Yesterday, Radio Rivadavia journalist Ricardo Benedetti announced on his account Twitter a copy of an alleged internal document of the National Administration of Drugs, Food and Medical Technology (Anmat) according to which Sputnik V vaccine had a total of 12 serious adverse events at the time of analysis, three of which occurred in adults over 60 years of age.
Infobae was able to confirm with agency sources that the five-page text dated December 23 at 11.13.04“It is a report of the file” NO-2020-89948949-APN-DERM # ANMAT.
As it is, the document entitled Drug Evaluation and Registration Directorate Report, signed by Nélida Agustina Bisio, technical analyst and head of the Directorate of Evaluation and Registration of Medicines, exposes some of the information that the Russian Direct Investment Fund (RDIF) has not yet made public on the total number of Phase III volunteers who had adverse effects and which ones were the same.
The report contains the analysis of the results corresponding to 12,296 volunteers aged 18 to 87 years, of which 9,258 received the vaccine and 3,038 a placebo.
According to the text, the most common adverse event observed was a flu-like syndrome in people who received the vaccine versus placebo. In addition, in total 12 serious adverse events were reported, three of which occurred in 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.
And after detailing that the unwanted effects are renal colic, deep vein thrombosis, and a limb abscess, the report assures that Phase III results of the immunogenicity assay were not reported, that is, the ability of an antigen to activate the immune system and induce an immune response.
The document, which is directed by Marcelo Alberto Carignani, head of the National Institute of Medicines (INAME); and to Manuel Limeres, head of the Anmat and his second in charge of the organization, Valeria Teresa Garay, does not give an account of whether the researchers from the Gamaleya National Research Center for Epidemiology and Microbiology stopped the investigation to study cases of adverse events, just as the Pfizer and AstraZeneca laboratories had done at the time in the trials of their respective vaccines.
The document also highlights: “On December 23, within the framework of Law 27,573, this National Administration, raised the recommendation report on the Sputnik V vaccine, to the Secretary of Health Quality, Dr. Arnaldo Medina, to the effects that the Ministry of Health of the Nation decides by virtue of its powers ”.
The report came two hours before the Ministry of Health gave its authorization to Sputnik V, an attribution that is framed in the law approved by Congress during the pandemic, and there 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.
The communication of the decision of the health ministry coincided with the arrival of an Aerolineas Argentinas plane to Moscow to bring to the country the first 300 thousand doses of the formula made in Russia, that finally made its arrival in the country on December 24 and that are already being distributed and will begin to be applied tomorrow, Tuesday.
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