The National Agency for the Safety of Medicines and Health Products (ANSM) makes available to the general public and health professionals the first pharmacovigilance data concerning the safety of compulsory vaccines for children under 2 years of age.
Known side effects
Adverse reactions reported are mainly fever, local reactions, persistent crying, transient rash and urticaria. Diarrhea or vomiting have also been reported. For the most severe cases, high fever and/or convulsions as well as episodes characterized by a decrease in muscle tone and a drop in reactivity were most often reported. These adverse effects are known, transient and are mentioned in the vaccine leaflet.
Confirmed safety
Regardless of the study period (2012-2017) preceding the extension of compulsory vaccination and over the first 6 months of its implementation, the adverse effects reported are of the same nature. During the first half of 2018, the safety profile is comparable to that observed in the 2012-2017 data before the implementation of the vaccination extension.
These data confirm the safety of compulsory vaccines for children under 2 years old. Around 1.5 million children are affected by vaccination each year.
 Didier Galibert
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15/07/2019 | 
