This announcement follows the report last August of numerous cases of narcolepsy in children and adolescents who have been vaccinated with Pandemrix, particularly in Finland and Sweden.
The European Medicines Agency also specifies that Canada, a country in which this type of vaccination is particularly widespread, has not recorded any increase in cases of narcolepsy in adolescents and children.
Pending new results and analyzes, the EMA announces that there will be no modification of the recommendations for the use of the offending vaccine.
The Swedish Medicines Agency launched an investigation on August 18 into possible side effects caused by Pandemrix. This decision was made following numerous reports of symptoms compatible with narcolepsy reported in adolescents aged 12 to 16 years, one to two months after their vaccination against influenza A.
The French Agency for the Safety of Health Products (Afssaps), for its part, reported, on August 26, six cases of narcolepsy cataplexy in French people vaccinated against influenza A (H1N1). However, no link has really been established between the vaccine and the onset of the disease.
Narcolepsy is a neurological condition resulting in daytime sleepiness and muscle weakness.