverse data had not been reported in detail by the RDIF: “They were not verbose in communication and that is what caused some of the doubts that exist“.
THE NATION The RDFI communication team in Argentina was contacted, who indicated that they did not know the leaked document and that they would analyze it before making any statement.
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