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BUENOS AIRES – The leak of a report from the directory of the National Administration of Medicines, Food and Medical Technology (Anmat) of Argentina obtained by the newspaper La Nación that indicates that three adults over 60 years of age presented adverse effects during the voluntary tests of the Sputnik V vaccine prompted authorities at the Gamaleya Institute in Russia to provide hitherto unknown details about the immunizer. Sputnik began to be mini-administered to the Argentines on Tuesday morning. Anmat is the equivalent of the National Health Surveillance Agency (Anvisa) of the neighboring country.
In Brazil, the states of Paraná and Bahia signed agreements with the Russian institute for testing and applying doses. However, the vaccine has not yet been approved by Anvisa. So far, the agency has not received a formal request from Gamaleya to register the immunizer in the country.
Denis Logunov, deputy director of Gamaleya, pointed out the origin of the three adverse effects highlighted in the report: “Renal colic, deep vein thrombosis and abscess (pocket of pus from infection) of the limb caused by an unfortunate nail cut.”
“Twelve participants in the Sputnik V clinical study experienced serious adverse effects (SAEs) among 12,296 participants,” Logunov said, adding that these effects were not “vaccine-related” but “based on pre-existing and documented diseases prior to the start of the test “.
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“Everything was resolved successfully. All adverse effects must be presented in accordance with the requirements of clinical trial procedures, including those that are not related to inoculation, ”Logunov explained of the reported cases, which were not detailed in Anmat’s internal report.
The short half-page report was delivered to the Ministry of Health at Christmas two hours before the folder gave the green light to vaccination in Argentina with Sputnik V.
“Anmat made a correct analysis and is in favor of the vaccine,” Eduardo López, infectologist and head of the Medicine Department of the Ricardo Gutiérrez Children’s Hospital, told La Nación after reading the document.
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The text explains that Anmat’s analysis was based on the information sent by Gamaleya to some 12,296 volunteers, between 18 and 87 years old, of the 40 thousand who participate in phase 3 of the clinical trial. Of these, 10,900 were up to 60 years old and the remaining 1,369 were older. By December 10, 9,258 had received the vaccine and 3,038, 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 RDIF (Russian Direct Investment Fund, responsible for the Gamaleya vaccine) on December 14, 92%. The data in both cases are sustainable and consistent, ”said López.
The details of the interim analyzes for phase 3 of the Sputnik V tests, which will end in May next year, have not yet been published in scientific journals.
Vaccine for people over 60 years old
The Anmat document also detailed that, of the volunteers over 60 years of age, only two positive cases of Covid-19 were confirmed among the 340 who received the placebo and none among those who received the vaccine. However, its use is not recommended in people over 60 years of age because “due to the small number of cases, a level of statistical significance has not been reached (p = 0.062)”.
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López explains: “With the reduced sample and the few cases of Covid-19 among the volunteers, it is not possible to obtain conclusive statistical results in this cut, but there is a trend towards effectiveness, since it is very close to the determined floor of 0.062. This means that, with a greater number of people analyzed, it could be reached ”.
The epidemiologist analyzed the information on adverse effects and cautioned: “Probably, almost certainly, they are not (really) related to the vaccine. An abscess is unlikely to be caused by an immunizer. Or even kidney colic and thrombosis. It’s not common”.
* The newspaper “La Nación” is one of the 11 newspapers that are part of the Grupo de Diarios América (GDA), as well as O GLOBO
