The National Agency for the Safety of Medicines recalls this Friday, April 15, cases of vasculitis after vaccination with the Moderna vaccine (Spikevax). Vaccination-related side effects that require special expertise. The ANSM holds a possible signal to study.
A new report released this Friday, April 15 by the ANSM (the National Agency for the Safety of Medicines) reports on several case of side effects observed in data from March 25 to April 7, 2022. According to the agency, since the start of vaccination with the Spikevax vaccine (Modern) 25,314 cases of side effects were analyzed, of which “a large number of cases concern non-serious late local reactions,” it says.
But after “an analysis of the cases of vasculitis‘ the Monitoring Committee believes that this could be ‘a potential signal with the Spikevax vaccine’ leading to a ‘expertise special“.
While the number of reported cases, 26 out of 62 analyzed, is very small compared to the number of people vaccinated with Moderna, this new study analyzes several autoimmune diseases and inflammatory pathologies identified after an injection of the vaccine. But what are we talking about?
“Vasculitides are a group of diseases that have the following in common: a inflammatory damage leads to a fibrosis the walls of arterial, venous and capillary vessels. The symptomatology depends on the type and number of vessels affected,” states the ANSM.
The addition “itis” indicates cases of vascular inflammation, i.e. blood vessels. This inflammation can thus damage the tissues and organs directly supplied by these vessels. In all, it is estimated that there are about fifteen fairly rare pathologies associated with vasculitis. They can affect both women and men of any age. . The median time to onset is 9.3 days after vaccination.
Links to Kawasaki disease
Covid-19 and Kawasaki disease in children are closely linked. This is what scientists are reminding of these potential side effects of the vaccine.
Children, inflammatory syndromes and Covid-19: the warning of the Necker center in Paris
“Vasculitides are recognized complications of SARS-CoV2 disease (which include complications of type Kawasaki reported especially in children). They would be linked to the inflammatory and immune response of the disease, relative severity since intensive care is required for a third of the patientsand mortality is 16% based on summary study of SARS-CoV2 complications,” it said.
“Apart from Kawasaki, large and small vessel vasculitis and cutaneous vasculitis are described, which occur within 2 weeks of COVID-19 and can be severe and affect multiple organs,” the document further specifies.
In light of this study, the ANSM considers as serious the risk of vasculitis following an injection of the Moderna vaccine: “Particular vigilance is required in patients who present shortly after vaccination and after excluding the reactogenicity link, non-specific symptoms persisting in an inflammatory link,” estimates the agency, which announces that it will continue the observations because they are “particularly small vessel damage,” of a “potential signal” .
In total, more than 23,571,000 injections have been administered since Moderna vaccination began through April 7, 2022.