Moderna vaccine: what are vasculitis, possible complications monitored by the ANSM?

Arm pain, headaches, fatigue… The side effects of vaccines are multiple. But the majority are expected and not serious. In total, more than 109,573,000 injections have been performed as of April 7, 2022, for 99,331 cases of adverse effects. For the past few weeks, it has been the Moderna vaccine (Spikevax), which has been scrutinized by the ANSM. In question: several cases of vasculitis (an inflammation of the wall of blood vessels) have been identified following an injection.

Moderna vaccine: 26 cases of “vasculitis” have been declared

Since the start of vaccination with the Spikevax (Moderna) vaccine, 25,314 cases of adverse reactions have been analyzed for more than 23,571,000 injections performed as of April 7, 2022.”Following an analysis of cases of vasculitis (inflammation of blood vessels), the committee considers that this is a potential signal with the Spikevax vaccine. A total of 26 cases have been reported since the start of follow-up, all with favorable outcome after corticosteroid therapy. The time to onset as well as the immuno-inflammatory mechanism of these events cannot currently exclude a role for the vaccine. These events will be shared at European level. There were no other signals identified during the period with the Spikevax vaccine.“.

Vasculitis – these rare autoimmune inflammatory diseases – can, however, cause serious complications.

Inflammation of the wall of blood vessels – which can affect people of any age – is often accompanied by ischemia (insufficiency of blood supply to an organ), necrosis, hemorrhages.

The National Agency for the Safety of Medicines for its part recalled that “the symptomatology depends on the type and number of affected vessels“.

Other important information: the median age of the cases observed in the study “is 62.5 years” and the average time to onset is “9.3 days after vaccination“.

Although young people seem to be more “spared” by these vasculitides, other large-scale surveys must be carried out before drawing conclusions.

Covid-19 and Kawasaki disease

Still according to the agency, vasculitis caused by Covid-19 is closely linked to Kawasaki disease; a pathology characterized by inflammation of the blood vessels occurring mainly in children.

“Vasculitis is a recognized complication of SARS CoV2 disease (which includes Kawasaki-like complications reported particularly in children). They would be linked to the inflammatory and immune response of the disease, of relative severity since intensive care is necessary for a third of patients, and mortality is at 16% according to a summary study of the complications of SARS CoV2.can we read in the pharmacovigilance survey.

According to these results, complications are also reported post-COVID vaccine. “For Spikevax, there are several specific cases”, specifies the ANSM report. The main difficulty being to detect the first symptoms “which are often non-specific (headaches, joint pain, flu syndrome, nausea, vomiting)“.

In this context, the ANSM continues to observe “patients who present, shortly after vaccination and once the context of reactogenicity has been ruled out, non-specific symptoms which persist in an inflammatory context”.

These cases and attacks on “small vessels” will be subject to very special monitoring.