As part of the increased surveillance of vaccines against Covid-19, a pharmacovigilance survey has been set up to monitor in real time the safety profile of the vaccines available in France, based on declarations from healthcare professionals, vaccinated people or their families.
The results of this assessment and this surveillance were presented on April 14, 2022 in the supervisory committee of the ANSM (National Agency for the Safety of Medicines and Health Products) with the French network of CRPV (Regional Center for PharmacoVigilance) to identify possible signals and, if necessary, examine the actions to be taken.
Adverse reactions reported with the Spikevax vaccine include validated data from March 25, 2022 to April 7, 2022.
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Since the start of vaccination with the Spikevax vaccine (Moderna), 25,314 cases of adverse reactions from the reporting CRPVs (Lille and Besançon) have been analyzed.
First, it is important to emphasize that the results of this study are not alarming given the number of cases monitored. Above all, it reflects the transparency shown by pharmacovigilance in its fortnightly reports.
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Nevertheless, a large number of cases are non-serious local late reactions. As of November 8, 2021, use of the Spikevax vaccine will be restricted to people aged 30 and over. A total of more than 23,571,000 injections have been performed as of April 7, 2022.
After analyzing cases of vasculitis (inflammation of blood vessels), the Committee believes this is a potential signal from the Spikevax vaccine.
Vasculitis is vascular inflammation, more specifically inflammation of the walls of blood vessels.
A total of 26 cases of vasculitis have been reported since the start of follow-up, all with a positive outcome after corticosteroid therapy. The time to onset and the immune-inflammatory mechanism of these events cannot currently rule out a role for the vaccine. These events are shared at European level.
“Due to the severity of certain vasculitides […] the chronological plausibility of the observations obtained in France, which coincide with those published, the study of disproportionality in favor of a risk for vessels of the large-vessel type, but also the possible mechanisms related to inflammation and the immune response to vaccines, particular vigilance is required patients, who show non-specific symptoms shortly after vaccination and after exclusion of the context of reactogenicity, which persist in an inflammatory context.
These observations continue to be closely monitored. These cases, and damage to small vessels in particular, are a potential signal. No other signals were identified during the Spikevax vaccine period.“