Allergic reaction after meningococcal vaccination Nimenrix

14-11-2023

The meningococcal ACWY vaccine Nimenrix rarely causes an allergic reaction, as reported to Lareb. Acute allergic reactions are often serious and should be treated by a doctor immediately. A delayed reaction is usually not serious and does not always require treatment.

An allergic reaction is a hypersensitivity reaction of the immune system to a certain substance, in this case the meningococcal vaccine. Mild complaints include hives and rashes. Serious complaints include shortness of breath, low blood pressure and reduced consciousness. Anaphylaxis occurs if multiple organs are involved and can be life-threatening.

Meningococcal vaccine at 14 years
Since 2018, Nimenrix has been in the National Immunisation Program for children aged 14 years. Children aged 14 months also receive a meningococcal vaccination, but from a different brand since August 2022: MenQuadfi. This signal is only for Nimenrix. There have been no reports of allergic reaction after use of only MenQuadfi.

Reports received by Lareb
From 2018 to the end of August 2023, Lareb received 44 reports of possible allergic reactions after vaccination with Nimenrix. In 32 of those reports, the MMR-vaccine (mumps, measles, rubella) was co-administered. In these reports it is unclear which vaccine provoked the allergic reaction. Out of twelve Nimenrix-only reports, two had an acute allergic reaction. One of them had other allergies in their medical history.

Nimenrix SmPC
Hives, rash and redness are currently mentioned as adverse events in the Nimenrix SmPC, but allergic and anaphylactic reactions are not. Lareb has informed the Medicines Evaluation Board (MEB) about the findings, and they will discuss with the European network to decide whether the SmPC needs to be adjusted.

Read the analysis of the reports here.