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Overview reports on Meningococcal group ACWY vaccine (Nimenrix®)


24 July 2019

  • Since May 1st, 2018, all children aged 14 months in the Netherlands are vaccinated against Meningococcal type ACWY with the vaccine Nimenrix®. The Netherlands Pharmacovigilance Centre Lareb received 698 reports associated with Nimenrix® vaccination. It mainly concerned known ADRs. No serious safety signals were found. 

    Nimenrix®
    In the past, children at the age of 14 months received vaccination against Meningococcal type C. Nimenrix® is a new vaccine for vaccination against Meningococcal type ACWY. In addition to children aged 14 months, children between 14 and 18 years were invited to be vaccinated as well. About 500,000 children have currently been vaccinated with Nimenrix® in the Dutch National Immunisation Program. 

    Reports
    Since registration of Nimenrix® until May 1st 2019, the Netherlands Pharmacovigilance Centre Lareb received 698 reports of adverse drug reactions (ADRs) associated with this vaccine. These were mostly ADRs that are described in the Summary of Product Characteristics (SPC), like fever, injection site reactions, fatigue, headache, fainting, agitation and a decreased appetite.

    Analysis of the reports demonstrated that lymphadenopathy, convulsions, and urticaria can occur after vaccination with Nimenrix®. Convulsions were only seen after vaccination of children aged 14 months. Urticaria is possibly related to a hypersensitivity reaction. These ADRs are expected, but are not described in the SPC of Nimenrix®. The Netherlands Pharmacovigilance Centre Lareb informed the Dutch Medicines Evaluation Board and the National Institute for Public Health and the Environment about these safety signals. 

    Click here  for the analysis of lymphadenopathy and Nimenrix®

    Click here  for the analysis of convulsions al and Nimenrix®

    Click here  for the analysis of urticaria and Nimenrix®