New adverse effects identified following vaccination against Covid-19? “After blood clots in young people, the FDA recognizes blood clotting in the elderly. But our ministers still do not read this information from the US, ”says a user on Twitter. Many of them share this information, relying most of the time on an article from the cogiito.com website, “the free media of citizens who allow themselves to think! as he describes himself.
The article in question is based on a study reportedly conducted by the FDA, the US Food and Drug Administration, titled “Covid-19 Vaccine Safety Monitoring in People Age 65 and Older.” », and published in November in the journal Vaccinated. “The hour of truth is approaching for an unprecedented health scandal”, comments a user. What about this investigation? 20 minutes make the point.
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The article on which Internet users rely does indeed explain that the FDA investigation “highlights the fact that covid injections cause blood clotting in the elderly”. Adding that the phenomenon is “so widespread among the ‘fully vaccinated’ that further investigation is warranted”.
Regarding this famous FDA investigationit was conducted in conjunction with researchers from the US Drug Administration, as well as Acumen LLC which is Stanford University and the Center for Medicare and Medicaid Services.
As for the method, it is as follows: “We evaluated 14 outcomes of interest after vaccination against COVID-19 using data from the United States Centers for Medicare & Medicaid Services (CMS) covering 30,712,101 elderly people. CMS data from December 11, 2020 to January 15, 2022 included 17,411,342 COVID-19 vaccinees who received a total of 34,639,937 doses. »
A study to be interpreted with caution
Various analyzes were carried out, in particular on blood coagulation, but also on acute myocardial infarction and pulmonary embolism among others. According to the analyses, four results reached “the threshold of a statistical signal after vaccination”, among which, disseminated intravascular coagulation, which is discussed in the posts on social networks.
But then it is explained that “after further evaluation”, the statistical threshold for a signal was no longer met for three of the results, including disseminated intravascular coagulation. Only the pulmonary embolism remained above the signal threshold, and therefore remained of concern.
The researchers noted that the results “must be interpreted with caution because the early warning system [NDLR : Nom de la méthode d’enquête] does not prove that the vaccines caused the results”. They also concluded, “The FDA strongly believes that the potential benefits of vaccination against COVID-19 outweigh the potential risks of infection with COVID-19. »
For its part, the European Medicines Agency (EMA) has already studied cases of bleeding disorders. “The summary of product characteristics (SmPC) and package leaflet have been updated to include adverse reactions such as thrombotic thrombocytopenic syndrome and coagulation disorders”, mentions the follow-up summary of adverse effects cases published in June last by the ANSM.
This only applies to Astrazeneca and Janssen vaccines. For the latter, it was even indicated that “everyone vaccinated should consult a doctor immediately if they develop signs and symptoms suggestive of bleeding disorders”.