The leak of a report from the ANMAT Drug Evaluation and Registration Directorate in which it was stated that three adults over the age of 60 who were volunteers in phase 3 of the Sputnik vaccine suffered Serious adverse effects, but without specifying what each one was, led to the authorities of the Gamaleya Center providing details, until now, unknown.
After a consultation from LA NACION on the internal document of the AnmatThis noon from the laboratory they indicated that they were unaware of it and that they were going to evaluate it.
At 7:43 p.m., through a press release, the answer came in the mouth of Denis Logunov, deputy director of the Gamaleya Center, who pointed out the origins of the three adverse effects highlighted in the report: “Renal colic, deep vein thrombosis and a limb abscess”.
“Twelve subjects in the Sputnik V clinical study have experienced serious adverse effects (SAE) from 12,296 subjects “, Logunov started in his explanation. And he added that these effects were not “related to the vaccine”, but were “based on pre-existing diseases and documented before the start of the trial.” Then, the executive detailed the cases of those over 60 years old.
According to the deputy director of the center in charge of the manufacture of the vaccine, which will begin to be applied on Tuesday morning throughout the country, the SAE includes “kidney stone disease, deep vein thrombosis and limb abscess, caused by an unfortunate nail clipping“.
“All these conditions have been resolved successfully. All SAEs should be reflected in accordance with the requirements of clinical study procedures, including those not related to inoculation“Logunov clarified to clear up doubts about the reported cases that were not detailed in the ANMAT internal report, which bears the signature of Nélida Agustina Bisio, technical analyst and head of the Drug Evaluation and Registration Directorate.
Entitled: “Drug Evaluation and Registration Directorate Report”, the five-page text is dated December 23 at 11.13.04 and is part of the file: NO-2020-89948949-APN-DERM # ANMAT. The document is addressed to Marcelo Alberto Carignani, head of the National Institute of Medicines (INAME), Manuel Limeres, head of the Anmat, and his second head of the agency, Valeria Teresa Garay.
The report came two hours before the Health Ministry gave the green light to Sputnik V, attribution that is framed in law 27,573, approved by Congress during the pandemic. The Anmat, meanwhile, acts “within the framework of its powers” and submits a report to the Ministry of Health of the Nation with the recommendation to approve or not. That report, of a page and a half, was known during Christmas and 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 Medicine Department of the Ricardo Gutiérrez Children’s Hospital after reading the document.
The text explains that Anmat’s analysis was based on the 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. Of these, 10,900 participants were up to 60 years old and the remaining 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 (Russian Direct Investment Fund) 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. The details of these” interim analyzes “of phase 3 have not yet been published in any scientific journal. it will end in May next year.
In the Anmat document, it was detailed that, of the 1,369 volunteers over 60 years of age, only two positive cases of 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 this sample and the few cases of Covid-19 that 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 that 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.
To close, the epidemiologist analyzed the information on adverse effects and warned: “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. It is not usual. 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. “
According to the criteria of